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What is TRIPs Plus? What is Data Exclusivity?

World Trade Organization has emerged as the governing body for international trade since its inception in 1995. One of the important agreement of the WTO is the Trade Related Intellectual Property Rights (TRIPs), which deals about the protection of Intellectual Property Rights (IPRs) across countries.

TRIPs and the minimum standards

TRIPs Agreement stipulates minimum standards in the international rules governing patents, including that on pharmaceuticals or medicines. Member countries have to enact the necessary legal framework by including these minimum regulations. These standards include, amongst others, a minimum patent period of 20 years; provision for product patents; and the protection to pharmaceutical test data from ‘unfair commercial use’.

The developed countries are not happy about the TRIPs provisions. They demand higher protection to intellectual property rights including inventions, internationally. These higher levels of protection norms are named as TRIPs Plus. Since it is the developed countries who owns most of the technologies and patents, they are using various international forums to pressurize higher level of protection for intellectual property. Over the last few decades they are creating Free Trade Agreements to give higher level of protection to IPRs. Often these FTAs are outside the WTO framework and hence they can give higher level of protection to IPRs there.

What is TRIPS Plus?

TRIPs Plus are higher level of protection norms demanded by the developed countries that are not prescribed by the WTO’s TRIPs regime. Although they are named as ‘TRIPS-Plus,’ they are not formally related to TRIPs. Rather, the term is used to indicate that these requirements go beyond the minimum standards imposed by TRIPs. Many developing countries who are members of FTAs are under pressure to enact these tougher conditions in their patent laws.

The developing countries have concerns over the higher level of protection demanded by the developed world. They fear that once such levels of protection are given multilaterally, it will reduce competition and may led to price rise of medicines, affecting health security in poor countries.

Data exclusivity and TRIPS Plus

An example for advanced norms under TRIPs Plus is the protection demanded by developed countries for data exclusivity.

What is Data Exclusivity?

Data exclusivity is the protection of clinical test data submitted to a regulatory agency to prove safety, quality and efficacy of a new drug, and preventing the generic drug manufacturers from relying on this data in their own applications. Such a data exclusivity will stop generic drug manufactures of developing countries from using these data while applying for licenses.

The demand for protecting exclusive data that have high commercial value is a major demand from the developed world which doesn’t usually come under TRIPs.

India’s stand on TRIPS Plus

India has consistently objected to put higher level of protection (TRIPs Plus) than provided by the TRIPs. The implication of TRIPs Plus on India is that it will restrict the operation of the countries’ generics drugs manufactures. Similarly, it will prevent India firms from obtaining high technology at affordable prices. All these will led to reduced exports from India.

India’s opposition to TRIPs Plus is reflected in the country’s FTA negotiation with countries like Japan and the EU who demand TRIPs Plus level of protection in their proposed CEPA (Comprehensive Economic Partnership Agreement).

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Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement)

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

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• First Online: 28 October 2021
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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

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, 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 .

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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.

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

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El Said, M. (2022). The Impact of ‘TRIPS-Plus’ Rules on the Use of TRIPS Flexibilities: Dealing with the Implementation Challenges. In: Correa, C.M., Hilty, R.M. (eds) Access to Medicines and Vaccines. Springer, Cham. https://doi.org/10.1007/978-3-030-83114-1_11

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All costs, no benefits: how trips plus intellectual property rules in the us-jordan fta affect access to medicines.

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The USA continues to impose TRIPS-plus rules on developing countries, thus preventing poor people from accessing inexpensive, generic medicines. Jordan was required under the terms of its WTO accession package and its free trade agreement (FTA) with the USA to introduce TRIPS-plus rules. Medicine prices have increased drastically, and TRIPS-plus rules were partly responsible for this increase. Furthermore, stricter levels of intellectual property protection have conferred few benefits with respect to foreign direct investment, domestic research and development, or accelerating introduction of new, effective medicines. Medicine prices will continue to rise in Jordan, but the country will be unable to use TRIPS safeguards to reduce their cost. Other developing countries implementing or considering FTAs with TRIPS-plus rules should consider the consequences for public health.

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TRIPS-plus Rules in International Trade Agreements and Access to Medicines: Chinese Perspectives and Practices

Since ascending to the World Trade Organization (WTO) in 2001, China has focused extensively on increasing protection for intellectual property rights (IPRs). Additionally, in 2019, China signed a Phase One trade agreement with the United States to accelerate that process even more. These heightened intellectual property rules are beyond what is required by the WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and have become known as TRIPS-plus provisions.

As Han Bing demonstrates in a new working paper , China has now implemented several of the TRIPS-plus legal standards demanded under free trade agreements today, partly due to external factors and partly due to a desire to foster its own innovation in pharmaceuticals. The most important and long-standing of such standards is China’s data exclusivity law, which keeps generic manufacturers from relying on the underlying test data from the innovative product to gain marketing approval for at least six years (12 years for biologics).

Although the outcomes of these policies are mixed, the data on data exclusivity has had some decidedly negative consequences. Chinese pharmaceutical companies continue to struggle to break into the global market and in at least one case, data exclusivity kept a key treatment for Hepatitis C out of the domestic market, even though the product was not patentable under Chinese law.

China’s example demonstrates the complex relationship between IP protection and access to medicines. As Han Bing notes, at an international level, the focus of TRIPS-plus regimes needs to shift away from a concern about free riders and move towards offering a return, in the form of affordable access to the consumers who share in the innovation costs.

Dr. Han Bing is a senior research fellow at the Institute of World Economics and Politics (IWEP) of Chinese Academy of Social Sciences (CASS). Han Bing’s research interests are in international investment law, international trade law and China’s business environment.

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I. introduction.

• II. FTAs and BITs: scaling up the TRIPS Agreement
• III. How the RCEP matters to the IP system?
• IV. Final thoughts
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RCEP IP Chapter: Another TRIPS-Plus Agreement?

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María Vásquez Callo-Müller, Pratyush Nath Upreti, RCEP IP Chapter: Another TRIPS-Plus Agreement?, GRUR International , Volume 70, Issue 7, July 2021, Pages 667–671, https://doi.org/10.1093/grurint/ikab047

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On 15 November 2020, 15 Asian states signed the Regional Comprehensive Economic Partnership (RCEP) 1 that concluded years of negotiations despite uphill geo-political issues. The agreement is likely to create a populous trade area, boosting intra-regional investment and resulting in an important foreign direct investment destination. 2 Generally speaking, the RCEP builds on the free trade agreements (FTAs) signed between RCEP members with a commitment to market access and harmonizes the rules related to trade and investment. It also provides a skeleton for future negotiations based on the existing commitments. According to the recently released summary by the Secretariat, the RCEP aims to establish a ‘modern, comprehensive, high-quality, and mutually beneficial economic partnership that will facilitate the expansion of regional trade and investment and contribute to global economic growth and development’. 3

The significance of the RCEP is more geo-political rather than a classical norm-maker – norm-taker relationship. No doubt, certain countries such as China will use the RCEP to benefit and strengthen their geo-political influence in the region. This does not necessarily make the RCEP a game-changing agreement, nor does it confirm a global geo-political shift. The perception of the ‘RCEP’ as a new global standard is farfetched, in fact even at regional level, the ‘RCEP does not herald a dramatic liberalization of Asian trade’. 4 It does nonetheless consolidate in a single agreement various intra-ASEAN FTAs and other Asia-Pacific FTAs. In light of this general background, this opinion analyzes the intellectual property (IP) Chapter of the RCEP and its relevance.

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From TRIPS-minus to TRIPS to TRIPS-plus: Implications of IPRs for the Arab world

The Journal of World Intellectual Property | Vol 8, No 1, January 2005 | Werner Publishing Co | Geneva | pp 53-65

The Road from TRIPS-Minus, to TRIPS, to TRIPS-Plus Implications of IPRs for the Arab World

Mohammed EL-SAID*

I. INTRODUCTION

The advent of the World Trade Organization (WTO) in 1994 marked a new beginning in international trade and economic relations. The WTO’s main components, the General Agreement on Tariffs and Trade (GATT), the General Agreement on Trade in Services (GATS) and the Trade-Related Aspects of Intellectual Property Rights (TRIPS), represent today the main pillars of the “new global economic order”. The conclusion of the TRIPS Agreement came about as a result of the developed countries’ relentless efforts driven by their domestic interest groups to include the protection of intellectual property rights under the multilateral forum.  [ 1 ] It is not surprising therefore that the TRIPS Agreement was regarded as the “most contentious and anomalous component of the Uruguay Round” of trade negotiations.  [ 2 ] Almost a decade after the WTO creation, there continues to be a lack of agreement and controversy over the expected benefits of this Organization, including its TRIPS Agreement.  [ 3 ] While proponents of the WTO have labelled it as “the greatest trade agreement in history”,  [ 4 ] opponents view it as a mere “TRAP” to both the developed and developing countries.  [ 5 ]

The TRIPS Agreement represents the most comprehensive agreement ever to be concluded in the field of IPRs. It contains provisions which lay down universal minimum standards for each protected branch of intellectual property rights including protection of copyrights, patents, trademarks, geographical indications, layout-designs, trade secrets and unfair competition.

The TRIPS Agreement is part of a “package” to which those countries seeking WTO membership have to adhere. Hence, countries seeking to join WTO have to accept and implement all obligations as required under TRIPS, GATS and GATT.  [ 6 ] Hence this called for the incorporation, into domestic legislations, of the requirements of the TRIPS Agreement even before signing up to the Organization. To cope with the short-term costs and to enable Member States to prepare their accession to the WTO, transition periods were agreed upon and provided during the Uruguay Round of trade negotiations which was concluded in I994.  [ 7 ] These periods correspond to each country’s level of development and economic prosperity. Accordingly, five- and ten-year transition periods were granted to developing and least-developed countries (LDCs) respectively, to bring their IPR protection into conformity with TRIPS standards while the developed countries were awarded one year to implement the TRIPS Agreement.  [ 8 ]

However, in recent years, a new development in the international regulation of IPRs emerged: it represents the latest wave of shifting the discussion on issues related to IPR protection from the ambit of the multilateral framework to a more forceful one-to-one system.  [ 9 ] This wave was clearly manifested by the growing tide of recent bilateral trade and investment agreements between developed and developing nations.  [ 10 ]

This article sheds light on the evolution of free trade agreements (FTAs) and the IPR protection incorporated within such agreements. The emphasis will be on the latest free trade and investment agreements concluded between the United States and the European Union (EU) with the Arab world and their “TRIPS-Plus” nature. The article argues that FTAs are being used as political instruments to reward allies while, at the same time, enhancing the protection of intellectual property rights globally beyond the agreed levels of the TRIPS Agreement, hence resulting in a negative effect on both the developing and the Arab countries. This will circumvent and hinder the efforts of these countries to acquire the desired levels of technology and development.

II. THE TRIPS BARGAIN

The need to protect intellectual property rights on a global scale came mainly as a result of increased pressures from the governments of Western industrialized countries, steered by their giant enterprises and multinationals, which were arguing that counterfeiting and imitation in the developing world was costing them billions of dollars in losses every year.  [ 11 ] This encouraged industrialized countries, particularly the United States and the European Union, to pursue a unilateral and a bilateral agenda to bring about the desired tougher levels of IPR protection at an international level despite the developing countries’ unwelcoming approach to such protection.

