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The Impact of ‘TRIPS-Plus’ Rules on the Use of TRIPS Flexibilities: Dealing with the Implementation Challenges

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• Mohammed El Said 3  

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Improving the health and well-being of society is a priority to many governments. One essential element within this debate focuses on the accessibility and affordability of medicines for patients. Although interest in this area has persisted for decades, the recent shift in this field is manifested by this now being treated as a global concern, rather than as a regional or a national one. Patients in both developed and developing countries alike are facing the same challenges and are under an increased pressure to access and afford treatment. The recently published UN High Level Panel for Access to Medicines Report explicitly stated its view of ‘access to medicines, vaccines, diagnostics and related health technologies as a serious, multidimensional global problem, with challenges that affect all people and all countries.…the High-Level Panel recognizes that the costs of health technologies are rising globally and are being felt by individuals and by public and private insurance schemes in both wealthy and resource-constrained countries alike’ (UN Secretary General High Level Panel, ‘The United Nations Secretary-General High-Level Panel on Access to Medicines Report: Promoting Innovation and Access to Health Technologies’, (September 2016), 12. https://apps.who.int/medicinedocs/documents/s23068en/s23068en.pdf .). This thinking represents a fundamental departure from the previous approach which classified the problem related to access to medicines as one mainly attributed to developing and least developed nations. It is within this debate that the role of intellectual property protection in general and by way of the rise of TRIPS-Plus agreements and their impact on accessibility and affordability of medicines takes centre stage.

The author would like to thank Professor Graham Dutfield for his valuable feedback and insights on this chapter. The usual disclaimer applies.

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Between Regional Recommendations and National Implementation: An Analysis of the East African Community Partner States’ Legislative Responses to TRIPS Obligations

Olugbenga A. Olatunji

Equitable Access to Medicines, Vaccines, and Medical Devices

Policy approaches to improve availability and affordability of medicines in mexico – an example of a middle income country.

Daniela Moye-Holz, Jitse P van Dijk, … Hans V. Hogerzeil

1 Introduction

There are many factors which impacts the access to medicines debate. Government policy, industrial development, demography, manufacturing capabilities, market conditions and procurement and tax regimes are some factors. However, for some time, the role of intellectual property monopolies especially patents granted to innovator drug companies to protect their research and development (R&D) investments and provide market exclusivity by restricting competition became an integral part of this debate. Footnote 1 This chapter will look at various factors affecting the accessibility and affordability debate and will focus on the role of intellectual property protection in that process. It will provide useful examples of the positive impact arising from the use of the TRIPS flexibilities and on the other hand will explain the dangers affiliated with adopting TRIPS-Plus regimes in this regard. It will also provide examples of practises and strategies which would limit the impact of TRIPS-Plus commitments under national laws.

2 Expensive Medicines: National Implications and Global Challenges

The price of medicines has been on a steady increase for some years. In the US, prices for branded prescription drugs doubled in five years between the period of 2011–2016. Footnote 2 Further, it was projected that the prices of medicines in the US will increase on average 5.8% in 2020. Footnote 3 More than 13% of Americans—about 34 million people—say a friend or family member recently passed away in the last five years after being unable to afford treatment for a condition while 58 million adults report inability to pay for needed drugs in the past year, according to a new poll from Gallup and West Health. Footnote 4 A recent study in the UK found that total National Health Service (NHS) spending on medicines in England has grown from £13 billion in 2010/11 to £17.4 billion in 2016/17—an average growth of around 5% a year. The same study concludes, ‘These figures are uncertain due to gaps in data, but the rate of increase is substantially faster than for the total NHS budget over the same period’. Footnote 5 With the prevalance of the COVID 19 pandamic, pressure on national health providers have reached unprecedented levels.

The year 2019 was phenomenal in terms of setting new high records in medicines prices. In March 2019, the United States Food and Drug Administration (USFDA) approved the most expensive medicine in history up to date called Zolgensma (priced at $2.125 million), a medicine used for a rare disorder that destroys a baby’s muscle control and kills nearly all of those with the most common type of the disease within a couple of years. Other more commonly used medicines’ prices have also been notably high. For example, a 2018 WHO report on cancer medicines concluded that ‘in the absence of insurance coverage, cancer treatment is unaffordable for many patients. A course of standard treatment for early stage HER2 positive breast cancer (doxorubicin, cyclophosphamide, docetaxel, trastuzumab) would cost about 10 years of average annual wages in India and South Africa and 1.7 years in the United States of America. The costs associated with other medical care and interventions (such as surgical interventions and radiotherapy) and supportive care (such as anti-emetics and haematopoietic growth factors) would make overall care even more unaffordable. Even with insurance coverage, patients living with cancer in many countries have reported financial stress, to the extent that they may lower the treatment dose, partially fill prescriptions or even forego treatment altogether’. Footnote 6 In France, in December 2015, the Ligue contre le cancer—which spends around €38 million ($43 million) a year on cancer research, making it the largest French non-governmental funder of cancer R&D—condemned cancer drug prices as ‘exorbitant, unfair and unbearable’ and warned that if unabated, price inflation for new drugs posed a direct threat to the French medical system Footnote 7 while others have expressed that “economic considerations significantly influence and, in some instances, take precedence over the scientific evidence” with relation to French Guidelines on antiretroviral therapy treatment. Footnote 8

Newly developed hepatitis C drugs’ prices have also raised eyebrows. The efficient drug Sovaldi was launched at a list price of $84,000 for a standard twelve-week treatment course, or about $1000 a pill. At the most recent average net price of $45,000 per patient for all sofosbuvir-based products in the US, it would cost $135 billion dollars to treat the estimated three million people with chronic hepatitis C in the US—over one third of total annual spending on all prescription drugs in the US. Footnote 9 In the UK, the list price for a 12-week course of sofosbuvir was nearly £35,000 (excluding VAT) and double that for a 24-week course. Footnote 10 Notwithstanding the high price, in early 2015 sofosbuvir was recommended for funding based on its cost effectiveness. However, because of the budget impact of the treatment, in the following months the NHS England delayed consistent provision of sofosbuvir, instead phasing introduction through the use of quotas and prioritising patients with the most severe need. Footnote 11 From 2012 to 2019, the average price of AbbVie’s rheumatoid-arthritis drug Humira climbed from $19,000 a year to $60,000 a year. Footnote 12

The effects of this are felt in both developed and developing countries. Greater number of patients are now unable to afford medicines while governmental health budgets are struggling to cater for the needs of its citizens, a situation made worse during the COVID 19 pandamic. Henceforth, patients in the developing countries are lacking essential medicines and lifesaving treatments, diabetics have died in the US due to high price of insulin while the Dutch government has had to suspend its acquisition of the immune-oncology drug Keytruda (despite the fact that it helped in its development) because it was too expensive. Footnote 13 The NHS in the UK—a wealthy country which, unlike the United States, has a publicly funded and all-inclusive health service with considerable bargaining power—is having to ration the supply of cancer drugs due to financial restrictions on treatment Footnote 14 while waiting times for those actually offered the treatment are far too lengthy. Footnote 15

3 Unequal Investment and More Monopoly

The problem which high prices of medicines poses should not be viewed in isolation of other contributing factors engulfing this debate. One issue which ranks high within this context is the challenge of inadequate funding for diseases primarily affecting the financially underprivileged or for which the opportunities to make large and long-term profits are considered by the industry to be limited.

Growing criticism has been made regarding the deficiency of the global regime in finding solutions to long standing diseases (or as some refer to as neglected diseases) or the unequal distrbution of COVID 19 vaccines as an example. One visible area of concern is that related to the development of new antibiotics, an issue the WHO have classified as a global challenge in recent years. According to WHO, “No major new class of antibiotics has been discovered since 1987 and too few antibacterial agents are in development to meet the challenge of multidrug resistance.” Footnote 16 One of the main issues related to lack of investment and R&D in this field is attributed to the industry’s fear that resistance to these drugs would develop eventually hence eliminate the usefulness of the drug rapidly which may explain why most major pharmaceutical companies have stopped research in this area, a situation that has been described as a “serious market failure” and “a particular cause for concern”. Footnote 17

In a recently published two reports, the WHO warned about the adverse effects of the declining private investment and lack of innovation in the development of new antibiotics. The WHO further highlighted how this is also undermining efforts to combat drug-resistant infections and diseases. The WHO reports found that the 60 products currently in development (50 antibiotics and 10 biologics) bring little benefit over existing treatments and very few target the most critical resistant bacteria (Gram-negative bacteria). Footnote 18 The Chairman of the UK Review on Antimicrobial Resistance warned recently that, if left unaddressed, drug-resistant infections could be responsible for the deaths of some ten million people a year by 2050, and $100 trillion in economic damage. Footnote 19

Other neglected diseases also share similar challenges and evident lack of investment and innovation. For example, a 2002 analysis of new chemical entities developed between 1975 and 1999 found that only 1.1% were actually treatments devoted to tuberculosis (TB) and tropical diseases, despite them causing 11.4% of the global disease burden. Footnote 20 Although the years between 2000 and 2011 witnessed some improvement whereby of the 850 new therapeutic products registered, 4.4% were for neglected diseases. Footnote 21 However, according to the same study, only 4 of the 336 new chemical entities brought to the market during the same period were for neglected diseases (including malaria)—just 1.2% of the total.

TB which is the biggest infectious disease killer in the world today is another case in point, whereby the death toll alone in 2014 was 1.5 million lives. Until very recently, no new drug was introduced for nearly 50 years . Footnote 22 Furthermore, the last treatment—largely inadequate due to its side effects—developed for Chagas disease (leading cause of infectious heart disease in Latin America) was over 40 years ago.

Ebola also placed the global treatment regime under security. Médecins Sans Frontières (MSF) who often operates within the disease-stricken countries further states that the ‘fact that MSF frontline health workers lacked a treatment or a vaccine for Ebola virus as the outbreak engulfed Guinea, Sierra Leone and Liberia in 2014 is a poignant illustration of this problem. But the problem of inadequate or non-existent treatments and vaccines was a challenge for MSF long before 2014’. Footnote 23 Notably, it was only in late 2019, it was announced that a new vaccine was approved in the US and EU for Ebola. Footnote 24

4 The Double Taxation of Society

One of the strongest criticisms against pharmaceutical companies is the way they engage in business activities and R&D operations. It is vital to acknowledge that innovator pharmaceutical companies need incentives to protect their investments. Yet to what extent that should be sought at the expense of public health policy concerns is questionable. The high prices of medicines does not only have a negative effect regarding accessibility, but have also attracted criticism due to the fact that a vast number of medicine discoveries and some of the subsequent drug development, or indeed much of it in some cases, was funded by tax payers. The situation is made worse by anticompetitive behaviour of some of these companies.

It is no secret that the governmental levels of financial and technical support for biomedical innovations are considerable. The public sector makes substantial contributions to research and development upfront, through grants, subsidies and tax credits. In fact, some studies suggest that 30% of the estimated $240 billion yearly total global investment across all health R&D comes from the public sector. Footnote 25

Several cases illustrate this, including Truvada. The drug was initially developed and patented by the US government after the Centers for Disease Control and Prevention (CDC) received $50 million in federal grants in addition to $7 million from the Bill and Melinda Gates Foundation in 2015. However, the government did not receive any income and no improvement in terms of accessibility rates was observed (it is believed that less than 10 percent of the 1.1 million people who should be on treatment are receiving it) despite the fact that Gilead Sciences the maker of the drug earned $3 billion in sales in 2018 prompting the US government to initiate legal action against Gilead. Footnote 26

Moreover, a study found that during the past four decades, 153 new FDA-approved drugs, vaccines, or new indications for existing drugs were discovered through research carried out in public sector research institutions (PSRIs). It was reported that these drugs included 93 small-molecule drugs, 36 biologic agents, 15 vaccines, 8 in vivo diagnostic materials, and 1 over-the-counter drug. More than half of these drugs have been used in the treatment or prevention of cancer or infectious diseases. Footnote 27

Similar trends are observed elsewhere outside the US. In 2017, campaigners in the UK claimed that the NHS spent more than £1 billion on drugs developed from publicly funded research in 2016. A report published by campaign groups Global Justice Now and Stop Aids claimed that UK tax payers and patients worldwide are being denied the medicines they need, despite the public sector playing a pivotal role in the discovery of new medicines. It concluded that ‘In many cases, the UK taxpayer effectively pays twice for medicines: first through investing in R&D, and then by paying high prices for the resulting medicine once ownership has been transferred to a private company.’ Footnote 28 The report cites several examples of drugs which received public funding but now are out of the reach of majority of patients. For example, the report explains how Alemtuzumab was originally developed at Cambridge University and first approved for the treatment of B-cell chronic lymphocytic leukaemia (B-CLL). Cambridge scientists then led further investigations of its usefulness, at a smaller dosage, in treating multiple sclerosis (MS). Sanofi Genzyme, who had acquired the rights to the drug, removed it from the market as a B-CLL medicine and re-launched it as a medicine for MS. The Report verifies that ‘At the time of withdrawal there was speculation that the exercise was motivated by commercial reasons. When it was used off-label (i.e. used for a non-licenced purpose) for MS prior to being withdrawn from the market, the price in the UK was around £2,500 per MS treatment course in 2012’. In 2017, it costs was £56,000 per treatment course—a 22-fold increase. Footnote 29

On the other hand, several anticompetitive practises have had a far-reaching impact on prices. Even when there are opportunities to reduce prices, we find that this is not taken advantage of (and even intentionally delayed). A recent study found that of the more than 1600 generic drugs approved by the FDA since January 2017, more than 700—or 43 per cent—are not for sale in the US. Footnote 30

Delaying tactics have also incurred huge costs on society. One study estimates that the American health system is poised to incur $55 billion during the next 15 years on three drugs (related cancer and hepatitis C treatment) alone due to patents blocking and delaying the entry of generic competition on these drugs only. Product lifecycle management, whereby branded companies obtain unmerited patents to delay competition, Footnote 31 is the primary strategy identified and evaluated by this study. The study also highlights that another related strategy is “pay-for-delay” whereby branded companies pay generics to stay off the market for some time. Footnote 32

5 More Pharmaceutical Patents, Weaker Innovation

An equally troubling development which has contributed to the increase in medicines prices and extended monopoly patent terms in recent years is the increase in the number of drug patents granted, particularly those ‘inventions’ which are of a low and inferior quality, or as may be referred to as frivolous/trivial patents. This process is leading to what is referred to as the ‘evergreening’ of drugs. Footnote 33

This development may be explained by looking at some national statistics in this regard. For example, it was found that between the years 2006 and 2016, the number of drug patents granted in the US doubled. The granted patents were mainly dedicated to accumulating patents not for new medicines but rather for small changes to existing ones, which allows them to build and extend monopolies, block competition and drive prices up. Footnote 34 Moreover, on the 12 best-selling drugs in the US, drug makers have filed an average of 125 patent applications and have been granted an average of 71 patents for each. Footnote 35 Another study found that 74 applications have been filed on Lantus (it is a man-made form of a hormone (insulin) that is produced in the body which works by lowering levels of glucose (sugar) in the blood) only in the US, which have the potential to delay competition for 37 years. Footnote 36 This kind of “over patenting” blocks competition and enables pharmaceutical companies more freedom to regulate the pricing market of medicines. Footnote 37

Elsewhere the findings are similar. A study in Australia found an average of 49 secondary patents granted for each of the 15 highest-cost drugs over a 20-year period. One-quarter of these secondary patents were believed to be evergreening patents. Footnote 38 The Office of Patented Medicines and Liaison at the Therapeutic Products Directorate of Health Canada estimates that 44% of the 419 medicines on the Patent Register are covered by more than one patent. Footnote 39

Moreover, an EU investigation concluded in 2008 that out of the 219 molecules in the sample under the investigation, originator and generic companies identified at least 1300 patent-related out of court contacts and disputes concerning the launch of generic products in the period 2000 to 2007. The vast majority of disputes were initiated by the originator companies, which most often invoked their primary patents, e.g. by sending warning letters. In this respect the inquiry finds that individual medicines are protected by up to nearly 100 product-specific patent families, which can lead to up to 1300 patents and/or pending patent applications across the Member States. Despite the lower number of underlying patent families based on European Patent Office (EPO) applications, looking from a commercial perspective, ‘a challenger may, in the absence of a European Community patent, need to analyse and possibly confront the sum of all existing patents and pending patent applications in those Member States in which the generic company wishes to enter’. Footnote 40

Elsewhere, another analysis found of the 1015 new drugs and indications approved in France between 2004 and 2013, only 6.3% offered a clear therapeutic advantage, almost none were considered breakthroughs, and the majority (69.3%) offered no clear therapeutic benefit or were prematurely approved even though their clinical evaluation showed them to be more harmful than beneficial. Footnote 41 A second analysis found that 85 to 90% of new products approved over the last four decades have provided only limited benefits. Footnote 42 A third study that looked not just at registered products, but specifically at new chemical entities and new biologics, found that the majority of those launched in the UK between 2001 and 2012 were only “slightly innovative” and only a quarter (26%) were believed to be “highly innovative”. Footnote 43

Rather than using the patent regime as an incentive to innovate and recoup investment for worthy inventions, ‘evergreening’ tactics and practises are in fact blocking accessibility and weakening innovation capabilities by undermining the true foundations of the patent regime and turning it into monopoly creator with no positive contribution to society’s needs. Footnote 44

6 Increased IP Standards: From TRIPS-Minus to TRIPS-Plus

The global regulation of intellectual property rights is a relatively modern concept. Prior to the creation of the World Trade Organization (WTO) in 1996, countries had considerable policy space and full discretion in designing their national intellectual property legal regimes in accordance with their development stage and national priorities. Footnote 45 As such, a large number of countries did not award legal protection to patents related to drugs and pharmaceutical products. Footnote 46

This was no longer the case with the creation of the WTO. The Agreement on Trade Related Aspects of Intellectual Property Rights (the TRIPS Agreement) Footnote 47 obligated member states to provide legal protection for inventions in all technological fields including pharmaceutical products. This was an important development whereby for the first time in history, countries lost the ability to regulate their national intellectual property regimes freely and in accordance with their national development plans.

Reaching consensus regarding the TRIPS agreement was not a simple act. The intellectual property negotiations during the Uruguay Round of Trade Negotiations were amongst the most contentious and complex. As such and in order to strike a balance between the rights of users and intellectual property holders on the one hand, and the society on the other, several ‘flexibilities’ were introduced within TRIPS in order to curtail the negative impact which may arise from excessive intellectual property protection and at the same time to enable countries to deal with their public health challenges and emergencies.

6.1 The Flexibilities Explained

The TRIPS ‘flexibilities’ may best be explained as options available to member states allowing them to comply with the TRIPS Agreement requirements and at the same time maximise the implementation space available to them in accordance with their priorities. Footnote 48 Following are some examples of the health-related flexibilities available under the agreement to member states:

Transitional periods. According to the WTO, least developed countries (LDCs) are given an extended transition period to protect intellectual property under the WTO’s TRIPS Agreement. This is in recognition of their special requirements and status, their economic, financial and administrative constraints, and the need for flexibility so that they can create a viable technological base. Several extensions of the transition period were provided by the TRIPS Council. The last 6th of November 2016 Council decision extends until January 2033 the period during which key provisions of the WTO’s intellectual property agreement, the TRIPS Agreement, do not apply to pharmaceutical products in LDCs. Footnote 49 This means LDCs can choose whether or not to protect pharmaceutical patents and clinical trial data before 2033. The decision also keeps open the option for further extensions beyond that date. Footnote 50

Compulsory licensing. A tool through which the state authorizes a third party to exploit patented inventions, generally against a specified royalty paid to the patent holder provided that several conditions set under the TRIPS Agreement (Article 31) are complied with. The objective behind this is to curtail anti-competitive behaviour and ensure the transfer of technology and dissemination of knowledge. Footnote 51

Government use exceptions. A tool which grants the state the right to use the patent without obtaining the consent of the patent holder for the purpose of public interest, including public health necessities. Although government use conditions are similar to compulsory licensing, government use exceptions provide an added advantage by fast-tracking the process, through granting the government the right to use the pharmaceutical patent without the need for prior negotiations with the owner.

Parallel importation. This tool gives the option to member states to obtain patented products when they are lawfully available in a foreign market at a lower price, thus enabling countries to shop for cheaper patented products. This requires as a prerequisite that a country adopt an exhaustion regime suitable to its needs and priorities. Footnote 52

Exceptions to patents rights. Article 30 of TRIPS provides that members “may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.” Footnote 53 However, the above provision does not define the scope of the permissible exceptions thus awarding member countries some considerable discretion to operate. Examples of these exceptions include the Bolar exception Footnote 54 and the research and experimental use exception.

Standards of patentability. Under TRIPS, patent protection must be granted for products and processes which are new , involve an inventive step and are industrially applicable . Footnote 55 However, each of these are not defined and can be interpreted and applied by member states in accordance with their national priorities and objectives. For example, TRIPS do not specify the patenting of new uses of known products, including pharmaceutical drugs, thus allowing member countries the possibility of rejecting these new uses for lack of novelty, inventive step or industrial applicability.

Other procedural flexibilities . Another identified policy tool that may be used to improve the quality of granted patents and limits “evergreening” is pre-grant and post-grant patent oppositions, in addition to patent revocation proceedings. These methods have been used at different times in a wide range of developed and developing countries. Such proceedings enable interested parties to bring claims before the patent office on the basis that a particular patent does not meet local requirements.

6.2 Putting the Flexibilities into Use

We now have a considerable body of literature and empirical research dedicated to the benefits of utilising the TRIPS Agreement’s flexibilities under national laws. Despite this, some would still argue that the use ‘of the TRIPS flexibilities has been sporadic and limited’ Footnote 56 and that more could still be achieved in this regard. Footnote 57

A much widely affiliated issue with the use of the flexibilities is the issue related to the impact of generic drugs entry into the market and the savings achieved as a result. In many cases, this is enabled by the flexibilities effect in curtailing ‘evergreening’ and in opposing low quality patents. As such, it is common to see medicine prices dropping substantially (ranging between 30–90 percent in some cases) when generic medicines enter a market following the expiry of a patent. Footnote 58

Compulsory licensing is the most used flexibility in this regard. Footnote 59 There is no scarcity of evidence with relation to the positive impact compulsory licensing has had upon improving access to medicines. Malaysia was one of the latest countries to issue a “government use” compulsory license to obtain much cheaper version of a generic version of the famously known hepatitis C medicine Sofosbuvir in September 2017. It is believed that compulsory license issuance have enabled treatment cost at RM1000 to RM1200 ($240–$285) for 12 weeks course, compared to RM300,000 (approx. $72,000) which was the cost of treatment with the patented version and prior to issuance of the license. Footnote 60 Moreover, it was reported that between 2013 and 2017, the Ecuadorian Institute of Intellectual Property (IEPI) issued ten compulsory licences for various medications including antiretroviral drugs. Footnote 61 According to health officials in Ecuador, the compulsory licenses granted between 2013 and 2014, generated the potential for savings of 23 per cent to 99 per cent. Footnote 62 Similar findings may also be found in the case of other compulsory licenses issued by Thailand, India, Indonesia, Brazil and Columbia. Footnote 63

One of the other important flexibilities available to countries is related to the issue of patentability standards. As highlighted, member countries have a wide discretion and freedom to apply and define the patentability criteria of an invention under their national regime. As such, India has applied a strict patentability criteria aimed towards limiting the number of frivolous or secondary pharmaceutical patents granted. Footnote 64 Although we cannot measures the direct price impact this will have on medicines nevertheless it is believed that the utilisation of this flexibility have a substantial impact in preventing patent abuses and the granting of low quality patents (anti-evergreening strategy). Footnote 65 Other countries such as China and Philippines are following a similar approach to the Indian one in this regard. Footnote 66

Egypt provides an interesting case as well. The country is home to the highest rate of HCV infections in the world. The Egyptian’s Patent Office practise won praise couple of year ago when it rejected one of Sofosbuvir patent applications through its application of a strict patentability criteria. This allowed a local generic producer to produce the drug for less than $200 per 12-week treatment. Footnote 67

Parallel importation is another flexibility already used by several countries with positive results. For example, six African countries (Ghana, Kenya, Mauritius, Namibia, South Africa and Zimbabwe) have incorporated an international exhaustion regime in their laws, allowing parallel imports from anywhere in the world. More specifically, Kenya has actively and effectively used parallel importation to improve access to antiretroviral medications. Footnote 68

Opposition procedures have been applied usefully and efficiently in several countries. This issue is posed to gain more importance due to the increased volume of pharmaceutical patents granted worldwide. To give a glimpse, it is believed that current estimates suggests that at least 27% of current patents would be found invalid by US courts due to low quality. Footnote 69

There are many more examples of the use of the flexibilities by both developed and developing countries which this chapter will not delve into. However, a number of observations could be made about the efficient and successful use and implementation of these flexibilities under national regimes. First, the need for a proactive national legislature is fundamental for the success of this process. Although these flexibilities are available under the international intellectual property regime, their implementation would not take place directly without legislating—in details—them under national laws and regulations. Second, awareness about the existence of these flexibilities is vital for their utilisation. Thirdly, the need for an engaged public, national entities and active civil society is essential for the success of this process as demonstrated by many thus far. Lastly, independent and highly trained judiciary is vital in the process of implementation and interpretation of these flexibilities under national legal frameworks.

6.3 The Shift Towards TRIPS-Plus

The TRIPS Agreement was subsequently used as a platform for further regulation of intellectual property rights globally. Although the initial understanding of developing countries was that TRIPS would put an end to unilateralism and coercion in the regulation and enforcement of intellectual property by developed countries particularly the United States, that vision turned out to be misguided. Within a short period of time following the creation of the TRIPS Agreement, a new generation of bilateral and regional Free Trade Agreements (FTAs) started to emerge, with a far-reaching WTO-Plus agenda.

