The TRIPS Agreement and Public Health Roger Kampf WTO Secretariat

1. WIPO National Workshop onIntellectual Property for DiplomatsSana’a, Republic of Yemen20-21 March 2007 The TRIPS Agreement and Public Health Roger Kampf WTO Secretariat

2. I. Overview: Relevant TRIPS Provisions Transition Periods

3. TRIPS Provisions ofDirect Relevance to Public Health • TRIPS Objectives and Principles • Patents (incl. compulsory licences) • Exhaustion • Protection of Undisclosed Information • Competition • Measures against Counterfeiting • Transition periods

4. « Patent Table » Art.27.1: Patentable Subject-Matter ↓ ← Exclusions:Art.27.2 + 3 Art.29: Patent Application ↓ Art.28: Rights conferred ← Exceptions / Limitations: Art. 30 + 31 ↓ Art.33: 20 Years of Protection

5. Article 30: Exceptions • Exceptions may be provided if they • are limited • do not unreasonably conflict with normal exploitation of the patent and • do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties • Examples in national legislation: • Experimental use • Use to develop test data required to obtain marketing approval

6. Article 31: Compulsory Licences • Use of invention without authorization by right holder: • government use • use by third parties • not limited to specific purposes • must meet certain conditions, including: • prior efforts to obtain voluntary licence exception: public non-commercial use or national emergency • predominantly for supply of domestic market exception: adjudicated anti-competitive practices • adequate remuneration paid to patent owner ⇒ Doha Declaration / Para.6 System

7. Exhaustion of Rights • DS mechanism does not apply • Except for: national / MFN treatment obligations • Effects in pharmaceutical sector ⇒ Doha Declaration: freedom to establish regime which best fits domestic policy considerations

8. Article 39.3: Data Exclusivity • Members are obliged to protect test data against: • unfair commercial use when: • marketing approval for pharmaceuticals or agro-chemicals requires submission of undisclosed data; • new chemical entities are utilized; • origination of data involves considerable efforts; • information is not publicly available • disclosure, unless: • disclosure is necessary to protect the public • steps have been taken to protect the data against unfair commercial use

9. Transition Periods 1996 2000 2005 2013 2016 _________________________________ ↓ ↓ ↓ ↓ ↓ Industrialised DCs and DCs LDCs 1) LDCs Countries Economies products· pharma in Transition 1) not (patents & previously test data) patented ·EMRs waived • National treatment and MFN treatment obligations apply as of 1996

10. II. The Doha Declaration on the TRIPS Agreement and Public Health

11. The Declaration: General Statements • Recognition of the gravity of the public health problems...,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 recognize 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

12. Content of the Declaration • Guidance for disputes • Clarification compulsory licences: • right to grant • freedom to determine the grounds • Clarification of emergency situations: • right to determine what constitutes a national emergency of other circumstance of extreme urgency • Clarification of exhaustion: • freedom to establish own regime • Transfer of technology: • reaffirmation of Article 66.2 commitment

13. 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) • Extend LDC transition period as regards protection and enforcement of patent rights / undisclosed information in the field of pharmaceuticals: ⇒ TRIPS Council Decision extends LDC transition period until 1/1/2016 (IP/C/25) ⇒ General Council Decision waives obligations under Article 70.9 (WT/L/478)

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

15. What is the problem ? • Members can issue compulsory licences for importation / domestic production • Concerns: • availability of supply from generic producers in third countries • mandatory patent protection for pharma products as from 2005 in exporting countries with important generic industry • Problem: Art. 31(f) requires production under compulsory licenses “predominantly for the supply of the domestic market of the Member“

16. Solution: “Paragraph 6 System” (1) • August 2003 Decision is about addressing health problem in importing Member and legal problem in exporting Member • Decision consists of three waivers and calls for TRIPS amendment • General Council Chairman’s statement • Decision in effect since 30 August 2003, terminates when amendment replaces it for each Member

