Ma’at Arowora
In developing countries, masses of individuals have no access to some of the most basic needs that as humans we rely on everyday. The most basic is healthcare, which includes health services as well as safe and effective medicines. This epidemic has lead to global heath crisis where diseases such as HIV/AIDS, tuberculosis (TB) and malaria are spreading in countries that don’t have the resources or the services to deal with them.
One of the biggest hurdles to facilitating health care in the developing world comes from intellectual property rights and agreements. In Human Rights Obligations of Non-State Actors, Andrew Clapham wrote, “Perhaps the most obvious threat to human rights has come from the inability of people to achieve access to expensive medicine, particularly in the context of HIV and AIDS.”1 He was referring to threats to human rights from intellectual property agreements under the World Trade Organization, which are often seen as obeying a different and many would say extremely incompatible logic than human rights. The right to health, in the interpretation of the Committee on Economic Social and Cultural Rights, means “States Parties … have a duty to prevent unreasonably high costs for access to essential medicines.”2
This paper will provide some context to the role of Intellectual Property (IP) to health care in the developing countries. The IP arrangements in place have tolerably but not adequately addressed the access issues developing countries have in obtaining applicable health care, specifically as it deals with essential medicine.
“Essential medicines”, according to the World Health Organization (WHO), are those that “satisfy the priority health care needs of the population” and “are intended to be available within the context of functioning health systems at all times in adequate amounts, in the appropriate dosage forms, with assured quality, and at a price the individual and the community can afford.”3 The United Nations Development Group defines “access” in this context as “having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour’s walk from the homes of the population.”4
In 1975, half of the world’s population was without access to lifesaving and other essential medicines.5 While the proportion has decreased to about one third of the world’s population, the absolute number has remained constant at approximately two billion people, most of which are centered around developing countries.6 According to the WHO, expanding access to existing interventions, including medicines, for infectious diseases, maternal and child health, and non-communicable diseases would save more than 10.5 million lives a year by 2015. 6
Recent agreements involving intellectual property have resulted in a noteworthy extension in the global patent rights available to pharmaceutical firms. At the close of the Uruguay round of the General Agreement on Tariffs and Trade (GATT) in 1994, members agreed to a common set of international rules against a background of long running bilateral pressure on selected developing countries to strengthen their patent laws. While, many developing countries have excluded pharmaceutical innovations from patent protection, offering only very brief protection for new manufacturing processes. Now all members of the World Trade Organization (WTO) are expected to implement new laws that look very much like those in the United States and Europe if they have not done so already. 7
The issue of better access to healthcare commodities for poor populations has been the subject of many World Health Assembly resolutions. In May 2006, at the Fifty-ninth World Health Assembly, Member States established an Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG). The Working Group's mandate was to prepare a global strategy and plan of action on public health, innovation and intellectual property to address conditions disproportionately affecting developing countries.
The Working Group on Access to Essential Medicines of the United Nations Millennium Project approached the problem from the human rights perspective. It opened its report by stating: “The lack of access to lifesaving and health supporting medicines for an estimated 2 billion poor people stands as a direct contradiction to the fundamental principle of health as a human right.” 8 The Group gave priority consideration to improving access to medicines in resource poor settings and promoting research on new medicines for diseases of poverty. It identified six barriers to access the medicines: Inadequate national commitment, inadequate human resources, failure of the international community to keep its promises to developing countries, lack of coordination of international aid, obstacles created by the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement, and the current incentive structure for research and development of medicines and vaccines to address priority health needs of developing countries.9
In examining the solutions to the problem, the UN Working Group underscored the “consensus that human rights should incorporate the ability of individuals to maintain and restore good health through access to at least a basic level of primary care, including essential medicines”10 The Group recommended specific steps for promoting the safety, affordability, and appropriate use of medicines.11 Finally, it devoted attention to the barrier created by the system of intellectual property protection, specifically citing the conclusion of the UN Millennium Project Task Force on Trade that the TRIPS agreement, and “TRIPS Plus” provisions of freetrade agreements, which it said over time will probably have a negative impact on access to drugs in developing countries.12
UN Special Rapporteur on the right to health, Mr Anand Grover states that the WTO TRIPS Agreement and the TRIPS-plus provisions in Free Trade Agreements (FTAs) have had an adverse impact on prices and availability of medicines, making it difficult for countries to comply with their obligations to respect, protect and fulfill the right to health.13
From the standpoint of the primary legal regime governing trade in products invented and manufactured by business entities, essentially transnational corporations, the issues of access to medicines is a clear matter of the patenting of a new chemical product and the process for its use, together with the protection of the patents involved in the markets where the producers intend to sell them. The patents, which protect the inventor from anyone copying the product without license, and allow the inventor to set the price, are protected internationally under the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS).
