Overview of the Benefits of the Doha Agreement on TRIPS and Public Health.

Here is a quick tour of primary benefits of the Doha agreement on TRIPS and public health.

James Love love@cptech.org

Paragraph 4 is where the WTO agrees that the TRIPS can and should be interpreted and implemented in a manner supportive of public health, and "in particular, to promote access to medicines for all." This makes it clear that public health is the priority in terms of intepretation, and it even tells countries to implement the TRIPS in a way that protects public health. By singling out public health as a special issue for intellectual property, the WTO is making it clear that member countries can do the same.

4. We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.

In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose.

Paragraph 5 provides various "clarifications" of the agreement, which are completely consistent with the interpretations that public health groups have asked for. All four are important, but I would highlight (b) and (c):
5 (b) Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.
This makes it clear that Member countries can choose any grounds upon which to grant compulsory licenses, including of course such issues as high prices or the need to promote broader access to health care, but also to promote technology transfer to or achieve other social objectives.
5 (c) Each Member has the right to determine what constitutes a national emergency or other circumstances of extreme urgency, it being understood that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency or other circumstances of extreme urgency.
This paragraph clarifies Article 31.b language on national emergencies or circumstances of extreme urgency, which permit countries to waive TRIPS requires for prior negotiation with patent owners, prior to overriding a patent. What is significant here is that the WTO agrees that this is not only for "time is the essence" problems, but for situations that can exist for decades, an important clarification, in my opinion. Under 5(c), countries can adopt fast tract proceedures for the issuance of compulsory licenses, featuring automatic licensing of generic drugs, to address broad health care problems, and the Member Countries, not the WTO, will determine what constitutes an emergency or urgent circumstance.

For the press, PLEASE NOTE THAT THE TRIPS AND THE DOHA DECLARATION COVER MUCH MORE THAN COMPULSORY LICENSES WHEN THERE IS AN EMERGENCY. Indeed, the strategy of the US and some European countries was to narrow the declaration to things like emergencies or essential drugs, or to infectious diseases. And while there are some references to special cases involving some diseases or epidemics, these are not in any way limiting in terms of the overall declaration, and even here, within the special case of an emergency, the cases are illustrative, but not limiting. Countries, could, for example, adopt a much different definition of an emergency, such as a poor life expectancy or more generally conditions such as lack of access to medicines. I can't imagine even one country in Africa that could not use 5(c) to very broadly embrace automatic licensing of large categories of pharmaceuticals products and medical devices. But it is also not necessary for any country to even use 5(c), unless they want to eliminate the prior negotiation on voluntary licenses, for commerical applicants for a compulsory license. Indeed, for most countries, the provisions of 5(b) will probably be more important and useful, so long as they can develop fast tract methods of making 5(b) work, and take advantage of existing TRIPS language on government use.

Paragraph 6 was our biggest disappontment, but only because we set our sights so high, and it still represents a significant and imporant victory. The WTO recognizes the problems in 31.f of the TRIPS, and agrees to find a solution by next year. All of the NGOs pushed hard on this one, pushing for a broad acceptance of the use of Article 30 for the export of medicines, a proposal tabled by developing countries in a September 19 in TRIPS council non-paper, and again by Peru during the Doha meeting. I believe we will get this in the TRIPS council, but it will be discussed next year.

6. We recognize that WTO Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002.
Paragraph 7 gives LCD members until 2016 to implement TRIPS for pharmaceutical products, and at the insistence of the developing countries and with the agreement of the US, without prejudice to ask for further extensions. Among other things, this will provide a place where pharmaceuticals can be manufactured for export markets, until 2016, if the WTO does not solve the 31.f problem sooner.
7. We reaffirm the commitment of developed-country Members to provide incentives to their enterprises and institutions to promote and encourage technology transfer to least-developed country Members pursuant to Article 66.2. We also agree that the least-developed country 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 of the transition periods as provided for in Article 66.1 of the TRIPS Agreement. We instruct the Council for TRIPS to take the necessary action to give effect to this pursuant to Article 66.1 of the TRIPS Agreement.

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