IP Issues in Global Health. Lenias Hwenda, Ph.D. The African Group, WHO/UNAIDS Geneva. Trondheim, 27 September 2012

Transcription

1 IP Issues in Global Health Lenias Hwenda, Ph.D. The African Group, WHO/UNAIDS Geneva Trondheim, 27 September

2 Summary Intellectual property rights The global health policy landscape A viable policy alternative 2

3 The Purpose of the IP System in Global Health Exclusive legal rights granted for inventions Novel, inventive, industrially applicable, utility Clinical value not a prerequisite for patentability Promotes innovation, its value and direction Major source of technological and economic intelligence Ensures equitable access to the products of innovation 3

4 Bridging Innovation and Access Incentive Encouraging risktaking Promoting effective partnership Tool Mechanism Encouraging INNOVATION Investmenting in product development Disseminating scientific advances Enabling ACCESS Sharing valuable data/know how Improving availability of innovations 4

5 Global Patent Harmonisation Prior to 1990 great variation in types/lengths of patents (5-10; yrs) Exceptions - food, medicines, agriculture technologies Trade-related Aspects of Intellectual Property Rights 1995 Minimum standards of IPR protection in public health Harmonisation of patent laws to levels of HICs (20 years) ( )concerns about the effect of IP protection on prices 5

6 Rationale for Global Patent Harmonisation A global public good - non-excludable/non-rival Fair distribution of costs, prevents free-riding Patents - main policy tool driving R&D investment 6

7 The Flawed Logic of Global Patent Harmonisation Out of pocket expense in LMICs (~90%) Uniformly distribute R&D cost to all countries Identical pricing of medicines World uneven great wealth/income disparities Cost of accessing 60 5mg Gilbenclamide tablets for diabetes, in the private sector 7

8 Mapping the Global Policy Landscape What s going on? What are the issues? What does it amount to? Financing Unsustainable Prices Unaffordable Poor Access to Products of Innovation Innovation Inefficient Governance Inequitable What should be done? Unreliable (ad hoc, fragmented), costly Unbalanced- limited no. of diseases, 8

9 Growing Medical Needs WHO, 2005 Old and emerging challenges- double burden of disease Poor access to new and existing medicines. 9

10 Balancing Innovation and Access - WTO TRIPS Agreement (1995) Makes exceptions to the strict application of IP law The Doha Declaration (2001) recognises; ( ) the gravity of the public health problems ( )concerns about the effect of IP protection on prices TRIPS Intepretation and Implementation; supportive of public health interest promote acess to medicines for all 10

11 Balancing Innovation and Access- WHO/WIPO Resolution WHA57.19 (2004) Commission on IP rights Innovation and Public Health The WHO GSPOA on Public Health Innovation and IP (2008) promote transfer of and access to key health-related technologies WIPO Development Agenda (2007) promote the transfer/dissemination of technology 11

12 Challenges to Access within Countries IP-related Factors Complex IP regimes Patent thickets, digitisation Legal Uncertainty on TRIPS flexibilities TRIPS PLUS Other Policy Factors Weak Health Systems Unrelable Supply Chains Low Investment in Product Development Tarrifs, Duties and Taxes Pricing and Competition Policies Weak National Medicines Regulatroy Authorities Irrational Selection of Medicines IP is one of many factors that contribute to poor access 12

13 Complementing/Leveraging Existing Policies - R&D Treaty Push Mechanisms Technology transfers Open source approaches R&D Tax Credits, prize funds Product development partnerships Incentivises R&D Pull Mechanisms Advance market commitments Market creation, patent pools Priority regulatory reviews TRIPS flexibilities Binding Balanced Equitable 13