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