17. Three Distinct Waivers • Of 31(f) to exporting Members subject to conditions on transparency and safeguards: • scope and coverage: diseases and products • importing Members: • who is eligible • notification requirements • assessment of manufacturing capacities • notification requirements applying to exporting Members • safeguards against diversion • 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

18. WTO Member with manufacturing capacity TRIPS 1995 Art. 31(f): no export of predominant part of production Government / competent authority Patent ⇒ compulsory licence • PARA.6 SYSTEM • Art. 31(f) may be waived if: • - notifications are made • - special marking/labelling of • exported products • - other conditions are met Generic Manufacturer Difference BetweenTRIPS 1995 and Para.6 System WTO Member with insufficient manufacturing capacity for pharmaceuticals • Art. 31(h) may be waived to avoid double remuneration • special provisions for RTAs with 50% LDCs • other Art.31 conditions continue to apply

19. Other Elements • 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

20. Chairman’s Statement • Represents key shared understandings of Members: • Good faith use of the system • All reasonable measures to prevent diversion • Information on manufacturing capacities (“how”) • Expeditious review in TRIPS Council and good offices of DG or Chair of TRIPS Council • List of voluntary partial/full opt-out countries

21. IV. December 2005 Decision: Protocol Amending the TRIPS Agreement

22. GC Decision WT/L/641 of6 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 • Adopts Protocol amending the TRIPS Agreement and submits it to Members for acceptance • Protocol open for acceptance until 1/12/2007 • Takes effect upon acceptance by two thirds of membership →Note that Paragraph 6 System as established under August 2003 Decision continues to apply until entry into force of amendment in a Member

23. TRIPS Amendment • Waivers of August 2003 Decision are transformed into permanent TRIPS amendment → “technical exercise”, no changes in substance to Paragraph 6 System • Inserts in TRIPS Agreement: • new Article 31bis consisting of: • 3 waiver provisions of August 2003 Decision • non-application of non-violation complaints • preservation of TRIPS flexibilities • Annex setting out terms for using Paragraph 6 system • Appendix to Annex dealing with assessment of manufacturing capacities (former annex to August 2003 Decision)

24. Statements by ChairmanRecognition by MC • Chairman’s Statement: • re-read prior to adoption of GC Decision • updates list of full opt-out countries • Chairman’s Statement on non-violation complaints: amendment without prejudice to overall question of applicability of NVCs to TRIPS • Hong Kong MC in December 2005: Ministers welcome work on TRIPS amendment to implement August 2003 Decision

25. V. Final Remarks

26. Implementing Legislation in Exporting Members • Based on information shared in the TRIPS Council: • Norway, Canada, India, EC (in effect) • Korea • Switzerland (in process) • China also adopted implementing legislation in December 2005

27. Use of Paragraph 6 System • Possible reasons for absence of notifications so far: • generic medicines available outside patent system • legislative changes in exporting countries recent or not yet done • meant to address situation where non-predominant limit proves restrictive • voluntary licences and reduction of prices offered by patent owners • Remember: system not to be used if • local production • voluntary licences • no patents in exporting country • exporting country not a WTO Member

28. Concluding Remarks • TRIPS forms part of the solution next to other important factors: infrastructure, national health systems, procurement regimes, import tariffs, etc. • Increased recognition of TRIPS flexibilities → but: need for each country to take the necessary steps at national level to avail itself of such flexibilities • TRIPS beyond Doha: new rules ? What role for DSU and FTAs ?

29. Some References • Doha Declaration on TRIPS and Public Health (WT/MIN(01)/DEC/2) • Decision on the implementation of paragraph 6 of the Doha Declaration on TRIPS and Public Health (WT/L/540 and Corr.1) • Decision on an amendment to the TRIPS Agreement (Protocol) (WT/L/641) • Decision on extension of transition period for LDCs with respect to pharmaceutical products (IP/C/25) • Decision on general extension of transition period for LDCs (IP/C/40)