1. 1 CUTS International Capacity Building Training Programme on Advance IPR, WTO-Related Issues and Patent Writing April 28-May 02, 2008, Jaipur Session 10 The TRIPS Agreement and Public Health May 02, 2008 B. K. Zutshi

2. 2 OUTLINE OF PRESENTATION The Doha Declaration on the TRIPS Agreement and Public Health August 2003 Decision and December 2005 amendment - Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health

3. 3 The Doha Declaration: General Statements Recognition of the gravity of the public health problems afflicting developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics Recognition that intellectual property protection is important for the development of new medicines and that there are concerns about its effects on prices Agreement that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Reaffirmation that TRIPS can and should be interpreted and implemented in a manner supportive of Members’ right to protect public health and, in particular, to promote access to medicines for all

4. 4 Content of the Doha Declaration Guidance for interpretation –Reference to objectives and principles Clarification on compulsory licences: –right to grant –freedom to determine the grounds Clarification of emergency situations: –right to determine what constitutes a national emergency and of other circumstance of extreme urgency Clarification of exhaustion: –freedom to establish own regime

5. 5 Content of the Doha Declaration –special provisions for LDCs Transfer of technology: –reaffirmation of Article 66.2 commitment Extension of transition period for LDCs until 1 January 2016 with respect to pharmaceutical products –Need not implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement nor enforce rights provided for under these Sections, without prejudice to the right to seek further extensions of the transition periods as under Article 66.1

6. 6 Instructions for Further Work / Implementation Find expeditious solution to difficulties of Members with insufficient / no manufacturing capacities in pharmaceutical sector in making effective use of compulsory licensing: –General Council Decision of August 2003 (WT/L/540); Chairman’s Statement (WT/GC/M/82, para.29) –General Council Decision of 6 December 2005 (WT/L/641) - Protocol Amending the TRIPS Agreement; Chairman’s Statement (WT/GC/M/100)

7. 7 Extension of transition period for pharmaceutical products IP/C/25 –Decision of 27 June 2002 –LDC Members will not be obliged, with respect to pharmaceutical products, to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement or to enforce rights provided for under these Sections until 1 January 2016 without prejudice to the right of least-developed country Members to seek other extensions WT/L/478 – Decision of 8 July 2002 –The obligations of LDC Members under Article 70.9 of the TRIPS Agreement shall be waived with respect to pharmaceutical products until 1 January 2016. Annual review of waiver

8. 8 August 2003 Decision: Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health

9. 9 August 2003 Solution: “Paragraph 6 System” Decision is about addressing health problem in importing Member and legal problem in exporting Member –Art. 31(f) requires production "predominantly for the supply of the domestic market of the Member“ 3 distinct waivers granted –Of 31(f) to exporting Members subject to conditions on transparency and safeguards –Of 31(h) to importing Members provided paid in exporting Member on same products –Of 31(f) to any LDC or developing country part of RTA where at least half LDCs General Council Chairman’s statement Decision in effect since 30 August 2003, terminates when amendment replaces it for each Member

10. 10 Scope and Coverage: Diseases and Products Definition of "pharmaceutical product": –Any patented product (or product of patented process) of pharmaceutical sector –Needed to address the public health problems as recognized in para 1 of Doha Declaration, including Active ingredients needed for manufacture Diagnostic kits needed for using these products

11. 11 Eligible Importing Members LDC Members automatically eligible Any other Member eligible, subject to mandatory notifications But: 44 Members have voluntarily opted out partially or fully Non-WTO countries?

12. 12 Other Elements of the Decision Notification Requirements of Importing Members Notification Requirements of Exporting Member Assessment of manufacturing Capacities Safeguards Against Diversion Regional Trade Agreements Facilitation of transfer of technology Annual review substitutes review of waiver by the General Council Preservation of existing flexibilities: –including under Article 31(f) –non-violation complaints not available

13. 13 Chairman’s Statement Good faith use of the system All reasonable measures to prevent diversion Information on manufacturing capacities Expeditious review in TRIPS Council and good offices of DG or Chair of TRIPS Council List of voluntary partial/full opt-out countries

14. 14 December 2005 Decision: Protocol Amending the TRIPS Agreement

15. 15 GC Decision WT/L/641 of 6 December 2005 Basis: para.11 of August 2003 Decision which instructed TRIPS Council to initiate work on amendment by end 2003 with a view to its adoption within 6 months GC adopted a Protocol amending the TRIPS Agreement and submitted it to Members for acceptance Protocol open for acceptance until 1/12/2007 Takes effect upon acceptance by two thirds of membership –Date could be extended if necessary Note that Paragraph 6 System as established under August 2003 Decision continues to apply until entry into force of amendment in a Member

16. 16 Acceptance of the Protocol Status of acceptances: – The latest acceptances are 14 in total, counting EU (27) as one member;India, US among those who have accepted How to accept the Protocol: –depends on domestic constitutional requirements ⇒ no single template –notifications to WTO: need to refer to Protocol and clearly state that it is accepted signature by Minister of Foreign Affairs / External Relations or by ambassador with powers to sign Distinction between Protocol acceptance and implementation of Paragraph 6 System