EGA Press Release

Thursday, 21 January 2010

EGA CALLS FOR IMPROVED REGULATORY FRAMEWORK WITH VISION 2015 TO CREATE A STRONGER EUROPEAN GENERIC MEDECINE INDUSTRY AND INCREASED PATIENT ACCESS TO AFFORDABLE HEALTHCARE.

Greg Perry, director general of the European Generic medicines Association (EGA) opened the 9th edition of the EGA Scientific and Regulatory Affairs Conference in London, by reiterating the association’s vision to create an improved European regulatory framework for generic and biosimilar medicines. Entitled Vision 2015, the plan aims to meet three main objectives: create a globally competitive generic industry, increase patient access to affordable quality medicines and ensure sustainable healthcare in Europe.

Greg Perry emphasised that significant successes had been achieved in the regulatory system since its reform in 2003 but there is clearly room for improvement. “Generic medicines are one of the most competitive sectors in Europe, accounting for almost 50% of all the medicines dispensed, bringing combined savings of between 25 and 30 billion Euros yearly. And yet numerous hurdles crop up as a result of anti-competitive activities that create unnecessary delays in the development and introduction of new generic medicines. Our vision will create a clear, open market that will benefit patients everywhere, spur innovation and generate considerable savings. Some reforms will require new law others can be achieved by better application of the current law." Greg Perry said.

The EGA believes 5 key steps are necessary to meet their main objectives:

1. Enhance competitiveness of the EU generic medicines industry by introducing more tax and R&D incentives for generic and biosimilar research and clinical trials, as this would further spur innovation within the industry and safeguard the development of the European generic industry as a whole.

2. Eliminate barriers to generic competition by restricting third party intervention in procedures that enable anti-competitive strategies and unjustifiable delays in Market Authorisation. The regulatory process should be free from all patent linkage, and clear regulations should prevent new hurdles such as the “early notice mechanism”. Furthermore, when considering innovation, products with little therapeutic value should be distinguished from real therapeutic innovations.

3. Introduce better regulation by building on the current success of the European authorisation systems including streamlining the Decentralised Procedure (DCP) and better adaptation of the Centralised Procedure (CP) to generic medicines. Generic applications currently account for 85% of all DCP and 41% of all CP applications.

4. Strengthen single market harmonisation by more strict adherence to the principle of Mutual Recognition - no repeat assessments by Concerned Member States and an enhanced role of CMDh

5. Increase information on generic and biosimilar medicines to patients and health care professionals across Europe. The Association is also pleading for measures to be instated eliminating negative information campaigns, an issue of major concern raised in the recent Pharmaceutical Inquiry.

With over 700 companies employing over 150,000 people in Europe, the generic and biosimilar industries are uniquely placed to ensure patient access to affordable quality medicines while helping to control national health expenditures.

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For further information contact Beata Stepniewska
Tel: +32 (0)2 736 84 11