Ondina Fachel Leal
The current international patenting system, prominently the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) of the World Trade Organization (WTO) causes arbitrary and abusive increases in the price of essential medicines, impeding access for most of the world's population. The TRIPs agreement has established very high levels of patent protection, and has created effective barriers for countries to draw up their own public policies and develop their own industrial technology, thereby privileging, in an unacceptable manner, profit to the detriment of life. A striking example of this distortion are the new medicines to combat AIDS which, under patent protection, are totally inaccessible for the majority of people who suffer from the illness. What is at stake here is that access to health has to be supported by public policies through a human rights approach.
During the last 30 years, the scope and role of intellectual property (a category of public law that includes copyrights, patents, trademarks) rules and standards expanded at an unprecedented pace. In 1998, with the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) a new global order was established in the world, imposing a set of rules to countries. When the Uruguay Round of trade negotiations was launched, many countries (including developed countries) did not have patent protection on pharmaceuticals as a way of protection to promote access to drugs at competitive prices. Prior to the entry into force of the TRIPS, most intellectual property negotiations and standard setting took place at the World Intellectual Property Organization (WIPO). The situation changed significantly when the TRIPS introduced the concept of minimum standards for the so called Intellectual Property Rights (IPRs) regulation. To understand the IP rule-making regime, the reasons why TRIPS is a WTO agreement instead of a WIPO treaty has to be pointed out: WTO mechanism for dispute settlement is an efficacious tool which members can use to enforce the TRIPS obligations of their trading partners, backed by the threat of cross trade sanctions. To date, the vast majority of cases of dispute settlements concerning TRIPS in WTO have been brought by the US and EU. But it is also important to highlight that WIPO as a multilateral organization only came into being in 1974, when it became a specialized agency of the United Nations (UN). Before that, WIPO was the Office for the Protection of Industrial Property, a body established to administer service for the Paris and Berne conventions on industrial property and copyright.
An important political issue to be addressed here is the fact that, differently from any other UN system organization, 90 percent of WIPO funding does not come from members governments but from the private sector through fees paid by patent applicants (patent holders). This helps to understand why WIPO is only concerned with the promotion of IPRs, and interpreting its mission as an advocate of stronger IP in developing countries. Its objective and functions do not include development goals, as should be the case of all UN agencies. The argument here, appropriately, pointed out in the last WIPO Assembly by the Brazil-Argentina filed document is that as a member of the United Nations system, the WIPO should be fully guided by the broad development goals that the UN has set for itself, which established a firm commitment by the international community to address the significant problems that affect developing countries. The UN Millennium Development Goals recognize the importance of reducing poverty and hunger, improving health and education, and ensuring environmental sustainability. Development concerns should be fully incorporated into all WIPO activities and WIPO’s role, therefore, is not to be limited to the promotion of intellectual property protection. Intellectual property protection is intended to be an instrument to promote technological innovation, as well as transfering and disseminating of technology. The argument is that intellectual property protection cannot be seen as an end in itself, nor can the so called “harmonization” of intellectual property laws lead to higher protection standards in all countries, without taking in to account their levels of development.
Both processes, first, WIPO from a individual and corporate patent holder office structure becoming an UN regulating agency; and, second, the advent of TRIPS as a WTO agreement, with all its global trade sanction power, mark the beginning of an era of unprecedented commoditization and globalization in the world, as well as global competition, technological change and high regulatory barriers for the world. As Joe Karaganis, puts it: “intellectual property is not only a regulatory structure that defines rights of exploitation for knowledge and creative work, but also a discourse of legitimization for the structure of power underlying the emerging global knowledge economy”(IPR Consultancy Report, Ford Foundation 2004). There are two strong position related to IPR. On one hand, developed countries governments and patent holders industries (mainly pharmaceutical and information technology sector) argue that IPRs stimulate inventiveness, economic growth, regulate the transfer and dissemination of technology and, as such reduce poverty. That argument is that if it works for developed countries, why would it not work for developing countries. On the other hand, mainly civil society organizations such as consumer international organizations, public health sector representatives and governments from developing countries argue that an IPR global system can do little to stimulate invention where human resources and technical capacity is absent. Moreover, the system increases the costs of essential medicines and agricultural inputs. What is highlighted is that although technological innovation, science and creative activity are important sources of development, the IPR is the legal framework to guarantee the monopoly of knowledge and technology – once established it did not take into account the existing “knowledge gap” and the “digital divide” that continue to separate the wealthy nations from the poor ones. The existing IPR regime was created to protect those that who have (knowledge, technical capacity, resources and information) – where in a very perverse equation, knowledge becomes a commodity, with a high market value. Knowledge becomes private property.
It seems that the existing IP system raises genuine concerns, even in developed countries. The submission of patent applications has increased tremendously in recent years. Companies may incur considerable costs in patent litigation. The Commission on IPR final report recommends: There are no circumstances in which the most fundamental human rights should be subordinated to the requirements of IP protection. IP rights are granted by states for limited times whereas human rights are inalienable and universal. But describing them, as “rights” should not be allowed to conceal the very real dilemmas raised by their application in developing countries, where the extra costs they impose may be at the expense of the necessities of life for poor people. Developed countries should pay more attention to reconciling their commercial self-interest with the need to reduce poverty in developing countries, which is in everyone’s interest. (cf. Report of the UK Commission on IPR, 2002)
In recent years, there have been major technological breakthroughs in the medical and pharmaceutical fields, such as the mapping of the human genome, antiretroviral therapy for HIV-AIDS treatment and second line treatments for tuberculosis and malaria. This coincides with the expansion of patent protection to pharmaceutical products and processes under TRIPS, which became an obstacle to access to medication in the developing countries. The commercial forces, giving very little voice to public interest have commanded patenting of pharmaceutical products. The TRIPS signatory countries and their governments, among them, most Latin American countries, have very little control over the production, commercialization, pricing and even distribution of medicines.
