Publication: Yale Human Rights and Development Law Journal
Publication Date: 01-JAN-03
Format: Online - approximately 18408 words
Delivery: Immediate Online Access
Author: Lazzarini, Zita
Article Excerpt
The HIV/AIDS epidemic has made the problem of access to pharmaceuticals in developing countries a subject of intense public debate. This Essay contends that tensions between intellectual property rights and human rights are largely resolvable through the full utilization of exceptions under new international trade and intellectual property rules. Rather than undermining these regimes, the approach laid out in this Essay was anticipated by the international forum that established the World Trade Organization and issued the Trade-Related Aspects of Intellectual Property Agreement (TRIPS). Brazil's experience illustrates possible strategies, relevant to developing countries, which can be used to strike a balance between respect for public health and human rights and protection of intellectual property rights.
I. INTRODUCTION
Extreme disparities in access to pharmaceuticals for life-threatening diseases are not new. Although much of the world has always lacked access to new and expensive drugs, only now are we seriously discussing these disparities. Spurred by the growing HIV/AIDS epidemic as well as the globalization of international trade, these questions have landed squarely in the public arena.
This Essay will investigate the problem of access to pharmaceuticals in the context of intellectual property rules and human rights. As long as concepts like sharing equitably in the benefits of science and technology, safeguarding the rights of indigenous peoples, and protecting "authors' rights" remain unrealized and unreconciled, access to pharmaceuticals will continue to be an issue of charity rather than of rights, and good health will remain beyond the grasp of most of the world. In this Essay, I will not venture an exhaustive exploration of the empirical evidence related to drug pricing or a detailed examination of the legal mechanisms available to facilitate access in all countries. Instead, I will lay the groundwork for possible ways to resolve the tension between intellectual property rights and human rights in the effort to guarantee access to pharmaceuticals.
This Essay suggests that many middle-income countries could provide wider access to pharmaceuticals by fully utilizing the exceptions permitted under new international trade and intellectual property rules. For the poorest nations, however, these rules as written do not offer easy solutions. Moreover, rich nations have been slow to recognize--and poor nations have been slow to use--the potential exceptions within the existing regime. This Essay will draw on the recent experience of Brazil to illustrate possible strategies and several notable trends.
Part I briefly describes global disparities in health and access to pharmaceuticals. Part II sheds light upon some of the barriers to wider access to pharmaceuticals related to HIV/AIDS and reviews the basic structure of international intellectual property law. Part III characterizes access to pharmaceuticals as a human right. Part IV considers ways to reconcile the existing tension between intellectual property rules and human rights. Part V presents Brazil as a case study, considering the relevance of its experience for other developing countries. Finally, Part VI concludes with proposed directions for further inquiry.
II. DISPARITIES IN HEALTH AND DISPARITIES IN ACCESS
If you live in a poor country, you are much more likely to suffer early sickness, disability and death than if you live in a rich country. The World Health Organization (WHO) reports that such glaring disparities in health conditions, incidence and prevalence of disease, and life expectancy persist. (1) Unsurprisingly, access to pharmaceuticals also varies tremendously around the world. Despite years of WHO's essential drug programs and the adoption of essential drug lists by many countries, (2) availability of drugs remains highly uneven. (3) The World Health Assembly has noted that "one third of the world's population has no guaranteed access to essential drugs." (4) In many developing countries, individuals and their families are expected to purchase drugs and medicines to treat their illnesses. (5) Weak government regulation and improper prescriptions from doctors may result in unsafe and ineffective drug use. (6) The danger of misuse is especially strong with antibiotics. (7) For many serious diseases, treatments are either unavailable or unaffordable. (8) In rural areas the situation is particularly difficult, as the only supplier of drugs is typically either a local hospital or health clinic which often lacks even the most basic drugs to treat common illnesses such as respiratory infections and diarrhea and very rarely has access to new drugs used to treat tuberculosis or HIV/AIDS. (9) Only a wealthy few in most countries can even think of obtaining HIV/AIDS drugs independently. (10)
Disparities in access to pharmaceuticals exact an unmistakable impact on health. Three million people died of AIDS in 2001. In 2000, 1.7 million died of tuberculosis and more than one million from malaria. (11) With the use of combination therapy in the United States and in other developed countries since 1996, AIDS cases and deaths have dropped substantially for the first time since the beginning of the epidemic. (12) Ninety-five percent of those infected with HIV worldwide live in developing countries, (13) and fewer than five percent have access to effective treatment. (14) Unlike in wealthy countries, AIDS cases and deaths in developing countries have continued to climb. (15) The United Nations Joint Programme on AIDS (UNAIDS) has identified unequal access to affordable treatment as one of the principal reasons for the drastically lower survival rates in developing countries. (16)
Disparities in access to treatments raise worrisome issues of equity. Although public health officials have emphasized solidarity among all people, (17) those living with HIV/AIDS perceive quite the opposite situation: a dissonant, two-tiered system. Since 1996, in the developed world, HIV/AIDS has become akin to other treatable chronic illnesses. In the developing and undeveloped world, it remains a deadly plague. Differential investment in AIDS prevention mirrors these disparities. In the mid-1990s, even though more than eighty five percent of infections occurred in the developing world, only about ten percent of the estimated $2 billion spent annually on prevention went to slow the spread of HIV and AIDS in developing countries. (18) Today, with ninety-five percent of infections occurring in the developing world, the total funding for treatment and prevention in the poorest countries hovers around $2 billion. (19) While this looks like a substantial increase in spending in the developing world, spending still falls far below official estimates of $10 billion needed annually to effectively treat HIM/AIDS and prevent its spread. (20)