With relation to intellectual property, FTAs often contained dedicated chapters incorporating extensive intellectual property provisions which often include TRIPS-Plus obligations going beyond those required by the TRIPS Agreement. These TRIPS-Plus obligations restricted the available policy space of member states and gradually eliminated the options and flexibilities available to them under the TRIPS Agreement. Footnote 70 Although the full impact of these TRIPS-Plus agreements is yet to materialise, we already have a considerable and rather frightening understanding—as will be explained in the next part of this chapter—about the negative impact these agreements have on affordability and accessibility to medicines.

6.4 Impact and Examples of TRIPS-Plus Obligations

Before looking into the negative impact of TRIPS-Plus, it would be helpful to understand how do FTAs increase intellectual property protection levels beyond the TRIPS standards? An important objective of TRIPS-Plus obligations is to limit the use of the flexibilities available under the international intellectual property regime thus making it more difficult to utilise such flexibilities. There are a number of areas where this may take place with relevance to patents and public health. These include the following examples:

Expanding the scope of pharmaceutical patents and creating new drug monopolies: this is achieved through a number of ways such as:

lowering the patentability standards,

requiring patents be available for surgical and treatment methods,

minor variations on old medicines, new and second uses, and Footnote 71

Further extension of protection to biological products which include vaccines, blood and blood components, and gene therapies in addition to other forms of protection.

Extension of monopolies by extending patent terms if review at the patent office or regulatory authority failed completion within a certain period of time.

Risk facilitating patent abuse by requiring countries to condition marketing approval on patent status (patent linkage).

Protection and Extension of “data exclusivity”: by providing at least 5 years exclusivity for information related to new products and 3 more in cases of new uses for old medicines—even when that information is disclosed and available in the public domain. More recent FTAs have also provided 10 years of “effective market protection” for biologics. Footnote 72

Prohibition/restriction pre-grant oppositions —forbid challenges to weak or invalid patents until after they have been granted.

Regulate the decisions to reimburse new drugs: this gives drug companies new rights to challenge decisions on reimbursements if not favourable as currently proposed under the Transatlantic Trade and Investment Partnership (TTIP).

Require new forms of intellectual property enforcement–grant: customs authorities detaining shipments, including in-transit shipments, suspected of non-criminal trademark/copyright/patent infringements; require mandatory injunctions for alleged intellectual property infringements; raise damages amounts, etc.

Introducing Investor-State Dispute Settlement (ISDS) procedures: this leads to bypassing the WTO’s multilateral dispute settlement procedure and opting for a more pro-investment one. This development has been highly controversial as this grant private investors considerable power, especially big multinational corporations, to claim high amounts of money of compensation from investor sympathetic tribunals. Indirectly, this questions the impact of these claims on states’ power to regulate in the public interest, in order to safeguard public health priorities. Other flaws of the ISDS system include the lack of consistency in decision making and the huge costs incurred. There is now growing evidence that the threat of using these ISDS procedure is enough to obligate countries to change their policies. Footnote 73

The undisputed recommendation in this regard from a public health perspective remains that countries should avoid entering into arrangements which obligates them to apply TRIPS-Plus standards under national law. As states by UNDP and UNAIDS: Footnote 74

Countries at minimum should avoid entering into FTAs that contain TRIPS-plus obligations that can impact on pharmaceuticals price or availability. Where countries have undertaken TRIPS-plus commitments, all efforts should be made to mitigate the negative impact of these commitments on access to treatment by using to the fullest extent possible, remaining public health related flexibilities available.

The thus far realised impact of TRIPS-Plus obligations on public health and access to medicines is frightening upon both developed and developing nations. Footnote 75 In one of the first studies ever conducted on the impact of TRIPS-Plus obligations, a 2007 Oxfam study on the effect of the US-Jordan FTA found that since 2001 (which is the year the FTA was signed with the US), the prices of medicines in Jordan have increased by 20% (this led to price increases between two and ten-fold for key medicines to treat cardiovascular disease and cancer), and data protection provisions has resulted in delaying generic drugs entry for 79% of medicines newly launched between the years 2002 and 2006. Footnote 76 The study estimates that the availability of generic equivalents would have reduced Jordan’s expenditure on medicines by $6.3 and $22 million between mid-2002 and 2006. Footnote 77 The study also shows that no real know-how transfer has occurred in the country despite the rhetoric that FTAs would in fact encourage the flow of know-how and Foreign Direct Investment (FDI).

Although the 2007 Oxfam study was conducted under less than 5 years of the FTA implementation, we came a long way since then in terms of assessing and understanding the impact of FTAs on accessibility and affordability of medicines. More and more studies are affirming and exposing the negative impact of these obligations on public health and access to medicines.

Amin and Keselheim conducted a study on the impact of ‘evergreening’ resulting from the granting of secondary patents. The authors concluded that secondary patents could extend market exclusivity and thus delay generic competition from entering the market for many years. The study identified 108 patents related to two HIV medicines (ritonavir (Norvir) and lopinavir/ritonavir (Kaletra)) which impact could delay generic competition until at least 2028. This is a twelve years additional period after the expiration of the patents on the drugs’ base compounds and thirty-nine years after the first patents on ritonavir were filed. Footnote 78

For instance, research by Lexchin concluded that extension of legal protection in data protection for biologics have resulted in increase in spending in drug expenditure in Canada. He estimated the lost savings from data protection extension to range from $0 to $305.8 million. Footnote 79 Another study in Australia found: Footnote 80

At the time that the EOT [extension of the term] was introduced, the annual cost to the Pharmaceutical Benefit Scheme (PBS) was estimated to grow from $6 million in 2001-02 to $160 million in 2005-06. This cost arises because there is a delayed entry to the PBS of cheaper generic drugs. The estimate for 2012-13 is around $240 million in the medium term and, in today’s dollars, around $480 million in the longer term. The total cost of the EOT to Australia is actually about 20 per cent more than this, because the PBS is only one source of revenue for the industry.

Another study conducted by the Australian Generic Medicines Industry Association analysed the costs to the health system for 39 PBS-listed medicines for which generic competition was delayed after the patent on the active pharmaceutical ingredient expired, as a result of secondary patenting found that in the 12 months to November 2012, the cost of delayed generic launch was calculated at $37.8–$48.4 million. Footnote 81 This estimate does not include subsequent price reductions due to price disclosure. Another study estimated the costs of patent extensions to the PBS in 2012–13 at about $240 million in the medium term and about $480 million in the longer term. Footnote 82 It was also found that data protection had no impact on the levels of pharmaceutical investment in the country as highlighted with the case of the US FTA with Jordan.

There has been much more work conducted recently in terms of alerting to the negative impact of the highly controversial Trans-Pacific Partnership Agreement (TPPA) agreement in this regard. Footnote 83 The TPPA which is widely promoted as a “model for 21st century trade agreements” is a comprehensive trade and investment deal covering many areas including trade, investment, labour and intellectual property rights in in addition to its investor-state dispute settlement procedure. Footnote 84 Brook concludes that ‘Provisions in the Intellectual Property (IP) Chapter of TPP lengthen, broaden, and strengthen patent-related monopolies on medicine and erect new monopoly protections on regulatory data as well. IP Chapter enforcement provisions also mandate injunctions preventing medicines sales, increase damage awards, and expand confiscation of medicines at the border’. Footnote 85

In comparing the TPPA with similar agreements, a study found that the US-Mexico-Canada Agreement’s (USMCA) intellectual property chapter is closely based on the corresponding chapter of the TPPA, but includes 10 years of “effective market protection” for biologics in addition to including a broader definition of biologics, potentially expanding the array of drugs which will be eligible for this longer period of exclusivity, longer than the period negotiated in the TPPA. Footnote 86 For Canada, this will increase the period of market protection for biologics by 2 years; two studies of the potential impact on pharmaceutical expenditure (using different methods and based on different assumptions) have estimated the savings foregone at between CDN$0 and $305.8 and up to CDN$169 by 2029. Footnote 87

7 What Could Be Done and What Is Done?

As explained, we have a considerable wealth of empirical research about the positive impact of TRIPS flexibilities use and the negative impact of TRIPS-Plus obligations on the health care and access to medicines regimes in several developed and developing countries. However, it has been more difficult to observe how countries with TRIPS-Plus regimes have in fact attempted to utilise the remaining policy space available to them in order to mitigate the negative impact these TRIPS-Plus rules have on their national health care regimes. This is so primarily due to the difficulty in observing national practises and the lack of international jurisprudence arising from disputes about the implementation of these obligations (or rather about if such an implementation was in line with international norms or otherwise) under national frameworks.

In addition, it should be realised from the outset that the effect of TRIPS-Plus commitments will vary from each country and will depend on many factors, including market side, pharmaceutical protection capacity, development of legal regime, judiciary and so forth.

Nevertheless, and despite the above-mentioned difficulties, by looking into several cases, we have been able to observe some important contributions in this regard. The important aspect in this case is to continue applying and implementing a nationally creative thinking and interpretive policy aimed towards limiting the negative impact of the committed TRIPS-Plus rules. Following are examples of a number of national experiences of how countries attempted to limit the negative impact arising from TRIPS-Plus obligations.

7.1 Australia

One of the countries which have taken several serious steps in this field is Australia. This is because the country has agreed to a TRIPS-Plus obligations regime arising from the US-Australia FTA Footnote 88 which had a huge cost on the national health budget and the accessibility and affordability of medicines. Accordingly, in 2013, Footnote 89 the Australian legislator (following national consultation) introduced a number of reforms aimed towards mitigating the effects of the ‘evergreening’ of patents starting with applying a stricter patentability criteria by removing any geographical limitation upon the common general knowledge and by removing the requirement for a prior art document to be “ascertained”. Footnote 90 The effect of this is to require a higher and more consistent inventive step standard for Australian patents granted in the country.

Another area tackled by the Australian legislator is the issue of patent term extension granted in order to compensate for the delays during marketing approval as dictated under the FTA with the US. Footnote 91 To start with, the 2013 Patent Law reform attempted to limit the possibilities of allowing patent term extension by further confining such type of extensions to certain and specific categories of products related to patents claiming new active ingredients or formulations only. Footnote 92

Moreover, the Australian 2013 Patent Law reform imposes additional substantive conditions specifically applicable for the extension of patent duration for “pharmaceutical substances.” Based on this, the extension of the term is possible only if either or both of the following conditions are satisfied: Footnote 93

one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;

one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.

In addition, both of the following conditions must be satisfied in relation to at least one of those pharmaceutical substances:

goods containing, or consisting of, the substance must be included in the Australian Register of Therapeutic Goods;

the period beginning on the date of the patent and ending on the first regulatory approval date for the substance must be at least 5 years.

(4) The term of the patent must not have been previously extended under this Part. Meaning of first regulatory approval date.

More reforms were introduced with relation to opposition procedures as well. As such, detailed and expansive opposition grounds against patent term extension procedures were included under the 2013 Patent Law reform. Accordingly, Article 78 of the Patent Law states:

If the Commissioner grants an extension of the term of a standard patent, the exclusive rights of the patentee during the term of the extension are not infringed:

by a person exploiting:

a pharmaceutical substance per se that is in substance disclosed in the complete specification of the patent and in substance falls within the scope of the claim or claims of that specification; or

a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology, that is in substance disclosed in the complete specification of the patent and in substance falls within the scope of the claim or claims of that specification; for a purpose other than therapeutic use; or

by a person exploiting any form of the invention other than:

a pharmaceutical substance when produced by a process that involves the use of recombinant DNA technology, that is in substance disclosed in the complete specification of the patent and in substance falls within the scope of the claim or claims of that specification.

Patent linkage is another TRIPS-Plus issue whereby Australia’s approach may provide some valuable lessons for others. Article 17.10.4 (in the Intellectual Property chapter) of the US-AUS FTA provides for an attenuated or ‘weak’ form of patent linkage with relation to two aspects as explained by Son et al: Footnote 94

measures in the marketing approval process to prevent a third party from marketing a product during the term of a patent without the consent of the patent owner; and

no provision for the owner to be notified of a marketing approval request made during the term of a patent. This wording provided scope for Australia to implement a patent linkage mechanism in a very different way to the United States.

In addition, the Australian regime excludes from protection patents covering (1) the drug substance, (2) the drug product including composition and formulation, and (3) the approved use from the patent linkage mechanism. Footnote 95 Penalties for providing false or misleading information, however, are disproportionately higher for a patent holder certificate than for a generic producer certificate. Moreover, Australia’s Pharmaceutical Benefit Scheme (PBS) imposes automatic and irreversible price cuts on medicines as soon as competing versions enter the market, this often incentivise generic companies to launch faster at risk, and innovator companies must pursue preliminary injunctions in order to resolve patent disputes. Footnote 96 At the same time, since 2012, Australia’s Department of Health has pursued market-sized pecuniary damages (on top of those sought by the generic company) aimed at compensating for a delay in the PBS price reduction that would have been applied to a patented medicine during the period of a provisional enforcement measure. Footnote 97 However, there is no corresponding mechanism for the government to compensate innovators for the aforementioned losses if an infringing product is launched prematurely. Footnote 98

Although such reforms are vital, they should not be viewed as the only solutions to the accessibility of medicines challange and therefore the intellectual property regime should be viewed as one of several components and government strategies—one element of an eco-system—in this regard which would improve accessibility and affordability of medicines. For an example, in February 2019, the Australian government signed a five-year deal with pharmaceutical companies, involving a lump sum payment of about $ 766 million for an unlimited five-year supply of the most advanced Hepatitis C (HCV) drugs. Footnote 99 This innovative approach which has been called the “subscription” or “Netflix” model, have reduced the per-patient costs of these cutting-edge treatments by roughly 85% in the country. Footnote 100

Chile also proved an interesting case of a developing country which adopted a TRIPS-Plus regime as a result of signing an FTA with the US in 2006 (the US-Chile FTA). Following a rigorous national debate with relation to the negative effect of data exclusivity and patent linkage included under the FTA, the Chilean government amended the patent law by limiting the availability of data protection under its national law to those pharmaceutical products that have been marketed in the national territory in the year after the grant of marketing approval and therefore if the drug was not marketed within a year, the test data submitted for approval purposes will not be protected. Footnote 101 The rationale behind such a requirement is to encourage early registration of drugs after first registration abroad, so that the period of protection for the pharmaceutical test data starts early.

In addition, the law excluded several elements from the scope of protection. Accordingly, article 91 of the Chilean law states:

The protection of this Paragraph shall not apply when:

The owner of the test data referred to in Article 89 has engaged in forms of conduct or practices declared as contrary to free competition in direct relation to the use or exploitation of that information, according to the final decision of the free competition court.

For reasons of public health, national security, non-commercial public use, national emergency or other circumstances of extreme urgency declared by the competent authority, ending the protection referred to in Article 89 shall be justified.

The pharmaceutical or chemical-agricultural product is the subject of a compulsory license, according to what is established in this Law.

The pharmaceutical or chemical-agricultural product has not been marketed in the national territory after 12 months from the health certificate or clearance granted in Chile.

The pharmaceutical or chemical-agricultural product has a health certificate

Furthermore, Chile implemented the linkage obligation established by the US-Chile FTA through the provision of information to the patent owner about a third party intending to commercialize a product with similar characteristics to one that is already patented. Footnote 102

The aim of these measures is to explore whatever policy space remains available to the country in order to restrict the application of data exclusivity.

7.3 What Others Are Doing and How They Are Doing It?

There are many examples of interpretations and flexibility use taking place regularly in different parts of the globe. Footnote 103 These developments are either legislative, administrative or judicial in nature. Calls are made for countries to take advantage of the remaining policy space in this regard and share their experiences with others. Following are some non-exhaustive recommendations.

Several recommendations were made more with connection to data exclusivity obligations. As a result, it is advisable for those regimes’ committing to TRIPS-Plus data exclusivity provisions not to grant protection unless a specific application is made (within a specific period—no more than 6 months—of time after the first approval in the world of a medicine) and where certain conditions are met. Countries may also charge for these applications and require annual maintenance fee (such as those applicable to trademarks). In addition, detailing when protection will terminate is recommended. Correa suggests the following situations as examples: Footnote 104

When the right-holder or a person authorised by him does not commercialise the approved product in a manner sufficient to supply the demand within a period (e.g. twelve months) from the date of approval for commercialisation or when the commercialisation is interrupted, for more than x consecutive months (e.g. six months), except in cases of force majeure or government’s acts that prevent such commercialisation.

For public interest reasons such as national security, emergency or circumstances of extreme urgency that justify the termination of the period of exclusivity.

When, as a result of administrative or judicial procedures, it is determined that the right-holder has abused his rights, for example, through practices declared as anticompetitive.

Keeping health out of the FTA agenda is one right step in this regard. We can observe some positive steps taken in this area. The recently concluded FTA between Australia and Peru have explicitly excluded public health measures and/or specific health programs from its scope. Article 8. 16 of the FTA states: Footnote 105

Nothing in this Chapter shall be construed to prevent a Party from adopting, maintaining or enforcing any measure otherwise consistent with this Chapter that it considers appropriate to ensure that investment activity in its territory is undertaken in a manner sensitive to environmental, health or other regulatory objectives.

Compulsory licensing in TRIPS agreements is stated with ambiguous wording such as ‘national emergency’, ‘other circumstances of extreme urgency’, and ‘public non-commercial use’. To deal with this ambiguity, active interpretations of these terms should be persued. In this context, the Thai experience is noteworthy. The legislator there defined public non-commercial use as ‘nutrition and public health service’ and ‘protection of natural resources and environment’. Also, the legislater interpreted the non-use of a patent as ‘insufficient use of a patent due to the high price’ and ‘severe shortage of food and drugs’. Footnote 106

It is worth noting that the above referred to examples should not emanate from separate national initiatives but rather as a part of a more comprehensive approach dealing with public health challenges within these countries. As seen, several developed countries acknowledge today the negative consequences to TRIPS-Plus rules on public health and have taken steps to rectify the situation. Developing countries should follow suit and take serious notice of such implications.

8 Final Thoughts

The world is at a crossroads. At the time of completion of this chapter, the world was struggling in confronting the outbreak pandemic of the Corona virus (Covid-19). Although several vaccines are available today, the daily loss of life is having grave ramifications for the global economic and public health regimes. These outbreaks are not new, however how we deal with them will depend on our ability to access and grant funding for those working around the clock to find a cure. The intellectual property regime needs reorientation to become truly an incentive rather than an impediment to accessibility and treatment.

Some final thoughts could be made here with relation to supressing the impact of TRIPS-Plus conditions on access to medicines within the framework of trade and investment agreements. First, comprehensive assessment of the health impact of FTAs and TRIPS-Plus commitments should be undertaken by policy makers and negotiators. This should take place before an agreement is entered into. Second, public and stakeholder engagement and collaboration is needed and should be a priority. A national intellectual property committee with authorities and mandates should be tasked with implementing a balanced national intellectual property Agenda. Alternative and new business models for research and development are needed to achieve better pricing of medicines. Push, pull and pooling strategies should be given more thought and experimented with in this regard. Footnote 107 Finally, transparency in drug pricing is pivotal to ensure that (i fair compensation is granted to those who invest in finding medical solutions to diseases, and (ii affordable drug prices are applied so that patients can afford them. The 2019 World Health Assembly’s resolution supporting greater public disclosure of prices for medicines and other health products is a step in the right direction. Footnote 108

The legal recommendation stands today the same as before; governments should resist accepting and introducing TRIPS-Plus obligations even if others do so. At the same time, those who committed to such obligations should undertake a thorough review in order to identify areas where they can still utilise the TRIPS Flexibilities. We may not be able to stop the spread of TRIPS-Plus commitments around the globe; however, we should try and do our best to slow down the process of eroding the remaining policy space.

It should be highlighted that there are also other regulatory regimes and intellectual property exclusivities—apart from patents—aimed towards extending protection including those protecting use of test data, various regulatory linkages, and also trademarks covering not just names but also shapes and colours.

MSF ( 2016 ). http://apps.who.int/medicinedocs/documents/s23020en/s23020en.pdf .

In 2019 more than 50 companies raised the prices on hundreds of drugs in the US by an average of more than 6%, according to the analysis. Hopkins explains that the price of rheumatoid arthritis treatment Humira, the world’s top-selling drug, was raised by 7.4%. Similarly, heparin products—which are generic blood thinners typically administered in hospitals—prices rose by 15%. For more see Hopkins ( 2020 ) < https://www.marketwatch.com/story/drug-prices-rise-58-on-average-in-2020-2020-01-02 >.

Gallup and West Health ( 2019 ). https://news.gallup.com/poll/268094/millions-lost-someone-couldn-afford-treatment.aspx?version=print .

The King’s Fund ( 2018 ) https://www.kingsfund.org.uk/sites/default/files/2018-04/Rising-cost-of-medicines.pdf .

WHO ( 2018 ), p. xi https://apps.who.int/iris/bitstream/handle/10665/277190/9789241515115-eng.pdf?sequence=1&isAllowed=y .

Sciences Avenir with AFP ( 2015 ). http://www.sciencesetavenir.fr/sante/cancer/20151216.OBS1499/la-ligue-contre-le-cancer-denonce-les-prixexorbitants-des-medicaments-innovants.html .

Raffi and Reynes ( 2014 ), p. 1158.

I-MAK ( 2017 ).

Boseley ( 2015 ) https://www.theguardian.com/society/2015/jan/16/sofosbuvir-hepatitis-c-drug-nhs .

Gornall et al. ( 2016 ), p. 4117.

Entis ( 2019 ).

The Economist ( 2019 ).

Donnelly ( 2015 ). The article further identifies that in total, 17 cancer drugs for 25 different indications will no longer be paid for in future in the UK.

According to January 2019 NHS England data, almost 25% of cancer patients didn’t start treatment on time despite an urgent referral by their primary care doctor. This represents the worst performance since records began in 2009. For more see Pipes ( 2019 ). https://www.forbes.com/sites/sallypipes/2019/04/01/britains-version-of-medicare-for-all-is-collapsing/#4c6ebeb736b8 .

WHO ( 2015 ), p. 5 http://apps.who.int/iris/bitstream/10665/193736/1/9789241509763_eng.pdf . However, it was announced in late 2019 that a new antibiotic for drug-resistant tuberculosis—pretomanid was finally approved by the FDA. Interestingly, the drug was developed by the non-profit TB Alliance rather than the industry. For more see Dearment ( 2019 ) https://medcitynews.com/2019/08/new-antibiotic-for-drug-resistant-tuberculosis-scores-fda-approval/ .

The two WHO reports cited below also found that research and development for antibiotics is primarily driven by small- or medium-sized enterprises with large pharmaceutical companies continuing to exit the field. For more see WHO ( 2017 ) https://apps.who.int/iris/bitstream/handle/10665/258965/WHO-EMP-IAU-2017.11-eng.pdf?sequence=1 , and WHO ( 2019 ) https://apps.who.int/iris/bitstream/handle/10665/330290/WHO-EMP-IAU-2019.12-eng.pdf .

O’Neill ( 2015 ).

Trouiller et al. ( 2002 ), p. 2188.

Pedrique et al. ( 2013 ), p. 371.

See MSF ( 2016 ).

See MSF ( 2016 ), p. 8.

For more see Herder et al. ( 2020 ), pp. 1–14.

Røttingen et al. ( 2013 ), p. 1286, also see MSF ( 2016 ).

Rowland ( 2019 ).

Stevens et al. ( 2011 ), p. 535.

Global Justice Now and Stop AIDS ( 2017 ), p. 7. https://www.globaljustice.org.uk/sites/default/files/files/resources/pills-and-profits-report-web.pdf .

Ibid at 10.

Mole ( 2019 ) https://arstechnica.com/science/2019/02/drug-companies-are-sitting-on-generics-43-of-recently-approved-arent-for-sale/ .

It should be noted that the product lifecycle management starts at the development and regulatory approval stages and extends beyond the expiry of the granted patent. Notably, drug manufacturers do not only rely on patent protection when devising their lifecycle strategies. For example, reliance on trademark protection and branding is also vital in providing effective means to secure and maintain a strong market position. For more on this see Dutfield ( 2020 ). file:///C:/Users/melsaid/Downloads/Not_Just_Patents_and_Data_Exclusivity_Th.pdf.

I-MAK identifies the following three multi-billion-dollar drugs as having questionable patents that are providing excess exclusivity periods:

Revlimid® (lenalidomide): Unmerited patents enable a minimum exclusivity period from 2019 through 2028. Payers are projected to spend $45 billion in excess costs for the drug within this period, prior to the first generic product entering the market.

Sovaldi® (sofosbuvir): Unmerited patents will prevent competition from now through 2034, when final patents held by Gilead Sciences expire on the drug. Payers are projected to incur $10 billion in excess costs.

Gleevec® (imatinib): In the one-year period from 2015–16, approximately $700 million dollars in excess costs were passed onto payers as a result of a pay-for-delay deal cut by Novartis to a generic company in exchange for delaying the entry of generic imatinib.

For more see I-MAK ( 2017 ).

The majority of these patents focuses on developing so-called ‘me-too’ drugs—medicines which have only small clinical advantages over existing drugs, but which can be patented and bring substantial profits. The effects of evergreening vary but the primary impact would be to extend the monopoly term granted to patents. For more see Kesselheim et al. ( 2006 ), p. 1637.

Amin and Kesselheim ( 2012 ), p. 2286.

I-MAK ( 2018a ) http://www.i-mak.org/wp-content/uploads/2018/08/I-MAK-Overpatented-Overpriced-Report.pdf .

I-MAK ( 2018b ). http://www.i-mak.org/wp-content/uploads/2018/10/I-MAK-Lantus-Report-2018-10-30F.pdf .

Amin and Kesselheim examined patents granted for two HIV drugs (ritonavir and lopinavir/ritonavir) and found that Abbott owned 82 secondary patents and had a further 26 pending applications in the US, all of which involved small variations on the original patents for these drugs. They found that these evergreening patents could delay generic competition for 19 years beyond the date from which generic entry would have been anticipated. For more see Amin and Kesselheim ( 2012 ).

Christie et al. ( 2013 ), p. e60812.

Office of Patented Medicines and Liaison ( 2005 ).

EU Commission ( 2008 ), p. 10. https://ec.europa.eu/competition/sectors/pharmaceuticals/inquiry/communication_en.pdf .

Prescrire International ( 2005 ), pp. 68, 71.

Light and Warburton ( 2016 ), p. 34.