Developing countries, on the other hand, initially heavily opposed stronger IPR regulation under GATT and favoured the World Intellectual Property Organization’s (WIPO) role in the matter which was more sympathetic to their demands. However, eventually, and under intensive pressure and increased promises of concessions in other areas from developed countries (including increased market access for agriculture and textile as well as guarantees and assurances that developed countries will refrain from resorting to unilateral and bilateral pressures), developing countries accepted the adherence to a multilateral forum that incorporated globally higher minimum levels of IPR protection.  [ 12 ]

Accordingly, developing countries believed that the conclusion of the TRIPS Agreement would represent the end of the road and the last multilateral effort to regulate internationally the issue of IPRs. By removing the “burden” of intellectual property rights out of their way in exchange for several concessions in other vital sectors, developing countries hoped that they would succeed in preventing developed countries, especially the United States, from pursuing their unilateral and bilateral practices against them. Such a belief was reinforced by the developed countries’ own determination to shift the discussions surrounding IPRs to a more efficient and cohesive multilateral forum rather than depending on the already existing soft and fragile WlPO.  [ 13 ]

From the point of view of the developed countries, however, the WTO’s TRIPS Agreement was no more than just the beginning of a more heavily regulated global market for intellectual property rights.  [ 14 ] Thus, it appeared that TRIPS aimed at universalizing the IPR protection according to Western intellectual property rights levels and standards as a first step towards further and wider protection.  [ 15 ] In this context, the subsequent collapse of the WTO Ministerial Conferences in Seattle and Cancun came mainly as a result of the developing countries’ frustration and scepticism about developed countries’ readiness to fulfil their earlier promises undertaken during the Uruguay Round of Negotiations and their resolve to unilateralism and bilateralism instead.  [ 16 ]

III. INTELLECTUAL PROPERTY RIGHTS IN THE ARAB WORLD

Generally, the Arab countries (as part of the developing countries) viewed IPR protection negatively. Emanating from a clear lack of awareness and a weak comparative advantage, Arab States awarded little attention to IPR protection and regulation. Thus, Arab States in their own mindset always followed a passive approach of only acting on the protection of IPRs “whenever they have to”.  [ 17 ]

This is not to say that IPR protection did not exist or was a new issue in the Arab region prior to 1994. In fact most Arab countries have had IPR laws and legislations for decades; the problem has often been the evident lack of implementation and enforcement of these rights.  [ 18 ]

However, in recent years, a large number of Arab countries have acceded to the WTO, while others are on the way to doing so. As a prerequisite to such accession, these countries had to undertake sonic major legislative changes in their IPR regime which resulted in upgrading their IPR laws to the international minimum levels of protection as required under the TRIPS Agreement. In other words, some Arab States have moved from a TRIPS-Minus situation, where the application and enforcement of intellectual property rights was weak, to a TRIPS situation, where stronger universal minimum levels of IPR protection were required with very little preparation and national debate.  [ 19 ]

IV. BILATERALISM AND THE ARAB COUNTRIES

The collapse of the 1999 WTO Ministerial Conference in Seattle signalled the official beginning of more difficult times ahead for the global multilateral system as embedded under the WTO structure. However, the subsequent abrupt failure of the Cancun Ministerial Conference in 2003 led many to believe that the future of the world multilateral framework co-operation is in real jeopardy. However, what is interesting to note in this regard is the fact that even before the latest stalemate in discussions under the multilateral framework occurred, developed countries have already undertaken several measures that undermined the proper functioning of the world multilateral regime.

Although developed countries, and in particular the United States, made promises that they would not resort to unilateral or bilateral measures if a multilateral trading system was established during the Uruguay Round of Negotiations in 1994, empirical evidence refutes these arguments. One example is found in the increase in recent years in the number of bilateral trade and investment initiatives and agreements sought by the United States, and the European Union, to strengthen their trade relations with other developing countries. The world has experienced a tremendous rise in the number of bilateral free trade agreements in recent times, not only between developed countries but also between them and LDCs. The United States has already completed eight bilateral free trade deals, and is currently negotiating another fourteen agreenients.  [ 20 ]

Such agreements deal with various issues of trade, tariff reduction, market access, services, labour and environment. However, what is of relevance here are the detailed chapters incorporated within these agreements that emphasise the importance of protecting IPRs in accordance with the “highest international standards” and levels of protection. Such standards are achieved through a number of bilateral free trade and investment agreements.

Arab countries did not escape the recent wave of bilateralism. In fact, in less than half a decade, the United States has signed FTAs with three Arab countries. These are the U.S.-Jordan FTA,  [ 21 ] the U.S.-Morocco FTA,  [ 22 ] and finally the U.S.-Bahrain FTA.  [ 23 ]

Other developed nations are also following suit. The European Union has recently completed more than thirty bilateral association agreements with countries located in the Middle East and North Africa (MENA) (including Jordan, Syria. Egypt, and the Palestinian Authority), and Eastern Europe,  [ 24 ] while Japan has also concluded a number of FTAs during the last year.  [ 25 ]

What is interesting about these FTAs and association agreements is the effect they are having upon their weaker Member States (in such cases Arab and developing countries). Such agreements have resulted in what sometimes is referred to as TRIPS-Plus effect. However, it is important to pay close attention to the meaning and implications of such a development as far as Arab countries are concerned.

V. THE DEFINITION OF “TRIPS-PLUS”

The WTO’s TRIPS Agreement laid down minimum international standards for IPR protection. Although Members cannot derogate or provide lower ceilings of protection,  [ 26 ] they still have the right to apply and incorporate higher amid more extensive levels of protection if they deemed so wittingly, as long as they apply the general principles of most-favoured nation (MFN) and national treatment under this Agreement. In addition, the TRIPS Agreement also provides Member countries with the discretion to incorporate their own standards and procedures about how to implement the Agreement within their jurisdictions.

However, if a country is being forcefully required to implement more extensive levels and standards of IPR protection than that required under time TRIPS Agreement, or undertakes the elimination of an option which was awarded to it under the Agreement, it may then be said that this country is implementing a TRIPS-Plus recipe.  [ 27 ] Additionally, a TRIPS-Plus mechanism may also mean that countries are to interpret the TRIPS Agreement in a narrower sense thus ensuring the compliance of these countries in accordance with this Agreement with the utmost levels of efficiency.

However, during the past few years, it has been noticed that a number of countries have adapted and incorporated more enhanced levels of IPR protection unwillingly as a result of pressures exerted on them by the industrialized countries, either under the WTO or under some bilateral free trade agreements. The latter trend was championed by the United States and the European Union in their latest free trade and association agreements. In this context, an important question is often raised: what are the components of a TRIPS-Plus recipe under bilateral trade and investment agreements in relation to these agreements signed with the Arab World recently?

VI. THE GENESIS OF “TRIPS-PLUS”

Generally speaking, there can be no fixed definition for the term “TRIPS-Plus”. In fact, such a term is still in the process of evolution and has proven to be case- and country-specific. This can be viewed in conjunction with the emerging provisions of the recent FTAs in this field in which they all seem to add more to the existing literature. Following are some examples of the characteristics which may deem an agreement a TRIPS-Plus that characterizes bilateral trade agreements that have been signed between the United States and the European Union, on the one hand: and some Arab countries, on the other.

First, the TRIPS Agreement allows Member countries to exempt and exclude plant and animal patents from their national patent laws.  [ 28 ] Increasingly, countries are being forced through such FTAs to relinquish such a right by requiring them to award protection for such patents hence resulting in a TRIPS-Plus effect. A good demonstration of this trend is the U.S.-Jordan ETA which commits Jordan to provide protection for such patents,  [ 29 ] although this was not a condition attached to Jordan’s membership in the WTO. Such a provision was also echoed in the U.S.-Bahrain FTA and U.S.-Morocco FTA.  [ 30 ]

Moreover, on the issue of revocation of patents, the TRIPS Agreement grants Member countries the discretion to incorporate the wounds of such revocation within their national legislations.  [ 31 ] However, some FTAs are increasingly restricting the basis of such revocation to include cases of fraud and misrepresentation which represents further commitments beyond the TRIPS Agreement.  [ 32 ]

Second, a TRIPS-Plus effect may relate to extending certain periods of protection beyond the requirements of the TRIPS Agreement and forgoing certain benefits related to the enjoyment of transition periods by certain countries. An example of the earlier scenario is clearly manifested by the U.S.-Morocco FTA which provides that protection for copyrights should be calculated on the basis of the life of the author plus seventy years,  [ 33 ] a clear extension of the WTO’s TRIPS Agreement, which proposed that protection should be the life of the author plus fifty years.  [ 34 ]

In addition, the TRIPS Agreement provided a minimum ten-year period of protection for industrial designs.  [ 35 ] Under most FTAs, this period has been extended to at least fifteen years, therefore resulting in a TRIPS-Plus effect.  [ 36 ]

TRIPS-Plus effects can also be evident as a result of the pressure exerted on developing countries to forgo privileges related to the transition periods under the WTO, which is clearly manifested in several FTA and association agreements. For example, under the EU-Jordan Association Agreement, Jordan was pressured to implement shorter periods of transition than that provided under TRIPS regarding the protection of patents.  [ 37 ]

Third, a TRIPS-Plus arrangement may oblige countries to join a specific international agreement or treaty related to a specific field of intellectual property rights. Such an effect was present in the requirement of the U.S.-Jordan FTA and EU-Jordan Partnership Agreement. Both of these agreements require Jordan’s submission to a number of international agreements and treaties such as the WIP0’s Internet Treaties.  [ 38 ] Moreover, Jordan was also expected to submit to the International Convention for the Protection of New Varieties of Plants (UPOV Convention) and the Joint Recommendation Concerning Provisions on the Protection of Well-Known Marks of l999.  [ 39 ] Similar provisions can also be found in several other FTAs signed with other Arab countries as well, hence also rendering them of TRIPS-Plus nature.  [ 40 ]

Fourth, the TRIPS Agreement’s strength lies in its extensive provisions related to enforcement. Accordingly, any bilateral agreement that modifies and adds to such measures will most likely result in a TRIPS-Plus effect. A clear model of this is the U.S.-Jordan FTA that obligates Jordan to raise its criminal penalties to Jordanian Dinar 6,000  [ 41 ] for copyrights and trademark counterfeiting and piracy.  [ 42 ] The U.S.-Jordan FTA also provides that, in the event of copyright piracy and trademark counterfeiting, authorities may initiate criminal actions and border measures without the need for formal complaint.  [ 43 ]

Fifth, on the issue of trademark protection, the TRIPS Agreement adopts a broad definition of what constitutes a “trademark”, and provides several examples of what may constitute a trademark.  [ 44 ] Increasingly, subsequent FTAs are incorporating other emerging types of signs for registration including visual, scent amid sound marks thus resulting in further higher levels of protection.  [ 45 ]

Additionally, the TRIPS Agreement contains a separate part of provisions dealing with the issue of geographical indications. Currently, several FTAs are obliging Member States to treat geographical indications as trademarks for the purposes of protection, registration and implementation.  [ 46 ] Such treatment is most likely to result in additional protection for famous geographical marks belonging to the developed countries rather than the developing ones.

Moreover, protection for famous amid well-known trademarks is also being strengthened under such FTAs by extending that protection to include not only similar goods but also dissimilar goods as identified by the famous or well-known trademarks.  [ 47 ]

Sixth, the requirement of several FTAs and bilateral investment agreements for countries to adhere and implement “the highest international standards” of protection for intellectual property rights also makes such agreements subject to the TRIPS-Plus criteria. Although such standards are not defined precisely under these agreements, some suggest that such standards are being included to pave the way for the subsequent conclusion of a multilateral or bilateral investment treaty. Therefore, the effect of such provisions may not be felt initially, but is most likely to be felt subsequently in relation to variant issues including investment and attracting foreign direct investment (FDI).  [ 48 ]

Seventh, the imposition of alternative dispute settlement procedures under such FTAs other than that of the WTO is also considered as a TRIP-Plus clause. In a number of FTAs, new dispute settlement procedures are being proposed  [ 49 ] to solve disputes arising from the implementation and interpretation of such agreements.  [ 50 ] Such agreements are often based upon a binding arbitration mechanism. By bypassing the WTO dispute settlement, such FTAs are increasingly weakening the multilateral dispute settlement framework and squeezing weaker States to adhere to more sophisticated dispute settlement procedures (in which they have neither the resources nor the expertise to compete). This leaves the developing countries, including Arab States, with less and more restricted options regarding the implementation of such agreements.

VII. TRIPS, ARAB STATES AND THE FUTURE OF THE WORLD MULTILATERAL INTELLECTUAL PROPERTY REGIME

Immediately after the collapse of Cancun Trade talks in 2003, Robert Zoellick, the U.S. Trade Representative, declared that the United States would not be deterred from pursuing its unilateral amid bilateral trade agenda. In fact, he went further to divide countries into “can do” and “won’t do” FTAs with the United States.  [ 51 ] Such a development should not be seen as the beginning, rather a continuation of the United States approach of bringing around its desired modifications and changes to the world multilateral trading agenda, including the IPR protection through its unilateral and bilateral initiatives.

Such a process is not unprecedented in the history of IPR protection. It follows a pattern of a number of policies representing a “regime” and “forum shift”  [ 52 ] to force the necessary changes to the multilateral framework through a policy of coercion and enforcement rather than consensus building and democratic bargaining.  [ 53 ] Indeed, today’s bilateralism represents the third wave of such a process that builds upon the first and second waves starting with shifting the discussion on intellectual property rights from the ambit of the international conventions (Paris and Berne) to WIPO, and subsequently from WIPO to the umbrella of GATT and the WTO.

It could be argued that the world is experiencing, under the current wave of bilateralism, a policy of “competitive liberalization” advocated by the United States and the European Union. However, such a policy is undermining the world multilateral framework. The discriminatory nature of such agreements, coupled with the policy of rewarding allies for their political and international support  [ 54 ] rather than their trade credentials is indeed creating more complexities for the world multilateral framework.  [ 55 ]

The recent success of developing countries in blocking the adaptation of any further commitments under the WTO through their collective united stand and coalition against such matters led the United States to believe that any changes it needs to bring to the multilateral agenda can be achieved first through bilateralism and trade sanctions.

