Trish Groves: A European tale—data sharing at the EMA

This is a tale of extraordinary persistence by medical researchers—particularly those at the Nordic Cochrane Centre in Copenhagen—on behalf of patients. And it seems to have a happy ending.

It starts in the warmer climes of Rome and Lisbon, where treaties were signed to form the constitutional basis of the European Union. These treaties laid out the principle that all documents of EU institutions and agencies should be accessible to the public. But in 2010, just a few months after the Lisbon treaty was enacted, the European Medicines Agency (EMA) argued against disclosing full data from the clinical trials that underpinned its approval of medicines. There were four reasons to block public disclosure, said the agency: preparing the datasets would take an inordinate amount of effort; it would infringe data protection rights; it would scupper intellectual property rights as defined in the World Trade Organization’s TRIPs agreement; and it would damage the drug industry’s commercial interests.

The Nordic Cochrane group, who had applied unsuccessfully in 2007 for access to specific clinical trial data, made one of two key complaints to the EU ombudsman. In late 2010 the ombudsman ruled that EMA should disclose the requested data, because “EMA has not established that the requested documents fall within the scope of the commercial interests exception, as provided for in the Rules. It follows that their disclosure cannot undermine commercial interests. Even if one were to assume that certain information contained in the requested documents could fall within the scope of the commercial interests exception, there appears to be nothing to suggest that disclosure would specifically and actually undermine commercial interests.” Moreover, the ombudsman decided that it wouldn’t be too burdensome to disclose the data and that the dataset was well enough anonymised.

No sooner said than done. Indeed, the EMA swiftly released a new policy confirming the rights of EU citizens’ to have the widest possible access to the agency’s documents, and agreeing to grant access on written request. So far, so good. But what about public access to the data? That would come, said EMA, within three years.

And now we’re nearly there. At a hugely oversubscribed workshop on 22 November 2012 at the EMA’s windswept HQ in London’s Canary Wharf, the agency sought views on what it should do.

The workshop started well. “We are not here to decide if we publish clinical trial data, but how”, said Guido Rasi, EMA’s Executive Director, making at least one of the sceptical panellists hurriedly rewrite a script that pleaded for data release. And then the agency gave Peter Gøtzsche of the Nordic Cochrane Centre his rightful place as the first invited speaker.

Yet Peter and the other five panellists got only 5 minutes each, and were marshalled tightly by moderator Sir Mark Walport. The ensuing panel discussion and questions from the invited audience covered all the right topics: patients’ needs for full information balanced against research particpants’ rights to privacy, the needs of systematic reviewers and clinicians for the full evidence on the benefits and harms of drugs, and the technical and legal challenges of sharing the data. But it was a procession of comments rather a debate, none of it was covered in depth, and the EMA, meanwhile, said not a word.

That’s not to say the contributions weren’t important or interesting, and the several tweeters – including panellists @GinnyBarbour of PLoS and @BenGoldacre – captured all its wisdom and at times, wit, at #ctdata. In case you want to relive it, I’ve Storified it here and the EMA’s live webcast will soon be archived at Two Top Tweets summed it up for me:

Ben Goldacre @BenGoldacre: David Healy: “Do patients consent to their data being shared? Better to ask: do they consent to it being hidden?”

Andrew Jack @AJack: Who would have thought it? Clinical trials transparency vies with Thanksgiving Turkey as top Twitter trender

And then, as we were losing hope, came the happy ending. To a collective gasp from the audience (I’m not exaggerating—we really didn’t expect it), EMA’s senior medical officer Hans-Georg Eichler announced in the closing minutes that the agency would start to share clinical trial data publicly from January 2014. They’ve a lot to do in the meantime, including taking evidence from five advisory groups and the public.

Epilogue: nobody in the audience seemed sure whether this public data release will apply retrospectively, to the thousands of trials that underpin the treatments patients are taking now. It’s those retrospective data that we all need. Still, EMA did state very clearly at the workshop that those data will continue to be released on written request, under its 2010 policy.

Trish Groves is deputy editor, BMJ.

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