Access to essential medicines

Infectious diseases are responsible for almost half of all deaths in developing countries, and half of these diseases are caused by HIV (AIDS), tuberculosis and malaria. More than 2 billion inhabitants of the world do not have regular access to adequate treatment and cure. AIDS, tuberculosis and malaria alone kill 5 million people each year mostly in developing countries.

In February 2001 the Commission adopted the Programme for Action: Accelerated action on HIV/AIDS, malaria and tuberculosis in the context of poverty reduction, which is based on a comprehensive approach on the three major communicable diseases. This was adopted by the Council by resolutions and the European Parliament endorsed it. The Programme for Action focuses on:

• Maximising the 'impact' of measures to strengthen health care systems on a national basis,
• Increasing 'affordability' i.e. seeking to lower the prices of essential medicines.
• Identifying ways and means of promoting 'research' into new pharmaceuticals and vaccines to fight these diseases.

The Programme was recently updated by a Commission Communication COM (2003) 93 and COM (2004) 726.

External Trade's objective is to improve the affordability of medicines. In doing so, we aim to ensure that the least developed countries and the low income countries benefit from the lowest possible prices on medicines as a rule. This includes a sustainable framework for tiered priced products and assurances that these products do remain in the markets for which they are intended.

A Council Regulation to prevent import of tiered priced medicines into the EU has been adopted on 26 May 2003. This regulation offers manufacturers and exporters of strongly discounted medicines (tiered priced products) reinforced prevention at border level against imports into the EU market where higher prices prevail. The scope of diseases and scope of countries largely correspond to the Programme for Action. The first Annual Report (SEC(2005) 896) under this Regulation was transmitted to the Council and to the European Parliament on 23 June 2005.

Tariff and tax reductions in importing countries are another objective of the Commission, to be further examined at multilateral level. While EU and other developed country markets apply 0 tariffs on imports of pharmaceuticals from other developed WTO Members, developing countries should be encouraged to eliminate tariffs and other duties to lower consumer prices on pharmaceuticals on their markets.

Improved access to medicines is a topic also discussed by WTO Members in relation to the TRIPs Agreement (Agreement on trade-related aspects of intellectual property rights). EU is very active in this debate. At the Ministerial Meeting in Doha 2001, Members adopted a Declaration on the TRIPs Agreement and Public Health which clarifies the flexibility available to WTO Members when applying national health policies. On the 30th August 2003, the WTO General council adopted a decision ("temporary waiver") to authorize, through compulsory licenses, the production and export of generic medicines to developing countries which lack production facilities of pharmaceuticals. Compulsory licences allow the production of generic medicines without the consent of the patent holder.

On 6 December 2005, after more than two years of discussion about how to transpose the waiver Decision of 30 August 2003 into the TRIPs Agreement, the WTO General Council agreed to amend the TRIPs Agreement. The amendment takes the form of a new Article 29bis and an annex to be incorporated into the TRIPS Agreement. The new rules will allow the grant of compulsory licences for the purposes of manufacturing of pharmaceutical products for export to countries facing public health problems. The amendment takes effect for the WTO Members that have accepted it when two thirds of the WTO Members accepted the amendment and thereafter for each other Member upon acceptance by it. WTO Members have set themselves until 1 December 2007 to do this. The waiver Decision remains in force for each Member until the amendment becomes effective for that Member. On 27 April 2006, the European Commission presented a proposal for a Council Decision accepting, on behalf of the EC, the amendment of the TRIPS Agreement.

On 17 May 2006 the European Parliament and the Council adopted Regulation No 816/2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems. With this Regulation the EC has created a legal basis for the granting of compulsory licences for export purposes, as foreseen by the WTO General Council Decisions of 30 August 2003 and 6 December 2005. The Regulation aims to faithfully and completely implement the WTO General Council Decisions at EU level without any restrictions or unnecessary burden.