III. INTELLECTUAL PROPERTY--PREREQUISITE OR BARRIER TO HIM/AIDS TREATMENT IN THE DEVELOPING WORLD
Because of the great disparities in access to pharmaceuticals, active debate surrounds the international legal framework protecting intellectual property rights. On the one hand, some have argued that patents play little or no role in limiting access to essential AIDS drugs in Africa. (21) On the other hand, it has been widely reported that some countries have been reluctant to take any steps that could be interpreted as violating patent and intellectual property rules. Their uncertainty and fear over possible trade-related retaliation may deter them (as well as private industry) from exploiting opportunities for local manufacture or importation of pharmaceuticals. (22) In this way, the intellectual property system creates barriers, both perceived and real. (23)
The relationship between patent protection and price is another source of controversy. Studies demonstrate that the presence of generic drugs results in lower pharmaceutical prices overall. (24) In some developing countries where patent protections are rare, however, and where local production capacity is nonexistent, HIV drugs cost more than in western countries. (25)
The scope and details of intellectual property protection, especially the current WTO system, are important for identifying provisions that can both support and deter access to treatments for residents of poor countries.
A. Patent Protections Pre- and Post-TRIPS
The current World Trade Organization (WTO) system is a very new phenomenon. It focuses on achieving worldwide uniformity of patent protections through restrictive patent laws modeled on those of the United States. Before 1994, both developed and undeveloped countries used a wide variety of approaches to intellectual property protection, (26) including: U.S.-style restrictive patents of relatively long duration; (27) shorter-term patents;(28) patents on processes but not products; (29) compulsory licensing of important drugs; (30) requirements that patent holders produce and sell the drug in the country granting the patent or lose the protection; (31) no patent protection for pharmaceuticals at all (as was the case in Argentina and Brazil until recently). (32)
The range of widely varying national laws that existed prior to 1995 results in difficulties:
National patent laws can vary to such an extent that a given invention may be patentable in one country but not another, be broadly protected in one country but only narrowly protected in another, or even be patentable to different persons in different countries ... "Disharmony" [in patent laws across borders] creates trade barriers and friction at both the private and diplomatic level. (33)
Concerted and sustained lobbying by the pharmaceutical companies (34) succeeded in putting intellectual property issues on the trade agenda beginning in the 1980s and later established the U.S. model as the preferred version of patent protection. This version was officially enacted during the international forum that established the World Trade Organization and issued the Trade-Related Aspects of Intellectual Property Agreement (TRIPS). (35)
The stated purpose of TRIPS includes: "[reducing] distortions and impediments to international trade ... and [ensuring] that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade." (36) While TRIPS emphasizes the private right characteristic of intellectual property and the need for a multi-lateral, multinational framework to protect these rights, it also recognizes the "special needs of the least-developed country Members in respect of maximum flexibility in the domestic implementation of laws and regulations in order to enable them to create a sound and viable technological base." (37) Countries that are party to the treaty have bound themselves to protect all products and processes against use, sale, import, or manufacture without the permission of the patent holder, except under very specific circumstances. (38) TRIPS demands that countries enforce patents for twenty years from the date of filing. (39) When a patent holder suspects a manufacturer of using a patented process to manufacture a product which appears identical to one made by the patent holder, TRIPS assigns the burden of proof for showing that the product did not infringe the patent on its manufacturer rather than on the holder of the patent. (40)
B. Will Strong Universal Patent Protection Decrease or Increase Access to Pharmaceuticals?
One of the chief arguments for patent protections in general is the need to encourage innovation and risk-taking, which are necessary for the successful development of new drugs. (41) In fact, some scholars assert that the establishment of property rights (including intellectual property) and economic development in western countries have a clear, consistent, and even causative relationship. (42)
Rapp and Rozek, for example, refer to data relating degrees of patent protection to levels of development and find a close correlation between strong patent protections and high economic growth and levels of development. (43) They argue that the overall costs to the economy of failing to protect patents (low levels of development and growth) outweigh the benefits (temporarily easier access to pharmaceuticals). They also assert that by failing to protect patents in pharmaceuticals, countries risk having "fewer new pharmaceutical products, reduced future growth of the domestic industry and, most importantly, poorer health for the country's residents." (44)
Supporters of strong patent protection often overlook the potential harms that higher prices will have on countries' citizens and public health. Singham addresses this concern directly, arguing that increased patent protection will neither raise prices nor be harmful to consumers because the numbers of drugs going off patent will be matched by the number of new patented (more expensive drugs). The problem with this argument is that it assumes that older drugs will meet the needs of "consumers" just as well as new ones. (45) This is clearly not the case with HW medications. The very reason people with HIV are so anxious to gain access to the newest drugs is often that the new drug is a necessary part of combination therapy, because they need the new drug as an alternative to regimens that have been exhausted or to avoid serious side-effects.