TRIPS requires WTO members to protect patents of pharmaceuticals for 20 years, thus giving drug companies exclusive rights to prevent unauthorized use, subject to domestic and international enforcement. Countries that fail to protect patents may be brought before the dispute settlement body of the WTO. As a result in part of the outcry over drug pricing in countries confronted by the HIV/AIDS pandemic, the least developed countries, who were originally supposed to comply by 2006, now have until 1 January 2016 to implement TRIPS. However, all other WTO Members are bound, and even the poorest countries will be bound in less than a decade.
In addition to the delayed compliance until 2016, developing countries may avail themselves of “flexibilities” to avoid patent protections through parallel importing (importing cheaper versions of drugs from countries where pharmaceuticals are not patented or where their term of protection has expired) and compulsory licensing (manufacturing generic versions of patented medicines without the patent holder’s authorization under certain conditions). 14 Most agree that the system in place is necessary and beneficial to promote innovation and development, but there are various barriers to developing countries taking full advantage of the flexibilities. UN Special Rapporteur explains that for example, counties like India and the Philippines exclude from patentability new forms of known substances unless they are significantly more efficacious and new (or second) uses and combinations of known substances. Reducing the number of patents granted on medicines can limit the effect of patents on access to medicines and contribute to the early entry of generic competition. So countries with little or no manufacturing capacity face difficulties in utilizing compulsory licenses to import generic medicines.13
Access to patented medicines is a very controversial, with many scholars having different views on the subject. Pharmaceutical companies assert that Patent agreements are not the sole or even the principal obstacle to adequate provision of health products and medical devices to the poor population of developing countries. In fact, one study by Amir Attaran claims that, of the 319 products on the WHO Model List of Essential Medicines, only seventeen are patentable. Furthermore, many of those are not actually patented, bringing the patent incidence down to 1.4%. 15 The author not only challenges the assumptions among activists that patents cause lack of access to affordable medicines in poor countries and within the pharmaceutical industry, 16 and that IPRs are necessary to protect to assure future research and development, but also expresses doubt that compulsory licensing can be made practicable, considering that “zero generic medicines have been manufactured this way in the past decade, treating zero patients in any country worldwide.”17
In response to Attaran’s study, the Director of Medicines Policy and Standards at WHO wrote that “a statement on the percentage of patented medicines on the Model List is therefore not possible without specifying the geographical area and the specific time” and “a few patented medicines can greatly affect health expenditure”, noting that “the economic value and public health importance of the market of ARVs and future essential medicines for neglected disease are buried in the statistics” of the quoted study.18
While, numerous factors contribute to making essential medicines available in poor countries, including affordable prices; government commitment through a well conceived and implemented national medicines policy (NMP); adequate, sustainable and equitable public sector financing; generic substitution; transparent and widely disseminated consumer information; efficient distribution; control of taxes, duties and other markups; and careful selection and monitoring. 19 The point for the purposes of a human right to essential medicines is that challenging IPRs and urging use of TRIPS flexibilities constitute the main path toward realizing that right.