Targeting “soft countries” is also aiding the United States and the European Union in creating their global vision of a more regulated intellectual property rights universe. Thus, it may be realized that these countries are indulging in the process of modifying and amending issues which they deem necessary to change under the multilateral framework through bilateral means. In addition, since most bilateral agreements require their Member States accession to a number of international intellectual property agreements, the developed States are fostering the process of “maturity” for these agreements thus bringing them into force ahead of their time.  [ 56 ]

It is also important to draw attention to the flexible nature of each subsequent bilateral PTA between developed countries and a new LDC. They take a cumulative country-specific approach, adding more features on top of current FTAs. The upshot is what some referred to as “state-of-the-art” FTAs, particularly with regard to IPR protection.  [ 57 ] Each agreement is being used ex ante as a standard model of negotiations with new countries, leading to a more enhanced TRIPS-Plus recipe.  [ 58 ]

Although the creation of the TRIPS-Plus effect may be attributed to the pressure exerted by the developed countries, particularly the United States and the European Union, upon weaker developing countries through bilateralism, the deficient nature of the TRIPS Agreement itself also contributed and facilitated this process. In this regard, the TRIPS Agreement incorporates a number of vague, ambiguous and unpredictable provisions which may allow countries to deviate and interpret the agreement differently.  [ 59 ]

Such bilateral agreements arc also acting as an impediment to Arab regional cooperation and development. Any Arab State signing a bilateral agreement with a developed country will not only be susceptible to harsher requirements of protection, but will also force other neighbouring Arab States to adhere to even harsher provisions in order to be able to compete in attracting foreign direct investment. A clear example of this was the latest quarrel between the Arab Gulf Cooperation Council (AGCC) and Bahrain (which is a member of the AGCC) as a result of Bahrain’s signing of an FTA Agreement with the United States. In fact, the AGCC urged Bahrain to denounce amid drop its FTA with the United States because of its negative effect on the future cooperation and development of the AGCC.  [ 60 ]

To sum up, one can depict the creation of a systematic web of bilateral free trade agreements over which the developing countries will have no control. Industrialized countries are using different instruments to complete such agreements with LDCs, including the threat of trade sanctions and suspension of aid and FDI. Penetrating regional alliances is an important part of this policy. The United States now have in force at least one FTA or BIT in each region and continent, representing alliances with certain “soft” or “friendly” regimes that allows it to access such markets as well as facilitating its mission in creating a future multilateral investment treaty based on the previous failed Multilateral Investment Treaty model (MAI). Hence, one can anticipate that the real dangers of such a web of treaties are yet to be fully recognised in the near future after the completion of the current bilateral negotiations wave led by the United States and the European Union.

VIII. CONCLUSION

Jordan, Bahrain and Morocco represent an interesting case study for the protection of intellectual property rights in the world. These countries do so because in less than a decade, they have moved from a TRIPS-Minus situation to a TRIPS-Plus one with little preparation and at immense speed. Whilst some argue that the one-hundred years period which preceded the establishment of the WTO was not enough for the developing countries to adjust and upgrade their IPR regimes accordingly,  [ 61 ] the speed at which these three Arab countries reformed and upgraded their IPR regime provides a very unique situation for developing countries that have a weak comparative advantage and very limited intellectual property rights assets and resources to protect.

Several developments are affecting the evolution of the TRIPS Agreement in the global arena in a direction that is only adding more constraints and protection to IPRs in developing countries, including the Arab countries. Recent bilateral trade initiatives are increasingly rendering the TRIPS Agreement “ineffective” in the face of such initiatives.

The policy of “competitive liberalization” as advocated by the United States and the European Union is undermining the world multilateral framework. The discriminatory nature of such agreements, coupled with the policy of rewarding allies for their political and international support,  [ 62 ] rather than their trade credentials is indeed creating more complexities for the world multilateral framework. One must not look at the latest FTAs with Arab States as a separate development from international relations, but rather as a part of an organised global policy network-building exercised by the developed countries.

Such bilateral arrangements represent the third wave of shifting debate about IPRs from the WTO auspices to a mere State-to-State arrangement. Bypassing the WTO Dispute Settlement Procedure and the operation of such trade deals outside the ambit of the WTO should be considered as a major threat to the world multilateral trading regime under the WTO.  [ 63 ]

The push by the developed countries including the United States and the European Union to incorporate the TRIPS Agreement ahead of time and to further add more obligations which go beyond the TRIPS Agreement, upon the shoulders of Arab countries, should not be underestimated. This will result in restraining the ability of Arab countries to implement the TRIPS Agreement freely and will circumvent their negotiation power multilaterally.  [ 64 ]

Arab countries must play a more active role in the international arena by uniting their efforts under the multilateral framework. This can be achieved by joining forces with like-minded countries. Moreover, Arab States must also adopt a comprehensive policy towards creating a national economy capable of fostering creativity and innovation aiming to compete globally. In this regard, the 2002 Arab Human Development Report,  [ 65 ] published by the United Nations, stresses the need for establishing incentives to support greater creativity and innovation in the Arab world via enhancing the IPR protection. However, for Arab countries to reap the benefits of such protection, they need to develop a national and regional agenda that pays precise attention and care to their development needs and priorities. Arab States can ignore such recommendations, but only at their peril.

* Research Fellow. Faculty of Law, University of Manchester, UK. The author may be contacted at: [email protected].

[ 1 ]  Agreement on Trade-Related Aspects of Intellectual Property Rights, April 1994, The Marrakesh Agreement Establishing the World Trade Organization. Available at: www.wto.org/english/does_e/legal_e/... .

[ 2 ]  G. Dunkley, The Free Trade Adventure: The WTO, the Uruguay Round and Globalization-A Critique, Zed Books, Third World Network, New York, 2000, at 69.

[ 3 ]  See M. Trebiloek and R. Howse, The Regulation of International Trade, 2nd edition, Rootledge, London, 1999.

[ 4 ]  Statement by Peter Sutherland, GATT Director-General, in Dunkley, supra, footnote 2, at 3.

[ 5 ]  D. Chisum, commenting on why the term TRIP was selected instead of “why isn’t it ‘TRAP’, which might be more descriptive”, Remarks by Professor Chisum, 22 Vanderbilt Journal for Transnational Law 2. 1989, 341 at 342.

[ 6 ]  TRIPS Agreement, Article 72 provides: “Reservations may not be entered in respect of any of the provisions of this Agreement without the consent of the other Members.”

[ 7 ]  Braga comments on this by saying that: “... the TRIPS bad effects will be diluted by the transitional periods.” C. Primo Braga, Trade-Related intellectual Property Issues: The Uruguay Round Agreement and its Economic Implications, in W. Martin and A. Winters (eds.). The Uruguay Round and the Developing Countries, Chapter 12, Cambridge, Cambridge University Press, 1996, 341 at 367.

[ 8 ]  TRIPS Agreement. Articles 65-66. However, in the WTO Ministerial Meeting in Doha in 2001, least-developed countries were granted additional 10-year transition periods up until 2016 for pharmaceutical product patents.

[ 9 ]  L. Helfer, Regime Shifting: The TRIPS Agreement and New Dynamics of International Intellectual Property Lawmaking, 29 Yale Journal of International Law 1, 2004, 1.

[ 10 ]  P. Drahos, Developing Countries and International Intellectual Property Standard-Setting, 5 J.W.I.P. 5, September 2002. 765.

[ 11 ]  In 1986 some estimates were that over 27 per cent of U.S. exports contained intellectual property components. M. Gadbaw, Intellectual Property and International Trade: Merger or Marriage of Convenience? 22 Vanderbilt Journal of Transnational Law, 1989, 223 at 232.

[ 12 ]  May suggests that in 1995, developing countries took the “best deal” they could get by gaining market access to developed countries’ markets; developing countries believed that it was a price worth paying. C. May, Why IPRs are a Global Political Issue? 25 European Intellectual Property Review 1, 2003, 1 at I. Also, Abbott comments that developing countries agreed to TRIPS “not because they concluded that the agreement as a stand-alone matter was necessarily in their best interest rather than it being a part of the bargain”. F. Abbott, Commentary: The International Intellectual Property Order Enters the 21st Century, 29 Vanderbilt Journal of Transnational Law, 1996. 471 at 472.

[ 13 ]  Further remarks by some U.S. officials were hinting in that direction as well. For instance, in 1989, Emory Simon, Director of Intellectual Property at the Office of the U.S.T.R. stated that: “... what happens if we fail to [obtain TRIPS?] I think there are a number of consequences to failure. First, will be an increase in bilateralism. For those of you who think that bilateralism is a bad thing, a bad thing will come about.” E. Simon, Remarks of Emory Simon, 22 Vanderbilt Journal of Transnational Law. 1989, 367 at 370.

[ 14 ]  A letter from Pfizer (one of the world’s biggest pharmaceutical companies) to the U.S.T.R. in 1994 supports such a conviction; it states that: “Finally, GATT does not do it. Many Indians mistakenly (often very honestly) believe that if they endorse GATT they will have solved their intellectual property and pharmaceutical patent issue. Not so, particularly if they truly want to create an environment that attracts investment and provides better medicine legalistically agreeing to something (GATT) that brings this into play in ten years or more achieves neither of these two objectives.” Letter Irons C.L. Clemente, Senior Vice President, Corporate Affairs, Pfizer Inc., to Joseph Papovich, Deputy Assistant U.S. Trade Representative for Intellectual Property, 7 June 2004. Cited so P. Drahos, Expanding intellectual Property’s Empire: The Role of PTA, 2003. Available at: www.grain.org/rights/tripsplus/cfm?id28 .

[ 15 ]  See I. Elangi Botoy, From the Paris Convention to the TRIPS Agreement: A One-Hundred-and-Twelve-Year Transitional Period for the Industrialized Countries, 7 J.W.I.P. 1 January 2004, 115. Also C. Correa, Intellectual Property Rights, The WTO and Developing Countries. Zed Books, Third World Network, London, 2000.

[ 16 ]  Some even go as far as suggesting that the “developed countries never had any intention of fulfilling implementation commitments.” K. Mukherji, WTO and South Asia: From Doha to Cancun, Economic and Political Weekly, 13 September 2003, 3864 at 3864.

[ 17 ]  Sherif Saadallah, Director of the WIPO Arab Bureau, told Al-Ahram Weekly: “Thus far Intellectual Property (IP) laws have been misunderstood as not being in the interest of the general public.” N. Wahish, Tripping on TRIPS, Al-Ahram Weekly, Issue 604, September 2002.

[ 18 ]  Carroll comments: “... despite the host of Middle Eastern intellectual property laws, and some reported instances of enforcement, regulations are perceived to be lax and countries throughout the region tend not to enforce intellectual property law”. J. Carroll, Intellectual Property Rights in the Middle East: A Cultural Perspective, 11 Fordham Intellectual Property, Media and Entertainment Law Journal, 2000-2001, 555 at 560.

[ 19 ]  For instance, in one of its reports, the International Crisis Group (ICG) quoted a a major Jordanian entrepreneur complaining about such lack of consultation. He said that: “In the absence of parliament, major decisions are taken without the necessary checks and balances, for example, concerning Jordan’s membership in the World Trade Organization and the Free Trade Agreement with the United States. These agreements may have been rushed through and not have the best interest of Jordan in mind; better deals might have been negotiated.” ICG Briefing, The Challenge of Political Reform: Jordanian Democratisation and Regional Instability, Amman/Brussels, 8 October 2003. at 7.

[ 20 ]  Four of these agreements were signed with countries in the Middle East and North Africa (MENA), including Jordan, Morocco, Bahrain and Israel.

[ 21 ]  Signed 24 October 2000. This FTA was the first ever between the United States and an Arab or Islamic country and the first in the world of its type. It incorporates for the first time “WTO-Plus” requirements related to labour and environment. Text available at: www.jordanusfta.com . For more on the U.S-Jordan FTA, see R. Grynberg, The United States-Jordan Free Trade Agreement: A New Standard in North-South FTAs?, 2 J.W.I.P. 1, March 2001, 5.

[ 22 ]  Signed in 2003. It is the first ever FTA between the United States and a North African country. Text available at: www.moroccousfta.com .

[ 23 ]  Signed May 2004. It is the first ever FTA between the United States and an Arab Gulf country. Text available at: www.ustr.gov/trade_agreement/bilate... . The United States is also currently seeking further FTAs with the United Arab Emirates and Oman.

[ 24 ]  See Council of Canadians and Polaris Institute, WTO-FTAA: Making the Links Report, Bulletin Board, 24 July 2003; available at www.corpwatch.org/bulletins/PBD.jsp... .

