By Ben AdamsEMA's Noël Wathion
The EMA has published new rules as it prepares for a watershed year that will see the life science industry in Europe make public more clinical trial data than ever before.
On Jan. 1 last year, the European Medicines Agency set forth new rules that meant all successful applications to the agency from 2015 will eventually be published for public scrutiny in the form of clinical study reports, or CSRs.
After allowing the industry--which includes pharma, biotech and academia--time to get its data in order, the EMA said that the first lot of reports from 2015 will be published from September.
This has been a long time coming: The original start date had in fact been January 2014, with the plans for transparency first published all the way back in 2012.
Unhappy pharma companies, many of which have resisted the calls for transparency, have over the past four years fought back against the EMA, hence the delays and compromises over the release of data.
In fact, both InterMune--now owned by Roche ($RHHBY)--and AbbVie ($ABBV) sued the EMA over the potential release of data for their products in 2014--although both dropped the lawsuits after striking a deal with the regulator to limit what the public could see.
Now, after the legal spats and behind-the-scenes negotiations that saw the industry gain new limits on what they have to show, the EMA is keen to chalk up its plans as a victory for transparency.
Pressing ahead, it has now published new guidelines to help with the practical side of things, which includes how the industry can anonymize data (the methodology of which will largely be down to companies) as well as how it can apply to have some data redacted, should it meet the commercial confidential information (CCI) clause.
The EMA said that its guidance "makes clear that the vast majority of the information contained in clinical reports is not considered CCI." But where this might be the case, companies will need to submit to EMA for review a table justifying why such data have been redacted.
The new guidance clarifies which type of data EMA would typically refuse as being CCI and how the redaction of such data will be handled. The use of CCI was originally absent in the 2012 plans for transparency but crept into its final policy after voices from pharma swayed the agency.
The EU drugs regulator will also publish the redacted and/or anonymized clinical reports within 60 days of a final decision by the European Commission on new medicines. Applications that are withdrawn will also have their data published, but after 150 days of withdrawal.
The EMA said in a statement it will also start reaching out to companies that are "concerned" by the first wave of publications, as well as hosting a live webinar in the second quarter for companies to ask questions about the new policy.
"With this guidance, the agency is moving towards the operational implementation of its proactive publication policy, which launched a new era of transparency," says Noël Wathion, EMA's deputy executive director.
"The guidance will ensure that companies are aware of what is expected of them and are ready for the publication of these critical data."
While some are hailing this as a real step change in trial transparency, others have questioned the delays in getting to this point, and the limited data that are being allowed out in dribs and drabs.
Beyond CSRs (which contain only limited information) is also the separate need for the publication of individual patient data--something promised by the EMA in 2012, but a policy that has not made it into the final scope of its new rules.
The ability of companies and the EMA to redact some data for commercial reasons also irks campaigners such as Ben Goldacre, author of Bad Pharma, and the U.K. clinical trial transparency group AllTrials, as they fear this may be used to black out information that a company does not want shared.
There is also concern that almost all of the data for the drugs used by doctors and patients will not be made public under the EMA's rules, as they are only active back to drug applications from the beginning of last year.
Fundamentally, most of the data from nearly all the drugs regularly prescribed in Europe will still not be made available for external scrutiny after Jan. 1, 2015.
But what has been achieved is nothing short of a major shift, in just a few years, from a paternalistic attitude from both pharma and the EMA that believed the data need only be seen by these two groups, to a proactive stance by the regulator and even by some (though not all) in pharma to share this information more widely.
It is a quiet and steady revolution, but one that marks a major shift in pharma's business model and corporate culture from this year onward.
- read the EMA's latest guidance here