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EGA Press Release

Monday, 09 February 2004

Precise and Rapid Implementation of New EU Pharmaceutical Legislation is “Top of the Agenda” for EGA Regulatory Affairs Conference

Leading officials from European medicines agencies and key figures from the generic medicines industry will gather in London on 12-13 February at the EGA’s annual Regulatory Affairs Conference to explore the implications of the EU pharmaceuticals legislation adopted in December 2003. Conference participants will be stressing the importance of implementing the new legislation into national law rapidly and correctly.

The EGA, is urging the swift implementation of:

• The so-called “Bolar” provision, which will generate new jobs in clinical work in Europe by allowing early scientific development of generic medicines in the EU;
• The European Reference Product, aimed at facilitating the process of up-dating medicines dossiers in the New Member States;
• Guidelines for the new “Decentralised Procedure”, which must be agreed quickly;
• The legal framework for “similar biological medicinal products”.

Greg Perry, Director General of the EGA, stated:

“EU lawmakers clearly intended to make affordable generic medicines available to patients faster and more efficiently. Unless these provisions are implemented fully in time for the Directive’s entry into force in 2006, pharmaceuticals bills will continue to rise. Europe’s patients will lose out.”

Similarly, the EGA is keen to ascertain the meaning of “one-year non-accumulative” data exclusivity for new indications of well-established products. The EGA also seeks to ensure that the increased data exclusivity periods will only apply to new pharmaceutical products whose application for marketing authorisation is made after entry into force of the Directive, ie: 18 months after its publication in the Official Journal.

The EGA also urges rapid agreement on the definition of what constitutes a “reference product” and of the new Single Marketing Authorisation concept, both of which underlie the new data exclusivity rules. Greg Perry declared, “Without a clear understanding of the legislation’s precise intent on data exclusivity, it will be impossible to implemented this legislation correctly into national law and to deliver its benefits to Europe’s patients”.

The EGA has announced that it will work closely with the EMEA to ensure the smooth running of the Centralised Procedure for generic medicines. In that context, the EGA is particularly pleased with the participation of three high-level experts from the EMEA on this year’s programme: Dr Patrick Le Courtois, Head of Unit for the Pre-Authorisation of Medicines for Human Use, EMEA Heads of Sector, Anthony Humphreys and John Purves, and Deputy Head of Sector, Sabine Brosch.

Other distinguished speakers include Dr Philippe Brunet, Head of Unit for Pharmaceuticals Regulatory Framework, European Commission; Dr Rui Santos Ivo, Chairman of the Board, National Pharmacy and Medicines Institute of Portugal (INFARMED); and representatives from the Dutch, Slovenian, Swedish, and UK medicines agencies.

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