WIPO NATIONAL SEMINARON INTELLECTUAL PROPERTY RIGHTS AND THE PROTECTION OF PHARMACEUTICAL PRODUCTSDamascus, April 25 and 26, 2005 Current issues on Intellectual Property Protection and Access to Medicines WIPO Secretariat
Current issues The problem: TRIPS Article 31: “Where the law of a Member allows for other use of the subject matter of a patent without the authorization of the right holder, including use by the government or third parties authorized by the government, the following provisions shall be respected: […] (f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use;”
Current issues The problem (cont.): 1. WTO Member A is in need of a certain medicine which is not available on the international market (or which is, but at unaffordable prices) 2. But in A there is no company with technical knowledge and/or manufacturing capacity to manufacture that medicine; therefore there is no purpose for the government of A to issue a a c.l. for the local manufacture of the medicine in need 3. Besides, and because of Article 31(f), A cannot ask another WTO Member that it grants a c.l. with the exclusive or predominant purpose of exporting that medicine to its territories
Current issues The mandate: Doha Declaration on the TRIPS Agreement and Public Health (November, 2001): “1. We recognize the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from HIV/AIDS, tuberculosis, malaria and other epidemics. […] “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.”
Current issues Solution: Decision of the General Council of August 30, 2003: a) Under certain conditions and circumstances WTO Members may grant c.l. of patents for medicines (or for processes for making medicines) with the exclusive or predominant purpose of exporting to other WTO Members with no manufacturing capacity b) The remuneration of c.l. will take into consideration its economic value in the importing country. The remuneration is not supposed to be paid twice. c) The Decision is indefinitely valid until the TRIPS Agreement is amended.
Current issues Prospects: In December 2004 (with a Rev. in March 2005) Nigeria, on behalf of the African Group of countries, submitted a proposal aimed at amending the TRIPS Agreement (the proposal consists of adding a second paragraph to Article 31, which would transpose a summarized version of the General Council’s Decision into the Agreement; the proposal eliminates some of the transparency measures contained in the Decision). The US opposed. Any amendment must reflect the Decision fully as well as the Chairman’s statement (probably a footnote would be more adequate) There are divergences as to the nature of the amendment to the TRIPS Agreement (should it be limited by the scope of the decision? Should it incorporate the Chair’s statement? Could the Decision be modified?) The second deadline for the amednment (end of March 2005 has been missed)
Current issues Thank you.Nuno Pires de CarvalhoActing Director-Advisor Industrial Property Legislation for Development If you have any questions regarding this presentation do not hesitate to contact me at email@example.com