Ward et al. ( 2014 ), p. 6235.

Drahos ( 2010 ).

See generally Machlup and Penrose ( 1950 ), p. 1.

See El Said ( 2010 ).

See the Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establish the World Trade Organization, Annex 1C, 1869 U.N.T.S. 299 [hereinafter TRIPS Agreement] (listing the limitations on use of intellectual property by third parties authorized by the government).

There is a general differentiation in the literature between expressly provided safeguards, limitations/exceptions and countervailing legal principles and objectives on the one hand, and vague terminology on the other hand where there are provisions and omissions whose scope is subject to a wide range of interpretations in accordance with national and international legal regimes. For more see El Said ( 2010 ).

See the Council for Trade-Related Aspects of Intellectual Property Rights, Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products, Decision of the Council for TRIPS of 6 November 2015.

In 2019, Uganda notified the African Regional Intellectual Property Organisation (ARIPO) that it is exercising its right as a least-developed country by stating that pharmaceutical inventions are not eligible for patent protection in the country. See ‘t Hoen ( 2019 ). https://medicineslawandpolicy.org/2019/10/uganda-tells-aripo-no-more-patents-for-pharmaceuticals/ .

The special compulsory licensing system in the amended TRIPS Agreement, and the earlier 2003 waiver decision, (sometimes called the “Paragraph 6 System” because it refers to paragraph 6 of the Doha Declaration) only deals with compulsory licences to produce medicines expressly for export purposes.

See TRIPS Agreement, Article 6.

See TRIPS Agreement, Art. 30.

This important exception facilitates the production and introduction of generic medicines into the market on the date of patent expiry. Accordingly, this exception permits the use of an invention for the purpose of obtaining approval of a generic product before the patent actually expires and without having to obtain the patentee’s approval. The WTO ruled that the use of this exception is TRIPS-compliant. For more see the WTO ( 2000 ).

See TRIPS Agreement, Art. 27.

‘t Hoen et al. ( 2018 ), pp. 185–193.

For more see El Said ( 2014 ), p. 60.

See number of compulsory licenses issued in ‘t Hoen et al. ( 2018 ), p. 188. However, it should be kept in mind that the ability to use compulsory licensing is not an available option to all countries equally but is rather more relevant to those which possess manufacturing capabilities.

For more see Ling ( 2019 ). http://english.astroawani.com/malaysia-news/using-compulsory-licence-affordable-medicines-200558 .

The issued compulsory license were for three ARV medicines namely Ritonavir+Lopinavir and Lamivudine+Abacavir, for Etoricoxib (Arcoxia® for the treatment of diseases with acute pains); Mycophenolate Sodium (MYFORTIC) used in the treatment of reception of kidney transplants; sunitinib, an anticancer drug used for the treatment of carcinoma renal cells (CRC) and gastrointestinal stromal tumours (GISTs); and finally Certolizumab, used to counteract rheumatoid arthritis. See Correa and Velásquez ( 2019 ), p. 16. https://www.southcentre.int/wp-content/uploads/2019/04/RP85_Access-to-Medicines-Experiences-with-Compulsory-Licenses-and-Government-Use-The-Case-of-Hepatitis-C_EN-1.pdf .

For more see El Said ( 2016 ), p. 374.

See Chatterjee ( 2013 ). https://www.ip-watch.org/2013/04/01/novartis-loses-patent-bid-lessons-from-indias-3d-experience/ .

See Sampat and Shadlen ( 2017 ), p. 693.

Other countries are increasingly following India’s patentability path. The Philippines patent law, as amended in 2008, introduced a section similar to the Indian 3(d) section (although less stringent than India’s Patent Act).177

China has reformed its Patent Act in 2008 and 178. See Patent Law (promulgated by the Standing Comm. Nat’l People’s Cong., Mar. 12, 1984, rev’d Dec. 27, 2008 ), art. 22. For more see El Said ( 2016 ).

Velasquez ( 2019 ), p. 108.

UNAIDS ( 2011 ), p. 15. https://www.unaids.org/sites/default/files/media_asset/JC2260_DOHA%2B10TRIPS_en_0.pdf .

Miller ( 2012 ). https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2029263 .

See Drahos ( 2001 ), p. 791 and El Said ( 2005 ), pp. 53–66.

For more on this from an EU perspective please see Dutfield ( 2017 ), p. 453.

Ney ( 2019 ). https://www.centerforbiosimilars.com/contributor/joshua-ney/2019/08/exclusivity-for-biologic-products-under-the-usmca-what-is-changing-and-what-happens-next .

For instance, in 2016; and Ukraine de-registered a generic hepatitis C medicine after Gilead indicated that it would pursue arbitration. For more see Gleeson et al. ( 2019 ), p. 78.

UNDP and UNAIDS ( 2012 ) https://www.unaids.org/sites/default/files/media_asset/JC2349_Issue_Brief_Free-TradeAgreements_en_0.pdf .

Oxfam ( 2007 ), p. 5 https://oxfamilibrary.openrepository.com/bitstream/handle/10546/114080/bp102-all-costs-no-benefits-trips-210307-en.pdf%3Bjsessionid%3D089750820CF675173F0C3204C369D63F%3Fsequence%3D1 . Also see El Said ( 2006 ), p. 501.

Oxfam, Ibid.

See Amin and Kesselheim ( 2012 ).

Lexchin ( 2019 ), p. 10.

Harris et al. ( 2013 ), p. vi https://www.ipaustralia.gov.au/sites/default/files/2013-05-27_ppr_final_report.pdf?acsf_files_redirect . The Report found that about 58% of new molecules listed on the PBS from 2003 to 2010 received extensions of term. Of the term extensions granted since 1999, 47% received the full 5 years.18 The cost of these extensions to the PBS in 2012–13 was estimated at about $240 million in the medium term and about $480 million in the longer term.

Gleeson et al. ( 2015 ), p. 306.

Harris et al. ( 2013 ).

The Office of the U.S. Trade Representative (USTR) issued a letter in 2019 to signatories of the Trans-Pacific Partnership Agreement that the United States has formally withdrawn from the agreement.

The TPP is the first trade agreement to include provisions on pharmaceuticals that are, or contain, biologics, compounds produced through biological processes and which are used primarily for treating cancer and immune conditions.

Baker ( 2016 ), p. e1001970.

Swanson ( 2019 ). https://www.nytimes.com/2019/03/21/us/politics/nafta-drug-prices.html .

Gleeson et al. ( 2015 ).

The US-Australia Free Trade Agreement (US-AUS FTA) signed in 2004.

Intellectual Property Laws Amendment (Raising the Bar) Act 2012 No. 35, 2012 as amended. Start date15 April 2013, hereafter the 2013 Patent Law.

Dixon ( 2017 ).

See US-AUS FTA, Art.17.9.8(b) states:

[E]ach Party shall make available an adjustment of the patent term to compensate the patent owner for unreasonable curtailment of the effective patent term as a result of the marketing approval process.

See El Said ( 2016 ).

See Patents Act 1990 (Cth) ch 6 pt 3 s 70 sub-divs (2)-(3) (Austl).

Son et al. ( 2018 ), p. 101.

GIPC ( 2019 ). https://www.theglobalipcenter.com/wp-content/uploads/2019/09/GIPC-Linkage-Zoom-In-Report.pdf .

Australian Government Department of Health ( 2016 ). http://www.pbs.gov.au/industry/pricing/price-disclosure-spd/price-disclosure-operational-guidelines-06-2016.pdf .

GIPC ( 2019 ).

The government also announced an investment of more than 1 Billion USD to enable universal access to HVC treatment. See Velásquez ( 2017 ). https://www.southcentre.int/wp-content/uploads/2017/05/RP77_Access-to-Hepatitis-C-Treatment-A-Global-Problem_EN-2.pdf .

Moon and Erickson ( 2019 ), p. 607. Furthermore, the State of Louisiana announced in January 2019 that it was pursuing a similar approach for HCV. For more see Crisp ( 2019 ) https://www.theadvocate.com/baton_rouge/news/politics/article_614e4f42-1523-11e9-8c90-4fcb305d17e8.html .

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Exceptions to Exclusive Rights (Article 30 of TRIPS)

Article 3 and 4 o f the trips agreement mirror gatt articles 3 and 1 pertaining to national, 3.9 exceptions to exclusive rights (article 30 of trips).

The TRIPS Agreement has laid out exceptions to exclusive patent rights in two separate provisions, i.e., Article 30 titled exceptions to exclusive rights and Article 31 titled Compulsory Licenses. Pursuant to Article 30 of the TRIPS Agreement, there are exceptions to exclusive rights granted to the patentee. The provision provides that in order to grant exceptions three conditions must exist: they must be limited, they should not unreasonably conflict with the normal exploitation of the patent and exceptions should not unreasonably prejudice the legitimate interests of the patent owner.126 Carlos Correa argues that due to the vagueness of the provision, national authorities may allow for exceptions in the following areas: private acts on a non-commercial scale, use of invention for research, experiments made or the purpose of seeking regulatory approval immediately after the term of patent expires (Bolar Exception), and importation of a patented product that has been marketed in another country without the consent of the patent owner (parallel importation).127

Article 31 of the TRIPS contains a detailed set of requirements for dealing with compulsory licenses. Compulsory licensing is the granting of rights to entities other than the patent holder, without its consent, to utilize a patented product or process. Under the Agreement there are five specific grounds for granting a compulsory license, namely the refusal to deal by the patent holder, emergency or extreme 126 TRIPS Art 30.

urgency, anti-competitive behaviour, non-commercial use and dependent patents. It is arguable whether this provision sets the ceiling on compulsory licensing or if it is in fact, a minimum standard. For example, can environmental concerns be grounds for a compulsory license? Although the US is one of the major users of compulsory licenses, it nevertheless, confines itself mostly to federal agencies working on pharmaceutical experimentation or defence industry products without commercial use. The US and the EU do not desire a broader application of compulsory licensing, whereas the developing countries would like to see the requirements set forth as only minimum standards for compulsory licenses. For instance, a “public interest” grounds would benefit developing countries, as it would allow them more flexibility in granting compulsory licenses.129

Furthermore, Article 31 not only sets forth certain legitimate uses of the compulsory licenses but also describes the conditions under which a grant of compulsory license can be made. They include case-by-case evaluation by domestic authorities, prior negotiation with patent holder for a voluntary license, scope and duration of license, non-exclusivity, non-assignability, remuneration and administrative or judicial review of the grant. The cohesion or reasons for the separation of Articles 30 and 31 is unclear, as article 30 provides for general exceptions to exclusive rights whilst Article 31 allows for “other uses” of a patent grant, however, with a list of uses which are proper. These provisions define the limits of patent rights that developing countries could look to when formulating national intellectual property regulations.

128 Scherer, F., The Patent System and Innovation in Pharmaceuticals, 1999, in Crop Science Society of America, American Society o f Agronomy, Intellectual Property Rights Associated with Plants, ASA Publication No. 52.

129 Adede, A.O., The Political Economy o f the TRIPS Agreement: Origins and History o f Negotiations, 2001, pp. 26-29, paper presented at the International Centre for Trade and Development in collaboration

As mentioned above, one of the main elements of interest within the TRIPS Agreement for developing countries could be the exception to exclusive rights under Article 30. The scope of this provision defines to a certain extent, the contours of the flexibility to implement the Agreement for these nations. This provision allows Members to exclude certain rights from the IP holder. This exclusion is most often used for research and experimentation in the field of pharmaceuticals. Exceptions relating to research can be an important tool to create favourable grounds for innovation. It can allow for researchers to find more information about the product and its possible alternative uses.

Another important exception deals with the use of an invention relating to pharmaceuticals to conduct tests and obtain approval from the health authorities of a Member before the expiry of the patent in order to market the generic form as soon as possible afterward. This can play a very important role for developing countries’ health policy as generic drugs reach the consumer at the earliest possibility without any delay due to regularity requirements. Developing countries should be given maximum leeway in allowing exceptions to exclusive rights in most fields of technology but especially with regard to pharmaceuticals. The development approach would encourage the use of these exceptions so as to secure a desirable level of health in these countries. The desired level will be deferred to national authorities and would stay within the bounds set by the language of Article 30 of TRIPS. The DSB has resolved one major case to date in relation to Article 30.

3.9.1 Canada-Pharmaceuticals130and Exceptions to Exclusive Rights Pursuant to Article 30

The Canada-Pharmaceuticals case is the first and only case directly dealing with Article 30 of the TRIPS and as such will be analysed in order to better understand how the adjudicators of the WTO have decided this issue and how it may or may not adhere to the development approach to fair adjudication. Although the parties were not developing Members many participated as third parties because they deemed it of great interest as a matter of practice and precedent.

3.9.1.1 Facts o f the Case

In the Canada-Pharmaceuticals case the panel decided on two forms of exception: 1) known as the “regulatory review provision” of Canada, which permits generic manufacturers to complete the regulatory approval process before the patent term is expired, and 2) the “stockpiling” provision of Canadian law which allowed generic manufacturers to produce the patented product and put them in inventory until the exact day the patent expires thereby accessing the market immediately after the expiry. The panel decided to uphold the first Canadian provision whilst rejecting the second, based on Article 30 of TRIPS.

The Canadian regulatory review provision allows the generic manufacturer to produce samples of the patented product for use during the review process.131 If the generic manufacturer is able to get approval for its product it is able to begin selling it immediately upon expiration of the patent, instead of beginning the process at that 130 Canada-Patent Protection o f Pharmaceutical Products (WT/DS114/R adopted April 7,2000).

time which would take up to 30 months for approval. Furthermore, Canadian “stockpiling” law allowed generic manufacturers to make the drug and begin stockpiling six months prior to the expiration of the patent.132 This provision is available only if the regulatory review provision had been invoked.

The EC contended the Canadian Patent Act is in violation of Article 28.1 of the TRIPS which stipulates that: A patent shall confer on its owner the following exclusive rights: a) where the subject-matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of making, using, offering for sale, selling or importing for these purposes that product. The Canadians did not dispute the fact that these two provisions violate Article 28.1 but they claimed that they are justified to do so under the exception granted by Article 30 of the TRIPS.

3.9.1.2 Reasoning and Holding 3.9.1.2.1 The Stockpiling Provision

The panel ruled against Canada’s stockpiling provision, arguing that Canada violates Article 28.1 but is not able to justify this violation in accordance with Article 30.133 It stated that Article 28.1 grants five legal rights to IP holder, i.e., making, using, offering for sale, selling an importing. The stockpiling provision clearly violates the making and using elements of that right. On the other hand, Article 30 which sets out the exceptions to the obligations of Article 28.1, creates three requirements that must be met before the exceptions can be invoked: a) the exception must be limited; b) they must not unreasonably conflict with the normal exploitation of the patent; and

• Indications of Development
• The Uruguay Round and Problems for Developing Countries
• Teleology and the Development Approach to Fair Adjudication
• The Need for Justice in Adjudication of Disputes
• Judicial Politics of the WTO
• Theoretical Concepts of the Development Approach to Fair Adjudication
• Description of Justice and Its Relationship to the Normative Concept of Law in the WTO
• Appeals under Article 11 of DSU
• Burden of Proof
• India-Blouses supra at note AO, Argentina-Footwear supra at note 17.
• Turkey-Restrictions on Imports o f Textiles and Clothing Products, WT/DS34/AB/R (Adopted 19 Nov 1999).
• US-Imposition o f Countervailing Duties on Certain Hot-Rolled Lead and Bismuth Carbon Steel Products
• Asbestos case, Supra at 81, para 52.
• Definition of Intellectual Property Rights
• The India-Pharmaceutical Patents Case (Mail Box Case)
• Problems and Prospects for Patent Protection in Developing Countries
• Copyrights and Developing Countries
• Trademarks and Developing Countries
• The Doha Ministerial Declaration
• Exceptions to Exclusive Rights (Article 30 of TRIPS) (You are here)

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TRIPS Provisions as Interpreted by the WTO Dispute Settlement Organs