[ 25 ]  Such as the Japan-Singapore FTA; Japan-Mexico FTA; both concluded in 2004.

[ 26 ]  TRIPS Agreement, Article 1.1 states: “Members shall give effect to the provisions of this Agreement. Members may. but shall not be obliged to, implement in their law more extensive protection than is required by this Agreement, provided that such protection does not contravene the provisions of this Agreement. Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice.”

[ 27 ]  P. Drahos. BITs and BIPS: Bilateralism in Intellectual Property, 4 J.W.I.P. 6, November 2001, 791.

[ 28 ]  TRIPS Agreement, Article 27(3)(b) states: “Members may also exclude from patentability:....(b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. However, Members shall provide for the protection of plant varieties either by patents or by an effective sui generis systeus or by any combination thereof”.

[ 29 ]  U.S-Jordan FTA, Article 4(18) states: “... each part may exclude from patentability: (a) inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudices to the environment provided that such exclusion is not made merely because the exploitation is prohibited by their law.”

[ 30 ]  The U.S-Morocco FTA, Article 15.9(3) and the U.S.-Bahrain FTA, Article 14.8(1) and (2).

[ 31 ]  TRIPS Agreement, Article 23.

[ 32 ]  As in the U.S-Morocco FTA, Article 15.9(5) and U.S.-Bahrain FTA, Article 14,8(4).

[ 33 ]  See U.S-Morocco FTA, Article 15.5.3(a) and U.S.-Bahrain FTA. Article 14.4(4)(a).

[ 34 ]  TRIPS Agreement, Article 12.

[ 35 ]  TRIPS Agreement, Article 26(3).

[ 36 ]  EFTA-Morocco, signed 19 June 1999, Annex 5, Article 3(1) states: “... the States parties to this agreement shall ensure in their national laws at least the following: - adequate and effective protection of industrial designs by providing in particular a period of protection of five years from the date of application with a possibility of renewal for two consecutive periods of five years.”

[ 37 ]  EU-Jordan Association Agreement. Annex vit.3 provides: “Jordan undertakes to provide for adequate and effective protection of patents for chemicals and pharmaceuticals in line with Articles 27 to 34 of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights, by the end of the third year from the entry into force of this Agreement or from its accession to the WTO, whichever is the earliest.”

[ 38 ]  These include the WIP Copyright Treaty 1996 and the WIPO Performances and Phonograms Treaty 1996.

[ 39 ]  See Article 4.1(2-1) U.S-Jordan FTA and Annex VII of the EU-Jordan Partnership Agreement, Article 1.

[ 40 ]  For example, see U.S-Morocco FTA, Article 15.1(2-3), the U.S.-Bahrain FTA, Article 14.1(2) and the EU-Egypt Association Agreement. Annex VI.

[ 41 ]  Approximately US$ 9,000.

[ 42 ]  Memorandum of Understanding on Issues Related to the Protection of Intellectual Property Rights Under the Agreement between the United States and the Hashemite Kingdom of Jordan on the Establishment of a Free Trade Area. Article 3 states: “... with respect to article 4.25 of the Agreement, Jordan shall raise its criminal penalties to JDs 6000, so as to meet its obligation to ensure that statutory maximum fines are sufficientlyhigh to deter future acts of infringement.”

[ 43 ]  U.S-Jordan FTA, Article 4.26 stipulates: “... each party shall provide, at least in cases of copyright or trademark counterfeiting, that its authorities may initiate criminal sanctions amid border measure actions ex officio, without the need for a formal complaint by a private party or right holder.”

[ 44 ]  TRIPs Agreement, Article 15.1

[ 45 ]  U.S-Morocco FTA, Article 15.2(1); U.S.-Bahrain FTA, Article 14.2(1).

[ 46 ]  U.S.-Jordan FTA, Article 4.6.

[ 47 ]  U.S-Jordan FTA, Article 4.7.

[ 48 ]  See P. Drahos, supra, footnote 14.

[ 49 ]  “Such as the International Center for Settlement of Investment Disputes (ICSID), the International Chamber of Commerce and the UN Commission on International Trade Law (UNCITRAL).

[ 50 ]  See U.S.- Jordan FTA. Article 17(2-4) and U.S.-Morocco FTA, Article 20.1 to 20.7.

[ 51 ]  R. Zoellick, America Will Not Wait For The Won’t-do Countries, Financial Times, London Edition, 22 September 2003, at 23. Can also be found online at: www.ustr.gov/speech-test/zoellick/2... .

[ 52 ]  Helfer defines “regime shifting” as “an attempt to alter the status quo ante by moving treaty negotiations, law making initiatives, or standard setting activities from one international venue to another”. See L. Helfer, Regime Shifting: The TRIPS Agreement and New Dynamics of International Property Lawmaking, 29 Yale Journal of International Law 1, 2004 1 at 14.

[ 53 ]  Drahos explains: “... when developing countries were successful in veto coalition on intellectual property, that success triggered a strategy of forum shifting.” He refers to the Treaty on Integrated Circuits which was rejected in 1989 by the developing countries but whose provisions were included in the TRIPS Agreement: P. Drahos, supra, footnote 10. at 780. Also Jean-Frederic Morin, Moving Forward from Cancun: the Global Governance of Trade, Environment and Sustainable Development; The Bilateral IP Agreements, paper presented at the International Conference, Institute for International and European Environmental Policy, October 2003: available at: www.ecologic-events.de/Cat-E/en/doc... .

[ 54 ]  A clear example of this is the U.S. suspension of negotiations of an FTA with Egypt in response to Egypt’s decision not to join the United Stares in a WTO complaint against the EU ban on genetically modified food. For more, see K. Mukherji, supra, footnote 16, 3864.

[ 55 ]  One can realize that there are limited and underwhelming gains and benefits for the United States from such agreements. For example, U.S. exports to Jordan are minimal (US$ 404 million in 2002), as are the U.S. shipments to Morocco (US$ 565 million in 2002) and Bahrain (US$ 419 million last year). Sidney Weintraud quipped “An FTA in other words is not necessarily an agreement in which all parties benefit from trade expansion, but rather a favour to be bestowed based on support of U.S. foreign policy”. S. Weintraud, The Politics of US Trade Policy, 3 September 2003, available at: news.bbc.co.uk/I/hi/business/3169649.stm . Moreover, Jackson states that the United States shifted to a “more pragmatic-some might say ad hoc approach-dealing with trading partners on a bilateral basis, and rewarding friends.” J. Jackson, The Trading System: Law and Policy of International Economic Relations, 2nd edition, MIT Press, Cambridge, Mass., London. 1997, at 173.

[ 56 ]  Such as the WIPO Internet Treaties (the WIPO Copyright Treaty 1996 and the WIPO Performances and Phonograms Treaty 1996).

[ 57 ]  For example, the U.S-Jordan FTA was the first trade agreement to incorporate provisions related to labour and environment. See Articles 5 and 6. Additionally, Grynberg remarks on the U.S-Jordan FTA by stating “... and within the space of a few weeks of its completion it became a template to future free trade agreements”. Grynberg. supra, footnote 21, at 11. Moreover, the subsequent U.S-Singapore FTA was described by Kang and Stone as “a-state-of-the-art” and “the first of its kind” as a result of adding up more commitments to previous agreements. P. Kang and C. Stone. IP, Trade, and U.S/Singapore Relations-Significant Intellectual Property Provisions of the 2003 U.S-Singapore Free Trade Agreement, 6 J.W.I.P. 5, September 2003, 721 at 722.

[ 58 ]  It is interesting how some U.S. officials describe these agreements. For example, R. Zoellick, the current U.S.T.R., remarks that: “... negotiating a free trade agreement with the U.S. is not something one has a right to-it’s a privilege.” T. Solo, Robert Zoellick’s Free Trade Evangelism, 17 November 2003, available at: www.corpwatch.com .

[ 59 ]  For example, Article 33 of the TRIPS Agreement permits an unlimited protection period when it says “the term of protection available shall not end before the expiration of a period of 20 years from the filing date”. Such a provision in reality does not provide a fixed term of protection and therefore allows Member States to adopt and incorporate their own vision which may vary from one country to another. For more, see D. Shanker, Legitimacy and the TRIPS Agreement, 6 J.W.I.P. 1, January 2003, 155.

[ 60 ]  Bahrain Defends Right to Sign FTA south U.S., Khaleej Times, 29 November 2004. For more on the U.S.-Bahrain FTA and intellectual property rights, see D. Price, The U.S.-Bahrain Free Trade Agreement and Intellectual Property Protection, 7 J.W.I.P. 6, November 2004, 829.

[ 61 ]  See generally Botoy, supra, footnote 15, at 116.

[ 62 ]  A clear example of this is the U.S. suspension of negotiations of an FTA with Egypt in response to Egypt’s decision not to join the United Stares in a WTO complaint against the EU ban on genetically modified food. For more, see Mukherji, supra, footnote 16, at 3864.

[ 63 ]  Economic gains from such bilateral initiatives are also being overestimated. A simulation study in the latest World Bank Report estimates that a broad global trade agreement could increase world income by US$ 263 billion by 2015, of which US$ 109 billion would go to poor countries. If developing countries all had bilateral agreements with big, rich trading partners (the European Union. the United Stares. Canada and Japan), global income would rise by much less: US$ 112 billion. The rich will scoop all this and more: US$ 133 billion. Although a handful of developing countries, such as Brazil and China, would gain a bit, poor nations as a group would be worse off than they are today. See World Bank Report, Global Economic Prospects, 2005, World Bank, Washington D.C., 2004.

[ 64 ]  There are increasing calls for developing countries to refrain from pursuing this bilateral route with the developed countries. For example, see Integrating Intellectual Property Rights and Development Policy, Report of the Commission on Intellectual Property Rights. September 2002, London, p. 1, available at: www.iprscommission.org . Also see United Nations Development Programme, Making Global Trade Work for People, 2003, Earthscan, U.K. and United Stares, 2003. Chapter 11; available at: www.undp.org/dpa/publications/globa... .

[ 65 ]  United Nations Development Programme, Arab Human Development Report 2002: Creating Opportunities For Future Generations, Arab Fund for Social and Economic Development, 2002.

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‘TRIPS Plus’ Provisions in US Free Trade Agreements

