Pharmaceutical Patents, Right to Health and Access to Essential Medicines: A Human Rights Critique

Abstract: Until recently, the areas of patent law and human rights law were treated separately. The tensions between pharmaceutical patents and the human right to health could be felt already in the 1980s, when the HIV/AIDS pandemic broke out and the pharmaceutical company that discovered a drug which could be used to treat this disease decided to patent it and set the price so high, that it was impossible for most people living in poor countries, where the disease was most prevalent, to access them. The conflict intensified when 40 pharmaceutical companies decided to sue South Africa for enacting a law improving access to medicines of its citizens, claiming that this was in conflict with the TRIPS Agreement. The trial was a complete disaster for the pharmaceutical companies, which decided to withdraw the claim. However, from that moment on, the international community became aware of the conflict between pharmaceutical patents and the human right to health. The TRIPS Agreement represents the biggest victory of pharmaceutical companies, since it obliges all Member States to provide patent protection for inventions belonging to all fields of technology, including pharmaceuticals, for a period of 20 years. Before TRIPS, States were free to choose whether they would provide patent protection for pharmaceutical products. However, TRIPS also provides for a few flexibilities that are of value for developing countries, such as compulsory licences and other exceptions to the exclusive rights conferred to the patent owner. The negotiations on the barriers to access to medicines caused by the Agreement resulted in the adoption of the Doha Declaration on TRIPS and Public Health and subsequent decisions on the so-called ‘Paragraph 6’ issue. However, apart from the price-setting of patented medicines, the pharmaceutical industry is in the position to impact people’s enjoyment of the right to health through deciding on the direction of research and development of drugs. For those diseases that affect mostly the developing countries, the industry does not feel the need to develop new drugs, since it cannot recoup what it had invested into their development, nor gain profit from the sales of the medicines in these markets. This leads to the so-called ‘90/10 gap’ and the existence of neglected diseases. This thesis starts with introducing the reader to the law on patents, by addressing the general characteristics of patents, while simultaneously trying to set its focus on the peculiarities of pharmaceutical patents. It presents the relevant international and EU documents on this issue. It then continues with the introduction of the right to health and the right to access to essential medicines. It reflects on the existing legislation on the right to health and presents all its implications and obligations of States stemming from it. Moreover, it establishes the right to access to medicines as a human right, which could be viewed as both being an indispensable part of the right to health, or arguably, as an independent human right, which is paving its way to even becoming a part of customary international law. The subsequent Chapters deal with the main subject of the thesis. Chapter 4 addresses the conflict itself and shows all the ways in which patents affect the human right to health and access to essential medicines. It presents the arguments of both the human rights proponents and those of the industry, in order to give an overall, objective picture of the conflict. It deals with the issues of neglected diseases, counterfeit drugs, and the particular situation in developing countries. The last Chapter gives an overview of existing and possible solutions to this conflict, including compulsory licences, other exceptions to the exclusive rights conferred to the patent owner, differential pricing schemes, generic competition and the Health Impact Fund. It also reflects upon the corporate social responsibility of pharmaceutical companies and good practices shown by numerous stakeholders.