August 29, 2013
The Guardian has published an article on the leaked email from the director of European Federation of Pharmaceutical Industries and Associations (EFPIA), asking the pharmaceutical industry to mobilise patient groups to fight the transparency directive. This has caused concern from various sectors. According to The Guardian, the email included a memo from Richard Bergström, director general of EFPIA, was addressed to “directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies (and) leaked by a drug company employee”. Although the email has not been published, the Guardian claims that the content reflects a campaign to resist sharing data more freely. Accorting to The Guardian the email starts with “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data”and goes on to explain a “four pronged approach to resist data sharing”.
In keeping with Regulation (EC)1049/2001, the European Medicines Agency aimed to increase transparency by providing access to institution documents to the public on request. However, two pharmaceuticals companies, AbbVie and InterMune, contested the release of certain documents provided by them to the EMA at the general court of the European Union. The general court of the European Union provided an interim judgement in favour of AbbVie and InterMune and has prohibited the EMA from releasing the concerned documents before the delivery of the final judgement. This has been a major setback, however, the EMA has tried to move ahead to try and work with the pharmaceutical companies by providing a draft guideline on the release of documents, which is now open for public consultation. However, industry groups are opposed to the plan of the European Medicines Agency, which oversees approvals in Europe, to make trial data public whenever a drug is approved.
In related news, EFPIA and Pharmaceutical Research and Manufacturers of America (PhRMA) have released a statement pledging to release detailed data about their drugs to outside researchers. Released days after The Guardians’ article, this proposal will take effect on 1 January 2014. It would apply to all new drugs and all new uses for existing drugs, whether approved in the United States or the European Union. This proposal has unanimous approval from the EFPIA and PhRMA member companies.