14 ‘ TRIPS Plus’ Provisions in US Free Trade Agreements T HE US BILATERAL Free Trade Agreements (FTAs) restore the standards of intellectual property protection that the US originally expected when concluding the TRIPS Agreement, bring precision to its ambiguous terms, raise the standards above those of TRIPS in certain fields, and introduce standards of protection in response to the situations created by new technologies such as the Internet. Raising the standards of IPR protection above the TRIPS Agreement is allowed under the second sentence of its Article 1.1, which provides that Members may implement more extensive legal protection than is required by the Agreement, provided that such protection does not contravene TRIPS provisions. This is an aspect of the flexibility that the TRIPS Agreement offers to Members. By the same token, these FTA provisions restrict the latitude of US FTA partners from invoking the standard-lowering flexibilities contained in the TRIPS Agreement. Thus, complex layers of TRIPS interpretations have emerged out of the positions taken by different industries and countries vis-à-vis the TRIPS Agreement. This chapter takes stock of US FTA provisions relating to IPRs and compares them with relevant TRIPS provisions. How and when these FTA provisions would impact socio-economic situations would depend on many factors outside the text of the agreements, including how they are implemented. Much, unfortunately, is in the realm of speculation. I ‘TRIPS PLUS’ PROVISIONS IN THE US FTAS A Beyond the Uruguay Round Results The TRIPS Agreement incorporated many proposals from developed countries, but still insufficiently reflected the US demands both on substantive standards of protection for new technologies and regulated products such as pharmaceuticals as well as on enforcement provisions. We have seen in chapter 4 that, towards the end of the Uruguay Round negotiations, the US pharmaceutical industry was opposing the draft text of what would be the TRIPS Agreement. Their dissatisfaction concerned the 10-year transition periods given before introducing product patent protection to such countries as India, Thailand and Brazil where most copies of drugs were produced at that time, and the fact that the Agreement would not offer protection for drugs in the ‘pipeline’. 1 The TRIPS Agreement incorporated many proposals from developed countries, but still insufficiently reflected the US demands both on substantive standards of protection for new technologies and regulated products such as pharmaceuticals as well as on enforcement provisions. Following the entry into force of the TRIPS Agreement, the built-in agenda discussions within the WTO TRIPS Council on the subject matter of biotech inventions stipulated in TRIPS Article 27.3(b) revealed that it is extremely difficult to modify TRIPS Agreement provisions or to give further discipline in the multilateral rules relating to intellectual property rights (IPRs) within the WTO (see chapters 5 and 12). The enforcement chapter of the TRIPS Agreement (Part III, Articles 41–61) where new rules concerning domestic enforcement producers and remedies were established for the first time in the history of public international law, did not seem to respond sufficiently to the expectations of US officials and industries who wished for clearer rules and a more effective enforcement system. Watal cites the examples of the language used in Part III of the TRIPS Agreement which disappointed US officials: it merely states that Members ‘shall make available to right holders’ certain procedures, or that judicial authorities ‘shall have the authority to . . .’ (chapter 5) 2 The rift that had existed during the Uruguay Round negotiations between developed countries, such as the US and the EU, and developing countries, such as India and Brazil, about what intellectual property rules should be within the GATT-WTO during the UR negotiations did not change significantly. The TRIPS interpretation instead became a new battleground for the access to medicines debate. The massive support given to the uncertain concept of TRIPS ‘flexibilities’ introduced further doubts about how reliable the TRIPS Agreement would be. This seems to have given additional reasons for the US to resort to pushing IP provisions in its bilateral agreements for the pursuit of the protection of intellectual property world-wide, relying simultaneously on the TRIPS Agreement and bilateral agreements on IP issues, depending in each case on what suits its agenda. The Panel in China–Intellectual Property Rights indicated the limits of Member’s discretion, 3 but no Appellate Body Report has yet dealt with the rules concerning the ‘flexibilities’ that the TRIPS Agreement offers. Traditionally, it was mainly the European Union (formerly the European Communities (EC)) that most often concluded a nexus of bilateral trade agreements, be it association agreements or other free trade agreements with countries in neighbouring regions. The agreements in the European region were aimed among other things at political and eventual market integration and at coping with immigration and security problems. In the 1980s, however, when it appeared that the Uruguay Round negotiations were not progressing well, the US started to negotiate bilateral free trade agreements (FTAs), first with Israel and secondly with Canada. The US-Israel FTA entered into effect on 1 September 1985, while the Canada-US Free Trade Agreement (CUSFTA) took effect on 1 January 1989. On 1 January 1994, the CUSFTA was expanded to include Mexico, through the North American Free Trade Agreement (NAFTA). At that time, the US resorted to bilateral relations only with countries with which it had pressing political and security or immigration issues. The US goal may be to create a global rule regarding commerce, but a single multilateral agreement is increasingly difficult to achieve. 4 Bilateral agreements provide a means to supplement various difficulties in strengthening multilateral rules. 5 Thus, there were three negotiating objectives regarding intellectual property stated in the Trade Promotion Authority (TPA). 6 The Bush Administration obtained these objectives from Congress in 2002, and they expired in July 2007. They were: to promote adequate and effective protection through various means, including the accelerated and full implementation of the TRIPS Agreement, any multilateral or bilateral trade agreement reflecting a standard of protection similar to that found in US law, responding to new and emerging technologies of transmitting and distributing products embodying IP, preventing or eliminating discrimination with respect to the availability, acquisition, scope, maintenance, use, and enforcement of IPRs, ensuring that standards of protection and enforcement keep pace with technological developments and providing strong enforcement of IPRs; to secure fair, equitable, and non-discriminatory market access opportunities for US persons who rely upon IP protection; and to respect the Doha Declaration on the TRIPS Agreement and Public Health. B TRIPS and NAFTA provisions relating to IPRs For the US, approximately the same draft text on IP protection served as the basis for the two parallel negotiations which started in 1986, one for the CUSFTA which entered into force on 1 January 1988, and the other for the TRIPS Agreement. In June 1991, Canada, Mexico and the US started negotiating the North American Free Trade Agreement (NAFTA), which was signed on 17 December 1992 and entered into force on 1 January 1994, one year before the entry into force of the TRIPS Agreement. The end results of these parallel negotiations differed on several points in relation to TRIPS provisions. NAFTA is less ambiguous and more detailed, because it has fewer Parties with diverging interests. There are some NAFTA provisions which deal with IPRs which do not exist in the TRIPS Agreement, or those which provide tighter limitations to the scope of exceptions than the TRIPS Agreement. These provisions can be called ‘TRIPS plus’. Concerning copyright, for example, NAFTA Chapter XVII contained certain provisions concerning rights which are not within the scope of the TRIPS Agreement, or which extend the protection or limit the scope of exceptions. For instance, Article 1705.6 restricts grounds for compulsory licensing by prohibiting the NAFTA Parties from granting translation and reproduction licences permitted under the Appendix to the Berne Convention, 7 while Article 1707 provides protection of ‘encrypted program[s] carrying satellite signals’, something which is absent in the TRIPS Agreement. 8 As for sound recording, Article 14.2 of the TRIPS Agreement provides merely that ‘producers of phonograms shall enjoy the right to authorize or prohibit the direct or indirect reproduction of their phonograms.’ Article 1706.1 recognises that the producer of a sound recording not only has this right, but also has extended rights over extended modes of distribution, namely, the right to prohibit ‘(b) the importation of copies of the sound recording made without the producer’s authorization, (c) the first public distribution of the original and each copy of the sound recording including by rental, and (d) the commercial rental of the original or a copy of the sound recording, except where expressly otherwise provided in a contract between the producer of the sound recording and the authors of the works fixed therein . . .’ Concerning trademarks, Article 1708.1 of NAFTA includes collective marks among trademarks and states that a Party may include certification marks. Article 1708.2 brings more clarifications to procedures for applying for the registration of trademarks, and Article 1708.6 of NAFTA clarifies the criteria in determining whether a trademark is ‘well known’, ie, that there is knowledge of the trademark in the relevant sector of the public, including knowledge in the Party’s territory obtained as a result of the promotion of the trademark. Article 1708.7 stipulates the term of trademark protection of 10 years, renewable for terms of not less than 10 years when conditions for renewal have been met, which is longer than the seven years stipulated in Article 18 of the TRIPS Agreement. Article 1708.8 of NAFTA provides an uninterrupted period of at least two years for non-use, unless valid reasons based on the existence of obstacles to such use are shown by the trademark owner, and examples are indicated justifying non-use which is independent of the right holder, such as import restrictions on, or other government requirements for, goods or services identified by the trademark. This period is shorter than the three years that is provided by TRIPS Article 19. Article 1708.14 of NAFTA provides what the TRIPS Agreement does not, ie, that ‘Each Party shall refuse to register trademarks that consist of or comprise immoral, deceptive or scandalous matter, or matter that may disparage or falsely suggest a connection with persons, living or dead, institutions, beliefs or any Party’s national symbols, or bring them into contempt or disrepute.’ Concerning patents, NAFTA introduces a tighter discipline in the grant and enjoyment of patents in Article 1709.8, which provides that a Party may revoke a patent only when: (a) grounds exist that would have justified a refusal to grant the patent; or, (b) the grant of a compulsory license has not remedied the lack of exploitation of the patent, whereas TRIPS Article 32 does not restrict the grounds for revocation or invalidity of patents. NAFTA also limits the scope of certain exceptions to the rights of patent holders. Article 34.1 of the TRIPS Agreement concerns the burden of proof for process patents, in the purposes of civil proceedings in respect of the infringement of the rights of the patent owner (referred to in paragraph 1(b) of Article 28). It states that the judicial authorities shall have the authority to order the defendant to prove that the process to obtain an identical product is different from the patented process and that any identical product when produced without the consent of the patent owner shall, in the absence of proof to the contrary, be deemed to have been obtained by the patented process: (a) if the product obtained by the patented process is new; or, (b) if there is a substantial likelihood that the identical product was made by the process and the owner of the patent has been unable through reasonable efforts to determine the process actually used. 9 Article 1709.11 of NAFTA, by contrast, allows either (a) or (b) above to establish that the allegedly infringing product was made by a process other than the patented process. Article 1709.3 of NAFTA offers the same options concerning the exceptions to patentable subject matter 10 to the Parties, as do Articles 27.2 and 27.3(a)(b) of the TRIPS Agreement. As for the term of patent protection, however, Article 1709.12 of NAFTA, in the second sentence, provides for patent term extensions due to regulatory delays, which the TRIPS Agreement does not. Regarding compulsory licensing, NAFTA provisions are similar to those in the TRIPS Agreement, with however, slightly more restrictive conditions with respect to the unauthorised use of the ‘first patent’ by the holders of second patents, which cannot be exploited without infringing ‘the first patent’ in Article 1709.10(l). 11 Furthermore, Article 1710 of NAFTA concerning layout designs of semiconductor integrated circuits (in paragraph 5) prohibits compulsory licensing of layout designs of integrated circuits. In contrast, the TRIPS Agreement permits such licensing under the conditions delineated in Article 31. For semiconductor technology, Article 31(c) of the TRIPS Agreement limits the grounds for compulsory licences only for public non-commercial use or to remedy anticompetitive practices determined after judicial or administrative processes. NAFTA has a specific rule for public authorities regarding liability 12 and Article 1715.7 provides for what is not in the TRIPS Agreement, ie, where: ‘a Party is sued with respect to an infringement of an intellectual property right as a result of its use of that right or use on its behalf, that Party may limit the remedies available against it to the payment to the right holder of adequate remuneration in the circumstances of each case, taking into account the economic value of the use.’ NAFTA clarifies the definition of trade secret, which in the TRIPS Agreement is referred to as ‘undisclosed information’. Article 1711.1 concerning trade secrets states the conditions on which they are protected, namely: (a) the information 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 that normally deal with the kind of information in question; (b) the information has actual or potential commercial value because it is secret; and (c) the person lawfully in control of the information has taken reasonable steps under the circumstances to keep it secret. Article 1711.2 further elaborates on these conditions: ‘A Party may require that to qualify for protection a trade secret must be evidenced in documents, electronic or magnetic means, optical discs, microfilms, films or other similar instruments.’ Article 1711.3 explicitly mentions that there is no time limit to the protection of trade secrets. 13 Article 1711.4 provides safeguards against abusive protection of trade secrets, and states: ‘No Party may discourage or impede the voluntary licensing of trade secrets by imposing excessive or discriminatory conditions on such licenses or conditions that dilute the value of the trade secrets.’ Concerning regulated pharmaceutical or agricultural chemicals products, NAFTA provides that if product patent protection is unavailable, administrative protection must be available for such products for the unexpired term of the patent (Article 1709.4). Articles 1711.5, 1711.6, and 1711.7 NAFTA concern the protection of test data submitted to regulatory authorities that the TRIPS Agreement refers to vaguely in Article 39.3. Article 39.3, defines the scope of data to be protected, merely as ‘undisclosed test or other data, the origination of which involves a considerable effort’. Article 1711.5 of NAFTA explains that the data in question is undisclosed test or other data ‘necessary to determine whether the use of such products is safe and effective’ and where ‘the origination of such data involves considerable effort’ except where ‘the disclosure is necessary to protect the public or unless steps are taken to ensure that the data is protected against unfair commercial use.’ Article 1711.5, together with Article 1711.6 of NAFTA, stipulate the obligation of Parties not only to protect against disclosure of the data of persons making such submissions, but ensure that ‘no person other than the person that submitted [the data] may, without the latter’s permission, rely on such data in support of an application for product approval during a reasonable period of time after their submission’ (ie, ‘non-reliance’, in the vocabulary of pharmaceutical companies – see chapters 4 and 13). The NAFTA, therefore, provides for the protection of ‘data exclusivity’. Further, in the first sentence of Article 1711.7, NAFTA, unlike the TRIPS Agreement, defines the reasonable period of protection to be ‘not less than five years from the date on which the Party granted approval to the person that produced the data for approval to market its product, taking account of the nature of the data and the person’s efforts and expenditures in producing them.’ Article 1711.7 of NAFTA states the starting point from which the protection of data exclusivity, the date of the first marketing approval relied on. Then, in the second sentence of Article 1711.7, NAFTA refers to the compatibility of its own provisions relating to data exclusivity and the abbreviated generic medicines’ entry conditions, on the basis of bioequivalence and bioavailability studies. Concerning enforcement procedures, NAFTA provides the rules relating to evidence, in Articles 1714 (general provisions), 1715 (specific procedural and remedial aspects of civil and administrative procedures), 1716 (provisional measures), 1717 (criminal procedures and penalties), 1718 (enforcement of intellectual property rights at the border), in more detail than the TRIPS Agreement does. A notable difference between the two treaties is that Article 1716.2(c) of NAFTA enumerates the matters which must be considered by the judicial authorities in determining the kind of provisional measures to be taken. 14 Thus, most NAFTA provisions are simply clearer or more detailed than the corresponding TRIPS provisions, but some of them set a relatively higher level of IP protection. In the cases where NAFTA provides for TRIPS-minus standards, for the three Members of the NAFTA, the TRIPS provisions prevail. Article 103 of NAFTA refers to the ‘existing rights’ and obligations with respect to the Parties under the General Agreement on Tariffs and Trade and other agreements to which Parties adhere. Paragraph 2 of the same Article adds that the NAFTA provisions prevail to the extent of the inconsistency, except as otherwise provided in the Agreement, in the event of any inconsistency between NAFTA and such other agreements. In paragraph 1(a) of Annex 1701.3 concerning intellectual property conventions, Mexico is held to make every effort to comply with the substantive provisions of the 1978 or 1991 International Convention for the Protection of New Varieties of Plants (UPOV) as soon as possible, and no later than two years after the date of signature of the NAFTA Agreement. II ‘TRIPS PLUS’ PROVISIONS IN THE POST-2000 US FTAS The United States has 17 FTAs (including multilateral FTAs with a group of countries) 15 as of 30 September 2010. Since 2000, the following FTAs have been negotiated and signed, most of which have entered into force: with Jordan (signed 24 October 2000; entry into force 17 December 2001), Singapore (6 May 2003; 1 January 2004), Chile (6 June 2003; 1 January 2004), Morocco (15 June 2004; 1 July 2005), Australia (18 May 2004; 1 January 2005), the Dominican Republic and Central America (CAFTA-DR, the Central American countries being Costa Rica, El Salvador, Guatemala, Honduras, and Nicaragua) (signed 5 August 2004), Bahrain (14 September 2004; 1 August 2006), Oman (19 January 2006; 1 January 2009), Peru (12 April 2006; 1 February 2009), Colombia (signed 22 November 2006), Panama (signed 28 June 2007), and the Republic of Korea (KORUS, signed 30 June 2007). In 2004, the US started negotiating FTAs with Thailand and the South African Customs Union (SACU). However, these negotiations stalled. Negotiations to create a Free Trade Areas of the Americas (FTAA), a single free trade area among 34 countries of the Americas, began in December 1994. These have also encountered obstacles. 16 Among certain US industries, approaches to IPRs have undergone considerable changes since the Uruguay Round. First of all, not all the industries actively involved in the Uruguay Round negotiations maintained their interest in strengthened IPR protection. ‘Pro-patent’ companies such as IBM, HP and General Electric gradually employed more subtle approaches to the issue, as appropriate (see chapter 1). The software industry’s concern with IPR enforcement against piracy seems to have increased. Business Software Alliance (BSA), for example, requested that Singapore provide administrative protection and the Republic of Korea implement the FTA provisions while the KORUS remains non-ratified. 17 Meanwhile, BSA has intensified campaign activities in Asian countries to promote awareness of copyright protection. 18 The motion picture and recording industries’ keen interest in strengthened global copyright protection occasionally conflicts with the interests of electronics hardware companies, since this could reduce sales of their hardware. Hardware industries also tend to oppose the levy system, which collects royalties from purchasers of recordable media such as CDs and DVDs. The levy system has developed to compensate private copies that are permitted by copyright laws, such as 17 USC § 1008. Since individual collection of royalties from such private use is practically impossible, intermediaries, such as the Alliance of Artists and Recording Companies for featured artists and copyright owners, and Harry Fox Agency for publishers, collect levies and distribute them among the right holders, normally through collecting societies. Whereas industries tend to oppose the levy system, 19 right holders support it. Research-based pharmaceutical companies and biotech ventures have continued to insist on incorporating, in the IP chapter of the US FTAs, the disciplines for global IPR protection that they did not succeed in including in the TRIPS Agreement, or TRIPS provisions which were not sufficiently detailed or clear. 20 A General Provisions All US FTAs affirm at the outset, in general provisions, that these FTAs are consistent with the disciplines of FTAs in Article XXIV of GATT (1994) and Article V of the General Agreement on Trade in Services (GATS), and that the Parties reaffirm their existing rights and obligations under existing bilateral and multilateral agreements to which both countries are Party, including the WTO Agreement. The IP Chapters of these US FTAs reiterate national treatment 21 and the transparency principle as part of the general provisions. 22 The transparency principle for the IP Chapters of the US FTAs impose, on the Parties, the obligation that all laws, regulations, and procedures concerning the protection or enforcement of IPRs are in writing and published. 23 Article 63.1 24 concerning transparency in Part V (Dispute Prevention and Settlement) of the TRIPS Agreement, in contrast, does not refer to the obligation for these national rules and procedures to be ‘written’. The General Provisions section of US FTAs also enumerates previously enacted treaties, 25 which the Parties should ratify or accede to, including those which the US has not ratified, such as the Patent Law Treaty of 2000. 26 B Trademarks The Chile-US FTA (Article 17.2.1) and CAFTA-DR FTA (Article 15.2.1) integrate sound marks as a mandatory subject matter, and scent as an optional one. Many US FTAs prohibit the denial of trademark registration solely on the grounds that the sign of which it is composed is a sound or a scent. 27 Protection of well-known marks is also provided for in all US FTAs. 28 Internet-related IP referred to in the US FTAs includes domain names. 29 In order to address the problems of trademark cyber-piracy, the US FTAs require that a Party’s country-code top level domain (ccTLD) provide a dispute procedure based on the uniform domain-name policy (UDP), and online public access to a database of contact information (see Singapore FTA Article 16.3(2); Chile Article 17.3.2; Morocco Article 15.4.2; Australia Article 17.3.2; CAFTA-DR Article 15.4.2; Bahrain Article 14.3.2; Oman Article 15.3.2; Peru Article 16.4.2; Colombia Article 16.4.2; Panama Article 15.4.2; and KORUS Article 18.3.2, except US-Jordan FTA). 30 C Copyright and Related Rights All the US FTAs (except US-Jordan FTA) prolong the term of protection for a literary and artistic work (including a photographic work), performance or phonogram, 31 by the specified method to calculate the term. In addition to those rights and enforcement means that are found in NAFTA or TRIPS, US FTAs introduce the obligations and responsibilities for a series of new or extended subjects of protection, restrain the scope of exceptions and strengthen enforcement measures, particularly in regard to Internet-related copyright or ‘related rights’. These probably reflect ongoing technological changes, but since agreement was reached in the US-Bahrain FTA in 2004, these enforcement measures have been either significantly extensive, or more detailed, particularly in US-Australia. US FTAs, with the exception of the US-Jordan FTA, include provisions relating to the protection of encrypted satellite signals. The US FTAs with Singapore (Article 16.1.1), Morocco (Article 15.8.1), Bahrain (Article 14.7.1), Oman (Article 15.7.1) and Peru (Article 16.8.1) made it a criminal offence to manufacture and trade in these tools and to ‘receive or further distribute’ such signals. The Chile-US FTA (Article 17.8.1(b)) defines all these acts in terms of either civil or criminal liability and states that the right holder or person holding an interest in the encrypted signal must prove that the act was done wilfully, to subject the offender to civil liability. Those US FTAs concluded after the year 2000 reflect the US software and copyright industries’ particular concerns about Internet piracy. 32 These FTAs create liability and provide specific remedies for those who circumvent the technological measure 33 that controls access to a protected work, performance, phonogram, or other subject matter, as well as for those who manufacture, provide, or sell devices, products, or components to do so (Jordan Article 4.13; Singapore, Article 16.4(7)(c); Chile, Article 17.7(5); Morocco Article 15.5.8(a); Australia Article 17.4.7(a); CAFTA-DR Article 15.5.7(a); Bahrain Article 14.4.7(a); Oman Article 15.4.7(a); Peru Article 16.7.4(ii); Panama Article 15.5.7(ii); and KORUS Article 18.4.7(a)). The US attaches importance to anti-circumvention obligations which are incorporated in both the 1996 WIPO Copyright Treaty (WCT) 34 and the Performances and Phonograms Treaties (WPPT). 35 However, the obligation is expressed in general language, and protection details are left to be dealt with through national law. These obligations were enacted in the US in the 1998 Digital Millennium Copyright Act (DMCA). 36 In the US FTA, the act of knowingly 37 circumventing, without authorisation of the right holder or law, through any effective technological measure that controls access to a protected work, performance, or phonogram, is civilly liable and, in certain circumstances criminal. There is, however, a variation according to the specific partner country of each FTA on the elements constituting the act of anti-circumvention, for example, whether or not the act is wilful. The prohibition of technological circumvention is not without limits in US domestic case law. Non-DMCA public interests are considered by US courts. 38 Civil remedies and criminal liabilities for the infringement of protection of rights management information are also mandated in Singapore (Article 16.4.8), Chile (Article 17.7.6), Morocco (Article 15.5.9), Australia (Article 17.4.8), CAFTA (Article 15.5.8), Bahrain (Article 14.4.8), Oman (Article 15.4.8), Peru (Article 16.7.5), Colombia (Article 16.7.5), Panama (Article 15.5.8) and KORUS (Article 18.4.8), but not found in the US-Jordan FTA. US FTAs also prohibit the re-transmission of television signals (whether terrestrial, cable, or satellite) on the Internet without the authorisation of the right holder of the content of the signal (see for example, Article 16.4.2 (b) of the US-Singapore FTA). This occurs except for traditional, free-to-air (ie, non-interactive) broadcasting and other limitations to this right for such broadcasting activity, as a result of each Party’s national laws. Aside from agreeing on these provisions aimed at adapting IP protection to the era of digital technologies, the US FTAs oblige the Parties to accede to the WIPO Copyright Treaty (1996) and WIPO Performances and Phonographs Treaty (1996). The US FTAs also enumerate those earlier treaties, 39 which the Parties should ratify or accede to, including those which the US has not ratified, such as the Patent Law Treaty of 2000. 40 D ‘Certain Regulated Products’ The US FTAs contain those provisions relating specifically to patent protection and regulatory approval processes for the safety and efficacy of pharmaceutical or agricultural chemical products. As does NAFTA, US FTAs (with the exception of the US-Jordan FTA) mandate the extension of patent terms, equal to delays caused by regulatory approval processes of up to five years. The US FTAs with Singapore, Morocco and Bahrain delimit the scope of experimental manufacturing and sales, and establish the ‘linkage’ between patent status and drug approval. They also link the status of patents and marketing approval in the original country to marketing approval in the FTA partner country where the drug approval is requested, and oblige regulatory authorities to make available to the patent-owner, the identity of any third party requesting marketing approval during the term of the patent (Jordan Article 4.23, Singapore Article 16.8.4, Chile Article 17.10.2, Morocco Article 15.10.4, Australia Article 17.10.4, CAFTA-DR Article 15.10.2, Bahrain Article 14.9.4, Oman Article 15.9.4, Peru Article 16.10.4, Colombia Article 16.10.4, Panama Article 15.10.4 and KORUS Article 18.9.5). In Article 39.3 of TRIPS, as we have seen in chapters 4, 5 and 13, it can be interpreted to mean that: (i) the data submitted to regulatory authorities may not be considered as intellectual property over which the owner has exclusive rights; (ii) the obligation imposed on regulatory authorities to protect data against unfair commercial use may concern a narrow scope of data; and (iii) there is no obligation on the regulator not to rely on the originator’s data on efficacy and safety for examining the later third party submission of the same data for marketing approval of the same medicines. Against this interpretation of Article 39.3 of TRIPS, US FTAs clarify that the data in this context means ‘undisclosed test or other data necessary to determine whether the use of such products is safe and effective’; the origination of which involves considerable effort except where ‘the disclosure is necessary to protect the public or unless steps are taken to ensure that the data is protected against unfair commercial use’. In all US FTAs, the Parties have the obligation of non-disclosure as well as ‘non-reliance’ for a period of five years from the date of the marketing approval for pharmaceutical products, and 10 years for agricultural chemical products. The US seems to have attempted to overhaul the ambiguities and omissions of Article 39.3 of the TRIPS Agreement by re-instituting its own model of data exclusivity in its FTAs. Alternatively, some governments and academics argue that the requirements of Article 39.3 should be interpreted in a way that reduces the cost of medicines in developing countries. 41 In mandating data exclusivity protection, the US FTAs define the term ‘new product’ from the point of view of the regulatory authorities that approve drugs, which is not the same as the ‘novelty’ requirement for patentability. The IPR Group of the Industry Trade Advisory Committee (ITAC-15) 42 explains that the US interprets the term ‘new chemical entity’ in TRIPS Article 39.3 based on the regulatory definition of a ‘new product’, ie, a product that does not contain a chemical entity that had been previously approved in the country for use in a pharmaceutical or agricultural chemical product. Thus, for the US, the FTA provisions on data exclusivity only clarify the intent of the US negotiations during the Uruguay Round, and do not impose any additional obligations beyond those contained in TRIPS Article 39.3.