Lack of access to essential medicines, particularly affordable medicines to treat HIV-AIDS is a global public health and human rights crises. One-third of the world population has no access to essential medicines and 95 percent of the world’s 40 million people living with HIV do not have access to affordable, life-prolonging, anti-retroviral therapy.
The Aids epidemic has many lessons to teach to other diseases. One of them is related to universal access to medications that was obtained through advocacy activities and social mobilization. If Aids universal access to medication is a feasible goal in Brazil, such a reality could be expanded to other developing countries and to other diseases. There is a widening gap between industry-sponsored research and public health demands in terms of drug development policies. Malaria, tuberculosis and dengue, typical diseases of less developed countries, are well known examples of diseases that have not received significant investment in drug development over the last decades.
In the case Brazil, the IPR regime directly affects public health, access to essential medicines and in particular the national program to combat HIV/AIDS. Efforts have been underway to find and enlarge the TRIPS agreement flexibilities in order to improve the availability and access to essential patented medication.
The adoption of the Doha Declaration on the TRIPS Agreement and Public health of the WTO at its 4th Ministerial Conference, in 2001, represented a significant achievement – it has since been the subject of much public discussion and debate, with significant attention being placed on the so-called “public health safeguards” and “flexibilities” within TRIPS that permit the taking of “measures to protect public health”. The Article 8 of TRIPS states that corrective measures may be necessary to curb practices that may adversely affect trade and international transfer of technology. It specifically addresses compulsory licensing and parallel importation, and more generally emphasizes that the TRIPS Agreement should be interpreted in a manner conducive to promoting access to medicines for all. The Decision on Implementation of Paragraph 6 of the Doha Declaration was adopted in 2003 (the “Medicines Decision”), with the objective of permitting countries with insufficient or no manufacturing capacity in the pharmaceutical sector to make effective use of compulsory licensing.
However, the global IPR regime has become increasingly complex, and includes a diversity of multilateral agreements, international organizations, regional conventions and bilateral arrangements. In order to restrict the existing TRIPS flexibilities, the current US administration has pursued bilateral and regional trade agreements that require countries to implement intellectual property rules that exceed WTO standards. There is pressure on developing countries to increase the levels of IP protection in their own legislations, based on standards in developed countries. All this generates a new international IP standard, referred as TRIP Plus. It is a consensus among international civil organizations, mainly among consumers and health advocators that with TRIPS-plus we get too much investment in non-innovative copy products, and too little investment in public goods, innovative medicines, vaccines and other health priorities. The proposal is to shift to a new framework – focusing directly on research and development (R&D) rather than patent rights or drug prices, which are mechanisms to finance R&D. The idea is to change the context from commerce to health. See Hubbard and Love: A New Trade Framework for Global Healthcare R&D. PLoS Biol 2(2).
The impact of TRIPS on public health and access to medicines has been overwhelming. The reasons can be summarized as: TRIPS agreement treats medicines as any other commodity; market concentration determines high prices for new medicines; patent protection delays generic marketing by 20 years; TRIPS mechanisms may weaken local industry-market concentration increasing technological dependency as it does not incorporate mechanisms of technology transfer and direct investments from developed to developing countries (cf. WHO Network for Monitoring TRIPS document 2003). The problem of high pharmaceutical prices and restricted access is not limited to developing countries. Populations in the developed countries are aging, and older populations are increasingly dependent on prescription medicines. The cost of medicines is straining government budgets and burdening private health benefits systems.
It has already been shown that the IP system hardly plays any role in stimulating research on diseases particularly prevalent in developing countries, except for those diseases where there is also a substantial market in the developed world (e.g. diabetes or heart disease). Nor is it likely that the globalization of IP protection will lead to greater investment by the private sector for the development of treatments for diseases that primarily affect developing countries. Global spending on health research by both the public and private sector represents about 2.7 percent of total annual health expenditures worldwide. Less than 10 percent of this is devoted to diseases that account for 90 percent of the global disease burden. Only 13 of the 1233 drugs that reached the global market between 1975 and 1997 were for tropical infectious diseases that primarily affect the poor. (cf. The Report on Health Research 2003-2004. Global Forum for Health Research)
Regarding public health, evidence points to that there is a pressing need for a more flexible IPR system. Developing countries are not taking full advantage of the existing TRIPS safeguards, the main reasons are lack of IPR legal expertise and insufficient technological resources. Countries can improve their legislation by including or expanding the scope of TRIPS safeguards in order to achieve better public health outcomes. January 1, 2005 will mark the end of the TRIPS Agreement transition period for pharmaceutical product patents with respect to developed and developing countries. This will culminate the effort launched by the patent-based pharmaceutical industry requirement for grant and enforcement of patents on medicines throughout the developing world. After January, 2005, it will be possible for producers of new medicines to obtain patent protection for a minimum term of 20 years. The end of the TRIPS Agreement transition period is another factor that will strengthen the trend toward IPR consolidation. Therefore is paramount that action to tackle all the possibilities of TRIPS flexibilization, in particular compulsory licensing, is taken. Brazil is one of the very few developing countries that may has governmental political will and technological capacity to undertake this endeavor and keep a strategic international leading position in this issue. A number of immediate effective actions in using TRIPS safeguards would establish an international jurisprudence for, let’s say, a TRIPS-Minus or Light TRIPS, pulling the IPR regime consolidation in the less developed countries interest direction and favoring them in this unequal tug-of-war.