Brussels, 19/07/2012 (Agence Europe) - In the latest step to improve the transparency of the European Medicines Agency (EMA), its Executive Director Guido Rasi has announced a plan for publishing the agendas and minutes of the Agency's scientific committees. Rasi was appointed to his post last November and has made transparency one of his priorities. He stated: “This latest initiative is an important part of opening up our operations, to reinforce the trust and reputation of the Agency as a public health body.”
This decision will allow independent researchers access to information through the thousands of pages of clinical trials results carried out by the industry. The first archives to be opened this week were those itemised by the Paediatric Committee (PDCO) and publication of documents belonging to the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Orphan Medicinal Products (COMP) will subsequently follow. The documents centralised by the four other committees will then be published at regular intervals. The EMA has promised that all documents would be made public before the end of 2013. It will be holding a conference in November to examine what needs to be done to ensure rapid and regular access to significant quantities of data. This move is unlikely to be appreciated by the pharmaceutical industry though it does not have any choice in the matter because European regulation compels pharmaceutical companies to submit their data to the EMA before marketing their medicines.
The EMA appears eager to redeem itself, after having been accused of having failed to communicate important information about secondary effect dangers from certain medicines such as Mediator and Septrin. It was metaphorically given a shove by the European Ombudsman, who considered that clinical trial data protection, using the pretext of industrial confidentiality, went against the general interest. Over the past 18 months, the EMA has published more than 1.5 million pages of clinical trial results, 100 times more than were published in 2009-2010. (IL/transl.fl)