EGA Press Release

Tuesday, 21 April 2005

EP REPORT ON PAEDIATRIC MEDICINES
FAILS TO MEET COST CONCERNS

The Rapporteur has missed an excellent opportunity to turn the Commission's proposal into a win-win situation for healthcare systems, taxpayers and — more importantly — for children.

The EGA has studied Mrs Grossetête’s draft Report on the Commission’s proposal for paediatric medicines with interest. It notes with disappointment that the Rapporteur has missed an excellent opportunity to turn this proposal into a win-win situation for healthcare systems, taxpayers and — more importantly — for children.

The Rapporteur has introduced amendments that reduce the obligations and requirements for developing paediatric uses of in-patent products. At the same time, the report fails to address the serious concerns that have been raised in relation to the disproportionate increase in the cost of healthcare for the general population caused by extending the market exclusivity of expensive in-patent products.

By failing to reduce the European Commission’s proposed automatic 6-month extension of SPC/patent protection for high selling products that have undergone paediatric trials, the draft report will deliver unnecessary sales windfalls. Even accepting the Commission’s highest cost estimate for paediatric trials, an additional six months protection would produce €50 million in sales for a mid-range product with €100 million in annual sales in the EU. An extra six months for blockbuster products would be worth up to €500 million in EU sales. This will be translated into added costs to healthcare systems and patients.

The EGA feels this disproportionate reward for obligatory trials is an unnecessarily costly approach.

While the EGA agrees in principle with applying reasonable compensation for the legally required paediatric trials, it feels society should not be asked to pay too far beyond the level of extra investment involved — especially when a simple, more affordable solution is available. A straightforward 3-month fixed extension of SPC/patent protection would provide more than ample rewards on the vast majority of products concerned.

Greg Perry, EGA Director General, stated:

“Granting an automatic 6-month blanket extension to the SPC-patent protection will unduly delay the introduction of generics, upsetting the delicate balance achieved between the two sectors of the industry during last year's Review of EU Pharmaceutical legislation. This will have serious effects on companies working to supply low-cost generic medicines to Europe’s healthcare systems and will generate undue additional cost burdens to Europe’s healthcare systems and patients.”

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