EFPIA and PhRMA Endorse EU Regs on Clinical Trial Transparency

By Dan Stanton

- Last updated on GMT

Related tags: Clinical trial, Pharmaceutical industry

EFPIA and PhRMA Endorse EU Regs on Clinical Trial Transparency
Industry bodies say they support the sharing of trial data following allegations yesterday they used patient groups to lobby new EU transparency regulations.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) issued a joint statement this morning endorsing the upcoming EU regulations​ which will require the sharing of clinical trial data.

“The data sharing commitments reflect EFPIA member companies’ strong support for sharing clinical trial data to benefit patients and foster scientific discovery in a way that maintains patient privacy, the integrity of regulatory systems, and incentives to invest in biomedical research,” ​said Richard Bergström, Director General of EFPIA.

In yesterday’s in-Pharmatechnologist.com​ we reported how an email written by Bergström was sent to a number of directors of pharma companies calling upon the mobilization of patient groups to express concerns to upcoming data sharing legislation.

The email - which was leaked to the Guardian​ – was part of an anti-transparency strategy drawn up with the Pharmaceutical Research and Manufacturers of America (PhRMA) and was denounced by several Big Pharma firms including Roche and GSK.

Privacy Concerns?

In a separate statement sent to this publication yesterday in response to these allegations, the EFPIA said it has “concerns about the EMA transparency policy”​ and would “share those concerns with other stakeholders.

“The industry supports improved sharing of research data to enhance public health while protecting the privacy of patients.”

The sentiment was echoed by PhRMA who said the “EMA’s proposed policies on clinical trial information raise numerous concerns for patients.”

However, in a response from the European Patients Forum (EPF), it said it has “unequivocal commitment to disclosure and transparency.”

“We strongly believe that any results – even of trials that ‘failed’ or produced unexpected or inconclusive outcomes – contribute to the totality of the evidence base on therapies, and can help target future research to where it is needed.”

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