Not all commentators agree that universal, strong patent protections are necessarily related to economic benefits. Some suggest that strong property protections can actually deter innovation by discouraging researchers from pursuing new products or processes that entail using one or more patent-protected materials. (46) Others argue that while countries with advantages in innovation, strong research infrastructure, and a tendency to "export information'-that is technical discoveries and innovations-will benefit from patent protections, those without those characteristics (mostly poorer countries) will be harmed by stronger protections. (47)
The degree to which patent protection and high prices are necessary to support research and development has been questioned. (48) Not only is the pharmaceutical industry consistently one of the most profitable industries, (49) but also those pharmaceutical firms that ranked among the Fortune 500 companies also devoted less of their total revenue to research and development of new drugs (R&D) (12.5 percent) than to profits (18.5 percent) or marketing and administration (30.4 percent). (50)
Even if high prices encourage R&D, they are not the only means of increasing R&D. (51) Governments could provide additional funding for R&D or, through international agreements, mandate public and corporate contributions to multi-national R&D funds. They could use general tax revenues or tax profits on drugs aimed primarily at developed world consumers to support R&D in "tropical" diseases, which primarily affect residents of developing countries. (52) A variation on this option--voluntary partnerships between governments, international organizations, private companies and researchers--exists in a limited form to address the need for more sustained research on tropical diseases. (53)
C. TRIPS: Constraints and Flexibility
As stated above, TRIPS was drafted following extensive lobbying by international pharmaceutical manufacturers and reflects many values favorable to large multi-national corporations. By establishing a set of rules that requires all countries to provide uniform patent protections to all intellectual property products and processes, it tightens the screws on those countries, including many developing countries, that try to avoid adopting U.S.-style patent protections.
TRIPS does offer some flexibility to developing countries moving from weaker to stronger intellectual property regimes, however, by delaying the entry into force of the requirements for TRIPS-compliant provisions in developing countries and by providing specific and general exceptions that could be used by developing countries to increase access (54) and to protect public health or the environment.
The terms of TRIPS allow at least four exceptions that would permit developing countries to increase access while remaining compliant; it allows a country to (1) exclude products from patent protection where necessary to protect public health and the environment; (55) (2) create limited exceptions to patents, provided the country can show that the interests of the patent owner are not unreasonably infringed upon; (56) (3) issue compulsory licenses subject to certain restrictions; (57) and (4) impose price controls and taxes that do not discriminate between domestic and imported goods, which can be waived if the patent holder will license its product or process non-exclusively. (58) The efficacy of these exceptions will depend on how courts interpret them and balance the interests of patent holders, developing countries, and third parties. (59)
D. Indigenous Rights and Intellectual Property
The emerging area of indigenous peoples' rights also provides opportunities to re-define how and when intellectual property will be protected and how access to benefits will be guaranteed. (60) Modern intellectual property protections have often disfavored the types of knowledge most commonly held and valued by indigenous peoples. The requirements for novelty of invention and description of the patentable item by an identifiable creator have made much indigenous knowledge difficult to patent and therefore vulnerable to use or exploitation by others. (61) In fact, some writers claim that intellectual property, as it is currently conceptualized, promotes "biocolonialism"--the appropriation and conversion of biologically or genetically unique information from indigenous cultures to private intellectual property, largely for the benefit of western pharmaceutical and seed companies. (62) Indigenous peoples themselves have reportedly expressed widespread dissatisfaction with western intellectual property schemes because of their failure to recognize and protect much of what is important to their cultures. (63)
Others, however, see new developments in intellectual property and science as assets to indigenous peoples' rights movements and as opportunities for these peoples to protect their heritage while accruing economic benefit. A working group on indigenous peoples' rights enunciated this claim as follows:
Indigenous peoples are entitled to the recognition of the full ownership, control and protection of their cultural and intellectual property. They have the right to special measures to control, develop and protect their sciences, technologies and cultural manifestations, including human and other genetic resources, seeds, medicines, knowledge of the properties of fauna and flora, oral traditions, literatures, designs and visual and performing arts. (64)
Whitt asserts that one solution is for indigenous communities to develop alternatives to western-style intellectual property standards. Possibilities include: "community intellectual property," which would allow communities, instead of individuals, to identify and protect from expropriation knowledge and resources that had existed for generations; an "inalienability of cultural property," which...
NOTE: All illustrations and photos have been removed from this article.
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