International Federation of Pharmaceutical Manufacturers & Associations The TRIPS Tightrope public health, innovation, incentives and access Helsinki, 6 September 2013 1 IFPMA 2013
Definitions (I) Doha declaration Paragraph 5 we recognize that these flexibilities include: In applying the customary rules of interpretation of public international law, each provision (...) shall be read in the light of the object and purpose of the Agreement (...). Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. Each member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency (...). The effect of the provisions in the TRIPS Agreement that are relevant to the exhaustion of intellectual property rights is to leave each member free to establish its own regime for such exhaustion (...).
Definitions (II) Chairman s summary at approval of Paragraph 6 Mechanism: (...)Members recognize that the system that will be established by the Decision should be used in good faith to protect public health and, without prejudice to paragraph 6 of the Decision, not be an instrument to pursue industrial or commercial policy objectives.
The early IP and health debate
An industry view (2000) Argentina remains the worst expropriator of the intellectual property of the research-based pharmaceutical industry in the Western Hemisphere, and one of the worst in the world. It intentionally permits the local industry to copy innovative pharmaceutical products immediately, without permission of the innovator and without having to expend resources for research and development to prove safety and efficacy.
An industry view (2013) [The pharmaceutical industry] recognizes that India has legitimate concerns regarding access to healthcare throughout the country and we acknowledge the challenges of the Government to make essential medicines available to the most vulnerable sections of society. However, we are concerned about inadequate intellectual property (IP) protections, including the recent issuance of a compulsory license, which pose significant market access barriers in India.
The new criticism of the IP system
Change was not only in semantics Today, most companies that own IPRs covering products for the treatment of HIV/AIDS have signed licence or immunity-from-suit agreements with various generic producers, or have issued non-assert declarations on their HIV/AIDS products. (Trilateral Study, p.180) 8 IFPMA 2013
International Partnerships 9 IFPMA 2013
14 billion treatments to be donated until 2020 10 IFPMA 2013
Access to Medicines: A Shared Objective Definition: timely availability, under varied physical and economic conditions, of quality drugs to patients in need Many inter-related factors determine access level: Health Care Systems Government Policies Infrastructure & Supply Medicines 11
Access to Medicines: A complex Picture Source: Levison, L and Laing, R 2003. Essential Drugs Monitor No. 033. Available at: at http://apps.who.int/medicinedocs/en/d/js4941e/4.8.html 12 IFPMA 2013
Medicines are just a part of the healthcare puzzle 13 IFPMA 2012
IMS: Half trillion dollar opportunity in avoidable healthcare system costs 14 IFPMA 2012
Are we going back to the starting point India statement at the WTO TRIPS Council, March 2013 It is unfortunate that some of the technologically developed countries would like to show case the positive effect of IP on innovation, when historically these countries including the proponents of this Agenda Item [IP and Innovation] have reached this stage of technological development by focussing solely on the development of their own domestic industry without caring for the intellectuals property rights of the foreigners or the right holders. After achieving a high level of development, they are now attempting to perpetuate their hold on their technologies by making a push towards a TRIPS plus regime. Their agenda is not to create an environment where developing countries progress technologically, but to block their progress through the stringent IP regime. It is therefore essential that the flexibilities provided by the TRIPS Agreement need to be secured at any cost, if the people in the developing countries are to enjoy the benefits of innovations. 15 May 11, 2012 IFPMA 2012