Making access to pharmaceuticals a reality: legal options under TRIPS and the case of Brazil.

• Author: Lazzarini, Zita

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.

1. 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.

2. 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)

3. 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.

   1. 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...