Could international compulsory licensing reconcile tiered pricing of pharmaceuticals with the right to health?
Tóm tắt
The heads of the Global Fund and the GAVI Alliance have recently promoted the idea of an international tiered pricing framework for medicines, despite objections from civil society groups who fear that this would reduce the leeway for compulsory licenses and generic competition. This paper explores the extent to which an international tiered pricing framework and the present leeway for compulsory licensing can be reconciled, using the perspective of the right to health as defined in international human rights law. We explore the practical feasibility of an international tiered pricing and compulsory licensing framework governed by the World Health Organization. We use two simple benchmarks to compare the relative affordability of medicines for governments – average income and burden of disease – to illustrate how voluntary tiered pricing practice fails to make medicines affordable enough for low and middle income countries (if compared with the financial burden of the same medicines for high income countries), and when and where international compulsory licenses should be issued in order to allow governments to comply with their obligations to realize the right to health. An international tiered pricing and compulsory licensing framework based on average income and burden of disease could ease the tension between governments’ human rights obligation to provide medicines and governments’ trade obligation to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights.
Tài liệu tham khảo
Berkley S: Improving access to vaccines through tiered pricing.Lancet 2014, 383(9936):2265–2267.,
Open Letter from Civil Society to Mark Dybul, Executive Director of the Global Fund to fight AIDS, Tuberculosis and Malaria. [http://infojustice.org/wp-content/uploads/2014/05/GF-tier-pricing-letter-Final-May13.pdf]
Balasubramaniam T: Former WTO Director-General, Pascal Lamy, mooted to chair Global Fund's Equitable Access Initiative. Knowledge Ecology International blog, November 11, 2014. [http://keionline.org/node/2123]
Oxfam, Save The Children, VSO: Beyond philanthropy: the pharmaceutical industry, corporate social responsibility and the developing world. [http://www.savethechildren.org.uk/sites/default/files/docs/Beyond_Philanthropy_1.pdf]
Committee on Economic, Social and Cultural Rights: General comment 14: the right to the highest attainable standard of health. [http://www1.umn.edu/humanrts/gencomm/escgencom14.htm]
World Trade Organization: Agreement on trade-related aspects of intellectual property rights. [http://www.wto.org/english/docs_e/legal_e/27-trips.pdf]
World Trade Organization: Declaration on the TRIPS agreement and public health. [http://www.wto.org/english/thewto_e/minist_e/min01_e/mindecl_trips_e.pdf]
World Trade Organization: Implementation of paragraph 6 of the Doha Declaration on the TRIPS agreement and public health. [http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm]
World Trade Organization: Amendment of the TRIPS agreement. [http://www.wto.org/english/tratop_e/trips_e/wtl641_e.htm]
Apotex: Submission to the Standing Committee on Industry, Science and Technology: Bill C-393, an act to amend the patent act (drugs for international humanitarian purposes) and to make a consequential amendment to another Act. [http://www.apotex.com/global/docs/submission_order_en.pdf]
Galloway G: Tories block bid to make cheaper medicines for poor nations. Globe and Mail. 2012, [http://www.theglobeandmail.com/news/politics/tories-block-bid-to-make-cheaper-medicines-for-poor-nations/article5759286/], [http://www.theglobeandmail.com/news/politics/tories-block-bid-to-make-cheaper-medicines-for-poor-nations/article5759286/]
Feldman J: Compulsory licenses: the dangers behind the current practice. J Int Bus Law. 2009, 8: 137-167.
WHO: Constitution of the World Health Organization. [http://apps.who.int/gb/bd/PDF/bd47/EN/constitution-en.pdf]
Kenyon C, Colebunders R: What is the optimal first line antiretroviral therapy in resource-limited settings?. PLoS Med. 2012, 9: e1001291-10.1371/journal.pmed.1001291.
Médecins Sans Frontières: Untangling the web of antiretroviral price reductions. [http://d2pd3b5abq75bb.cloudfront.net/2013/09/11/10/25/44/896/MSF_Access_UTW_16th_Edition_2013.pdf]
Belgian Center for Pharma-Therapeutic Information: Commented Medicines Repertory. [http://www.bcfi.be/]
World Bank: Data. [http://data.worldbank.org/]
UNAIDS: Regions and Countries. [http://www.unaids.org/en/regionscountries/countries/belgium/]
Hill A, Khoo S, Fortunak J, Simmons B, Ford N: Minimum costs for producing hepatitis C direct-acting antivirals for use in large-scale treatment access programs in developing countries. Clin Infect Dis. 2014, 58 (7): 928-936. 10.1093/cid/ciu012.
Fellows GK, Hollis A: Funding innovation for treatment for rare diseases: adopting a cost-based yardstick approach. Orphanet J Rare Dis. 2013, 8: 180-10.1186/1750-1172-8-180.
Elliott R: Managing the Market for Medicines Access: Realizing the Right to Health by Facilitating Compulsory Licensing of Pharmaceuticals – A Case Study of Legislation and the Need for Reform. Access to Medicines as a Human Right. Edited by: Forman L, Kohler JK. 2012, University of Toronto Press, Toronto