Regulation 2003/953 - Council Regulation 953/2003 to avoid trade diversion into the EU of certain key medicines - Main contents

EN

Official Journal of the European Union

L 135/5

On 21 February 2001, the Commission adopted a communication to the European Parliament and to the Council on accelerated action targeted at major communicable diseases within the context of poverty reduction, according to which the Commission was instructed, inter alia, to establish a global tiered pricing system for key pharmaceuticals for the prevention, diagnosis and treatment of HIV/AIDS, TB and malaria and related diseases for the poorest developing countries and to prevent product diversion of these products to other markets by ensuring that effective safeguards were in place.

In a resolution dated 14 May 2001 on accelerated action on HIV, TB and malaria, the Council underlined the need to reinforce safeguards against diversion of low priced pharmaceuticals destined for poor markets and prevent price erosion in developed countries markets.

On 15 March 2001, a resolution of the European Parliament on access to drugs for HIV/AIDS victims in developing countries noted the inclusion of a commitment to tiered pricing in the Commission's programme for action and called for a system allowing developing countries equitable access to medicines and vaccines at affordable prices.

Many of the poorest developing countries are in urgent need of access to affordable essential medicines for treatment of communicable diseases. These countries are heavily dependant on imports of medicines as local manufacturing is scarce.

Price segmentation between developed country markets and the poorest developing country markets is necessary to ensure that the poorest developing countries are supplied with essential pharmaceutical products at heavily reduced prices. Therefore, these heavily reduced prices cannot be understood as a reference for the price to be paid for the same products in developed country markets.

Legislative and regulatory instruments are in place in most developed countries to prevent importation, in certain circumstances, of pharmaceutical products, but these instruments risk becoming insufficient where substantial volumes of heavily discounted pharmaceuticals are sold to the poorest developing country markets and the economic interest in trade diversion into high priced markets therefore may increase significantly.

There is a need to encourage the pharmaceutical producers to make pharmaceutical products available at heavily reduced prices in significantly increased volumes by ensuring through this Regulation that these products remain on those markets. Donations of pharmaceutical products and products sold under contracts awarded in response to competitive tenders from national governments or international procurement bodies, or under a partnership agreed between the manufacturer and the government of a country of destination may qualify under this Regulation on equal conditions, bearing in mind that donations are not contributing to the improvement of access to these products on a sustainable basis.

For the purpose of this Regulation, it is necessary to establish a procedure which identifies the products, countries and diseases covered by this Regulation.

This Regulation serves the purpose of preventing tiered priced products from being imported into the Community. Exemptions are laid down for certain situations under the strict provision that it is...