Brussels, 30/07/2013 (Agence Europe) - The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced on 24 July that it had sealed an agreement with its American counterpart, the Pharmaceutical Research and Manufacturers of America (PhRMA), in which the two associations undertake to improve public health by approving common principles for the responsible sharing of data relating to clinical trials. The press release on this was published two days after an article published by The Guardian revealing a strategy concluded by the two major professional associations seeking to win the support of patient groups for their position on clinical trials, which is that a certain degree of confidentiality needs to be preserved.
In their press release, EFPIA and PhRMA underline that, out of concern for better understanding of data on clinical results diffused on public internet sites, the biopharmaceutical companies undertake to publish complementary information for the public and the patients involved in clinical trials and for qualified researchers. Richard Bergström, EFPIA Director General, said: “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”. In an article published two days earlier, The Guardian said that the European and American associations were seeking to influence patient groups so that they pass on their fears, namely that, if all the results of clinical trials were published, as the European Commission is suggesting, they could be wrongly interpreted by the media, inter alia, putting patient health at risk. The European Consumer Organisation, BEUC, takes the view that the announcement, made two days after the press article was published, comes too late. “The debate on data transparency has already moved on and there is no way back to their old secretive ways. It is no longer up to the industry”, BEUC Director General Monique Goyens said. Explaining that the EFPIA and PhRMA “pronouncements do not cover up big pharma's unethical attempts to mobilise patient groups solely to protect their commercial interests”, she went on to conclude by saying: “Several drug-related scandals could have been prevented and many lives saved had trial data been examined by independent researchers”.
The 2001 directive on clinical trials is currently being reviewed. In its proposal published on 17 July 2012, the Commission seeks to strengthen the competitiveness of clinical testing by making the authorisation process for those trials less burdensome while maintaining a high degree of protection for the patients (see EUROPE 10657). The proposal, which seeks to establish greater transparency on the findings of clinical trials, could make it an obligation for pharmaceutical companies to publish all their reports on clinical trials, despite EFPIA's opposition to this. On many occasions, EFPIA has recommended “responsible transparency” which respects privacy and commercial confidentiality (see EUROPE 10731). On 8 October, the plenary session of the European Parliament is to adopt the report on clinical trials in first reading. (IL/transl.jl)