7 TRIPS Provisions as Interpreted by the WTO Dispute Settlement Organs T HIS CHAPTER EXAMINES how the WTO dispute settlement organs have interpreted TRIPS provisions. Except for the initial period following the establishment of the WTO, there have been few dispute cases over the TRIPS provisions: only three cases have been appealed. Nonetheless, the reports on these disputes are important guideposts for interpreting TRIPS, especially about the objective and principles of the Agreement, its exceptions and limitations, non-discrimination principles and TRIPS ‘flexibility’ as understood by the WTO dispute organs. The WTO dispute organs emphasised the importance of the customary rules of international public law in interpreting the TRIPS Agreement, as has been the case for all the WTO-covered agreements, and, in particular, the wording of the treaty provisions to be interpreted. This may be due largely to Article 3.2 of the Understanding on Rules and Procedures Governing the Settlement of Disputes (DSU), which defines the role of the WTO dispute settlement system. According to Article 3.2 of the DSU, this system serves ‘to preserve the rights and obligations of Members under the covered agreements, to clarify the existing provisions of those agreements in accordance with customary rules of interpretation of public international law’, but cannot add to or diminish the rights and obligations provided in the covered agreements. This disciplined approach to interpreting TRIPS provisions seems to have prevented potential political arguments based on limited market data. I AN OVERVIEW From 1 January 1995 to 30 September 2009, there were a total of 399 requests for consultations and 122 Panel and Appellate Body Reports. 1 Of these, only 13 Panel and Appellate Body Reports concerning the TRIPS Agreement were adopted, in a total of eight cases. The findings of Panel Reports are binding only on the parties to the dispute, and although the Appellate Body reports can have a wider impact on legal, systemic questions, there are to date only three Appellate Body reports concerning this Agreement. At the initial period after the entry into force of the WTO Agreement, approximately 10 per cent of disputes, a relatively high level, concerned the TRIPS Agreement. 2 Most disputes were over differences between the systems of intellectual property protection in developed countries. For example, the first TRIPS dispute case was brought against Japan by the US, concerning retroactive protection of sound recordings in Japan. This dispute was resolved during the bilateral consultations between the two countries. Several dispute cases were brought to the dipute settlement procedures over the implementation of the TRIPS Agreement in developing countries. Among the total of 29 complaints concerning the TRIPS agreement, 14 cases garnered mutually agreed solutions. Three consultations remain inactive (Table 7.4). In May 2010, two requests for consultations relating to the TRIPS Agreement as well as the GATT 1994 were submitted by developing countries to the Dispute Settlement Body (DSB) 3 . The rate of TRIPS dispute cases dropped sharply after the initial period, as Tables 7.1 – to 7.4 show. WTO Disputes relating to the TRIPS Agreement Table 7.1: Disputes where a Panel report (P), or Panel and Appellate Body (AB) Reports are adopted Table 7.2 Cases where consultations have been initiated (pending) Table 7.3: Settled disputes Disputes Complainant Notification of Mutually Agreed Solution Portugal–Patent Protection under the Industrial Property Act (WT/DS37) US 3 October 1996 Japan–Measures Concerning Sound Recordings (WT/DS28, WT/DS42) US EC 24 January 1997 (US) 7 November 1997 (EC) Pakistan–Patent Protection for Pharmaceutical and Agricultural Chemical Products (WT/DS36) US 28 February 1997 Denmark, Sweden–Measures Affecting the Enforcement of Intellectual Property Rights (WT/DS83, WT/DS86) US 2 December 1998 (S) 7 June 2001 (DK) Ireland–Measures Affecting the Grant of Copyright and Neighbouring Rights (WT/DS82) US 6 November 2000 EC–Measures Affecting the Grant of Copyright and Neighbouring Rights (WT/DS115) US 6 November 2000 EC–Enforcement of Intellectual Property Rights for Motion Pictures and Television Programs (WT/DS124) US 20 March 2001 Greece–Enforcement of Intellectual Property Rights for Motion Pictures and Television Programs (WT/DS125) US 20 March 2001 Brazil–Measures Affecting Patent Protection (WT/DSDS199) US 5 July 2001 Argentina–Patent Protection for Pharmaceuticals and Test Data Protection for Agricultural Chemical Products (WT/DS171) US 31 May 2002 Argentina–Certain Measures on the Protection of Patents and Test Data (WT/DS196) US 31 May 2002 China–Measures Affecting Financial Information Services and Foreign Financial Information Suppliers(WT/DS372) EC 4 December 2008 Table 7.4: Disputes where consultations continue (inactive) Disputes Complainant Respondent EC–Patent Protection for Pharmaceutical and Agricultural Chemical Products (WT/DS153) Canada EC US–Section 337 of the Tariff Act of 1930 and Amendments thereto (WT/DS/186) EC US US–US Patents Code (WT/DS/224) Brazil US WTO Panels and the Appellate Body have interpreted the TRIPS Agreement by referring to the customary rules of treaty interpretation, notably the method delineated in Articles 31 and 32 VCLT, in the same cautious and consensual spirit and through the same textualist approach for TRIPS cases as they have for other cases, with, however, certain adaptations to the characteristics of the TRIPS Agreement as a treaty. TRIPS interpretation has so far relied much on finding the ordinary meaning of the terms in the Agreement, often supported by the effectiveness principle ( ut res magis valeat quam pereat ). Additionally, Panels and the Appellate Body have relied extensively on the provisions in the Paris and Berne Conventions, and their related documents, guidelines and preparatory work, as ‘context’, ‘contextual guidance’ or ‘extended context’ for the purpose of interpreting the TRIPS Agreement. From the previous GATT system, there has been some interpretative guidance for TRIPS dispute cases, but mainly on the issues of national treatment and most-favoured nation principles. The text of the TRIPS Agreement is brief, and little preparatory work is available. During the Uruguay Round negotiations, the Secretariat Notes and various written proposals from participants were available, but there was no drafting committee to keep track of the processes by which the text of the TRIPS Agreement was adopted. There was no accumulation of experience within the GATT regarding intellectual property rights (IPRs). When the meaning of a treaty provision is sufficiently clear, no interpretative guidance is sought from the Vienna Convention. In such cases, Panels and the Appellate Body have relied directly on the wording of the Agreement, including its titles and footnotes. In searching for the meaning of ‘rights holders’ to whom civil judicial procedures should be made available by the WTO Members, the Appellate Body in US–Section 211 Appropriation Act 4 simply relied on the footnote to Article 42 TRIPS, which states that: ‘For the purpose of this Part [III], the term “right holder” includes federations and associations having legal standing to assert such rights’. 5 Under the TRIPS Agreement, therefore, procedures should be available not only to those who obtain IPRs, but also to any party which has legal standing to assert such rights. Footnotes were also examined to determine the meaning of ‘nationals’ of the customs territory (footnote 1 to Article 1.3 TRIPS – see chapter 5), 6 and whether principles of national treatment apply to the use of IPRs generally, or if they only apply to ‘those matters affecting the use of IPRs specifically addressed in the TRIPS’ (footnote to Article 3.1). 7 The Panel and the Appellate Body, in dealing with TRIPS cases, have referred also to GATT Panel Reports and the 1994 GATT. 8 In EC–Geographical Indications , 9 the Panel referred to the GATT report on US–Section 337 , 10 as well as the Panel and Appellate Body reports in US–Section 211 Appropriation Act , and stated that national treatment relates to ‘effective equality of opportunities’ of the nationals of Members with regard to the protection of IPRs, to the nationals of the Member concerned. 11 When the examination of ‘preparatory work’ for the elaboration of the TRIPS Agreement was needed, the text, guidelines and model laws relating to the relevant provisions of the Paris or Berne Conventions were often referred to as ‘contextual guidance’ or ‘contextual support’. In examining the historical context of TRIPS provisions in terms of previous IP treaties, the Appellate Body in US–Section 211 Appropriation Act stated that Article 6 quinquies of the Paris Convention offered ‘contextual support’. 12 These concepts relating to ‘context’ in interpreting TRIPS do not necessarily derive from Article 31 VCLT. II TRIPS INTERPRETED BY WTO DISPUTE ORGANS A ‘Context’ for the purpose of Interpreting TRIPS Article 2 TRIPS concerning ‘intellectual property conventions’ stipulates in para 1 that ‘[i]n respect of Parts II, III and IV of this Agreement, Members shall comply with Articles 1 through 12, and Article 19 of the Paris Convention (1967)’, while Article 9 concerning ‘Relation to the Berne Convention’ provides that ‘Members shall comply with Articles 1 through 21 of the Berne Convention (1971) and the Appendix thereto’. 13 The Panel in US–Section 211 Appropriation Act interpreted the words ‘in respect of’ in Article 2.1 as limiting the incorporation of the provisions of the Paris and Berne Conventions to mean ‘in respect of what is covered by those parts of the TRIPS Agreement identified therein’. 14 The Panel also held that the phrase ‘intellectual property’ in Article 1.2 designated all categories of IP that are ‘the subject of Sections 1 through 7 of Part II’. For the question of whether trade names are included as the subject of protection under the TRIPS Agreement, the Panel did not find among the titles the word ‘trade name’ and excluded from the categories of intellectual property included under the TRIPS. The negotiating history of Articles 1.2 and 2.1 of the TRIPS Agreement was not conclusive. The Appellate Body examined the wording of Article 1.2 TRIPS and held that Article 1.2, which refers to ‘the subject of Sections 1 through 7 of Part II’, deals not only with the categories of intellectual property indicated in each section title , but with other subjects as well, as with the protection of sui generis rights, which is not found as a title but which is included under Article 27(3)(b) TRIPS 15 . The Appellate Body examined also Article 8 of the Paris Convention which covers only the protection of trade names, and reached the following conclusion: if the intention of the negotiators had been to exclude trade names from protection, there would have been no purpose in including Article 8 in the list of Paris Convention (1967) provisions incorporated into the TRIPS Agreement . The Appellate Body emphasised the need to give meaning and effect to all terms of a treaty. 16 Thus, the Appellate Body relied on the effectiveness principle rather than on the ‘preparatory work’, and quoted US–Gasoline 17 and Japan–Alcoholic Beverages II 18 in this regard. 19 The Panel in US–Section 110(5) Copyright Act 20 analysed also the extent to which the minor exceptions doctrine forms part of the Berne Convention acquis and whether this principle has been incorporated into the TRIPS Agreement, by virtue of Article 9.1 TRIPS, together with Articles 1–21 of the Berne Convention (1971). For determining whether this doctrine, which primarily concerns de minimis use for the Panel, is part of the Berne Convention and the TRIPS Agreement, or forms a ‘context’ within the meaning of Article 31 VCLT, the Panel explored the intention of the parties 21 as reflected in the wording of relevant documents. The Panel found that the minor exceptions doctrine forms part of the ‘context’ within the meaning of Article 31.2(a) of the Vienna Convention, of at least Articles 11 and 11 bis of the Berne Convention (1971). 22 The Panel then looked into the preparatory work, notably in the documents of the TRIPS Negotiating Group, which confirmed that the information concerning this doctrine was provided by the International Bureau of WIPO, 23 and that no record exists of any party challenging the idea that the minor exceptions doctrine is part of the Berne acquis on which the TRIPS Agreement was to be built. From this, the Panel concluded that, in the absence of any express exclusion in Article 9.1 of the TRIPS Agreement, the incorporation of Articles 11 and 11 bis of the Berne Convention (1971) into the Agreement included the entire acquis of these provisions, including the possibility of providing minor exceptions to respective exclusive rights. 24 Although it is not exactly reflected in the language of Article 9.1 TRIPS, the Panel concluded that ‘if that incorporation should have covered only the text of Articles 1–21 of the Berne Convention (1971), but not the entire Berne acquis relating to these Articles, Article 9.1 of the TRIPS Agreement would have explicitly so provided.’ 25 The Panel relied not only on various kinds of ‘context’ for treaty interpretation, but on a ‘general principle of interpretation’ to establish the legal status of the minor exceptions doctrine. According to the Panel, in the area of copyright, the Berne Convention and the TRIPS Agreement form ‘the overall framework for multilateral protection’. Furthermore, most WTO Members are also parties to the Berne Convention. For the Panel, adopting a meaning that would reconcile the texts of different treaties and avoid conflict between them, is a general principle of interpretation, based on public international law’s presumption against conflicts. 26 The Panel did not recognise either Article 10(2) of the 1996 WIPO Copyright Treaty (WCT – see chapter 2), as a subsequent treaty on the same subject matter within the meaning of Article 30 VCLT 27 , or subsequent agreements on the interpretation of a treaty within the meaning of Article 31.2(b) VCLT, or subsequent practice within the meaning of Article 31.3 VCLT. However, as all 127 signatories to the TRIPS Agreement in the WTO took part in all of the WCT meetings, the Panel held that it is also relevant to seek ‘contextual guidance’ in the WCT when developing interpretations that avoid conflicts within the overall framework of multilateral copyright protection, except where these treaties explicitly contain different obligations. 28 The Panel concluded, therefore, that the TRIPS Agreement and the WCT should be interpreted consistently with each other. 29 In an attempt to identify the scope and the level of protection provided by TRIPS provisions incorporating previous IPR treaties, the WTO Panels and the Appellate Body have resorted thus to different kinds of treaty ‘context’, which are not necessarily within the meaning of Article 31 VCLT. In Canada–Pharmaceutical Patents , 30 the Panel considered that Article 9(2) 31 of the Berne Convention for the Protection of Literary and Artistic Works (1971) is a ‘rule of international law which the interpreter must consider, together with the context’ which falls under Article 31.3(c) of the VCLT, and referred to it as ‘an important contextual element for the interpretation of Article 30 of the TRIPS Agreement’, calling this provision ‘extended context’. 32 The analysis of the ‘context’ for the purpose of interpretation based on the VCLT rule, determines important questions such as whether the scope of exceptions and the level of protection differs between the Berne Convention and the TRIPS Agreement based on Article 13. The main difference between Article 9(2) of the Berne Convention (1971) and Article 13 of the TRIPS Agreement is that the former applies only to the reproduction right, whereas Article 13 does not contain an express limitation in terms of the categories of rights under copyright to which it may apply. 33 The EC (today the European Union) argued that the provisions of Article 13 of the TRIPS Agreement and those of Article 11(1)(ii) and Article 11 bis of the Berne Convention provided different standards. The EC contended that parties to the Berne Convention could not agree that another treaty (ie the TRIPS Agreement) reduces the Berne Convention’s level of protection. From the wording or the context of Article 13 of the TRIPS Agreement, according to the EC, the Berne acquis could not be considered to be incorporated in the TRIPS Agreement. The EC contended therefore that Article 13 applied only to the rights newly adopted under the TRIPS Agreement. 34 The US argued that the TRIPS Agreement incorporates the substantive provisions of the Berne Convention (1971), and that Article 13 TRIPS provides the standard by which to judge the appropriateness of limitations or exceptions, with which s 110(5) is compliant. According to the Panel, Article 11 bis (2) 35 of the Berne Convention (1971) and Article 13 TRIPS cover different situations. 36 Reports of successive revision conferences of the Berne Convention refer to ‘implied exceptions’ allowing Member countries to provide limitations and exceptions to certain rights. The so-called ‘minor exceptions’ doctrine concerns those minor exceptions to the right of public performance, a concept which is close to the notion of ‘fair use’. 37 The doctrine is not explicitly described in terms of exceptions in the Berne Convention, which refers to the conditions allowing national laws to provide for exceptions, using a three-step test, with respect to Articles 11 and 11 bis , and other exclusive rights (such as the right of translation) of the Berne Convention. The three-step test is a standard by which limitations on exclusive copyrights are confined to ‘certain special cases’ which do not conflict with ‘normal exploitation of the work’, do not ‘unreasonably prejudice the legitimate interests of the author’, and are applied to the right of reproduction. 38 Article 13 of the TRIPS Agreement imposes three conditions to be met for testing permissibility of exceptions or limitations to the exclusive rights. These conditions represent situations that are ‘certain special cases’, ‘[do] not conflict with a normal exploitation of the work’ and ‘[do] not unreasonably prejudice the legitimate interests of the right holder’. If these three conditions are met, a government may choose between different options for limiting the right in question, including use free of charge and without an authorisation by the right holder. The Panel, in interpreting these three conditions in US–Section 110(5) Copyright Act , applied the effectiveness principle, which requires the treaty interpreter to give a distinct meaning to each of the three conditions and to avoid a reading that could reduce any of the conditions to ‘redundancy or inutility’. 39 B ‘Object and Purpose’ of the TRIPS Agreement At the close of the Uruguay Round negotiations, developed countries considered Articles 7 and 8 only ‘hortatory’, whereas developing countries regarded them as describing the objectives and principles of the TRIPS Agreement affecting rights and obligations of the Members under the Agreement (see chapter 4). The question of what the ‘object and purpose’ of the TRIPS Agreement are has increasingly become contentious, as access to medicines and transfer of technology, as well as other possible public policy issues in IPR protection come to be debated. In these discussions outside the disputes settlement procedures, the legal statuses and the interpretative roles of Articles 7 and 8 TRIPS became divisive issues. Only in a few dispute cases, have Panels and the Appellate Body dealing with TRIPS provisions been faced with the question of what the overall object and purpose of the Agreement is. In one of the earlier TRIPS dispute cases, India–Patents (US) , 40 the Appellate Body for the purpose of interpreting Article 70.8(a), referred to the Preamble, and said that: ‘The Panel’s interpretation here is consistent with the object and purpose of the TRIPS Agreement.’ According to the Appellate Body, the object and purpose of the Agreement is, inter alia, ‘the need to promote effective and adequate protection of intellectual property rights’. 41 The identification of the ‘object and purpose of the treaty’ for interpreting TRIPS provisions, for the WTO dispute settlement organs, has been based mostly on textual analyses, with some exceptional cases where the Panel did not exclude considerations of facts and policies. In Canada–Patent Term , 42 the Appellate Body stated that their task was to give meaning to the phrase, ‘acts which occurred before the date of application’, and to interpret Article 70.1 43 in a way that is in accord with the rest of the provisions of Article 70.1 and their context, having particular regard to the object and purpose of the treaty. 44 In this case, however, the Appellate Body added that: ‘we note that our findings in this appeal do not in any way prejudge the applicability of Article 7 or Article 8 of the TRIPS Agreement in possible future cases with respect to measures to promote the policy objectives of the WTO Members that are set out in those Articles. Those Articles still await appropriate interpretation.’ 45 Two years later, the Panel Report in Canada–Pharmaceutical Patents dealt with the question of the ‘object and purpose’ of the TRIPS Agreement and, 46 following the general rule of interpretation in accordance with Article 31 of the VCLT, identified what follows. Article 7 of TRIPS is not the only purpose of the TRIPS Agreement. Article 7 mentions that the purpose of the IPR system is the premise of the Agreement, and so the object and purpose of the treaty will also depend on other provisions. Even if the exceptions in Article 30 of the TRIPS Agreement allow certain limitations of the exclusive rights as provided in Article 28, they must not change the fundamental balance between the rights and obligations of the TRIPS Agreement. Thus, for the Panel in Canada–Pharmaceutical Patents , the ‘object and purpose’ of the TRIPS Agreement in the meaning of Article 31.1 VCLT is inferred from the general structure of the agreement in which the balance of rights and obligations is struck. The Panel in EC–Geographical Indications explicitly stated that many measures to achieve public policy objectives are different from intellectual property protection itself, and therefore outside the scope of the TRIPS Agreement. The Panel explained that the nature of intellectual property rights provides for the grant of negative rights to prevent certain acts. This fact leaves Members free to pursue legitimate public policy objectives which normally lie outside the scope of intellectual property rights without resorting to exceptions under the Agreement. The Panel Report thus delineated the principles in Article 8.1 (see chapter 5, p 157). 47 C Determining the Scope of Exceptions i Are exceptions interpreted narrowly? From GATT to WTO As stated earlier, the VCLT rule of interpretation does not include the axiom that ‘exceptions should be interpreted narrowly’. GATT Panels adopted this approach more often than the WTO dispute settlement organs, particularly concerning Article XX (see chapter 4). The most apparent difference between the GATT Panels and the WTO in dealing with ‘exceptions’, concerns the interpretation of Article XX GATT. In US–Gasoline , the Appellate Body stated: The relationship between the affirmative commitments set out in, e.g., Articles I, III and XI, and the policies and interests embodied in the “General Exceptions” listed in Article XX, can be given meaning within the framework of the General Agreement and its object and purpose by a treaty interpreter only on a case-to-case basis, by careful scrutiny of the factual and legal context in a given dispute, without disregarding the words actually used by the WTO Members themselves to express their intent and purpose. 48 The Appellate Body compared its approach with that under the GATT, and found a similar approach taken also by the GATT Panel, in the 1987 Herring and Salmon Report. The Appellate Body in US–Gasoline noted that: . . . as the preamble of Article XX indicates, the purpose of including Article XX(g) in the General Agreement was not to widen the scope for measures serving trade policy purposes but merely to ensure that the commitments under the General Agreement do not hinder the pursuit of policies aimed at the conservation of exhaustible natural resources. 49 The Panel in EC–Geographical Indications considered that most public policies are formulated outside IPR protection, without regard to the issue of IPR protection. 50 However, there may be arguments that good public policies can be realised through the use of exceptions to IPRs, such as ‘fair use’ of copyrighted works or regulatory exceptions to patent rights. For example, the interpretation of Article 17 which refers to ‘fair use’ of descriptive terms could refer to some public policies. 51 There may therefore be arguments that TRIPS exceptions must be interpreted widely to allow certain public policy objectives, such as public health or fair use. Fundamentally for the WTO dispute organs, it is the VCLT rule, ie, the analysis of ‘the terms of the treaty in their context and in the light of its object and purpose’, that determines the perspective taken by the treaty interpreter. In what follows, the Appellate Body explains that the word ‘exception’ alone cannot determine how this provision should be interpreted: The general rule in a dispute settlement proceeding requiring a complaining party to establish a prima facie case of inconsistency with a provision of the SPS Agreement before the burden of showing consistency with that provision is taken on by the defending party, is not avoided by simply describing that same provision as an “exception”. In much the same way, merely characterising a treaty provision as an “exception” does not by itself justify a “stricter” or “narrower” interpretation of that provision than would be warranted by examination of the ordinary meaning of the actual treaty words, viewed in context and in the light of the treaty’s object and purpose, or, in other words, by applying the normal rules of treaty interpretation. 52 The WTO method of interpreting exceptions is based thoroughly on the VCLT rule and, apparently, differs from interpreting exceptions narrowly, as shown, for example, in the following judgment at the European Court of Human Rights: [the Court is] faced not with a choice between two conflicting principles [human rights of the individual and the restrictions necessary for democratic society] but with a principle of freedom of expression that is subject to a number of exceptions which must be narrowly interpreted. 53 Many dispute settlement organs, including the European Court of Human Rights (ECHR), relied to some extent on the effectiveness principles 54 but have developed their own policies of treaty interpretation without specifically referring to or turning away from the VCLT rule of interpretation. The Court referred to the VCLT rule of interpretation in early cases such as Golder v UK 55 in 1975, before the entry into force of the VCLT. 56 However, the ECHR developed its own interpretative principles, among which is the principle that exceptions should be interpreted restrictively when they concern self-standing rights/principles which cannot be easily balanced against other policy considerations, such as the right to freedom of expression provided in Article 10 of the European Convention on Human Rights and Fundamental Freedoms. Ultimately, however, the ECHR also engages in a balancing exercise between different policies. For the WTO-covered agreements which are of a commercial nature, there seems to be no norm with authority that is automatically accepted and that stands out from others. The above difference in the interpretative methods relating to exceptions therefore concerns this kind of balancing. Significantly for the WTO Agreements, the question of burden of proof is important in arguing for exceptions. ii VCLT and Exceptions and Limitations to the Rights Conferred under the TRIPS Agreement The scope of exceptions or limitations to the rights conferred under the TRIPS Agreement may require special consideration. There are pre-existing IP conventions with provisions concerning exceptions to the rights conferred and specific provisions, relating to exceptions in the TRIPS Agreement, for separate categories of IPR. How provisions in the TRIPS Agreement concerning exceptions are interpreted, therefore, depends in part on how the treaty interpreter views the relationship between the relevant TRIPS exceptions provisions and provisions in the IP Conventions which are incorporated in the TRIPS Agreement. According to the Panel in EC–Geographical Indications , the scope of the exceptions in the TRIPS Agreement must be interpreted based on the terms of the provision in their context, in light of the ‘object and purpose’ of the Agreement as follows: The ordinary meaning of the terms in their context must also be interpreted in light of the object and purpose of the agreement. The object and purpose of the TRIPS Agreement, as indicated by Articles 9 through 62 and 70 and reflected in the preamble, includes the provision of adequate standards and principles concerning the availability, scope, use and enforcement of trade-related intellectual property rights. This confirms that a limitation on the standards for trademark or GI protection should not be implied unless it is supported by the text. 57 The Panel responds to an argument made by Australia that there was an ‘implied limitation’ on the rights in Article 16 – implied from the relationship between Article 16 (which is in Part II – Standards concerning the Availability, Scope and Use of Intellectual Property Rights) and Articles 3 and 4 in Part I (General Provisions and Basic Principles) of the TRIPS Agreement. The Panel responded that such a limitation had to be supported by the text, and found that it was not so supported. 58 iii Exceptions and public policy considerations The Panels in US–Section 110(5) Copyright Act and in Canada–Pharmaceutical Patents examined extensively the scope of exceptions in Article 13 (entitled ‘Limitations and Exceptions’) and Article 30 (entitled ‘Exceptions to Rights Conferred’) of the TRIPS Agreement. Both Panels followed an interpretative method based on the customary rules of interpretation as understood and developed by the WTO dispute settlement organs in non-TRIPS cases, examined the extent to which pre-existing intellectual property treaty provisions were incorporated and looked into the negotiating history of the TRIPS Agreement. Although the Panel in US–Section 110(5) Copyright Act was innovative in its use of economic data, both Panels emphasized the wording of the relevant provisions which they analysed in detail. The Panel in Canada–Pharmaceutical Patents recognized public policy implications of Article 30 without, however, expounding on substantive issues. a Article 13 TRIPS (Limitations and Exceptions) The Panel relied basically on the VCLT method of interpretation to find the criteria for judging the scope of the exceptions and limitation under Article 13 TRIPS which provides that: Members shall confine limitations or exceptions to exclusive rights to certain special cases which do not conflict with a normal exploitation of the work and do not unreasonably prejudice the legitimate interests of the right holder. In this case, the European Communities and their Member States alleged that the exemptions provided in subparagraphs (A) and (B) of Section 110(5) of the US Copyright Act were in violation of the US’s obligations under Article 9.1 of the TRIPS Agreement, together with Articles 11(1)(ii) 59 and 11 bis (1)(iii) 60 of the Berne Convention (1971). Section 110(5) of the US Copyright Act provides for limitations on exclusive rights granted to copyright holders for their copyrighted work, in the form of exemptions for broadcast by non-right holders of certain performances and displays, namely, (A)’home style exemption’ (for ‘dramatic’ musical works) and (B)’business exemption’ (works other than ‘dramatic’ musical works, eg the playing of radio and television music in public places such as bars, shops, restaurants, etc). For the EC, the above exemptions under the US law could not be justified under any express or implied exception or limitation permissible under the Berne Convention (1971) or the TRIPS Agreement. 61 Article 9.1 TRIPS stipulates that ‘Members shall comply with Articles 1 through 21 of the Berne Convention (1971) and the Appendix thereto . . .’. Article 13 of the TRIPS Agreement, in Section 1 concerning copyright and related rights, provides three conditions in which limitations and exceptions to exclusive rights are allowed. According to Article 13, ‘Members shall confine limitations or exceptions to exclusive rights to certain (i) special cases; (ii) which do not conflict with a normal exploitation of the work; and, (iii) do not unreasonably prejudice the legitimate interests of the right holder. The Panel and the parties agreed that these conditions are cumulative because the principle of effective treaty interpretation requires that the Panel avoids any reading that could reduce any of the conditions to redundancy or inutility. 62 The Panel found that the language of Article 13 TRIPS is similar to that in Article 9(2) of the Berne Convention, except that Article 9(2) applies only to the right of reproduction, whereas Article 13 has no such limitation. The Panel also noted at the outset that: ‘Article 13 cannot have more than a narrow or limited operation. Its tenor, consistent as it is with the provisions of Article 9(2) of the Berne Convention (1971), discloses that it was not intended to provide for exceptions or limitations except for those of a limited nature.’ 63 Having considered the examples of the minor exceptions in the context of the Berne Convention as well as national laws, the Panel concluded that Article 13 is a narrow exception which is allowed only if its scope is de minimis . 64 This analysis was based on the wording of the provision in its context and facts from national laws, not because of the general principle that exceptions must be interpreted narrowly. In the light of the minor exceptions doctrine which was recognised as being incorporated into Article 13 of the TRIPS Agreement, the Panel analysed each term, 65 first of all textually, 66 but also through economic data which represented the actual and potential effects of the exemptions. 67 The EC argued that the exceptions should be related to a legitimate policy purpose. In examining the scope and meaning of ‘certain special cases’, the Panel rejected equating the term ‘certain special cases’ with ‘special purpose’. The Panel explained that: ‘It is difficult to reconcile the wording of Article 13 with the proposition that an exception or limitation must be justified in terms of a legitimate public policy purpose’. 68 According to the Panel, ‘special cases’ in Article 13 require that a limitation or exception in national legislation should not only be clearly defined, but also ‘narrow in its scope and reach’. 69 Interestingly, the EC contended in this case that the US exemption is not based upon a ‘valid’ public policy or other exceptional circumstance that makes it inappropriate or impossible to enforce the exclusive rights conferred. 70 The Panel did not interpret Article 13 of the TRIPS Agreement from an a priori conception of public policy, with the intention of achieving appropriate balance based on such conceptions. 71 Interestingly, the Panel rejected the idea that the first condition of Article 13 requires ‘a value judgment on the legitimacy of an exception or limitation’. 72 The Panel added, however, that ‘public policy purposes could be of subsidiary relevance for drawing inferences about the scope of an exemption and the clarity of its definition’. It then reiterated that what is important for the interpretation of Article 13 is that the statements from the legislative history indicate an intention of establishing an exception with a narrow scope, and that the intention of Article 13, which incorporates the context of Arts 11 and 11 bis of the Berne Convention (1971), is to allow exceptions as long as they are de minimis in scope. 73 Concerning the second condition that exceptions must ‘not conflict with a normal exploitation of the work’, the Panel, after examining the ordinary meaning of the words, held that ‘normal exploitation’ means something less than the full use of an exclusive right 74 and that work includes ‘all’ of the relevant exclusive rights attached to the work. The US argued that whether or not the exception conflicts with normal exploitation should be judged by economic analysis of the degree of ‘market displacement’, ie, the forgone collection of remuneration by right holders. The Panel supported the EC argument that proof of actual trade effects has not been considered an indispensable prerequisite for a finding of inconsistency with the national treatment clause of Article III of GATT and it is rather ‘a potentiality of adverse effects on competitive opportunities and equal competitive conditions for foreign products, in comparison to like domestic products’. 75 In applying this GATT model of analysis to a TRIPS case, the Panel explained that: We wish to express our caution in interpreting provisions of the TRIPS Agreement in the light of concepts that have been developed in GATT dispute settlement practice. . . . Given that the agreements covered by the WTO form a single, integrated legal system, we deem it appropriate to develop interpretations of the legal protection conferred on intellectual property right holders under the TRIPS Agreement which are not incompatible with the treatment conferred to products under the GATT, or in respect of services and service suppliers under the GATS, in the light of pertinent dispute settlement practice. 76 The Panel analysed the preparatory work for the Berne Convention’s 1967 Revision Conference and arrived at the following criteria for judging whether the second condition was met: an exception or limitation to an exclusive right in domestic legislation rises to conflict with a normal exploitation of the work, if uses that are covered by that right but exempted under the exception or limitation, enter into economic competition with the ways that right holders normally extract economic value from that right to the work, depriving them of significant or tangible commercial gains. 77 The Panel rejected the US approach after the 1976 law amendment following the Aiken judgment 78 which equates ‘normal exploitation’ with ‘normal remuneration’ in a given market, at a particular point in time. The Panel further recalled that the US law exempts communication to the public of radio and television broadcasts, while the playing of musical works from CDs and tapes (or live music) is not exempted. 79 On the third condition of Article 13, ie, ‘not unreasonably prejudic[ing] the legitimate interests of the right holder’, the US argued that the focus should be placed on whether the right holder is ‘harmed by the effects of the exception’ and whether that prejudice is ‘unreasonable’. The Panel observed that this third condition implies a three-step test, ie, the determination of the terms ‘legitimate interests’ at stake and the extent of ‘prejudice’ to judge what amount of prejudice reaches the level of what is considered to be ‘unreasonable’. 80 The Panel stressed the need to take into account potential revenue loss and the need for right holders to own their rights such that they can engage in agreements like collective management organisations in the first place. Based on the economic impact of the provisions in US law for ‘normal use’ and ‘legitimate interest of the right holder’ incurred by the exemptions, 81 the Panel concluded that the US, which had the burden of proof in invoking the exception of Article 13, failed to demonstrate that the business exemption did not unreasonably prejudice the legitimate interests of the right holder. 82 The Panel’s method of interpretation of the scope of exception and limitations in Article 13 of TRIPS shows that the burden of proof concerning the consequences of an exception is more crucial than its justification in words, ie, a public policy, self-standing right or principle. Based on the analyses of data brought by the parties based on this methodology, the Panel concluded that the business exemption did not meet the requirements of TRIPS Agreement Article 13 and was inconsistent with Berne Convention Articles 11 bis (1)(iii) and 11(1) (ii) as incorporated into the TRIPS Agreement by TRIPS Agreement Article 9.1. 83 In US–Section 101 (5) Copyright Act , there was no debate on the dimension of public policy largely because of the wording of Article 13 of the TRIPS Agreement. According to the Panel, the phrase ‘certain special cases’ in Article 13 of the TRIPS Agreement is not the equivalent of ‘for a special purpose’ and does not refer to justifiable in the sense of normative policy (such as public policy or special circumstances). However, ‘for a special purpose’ is also included in ‘certain special cases’, so it is possible to interpret that Article 13 also has a public policy dimension. It would be possible under the TRIPS Agreement to consider public policy considerations for copyright protection to the extent that the scope of ‘minor exception’ allows. b Articles 30 TRIPS (Exceptions to Rights Conferred) The Panel in Canada–Pharmaceutical Patents 84 adopted a method of interpretation even more textualist than that in US–Section 101 (5) Copyright Act in that it did not resort to economic data in judging whether the ‘regulatory exception’ (popularly called the ‘ Bolar exemption’ 85 ) for drug marketing authorisation and the ‘stock-piling’ exception provided by the Canadian Patent Act 86 could be considered to fall within the scope of exceptions provided by Article 30 of the TRIPS Agreement. Article 30 TRIPS provides that: Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties. Canada, in interpreting the conditions of exceptions stipulated in Article 30 TRIPS to the exclusive rights conferred on the patent-owner under Article 28 TRIPS, called attention to Articles 7 and 8.1 TRIPS, as relevant to the object and purpose of Article 30. 87 According to Canada, Article 7 declares that one of the key goals of the TRIPS Agreement was a balance between the IPRs created by the Agreement and other important socio-economic policies of WTO Member governments. For Canada, Article 8 elaborates upon the socio-economic policies in question, with particular attention to health and nutritional policies. 88 With respect to patent rights, Canada argued that: ‘these purposes call for a liberal interpretation of the three conditions stated in Article 30 of the Agreement, so that governments would have the necessary flexibility to adjust patent rights to maintain the desired balance with other important national policies’. The EC, on the other hand, argued that Articles 7 and 8 describe a balancing that had already taken place during the TRIPS Agreement negotiations and that the negotiations were not intended to allow a Member to ‘renegotiate’ the overall balance. The EC pointed to the last phrase of Article 8.1, which requires that socio-economic policies that Canada refers to must be consistent with the obligations of the TRIPS Agreement. 89 For the EC, the first paragraph of the Preamble and Article 1.1 demonstrated that the basic purpose of the TRIPS Agreement was ‘to lay down minimum requirements for the protection and enforcement of intellectual property rights’. 90 The Panel stated the view that ‘Article 30’s very existence amounts to a recognition that the definition of exclusive rights contained in Article 28 would need certain adjustments’, but that ‘the three limiting conditions attached to Article 30 testify strongly that the negotiators of the Agreement did not intend Article 30 to bring about what would be equivalent to a renegotiation of the basic balance of the Agreement’. 91 The Panel considered that the exact scope of Article 30’s authority will depend on the specific meaning given to its limiting conditions. For the Panel, therefore, the scope of exceptions to the patent rights conferred must be determined by analysing the wording of Article 30 in the context of relevant TRIPS provisions, including Articles 7 and 8.1. Article 30 of the TRIPS Agreement stipulates three conditions which the Panel considered to be cumulative. 92 The exception must (1) be ‘limited’; (2) not ‘unreasonably conflict with normal exploitation of the patent’; and (3) not ‘unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties’. The language of Article 30 resembles that of Article 13 TRIPS, since the drafters drew the same inspiration from Article 9(2) of the Berne Convention as they did for Article 13 TRIPS. However, in condition (3) of Article 30, in contrast to Article 13, the phrase, ‘taking account of the legitimate interests of third parties’ is added which, according to the Panel in this case, leaves room for public policy consideration. The Panel interpreted the first condition, ‘limited exception’, to connote a ‘narrow exception – one which makes only a small diminution of the rights in question’. 93 For the Panel, this concerned legal rights which must be ‘measured by the extent to which the exclusive rights of the patent owner have been curtailed’, rather than by the size or extent of the economic impact. Canada argued that whether or not an exception to exclusive rights is ‘limited’ depends on whether the right holder has lost an exclusive right to sell, which is one of the five exclusive rights set out in Article 28 of the TRIPS Agreement, ie, making, using, offering for sale, selling or importing. 94 However, the Panel argued that if the right to sell was the only important right, there would be no point in setting out five rights in Article 28 of the TRIPS Agreement. 95 The Panel disagreed also with the EC on the methodology of ‘counting’ the number of legal rights impaired, and instead articulated a standard under which ‘the extent to which the patent owner’s rights have been curtailed must be measured’. 96 For the Panel, the stockpiling provision violates the criteria of ‘limited exception’ as there are no limitations on the quantity of production for stockpiling. Concerning the second condition, that exceptions must not ‘unreasonably conflict with a normal exploitation of the patent’, the parties differed on the meaning of ‘normal’. According to the Panel, the term ‘normal’ has a combined meaning of two possible dictionary meanings, ie, ‘what is common within a relevant community’, and ‘a normative standard of entitlement’. 97 No economic criteria for judging whether the effects of the Canadian law ‘unreasonably conflict with a normal exploitation of the patent’ were developed or applied in this case. The Panel held therefore that a right to extended term of protection due to regulatory delays falls outside the bounds of ‘normal’ 98 as the patent term erosion of this kind is an unintended consequence of the conjunction of the patent laws with product regulatory laws, which is not applicable to the vast majority of patented products. 99 For these reasons, the Panel concluded that Canada’s regulatory review provision does not conflict with a normal exploitation of patents under TRIPS Agreement Article 30. 100 As for the meaning of condition (3) of Article 30, ie, that the exception must not ‘unreasonably prejudice the legitimate interests of the patent owner, taking into account the legitimate interests of third parties’, the Panel relied on the dictionary definition. It interpreted the word ‘legitimate’ as a normative claim calling for protection of interests that are ‘justifiable’ in the sense that they are ‘supported by relevant public policies or other social norms’, and then looked into the preparatory work of Article 9(2) of the Berne Convention. The Panel concluded that the concept of ‘legitimate interests’ in Article 30 are construed as a broader concept than legal interests. 101 The EC invoked the time lost to the effective patent protection due to regulatory delays in obtaining marketing approval, but the Panel rejected the EC claim that this situation creates a ‘legitimate interest’ for the patent holder. The Panel asserted that this interest was ‘neither so compelling nor so widely recognized’ to constitute a ‘policy norm’ that would fall within TRIPS Agreement. According to the Panel, the concept of ‘legitimate interests’ should not be used to decide, through adjudication, a normative policy issue that was still obviously a matter of unresolved political debate. 102 From this, the Panel concluded that Canada had demonstrated that the regulatory review provision did not prejudice ‘legitimate interests’ of affected patent owners within the meaning of Article 30. 103 Thus, in evaluating the scope of exceptions allowed under Article 30, the Panel took a thoroughly ‘textualist’ approach. Intense discussions followed as to the extent to which this formalism is suited to intellectual property protection. The Panel’s extreme caution in confining itself to a textual approach for interpreting TRIPS provisions may partly be explained by the existence of potential political and industrial conflicts which could involve polarising debate. The formal, textual approach in Canada–Pharmaceutical Patents seems to have preempted endless political arguments, although the fact that no economic or social realities behind abstract concepts have been taken into consideration has left many other questions open to future debates. The Panel in Canada–Pharmaceutical Patents stated that the non-discrimination rule delineated in Article 27.1 applied also to exceptions. This gave rise to various criticisms, including those relating to research tool patents in biotechnology, as we will see below. D Non-Discrimination Principles in the TRIPS Agreement i National Treatment Principle and IP protection National treatment and most favoured nation principles, commonly called ‘non-discriminatory principles’, have been pivotal in trade liberalisation in goods throughout the GATT and the WTO history, and central to trade disputes and their settlement within these institutions. These principles are also enshrined in Part I of the TRIPS Agreement as basic principles, in Articles 3 and 4, respectively, but they had to be adapted to be applied to intellectual property owned by persons. In the TRIPS context, these GATT principles apply specifically to the ways in which IPR ‘protection’ is accorded to nationals and non-nationals, which include, according to footnote 3 to Article 3, ‘matters affecting the availability, acquisition, scope, maintenance and enforcement of intellectual property rights as well as those matters affecting the use of intellectual property rights specifically addressed in this Agreement.’ In Indonesia–Autos , 104 therefore, the US argued, as an ancillary complaint, that the Indonesian law and practices at issue, as far as they concerned the use of trademarks, were inconsistent with Article 3 TRIPS, national treatment and Article 20 of the TRIPS Agreement. 105 The Appellate Body in US–Section 211 Appropriation Act considered that Article III:4 GATT, which concerns equality of competitive opportunities for domestic and imported products, could serve as a ‘useful context’, even to this TRIPS dispute. 106 The relevant standard for its examination of Article 3.1 TRIPS concerning national treatment was ‘whether the measure provides effective equality of opportunities as between these two groups in respect of protection of intellectual property rights’. 107 The Panel in EC–Geographical Indications , admitted further that the language of Article 3.1 is similar to the language of GATT Article III:4, 108 but that the latter requires that ‘no less favourable treatment must be given to like products’. The Panel suggested that this combination of elements, the basic principles of GATT 1994 and of relevant international intellectual property agreements or conventions, characterises new TRIPS rules and disciplines as expressed in the preamble to the TRIPS Agreement. 109 The Panel in EC–Geographical Indications examined whether the difference in treatment affected the ‘effective equality of opportunities’ for nationals of the defendant Member’s country with regard to the ‘protection’ of IPR, to the detriment of nationals of other Members. 110 In this regard, the Panel quoted the Appellate Body in Korea–Various Measures on Beef

