EGA Press Release

Thursday, 19 June 2008 | Istanbul

4th EGA SOUTH EAST EUROPEAN SYMPOSIUM:
“Meeting the European Challenge for the National Drug Regulatory Agencies
and the Generic Medicines Industry”

In its on-going effort to encourage cooperation and improve regulatory procedures in the region, the European Generic medicines Association (EGA) is holding its 4th EGA South East Europe Symposium in Istanbul, Turkey. This year’s symposium has been organised in cooperation with the Pharmaceutical Manufacturers Association of Turkey (IEIS) and the Ministry of Health of Turkey. Previous editions of this event have been held in Split, Bucharest and Sofia — all in conjunction with the host country’s medicines authorities.

The delegates attending the symposium include top-level representatives from the medicines and patent authorities from throughout the region, including Albania, Bulgaria, Croatia, Federation of Bosnia and Herzegovina, Hungary, Kosovo, Macedonia (FYROM), Montenegro, Republic of Srpska, Romania, Serbia, Slovenia, and Turkey. In total, some 40 representatives of governmental agencies are taking part in the two-day event.

Greg Perry, director general EGA, expressed in his opening speech that such an enthusiastic participation at this year’s symposium was a reflection of the region’s eagerness to work jointly on issues of common European interest and its commitment to sustainable, quality healthcare. Mr Perry continued saying, “The fact that many of you are gathered here in Istanbul for the fourth such event speaks clearly of your genuine interest in pursuing broader levels of regional cooperation in the field of affordable generic medicines.”

Mr Perry highlighted that generic medicines play a critical role in the ability of the region’s authorities to provide affordable healthcare to their citizens. For this reason, Mr Perry advocated caution when considering the adoption of the “extra-curricular” legal and regulatory provisions that are being promoted by some pharmaceutical sectors. In particular, Mr Perry warned against adopting any new data exclusivity provisions which would negatively impact the rapid availability of generic medicines to patients in the region. Similarly, he reminded delegates that supplementary protection certificates (SPCs) must only be introduced as part of an EU membership package, and he reiterated that any patent linkage provisions were totally contrary to EU regulatory procedures and would only deprive patients of the medicinal care they deserve.

Mr Perry concluded by calling on governments in Europe to fully embrace the concept of headroom for generic competition based on the 3 principles of:

1. eliminating all barriers to immediate access to generic medicines after patent expiry;
2. introducing governmental measures to promote patients’ access to generic medicines;
3. stimulating long-term generic competition to ensure long-term savings as opposed to short-term price cuts.

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