WIPO Standing Committee on the Law of Patents – Twentieth Session
Speaker: Ms Yuanqiong Hu, Intellectual Property Advisor, MSF Access Campaign
Médecins Sans Frontières welcomes a discussion on patents and health as it provides an opportunity for sharing country experiences in using TRIPS flexibilities to promote public health. However, MSF is concerned that WIPO is not quickly addressing its mandate in providing technical assistance to countries to enable them to design and reform patent laws through the use of public health flexibilities. We also remain concerned that developing countries continue to face difficult challenges in balancing intellectual property, public health and access to medicines in national patent laws.
Recent events in South Africa have demonstrated the willingness of multinational pharmaceutical companies to secretly undermine a legitimate patent law reform process – the very sort of reform that WIPO should support – that could lead to the improvement of generic competition and promotion of access to medicines. South Africa faces one of the world’s most acute HIV and TB epidemics, where medicines prices can be 35 times higher than countries with more robust generic competition. While these revelations triggered intensive discussions at the WHO Executive Board meeting last week, with many countries expressing their solidarity and support for South Africa, the current session on patents and health is a particularly appropriate forum to address the issues under discussion in South Africa from a technical standpoint. MSF urges members of the committee to grasp the pressing need for WIPO to play an appropriate role to support patent law reform that can improve public health.
Firstly, MSF urges this committee to take concrete steps in adopting South Africa’s proposal - SCP/16/7 - that was submitted in 2011 by South Africa on behalf of the Africa Group and the Development Agenda Group, with a clear implementation plan. The proposal outlined the technical needs of developing countries, and a road map to apply WIPO’s technical abilities in supporting countries to understand the impeding impact of patents on access to medicines, and incorporating technical solutions in their national patent systems to mitigate such effects. WIPO needs to collaborate with WHO to implement the global strategy and plan of action on public health, innovation and intellectual property, and this proposal is a positive step forward to fulfil WIPO’s mandate.
Secondly, MSF encourages Member States of developing countries to increase information sharing and technical support to one other in the context of patent law reform that promotes public health. MSF also urges the Secretariat to provide facilitation for such exchanges as an extension of the sharing exercise that is underway at this committee. In recent years, debates and policy decisions regarding the intersection of intellectual property, public health and access to medicines have been reflected in a number of patent law reform processes – for example in Brazil and India. These efforts diverge greatly from South Africa, whom, in lacking substantive examination capacity, granted nearly 2,500 patents on pharmaceuticals in 2008 alone without an adequate assessment of the quality of patent applications. By contrast, Brazil granted just 273 in the five-year period up to 2008. These divergent experiences could be mitigated in part by encouraging governments to work more closely with each other to ensure that best practices can be adopted, in particular those that ensure public health considerations are not excluded from patent examination processes.
Thirdly, there is a need to ensure a consistent application of public health concerns across agenda items under consideration at this committee. For example, delegates have debated over the ambiguity and absence of a shared definition of quality of patents. In the context of public health, secondary patenting can significantly restrict access and hinder innovation, especially the development of fixed dose combinations and other formulations of medical products that could be beneficial in resource limited settings. Identifying public health-friendly patentability criteria in national patent laws can be a positive step to promote innovation and access. In addition, agenda items discussing patent opposition systems, patent exceptions, and limitations, must ensure that any analysis includes the public health considerations of policy choices. Such analysis has been done elsewhere many times over the last decade, and we believe it is long overdue for this committee to integrate such perspectives into its work now and in the future. Failure to do so would mean that these discussions would not reflect the challenges and realities facing developing countries today.