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 Text Availability Issues US strategy Regional agreements to ratchet up WTO provisions Subregional agreements to ratchet up FTAA provisions TRIPS-plus approach

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

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

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

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

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

Patent Term Extensions Proposed extension to offset delays in marketing approval

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?

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