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Does TRIPS (Agreement on Trade‐Related Aspects of Intellectual Property Rights) prevent COVID‐19 vaccines as a global public good?

Hans morten haugen.

1 Faculty of Theology, Diakonia and Leadership, VID Specialized University, Oslo Norway

Associated Data

The data that support the findings of this study are available from the corresponding author upon reasonable request.

The article analyses the global public goods approach to COVID‐19 technologies, embedded in 2020 affirmations by the World Health Assembly (WHA), the UN Human Rights Council and G20 on broad immunization against COVID‐19. After identifying the access to COVID‐19 tools (ACT) Accelerator members, the UN efforts are identified, focusing primarily on the UN human rights bodies, acknowledging how these and the WHA have mutually reinforced each others' efforts. The article finds that the global public goods terminology appeared in UN resolutions in 2020, while wording that included vaccines—on an equal footing as medicines—appeared in 2016, and recognition of generic medicines appeared in 2019. The so‐called Trilateral Cooperation on IP and public health between two UN specialized agencies and the World Trade Organization (WTO) has increased awareness of the flexibilities within WTO's TRIPS Agreement. These flexibilities are explained. With notable exceptions, like India, these flexibilities are not widely applied in domestic legislation. A different emphasis characterizes the millennium development goals era as compared to the sustainable development goals era, and this shift is explained by applying relevant theories. Among pro‐TRIPS developed countries there is an acknowledgment of obstacles created by the IP system, but their overall position has not changed.

1. A HUMAN RIGHTS AND GLOBAL PUBLIC GOODS APPROACH

The Leaders' Declaration from the G20 summit in Riyadh November 21–22, 2020 reads: “We recognize the role of extensive immunization against COVID‐19 as a global public good” (G20, 2020a , para. 3) and these terms are also found in the Statement from a G20 Joint Finance & Health Ministers Meeting September 17, 2020 (G20, 2020b ). The statement has three references to intellectual property (IP): on voluntary licensing, effective IP protection, as well as stating that IP has enabled medicines and vaccines and “not been an impediment to the common goal of ending this pandemic” (G20, 2020b ).

The same wording on global public goods is found in the Human Rights Council's resolution, adopted without a vote July 16, 2020, with the specification that the vaccines must be “safe, quality, efficacious, effective, accessible and affordable…” (UN Human Rights Council, 2020 , para. 7) and in a resolution by World Health Assembly of May 19, 2020 (World Health Organization [WHO], 2020a , para. 6, not including the terms effective and accessible). The two terms “safe and effective” are highlighted in the G20 Declaration and Statement (G20, 2020a , para. 3; 2020b ).

Two other differences are noteworthy. First, while the G20 Statement eight times mention medicines and vaccines together and twice applies the terms equitable and affordable together, the others apply the term “equitable access to and fair distribution of all … health technologies and products  …” (UN Human Rights Council, 2020 , para. 5; WHO, 2020a , para. 4; italics added). Second, while G20 said that IP “has not been an impediment” (G20, 2020b ), the two others, in the context of access and distribution, called for an “urgent removal of unjustified obstacles thereto, in accordance with … TRIPS … flexibilities …” (UN Human Rights Council, 2020 , para. 5; WHO, 2020a , para. 4).

Hence, we see that the IP, more specifically the TRIPS Agreement—Annex 1C to the World Trade Organization (WTO) Agreement—can allegedly serve as an obstacle or facilitator for promoting the such equitable access and fair distribution of vaccines and other health technology. The terms equity and equitable are in accordance with the Oxford Dictionary of Law Enforcement understood as synonymous to just, fair, and reasonable. The term global public good is in accordance with the Oxford Dictionary of Economics understood as a good that provides nonexcludable and nonrival benefits on a worldwide scale. Nonexcludable implies that the good is to be accessed by all, and nonrival implies that other's use of the good does reduce one's own possibilities to access the same good.

Immunization by providing vaccines has for decades been a responsibility of particularly the UN Children's Fund (Unicef) in those countries where the health authorities are not capable of providing vaccines. Since 2000, the Global Alliance for Vaccines and Immunization (Gavi) have strengthened domestic capacities for provding immunization. This author is not aware of any countries where individuals must pay for vaccines. Hence, it is reasonable to understand vaccines as standing out from other products produced by pharmaceutical corporations. The global market for vaccines can be characterized as an oligopsony whose core characteristic is few large buyers.

This article analyzes the context for the allegation that IP is among the crucial factors in promoting health innovation globally, and not preventing the universal and equitable access to vaccines, even if supply of medicines is held by developed countries to be “difficult” (WTO Secretariat, 2020a ). Biotechnology actors expressed criticism of the UN High‐level Panel on Access to Medicines ( 2016 ), arguing that IP tends to be overemphasized in debates over access to medicines, ignoring the wider context of what impedes such access (International Council of Biotech Associations [ICBA], 2016 ; Biotechnology Innovation Organization [BIO], 2016 ). Hence, developed countries and biotech associations concur in identifying weak funding of health care and lack of manufacturing capacity as constituting the core of the problem of access (WTO Secretariat, 2020a ; see also U.S. Department of State, 2016 ), as well as regulatory inefficiencies, trade policies and inadequate health insurance (ICBA, 2016 ).

While there are no international treaties that explicitly specify rights and obligations in the context of global public goods (Maskus & Reichman, 2005 ), the global dimensions of IP and access gained more prominence in the aftermath of TRIPS (Drahos & Mayne, 2002 ; Matthews, 2002 ). Moreover, antologies and monographies have analyzed the relationships between human rights and IP (Geiger, 2015 ; Grosheide, 2010 ; Grosse Ruse‐Khan, 2016 ; Helfer & Austin, 2011 ; Hestermeyer, 2007 ; Torremans, 2020 ). Human rights constitute primarily a proaccess and prodevelopment approach (Yu, 2020 ). Human rights in the context of medicines and vaccines are regulated in two provisions of the International Covenant on Economic, Social and Cultural Rights (ICESCR). First Article 12(2)(c) encompasses state measures for the “prevention, treatment and control of of epidemic … diseases.” Second, Article 15(1)(b) recognizes the right to “benefits of scientific progress and its applications.” As will be shown in Section 5.2 , there is also a provision on authors' rights in the ICESCR, Article 15(1)(c), whose expansive interpretation has been criticized (Koopman, 2008 , pp. 578–582). Moreover, the fact that the human right to property can justify IP claims has given rise to notions of “paradox” (Grosheide, 2010 ; Plomer, 2013 ).

It is important to acknowledge that the encounter between human rights and IP is an encounter between two regimes with different implementing institutions. The human rights regime has few specific prohibitions and more emphasis on taking the right measure, while the IP regime has more specific provisions and stronger mechanisms for enforcement. After identifying the core of the relevant human rights and TRIPS flexibilities, not elaborating on the corresponding obligations in great depth, the article will turn to soft‐law documents. While proposals for an access to knowledge (A2K; Shaver, 2009) treaty has not progressed further—with the exception of the 2013 Marrakesh Treaty to Facilitate Access to Published Works for Persons Who Are Blind, Visually Impaired or Otherwise Print Disabled (Helfer et al., 2017 )—such access has been emphasized in the context of the sustainable development goals (SDG) and science and technology for innovation (STI).

The article will proceed as follows: Section 2 elaborates on the theoretical framework of power and space‐claiming, and principled pragmatism, which will be applied in explaining both opposing and reapproaching views over IP. Section 3 presents the institutional framwork for vaccine development, approval, and dissemination. Section 4 identifies the TRIPS flexibilities and how these are applied. Section 5 reviews the 20 years of efforts to enhance access to medicines and vaccines within a human rights framework. Section 6 identifies initiatives and proposals in the millennium development goals (MDG) era practices for enhanced access to medicines and vaccines, particularly for states with limited purchasing capacity. Section 7 has a similar discussion for the SDG era, termed Agenda 2030. Section 8 provides a critical assessment of the role of IP in the context of STI. Section 9 is a concluding discussion, linking up to the rationales for the global public goods as identified above.

India will be central in the analysis as a core country in term of its pharmaceutical manufacturing capacity—being a producer of 70% of all vaccines globally (Upadhyay, 2020 , referring to the Director‐General of International Vaccine Institute)—its extensive use of TRIPS flexibilities—as reflected in both laws and court rulings—and its proactive role in the Council for TRIPS.

The research question this article seeks to answer is: How has the UN framed its efforts to enhance accessibility to medicines and vaccines, and has the framing of the COVID‐19 medicines and vaccines in a global equity context—representing global public good and being crucial for human rights fulfillment—had any impact on the position of the most pro‐TRIPS WTO member states?

2. INSTITUTIONAL AND THEORETICAL EMBEDDING: POWER ASYMMETRIES AND SPACE‐CLAIMING, AND PRINCIPLED PRAGMATISM

Unequal control over both technology and decision‐making give rise to power asymmetries. Power that comes with controlling technologies, including patents and other IP, seems relatively obvious. The power dimensions inherent in the structure and functioning of the WTO, particularly TRIPS, as well as the theory of principles pragmatism must be explained. The section will introduce and embed the theories in the context of WTO, TRIPS, and the UN Guiding Principles on Business and Human Rights, and aspects of WTO decision‐making will also be included in Section 2.2 .

2.1. Decision‐making in the WTO

In the WTO, decision‐making is neither based on financial contribution—as in the World Bank—nor on one state, one vote—as in the UN. The decision‐making principle that applies in the WTO is that of consensus. There are examples of Ministerial Conferences that have not been able to come to agreement because of opposition expressed by merely one state, like India at the Cancun Ministerial Conference in 2003.

For some decisions, for instance determining on a waiver, applying to one—or a few—member state(s), there is a requirement of a three‐fourths majority, as specified in the WTO Agreement, Article IX.3. Note 4 to the Agreement Establishing the WTO (hereafter: WTO Agreement) specifies that if a member state requests extension of its transition period—with less obligations imposed—the decision must be taken by consensus.

The meeting in the Council for TRIPS October 15 and 16, 2020 had before it a proposal by India and South Africa to adopt a waiver on the enforcement of IP—patents, industrial designs, trade secrets and copyrights—in relation to prevention, containment or treatment of COVID‐19 (India and South Africa, 2020 , para. 12). The term containment must be understood as encompassing vaccines. The duration of the waiver was specified to last “until widespread vaccination is in place globally, and the majority of the world's population has developed immunity” (India and South Africa, 2020 , para. 13). Not surprisingly, the debate was fierce, and concerns were expressed that the waiver proposal risks to “undermine the collaborative efforts to fight the pandemic” (WTO Secretariat, 2020a ). A proposal for a “Trade And Health” Initiative was subsequently proposed (Australia et al., 2020 ). Three developing countries joined this proposal: Brazil, Chile, and Kenya.

The WTO requires all waiver requests to be considered within 90 days and then brought before the General Council; see WTO Agreement Article IX.3(b). The proposal by India and South Africa ( 2020 ) is specified as applying to all WTO member states. The WTO General Council instructed in December 2020 the Council for TRIPS to work further with the waiver proposal (WTO, 2020 ).

Hence, it is reasonable to state that the WTO system is characterized by certain asymmetries, but it must also be acknowledged that interests of economically poorer states might prevail over interests of economically more powerful states, at least in specific decisions.

2.2. Power theories

A comprehensive model that builds on Lukes' theory on forms of power, distinguishing between visible (influence others), hidden (influencing what is and what is not on the agenda) and invisible (influencing overall perceptions) (Lukes, 1974 ) is the power cube (Gaventa, 2009 ). The power cube adds two dimensions: levels (global, national, and local) and spaces (closed, invited, and claimed/created). The realm of WTO is obviously on a global level. Hence, there is no need for a further elaboration on the dimension of levels, except from reminding of the fact that there are various traditions and legal frameworks for openness and transparency as regard IP and trade policies at the domestic level. Moreover, asymmetrical power relations might be exercised more directly in bilateral relations as compared to multilateral relations where alliances can be built. A characterization of the degree of openness in the WTO will be given below.

As regards the forms of power, it is obvious that the WTO system has a relatively rigid monitoring and enforcement system, able to influence the conduct of the member states. Hence, visible power is obviously relevant. First, there are regular reviewing of each member state's legal framework in accordance with the Trade Policy Review Mechanism, Annex 3 to the WTO Agreement. Second, the Dispute Settlement Understanding (DSU), Annex 2 to the WTO Agreement. The DSU outlines procedures for how to solve any dispute arising under any of the WTO agreements, specifying in Article 22.1 that two forms of measures can be determined—by the Dispute Settlement Body—in cases of noncompliance with a given recommendation and ruling: compensation and suspension of concessions.

To what extent is there also hidden power at play in the WTO particularly in the context of TRIPS? TRIPS has established a minimum level of IP protection with certain flexibilities, as will be shown below. Several bilateral and trade and investment treaties have introduced higher levels of IP protection, with less flexibility, termed TRIPS+. The Council for TRIPS has not always served to uphold the TRIPS flexibilities in its oral and written communication, as will be shown when discussing TRIPS flexibilities below. Hence, there can be no doubt that agenda‐setting power is exercised by the WTO and the Council for TRIPS.

Are the WTO and TRIPS processes also characterized by invisible power, which is about influencing overall perceptions? The overall perception that high levels of IP protection are an absolute requirement for private investors' willingness to invest, might ignore the fact that there are several other elements that must be in place in a given country (BIO, 2016 ; ICBA, 2016 ). Nevertheless, IP is important for enhancing predictability, particularly in the important phase from invention to a marketable innovation. What about perceptions about TRIPS flexibilities, specified in both the 2001 Doha Declarations (WTO, 2001a , para 17; 2001b ) and in the Trilateral Cooperation on Public Health, IP and Trade (WHO, World Intellectual Property Organization [WIPO], and WTO, 2020a ; 2013 )? We will come back to these in Section 4.1 . The G20 Statement emphasizing “effective IP protection” (G20, 2020b ) might sum up these overall perceptions. TRIPS has introduced high overall protection levels and rigorous enforcement requirements globally.

As regards the spaces of power, particularly applying to TRIPS, it is reasonable to state that while the TRIPS negotiations in 1986–1994 can be characterized as closed, there has gradually been more space for civil society in the overall WTO system, and accreditation procedures allow civil society organizations to be “invited.” Many of the IP negotiations within regional and bilateral trade and investment treaties are still relatively closed and asymmetrical. Civil society actors have tried to influence by various campaigns, advocacy efforts, and demonstrations, claiming a space for influencing decisions.

Tensions regarding IP between developed and developing countries are also evidenced in other forums, most notably WIPO, a UN specialized agency. An organizational review of WIPO found “an acute polarization between various groups of delegations…” (UN Joint Inspection Unit, 2014 , p. 10). It is therefore reasonable to state that it is IP on a broader term, and not TRIPS specifically, that explains IP tensions globally.

2.3. Theory on public–private cooperation

Additionally, a theory that is believed to capture the enhanced cooperation between public and private for‐profit actors is the theory of principled pragmatism, being embedded in human rights and identifying “what works best in creating change where it matters most…” (UN Special Representative of the Secretary‐General on the Issue of Human Rights and Transnational Corporations and other Business Enterprises, 2006 , para. 81). The Special Representative 2005–2011 was John Ruggie, one of the world's leading social constructivist scholars within international relations studies. His efforts resulted in the UN Guiding Principles on Business and Human Rights (“UN Guiding Principles,” UN Special Representative of the Secretary‐General on the Issue of Human Rights and Transnational Corporations and other Business Enterprises, 2011 ; see also UN Human Rights Council, 2011a , para. 1). The UN Guiding Principles consist of three pillars for the promotion of human rights: state duties to protect, corporate responsibility to respect, and access to remedies.

3. THE GLOBAL INSTITUTIONAL FRAMEWORK FOR THE COVID‐19 RESPONSE

Unicef and Gavi are already mentioned above, and there are other actors in the global response to COVID‐19. According to its Constitution (WHO, 2006 [1946]), its objective is the “attainment by all peoples of the highest possible level of health.” While WHO has adopted various tools to fight epidemic and endemic diseases—most notably the International Health Regulations, first adopted in 1969 (WHO, 2005 )—WHO's overall inadequacies have been highligthed (France and Germany, 2020 ). Three distinct efforts by the WHO in 2020 are reviewed.

3.1. WHO's coordination of vaccines testing and aprovals

WHO keeps a record of vaccines developments globally, currently being updated twice a week. On November 3, 2020 WHO published an overview of the various COVID‐19 vaccines initiatives, identifying 10 to be in the Phase 3 (WHO, 2020b ), implying that the vaccine is tested for efficacy and safety among several thousand persons (Robinson, 2016 ).

Within 3 weeks, 3 of 10 reported to have developed vaccines with 90%, 94.5%, and up to 90% efficacy, respectively (Moderna, 2020 ; Pfizer and BioNTech, 2020; 90% achieved in the smallest sample). 1 The first has challenging storing requirements (−70°C). Moderna has cooperated with the National Institute of Allergy and Infectious Diseases (NIAID), one of 27 institutes under the National Institute for Health (NIH, 2020 ). AstraZeneca has cooperated with the Jenner Institute and Oxford Vaccine Group at the University of Oxford.

Efficacy is measured during the testing phase, being the “protective effects of vaccination by the reduction in the infection risk of a vaccinated individual relative to that of a susceptible, unvaccinated individual” (Shim & Galvani, 2012 , p. 6700). Effectiveness is measured in the context of the actual vaccination, being defined as “the reduction in the transmission rate for an average individual in a population with a vaccination program at a given level of coverage compared to an average individual in a comparable population with no vaccination program” (Shim & Galvani, 2012 , p. 6700).

Together, the three first corporations indicate that approximately five billion vaccines can be produced by 2021 (AstraZeneca, 2020 ; Moderna, 2020 ; Pfizer & BioNTech, 2020 ). AstraZeneca seeks an Emergency Use Listing from the WHO to make vaccines available in low‐income countries.

3.2. WHO promoting access to COVID‐19 tools in developing countries

WHO has launched the Solidarity Call to Action, highlighting three elements in the headings of the Call: public common good, equitable global access, and pooling of knowledge, IP and data (WHO, 2020c ). Moreover the term response used in the Call must be understood to encompass both diagnosis, treatment, and vaccines, as well as broader measures to strengthen health systems. To facilitate pledges of commitments to the Solidarity Call to Action, the COVID‐19 Technology Access Pool (C‐TAP) has been established (WHO, 2020d ). The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), having 12 corporations—including AstraZeneca—and 12 national associations as full members (IFPMA, 2020a ), criticizes C‐TAP:

By urging licenses or non‐enforcement declarations for COVID‐19 treatments and vaccines to be granted on a non‐exclusive global basis, the Solidarity Call to Action promotes a one‐size‐fits all model that disregards the specific circumstances of each situation, each product and each country (IFPMA, 2020b ).

This must be understood as a form of assertion by the biotech corporations that they know best when to engage in voluntary licensing and nonenforcement of patent.

