Submission to the UN High-Level Panel on Access to Medicines: The importance of competition law in facilitating access to medicines

Abstract

Competition policy is an under-utilised tool. Policy coherence between the IP system and competition must be strengthened in order to promote to the full extent innovation and access to health technologies. Article 8(2) of the TRIPS Agreement provides flexibilities for governments to adopt competition law measures to prevent abuse of intellectual property rights, including IP rights related to the life sciences, namely the pharmaceutical industry and the biotechnology sector. Post-TRIPS, some countries have implemented competition laws but in practice are not using these effectively. Even when competition authorities are active, many anti-competitive practices lack adequate attention. This is particularly striking in the pharmaceutical sector, where reverse payment agreements, for instance, are heavily litigated in the United States but have become the focus of attention in the European Union only more recently. Other business practices of pharmaceutical companies delay generic entry but competition authorities do not deal with this behaviour at all. One example of potentially anti-competitive behaviour is strategic patenting, or as pharmaceutical companies call it, the life-cycle management practices in the form of patent thickets, secondary patenting (also known as evergreening) and defensive patenting. These practices delay considerably generic entry and innovative medicines and, despite being highlighted by the European Commission in its Pharmaceutical Sector Inquiry in 2009 and more recently in the Trilateral Study of the WHO, WIPO and WTO in 2012, in reality competition authorities have failed to deal with such practices thus far. Anti-competitive practices create particular challenges for the developing world, given that they allow pharmaceutical patent owners to extend patent monopolies and, when considered together with provisions on data and market exclusivity, can lead to significant barriers to innovation and access. It is imperative therefore that the full range of policy tools is utilised in favour of access to medicines. Strengthening policy coherence between the IP system and competition must be central to achieving the aims and objectives of the High-Level Panel. Used effectively, competition policy can be in the best interests of society. It is conducive to freedom of choice and lower prices while, potentially, also serving as an important driver for innovation and access.