The TRIPS Agreement: TRIPS Safeguards

2. The TRIPS Agreement: TRIPS Safeguards Compliance with TRIPS can have serious implications for access to essential medicines. Therefore TRIPS safeguards (flexibilities) are important. Main TRIPS safeguards are: • Compulsory licensing and ‘government use’ • Parallel importation • Bolar provision (‘early working’) • Exceptions to patentability 2

3. ‘TRIPS-plus’ Provisions Many countries have provisions in their national laws which restrict or eliminate use of TRIPS safeguards, sometimes introduced in Free Trade Agreements (FTAs) without realizing the public health consequences. Some ‘TRIPS-plus’ provisions are: • Data exclusivity • Patent term extensions • Limitations of the grounds for CLs • Linkage between patent status and generic registration • Patenting second indications 3

4. Trends in ‘Anti-counterfeiting’ Initiatives • (ACTA, IMPACT: another form of ‘TRIPS+) • Pluri-lateral; outside existing multilateral rules-based trading system and organizational arrangements • Private-public with private financing • Novel organizational arrangements • Disconnected but well coordinated parallel processes in various fora • Joint initiatives of industry and industrialized countries (US, EU, Japan) • Under-representation of low-income countries, civil society • A key argument is that stronger IP protection is the answer to protecting the public from dangerous medicines • Conflation/confusion of ‘counterfeit’ and ‘sub-standard’ (contrary to TRIPS) • …an ‘upward ratchet’ for IP protection

5. “Medicines fall under two separate legal and regulatory systems: the intellectual property system and the drug regulatory system. These systems have different objectives, are administered separately and function independently. Recent efforts to integrate these two systems via data exclusivity, “linkage” or other means are likely to have negative implications for access to medicines. Thus, (developing) countries would be well advised to keep these systems separate, and to reject any and all efforts to make connections between them.” Briefing Note: Access to Medicines. March 2006. WHO Regional Office for South-East Asia

6. A Diminishing Policy Space for Assuring Access to Affordable Medicines in Poor Countries ‘TRIPS+’, via FTAs Anti-counterfeiting initiatives (a form of TRIPS+); with seizure of legal generic drugs in transit Imposition of ACTA rules in economic cooperation agreements Resistance from Japan, US and Switzerland to re-examination of ‘Paragraph 6’ provision in TRIPS

7. A Growing Sense of Anger and Frustration • India, Brazil file WTO dispute settlement on EU customs seizures • India, China raise concerns on ‘TRIPS+’ at WTO TRIPS Council (India/China strategic alignment on IP?) • India, China, Brazil, Venezuela, Bolivia, Ecuador, Bangladesh, Egypt, Iran, Pakistan, SEARO (11 countries), UNASUR (12 countries ) and AFRO (46 countries) raise diverse concerns on IPR, IMPACT at World Health Assembly (…79 countries!) The Evidence:

8. "Clearly, IMPACT is ... an instrument of IPR policy and market access by some of the largest economies of the world" and it is "one of the prongs of the multi-pronged TRIPS+ enforcement drive of some developed countries and originator pharmaceutical companies". Statement by India, World Health Assembly May 2010

9. “…wait a minute, you need to listen to us” David Chiriboga, Minister of Public Health, Ecuador World Health Assembly May 2010

10. The Way Forward ? Progressive breakdown in co-operation on international trade, in context of growing power and cohesion of countries of ‘the South’ ?Return to bilateral, mutually respectful, non-patronizing collaboration in legitimate multilateral rules-based trading system

12. Miscellaneous matters for discussion period:

14. 14 Source: Prescrire International, 10(52): 52-54, April 2001.

15. WTO TRIPS (1994), Doha Declaration (2001) We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all. In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose. WTO Doha Ministerial 2001 15

16. “Each member has the right to grant compulsory licenses and the freedom to determine the grounds upon which such licenses are granted.” Doha Declaration (2001) 16