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Pharmaceutical Technology Europe

Europe needs generic medicines faster

"EU governments need to ensure fast generic medicines uptake as market access and low market volume in key EU countries is still a real problem and is having a major negative impact on patient access to more affordable treatments."

This was the key message delivered by Greg Perry, Director General of the European Generic Medicines Association (EGA), at the association's annual conference in Barcelona (Spain) during the launch of a new report, How to Increase Patient Access to Generic Medicines in European Healthcare Systems. The report examines certain aspects of the lack of promotion for competition from generic medicines in the European pharmaceutical sector.

Generic medicines have an important role in ensuring sustainable and affordable healthcare, especially during the global financial crisis, and also add competition to the marketplace. Despite these benefits, however, there are barriers hindering their market entry, including the failure of governments to create long-term generic medicines policies, continued price linkage (after generic medicines market entry) to originator reference products and delays to market caused by post-market authorization procedures for establishing price and reimbursement status.

Because of barriers such as these, Europe is not fully benefiting from the potential savings offered by generic medicines competition and the report has made a number of "urgent recommendations". It says "it can be argued that sustainable healthcare systems can only be achieved through the increased use of generic medicines".

The report made a number of recommendations, including implementing long-term generic medicines policies that remove the potential barriers and promote the sustainability of the sector, and a mechanism for granting automatic pricing and reimbursement status upon marketing authorization, which should eliminate current time delays.

Europe isn't the only one suffering from a lack of generic medicines; there are also delays to the market-entry of such medicines in the US. One possible cause could be brand-makers abusing authorized generics. In a recent US case, Heather Bresch, the Chief Operating Officer of Mylan, one of the world's largest generic manufacturers, was called to testify as part of a hearing to gather information about the effects of patent settlements. "When it comes to settlements, Congress need look no further than the use and abuse of authorized generics by brand manufacturers," said Bresch. "The increase in the number of patent litigation settlements in recent years is directly related to the increased use of authorized generics during the 180day market exclusivity period."

European brand-makers have also been investigated regarding the delayed market entry of generic medicines as part of the EU sector inquiry, which identified unjustifiable and anticompetitive factors being employed against generic medicines. In a response made in January 2009 to the preliminary findings of the sector inquiry, the EGA did not highlight, in particular, the use of authorized generics as a significant hurdle to generic medicines, but did mention brand-makers' "tool box" of strategies, which includes patent thickets, vexatious litigation and evergreening.

At the EGA conference, Perry said that he was hopeful that the inquiry may go some way to improving timely access to generic medicines in Europe, which will also offer economic savings to EU governments and patients.

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