The Commission has today placed 7 anti-retrovirals in the list of medicines placed under EU protection against trade diversion. The move is intended to enable pharma producers to significantly increase supplies of medicines at lower, so-called 'tiered' prices, to 76 developing countries, while keeping higher prices for the same items in the EU. The application was filed by GlaxoSmithKline (GSK) in February 2004. The products on the list will bear a logo allowing customs to easily identify them. Being on this list and bearing the logo will mean that imports of these products into the EU for free circulation, re-exportation, warehousing or trans-shipment will be prohibited.
EU Trade Commissioner Pascal Lamy said: “The anti-diversion mechanism the EU put in place last year is essential to ensure that manufacturers of HIV anti-retrovirals, such as GSK, actively engage in providing cheap medicines to poor countries severely affected by the AIDS pandemic. I have little doubt that other producers will soon follow this example.”
The products for which GSK have filed an application and which will be inserted into Annex 1 of the regulation are the following: TRIZIVIR 750mg x 60, EPIVIR 150 mg x 60, RETROVIR 250 mg x 40, RETROVIR 300 mg x 60, RETROVIR 100 mg x 100, COMBIVIR 300/150 mg x 60, EPIVIR ORAL SOLUTION 10 mg/ml 240ml.
GSK will be supplying these medicines at no more than 25% of the current prices in Europe.
In order to inform the public as well as customs offices, the Commission has created an internet website where all relevant information is accessible, including the list of medicines that are protected under the regulation. On this website, interested companies can also find information on how to file applications.
Council Regulation (EC) No 953/2003 of 26 May 2003 to avoid trade diversion into the European Union of certain key medicines is intended to enable producers to significantly increase supplies of medicines at lower prices, to countries of destination as specified in the Regulation, while keeping higher prices for the same items in the EU. Exporters are invited to put their products on a list run by the European Commission which constitutes the basis for subsequent enforcement by customs authorities. Both patented and generic products can be registered. In order to be added to the list, medicines have to be made available either with a price cut of 75% off the average 'ex factory ' price in OECD countries, or at the cost of production plus 15%.
There are 76 countries concerned, including the least developed countries, the countries with the lowest per-capita income, and those countries where HIV/AIDS is particularly prevalent. Most of these countries dispose of no local production facilities of their own.