Other pledges have been launched by other actors, most notably the Open COVID Pledge, whose call is to “organizations around the world to make their patents and copyrights freely available in the fight against the COVID‐19 pandemic” (Open COVID Pledge, 2020 ). Having support from main technology corporations, including Microsoft, IBM, and Facebook, as well as Amazon, the project is led and stewarded by Creative Commons.

3.3. WHO's overall promotion and facilitation of joint efforts in the context of COVID‐19

WHO has been instrumental in setting up the Access to COVID‐19 Tools Accelerator (ACT‐A), launched in April 2020 (WHO, 2020e ). ACT‐A coordinates efforts by nine global health organizations, as well as governments, scientists, businesses, civil society, and philanthropists. The highest body of the ACT‐A is the Facilitation Council.

An overview of the nine organizations which are behind ACT‐A—and how they interrelate to each other—is helpful in identifying the global landscape for COVID‐19 responses (year of founding in paranthesis). First, the Bill & Melinda Gates Foundation (BMGF, 2000) is the largest foundation in the world, and is a cofounder (with Norway, Germany, India, Japan and Wellcome Trust; see below) of the second organization, the Coalition for Epidemic Preparedness Innovations (CEPI, 2016). The third organization is Foundation for Innovative New Diagnostics (FIND, 2003), having six of the nine organizations in ACT‐A as donors (FIND, 2020 ), and the Memorandum of Understanding (MoU) entered between WHO and FIND February 10, 2020 refers to COVID‐19 (WHO, 2020f ). Fourth, Gavi, whose main funder continues to be BMGF. Fifth, The Global Fund to Fight AIDS, Tuberculosis and Malaria (The Global Fund, 2002). Sixth, Unitaid (2006), established by France and Brazil to transfer innovative sources of financing—like air ticket levies—to innovative health projects, acknowledged as a partner by the WHO ( 2020g ), and BMGF is also listed among the main donors (Unitaid, 2020 ). Seventh, Wellcome Trust (1936), listing its cooperation with CEPI and Unitaid in the context of COVID‐19 efforts (Wellcome Trust, 2020 ). Eight, the WHO (1946), Ninth, the World Bank (1944).

ACT‐A works within four pillars: diagnostics, treatments, vaccines, and health system strengthening. The Global Fund and FIND are the coconvenors of the Diagnostics Partnership. Unitaid and Wellcome are the coconvenors of the Therapeutics Partnership. The vaccines partnership is termed COVAX, with Gavi, CEPI and WHO as the coconvenors, operating through a mechanism called COVAX Facility (Berkley, 2020 ). The Global Fund and the World Bank are the coconvenors of the health system strengthening pillar. It is also relevant that Unicef has both facilities and experience in vaccine programmes—cooperating with WHO, CEPI and Gavi—and Unicef will be involved in the actual vaccination.

In addition to these organizations, the other categories: governments, scientists, businesses and civil society—supported by philanthropists—are working strenuously to provide vaccines and other medical technology, including tools for treatment and accurate diagnosis. Hence, the global institutional system for fighting COVID‐19 by all means is complex and committed to find a solution to the COVID‐19 pandemic as soon as possible.

4. TRIPS FLEXIBILITIES AND THEIR APPLICATION

A full review of all the TRIPS flexibilities is neither possible nor necessary. In addition to the possibilities to adopt waivers under Article IX.3 of the WTO Agreement, as shown above, at least five provisions of TRIPS must be mentioned: Articles 6, 30, 31, 32, and 39. It is also relevant to emphasize that TRIPS Article 40 regulates anticompetitive practices, as will be seen in Section 6.2 .

Moreover, TRIPS Article 7 (Objectives) and Article 8 (Principles) are important for “integrating and accommodating competing concerns within IP protection…” (Grosse Ruse‐Khan, 2020 ; p. 206; see also 2016 , pp. 439–481). While finding that these provisions were not frequently applied by the WTO dispute settlement system (Grosse Ruse‐Khan, 2011 ; Rochel, 2020 , p. 34), Grosse Ruse‐Khan ( 2020 ) endorses the Panel's report in Australia—Plain Packaging which emphasized that each provision of the TRIPS Agreement is to be interpreted in light of these two provisions (WTO, 2018 , para. 7.2410; see also WTO, 2001b , para. 5a). The panel emphasized that the 2001 Declaration on the TRIPS Agreement and public health is not an authoritative interpretation under Article IX:2 of the WTO Agreement, but a “subsequent agreement” in the words of the Vienna Convention on the Law of Treaties Article 31(3)(a), that is to be taken into account in the interpretation (WTO, 2018 , para.7.2409).

It is also relevant to emphasize each state is able to determine its own standards of what is eligible for patentability, in accordance with TRIPS Article 27, but this is not further elaborated upon.

4.1. Five flexibility provisions in TRIPS

TRIPS Article 6 establishes each country's freedom to establish its own regime of IP exhaustion. In 2001 it was specified that this must be done “without challenge…” (WTO, 2001b , para. 5d). Hence, provided that a country has chosen international exhaustion in its domestic legislation (WIPO Secretariat, 2010 , pp. 32–42), a product legally placed in the market of one state can be subject to parallel importation. This might reduce the potential for monopoly tendencies and inadequate supply in the importing countries. EEA states and Switzerland practice regional exhaustion; India practices international exhaustion (WIPO Secretariat, 2010 , p. 36).

TRIPS Article 30 applies the term “limited exceptions” provision, specifies that national legislation must comply with the TRIPS Agreement while “taking account of the legitimate interests of third parties.” This phrase can be read to permit states to enact “innocent infringer” provisions, but not to allow stockpiling of generic medicines (WTO, 2000 ). Generic medicines must be distinguished from what is in normal language referred to as counterfeit products, whose new term is “substandard and falsified (SF) medical products” (WHO, WIPO, and WTO, 2020a , p. 214).

TRIPS Article 31 specifies the conditions for compulsory licenses. This provision underwent a long process of formal amendment, ending in 2017 and incorporating a new Article 31 bis and Annex. This provision specifies that the general requirement that compulsory licenses shall be for the supply of the domestic market (TRIPS Article 31(f)) does not apply in certain situations. Such situations are specified in Article 31 bis and in the Annex, including that the country in question has “insufficient or no manufacturing capacities in the pharmaceutical sector …” (TRIPS, Annex, Article 2(a)(ii)). Moreover, it is relevant to note that TRIPS Article 31(b) permits compulsory licenses for public noncommercial use, specifying that in such situations, “the right holder shall be informed promptly.” WIPO has published an overview of compulsory license provisions—country by country—demonstrating that almost all countries include in their patent legislation provisions allowing for either compulsory licenses for public interest use or government use (WIPO Secretariat, 2010 , pp. 1–31). India has provisions for all six categories of compulsory licenses (WIPO Secretariat, 2010 , p. 11).

TRIPS Article 32 (“Revocation/Forfeiture”) is rarely understood as an exceptions provision, and its wording is simply “An opportunity for judicial review of any decision to revoke or forfeit a patent shall be available.” Procedures for revocation are also specified in four other provisions of TRIPS: Articles 41.2, 41.3, 62.4, and Article 62.5. The Paris Convention for the Protection of Industrial Property regulates forfeiture and revocation of patents in even greater detail (Article 5A(3) and 5A(4)), and TRIPS Article 2.1 specifies that the Paris Agreement must be complied with. Because TRIPS Article 32 specifies no requirements for when revocation or forfeiture can be decided, specifying only the availability of judicial review, TRIPS does not prohibit states from authorizing patent revocation or forfeiture to protect prevailing public interests (Haugen, 2014 , p. 205). India's Patent Act, Act No. 39 of 1970, is an example of a national legislation that authorizes revocation, if the patent is exercised in a manner that is “mischievous to the State or generally prejudicial to the public…” (Article 66), or in cases of nonworking of the patent (Article 85). The WIPO Secretariat ( 2012 , pp. 52–56) lists other examples of domestic revocation provisions.

TRIPS Article 39 is on protection of undisclosed information; also termed trade secrets. Article 39.3 regulates protection of test data for pharmaceuticals or agricultural chemical products. It requires such test data to be protected if the domestic legislation requires such test data for approving marketing of products. India is among those countries which do not require this, even if there has been attempts of introducing this requirement (Haugen, 2021 ). On this background, it is unfortunate that the Council for TRIPS Chair did not challenge, but rather affirmed Switzerland's criticism of India's lack of test data protection (WTO Council for TRIPS, 2015, para 6.5; see also para 4.42).

Most of these flexibilities—but not Article 32—are analyzed in two publications from the so‐called Trilateral Cooperation, which include a correct understanding of TRIPS Article 39.3 (WHO, WIPO, and WTO, 2020a , p. 82; 2013 , p. 65). In summary, flexibilities in the TRIPS Agreement are applied to various degrees by the member states. India's legislation allows for most flexibility in the implementation of TRIPS (WIPO Secretariat, 2010 ).

4.2. More on licensing

TRIPS does not use the term voluntary licensing, unlike the G20 ( 2020a , para. 3; 2020b ). According to IFPMA, a voluntary license is “an authorization given by the patent holder to a generic company, allowing it to produce the patented article …” (IFPMA, 2010 ). The agreement might include conditions for such authorization (Médecins Sans Frontières [MSF], 2020 ; South Africa, 2020 ). Voluntary licenses are, however implicitly addressed in TRIPS Article 31(b), specifying the conditions for when compulsory licencing is permitted; there are three situations; the two first are identified above, namely in situations of public noncommercial use, specifying that in such situations, “the right holder shall be informed promptly” and in the situation of production for countries lacking manufacturing capacities (TRIPS Article 31 bis and Annex).

The third situation is specified as follows in TRIPS Article 31(b), stating that use without the right‐holder's authorization

may only be permitted if, prior to such use, the proposed user has made efforts to obtain authorization from the right holder on reasonable commercial terms and conditions and that such efforts have not been successful within a reasonable period of time.

TRIPS Article 31(h) specifies that the right holder shall be paid adequate remuneration in situations of compulsory licenses, and the general principles in TRIPS Article 41, as interpreted in light of Article 7 and 8, will apply.

In reality, therefore, there are four situations of licensing by a right‐holder: (i) voluntary licence, (ii) compulsory licence if negotiation efforts for a voluntary licence are not successful, (iii) compulsory licence for public noncommercial use, if the right‐holder is adequtely informed, and (iv) compulsory licence for export to countries lacking manufacturing capacities. In all situations, the right‐holder is to receive adequate remuneration for others' use of the patented technology, but this can be exempted in situations of voluntary licensing. The main purpose of voluntary licensing agreements is to enhance production and distribution (Raju, 2017 ).

According to the Trilateral Cooperation, the system established by TRIPS Article 31 bis and Annex, “does not apply to most procurement scenarios …” (WHO, WIPO, and WTO, 2020a , p. 242), listing three such situations: (i) the product is available from countries with no patent in force; (ii) product prices are sufficiently low; and (iii) voluntary licensing. I like to add: (iv) the product is legally placed in the market in countries practicing international exhaustion of patent rights, in accordance with TRIPS Article 6.

5. TWENTY YEARS WITH HUMAN RIGHTS‐EMBEDDED EXPLORATION OF IP—AND ITS RESULTS

A 1998 seminar convened by WIPO to celebrate the 50th anniversary of the Universal Declaration of Human Rights was the first comprehensive effort of specifying human rights in the context of IP (WIPO, 1999 ). Three human rights, to health, culture and scientific progress, recognized in Articles 12, 15(1)(a) and 15(1)(b) of the ICESCR, respectively, were highlighted. Three other presentations framed the IP‐human rights debate, addressed IP and traditional knowledge, and elaborated on links between IP and nationality embedded in nondiscrimation. Before 2000 the number of scholarly publications on human rights and IP were few. The attention of the civil society towards IP grew rapidly, with various campaigns, the first focusing on so‐called “biopiracy”—practices contrary to the Convention on Biological Diversity Articles 15 and 8(j)—and on medicines and pricing.

5.1. Initial clarifications

Starting in 2000, various human rights bodies became very active in analyzing IP‐human rights links. It started with the [then] Subcommission on the Protection and Promotion of Human Rights (UN Subcommission, 2000 ; 2001 ), inviting a broad range of actors—including the UN Secretary‐General and the UN High Commissioner for Human Rights—to clarify the IP‐human rights links, 2 highlighting the role of TRIPS specifically.

5.2. More elaborate clarifications

Another actor that was challenged by the Subcommission was the UN Committee on Economic, Social, and Cultural Rights (UN CESCR). It responded initially by a Day of General Discussion (2000a), followed by a Statement (2001), and then by a General comment (2006; adopted in 2005), all of which seek to clarify the content of the Article 15(1)(c) of the ICESCR, on human rights arising from the moral and material interests of authors of scientific, literary or artistic production. With the exception of a clear distinction between this human rights and IP in the initial paragraphs—a distinction that is not practiced consistently (Haugen, 2012 , pp. 37–53)—there are few explicit references to IP. One paragraph specifies, however (UN CESCR, 2006 , para. 35, extracts):

Ultimately, intellectual property is a social product and has a social function. States parties thus have a duty to prevent unreasonably high costs for access to essential medicines … undermining the rights of large segments of the population to health…

In addition to medicines, plant seeds and schoolbooks and learning materials are referred to in this paragraph, and affordability of facilities, goods and services is specified as one of the essential elements of the right to health (UN CESCR, 2000b , para. 12(b)(iii)).

The most recent General comment is on science and economic, social, and cultural rights (UN CESCR, 2020a ), 3 preceeded by a Day of General Discussion, with experts and written responses to an open call to respond to a Discussion Paper (UN CESCR, 2018 ). The core provision is ICESCR Article 15(1)(b) on the human right of everyone to enjoy the benefits of scientific progress and its applications, a provision that was analyzed in the Venice Statement (Haugen, 2012 , pp. 30–34; Müller, 2010 ; UNESCO, 2009 ). Three forms of benefits are identified by the UN CESCR: material results, like vaccines; knowledge and information; and “the role of science in forming critical and responsible citizens …” (UN CESCR, 2020a , para. 8). As regards science and IP, the UN CESCR acknowledges that IP enhances science and technology by providing economic incentives for innovation, but IP can also distort research funding, restrict information sharing and impede physical and affordable access (UN CESCR, 2020a , paras. 60–61). Generics are seen as a way to overcome the affordability problem (UN CESCR, 2020a , paras. 69–70; see also UN High Commissioner for Human Rights, 2001 ).

At the same session, the CESCR adopted a Statement on COVID‐19, emphasizing that if public measures adopted do limit the human rights recognized in the ICESCR, Article 4 on justified limitations should be applied. These Article 4 requirements were specified as “necessary to combat the public health crisis posed by COVID‐19, and be reasonable and proportionate” (UN CESCR, 2020b , para. 11). Such considerations also apply when securing national supply, calling upon states to take other countries' urgent needs into account (UN CESCR, 2020b , para. 20).

5.3. States' acknowledgment of access to medication in the context of human rights

The first resolution on access to medication was adopted by the [then] UN Commission on Human Rights ( 2001a ); from 2006 replaced by the UN Human Rights Council. These resolutions have operationalised ICESCR Article 12(2)(c). This first resolution was adopted with 52 votes to none with 1 abstention: the USA (UN Commission on Human Rights, 2001b , p. 410). Its scope was narrow, focusing on HIV/AIDS, and its wording addressed only states. The emphasis was on the pharmaceutical corporations in the 2000 Millennium Declaration: “To encourage the pharmaceutical industry to make essential drugs more widely available and affordable by all who need them in developing countries” (UN General Assembly, 2000 , para. 20 [extract]). The first UN General Assembly access to medication resolution extended the scope from HIV/AIDS to tuberculosis and malaria (UN General Assembly, 2004 ; adopted 2003), in line with MDG indicators 6.9 and 6.6, respectively (UN Statistics Division, 2008 ).

A full review of all resolutions is not possible, and in the final section I will return to how vaccines were initially ignored in the resolutions. The Trilateral Cooperation refers to 20 UN resolutions and seven reports by Special Rapporteurs on the right to health, specifying that the “list does not imply any evaluation of importance” (WHO, WIPO, and WTO, 2020a , p. 294), as well as 35 resolutions from the World Health Assembly (WHO, WIPO, and WTO, 2020a , pp. 300–301). Three aspects of the political declaration from the 2019 high‐level meeting on universal health coverage are interesting: (i) generics are explicitly acknowledged in a substantive paragraph on increased acccess, together with medicines, vaccines, diagnostics and health technologies (UN General Assembly, 2019a , para. 51); (ii) the 2001 Doha Declaration (WTO, 2001b ) is explicitly reaffirmed (UN General Assembly, 2019a , para. 51); and (iii) the resolution was adopted without a vote (UN General Assembly, 2019b ).

5.4. More on the right to enjoy the benefits of scientific progress and its applications

The mandate of the Special Rapporteur in the field of cultural rights was in 2012 extended to encompass the right to enjoy the benefits of scientific progress and its applications (UN Human Rights Council, 2012 , para. 9–11; adopted without a vote). This led—via experts seminars and broad consultations—to an initial report and two final reports, one on patents and one on copyrights for the human right to science and culture (UN Special Rapporteur in the Field of Cultural Rights, 2012 , 2014 ,  2015 ).

Most interesting is the assertion that “States have a human rights obligation not to support, adopt or accept … [TRIPS+, and] … reconciling patent protection with human rights” (UN Special Rapporteur in the field of cultural rights, 2015 , para. 104). The term “obligation” is most interesting, as well as the acknowledgment that it is only by using TRIPS exclusions, exceptions and flexibilities that IP and human rights can be reconciled. Moreover, she recommends that pharmaceutical companies “should disclose information about the costs for developing drugs, the items included in such costs and the sums they reinvest in research and development” (UN Special Rapporteur in the field of cultural rights, 2015 , para. 94); for an emphasis on transparency and accountability in the context of COVID‐19, see UN Human Rights Experts ( 2020 ).

Unlike the UN High‐level Panel on Access to Medicines ( 2016 ), which received strong criticism (BIO, 2016 ; ICBA, 2016 ), the 2015 report from the UN Special Rapporteur in the field of cultural rights did not receive much opposition. This might be because the report did not directly specify that IP are subordinate to human rights, as was done in another report (Commission on Intellectual Property, 2002 , p. 6). A more realistic explanation is that it went under the radar of the pharmaceutical and biotech associations.

5.5. What has been achieved?

In summary, an assessment of 20 years of human rights‐embedded exploration of IP is that there is more insight regarding the IP‐human rights interface in 2020 as compared to the situation in 2000, when the UN Subcommission identified “actual or potential conflicts exist between the implementation of the TRIPS Agreement and the realization of economic, social and cultural rights…” (UN Subcommission, 2000 , preambular para. 11; see also UN Subcommission, 2001 , preambular para. 11). Even if there have been mutual references between World Health Assembly resolutions and UN human rights resolutions, there is no evidence to indicate that the human rights resolutions have had a substantial impact on domestic legislative IP processes.

On the international level, Grosse Ruse‐Khan argues that there has been an “attempted regime capture …” of the IP system by human rights actors (Grosse Ruse‐Khan, 2016 , p. 265; see also 2020 ; p. 206). However, the strategy has shifted from a confrontational to a more accomodating approach (Grosse Ruse‐Khan, 2020 , p. 204; see also p. 486) by promoting the maximum use of flexibilities provided by TRIPS to also comply with human rights. His own approach is to apply TRIPS Article 7 and 8(1), particularly when faced with broad and open legal concepts, terming Article 7 “the single most important element in the process of interpretation…” (Grosse Ruse‐Khan, 2020 , p. 235; contra : Pires de Carvalho, 2014 ), arguing also for IP ceilings to enhance the enjoyment of global public goods (Grosse Ruse‐Khan, 2016 , p. 492; Grosse Ruse‐Khan, 2009 ).

The 2019 General Assembly Political declaration does, however, stand out from other UN resolutions, as noted above, inter alia by including generics (UN General Assembly, 2019a , para. 51). Neither this nor previous resolutions do, however, explicitly regard medicines and vaccines as a global public good, but this was emphasized one year later (UN Human Rights Council, 2020 , para. 7).

Expert seminars on the right to benefit from science have brought up concepts like public assets and public knowledge (UN High Commissioner for Human Rights, 2014 ). In her initial report, the UN Special Rapporteur in the field of cultural rights proposed “the adoption of a public good approach to knowledge innovation and diffusion, and … a minimalist approach to IP protection” (UN Special Rapporteur in the Field of Cultural Rights, 2012 , para. 65; see also 2015 , para. 12; 2014 , para 14). Hence, despite these references, it is fair to state that the global public good terminology has generally been absent from the UN human rights system.

6. HAVE 20 YEARS WITH MDGS AND SDGS IMPROVED OVERALL ACCESS TO MEDICINES? THE MDG ERA

To capture the MDG era, it is relavant to identify positive efforts and inadequate results of making medicines more accessible, and a particular focus on developing countries is warranted.

6.1. Positive efforts

Access to medicines was high on the international agenda in 2000–2001, and the Doha Declaration on TRIPS and Public Health (WTO, 2001b ) was the culmination. As seen above, the Millennium Declaration included a paragraph on affordability of essential drugs for persons in developing countries, using the term “encourage” (UN General Assembly, 2000 , para. 20). The ambitions, particularly for HIV/AIDS, were subsequently strengthened (UN General Assembly, 2005 , para. 57(d)), resulting in a new target: 6.B: “Achieve, by 2010, universal access to treatment for HIV/AIDS for all those who need it” (UN Statistics Division, 2008 ; also MDG targets 1.B, 5.B, and 7.B were added after 2005).

The 2010 deadline was not met. A Special Session of the UN General Assembly in 2011 specified that 15 million persons should receive antiretroviral treatment (ART) by 2015 (UN General Assembly, 2011 , para. 66). The 2015 MDG Report specified that this was on track, as 13.4 million had such access in June 2014 (UN, 2015 , p. 46).

In addition to MDG target 6.B on universal access to ART, there is one other MDG target that directly addresses IP in the context of medicines. This is 8.E, reading: “In cooperation with pharmaceutical companies, provide access to affordable essential drugs in developing countries,” and it is specified in the indicator that such affordable access is on a sustainable basis (UN Statistics Division, 2008 ). Sustainable is in the context of affordable access understood as enduring, implying that there are mechanisms in place to ensure predictable delivery at affordable prices. In the General comment on the rights to health this is specified to encompass equity (UN CESCR, 2000b , para. 12(b)(iii)). If equity is operationalized as implying that household incomes are not decisive for one's access, there is still a long way to go. This does not imply, however, that there have not been considerable efforts by a wide range of actors to foster such affordable access.

Hence, two of 22 MDG targets (6.B and 8.E) highlighted IP, at least implicitly, in the context of affordable access to medicines, and the efforts to enhance such access for at least some medicines must be acknowledged. Therefore, at least as regards some types of medicines there has been improved overall access to medicines, as well as higher awareness among relevant actors. This positive acknowledgment must, however, be nuanced.

6.2. Inadequate results

First, WHO's efforts of establishing a voluntary fund, proposed to be named Health Product Research and Development Fund, to finance neglected disease research, was not successful, due to lack of funding (WHO, WIPO, and WTO, 2020a , p. 161; WHO, 2017 , p. 49). The proposal came from WHO's Special Programme for Research and Training in Tropical Diseases (WHO, 2016 ). In 2020, the World Health Assembly (WHA) adopted a new road map for neglected tropical diseases for the period 2021–2030 (WHO, 2020h ; WHO, 2020i ). It is relevant to mention that WHO was a cofounder of the Drugs for Neglected Diseases initiative (DNDi) in 2003 (DNDi undated).

Second, the prices for certain newly introduced medicines are still very high. A decision at the 2020 WHA called for further discussions on “promoting and monitoring transparency of medicines prices and actions to prevent shortages” (WHO, 2020j , para. 3). To enhance affordability in situations of too high prices, TRIPS Article 40(2) is relevant (extract):

Nothing in this Agreement shall prevent Members from specifying in their legislation licensing practices or conditions that may in particular cases constitute an abuse of intellectual property rights having an adverse effect on competition in the relevant market.

What price level that constitutes “abuse” has not been clarified by the WTO's Dispute Settlement Body or any other WTO organ, as seen in the WTO's Analytical index (WTO Secretariat, 2020b ). Even powerful states might have to accept the price as determined by the pharmaceutical corporations. Depending on the specific priorities, states might nevertheless be able and willing to pay the excessive costs to enable affordable access, as few individuals are able to pay for particular treatment by their own. There are also examples of crowd‐funding or philanthropic efforts—but these efforts are not addressing the structural problem of affordability.

6.3. Diverse approaches for various countries

The date for least‐developed countries' implementation of the TRIPS Agreement has been extended several times, for pharmaceutical products the extension is until 2033 (WTO, 2015 ). Extension for other products—also untill 2033—has been proposed to the Council for TRIPS (Chad, 2020 ). Hence, there are limited TRIPS obligations for least‐developed countries, having a GNI/capita of $1018 or below, but there are no distinctions between other countries.

Beyond the actual diverse approach within the WTO, the most specific proposal for a diverse approach of IP protection was presented in the report from the UN Millennium Project ( 2005b ). This Task Force was one of 13 Task Forces under the UN Millennium Project. Those five Task Force reports that addressed IP did so in a critical manner (Haugen, 2021 ), as reflected in the overall report, that called for “revisiting … the rules to examine … any additional flexibility required” (UN Millennium Project, 2005a , p. 219). The UN Task Force on Science, Technology, and Innovation proposed a “three‐tier system,” based on the level of GDP/capita, with less onerous obligations for states with less than 5000 USD in per capita income, and even less onerous obligations for states with less than 1000 USD (UN Millennium Project, 2005b , pp. 112–113). This proposal has not proceeded further, and it is not likely that TRIPS will be amended.

The UN Millennium Project reports' assessments of the IP system can be characterized as overall highly critical (UN Millennium Project, 2005a , 2005b ) and the same applies to the Commission on Intellectual Property ( 2002 ).

