Trips Agreement Article 31 Bis

In this sense, due to the lack or absence of drug production capacity in the least developed countries, this provision would create a “catch 22” situation for those countries, given that they were allowed to grant compulsory licenses for public health reasons, but could not use them due to a lack of production capacity. Following the Doha Declaration and a subsequent Council decision, a permanent amendment to the TRIPS Agreement was approved, creating the new Article 31a. This Article partly waives Article 31(f) for least developed countries, which allows them, for reasons of public health, to issue compulsory licences by importing drugs from other countries. The article also contains an open definition of “pharmaceutical products” and certain formalities that should be followed by importing and exporting countries in order to prevent fraud. Subject matter of this proposal This proposal for a Council Decision aims to adopt, on behalf of the European Community, the Protocol amending the Agreement on Trade-Related Aspects of Intellectual Property Rights (`the TRIPS Agreement`) concluded in Geneva on 6 December 2005. On 6 December 2005, the General Council of the World Trade Organisation (hereinafter referred to as `the WTO`) submitted to WTO Members a proposal to amend the TRIPS Agreement for adoption. This amendment would make permanent a decision to exempt compulsory licences, originally adopted in 2003. Once adopted and entered into force, this amendment will conclude a process that began with the Declaration on TRIPS and Public Health made by Ministers at the Doha Ministerial Conference in November 2001. This is the first time that a basic WTO agreement has been amended. Doha Declaration on TRIPS and Public Health On 14 November 2001, the fourth meeting of the WTO Ministerial Conference in Doha adopted the Declaration on TRIPS and Public Health. The Doha Declaration clarifies the link between the TRIPS Agreement and the health policy of WTO members and confirms the right of members to issue compulsory licenses for patents on public health grounds. With regard to WTO members without production capacity in the pharmaceutical sector that have not been able to import the necessary medicines, paragraph 6 of the Doha Declaration ordered the Council to find a rapid solution to this problem. Waiver Decision of 30 August 2003 On 30 August 2003, the WTO General Council adopted the Decision on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and public health.

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