Brussels, 18/07/2012 (Agence Europe) - EPP MEPs Peter Liese (Germany) and Philippe Juvin (France) have applauded the new draft regulation on clinical trials proposed by the European Commission (see EUROPE 10657). EPP spokesman on health questions Liese highlighted the absolute necessity of reforming current rules and asserted: “For the moment, it is very difficult to carry out academic research on rare diseases and children's diseases… We need less red tape for multinational clinical trials to kick-off more research”. He declared that the Commission is proposing a more co-ordinated and secure approach for speeding up the procedures. This will be particularly beneficial for international trials but also for trials carried out in non-EU countries, particularly developing and emerging countries. Juvin, a member of the environment, public health and food safety committee, said that the Commission had been able to respond to the lack of progress in European clinical research by proposing concrete measures. He particularly welcomed the adoption of the following three measures: - implementation of a single European portal, which will centralise demands; - standardised submission requests; - and the reduction in the time taken for approval. He also considered that the choice of a regulation instead of the directive was more beneficial because it would enable swift implementation of the new system, as measures would not need to be transposed into national law as a preliminary. Nonetheless, he regretted that the Commission “had not sought to harmonise the roles, the number of ethics committees and the way in which they operated”.
The European Federation of Pharmaceutical Industries' Associations (EFPIA) also welcomed the proposals unveiled by Commissioner Dalli. Richard Bergström, Director General of EFPIA, declared that “the Commission's proposal provides a unique opportunity to create a competitive European medical research environment for the next 20 years capable of supporting the discovery and development of tomorrow's treatments for the benefit of European patients”. The EFPIA particularly welcomed the simplification of the administrative processes and hoped that cooperation begun in the authorisation process for clinical trials will be further developed. (IL/transl.fl)