EGA Press Release

Tuesday, 08 July 2003

EU Pharmaceutical Law Threatens Access to Medicines in Central and Eastern Europe

Access to affordable medical care in EU Accession Countries is being jeopardized by the European Commission’s insistence on pushing through — before accession — controversial EU legislation on pharmaceuticals, which will delay the availability of competitively priced generic medicines.

In a speech made at this week’s conference of the Pan-European Regulatory Forum on Pharmaceuticalsa, EGA Director General, Greg Perry, stated: “It must be recognized that Eastern Europe has a major health gap with the current EU-15. Real spending per capita on healthcare in these countries is less than €400 per annum compared to over €1,600 in the EU-15.”

Access to affordable generic medicines, which represent up to 70% of all medicines dispensed to patients at only 30% of the total budget spend on medicines, are absolutely critical to healthcare delivery in the region.b

Mr Perry criticized last month’s decision by the Council of Ministers to extend current periods of data exclusivity, which would create the longest period of regulatory delay for generics medicines in the world.

The proposals were strongly opposed by the incoming Member States and by many of the current EU Members States. But at the end of the day, their views were ignored.c

“The way in which Acceding Countries are being treated is shocking, especially since major concessions to big pharmaceutical interests have already been made by these countries in their accession treaties by retroactively introducing EU legislation on Supplementary Protection Certificates (SPCs) on pharmaceutical products. These new patent extensions are costing countries like Poland some €0.37 billion a year. The new law on data exclusivity will add to these costs and is being pushed through before accession and without the agreement of the very countries who are going to be most affected”, states Perry.

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a Ljubljana – 7-8 July 2003

b

c Political Agreement of the European Council of 3 June 2003, referring to the proposal for a European Parliament and Council directive amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.

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