In negotiations, Members of the European Parliament (MEPs) amended EU law on clinical trials to require that detailed summaries of clinical trials be published in a publicly-accessible EU database. Full reports must be made available once a drug reaches marketing authorisation stage, and fines will be imposed on sponsors who do not observe deadlines.
Additionally, the new legislation means sponsors will submit their applications for trial approval just once via an online unified EU portal. Member states will make have to make a joint assessment and one decision at national level, within a fixed deadline.
The draft rules received overwhelming approval from MEPs, who passed it 594 votes to 17, with 13 abstentions. Publication of the finalised EU Clinical Trials Regulation is expected by summer 2014.
Opposition
A campaign backed by the British Medical Journal and the Cochrane Collaboration, using the Twitter hashtag #AllTrials, has been lobbying since January 2013 for the publication of all trial results including failed studies. Campaigners claimed the suppression of trial results hampers research, while opponents cited patient privacy concerns.
Last year, the European Federation of Pharmaceutical Industries and Associations (EFPIA) and Pharmaceutical Research and Manufacturers of America (PhRMA) were accused of manipulating patients’ groups to lobby against clinical trial transparency legislation, after The Guardian published a leaked EFPIA email proposing "mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data."
However at last week’s DIA Euromeeting in Vienna, Richard Bergstrom, EFPIA Director General, said the pharmaceutical industry was “committed” to “increased sharing of its clinical trials data to advance public health goals and achieve the best end results for patients.”
In an EFPIA statement released today, the federation said it “welcomes” the draft law as a way of keeping Europe competitive at a time when it “runs the risk of losing its status as an attractive environment for clinical trials research.” However, there is “still work to be done,” added Bergstrom, to make sure the new Clinical Trials Database runs efficiently and trial applications are processed as quickly as possible.
In recent months, many pharmaceutical giants have taken steps towards greater transparency, with Pfizer, MSD, Roche and UCB updating their policies on clinical trials data sharing, and Novo Nordisk, Johnson & Johnson, GSK, Boehringer Ingelheim and Roche committing to using various online portals to share trial data.
Bonus for rare diseases
The European Parliament said yesterday’s law would help co-operation across borders, and make clinical trials larger, more viable and more reliable, helping to develop specialised treatments such as those for rare diseases.
“There are simply not enough patients in one country alone to develop new or improved treatments for rare diseases,” said Glenis Willmott, the British MEP who piloted the legislation. “By working at EU level we can reduce the huge cost and burden of conducting trials across borders."
The BioIndustry Association said it hoped yesterday’s vote would improve Europe’s attractiveness as a location for clinical research. “For that to happen we now need to ensure the legislation delivers simplification, efficiency, standardisation and speed in starting clinical trials,” said Steve Bates, CEO, BIA.