More moderate proposals, not amending TRIPS, are proposed by the WHO‐mandated Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) under the four headings discovery, development, delivery, and promote innovation (2006, pp. 175–185). When mandating the CIPIH, the report by the WHO Secretariat emphasized voluntary licensing (WHO, 2003a )—unlike the resolution (WHO, 2003b )—and the importance of voluntary licensing is addressed in the final report (CIPIH, 2006 , pp. 121–123).

The CIPIH report refers to public goods once (CIPIH, 2006 , p. 56), in the context of presenting the international agricultural research centers operating under the umbrella of the Consultative Group on International Agricultural Research (CGIAR), indentifying three previous studies promoting a CGIAR‐like model as highly relevant in mobilizing resources for under‐funded research (CIPIH, 2006 , p. 187). It is relevant, however, that several of the actors identified above, like Gavi, The Global Alliance and Unitaid, are relevant responses to this underfunded research.

7. HAVE 20 YEARS WITH MDGS AND SDGS IMPROVED OVERALL ACCESS TO MEDICINES? THE SDG ERA

Initially, it is relevant to observe that the processes for formulating the MDGs and the MDG targets—and indicators—differ substantively from the process for formulating the SDGs and SDG targets. The MDGs and MDG targets and indicators were formulated by the Interagency and Expert Group on the Millennium Development Goal Indicators (IAEG‐MDGs) after the adoption of the Millennium Declaration (UN General Assembly, 2000 ). The formulation of the 169 targets of the SDG were negotiated before the adoption (UN General Assembly, 2015a ), but the efforts to formulate SDG indicators were left to a process under the auspices of the UN Statistics Division. The first list of the SDG indicators were adopted in 2016 (UN General Assembly, 2016 ), and are subject to annual refinement (UN Statistics Division, 2020 ).

7.1. The SDGs targets

Among the 169 SDG targets, only two address IP in the context of medicines, one implicitly and one explicitly. Target 3.8 is on (extract) “access to safe, effective, quality and affordable essential medicines and vaccines for all.” Target 3.B reads (extracts):

Support the research and development of vaccines and medicines …, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration… [WTO, 2001b ] which affirms the right of developing countries to use to the full the … [TRIPS] flexibilities to … provide access to medicines for all.

We see that both provisions refer to medicines and vaccines, while the MDG targets merely referred to medicines. There are also three SDG targets on technology under SDG 17, but these are are not in themselves adding much to the problem complex of access to medicines. It must be noted, however, that the SDG Multistakeholder Forum on science, technology, and innovation for the Sustainable Development Goals (STI Forum; UN General Assembly, 2015a , target 17.6) is a forum for addressing IP–STI–SDG relationships, as will be further analyzed in Section 8.1 below.

It is relevant to ask whether the SDG era or Agenda 2030 can be characterized by terms from the theory of principled pragmatism. As an initial illustration, the UN High‐level Panel on Access to Medicines ( 2016 )—which was met with criticism (BIO, 2016 ; ICBA, 2016 )—was rather moderate at least if compared with the UN Millennium Project ( 2005a , 2005b ; Haugen, 2021 ), as seen above. The UN High‐level Panel on Access to Medicines called for utilizing TRIPS flexibilities provisions and interpreting TRIPS provisions in accordance with TRIPS Article 7 and 8(1) (The UN High‐level Panel on Access to Medicines, 2016 , p. 60; see also WTO, 2001b ).

7.2. Stronger emphasis on public–private cooperation

The UN Guiding Principles are inspired by principled pragmatism, and norms dissemination through distributed networks globally and domestically, being embedded in reflexive dynamics and process legitimacy (Ruggie, 2015 ). They imply greater acknowledgment of corporations' potential for doing good and their responsibilites to avoid doing harm. Doing harm can either happen by their own activities or because of their business relationships with corporations, where knowledge about harmful conduct is not acted upon. According to Jägers ( 2020 , p. 147), the MDGs were viewed as having too little attention to the private sector, while the SDGs “recognize business as a key partner…”

It is on this background that we can understand this statement:

The private sector and public‐private partnerships can promote innovations aimed at sustainable development, appropriately protecting intellectual property rights while increasing access of developing countries to essential goods and technologies (UN, 2019 , p. 37).

This is the most substantial statement on IP in the Global Sustainable Development Report , whose 2019 edition highlights science. This harmonious relationship between IP protection and increased access to essential goods is reflecting the SDG era, influenced by the UN Guiding Principles. Moreover, there have been several IP and access‐related initiatives over the last two decades, in addition to the processes within TRIPS and the Trilateral Cooperation.

Hence, new forms of cooperation and funding, often with specified conditions for how the resulting products are to be made available, are gaining ground.

7.3. IP acting as impediments in the fights against COVID‐19?

Full freedom to operate, implying that for instance developers of new vaccines can progress without having to consider existing patents, is illusory. One example is the mNeonGreen, which is a green fluorescent protein, patented by Allele Biotechnology, based in San Diego (U.S. Patent No. 10,221,221). On October 5, 2020 Allele brought two lawsuits, one against Pfizer and BioNTech for patent infringement, for using the technology for their COVID‐19 vaccine without a licence (Egbuonu, 2020 ). 4

In this context it is relevant that the Public Readiness and Emergency (“PREP”) Act, 42 U.S.C. §247d–6d, adopted in 2011 and applying if the Secretary for Health determines a “public health emergency” as specified in Section §247d–6d(b)(1) might constitute a legitimate defense to patent infringement (Alosh, 2020 ).

Moreover, it is relevant that the Pandemic Influenza Preparedness (PIP) Framework was adopted by the 2011 World Health Assembly (WHO, 2011 ). The PIP Framework specifies IP concerns in Article 6 of its Standard Material Transfer Agreement (“SMTA 1”). The SMTA 1 intends to enhance access to vaccines and other benefits between authorized laboratories and while Article 6.1 discourages IP, Article 6.3 emphasizes respect of IP (WHO, 2011 , p. 31). Even if the PIP Framework was adopted in the MDG era, it will be applied in the SDG era.

While IP can act as an impediment, as legal proceedings might not be finalized on time, no actor will like to be seen by the international community as an obstacle for an effective COVID‐19 response. Hence, it is likely that in this situation, solutions will be found.

7.4. Overall assessment of the MDG and SDG era

To sum up, the overall context for development‐related efforts over the last two decades have been the MDGs and more recently the SDGs, driven in large parts by the various UN specialized agencies, funds and programmes. Four trends can be identified within these two frameworks. First, the role of the business actors have been more acknowledged in the SDG era as compared to the MDG era. Second, while there has been shifting emphasis on the issue of voluntary licensing (CIPIH, 2006 , pp. 121–123), it is reasonble to state that voluntary licensing is more recognized and practiced today than at least at the start of the MDG era. Third, vaccines are explicitly included, in addition to medicines, in the context of identifying TRIPS flexibilities. Fourth, there are new institutional mecanisms for promoting STI globally, to which we will now turn.

8. THE ROLE OF IP IN PROMOTING STI FOR THE SDGS

The IP‐STI‐SDG relationships are complex, but I will highlight three distinct issues. These three issues are chosen because they are the most specific in the context of implementing an IP policy that seeks to promote enhanced access, and hence most interesting. First, if generic medicines and vaccines is acknowledged. Second, what role voluntary licensing can play for enhanced access. Third, why not more countries follow the example of India and make use of the flexibilities that TRIPS provides.

8.1. Acknowledgment of generic medicines and vaccines

Initially, as specified above, it is relevant that the 2015 General Assembly resolution adopting the 17 SDGs and the 169 SDG targets endorsed the multistakeholder Forum on science, technology, and innovation for the Sustainable Development Goals (UN STI Forum; UN General Assembly, 2015a , target 17.6). The STI Forum had already been established by the Third International Conference on Financing for Development (UN General Assembly, 2015b , para 123). It is the third component of the Technology Facilitation Mechanism (TFM); the others are UN interagency task team on STI for the SDGs (UN IATT) and the online platform on STI for the SDGs, titled 2030 Connect (UN Secretariat, 2020a ). 5

The two first meetings in the UN STI Forum addressed IP, summarized by the term “effective” protection (UN STI Forum, 2017 , paras. 21 and 68; see also G20, 2020b ), and seeing IP as an element of “robust legal environments…” (UN STI Forum, 2016 , para. 21). Similar terminology was not included in the summaries from the three subsequent forums. While these are merely summaries of the issues discussed at the STI Forums, these terms have a different emphasis than found in other UN documents, like “balanced” (UN Secretary‐General, 2014 , para. 11) and “access” (UN General Assembly, 2020 , para 7). Nothing on generics is specified in these reports.

The UN STI Forum reports to the annual UN High‐level Forum on Sustainable Development, which so far has not addressed IP in great detail. Specific advice on IP could have been foreseen in the 2020 UN Guidebook for the Preparation of STI for SDGs Roadmaps, developed under the auspices of the UN IATT. The most specific paragraph on IP merely refers to internal UN processes, expecting these to overcome the previous “political gridlock over [IP] and technology transfer issues” (UN IATT's Sub‐Working Group on STI Roadmaps coled by World Bank, DESA, UNCTAD and UNESCO, 2020, p. 68). While this escape from the “political gridlock” is positive, the new approaches, including potentials for generics, is not addressed.

Hence, during the 5 years since the adoption of the SDGs, the issue of generic medicines and vaccines has seemingly not proceeded, with the exception for the 2019 Political declaration (UN General Assembly, 2019a , para. 51).

8.2. Voluntary licensing

Voluntary licensing is addressed in two various ways in the UN MDG Gap Task Force report ( 2015 ), produced through an interagency coordination. The main part of the report reads (UN MDG Gap Task Force, 2015 , p. 62):

Full incorporation and use of TRIPS flexibilities will thus continue to be important to encourage pharmaceutical companies to license their products to increase access while not discouraging innovation.

In this context, the TRIPS flexibilities per se are seen as important to foster enhanced licensing by the corporations. Even if no specification of such licensing is given, the context implies that it is voluntary licensing. Voluntary licensing is not explicitly regulated in TRIPS, as seen in Section 4.2 above. Nevertheless, the wording in the UN MDG Gap Task Force report implies a link between using TRIPS flexibilities and promoting voluntary licensing.

In the summary part of the report, voluntary license agreements are specified as “other means,” in addition to public health flexibilities (UN MDG Gap Task Force, 2015 , p. xv). This seems to be more in line with the realities: The voluntary licensing is another means—beyond ultilizing TRIPS flexibilities—in enhancing access to medicines and vaccines. Extensive use of TRIPS flexibilities does not necessarily imply more licensing.

Hence, the summary is more precise as regards the “framing” of voluntary licensing, as compared to the main text. It is not certain that voluntary licensing will be the preferred option by pharmaceutical corporations in a situation where these corporations are pressed by the relevant legislation to enjoy less favorable IP protection, as is the situation in India.

Voluntary licensing has not been addressed within the STI Forum, but was emphasized in the 2020 study by the Trilateral Commission, sometimes together with voluntary pooling and generics (WHO, WIPO, and WTO, 2020a , pp. 20–21; WHO, 2020a , para. 8(2); on patent pools, see WIPO Secretariat, 2014 ). Moreover, the Trilateral Commission refers to Unitaid's Medicines Patent Pool (WHO, WIPO, and WTO, 2020a , p. 157).

8.3. India's strategies

Why not more countries apply flexibilities as done by India is a question that will have many answers. The obvious answer is that India has a considerable generic medicines industry, as well as other relevant bioech industries and wants to protect their interests.

This explanation has to be supplemented by other explanations, and the theories on forms of power—visible, hidden, invisible (Lukes, 1974 )—and spaces of power—closed, invited, claimed (Gaventa, 2009 )—is relevant.

As regards forms of power, there is no doubt that India is powerful enough in itself to make several actors change their conduct. While all states have laws and court systems to regulate the conduct of corporate actors, the Indian parliamentary, executive, and judicial systems together represent a strength that can influence both WTO negotiations globally and biotech corporations domestically. As regards the hidden form of power, this also applies, as India can at least domestically determine what is not placed on the political agenda. This applies as long as there are no rulings from the WTO dispute settlement system that India has to comply with.

The (no‐)agenda‐setting power on the global level is obviously more restricted. The invisible power, being about perceptions, is also more difficult to identify, at least on the global level. The positive role of generics in the Political declaration (UN, 2019 , para. 51) is, however, important to acknowledge. Moreover, WIPO' Standing Committee on Patents (SCP) has two on‐going agenda items: Agenda item 5 on Exceptions and limitations to patent rights and Agenda item 7 on Patents and Health. Countries like South Africa and particularly Brazil are more active in the SCP than India (Argentina Brazil Canada and Switzerland, 2018 , para. 1; acknowledging generics). It is noteworthy that Switzerland—being one of the strongest proponents of an IP system with high protection standards—is acknowledging generics. Brazil, together with Argentina, was also behind the proposal to establish the Development Agenda for WIPO ( 2004 ), leading to the establishment of the Committee on Development and Intellectual Property (CDIP). India, on the other hand, is one of the most proactive countries in the Council for TRIPS.

This brings us over to the spaces of power. India is obiously neither excluded from nor merely invited to the relevant global forums where IP is discussed. Rather India is able to claim a space for the broadening of issues which are relevant to discuss in an IP context. India is not alone in seeking to broaden the agenda, but India is a leading actor. When India justifies its IP policies (see also WIPO Secretariat, 2010 ), the former WIPO's Director‐General, Francis Gurry (2008–2020), is quoted twice when reminding of “how IP can not only be about protecting investment, but also social benefit” (Thomas, 2013 , p. 19; see also p. 4).

8.4. Promoting innovation and access in a global context

In summary, the complex issues of how to ensure the optimal balance between innovation and access for meeting the SDGs has not been brought much forward by the STI mechanisms under the TFM. The Trilateral Cooperation provides the richest source for measures that can overcome inadeaquate access, either because of quantity or because of too high prices. These measures include pricing agreements, based on negotiations, voluntary licensing, compulsory licensing, patent oppositions, and buyers' clubs (WHO, WIPO, and WTO, 2020a , pp. 224–225).

9. CONCLUDING DISCUSSION

The last two decades have seen a shift from the very high tensions over patenting and accessibility in 2000–2001 to a broader acknowledgment of the need to find a better balance between protection of innovations and access to such innovations. While the most important actor on the global scene is the WHO, the so‐called nonpaper by France and Germany ( 2020 ) identifies the need for changes in the WHO governance. The initial framing of wide‐spread immunization against COVID‐19 as a global public good was done by the World Health Assembly (WHO, 2020a , para. 6), with others repeating its core (UN Human Rights Council, 2020 , para. 7; G20, 2020a , para. 3; G20, 2020b ). The global public goods terminology has been most consistently applied in the three reports on science by the former UN Special Rapporteur in the Field of Cultural Rights ( 2012 , para. 65,  2014 , para 14,  2015 , para. 12). As seen above, her reports were not met with opposition and her involvement of recognized IP scholars in the preparation of her two last reports must be acknowledged.

How much acknowledgment for the changes in the perceptions among political leaders should be given to the various UN human rights bodies that have been engaged? Most notably, the 2019 Political declaration must be seen as a culmination for the enhanced access, by the explicit acknowledgment of generic medicines (UN General Assembly, 2019a , para. 51). In this context it is relevant to note that in the draft resolution for the 2018 UN Special Session on Tuberculosis, nothing was said about TRIPS flexibilities (UN Intergovernmental Consultations for the High‐level Meeting on the Fight Against Tuberculosis, 2018 ), but this came in the final resolution (UN General Assembly, 2018 , para. 19). The mutual influence takes place between the UN human rights bodies and the WHO through the World Health Assembly, which in turn influences the WHO–WIPO–WTO Trilateral Cooperation.

The new mechanisms on STI within the SDGs have so far not contributed to alternative perspectives. However, the UN Millennium Project ( 2005a , 2005b ; Haugen, 2021 ) and the UN MDG Gap Task Force ( 2015 ) did identify the need for changes in IP policies. Furthermore, SDG targets 3.8 and 3.B both refer to vaccines and medicines together, which was a progress as compared to the MDG era.

As regards the latter part of the research question formulated at the end of the first section on whether the global equity, global public goods and human rights framing has had any impact on the position of the most pro‐TRIPS WTO member states, this is also complex. It is a too strong assertion to claim that the position of these states have been substantively modified, but I have found that there is an increased openness to discuss alternative approaches—within an IP framework.

A relevant question is if it is only in the case of a pandemic—defined by the WHO as the widespread human infection of a new disease in at least three countries in at least two different WHO regions (WHO, 2009 )—that a global public goods approach to vaccines (and medicines) is relevant. In other words, if there is widespread human infection of a new disease in several countries in only one WHO region, this will not be declared a pandemic. As an example, Ebola was declared as a “public health emergency of international concern” (WHO, 2014 ).

Notwithstanding these distinctions, merely the risk of spread of infectious diseases to other WHO regions should allow the global public goods approach to vaccines and medicines to be applied also in situations which are not declared a pandemic.

The language of the UN resolutions on access to medicines has been strenghtened overall. The first UN resolution on access to medicines included neither of the terms equitable or fair (UN Commission on Human Rights, 2001a ). In the access to medication resolution adopted at the peak of the swine flu pandemic (H1N1), neither the terms equitable or fair nor the term vaccines is applied (UN Human Rights Council, 2009 ). Moreover, the first time the term vaccines appeared in the access to medication resolutions, it was in the context of recognizing innovative funding mechanisms (UN Human Rights Council, 2011b , para. 8). Only in 2016 was the term vaccines applied in a stricter manner, specified as to “ensure their sustained accessibility, affordability and availability and to ensure access to treatment for all those in need…” (UN Human Rights Council, 2016 , para. 5). It is reasonable that the SDGs, which referred to vaccines and medicines together (UN General Assembly, 2015a , targets 3.B and 3.8) is an important explanation for this shift.

The terms equitable and fair are applied in the 2020 resolutions on COVID‐19, which also calls for the “urgent removal of unjustified obstacles … in accorance with [TRIPS] … as confirmed by the Doha Declaration … [WTO, 2001b ]” (World Health Assembly [WHO, 2020a ], para. 4; UN Human Rights Council, 2020 , para. 5).

The biannual resolutions on STI for sustainable development, which are adopted without a vote are, however much softer, by “encouraging access” within an “efficient, adequate, balanced and effective [IP] framework…” (UN General Assembly, 2020 , para. 7). This is a resolution that is linked to UN's STI agenda for the SDGs, and hence not a “pure” human rights resolution.

Hence, the direct influence of the UN human rights resolutions on domestic legislative outcome is somewhat difficult to identify. As regards norms development globally, it seems reasonable that the elements identified by Ruggie as crucial in norms dissemination, taking place through distributed networks globally (Ruggie, 2015 ) explain the overall positive role that the UN human rights system has exercised in the context of medicines and vaccines. The debates within the WTO are of course also influenced by this development, as witnessed in the Trilateral Cooperation. The urgency of identifying the best possible responses to COVID‐19 within the IP framework has made the Trilateral Cooperation publish an extract of its 2020 report that applies particularly to COVID‐19 (WHO, WIPO, and WTO, 2020b ). It is reasonable to state that among pro‐TRIPS developed countries there is an acknowledgment of obstacles created by the IP system, some of which are identified by South Africa ( 2020 )—and of the social functions of an IP system—but their overall position on the IP system has not changed.

Hans Morten Haugen , Cand. Polit, Dr. Jur. is Professor of International Diakonia at VID Specialized University, Oslo, Norway. He has written extensively on the encounters between international economic law, particularly intellectual property law, and human rights law, ranging from the right to benefit from science, to indigenous peoples' rights. He has provided advice on these matters as an invited expert at UN meetings; see for instance A/HRC/26/19, see also A/70/279.

Haugen, H. M. (2021). Does TRIPS (Agreement on Trade‐Related Aspects of Intellectual Property Rights) prevent COVID‐19 vaccines as a global public good? J World Intellect Prop . 24 , 195–220. 10.1111/jwip.12187 [ PMC free article ] [ PubMed ] [ CrossRef ] [ Google Scholar ]

1 Sinovac's efficacy is only 50.4%; see BBC ( 2021 ); on efficacy of vaccines developed by Johnson & Johnson and Novavax, see Clinical Trials Arena ( 2021 ); Sputnik V is in phase 2 (January 2021).

2 Two reports are compilations of responses by nongovernmental and international organizations, by the UN Secretary‐General (see Haugen, 2012 , p. 38 (no. 7)); one is a substantive analysis, by the UN High Commissioner for Human Rights ( 2001 ); identifying in para 43–49 measures like generic substitutes, differential pricing and price negotiations, and parallel importation.

3 Space does not allow a full review of General Comment 25, but it is surprising that it contains no references to the two comprehensive report by the UN Special Rapporteur in the Field of Cultural Rights ( 2015 , 2014 ), only to her initial report (UN Special Rapporteur in the Field of Cultural Rights, 2012 ). Between these two reports, there were three expert seminars, in Geneva in 2013 (UN High Commissioner for Human Rights, 2014 ) and in New York and Geneva in 2014 (UN Special Rapporteur in the Field of Cultural Rights, 2014 , para. 5 and Annex).

4 Allele's Licensing Director explains: “The purpose of these lawsuits is to maintain Allele's patent rights and to ensure that an agreement can be put in place to protect the rights of current and future licensees” (Egbuonu, 2020 ). Moverover, Allele's CEO asserts that “in no way does Allele want to prohibit, or slow down development of vaccines or therapeutics discovered using this technology” (Egbuonu, 2020 ).

5 Three UN bodies were responsible for the first launch of the Connect 2030, on July 15, 2020: UNCTAD (UN Conference on Trade and Development), UN Department on Social and Economic Affairs, which has a Division for Sustainable Development Goals (DESA/DSDG), and UN Office of Information and Communications Technology (OICT) (UN Secretariat, 2020b ). It is specified: “Materials provided on this Site are provided 'as is'…”; and: “The United Nations in collaboration with the UN and non‐UN partners, periodically adds, changes, improves or updates the Materials on this Site without notice” (UN Secretariat, 2020c ). As there is a login function, it seems that anyone who is registering as user can place documents on the 2030 Connect. For one example of what was found by the search term “patents,” see Sehgal ( 2020 ).

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2024 solar eclipse map: Where to see the eclipse on April 8

These 2024 solar eclipse maps will help you make the best decision about where and how to watch the total solar eclipse on Monday (April 8).

It's finally here: Today, (April 8) a total solar eclipse will pass across the skies North America, giving more than 33 million people living in 15 U.S. states a rare view of the totally-obstructed sun, and — weather permitting — a taste of some seriously strange eclipse phenomena .

If you’re wondering where the total and partial phases of the eclipse will be visible, the good news is that almost everyone in the contiguous U.S. will be able to see the celestial spectacle to some extent. But for a more detailed view of the eclipse’s path, take a look at these handy eclipse maps, courtesy of GreatAmericanEclipse.com. 

Solar eclipse 2024 path of totality map

Totality is the moment that every eclipse-chaser lives for: The moment when the moon completely covers the sun’s face, resulting in a brief but eerie darkness in the daytime. The path of totality , shown in the map above, is the path of the moon’s shadow across Earth’s surface. 

On Monday (April 8), totality will begin in Sinaloa, Mexico, then move northeast up to Texas, ultimately crossing 15 states before moving on to Canada. The states where totality will be visible are: Texas, Oklahoma, Arkansas, Missouri, Kentucky, Tennessee, Illinois, Indiana, Ohio, Michigan, Pennsylvania, New York, Vermont, New Hampshire and Maine — although Tennessee and Michigan will only be glanced by the moon's shadow.

Related: April 8 solar eclipse: What time does totality start in every state?

Viewers MUST be within the path of totality to witness the total phase of the eclipse; if you are off the path by even a mile, you will only see a partial eclipse, and miss out on the spooky daytime darkness. Furthermore, the closer you are to the center of the path of totality, the longer totality will last for you — up to a maximum duration of 4 minutes, 27 seconds in Torreón, Mexico.

Note: Totality is the ONLY TIME when it is safe to view the sun without protective eyewear like certified solar eclipse glasses . You must protect your eyes during the entire partial phase of the eclipse, no matter where you are.

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Solar eclipse 2024 partial eclipse map

If you live in the U.S. and can’t make it to the path of totality, a partial eclipse still awaits you on April 8. The entire contiguous U.S. will have some view of the partial eclipse, ranging from 99% coverage of the sun just off the path of totality to about 15% coverage far to the northwest of the path.

The map above shows how much of the sun’s disk will be blocked from your location. Watching the partial phases of the eclipse — which last about an hour and 20 minutes before and after totality — means wearing protective eyewear at all times. Failure to do so could result in permanent eye damage, according to NASA .

If you want to experience the celestial spectacle but don’t have a pair of eclipse glasses handy, there are many other ways to safely enjoy the partial eclipse . These include making a homemade pinhole projector , using a pasta strainer to project the shadow of the moon onto the ground or watching one of the various eclipse live streams available.

2024 eclipse travel maps

If you want to see totality but don’t live within the path, driving or taking public transit to a city within the path may be possible. The map above shows how far the drive is to the path of totality, based on where you’re coming from. Meanwhile, the map below shows the most populated cities within the path of totality — many of which are expected to be flooded with millions of eclipse tourists on April 8.

The biggest cities within the path of totality include: San Antonio, Dallas, Austin and Fort Worth in Texas; Indianapolis, Indiana; Hamilton and Montreal in Canada; and Torreón and Mazatlan in Mexico.

Wherever you are on April 8, we wish you clear skies and protected eyes during this rare, wondrous eclipse over North America.

Brandon is the space/physics editor at Live Science. His writing has appeared in The Washington Post, Reader's Digest, CBS.com, the Richard Dawkins Foundation website and other outlets. He holds a bachelor's degree in creative writing from the University of Arizona, with minors in journalism and media arts. He enjoys writing most about space, geoscience and the mysteries of the universe.

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When is Eid al-Fitr 2024 and how is it celebrated?

The three-day festival celebrates the completion of the fasting month of Ramadan by Muslims across the world.

As a new moon was not sighted on Monday evening after Maghrib prayers, Muslims in Saudi Arabia and neighbouring countries will fast one more day, completing 30 days of Ramadan. The first day of Eid will then be celebrated on Wednesday, April 10.

