Ethical and Procedural Barriers to Accessing Critical Medicines in Least Developed Countries: A Look at TRIPS and the Doha Documents

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) came into effect in 1995, in order to standardize intellectual property rights internationally. Since its adoption, nearly all of the 161 World Trade Organization (WTO) members have adopted the required minimum standards set forth in the TRIPS Agreement. However, while this standardization has allowed corporations greater return on their patents, it has also created concerns about access to critical medicines in developing and least developed countries. As greater standardization (and enforcement) of intellectual property property rights occurs internationally, fewer generics are available, meaning the international price of drugs is generally higher. As such, individuals in least developed countries are required to pay higher prices for access to critical medicines to treat HIV/AIDS, tuberculosis, malaria, and other critical diseases. Access to these medications could save millions of lives each years. Although the Doha Documents: the Doha Declaration and the Doha Implementation Agreement sought to rectify this problem of access, on the whole they have been largely unsuccessful. The Doha Documents affirm the right of access, and describe the steps involved in compulsory licensing. Compulsory licensing-which occurs when a government grants a non-patent holder the right to produce a patented medication-may occur under the Doha Documents between a (presumably) developed and least developed country. Under such an agreement, the developed country may manufacture the critical medicine, and export it to a least developed country. However, there are many procedural hurdles to such a partnership, and countries considering compulsory license have been subject to immense pressure by pharmaceutical corporations. Consequently, there has only been one attempt to utilize the compulsory licensing provisions of the Doha Implementation Agreement. These strong international patent rights are justified by most philosophical approaches to intellectual property rights. For example, utilitarianism, labor theory, personality theory, and social planning theory all (to varying degrees) support patent rights-and thus the pharmaceutical corporations' right to enforce their patents. However, elements of the personality theory and social planning theory, as well as the human right to health care sit in tension with the property right of a patent. Specifically the human right to health care is well-established by several international documents, and although the specific standard of health care may be disputed, generally most agree that at a minimum individuals should have access to critical medicines. With this tension in mind, a solution should be adopted that both respects the property right of a patent, while also not denying the human right to health care. As such, the strong international intellectual property protection regimes should remain in place. Additionally, the Doha Documents should become more robust, and given the same legal force as TRIPS, so countries can more easily take advantage of the compulsory licensing provisions. Finally, drugs treating critical diseases, i.e. those critical medicines which least developed countries cannot access, should be subject either to cost margins limiting the maximum price, and/or subsidization, which incentivizes research for drugs having comparatively less economic incentive to research.