TRIPS-Plus Provisions and the Access to HIV Treatments in Developing Countries

In recent years, a maximalist trend regarding intellectual property (IP) rights has been observed among high-income countries while negotiating bilateral, regional and multilateral trade agreements. In fact, the provisions regarding intellectual property included in recent trade agreements, known as TRIPS-Plus, have a tendency to either far exceed the minimum global standard on IP set by the 1995 Agreement on Trade-Related Aspects on Intellectual Property Rights (TRIPS) or to eliminate the flexibilities that this multilateral agreement assured to its members for the purpose of promoting universal access to medicines (Chen et al., 2013).

Since its establishment a considerable body of literature has been published on the impact of the TRIPS agreement on public health, however, far too little attention has been paid to the fact that TRIPS-Plus provisions have a much more negative impact on the affordability of treatments for spreadable diseases such as the human immunodeficiency virus (HIV) that affects the lives of 37.9 million people (Unaids.org, 2019).

Furthermore, a point that is worth stressing is that this exacerbating effect is disproportionally felt by the poorest communities living in developing countries that are more vulnerable to HIV spreading. In fact, “the vast majority of people living with HIV are located in low- and middle-income countries, with an estimated 68% in living in sub-Saharan Africa”. (Carlson, 2019).

Hence, the intent of this essay is to provide evidences that disclose that the inclusion of TRIPS-Plus provisions in recent trade agreements is a strategic move carried out by high-income countries to limit the generic competition in the pharmaceutical industry that represents for the global South because it further limits the possibilities of developing countries to obtain affordable medicines needed to face the epidemic of HIV.

Therefore, in the first part, this essay will address the minimum global standard of intellectual property protection set by the 1995 TRIPS agreement with regards to patent regulations as well as theoretical arguments supporting the inclusion in recent trade agreements of stronger provisions on intellectual property. Subsequently, this essay will challenge these arguments by presenting evidence suggesting that TRIPS-Plus provisions are largely justified by profit-driven motives and that they pose a serious threat to public health in developing countries because they reduce access to essential treatments for HIV by delaying the entry of cheaper generics in domestic markets and causing significant price increases in medicines. This essay will conclude that the theoretical justifications in support of TRIPS-Plus provisions can be partially considered reasonable, however, once they are applied to the reality of international trade, they tend to disclose their shortcomings. Hence, the inclusion of TRIPS-Plus provisions in recent trade negotiations serves primarily as a strategic tool in the hands of developed countries for avoiding competition with cheaper generic drugs produced in developing countries, however, this comes at the expense of developing countries’ ability to access affordable antiretroviral regimens for HIV treatments.

  TRIPS Agreement and IP Regulations 

The multilateral agreement on Trade-related Aspects on Intellectual Property (TRIPS) represents the most comprehensive, yet highly controversial, international agreement regarding intellectual property (IP). The agreement was established in 1994 as part of the seismic change in international trade caused by the 1994 Marrakesh Agreement Establishing the World Trade Organization.

The TRIPS agreement covers vast areas of intellectual property including provisions that concern “copyright, trademarks, geographical indications, industrial designs, patents, the layout-designs of integrated circuits and undisclosed information including trade secrets” (World Trade Organisation, 2020). In particular, this essay will focus on the branch of intellectual property that deals with patent regulations.

The agreement sets a minimum global standard for patent regulation that needs to be observed by member states. In fact, the agreement only states that patents should be granted for new, inventive and useful process and products, leaving to members the prerogative to decide whether a new formulation of a drug or a new combination of existing molecules deserves a new patent (Médecins Sans Frontières Access Campaign, 2020).

A particularly controversial set of provisions included in the agreement concerns the possible, yet limited, exemptions to the provisions of the agreement, the so-called TRIPS flexibilities. Among TRIPS flexibilities, compulsory licensing and parallel imports represent by far the most debated forms of exceptions to the TRIPS agreement. The term “compulsory licensing” indicates a government decision to allow a firm to produce the patented drug without the consent of the right holder, while “parallel imports” indicate products marketed by the patent owner in a country and imported into another country without the approval of the right owner. These flexibilities are allowed under the TRIPS agreement in order to attempt to balance the intent of promoting access to existing drugs and promoting research and development into new medicines, however, they have to be interpreted in light of the protection of the rights of the patent holder (World Health Organization, 2020).

Hence, it is significant to highlight that the agreement adopted a narrow understanding of this possibility as well as a significant vagueness in its wording causing ambiguity regarding the impact on public health of the terms of the agreement. Therefore, many low- and middle-income member states raised awareness on the possible negative impact of these patent regulations on public health.

Doha Declaration

In 2001, WTO Members adopted a Ministerial Declaration at the WTO Ministerial Conference in Doha to address the impact of the agreement on the affordability of medicines for populations living in underdeveloped countries in their attempts to control spreadable diseases such as HIV, tuberculosis, malaria and other sexually transmitted diseases. While acknowledging the role of IP rights as an incentive for the creation of new drugs, the Declaration recognizes concerns about its effects on the affordability of medicines. The Doha Declaration affirms that “the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health” (World Health Organization, 2020). WTO members stressed the importance of interpreting the TRIPS Agreement with the intent of promoting access to medicines and the creation of new ones. As a result, Article 5 of the Doha Declaration confirms that WTO Member States have the right to use measures such as compulsory licences or parallel importation to promote access to affordable medicines and their freedom to determine the grounds for granting compulsory licensing in case of national emergencies such as the HIV epidemic (World Trade Organisation, 2001).

An Opposing Tendency in IP Regulation 

It has recently been observed a tendency in international trade that concerns IP regulations, especially dealing with patent law. In fact, it can be noted that developed countries, among others the United States, Japan and the EU, are currently pressuring developing countries for the implementation of a stronger IP regulation that either limits the use of flexibilities allowed under the TRIPS agreement or far exceeds the minimum global standard for IP protection set by the agreement.

For example, according to Jing Chen et al. (2013), China has been placed on the U.S. Trade Representative’s Office (USTR) priority watch list, a report that identifies countries with an IP regulation that not satisfies the minimum standard set by the TRIPS agreement. According to the report, there is a necessity to make amend the domestic IP regulation to address a variety of IP issues including barriers towards pharmaceutical innovation. The US has issued a complaint to the WTO Dispute Settlement Mechanism (DSM) over China’s IP regulations, therefore, pressuring the country to straighten its IP regulation by implementing TRIPS-Plus provisions in its domestic law. Along with China, other countries such as Indonesia, India, Russia, Ukraine and Venezuela are also been pressured to adopt similar provisions.

Arguments for Stronger IP Regulations

A question that, therefore, is worth raising regards the justifications that have been raised by developed countries for the support of the implementation of maximalist intellectual property provisions. Generally speaking, the rationale in support of a stricter intellectual property protection gravitates around four core assumptions that can be summarised by these essential words: incentives, compensation, piracy and natural right.

In fact, the rationale behind stronger IP provisions is based on the assumption that IP rights motivated the dissemination of innovation through research and development. Advocates of stronger IP provisions highlight the high costs of developing new drugs and the need for substantial compensation for providing lifesaving drugs that without patent protection they may be freely counterfeited and plagiarized at the expense of the inventor (CNIPA, 2019). On the other hand, the assumption that intellectual property is a natural right that has to be treated and enforced just like other forms of humane property can be traced back to John Locke and his Natural Law theory.

According to Robert P. Merges (2011), Locke’s theory can be used as an ethical justification for enhancing IP provisions. The author suggests that “appropriation is a movement” that brings unowned things lying in an impersonal world to the space of humanity in which these things acquire a purpose. This movement occurs once physical or intellectual labour is applied to the “found” environment. Therefore, according to this theory, IP provisions represent necessary legal protections towards creative works carried out by humanity for humanity’s sake. Furthermore, it can be argued that a stricter IP regulation can be preferred because the globalised world carries a threat towards individual ownership, especially with reference to intangible and incorporeal assets such as the kind protected by intellectual property provisions.

However, if TRIPS-Plus provisions are truly necessary, beneficial and ethical why do they represent a so controversial concept once they are applied to the reality of international trade, especially with reference to its effect on the affordability of medicines for populations living in developing countries in their efforts to control spreadable diseases such as HIV, tuberculosis and malaria?

90-90-90 Targets and TRIPS-Plus Provisions

In 2014, the Joint United Nations Programme on AIDS (UNAIDS) launched the ambitious 90–90–90 targets aiming at the elimination of spreadable diseases such as HIV, viral hepatitis and sexually transmitted infections by 2030. In order to do so, UNAIDS set the global target of diagnosing 90% of all people living with HIV, provide antiretroviral therapy for 90% of all HIV-positive persons and ensure that, by 2020, 90% of people living with HIV and receiving ART treatment have suppressed viral loads (World Health Organisation, 2019, p.8).

In order to reach this fundamental goal, there is a necessity to guarantee that affordable and sustained treatments are in reach of people living in low-income countries, however, TRIPS-Plus provisions seem to go against this necessity by raising the price of medicines and causing HIV treatments to be available discontinuously.

As a matter of fact, these provisions, limiting the possibility of using the flexibilities allowed under the TRIPS agreement, tend to maximise the profit of wealthier countries over developing countries’ public health by limiting the competition between generic drugs and patented ones.

Researches (Ramani, 2015) have shown that the threat of compulsory licences represents an important tool in the hands of developing economies because it can increase the bargaining power of governments in price negotiations. In 2001, brand name antiretroviral (ARV) drugs cost over $10,000 per person per year, which made them unaffordable for people living in developing countries. Subsequently, Cipla, an Indian pharmaceutical company, began to reproduce the same treatment for a dollar a day and since then, the cost of ARVs has fallen to 10% of their original price due to the same competition between generic drugs and brand name ones that TRIPS-Plus provisions tend to limit.

Another form of IP provision that is worth addressing is data exclusivity because it can have an extremely negative impact over the generic competition by delaying the entrance of generic drugs into national and international markets. Data exclusivity prohibits generic competitors to use clinical test data that have been submitted by original pharmaceutical companies, therefore impacting generic companies, usually located in developing countries, that are unlikely to have the necessary funds and capabilities to reproduce the time-consuming clinical trials needed, for example, by the Food and Drug Administration (FDA) to prove the safety and efficacy of a certain drug.

Case Study: Vietnam

In order to address how these provisions have a tangible impact on developing countries, this paper will now present the case of Vietnam. The country, with a GDP per capita of only US$8.07 thousand in 2019 (International Monetary Fund, 2019), is arguably highly vulnerable to provisions that tend to limit the affordability of medicines for treating HIV. Especially, if we take into consideration that in 2018, 230 000 people were HIV-positive and of all adults aged 15 years and over living with HIV only 65% were on treatment (UNAIDS.org, 2018). A situation that is not likely to improve and reach the 90-90-90 target set by UNAIDS, since in 2019 the European Union and Vietnam signed a Free Trade Agreement that includes TRIPS-Plus provisions.

As a matter of fact, article 12.40 paragraph 3 states that:

“a Party may make available an extension, not exceeding five years, of the duration of the rights conferred by the patent protection to compensate the patent owner for the reduction in the effective patent life as a result of the marketing authorisation procedure” (European Commission, 2018, p.38).

This article, granting the possibility to extend the duration of the exclusive right of a patent owner over his invention beyond the twenty years set in the TRIPS agreement, has a significant impact towards Vietnam’s ability to access affordable medicines because patent protection implies that a creation cannot be commercially made, imported, or sold by others without the patent owner’s consent.

Furthermore, the Free Trade agreement signed, includes another provision that is worth highlighting because it significantly limits the production of generic, and therefore more affordable, drugs. Article 12.40 paragraph 2 declares that:

“no other applicant for marketing approval may, without permission of the person that submitted the data, rely on that data in support of an application for marketing approval during a reasonable period, which shall normally mean not less than five years from the date on which the Party granted approval to the person that produced the data for approval to market its product” (European Commission, 2018, p.39).

Case Study: Jordan vs Egypt

There are a number of studies that have identified data exclusivity as one of the elements in free trade agreements that affects the price of medicines available in the market by limiting the possibility of international competition in this particular field. According to Oxfam (2007), before 2000 Jordan mainly relied on generic medicines, however, the US–Jordan Free Trade Agreement, signed in 2001, “led to a 20% increase in medicine prices, and delayed generic entry for 79% of newly launched medicines” (Malpani, 2007, p.2). Moreover, compared to Egypt, which adopted no TRIPS-Plus policies, medicine prices were two to ten times higher and “additional expenditures for medicines with no generic competitors were estimated to be between $6.3 and $22.04 million” (Malpani, 2007, p.2).

Therefore, these provisions shaping the commercialisation of knowledge, they can be considered as signals of a motive lurking behind intellectual property regulations that cannot be considered as ethical but rather pure utilitarianism.

