In May, clinical trial data transparency moved towards becoming a reality when the European Parliament’s Committee on Environment and Public Health (ENVI) voted to adopt draft rules to Clinical Trials Regulations.
However, in an email leaked to the The Guardian , the European Federation of Pharmaceutical Industries and Associations (EFPIA) has called upon Big Pharma to mobilise "patient groups to express concern about the risk to public health by non-scientific re-use of data,” as part of an attack on the new legislation.
The Pharmaceutical Research and Manufacturers of America (PhRMA) – cited by the British newspaper as drawing up the strategy with the EFPIA – sent in-Pharmatechnologist.com a statement saying the “EMA's proposed policies on clinical trial information raise numerous concerns for patients.
“We believe it is important to engage with all stakeholders in the clinical trial ecosystem, including the patients who volunteer to participate in clinical trials, about the issue.”
The transparency amendment was unanimously voted in by the European Parliament will and is expected to come into force in 2016. The office of Glenis Willmott MEP, who steered the legislation, told in-Pharmatechnologist.com in May “transparency requirements are proportionate and achievable and clearly in the public interest.”
The EFPIA did not respond to requests for comment.
Patient Group and Big Pharma Respond
The allegation that Big Pharma is trying to patient groups to combat the proposed legislation was denounced by the European Patients Forum (EPF), an umbrella organisation that works with patients’ groups across Europe.
In a statement sent to this publication, the group said it “consistently called for the publication of all results of all clinical trials, be they industry or publicly funded, in a timely manner, regardless of the outcomes,” as reflected in its support of transparency advocates Alltrials.net.
Furthermore, the EPF said they were “not aware of any bona fide patient group that would advocate another stance” and questioned who the "army" of patients ready to mobilise on behalf of Big Pharma referred to in the Guardian actually are.
Pharma companies too targeted by the memo - including Roche, GSK and Eli Lilly - told the Guardian they had not been involved in the EFPIA’s plan to target patient groups.
Furthermore, GSK has been actively supporting clinical trial transparency in its own data, stepping away from the industry groups’ attempts to halt legislation. Last year the company announced it intended to publish all its clinical study reports since 2000, aligning itself with Alltrials.net and the British Medical Journal.