Resolución Legislativa del Parlamento Europeo relativa al otorgamiento de licencias obligatorias de Patentes de Productos Farmacéuticos destinados a la Exportación a Países con Problemas de Salud Pública

Anuario Andino de Derechos Intelectuales.
Año III - N.º 4. Lima, 2008
The European Parliament and the Council
of the European Union
Having regard to the Treaty establishing the European Community, and in particu-
lar Articles 95 and 133 thereof, Having regard to the proposal from the Commission, Ha-
ving regard to the Opinion of the European Economic and Social Committee1, Ac-
ting in accordance with the procedure laid down in Article 251 of the Treaty2, Whereas:
(1) On 14 November 2001 the Fourth Ministerial Conference of the World Trade Or-
ganisation (WTO) adopted the Doha Declaration on the Agreement on TradeRelated As-
pects of Intellectual Property Rights (TRIPS Agreement) and Public Health. The Declara-
tion recognises that each WTO Member has the right to grant compulsory licences and the
freedom to determine the grounds upon which such licences are granted. It also recognises
that WTO Members with insuf cient or no manufacturing capacity in the pharmaceutical
sector could face dif culties in making effective use of compulsory licensing.
(2) On 30 August 2003 the WTO General Council, in the light of the statement read out
by its Chairman, adopted the Decision on the implementation of paragraph 6 of the Do-
ha Declaration on the TRIPS Agreement and Public Health (“the Decision”). Sub-
ject to certain conditions, the Decision waives certain obligations concerning the issue
of compulsory licences set out in the TRIPS Agreement in order to address the needs of
WTO Members with insuf cient manufacturing capacity.
(3) Given the Community’s active role in the adoption of the Decision, its com-
mitment made to the WTO to fully contribute to the implementation of the Deci-
sion and its appeal to all WTO Members to ensure that the conditions are put in pla-
ce which will allow the system set up by the Decision to operate ef ciently, it is impor-
tant for the Community to implement the Decision in its legal order.
(4) Uniform implementation of the Decision is needed to ensure that the conditio-
ns for the granting of compulsory licences for the manufacture and sale of pharmaceutical
products, when such products are intended for export, are the same in all Member Sta-
tes and to avoid distortion of competition for operators in the single market. Uniform rules
1 OJ C 286, 17.11.2005, p. 4.
2 Opinion of the European Parliament of 1.12.2005 (not yet published in the Of cial Journal), and Coun-
cil Decision of… (not yet published in the Of cal Journal).

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