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The European Federation of Pharmaceutical Industries and Associations (EFPIA) has welcomed guidance from the European Medicines Agency to improve transparency and access in applications for marketing authorisation, 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 involves most of its members, the organisation gives the message that it is 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),” said Richard Berggström.
“An important consequence of the release of all this information is that we must update the concept of ‘regulatory data protection’ (RDP), that is 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.