INTRODUCTION

The subject of this dissertation is the issue of access, or lack thereof, of medicines for patients in developing countries. The argument often made in that regard is that patent protection for medicines results in higher prices and therefore negatively impacts patients’ access to such medicines. That is to say, patent protection provides the patent holder with a monopoly position for a set number of years excluding competitors from the market. Such a monopoly position is argued, particularly by the pharmaceutical industry, to be justified due to the fact that patents are vital in order to recoup their substantial research and development costs; since without patent protection pharmaceutical companies would have no incentive to invest in innovation. This issue is studied from the perspective of international human rights law and international patent law and trade law. The inclusion of intellectual property rights (IPRs), such as patents, trademarks, copyright etc, into the framework of the World Trade Organisation (WTO) through the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) has brought about significant changes to the manner in which IPRs are granted, protected and enforced. It has been argued that the introduction of global minimum standards for IPRs, particularly patents, negatively affecting patients’ access to affordable medicines creates tension with international human rights law, which protects access to essential medicines. In this study this alleged tension is researched in more detail.

Although the issue of access to medicines to an extent is a global problem, its specific characteristics differs from country to country depending on a wide range of factors on the ground, such as a country's level of development, public health burden, public health-care system, manufacturing capacity, level of intellectual property (IP) protection, environmental conditions etc. The system for protection of IPRs is largely influenced by norm-setting at the international level, particularly through the adoption of the TRIPS Agreement. The inclusion of intellectual property into the multilateral trading framework has had far-reaching consequences.