EGA Press Release

Wednesday, 3 May 2006

2nd EGA South East Europe Pharmaceutical Symposium
MAINTAINING PATIENT ACCESS TO AFFORDABLE MEDICINES
IN THE REGION

Greg Perry, speaking today in Bucharest, reminded EU Accession Countries to be wary of attempts to have them create obstacles to the production of generic medicines when adapting their legislation to the acquis communautaire.

“Acceding Member States”, he warned, “must be particularly vigilant against efforts to introduce patent linkage”. This consists of linking the registration and reimbursement status of a generic product to the patent of the originator product. “Patent linkage”, Perry continued, “is contrary to EU law. It is not required by international agreements such as TRIPs. And it could damage the generic medicines industry in your country, which plays such a vital role in supplying medicines to your populations at affordable prices.”

Mr Perry’s comments were delivered during the 2nd EGA South East Europe Pharmaceutical Symposium in Bucharest, Romania, which has been organised within the EGA’s continuing tradition of working with countries prior to their entry into the EU. This year’s symposium was designed to explore the challenges facing the generic medicines industry in Romania and Bulgaria as they prepare for EU accession scheduled for 2007.

The symposium, entitled “Meeting the European Challenge for the National Drug Regulatory Agencies and the Generic Medicines Industry”, follows on from a similar event organised in Sofia, Bulgaria in 2005. Today’s gathering brought together medicines regulators and industry representatives from throughout the region. Discussions focussed on assessing the current legal and regulatory measures in effect in the European Union and the impact of accession on the pharmaceutical regulatory environment of the region.

Of particular concern to these countries is ensuring the successful integration of their generic medicines industry into the EU legislative and regulatory framework in order to continue providing quality generic medicines at prices their patients and healthcare budgets can afford. Mr Perry praised representatives from the Bulgarian and Romanian health ministries and medicines agencies for their work toward adapting their legislation to meet EU requirements, and praised their efforts to ensure the highest standards of generic medicine production in their countries.

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