Europe votes yes on greater trial transparency
pharmafile | June 3, 2013 | News story | Research and Development, Sales and Marketing | Europe, Goldacre, alltrials, transparency
Europe has taken one step closer to increasing clinical trial transparency on the continent after MEPs voted yes on new amendments to drug study laws.
The European Parliament had already put forward new regulations for a Clinical Trial Directive, but some were concerned that it didn’t go far enough to increase trial transparency, currently a hot topic in the UK.
New amendments to make transparency assured in the Directive were brought by rapporteur Glenis Willmott, Labour MEP, and were unanimously backed by her fellow MEPs last week.
Specifically, the European Parliament’s Committee on Environment and Public Health has endorsed Willmott’s proposals that would see clinical trials needing to be registered on a publicly accessible EU database, and their main findings reported within a year of the study ending.
The MEPs also backed amendments that say if pharma firms did not comply with these transparency provisions, it would result in sponsors being fined.
The Directive is not yet law however, and the regulation must now be voted for by the entire European Parliament – a final vote on the legislation is expected in the autumn.
Willmott says: “Clinical trials are essential for developing new medicines. However, between 2007 and 2011, the number of clinical trials started in Europe fell by 25 per cent.
“Much criticism has been directed at the existing directive, which is widely believed to have led to an increase in unnecessary bureaucracy. The aims of the Directive were admirable, but many of the requirements were geared towards trials sponsored by pharmaceutical companies, while those with non-commercial sponsors were overlooked, and true harmonisation was never achieved.
“Getting better legislation in place soon is crucial to enable and encourage life-saving research,” she added.
The British political party and Coalition partner the Liberal Democrats have also taken a keen interest in the vote. Its European health spokesperson Rebecca Taylor, MEP, said: “Doctors should have access to vital safety and efficacy information on the medicines they prescribe to patients.
“In the past, that has not been the case. [The vote] is the start of a sea change in data transparency that will lead to important clinical trial data being made publicly available as never before.”
Success for AllTrials
The AllTrials campaign, which is seeking to increase clinical trial transparency around the world, has spoken of its impact on the vote, saying it had asked the 40,000 plus signatories of their movement to write to MEPs, urging them to back the new proposals.
In a statement AllTrials, which is run by Sense about Science, Dr Ben Goldacre and others, said: “MEPs told us that the letters they got from hundreds of [signatories of AllTrials] which made a difference in winning some of the votes.”
But the campaign warned that there ‘is a battle ahead’ because a number of Member States “don’t even believe that there should be a publicly accessible clinical trials database”.
Both the ABPI and the European pharma group EFPIA are still refusing to sign the AllTrials register, with the ABPI’s chief executive Stephen Whitehead recently saying it was nothing more than a ‘PR initiative’.
Speaking after the vote, EFPIA said it was still concerned about what it sees as the “unbalanced approach adopted by the Committee on the issue of confidentiality of clinical data”.
The group went on to warn that several of Willmott’s amendments: “Will jeopardise patient privacy, the integrity of regulatory systems, and incentives for investment in biomedical research in Europe.”
Ben Adams
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