As thoroughly demonstrated by Lisa Forman, corporate innovation for diseases affecting poor countries does not occur for commercial reasons but in response to “growing public pressure over corporate failures to address developing country needs”. 20 Drawing on the experience of the 1997 to 2001 litigation and trade pressure by the US Government and 40 pharmaceutical companies to resist South African’s law aimed at gaining access to affordable medicine, which she considers the “tipping point” of the struggle, Forman demonstrates how the Treatment Action Campaign case “brought human rights arguments drawn from international and domestic law, arguing that the right to health provided constitutional authority for the legislation itself, and was a legal interest that should be prioritized over corporate property rights.”21. She concludes that this experience “can be seen to provide a strategic roadmap for advancing the completion of the process of normative diffusion, so that access to medicines as a human right starts to assume a ‘taken for granted’ quality in politics, law, and public opinion.” 22 The “normative diffusion” is reflected by the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG), whose Global Strategy and Plan of Action was adopted by the World Health Assembly on 24 May 2008.23
This group was set up in 2006 as a follow up to the Commission on Intellectual Property Rights, Innovation and Public Health with the aim of “securing an enhanced and sustainable basis for needs driven, essential health research and development relevant to diseases that disproportionately affect developing countries”. 24 The IGWG considered inputs not only from governments but also from academia, public private partnerships, product development partnerships and industry.25
In its Global Strategy, the IGWG both acknowledges that intellectual property rights are “an important incentive for the development of new healthcare products” and quotes the provisions of the Universal Declaration of Human Rights on sharing in scientific advances and its benefits and protection of moral and material interest resulting from scientific production.26 Thus, for the IGWG, the “context” of its global strategy includes intellectual property rights, human rights and the importance of flexibilities in intellectual property agreements to facilitate “increased access to pharmaceutical products by developing countries”.27
Given the diversity of stakeholders involved, it is significant that the importance of IP rights, human rights and the importance of flexibilities in intellectual property agreements was acknowledged. In enumerating the “principles” of the strategy, the IGWG inserted the following: “The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”28 It is clear from this effort, which will continue through the further elaboration and implementation of the elements and plan of action, that the claim of a human right to essential medicines has been a difficult case to make. But over the past decade, the tide appears to have shifted in favor of the human right to essential medicines and perhaps even more broadly to health products and medical devices.
Affirmation of the human right to essential medicines as mentioned above, the human right to essential medicines is much broader than a claim against the negative impact of IPRs. Nevertheless, the withdrawal of the challenge by 40 pharmaceutical companies to South Africa’s access to drugs law, the Doha Declaration, the deliberations of IGWG and similar events have used the tension with the international trade regime as a motivation for the affirmation of this right.
The TRIPS flexibilities provide a legal basis for poor countries to avoid the consequences of the patent system with regard to their capacity to make essential medicines available to their populations. The international trade regime is based on the logic of the global market and globalization. It has adjusted to the political imperative of promoting development and strategies defined by the international financial institutions in the poverty reduction programs and the UN system in the Millennium Development Goals.
One of the most significant events, legally and politically, for the right to essential medicines was indeed the Doha Ministerial meeting of the WTO, which adopted the Doha Declaration on the TRIPS Agreement and Public Health. In an unusually direct statement emanating from the WTO, better known for highly technical and legally complex sentences, the meeting declared: “The TRIPS agreement does not and should not prevent members from taking measures to protect public health … in particular to promote access to medicines for all.”41
To be perfectly clear, the Declaration added, “In this connection, we reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose,” meaning parallel importing and compulsory licensing. The text acknowledges that “each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted and the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.”42
The next paragraph instructed the Council for TRIPS to find an expeditious solution to the problem of compulsory licensing for countries “with insufficient or no manufacturing capacities in the pharmaceutical sector,”43 which was done in August 2003. The Doha Declaration also extended the deadline to 1 January 2016 for the least developed countries to apply provisions on pharmaceutical patents.
In conclusion, nearly two billion people do not have access to essential medicines and an estimated four million people could be saved annually in Africa and Southeast Asia if diagnosis and treatment with appropriate medicines were available. This is not an issue that is resolvable overnight, as we have seen that Intellectual property rights as pertains to health care promise both benefits and costs to developing nations.
References:
- Andrew Clapham, Human Rights Obligation of Non-State Actors (Oxford: Oxford University Press, 2006), at 175.
- Committee on Economic, Social and Cultural Rights, General Comment No. 17 on the right of everyone to benefit from the protection of the moral and material interests resulting from any scientific, literary or artistic production of which he or she is the author, UN doc. E/C.12/GC/17, 12 January, 2006, at 35.
