WIPO National Workshop on Intellectual Property for Diplomats

WIPO National Workshop on Intellectual Property for Diplomats Sana’a, Republic of Yemen 20 -21 March 2007 The TRIPS Agreement and Public Health Roger Kampf WTO Secretariat 1

I. Overview: Relevant TRIPS Provisions Transition Periods 2

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

» 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 4

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 5

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 6

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 7

Article 39. 3: Data Exclusivity • Members are obliged to protect test data against: – unfair commercial use when: • marketing approval for pharmaceuticals or agrochemicals 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 8

Transition Periods 2016 2013 2005 20001996 ___�_______�______ __�__ ↓ ↓ ↓ Industrialised Countries 1) DCs and DCs Economies products in Transition 1) not previously patented LDCs 1) LDCs · pharma (patents & test data) · EMRs waived National treatment and MFN treatment obligations apply as of 1996 9

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

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 11

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 12

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) 13

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

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“ 15

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 16

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 17

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

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 19

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 20

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

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 • 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 22

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 31 bis 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) 23

Statements by Chairman Recognition 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 24

V. Final Remarks 25

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 26

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 nonpredominant 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 not a WTO Member 27

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 ? 28

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) 29