EGA Press Release
Monday, 9 December 2002
Generic medicines producers back measures to help stimulate access to medicines in least developed countries
The European Generic medicine Association (EGA) has given its support to a series of measures and approaches for increasing the provision and development of affordable priced medicines to least developed countries.
The EGA supports five key measures that it believes should help stimulate both research based and generic companies to be more actively engaged in improving access to medicines.
- Adoption of the European Commission’s recent Proposal for a Regulation to encourage provision of specially discounted medicines to least developed countries by providing a system to prevent re-importation by traders of such medicines into the EU(1). Recent evidence of the re-importanction of specially priced patented medicines into the EU, which were for specific use in least developing countries, is evidence that such measures are urgently required.
- Adoption of the European Parliament’s Amendment 196 to the Commission’s proposed Directive on Medicinal Products for Human Use(2), which would allow the manufacture for export of generic versions of patented medicines in response to a compulsory license or healthcare needs of third countries. This provision would help overcome shortages of essential patent medicines in these countries particularly where there is no local production.
- Adoption of an interpretation of Article 30 of the TRIPs Agreement (“general exemption Article”), which would encourage and enable the quick adoption at national level of measures such as those proposed in Amendment 196. According to EGA Director General, Greg Perry “An interpretation of the 'general exemption Article' is the only practical way forward as it would eliminate the need to both amend TRIPs and to the create a complicated system of export licenses as would be envisaged under an amendment to Article 31 (compulsory license Article). The EGA regrets that at present the EU appears to prefer amending Article 31.”
- Widespread provision by EU Member States of tax relief and research grants for pharmaceutical companies involved in R&D for HIV/AIDS, TB, Malaria and other tropical diseases. This is one of the most obvious and important instruments that can be given by EU Member States and can be introduced very quickly.
- Extending the current EU Orphan Drug Regulation to cover tropical diseases, so as to provide rapid and low cost assessment of newly developed products or existing products with new use especially for disease in least developed countries. The recent statement by the UK Secretary of State for International Development supporting such a measure is highly welcomed. Hopefully the UK’s statement could encourage such proposal to be brought forward by the European Commission in 2003.
(1) Commission proposal (of 30 October 2002) for a Council Regulation to avoid trade diversion into the European Union of certain key medicines.
(2) European Parliament legislative resolution on the proposal for a European Parliament and Council directive amending Directive 2001/83/amendment to Community codes relating to medicinal products for human use.
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