- World Health Organization, ‘Essential Medicines: Definition’, available at http://www.who.int/medecines/services/esmedicinesdef/wn/.See also MDG Gap Task Force, Millennium Development Goal 8: Delivering on the Global Partnership for Achieving the Millennium Development Goals: MDG Gap Task Force Report 2008 (New York: United Nations, 2008) at 36.
- MDG Gap Task Force, supra note 3, at 35.
- UN Millennium Project, Prescription for Healthy Development: Increasing Access to Medicines, Report of Task Force on HIV/AIDS, Malaria, TB and Access to Essential Medicines, Working Group on Access to Essential Medicines, 2005, at 4.
- World Health Organization, WHO Medicines Strategy 2000–2003: Framework for Action in Essential Drugs and Medicines Policy 2000–2003 (Geneva: WHO, 2000), available at www.who.int/medicines/strategy/strategy2000=2003.shtml.
- Abbott, Frederick M. (2002b) “Compulsory Licensing for Public Health Needs: The TRIPS Agenda at the WTO after the Doha Declaration on Public Health,” Occasional Paper no. 9. Quaker United Nations Office. Geneva. Available at http://www.quno.org.
- MDG Gap Task Force, supra note 3, at 1.
- Id. at 29–31.
10. Id. at 35.
11. Id. at 110–118.
12. Id. at 72–73.
13. Kanaga Raja, TRIPS and FTAs have adverse impact on access to drugs, public health movement (2009) Available at http://www.phmovement.org/en/node/2039
14. TRIPS Art. 31 provides for the use of a patented product without the authorization of the right holder, under the following condition: “(f) Any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;” and “(h) The right holder shall be paid adequate remuneration in the circumstances of each case, taking into account the economic value of the authorization.” Thus, compulsory licensing is not available to many countries without a significant pharmaceutical sector.
15. Amir Attaran, ‘How Do Patents And Economic Policies Affect Access To Essential Medicines In Developing Countries?’ 23(3) Health Affairs (2004), 155–156, at 157.
16. Id., at 159.
17. Id., at 161.
18. EDRUG, ‘WHO Model List of Essential Medicines and Patents’, posting on essentialdrugs.org by Hans Hogerzeil on 23 March 2005, available at http://www. Essentialdrugs.org/edrug/archive/200503/msg00071.php
19. The WHO essential medicines strategy has the following seven components: (1) National policies on medicines; (2) National policies on traditional medicine and complementary and alternative medicine; (3) Sustainable financing mechanisms for medicines; (4) Supplying medicines; (5) Norms and standards for pharmaceuticals; (6) Regulation and quality assurance of medicines; (7) Using medicines rationally: World Health Organization, WHO Medicines Strategy 2004–2007: Countries at the Core, WHO publication No. WHO/EDM/2004.5, 2004, at 25–129.
20. Lisa Forman, “‘Rights’ and Wrongs: What Utility for the Right to Health in Reforming Trade Rules on Medicines?” 10(2) Health and Human Rights: An International Journal (2008).
21. Id.
22. Id.
23. WHO Resolution 61.21 adopted by the Sixtyfirst World Health Assembly on 24 May 2008. It is significant for the purpose of the present examination of the tensions between international trade and human rights to note the shift in the title of the Commission to that of the IGWG with respect both to the order of the terms and the deletion of “rights” attached to “intellectual property”.
24. WHO Resolution 59.24 adopted by the Fifty ninth World Health Assembly on 27 May 2006, at. 3.
25. World Health Organization, Public Health, Innovation, and Intellectual Property: Progress Made by the Intergovernmental Working Group, Report by the Secretariat, 5 April 2007, WHO publication number A60/27,at 4.
26. World Health Organization, Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property, 24 May 2008, WHO publication number WHA61.21, annex, at. 7, 10.
27. Id. at 12.
28. This language, taken form the WHO constitution, was retained after an additional provision on human rights was deleted following a divisive debate.
29. World Trade Organization, Ministerial Conference, Fourth Session, Doha, 9–14 November 2001, Declaration on the TRIPS agreement and public health, adopted on 14 November 2001, Doc. WT/MIN(01)/DEC/2, 20 November 2001, at. 4, available at http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_trips_e.htm.
30. Id. at. 5.
31. Id. at. 6.