EGA Press Release

Thursday, 24 May 2007

3rd EGA South East Europe 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) has organised its 3rd EGA South East Europe Symposium this year in Split, Croatia.

During his opening speech, EGA Director General, Greg Perry, said it was “heartening” to see such a broad participation at this year’s symposium, which included 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, Montenegro, Republic of Srpska, Romania, Serbia, Slovenia, and Turkey. In total, some 140 participants are taking part in the two-day event.

Greg Perry praised the representatives from the thirteen medicines agencies for their commitment to understanding EU pharmaceutical legislation, and encouraged them to actively pursue regional cooperation beyond initiatives such as the EGA Symposium. “Generic medicines play a major and ever increasing role in your countries’ ability to provide affordable healthcare to your citizens,” Mr Perry said.

In this regard, Mr Perry advocated caution in the adoption of any data exclusivity provisions which could have a major negative impact on the availability of affordable generic medicines in the region. He also reminded delegates that supplementary protection certificates (SPCs) must only be introduced as part of an EU membership package. And he stressed that here also there is a need to take into account local issues affecting access to medicines. In relation to patent linkage, Mr Perry emphasised that these were totally contrary to EU regulatory procedures. He was happy to report that, with the exception of Slovakia, no European country had submitted to US pressure to adopt such measures and informed delegates that the European Commission was now looking into the issue of patent linkage legislation in the Slovak Republic.

Mr Perry reiterated the importance of aiming for the highest standard of regulatory procedures for the assessment and registration of generic medicines, and the need for authorities to communicate regularly amongst themselves to better ensure the harmonisation of national requirements and procedures.

This year’s event has been produced in cooperation with the Croatian Agency for Medicinal Products and Medical Devices (ALMP), with sponsorship from EGA member companies Pliva and Belupo, both major providers of generic medicines in the region and elsewhere in Europe. The first SEE Symposium was organised in Sophia in 2005 and the second took place last year in Bucharest. All three have been organised in conjunction with the respective medicines authorities.

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