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Wolf R. MEIER-EWERT World Trade Organization

Workshop on the TRIPS Agreement Ankara, Turkey 17-18 January 2007 - Decision on Para. 6 of the Doha Declaration on TRIPS and Public Health -. Wolf R. MEIER-EWERT World Trade Organization. Paragraph 6 of the Doha Declaration.

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Wolf R. MEIER-EWERT World Trade Organization

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  1. Workshop on the TRIPS Agreement Ankara, Turkey 17-18 January 2007- Decision on Para. 6 of the Doha Declaration on TRIPS and Public Health - Wolf R. MEIER-EWERT World Trade Organization

  2. Paragraph 6 of the Doha Declaration • Recognizes that Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under TRIPS • Instructs the TRIPS Council to find an expeditious solution and report to the General Council before the end of 2002 • Problem ? • Members can issue compulsory licences for importation / domestic production • But: Art. 31(f) requires production "predominantly for the supply of the domestic market of the Member“

  3. WTO Member with manufacturing capacity Art. 31(f): no export of predominant part of production Government / competent authority compulsory licence • Art. 31(f) may be waived if: • - notifications are made • - special marking/labelling of • exported products • - other conditions are met Generic Manufacturer TRIPS and Public Health: The para.6 System WTO Member with insufficient manufacturing capacity for pharmaceuticals • Art. 31(h) may be waived to avoid double remuneration • other Art.31 conditions continue to apply • Special provisions for Regional Trade Agreements with 50% LDCs

  4. Solution: “Paragraph 6 System” • August 2003 Decision is about addressing health problem in importing Member and legal problem in exporting 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

  5. 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

  6. 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?

  7. Notification Requirements Importing Members • First use: notification of intention to use system, can be made at any time (except LDCs) • Each use: notification that • specifies names and expected quantities of products needed • confirms establishment of insufficient or no manufacturing capacities for the products specified (LDCs exempted) • confirms grant or intention to grant a compulsory licence if product is patented in that country

  8. Assessment ofManufacturing Capacities • LDCs deemed to have insufficient or no manufacturing capacities • All other eligible importing Members must confirm absence of sufficient manufacturing capacities • GC Chairman’s Statement: notification to include information on how this was established

  9. Notification RequirementsExporting Member • Grant of CL and conditions attached to it • only amount necessary to meet needs of importing country • export of entire production (waiver Article 31(f)) • clear identification of products through specific labelling or markingand special packaging and/or special colouring/shaping of products themselves • Details of licence • name and address of licensee • products covered • quantity • importing countries • duration of licence • Licensee shall post on website: • quantities being supplied to each destination • distinguishing features of products

  10. Safeguards Against Diversion • Importing Members shall take reasonable measures to prevent re-exportation • within their means • proportionate to their administrative capacities • proportionate to the risk of trade diversion • Members shall ensure effective legal means to prevent diversion using TRIPS-required means

  11. Regional Trade Agreements • Objective: economies of scale, enhance purchasing power, help local production • Waiver of Art. 31(f) if: • at least half of the RTA members are LDCs • necessary to enable a pharmaceutical product produced or imported under a CL in a member to be exported to the markets of other members • Members concerned share the health problem in question • Promotion of regional patent systems

  12. 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

  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. Product not patented Product patented Compulsory licence in compliance with Art 31 TRIPS Agreement with originator Pharmaceutical product cannot be manufactured domestically Pharmaceutical product can be manufactured domestically Product patented in exporting Member Product not patented in exporting Member Supply by non-WTO Member Need to use para. 6 System if exported amount is predominant share of production Recap: Use of the Para. 6 System Public Health Problem in WTO Member requiring pharmaceutical product

  15. Recap: Timeline for using Para. 6 System

  16. II. December 2005 Decision: Protocol Amending the TRIPS Agreement

  17. 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

  18. 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)

  19. 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

  20. III. Final Remarks

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

  22. 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

  23. Observations • Need for each country to take the necessary steps at national level to avail itself of TRIPS flexibilities • TRIPS forms part of the solution next to other important factors: infrastructure, national health systems, regulatory environmnet, procurement regimes, import tariffs, etc.

  24. www.wto.org For more information: wolf.meier-ewert@wto.org Tel.: +41 22 739 63 44

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