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FTAA and Access to Medicines

FTAA and Access to Medicines. FTAA Overview Compulsory Licensing Issues Data Exclusivity Regulatory Issues Patent Term Extensions Investment Chapter. FTAA Overview. All countries in North, Central and South America and Caribbean, but for Cuba All existing members of WTO

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FTAA and Access to Medicines

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  1. FTAA and Access to Medicines • FTAA Overview • Compulsory Licensing Issues • Data Exclusivity • Regulatory Issues • Patent Term Extensions • Investment Chapter

  2. FTAA Overview • All countries in North, Central and South America and Caribbean, but for Cuba • All existing members of WTO • Text Availability Issues • US strategy • Regional agreements to ratchet up WTO provisions • Subregional agreements to ratchet up FTAA provisions • TRIPS-plus approach

  3. Compulsory Licensing Issues - I • TRIPS: public or private • Public Sector Limitation • (“Government of the Party of by a private entity acting on behalf of the Government of the Party” • National emergency exception • Conflicts with existing and proposed US law

  4. Compulsory Licensing Issues - II • TRIPS requirement of CL primarily for domestic market • FTAA proposal prohibit exports

  5. Data Exclusivity • What is marketing approval data? – showing safety and efficacy • TRIPS requirement: “reasonable” protection • US law and proposal: 5 years • Impact: severe impediment to effective compulsory licensing • Key US demand in bilateral pressures

  6. Regulatory Issues - I • Linkage of marketing approval with patent status • Proposal to follow US-style rule • Impact in US: 30 month extension, repeatedly • Need to assess: FTAA impact on US reform proposals, including White House proposed rule

  7. Regulatory Issues - II • Enforcement – proposed mandated punitives and criminal liability • Mandating life patents

  8. Patent Term Extensions • Proposed extension to offset delays in marketing approval

  9. Investment Chapter • Modeled on NAFTA • Key issue: investor standing to sue • Ban on performance requirements – Compulsory Licensing as example • Expropriation – compulsory licensing as example • Draft proposal is inclusive of intellectual property, exception for compulsory licensing • Will this cover data exclusivity exceptions?

  10. Conclusion: Why IP in FTAA • Countries already members of WTO • Danger of overlapping TRIPS-type obligations • Danger of TRIPS-plus • Difficulty of positive proposals, but absence from text – eg, research sharing

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