AUDREY R. CHAPMAN, PH.D. UNIVERSITY OF CONNECTICUT HEALTH CENTER INTELLECTUAL PROPERTY AND HUMAN RIGHTS MEETING PANEL 1: IP AND HEALTH FEBRUARY 21, 2013 Intellectual Property, Human Rights, and Access to Essential Medicines

Right to Essential Medicines: GC 14 General Comment No. 14 (2000) of the UN Committee on Economic, Social and Cultural Rights identifies the provision of essential drugs, as from time to time defined under the WHO Action Programme on Essential Drugs as a core obligation of state parties to the Covenant on Economic, Social and Cultural Rights (para 43 [d]). Core obligations create an immediate duty and therefore are not subject to the availability of resources.

Issue Some two billion people, one third of the world’s population, lack access to the essential medicines necessary for their health care. Estimated improving access to essential medicines could save some 10 million lives each year. Providing meaningful incentives for development new medications for neglected diseases affecting world’s poor could reduce disease burden even further. Variety of studies identified IP restrictions as major constraint.

Approaches Proposed to Overcome Bottleneck Efforts to identify and promote the human rights responsibilities of pharmaceutical companies in relation to access to medicines. Proposals to replace patenting with other incentives for drug development. Broadening & implementing the flexibilities in TRIPS Agreement that permit compulsory licensing & parallel importing. To date none of these approaches been effective.

Statement of CESCR on IP & HR A HR approach vests responsibility in state/government as the duty holder The Statement by the Committee on Economic, Social and Cultural Rights on HR & IP (2001) observes “International rules concerning intellectual property should not necessarily be uniform if this might lead to forms of intellectual property protection inappropriate for development goals” (para. 15). It also notes fundamental importance of integration HR norms into enactment & interpretation IP law.

Statement of CESCR cont Emphasizes “that any intellectual property regime that makes it more difficult for a State party to comply with its core obligations in relation to health, food, education, especially, or any other right set out in the Covenant, is inconsistent with the legally obligations of the State party” (para. 12). Important for state/govt to adopt a law or at least make official statement indicating need for IP standards it conforms with be consistent with its HR obligations.

Alternative HR-Based Initiatives Adopt a legally-based national policy recognizing a right to health or health care incorporating a right to essential medicines Adopt a national drugs policy consistent with HR obligations: Model of South Africa’s 1996 National Drugs Policy with its goal of “ensuring an adequate and reliable supply of safe, cost-effective drugs of acceptable quality to all citizens of South Africa.” Review and amend all national patent laws to make them consistent with a human rights approach

HR- Based Initiatives cont Better conceptualize the right to essential medicines  Provide a clear definition of what is meant by essential drugs  Develop a mechanism to identify a list of essential drugs relevant to needs of country, such as reviewing and revising the WHO Action Programme on Essential Medicines and should include key drugs whether or not they are patented  Institute a mechanism to monitor the availability & cost of essential drugs in regions of the country in both public and private health institutions.  The law should identify the obligation of specific institutions in the government(s) to ensure that essential drugs be available, accessible, affordable, acceptable, and of good quality and be explicit as to what that entails.

HR-Based Initiatives cont. Adopt higher standards of patent protection related to pharmaceuticals– reduce number of easily granted patents Govts should refuse to adopt “Trips plus” standards IP protection Preclude “evergreening” of patents – new patents when patent about to expire by making small changes Preclude patenting new uses, forms, formulations, or combinations of know medicines

HR-Based Initiatives cont Make policies regarding patent protection and free trade agreements transparent Hold forums with representatives from civil society to discuss IP and its role in access to essential medicines Remove criminal sanctions for IP infringement

Maastricht Principles on Extra-Territorial Obligations Drafted 2011 by group experts in international law & HR convened by Maastricht Centre for HR & International Commission of Jurists Central provision – all states must take action separately & jointly thro international cooperation to refrain from conduct which nullifies or impairs enjoyment & exercise of economic, social & cultural rights Obligation for states take necessary measures ensure non- state actors in position regulate, including TNCs & business enterprises not nullify or impair enjoyment economic, social & cultural rights in other states Implications for way developed countries promote interests of transnational pharmaceutical corporations thro their IP & trade policies

Exercise TRIPS Flexibilities Anand Grover’s 2009 report (A/HRC/12/12) underscores important national laws, particularly of developing countries and LDCs incorporate flexibilities in TRIPS  Make full use transition periods (already too late for most)  Define criteria of patentability  Issue compulsory licenses and provide for govt use  Adopt international exhaustion principle, to facilitate parallel importation  Created limited exceptions to patent rights  Allow for opposition and revocation procedures

Exercise TRIPS Flexibilities cont. Freedom to exclude certain inventions whose commercial exploitation is detrimental to human life or health  Grover proposes exclude diagnostic, therapeutic, & surgical methods for treatment of humans Make broad use of compulsory licenses to protect public health and promote access Streamline and simplify laws and regulations to issue compulsory licenses Adopt broad research exemption