Trips Agreement 31 Bis 2001, the World Trade Organization (WTO) opened negotiations on patent and access rules. While several issues were resolved and resolved in the Doha DECLARATION on TRIPS and Public Health of November 2001, it took almost two more years for the negotiations to be adopted on 30 August 2003, a decision that constituted a “limited export restriction waiver” for drugs and diagnostic tests manufactured under compulsory licence. The final resolution was complicated. Controversial features included the definition of an “eligible import member,” which allowed WTO members to declare themselves ineligible in some or all cases. In 2017, this decision became a formal amendment to the TRIPS agreement. Today, 37 WTO members are allowed not to import drugs into another country under compulsory license, including the governments of Australia, Canada, Iceland, Japan, New Zealand, Norway, Switzerland, the United Kingdom, the United States and the European Union, including the following Member States: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden. Conclusion of the Protocol The European Commission participated, on behalf of the European Community, in the negotiations on the protocol. In accordance with Article 133, paragraph 5 of the EC Treaty, the European Community has jurisdiction to conclude agreements in the area of commercial aspects of intellectual property. The protocol should therefore be adopted on behalf of the European Community. Following the adoption of the European Parliament and Council regulations on the granting of compulsory licences for the manufacture of medicines for export to countries with public health problems, the Community will be solely responsible for this. Member States should therefore not accept the protocol. The President of the Council is authorized to appoint the person entitled to file the instrument for accepting the protocol with the Director-General of the WTO. In its instrument of acceptance, the European Community also confirms, in accordance with Article 300, paragraph 7, of the EC Treaty, that the protocol will be binding on its Member States.

For these reasons, the Commission proposes to the Council to adopt the attached decision. | 3. In order to exploit economies of scale, to increase purchasing power and local production of medicines: when a WTO member from a developing or least developed country is a party to a regional trade agreement within the meaning of Article XXIV of the 1994 GATT and the decision 28 November 1979 on the representativeness and increased participation of developing countries (L/4903), during which at least half of the current members are the commitment of that member under Article 31, (f) composed of countries currently on the United Nations list of least developed countries, does not apply to the extent necessary for a drug produced or imported into that Member State under compulsory licence on the markets of other contracting parties to the regional trade agreement that share the health problem to which the markets of the other contracting parties of the developing country or the developing countries less advanced can be exported.