The data published relates to all clinical trial data submitted by pharmaceutical companies to the EMA. One of the roles of the EMA is to review and approve medicines, issuing a license which allows the medicinal product to be marketed throughout the European Union.
Clinical trials provide important information about medicines. An effective trial is designed to provide answers to specific questions about biomedical and safety factors in relation to novel drugs.
For many years, many doctors (such as campaigner Ben Goldacre) and some members of the public have campaigned for trial results to be made available. The reason why some are keen to see data published is because the information is far more detailed than published research papers written by representatives of pharmaceutical companies.
As Goldacre has explained: “The practice of medicine is based on evidence. We need this evidence base to be complete, and of the highest quality, so that we can make the right decisions, but at present, drug companies produce most of the evidence we use. There is no doubt that these companies have a conflict of interest when they conduct trials.”
The argument against publishing data, put forward by some pharmaceutical organizations, relates to intellectual property and a concern that rival companies might gain a competitive advantage.
In response to the news, Yann Le Cam, chief executive of the rare-disease patient lobby group EURORDIS-Rare Diseases Europe, welcomed the decision: “Patients and clinicians have been waiting a long time for clinical-trial data.”
In October 2016, the EMA published the first set of data. This comprised of around 100 clinical reports relating to two medicines. According to Nature, these medicines were carfilzomib, a cancer drug, and lesinurad, a gout treatment. The data set and reports amounts to 260,000 pages.
The EMA has been building up to releasing trial data for the past two years; the policy relates to new trials going forwards. There is, as yet, no indication that other regions of the world will follow suit.