The first day of Eid al-Fitr is determined by the sighting of the crescent moon marking the start of the month of Shawwal, the 10th month of the Islamic (Hijri) calendar.

Keep reading

A ramadan no palestinian will ever forget, the cost of a ramadan iftar meal around the world, ramadan 2024: where do your dates come from, in washington, dc: celebrating ramadan, protesting israel’s siege of gaza.

Lunar months last between 29 and 30 days so Muslims usually have to wait until the night before Eid to verify its date.

Other countries follow independent sightings.

When the sighting has been verified, Eid is declared on television, radio stations and at mosques.

How do Muslims celebrate Eid?

Traditionally, Eid is celebrated for three days as an official holiday in Muslim-majority countries. However, the number of holiday days varies by country.

Muslims begin Eid day celebrations by partaking in a prayer service that takes place shortly after dawn, followed by a short sermon.

On their way to the prayer, which is traditionally held in an open area, Muslims recite takbeerat, praising God by saying “Allahu Akbar”, meaning “God is great”.

It is customary to eat something sweet before the prayer, such as date -filled biscuits known as maamoul in the Middle East. This particular festival is known as the “sweet” Eid – and the distribution of sweets is common across the Muslim world.

Muslims usually spend the day visiting relatives and neighbours and accepting sweets as they move around from house to house.

Each country has traditional desserts and sweets that are prepared before Eid or on the morning of the first day.

Children, dressed in new clothes, are offered gifts and money to celebrate the joyous occasion.

Girls and women in many countries decorate their hands with henna. The celebration for Eid begins the night before as women gather in neighbourhoods and large family gatherings for the application of henna.

In some countries, families visit graveyards to offer their respects to departed family members right after the morning prayers.

It is common for Muslim-majority countries to decorate their cities with lights and hold festivities to commemorate the end of the fasting month.

Eid amid the onslaught in Gaza

For some 2.3 million Palestinians in Gaza this Eid, this will be the first Muslim religious holiday after more than 33,000 people have been killed in Israeli attacks. With little food aid, and very limited water, Gaza’s Eid al-Fitr will be mired in destruction amid the continuing attacks.

What are common Eid greetings?

The most popular greeting is “Eid Mubarak” (Blessed Eid) or “Eid sa’id” (Happy Eid). Eid greetings also vary depending on the country and language.

The video below shows how people say Eid Mubarak in different languages around the world.

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Biden Announces Student Debt Relief for Millions in Swing-State Pitch

During an appearance in Wisconsin, President Biden said 10 million borrowers could see debt relief of at least $5,000. The plan could help rally support among young voters.

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Biden Announces New Plan for Student Debt Relief

President biden announced a large-scale effort to help pay off federal student loans for more than 20 million borrowers..

Today, I’m proud to announce five major actions to continue to relieve student debt for more than 30 million Americans since I started my administration. And starting this fall, we plan to deliver up to $20,000 in interest relief to over 20 million borrowers and full forgiveness for millions more. [applause] I will never stop to deliver student debt relief and hardworking Americans. And it’s only in the interest of America that we do it. And again, it’s for the good of our economy that’s growing stronger and stronger, and it is, by freeing millions of Americans from this crushing debt of student debt. It means they can finally get on with their lives instead of being put — their lives being put on hold.

By Michael D. Shear

Reporting from Madison, Wis.

President Biden on Monday announced a large-scale effort to help pay off federal student loans for tens of millions of American borrowers, seeking an election-year boost by returning to a 2020 campaign promise that was blocked by the Supreme Court last year.

Mr. Biden’s new plan would reduce the amount that 25 million borrowers still owe on their undergraduate and graduate loans. It would wipe away the entire amount for more than four million Americans. Altogether, White House officials said, 10 million borrowers would see debt relief of $5,000 or more.

“While a college degree still is a ticket to the middle class, that ticket is becoming much too expensive,” Mr. Biden said during a speech to a small but enthusiastic audience filled with supporters. “Today, too many Americans, especially young people, are saddled with too much debt.”

Mr. Biden announced the plan in Madison, Wis., the capital of a critical swing state and a college town that symbolizes the president’s promise to make higher-education affordability a cornerstone of his economic agenda.

But it is a promise he has so far failed to achieve, largely because of legal challenges from Republicans and other critics. They accuse Mr. Biden of unlawfully using his executive authority to enact a costly transfer of wealth from taxpayers who have not taken out federal student loans to those who have.

Officials did not say how much the new plan would cost in coming years, but critics have said it could increase inflation and add to the federal debt by billions of dollars.

Mr. Biden said his new effort would help the economy by removing the drag of enormous debt from people who would otherwise not be able to buy a home or pursue a more economically sound future.

“We’re giving people a chance to make it,” Mr. Biden said. “Not a guarantee. Just a chance to make it.”

Mr. Biden’s announcement was a presidential do-over. In the summer of 2022, he put in motion a plan to wipe out $400 billion in student debt for about 43 million borrowers. That was blocked by the Supreme Court , which said he exceeded his authority. In the months since, Mr. Biden has waived small amounts of debt using existing programs. But now he is attempting a larger effort closer to the scale of his first try.

The original plan relied on a law called the HEROES Act, which the administration argued allowed the government to waive student debt during a national emergency like the Covid pandemic. The justices disagreed after Republican attorneys general and others challenged the debt waiver plan.

The new approach is different.

For months, Mr. Biden’s Education Department has been developing regulations using a long process authorized by the Higher Education Act. Instead of an across-the-board waiver of debt, the new approach targets five groups of borrowers: those whose loans have ballooned because of interest; borrowers who have been paying for decades; those who have economic hardship; people who qualify for existing debt relief programs but have not applied; and people whose loans come from schools that have since been denied certification or have lost eligibility for federal student aid programs.

Administration officials said because the new approach is based on a different law, it is more likely to survive the expected challenges. They said lawyers for the White House and the Education Department have studied the Supreme Court ruling and have designed the new program to make sure it does not violate the principles laid out by the justices.

But lawyers for those who oppose the approach are likely to argue that waiving the debt is unfair to those who already paid back their loans or never took out college loans in the first place. That argument helped sway the justices in the last case.

Neal McCluskey, the director of the Center for Educational Freedom at the Cato Institute, called the new plan “dangerous policy” that is unfair to taxpayers and would cause colleges and universities to raise their prices.

“The Constitution gives Congress, not the president, the authority to enact law, and the Supreme Court has already struck down a unilateral, mass student debt cancellation scheme by the Biden administration,” he said. “It would stick taxpayers with bills for debts other people chose for their own financial advancement.”

The legal challenges will likely take months to resolve, and that could leave the debt relief plan in limbo as voters go to the polls in November to choose between Mr. Biden and former President Donald J. Trump.

Members of Mr. Biden’s administration fanned out across the country on Monday to talk about the new plan, betting that it will rally support among voters who were disappointed that the court blocked the first one, which would have eliminated up to $20,000 in debt for tens of millions of borrowers. Vice President Kamala Harris held a round-table discussion with a teacher, a nurse and a social worker in Philadelphia. Miguel A. Cardona, the education secretary, spoke in New York City.

“We need you to stay in these jobs doing this work,” Ms. Harris said in the library of an elementary school. “And you shouldn’t have to make a decision about whether you serve or are able to pay your bills.”

But beyond the threat of legal action, the president faces steep obstacles just because of the calendar. The new plan has not yet been published in the Federal Register, which will kick off a required, monthslong public comment period before it can take effect. Officials said on Sunday only that they hoped some of the provisions would begin going into effect in “early fall” of this year.

Administration officials hope that the president’s supporters will give him credit for trying, even if many of the borrowers do not end up seeing any relief before they go to the ballot box. Andrew O’Neill, the legislative director for Indivisible, a liberal advocacy organization, praised Mr. Biden’s announcement.

“Progressives have led the fight for student debt cancellation, and Joe Biden has responded,” he said in a statement. “More than 30 million folks will now get relief from Biden’s programs. That’s a huge deal.”

White House officials have been scrambling for months to respond to the anger about student loans among the president’s base. In one poll released last month, more than 70 percent of young people said the issue of student loan forgiveness was “important” or “very important” to them as they make their decision in the 2024 election campaign.

Officials said the five groups of people targeted in the new plan will address most of the egregious issues that some borrowers have with their student loans.

People whose loans have grown beyond the amount they originally borrowed because of interest would have up to $20,000 of that interest wiped away, leaving them to repay only the amount they originally borrowed. People making less than $120,000 a year, or couples making less than $240,000, would qualify to have all of their interest forgiven.

Officials said that 23 million people would most likely have all of their interest-related balances waived from that provision.

About two million borrowers who already qualify to have their student loans waived under existing programs have not applied for relief. Under the new rules, the Education Department would be authorized to cancel the debt for those people without their having to apply.

People who took out federal student loans for undergraduate degrees and began repaying them more than 20 years ago would automatically have the debt canceled under the new plan. Graduate students who borrowed money and began repaying 25 years ago would have their debt canceled.

Officials said that about 2.5 million people would qualify under that rule.

People who borrowed money to attend colleges that have since lost their certification or their eligibility to participate in the federal student aid program would have their debt canceled. Officials did not say how many people that would affect. And people who are especially burdened with other expenses — such as high medical debt or child care — could apply to have their student loans forgiven.

Officials did not estimate how many people might qualify for what they called the “hardship” programs.

Nicholas Nehamas contributed reporting from Philadelphia.

Michael D. Shear is a White House correspondent for The New York Times, covering President Biden and his administration. He has reported on politics for more than 30 years. More about Michael D. Shear

• Solar Eclipse 2024

‘20 or 30 Super Bowls.’ Drivers and Officials Brace for Massive Eclipse Traffic Jams

M elissa Schleig, a postmaster who lives in Strasburg, Virginia, drove more than 400 miles southwest to the Smoky Mountains to see the 2017 solar eclipse. The travel experience was miserable.

“It should have taken us about six to seven hours to go down there but it took us about a little over six hours just to go about two hours south of here. It was insane,” said Schleig, who began to drive down the day before the eclipse. 

At least 5 million people traveled for the 2017 eclipse, according to a journal by the Institute of Transportation Engineers, but even more are expected to gather to witness this year’s total solar eclipse on April 8. Already, an estimated 31.6 million people currently live in the roughly 115-mile wide path of totality —compared to the 12 million that did in 2017. 

“Having a total solar eclipse pass through the U.S. is kind of like having 20 or 30 Super Bowls happening all at once,” says Richard Fienberg, project manager of the American Astronomical Society's Solar Eclipse Task Force. “So many people are gathering for the spectacle over a long distance.”

Read More : How Cities Around the U.S. Are Celebrating the Eclipse

Transportation agencies are coordinating with the National Weather Service to spot areas of high interest for eclipse viewing to better prepare for traffic delays, but they say the impacts are unavoidable. “The Federal Highway Administration (FHWA) knows that there is great interest in this rare solar event, and that’s why we want everyone to be aware of the real traffic and safety impacts,” FHWA Administrator Shailen Bhatt told TIME in an email. “We want people to remember this day and this experience—that may be once in a lifetime—for all the right reasons.”

This year Schleig, who is part of a Facebook eclipse chasing group, is traveling to the Canadian side of Niagara Falls to view the eclipse. And she’s hoping to learn from her 2017 mistakes: she’s planning to avoid the traffic by extending her trip from April 4 through the 10th, instead of driving the day before like she did last time.

How bad will traffic be? 

The FHWA says Schleig has the right idea. It is advising people to drive early, and stay longer in the town where they’re viewing the eclipse to avoid traffic. The FHWA says it's hard to predict which cities or states will be most impacted by the eclipse traffic-wise, but they predict up to 5 million people will be traveling to the path of totality between Texas and Maine.   

While drivers and officials are looking to the 2017 eclipse for hints of what is to come, traffic will likely be much worse this time. That’s because the 2024 path of totality—the area where the moon will completely obscure the sun—is a 3-hour drive away from 8 major cities with a population greater than 2 million, including Chicago, Houston, and Toronto. By contrast, the 2017 eclipse path of totality was a 3-hour drive away from only three larger metropolitan areas: St. Louis, Kansas City, and Portland, Ore.

Read More : How to Use Your Smartphone to Take Photos of the Solar Eclipse

If the expected 5 million visitors were to leave the path of totality as soon as the eclipse ends, the ensuing traffic would be equivalent to 71 sold out football games ending all at once, according to a journal by the Institute of Transportation Engineers.

Where are people traveling?

Several eclipse chasers, like 62-year-old photographer Beth Hutter, told TIME that they were planning to travel to Texas because it has the lowest chance of cloud cover. “We didn't want to take a chance that the day of the eclipse it [would be] overcast and rainy,” said Hutter, who is traveling from Michigan to Kileen, Texas five days before the eclipse. “We made the mistake of trying to drive home the same day [for the 2017 eclipse]... So thankfully, because we're going to be right there, I don't think we're going to have to deal with the traffic nightmares that most people are going to have.”

Texas Department of Transportation media relations director Adam Hammons says that up to one million out-of-state visitors may be traveling to view the eclipse, in addition to the millions that already live in the state and will likely also be driving to different areas/cities.  

Hammons says the eclipse runs through I-35, which is a significant corridor in the state that traverses through small towns as well as larger metro areas like Austin, Dallas, and Fort Worth. “It really goes through a large portion of Texas,” he says. “There’s going to be some possible significant delays on these major corridors and/or farm roads…Give yourself extra travel time. Plan ahead your trip, plan your route,” Drivetexas.org, a website that shares real-time traffic updates, could be helpful in deciding which way to go. 

Regardless of where you choose to see the eclipse, Hammons says it's important to have a safe, designated place to park and enjoy the experience—as long as it's off the shoulder of the highway.

Read More : Here’s What Determines How Long the Total Eclipse Will Last in Your Location

Other states like Arkansas, which has a population of some 3 million people , could see anywhere from 300,000 to 1.5 million visitors. (State officials have cited varying estimates .) The most extreme traffic will be seen along AR Highway 70 to Benton, AR Highway 65 from Conway to Greenbrier, and more. "There’s no doubt our Interstates and highways could be tested," Arkansas Department of Transportation Director Lorie H. Tudor told TIME in a statement, "but we have put forth our best planning efforts and we are cautiously optimistic that we are as prepared as possible to address any foreseeable issues that may arise."

New York is another state expecting a high volume of visitors and traffic. Many residents and out-of-state visitors will be traveling to the western and northern regions of the state, with Niagara Falls being an area of high interest. "We are expecting as many as a million people to come to Erie County solely for the eclipse," says Peter Anderson, press secretary for the Erie County executive, where Niagara Falls is based. According to data collected by Priceline and shared with TIME, Buffalo, New York has the second highest average airfare price compared to the travel cost to seven cities along the path of totality— including Dallas, Indianapolis, and Cleveland—at $999, and the most expensive average nightly hotel room cost among those cities listed at $476.

Still, for many of the eclipse watchers, braving bad traffic will be worth it. “It's just one of those things where you just realize your place in the world, and how small you are in comparison to the rest of the universe,” says Hutter. “The world just kind of stops.”

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Where to buy solar eclipse glasses: Check out these last-minute locations before April 8

If you know where to look, you may just luck out and find a vendor or even a local library with some solar eclipse glasses still in stock..

You're running out of time to get your own pair of certified glasses if you're wanting to catch a glimpse of the total solar ecli pse that is nearly one week away.

If you're planning to be among the millions of people in the United States who will witness the spectacular sight on April 8, having a proper pair of glasses couldn't be more paramount . Until the moon completely blocks the sun's disc on the path of totality and ushers in darkness , the sun's rays will pose a danger to unprotected retinas gazing skyward.

At this point, proper eyewear may be hard to come by and some may be tempted to turn to alternative methods such as welding goggles . But if you know where to look, you may just luck out and find a vendor or even a local library with some still in stock.

Here's what to know about where to find last-minute solar eclipse glasses.

American Paper Optics, Warby Parker, among those offering glasses

Compared to regular sunglasses , proper eclipse glasses are 100,000 times darker to block nearly all visible, infrared and ultraviolet light and protect our sensitive retinas when looking upward near the sun.

That's why experts widely recommend them for those who will be watching as the upcoming solar eclipse charts a 115-mile-wide path of totality across North America.

Reputable vendors can be found on any eclipse websites like  NationalEclipse.com, which sells a variety of eyewear products, along with plenty of other gadgets one may need to see the eclipse. Additionally, American Paper Optics, the nation's largest supplier of eclipse glasses, offers express shipping and includes a  a countdown at the top of its website  to let you know the deadline to make a purchase to get your glasses in time for the big day.

Warby Parker, which actually plans to give out free solar eclipse glasses beginning Monday, may also be a good place to check.

Here are some other companies offering specials and deals timed for the big deal, including offers on eclipse glasses.

Finally, you may want to check your local library or other public institutions in your area, as many of these places have been offering free eclipse glasses to residents. Just don't count on supplies still being available.

Find a store near you: How to get your Warby Parker eclipse glasses

How to make sure your solar eclipse glasses aren't fakes

The responsibility of guiding American consumers to the safest eclipse glasses is largely left to the American Astronomical Society.

The organization maintains  a curated list of approved vendors  of solar eclipse glasses and its been updated to give priority to North American manufacturers for the upcoming astral event. Products you purchase that are listed on that site are guaranteed to be  in compliance with  the highest international safety standards.

Those standards are set by the International Organization for Standardization, which only vouches for solar eclipse glasses that are dark and strong enough to filter out a certain amount of the sun's harmful light.

Of course, plenty of fakes and cheap imitators are proliferating the online marketplace in the leadup to the eclipse.

A good rule of thumb is to avoid any vendors making the grand (and entirely made-up) claim that their products are endorsed by NASA. As the space agency reiterated to USA TODAY , it only advises that people get a pair of glasses, but does not recommend or certify any particular product.

The astronomical society also provides some  helpful tips  for other useful ways to spot scams and counterfeit glasses.

Solar eclipse forecast: Looking cloudy for some in path of totality

What else to know about the April 8 total solar eclipse

A total solar eclipse offers the unique opportunity for skygazers to witness the spectacular astral display with the naked eye – but only when the time is right.

Eclipse glasses are still very much needed for most of the show, so make sure to come prepared,  according to NASA .

But when the moon moves completely in front of the sun and blocks its light, you'll know it's safe to fully take in the dazzling display. That moment is what is called "totality," whereby uncharacteristic darkness falls and all but the sun's outermost layer known as its corona makes a rare appearance to us here on Earth.

Hundreds of cities in  13 states are on the path of totality  for this year's total solar eclipse, which will pass from southwest to northeast across North America. You won't want to miss it, as this is the last such eclipse in North American  until 2044 .

And as you make your eclipse-viewing plans,  these interactive maps  should help you chart the time and duration for when totality would occur in cities along the path.

Eric Lagatta covers breaking and trending news for USA TODAY. Reach him at [email protected]

Watch CBS News

Solar eclipse maps show 2024 totality path, peak times and how much of the eclipse people could see across the U.S.

By Aliza Chasan

Updated on: April 9, 2024 / 5:00 AM EDT / CBS News

A total solar eclipse  crossed North America Monday with parts of 15 U.S. states within the path of totality. Maps show  where and when astronomy fans could see the big event  as skies darkened in the middle of the day Monday, April 8.

The total eclipse first appeared along Mexico's Pacific Coast at around 11:07 a.m. PDT, then traveled across a swath of the U.S., from Texas to Maine, and into Canada.

About 31.6 million people live in the path of totality , the area where the moon fully blocked out the sun , according to NASA. The path ranged between 108 and 122 miles wide. An additional 150 million people live within 200 miles of the path of totality.

Solar eclipse path of totality map for 2024

The total solar eclipse started over the Pacific Ocean, and the first location in continental North America that experienced totality was Mexico's Pacific Coast, around 11:07 a.m. PDT, according to NASA. From there, the path continued into Texas, crossing more than a dozen states before the eclipse enters Canada in southern Ontario. The eclipse exited continental North America at around 5:16 p.m. NDT from Newfoundland, Canada.

The path of totality included portions of the following states:

• Pennsylvania
• New Hampshire

Small parts of Tennessee and Michigan also experienced the total solar eclipse.

Several major cities across the U.S. were included in the eclipse's path of totality, while many others saw a partial eclipse. These were some of the best major cities for eclipse viewing — though the weather was a factor :

• San Antonio, Texas (partially under the path)
• Austin, Texas
• Waco, Texas
• Dallas, Texas
• Little Rock, Arkansas
• Indianapolis, Indiana
• Dayton, Ohio
• Cleveland, Ohio
• Buffalo, New York
• Rochester, New York
• Syracuse, New York
• Burlington, Vermont

Map of when the solar eclipse reached totality across its path

The eclipse began in the U.S. as a partial eclipse beginning at 12:06 p.m. CDT near Eagle Pass, Texas, before progressing to totality by about 1:27 p.m. CDT and then moving along its path to the northeast over the following few hours.

NASA shared times for several cities in the path of totality across the U.S. People could have also  checked their ZIP code on NASA's map  to see when the eclipse was to reach them if they were on, or near, the path of totality — or if they saw a partial eclipse instead.

How much of the eclipse did people see if they live outside the totality path?

While the April 8 eclipse covered a wide swath of the U.S., outside the path of totality observers may have spotted a partial eclipse, where the moon covers some, but not all, of the sun, according to NASA. The closer they were to the path of totality, the larger the portion of the sun that was hidden.

NASA allowed viewers to input a ZIP code and see how much of the sun was to be covered in their locations.

Could there be cloud cover be during the solar eclipse?

Some areas along the path of totality had a higher likelihood of cloud cover that could interfere with viewing the eclipse. Here is a map showing the historical trends in cloud cover this time of year. 

You could have checked the latest forecast for your location with our partners at The Weather Channel .

Where did the solar eclipse reach totality for the longest?

Eclipse viewers near Torreón, Mexico, got to experience totality for the longest. Totality there lasted 4 minutes, 28 seconds, according to NASA. 

Most places along the centerline of the path of totality saw a totality duration of between 3.5 and 4 minutes, according to NASA. Some places in the U.S. came close to the maximum; Kerrville, Texas, had a totality duration of 4 minutes, 24 seconds.

What is the path of totality for the 2044 solar eclipse?

The next total solar eclipse that will be visible from the contiguous U.S. will be on Aug. 23, 2044.

Astronomy fans in the U.S. will have far fewer opportunities to see the 2044 eclipse they had on April 8. NASA has not yet made maps available for the 2044 eclipse but, according to The Planetary Society , the path of totality will only touch three states.

The 2024 eclipse will start in Greenland, pass over Canada and end as the sun sets in Montana, North Dakota and South Dakota, according to the Planetary Society.

Aliza Chasan is a digital producer at 60 Minutes and CBSNews.com. She has previously written for outlets including PIX11 News, The New York Daily News, Inside Edition and DNAinfo. Aliza covers trending news, often focusing on crime and politics.

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URUGUAY ROUND AGREEMENT: TRIPS

Part II — Standards concerning the availability, scope and use of Intellectual Property Rights

Sections 7 and 8

• PART I General Provisions and Basic Principles
• PART II Standards Concerning the Availability, Scope and Use of Intellectual Property Rights
• 1. Copyright and Related Rights
• 2. Trademarks
• 3. Geographical Indications
• 4. Industrial Designs
• 6. Layout-Designs (Topographies) of Integrated Circuits
• 7. Protection of Undisclosed Information
• 8. Control of Anti-Competitive Practices in Contractual Licences
• PART III Enforcement of Intellectual Property Rights
• 1. General Obligations
• 2. Civil and Administrative Procedures and Remedies
• 3. Provisional Measures
• 4. Special Requirements Related to Border Measures
• 5. Criminal Procedures
• PART IV Acquisition and Maintenance of Intellectual Property Rights and Related Inter-Partes Procedures
• PART V Dispute Prevention and Settlement
• PART VI Transitional Arrangements
• PART VII Institutional Arrangements; Final Provisions

Section 7: protection of undisclosed information

1. In the course of ensuring effective protection against unfair competition as provided in Article 10 bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3.

2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices  (10) so long as such information:

(a) is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;  

(b) has commercial value because it is secret; and  

(c) has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.

3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use.

Section 8: control of anti-competitive practices in contractual licences

1. Members agree that some licensing practices or conditions pertaining to intellectual property rights which restrain competition may have adverse effects on trade and may impede the transfer and dissemination of technology.

2. Nothing in this Agreement shall prevent Members from specifying in their legislation licensing practices or conditions that may in particular cases constitute an abuse of intellectual property rights having an adverse effect on competition in the relevant market. As provided above, a Member may adopt, consistently with the other provisions of this Agreement, appropriate measures to prevent or control such practices, which may include for example exclusive grantback conditions, conditions preventing challenges to validity and coercive package licensing, in the light of the relevant laws and regulations of that Member.

3. Each Member shall enter, upon request, into consultations with any other Member which has cause to believe that an intellectual property right owner that is a national or domiciliary of the Member to which the request for consultations has been addressed is undertaking practices in violation of the requesting Member’s laws and regulations on the subject matter of this Section, and which wishes to secure compliance with such legislation, without prejudice to any action under the law and to the full freedom of an ultimate decision of either Member. The Member addressed shall accord full and sympathetic consideration to, and shall afford adequate opportunity for, consultations with the requesting Member, and shall cooperate through supply of publicly available non-confidential information of relevance to the matter in question and of other information available to the Member, subject to domestic law and to the conclusion of mutually satisfactory agreements concerning the safeguarding of its confidentiality by the requesting Member.

4. A Member whose nationals or domiciliaries are subject to proceedings in another Member concerning alleged violation of that other Member’s laws and regulations on the subject matter of this Section shall, upon request, be granted an opportunity for consultations by the other Member under the same conditions as those foreseen in paragraph 3.

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• 10. For the purpose of this provision, “a manner contrary to honest commercial practices” shall mean at least practices such as breach of contract, breach of confidence and inducement to breach, and includes the acquisition of undisclosed information by third parties who knew, or were grossly negligent in failing to know, that such practices were involved in the acquisition. Back to text

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