EU welcomes permanent WTO solution on generic medicines

The EU welcomes the decision taken today in the World Trade Organisation to amend the WTO Agreement on Intellectual Property with a view to improving access to medicines for developing countries. The EU had called on WTO Members to adopt such measures as part of a development package for the Hong Kong Ministerial. This decision will allow poor countries without manufacturing capacities in the pharmaceutical sector to import generic medicines for humanitarian purposes. It will replace the temporary decision adopted by WTO on 30 August 2003 to this effect. This amendment will safeguard the balance of rights and obligations of the TRIPS Agreement. The EU took an active part, as honest broker, in the negotiations on the amendment.

EU Trade Commissioner Peter Mandelson said: "I am very glad that we have been able to reach agreement on this important question. It is a first contribution for a Hong Kong Ministerial development package. The EU has worked hard for this outcome and welcomes that others have moved to make this possible."

The EU is fully committed to implement at EU level the system set up by the decision. Last week, the European Parliament cleared the way for its full implementation by European Member States before the end of the year. The EU calls on other WTO members to implement the system as well.

Trade rules that answer the needs of the poorest

This decision shows that the WTO rules are flexible and that the WTO can adapt its rule book to answer humanitarian concerns. This decision is a positive signal before Hong Kong. It gives countries in need a permanent solution to the problem of crucial access to important medicines to treat pandemics. This is an important part of the development package the EU has proposed for adoption at Hong Kong.

This decision constitutes a key element in the fight against communicable diseases, especially in poor countries. Measures like this that make cheaper drugs available need to be combined with stable and functioning healthcare systems and better public awareness of disease risks through education.

A permanent solution for a pressing problem

At the launch of the Doha Development Agenda in Doha in November 2001, WTO members agreed to find a solution giving developing countries with no manufacturing capacity the possibility to import generic drugs from third countries. A temporary solution was found in August 2003. It has now been converted into a permanent solution.

This decision transposes the WTO temporary decision of 30 August 2003 into an amendment of the WTO Agreement on Trade-related Intellectual Property Rights (TRIPS Agreement).

The amendment of the TRIPS Agreement will allow countries to export generics to third countries with no manufacturing capacity in the pharmaceutical sector, by making effective use of compulsory licences. It includes safeguards against abuse and trade diversion and rules to ensure transparency.

WTO members will have until 1 December 2007 to ratify the amendment in accordance with their national laws.

The decision is the final piece of the jigsaw to make the Doha Declaration on the TRIPS Agreement and Public Health fully operational.

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• Speech by EU Commissioner Mandelson - Doha: Goals for Hong Kong (23/11/2005)
• EU Parliament backs moves to simplify exports of generic drugs to poorer countries  (12/7/2005)