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In a comprehensive sector enquiry, the Commission addresses the question why the market entrance of generic products is so often delayed in the European Union. The costs for the delaying tactics of the pharmaceuticals industry have to be borne by health insurance funds, patients and the labour force.
The market introduction of pharmaceuticals by the Pharma industry is in many cases an expensive matter. Often, companies have to spend large amounts on research and development, tests and marketing. To give them the opportunity to recoup their investments they can patent their products. Patents protect companies for a certain period against plagiarisers and competitors. If the patent has expired, however, competitors are free to bring generic products, i.e. replica products onto the market, which are usually significantly cheaper than the original preparations.

What looks easy at first glance is in reality often met with many obstacles. In the opinion of the Commission, the producers of original preparations use a wealth of tactics to delay the market entrance of lower priced generic products. In 2008, the European Commission therefore initiated a so-called sector enquiry to get to the bottom of these practices and to stop them.

This week, the Final Report on this enquiry was presented in Brussels. The result: the market does not function in the way it should. In the period from 2000 to 2007, the delaying tactics of the Pharma industry - which the Report describes in detail - resulted in the fact that on average 7 months passed, until a generic product could be sold once the patent of an original product had expired. The additional costs incurred as a result, amount to EUR 3 billion, which have to be paid for by the insured. The Commission has announced to intensify the antitrust enquires in the pharmaceutical sector subsequent to the Report. This announcement was already emphasised by opening antitrust proceedings against a French pharma company as well as against a number of generic product manufacturers.

Summary of the Report on the Pharmaceutical Sector Enquiry


Final Report (in English only)