Today, the European Medicines Agency released a guidance on increased transparency and access to information included in companies' applications for marketing authorisation. EFPIA, the voice of the research-based pharmaceutical industry, welcomes all moves to remove perceived secrecy, as long as legitimate trade secrets are protected.

Richard Bergström, EFPIA Director General says: “It is important that the general public trust regulatory agencies to be independent and the pharmaceutical industry to do the right thing”.

As the detailed guidance by EMA in large parts builds on an input from EFPIA and involving most of our members we are confident that commercial interests will be protected. The worry in the industry is not that data itself is made available, but the fact that data will be available for all sorts of re-analyses. It is important that EMA communicate best practices for re- and meta-analysis of data.

“Despite EFPIA´s reservations, EMA has decided to also release non-clinical data (preclinical). An important consequence of the release of all this information is that we must update the concept of "regulatory data protection" (RDP), i.e that second applicants cannot refer to submitted data until after 10 years. Similar provisions, but with different timelines, are in place in many countries around the world. As most of the data is now made public, the understanding must be that it is not the privacy of data that is protected, but the "reliance on data" that is not allowed. It is also important the international community agrees that interpretation, as the notion of "confidential data" is now markedly reduced”, Richard Bergström concluded.

Contact

Richard Bergström, Tel: (+32) 2 626 25 55
E-mail: newsroom@efpia.org

Useful links

www.efpia.eu

About EFPIA 
EFPIA represents the pharmaceutical industry operating in Europe. Through its direct membership of 31 national associations and 35 leading pharmaceutical companies, EFPIA provides the voice of 2,000 companies committed to researching, developing and bringing new medicines to improve health and quality of life around the world.

EFPIA members are committed to delivering innovative medicines to address unmet needs of patients and reducing the burden of chronic diseases for Europe’s ageing population. EFPIA believes in close cooperation with its stakeholders to help create sustainable healthcare systems and to develop prompt responses to health threats in Europe.

The pharmaceutical sector directly employs some 640,000 people in Europe including 115,000 working in research and development in 2010. The industry also generates around three to four times more employment both upstream and downstream.

Europe’s research-based pharmaceutical industry generates a substantial trade surplus, estimated at about €46,800 million in 2010, and has contributed significantly to reducing the European Union’s trade deficit in high-tech products. € 27,000 million were spent on research and development in Europe in 2010. Almost a quarter of the EU’s high-tech exports are pharmaceutical products.

Media Contact:

Nicholas Elles
Communications Manager
EFPIA 
Rue du Trone, 108
1050 Brussels
TEL:  +32 (0)2 626 24 79
Email : communications@efpia.eu