1. The Doha Declaration and the Protocol amending the TRIPS Agreement Islamabad, 28 November 2007 Octavio Espinosa WIPO

2. The Doha Declaration on TRIPS and Public Health (1/3) The Declaration on the TRIPS Agreement and Public Health was adopted on 14 November 2001 during the Ministerial Conference at Doha (Qatar) Main considerations of the Declaration: –the gravity of the public health problems afflicting many developing and least-developed countries –the need for the TRIPS Agreement to be part of the national and international action to address those problems –intellectual property protection is important for the development of new medicines but has effects on their prices –the TRIPS Agreement should not prevent Members from taking measures to protect public health: the Agreement should be interpreted and implemented to support WTO Members' right to protect public health and to promote access to medicines for all

3. WIPO The Doha Declaration on TRIPS and Public Health (2/3) The Declaration reaffirms the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose Each provision of the TRIPS Agreement should be read in the light of the object and purpose of the Agreement as expressed in its objectives and principles Flexibilities confirmed to exist already in TRIPS in relation to public health include: –the right to grant compulsory licences and the freedom to determine the grounds for such licences –the right to determine what constitutes a national emergency or other circumstances of extreme urgency –freedom to establish own regime as regards the rule of “exhaustion” of intellectual property rights

4. WIPO The Doha Declaration on TRIPS and Public Health (3/3) Paragraph 6 of the Doha Declaration - mandate: –the Council for TRIPS was instructed to find an expeditious solution to the problem that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector can face difficulties in making effective use of compulsory licensing Paragraph 7 of the Doha Declaration – extension for LDCs: –extension until 1 January 2016 of transition period for least-developed countries to implement or apply, with respect to pharmaceutical products, TRIPS provisions on patents and on undisclosed information (test data), and to enforce rights under those provisions

5. WIPO Implementation of paragraph 6 of the Doha Declaration on TRIPS and Public Health Decision of WTO General Council of 30 August 2003: –Set up an interim system for compulsory licensing and exportation of patented pharmaceutical products (or products of a patented pharmaceutical process) –Beneficiaries of system - “eligible importing Members”: any least-developed country any country that has established that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product in question –Established waivers from the obligations set out in paragraphs (f) and (h) of Article 31 of the TRIPS Agreement with respect to pharmaceutical products. These waivers apply until the amendment of TRIPS comes into force

6. WIPO Protocol amending the TRIPS Agreement (1/5) Decision of WTO General Council of 6 December 2005: –Adopts a Protocol amending the TRIPS Agreement –The Protocol introduces a new Article 31bis in the TRIPS Agreement and an Annex to the Agreement: they reproduce in substance the system established by the WTO General Council Decision of 30 August 2003 –The Protocol is open for acceptance until 31 December 2009 (as per extension in November 2007) or such later date as may be decided by the Ministerial Conference –The Protocol will take effect upon acceptance by two thirds of the WTO Members (Article X paragraph 3 of the WTO Agreement). To date 11 countries have notified their acceptance

7. WIPO Protocol amending the TRIPS Agreement (2/5) System under Article 31bis and Annex of TRIPS: –Article 31(f) of TRIPS (requirement that a compulsory licenses must be authorized predominantly to supply the domestic market) does not apply with respect to the grant of a compulsory licence for the purposes of producing a pharmaceutical product and exporting it to an eligible importing country –Article 31(f) of TRIPS does not apply for the purposes of allowing a pharmaceutical product produced or imported into a country under a compulsory license to be exported to other eligible countries in the same regional trade agreement –Article 31(h) of TRIPS (requirement to pay adequate remuneration for a compulsory license) does not apply in respect of products for which remuneration is already paid in the exporting country

8. WIPO Protocol amending the TRIPS Agreement (3/5) Procedure under Article 31bis and Annex of TRIPS: –Eligible importing country must notify to the Council for TRIPS: the names and expected quantities of the product needed that it has insufficient or no manufacturing capacities in the pharmaceutical sector for the product in question (except LDCs) that, where the product is patented in its territory, it has granted or intends to grant a compulsory licence to import the product –The importing country must take reasonable measures within its means, proportionate to its administrative capacities and to the risk of trade diversion, to prevent re-exportation of the products imported under the system

9. WIPO Protocol amending the TRIPS Agreement (4/5) Procedure under Article 31bis + Annex of TRIPS: If the product is patented in the exporting country, a compulsory licence may be issued in the exporting country under the following conditions: –only the amount necessary to meet the needs of the importing country may be manufactured and the entirety of this production must be exported to that country –the products produced under the licence must be clearly identified through specific labelling or marking, packaging, colouring or shaping of the products, provided this is feasible and does not have a significant impact on price; and –before shipment begins, the compulsory licensee must post on a website the relevant information The exporting country must notify the Council for TRIPS of the grant of the licence, including the conditions attached to it and contact details of compulsory licensee

10. WIPO Protocol amending the TRIPS Agreement (5/5) Procedure under Article 31bis + Annex of TRIPS: –All WTO Members must ensure effective legal means to prevent the importation into, and sale in, their territories of products produced under the system and diverted to their markets. If a Member considers that such measures are insufficient, the matter may be reviewed by Council for TRIPS upon request of that Member Cooperation by developed countries: technical cooperation to promote regional patent systems for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products technical and financial cooperation in order to facilitate implementation of the system by developing countries or LDCs that encounter difficulty

11. WIPO Concluding remarks www.wipo.int octavio.espinosa@wipo.int