The developing world, non-governmental institutions and strands of the civil society are currently manifesting their dissatisfaction with the “unfair” current IP regime. According to the protesters, high-income countries, such as the United States, Japan and the EU, tend to favour stricter forms of IP regulations designed and implemented not to maximise innovation or research, “but to maximise the profits of big pharmaceutical companies able to sway trade negotiations” (Stigliz, 2017).

They argue that the claim that IP rights provide incentives for the creation and dissemination of innovation through research and development is factually incorrect. Governments and philanthropy, not pharmaceutical companies, are driving innovation and funding research and development. In fact, governments and non-profit organizations in the US fund over 40 percent of research and development costs. Pharmaceutical companies then commodify that intellectual work under patent protection for 20 years or longer. This system causes U.S. taxpayers to pay higher prices for patented medicines because the level of prices includes the government-collected taxes to fund research plus the amount of money that pharmaceutical companies claim as a reward for the cost of producing the drug. Subsequently, instead of devolving these funds to develop a cure to mortal diseases such as HIV, profits are poured into marketing, lobbying and stock buybacks at the expense of those patients to which affordable medicines are denied and that have to face much higher healthcare costs overall (Treatment Action Group, 2018).

On the other hand, it needs to be highlighted that the claim that TRIPS-Plus provisions represent necessary legal protections towards creative works in order to prevent medicines to be freely counterfeited and plagiarized can be considered partially reasonable in the sense that without a rigorous method of control over highly impacting drugs such as the ones used for the treatment of HIV, versions of patented drugs could be freely produced and sold with the intent to deceptively present its authenticity or effectiveness at the serious detriment of the user.

The Indian Example

Large developing countries, among others are currently promoting this counterattack and are the first liners of this protest. India, for example, produces 80% of the HIV generic drugs that the organisation Médecins Sans Frontières (MSF) uses to treat over 200,000 people living in developing countries. India freely produced these medicines until 2005, when it was obligated to start granting patent protections according to the TRIPS agreement (Médecins Sans Frontières Access Campaign, 2017). However, the country decided to amend its domestic patent law including safeguards, such as strict standards on what deserves a patent trying to strike a fairer balance between acknowledging IP protection and protecting the right to affordable medicines. The multinational pharmaceutical industry, backing the US, the European Union and other countries, is currently pressuring India to strengthen its IP regulation in order to guarantee more monopoly power to pharmaceutical companies producing branded drugs at the expense of public health safeguards. This phenomenon poses a potential threat not only in relation to the affordability of drugs in India, but also worldwide. In fact, if the Indian Government would decide to give up this challenge, this could be disastrous for millions of people living in developing countries around the world and for international organisations like MSF, who rely on Indian generic medicine to guarantee sustained and affordable treatments across the globe (Médecins Sans Frontières Access Campaign, 2017).

Hence, if the theoretical case for a stricter IP legislation is partially sound, in reality, this regime has erected barriers to the use and circulation of knowledge, causing the gap between the private and public returns of innovation to widen (Stigliz, 2017). Developed economies have lobbied and shaped a regime within the WTO that clearly focuses solely on profits, posing a threat to developing economies in their intent to face serious health emergencies.

The IP regime, established in 1994, was not sustainable because it has maximised profits for a few at the expense of the development and welfare of many. Nonetheless, in 2020, the situation is even worse with an intellectual property that, limiting the use of TRIPS flexibilities or enhancing the provisions included in the original agreement, eliminates the possibilities for affordable and sustained treatments to HIV to be in reach of people living in low-income countries.  

Conclusions

This paper has investigated the extent to which the inclusion of TRIPS-Plus provisions in trade agreements affect the possibility for developing countries to access affordable HIV treatments. Returning to this question it is now possible to state that the inclusion of these provisions is a strategic move carried out by high-income countries to limit the generic competition in the pharmaceutical industry and represents a serious threat for developing countries because it further limits their possibilities to obtain affordable medicines needed to face the epidemic of HIV. In this essay, both supporting and opposing arguments to TRIPS-Plus provisions have been presented and, taken together, the results suggest that the theoretical case for a stricter IP legislation can be considered reasonable only in relation to piracy and counterfeit medications. In fact, the cases of India, Vietnam and Jordan presented in the essay provide sound arguments disclosing the negative externalities of TRIPS-Plus provisions and the exacerbating effect that they impose on developing countries. The analysis has some limitations, nonetheless, this work could represent a useful aid for decision-makers in developing countries in their efforts to resist the pressure coming from the multinational pharmaceutical industry, the US, the European Union and other countries, to strengthen their IP regulations at the expense of their citizens.

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Unaids.org. (2018).  Viet Nam . Available at:   https://www.unaids.org/en/regionscountries/countries/vietnam (Accessed: 6 January          2020)

Unaids.org. (2019). Global HIV & AIDS statistics — 2019 fact sheet. Available at: https://www.unaids.org/en/resources/fact-sheet (Accessed: 28 December 2019).

World Health Organization. (2020).  The Doha Declaration on the TRIPS agreement and   public health . Available at:             https://www.who.int/medicines/areas/policy/doha_declaration/en/ (Accessed: 4      January 2020).

World Health Organisation. (2019). Progress report on HIV, viral hepatitis and sexually   transmitted infections, 2019. Accountability for the global health sector strategies,         2016–2021 . Geneva: World Health Organization, p.8.

World Trade Organisation. (2001).  Declaration on the TRIPS agreement and public health .            Available at:             https://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.htm       (Accessed: 4 January 2020).

World Trade Organisation. (2020). Intellectual property – overview of TRIPS Agreement .   Available at: https://www.wto.org/english/tratop_e/trips_e/intel2_e.htm (Accessed:        4 January 2020).

Written by: Alessandro Pigoni Written at: University of Sussex Written for: Julian Germann Date written: January 2020

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• Is Universal Health Coverage Always the Best Solution to Health Challenges?
• 1.5 to Stay Alive: The Influence of AOSIS in International Climate Negotiations
• Intermestic Realism: Domestic Considerations in International Relations
• On the Ontological Existence of States: A Comparison Between Countries and Anthills
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Regional & bilateral agreements and a trips-plus world: the free trade area of the americas (ftaa).

Provides an overview, based on intellectual property rights negotiations in the Americas, of some of the implications of regional and bilateral Trade Related aspects of Intellectual Property (TRIPs) plus agreements for the current minimum standards under TRIPs. It discusses the Free Trade Agreement of the Americas (FTAA) in relation to TRIPs, and argues that the push towards ever-stronger IPRs threatens to undermine the balance achieved in many national laws and the capacity of developing countries to use flexibilities existing at the international level to achieve developmental and public policy goals.

This is TRIPs Issues Paper number 1, published by QUNO, Geneva and the Quaker International Affairs Programme (QIAP), Ottawa.

Author: 

• David Vivas-Eugui

Languages: 

Countries / regions: .

• North America
• Central America
• South America

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Related Areas of Work

• Trade & Development

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• IAS Preparation
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• Trade Related Aspects Of Intellectual Property Rights Trips

Trade Related Aspects of Intellectual Property Rights (TRIPS)

The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement is in the news now because of the recent US decision to support the temporary waiver of patent rules for the coronavirus vaccines. This is an important topic from multiple perspectives for the UPSC exam including economy, international relations, current affairs, etc. 

TRIPS Agreement

Trade Related Aspects of Intellectual Property Right (TRIPS) is an agreement on international IP rights.

• TRIPS came into force in 1995, as part of the agreement that established the World Trade Organisation (WTO) .
• TRIPS establishes minimum standards for the availability, scope, and use of seven forms of intellectual property namely, trademarks, copyrights, geographical indications, patents, industrial designs, layout designs for integrated circuits, and undisclosed information or trade secrets. 
• It applies basic international trade principles regarding intellectual property to member states.
• It is applicable to all WTO members.
• TRIPS Agreement lays down the permissible exceptions and limitations for balancing the interests of intellectual property with the interests of public health and economic development.
• TRIPS is the most comprehensive international agreement on IP and it has a major role in enabling trade in creativity and knowledge, in resolving trade disputes over intellectual property, and in assuring WTO members the latitude to achieve their domestic policy objectives. 
• It frames the IP system in terms of innovation, technology transfer and public welfare. 
• The TRIPS Council is responsible for administering and monitoring the operation of the TRIPS Agreement.
• TRIPS was negotiated during the Uruguay Round of the General Agreement on Tariffs and Trade (GATT) in 1986–1994.
• The TRIPS Agreement is also described as a “Berne and Paris-plus” Agreement.

Read about other WTO Agreements in the link.

What are Intellectual Property Rights?

Intellectual property rights are the rights given to persons over the creations of their minds. Intellectual property rights (IPRs) are legal rights that protect these creations. In contrast to rights over tangible property, IP rights give their owners rights to exclude others from making use of their creations only for a limited period. IP rights entitle the owners to receive a royalty or any sort of financial compensation or payment when another person uses their creations.

What is Intellectual Property?

“Intellectual property” refers to creations of the mind. These creations can take many different forms, such as artistic expressions, signs, symbols and names used in commerce, designs and inventions. 

IP rights are generally classified into two categories:

• Copyright and rights related to copyright: This rights relates to rights protecting art works, literary works, computer programmes, films, musical compositions, sculptures, paintings, etc. Related rights also include rights of performers, broadcasting organisations, and producers of phonograms (sound recordings). The main purpose of protection of copyright and related rights is to encourage and reward creative work.
• The protection of distinctive signs, especially trademarks (which differentiate the goods or services of one organisation/establishment from those of other undertakings) and geographical indications. These rights are aimed at protecting and ensuring fair competition consumer protection.
• The second type of industrial property rights are protected primarily to stimulate innovation, design and the creation of technology. These rights protect innovations by patents, trade secrets and industrial designs.

Read more on intellectual property rights in the linked article.

TRIPS Significance

The TRIPS Agreement makes protection of intellectual property rights an integral part of the multilateral trading system, as embodied in the WTO. The agreement is often termed one of the three “pillars” of the WTO, the other two being trade in goods (the traditional domain of the GATT) and trade in services.

Before TRIPS, the extent of protection and enforcement of IP rights varied widely across nations and as intellectual property became more important in trade, these differences became a source of tension in international economic relations. Therefore, it was considered prudent to have new trade rules for IP rights in order to have more order and predictability, and also to settle disputes in an orderly manner.

TRIPS Agreement Latest News

In view of the COVID-19 pandemic, India and South Africa had proposed to the WTO in October 2020 that the TRIPS Agreement (that included patent protection to pharmaceutical products including COVID vaccines) be waived off for COVID vaccines, medicines and diagnostics for the time period of the pandemic in order to make vaccines and drugs for COVID available to a maximum number of people worldwide.

If the vaccines are patent protected, only a few pharmaceutical companies from developed western countries would be able to manufacture it, making such drugs unavailable or inaccessible due to the high costs to people of other countries, especially, developing and least developed countries.

The US, which was opposed to any TRIPS waiver, has backed this proposal, along with the EU. This move has been welcomed by many since it might lead to the manufacture of more volumes of COVID vaccines enabling the whole world to get rid of the coronavirus at the earliest. However, pharmaceutical companies have protested the move saying this would not necessarily ensure vaccine availability since developing countries did not have the capability to produce the vaccines.

Arguments in favour of relaxing TRIPS rules 

• This would make the vaccines more available to people of developing countries and also LDCs.
• Life-saving drugs and vaccines should be made available to everyone and pharmaceutical companies should not be looking to make profits out of these. There is an ethical and moral issue here.
• With particular reference to the COVID-19 pandemic, it is said that no one is safe unless everyone is safe. In this respect, it is imperative that vaccines are made available to everyone in countries affected since it can easily spread to all countries as seen in the first wave.
• Rules granting monopolies that place the right to access basic healthcare in a position of constant peril must end.

Arguments made by opponents of TRIPS waiver

• Unless corporations are rewarded for their inventions, they would be unable to recoup amounts invested by them in research and development.
• Without the right to monopolise production there will be no incentive to innovate. 
• They also claim that companies in the developing world do not have the capacity to manufacture vaccines or drugs on a large scale.

Just a waiver of the IP rights rules without further assistance such as technology transfer to generic pharmaceutical companies in developing countries would render the move useless. This is because there would also necessitate tech transfer for the pharmaceutical companies to start the production since vaccines like the mRNA vaccines require highly sophisticated manufacturing equipment. Not only technology and equipment, raw materials and probably personnel would also need to be transferred for developing countries to be able to produce vaccines on a large scale.

It could also take several years before the generic pharmaceutical companies’ plants become operational at optimal capacity and produce vaccines, which is a problem because it is doubted whether vaccines produced today would be effective against any new strain of the virus.

TRIPS Agreement:- Download PDF Here

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