Richard Bergström, EFPIA, all trials, ema

EFPIA slams EMA data proposals

pharmafile | September 10, 2013 | News story | Research and Development, Sales and Marketing AZ, EFPIA, EMA, GSK, Pfizer, Roche 

The intense debate over how pharma should make trial data available has taken another turn as a major European industry body has slammed the European Medicines Agency (EMA)’s draft proposals.

The European Federation of Pharmaceutical Industries and Associations (EFPIA)’s comments on the EMA consultation are dominated by ‘serious concerns’.

The essence of the EMA’s plan is that, from next year, pharma companies should release all of their study information for independent scrutiny.

“We are worried by a move towards greater transparency of clinical trials data that appears to be putting transparency – at whatever cost – ahead of public health interests,” insisted EFPIA director general Richard Bergström.

In particular the organisation believes the EMA’s draft policy will weaken safeguards intended to ensure the privacy of patients who could be identified in marketing authorisation application documents.

As they stand, the EMA proposals will also “undermine the trust in the regulatory approval system governing biopharmaceutical products and introduce risks of misinterpretation and misuse of clinical data into the process”.

Finally, EFPIA says, the disclosure of commercially confidential information without justification will mean companies would increasingly decline to invest in R&D.

EFPIA has always said it welcomes efforts towards greater transparency of clinical trials – it’s just that it has “serious concerns about the EMA draft policy…which carries negative implications for public health in its failure to adequately protect the interests of patients and the research they benefit from”.

To observers of this battle of wills, the EFPIA’s intervention comes as no great surprise, since the organisation had already made its disquiet known, warning against the ‘indiscriminate’ release of data.

And in July a leaked memo from Bergström revealed EFPIA was attempting to mobilise patient groups in a bid to help stop new moves towards transparency.

The email went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Lilly, Novartis and many smaller companies, and was leaked by a drugs company employee.

The industry has long fought the need for data trial transparency, with both the ABPI and UK pharma executives saying that patients would rather see money spent on new medicines.

Pharma is also concerned about the misinterpretation of data if it is allowed into the public domain, as correctly identifying patterns in data sets requires highly specialist skills.

However, the sector has been under intense pressure this year to publish more of its trial results from the campaign group AllTrials, whose supporters include GlaxoSmithKline.

Adam Hill

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