0043 – Agent of the no secrets service?
Fearless in the face of corporate interests and revealing information from even the most secretive laboratories, Policy 0043 is unique, making the European Medicines Agency (EMA) the most open and transparent medical regulator in the world. Since its adoption in 2010, the policy means the EMA is the only regulator in the world to freely and unconditionally release clinical trial data from its holdings.
But when the principle of transparency meets reality of responding to requests for information, how does the EMA measure up?
Dr Tom Jefferson, an honorary research fellow at Oxford's Centre for Evidence based medicine and Dr Peter Doshi, assistant professor of pharmaceutical health services research at the University of Maryland, have published a paper in the journal Trials that takes an in depth look at 12 requests for data made to the EMA.
Tom Jefferson explains: 'Policy 0043 has been revolutionary. In previous studies we did show millions of pages of regulatory data have been released. But these analyses only gave a high-level view of how the system was working. If you're trying to get information on a particular drug or a particular trial, what's important is what you are going to get and how long it takes.'
The 12 EMA data requests were for 118,000 pages relating to 29 medicines and biologics from 2011 to 2015. This included the 2011 request for Tamiflu data by the pair that enabled a Cochrane review to begin to consider the detailed clinical study reports that regulators routinely use to understand and assess trials.
The researchers admit that their study based on a case series is not the ideal way to look at how the regulator is operating its open data policy. But practical limitations meant that it was the best approach they could take. What the series reveals is that the EMA's commitment to openness may be struggling in the face of everyday realities.
Dr Peter Doshi says: 'Our study showed that response times are getting longer, the output seems to be slowing down and bureaucracy is gaining the upper hand. It shows the way it has been for us for the last 5 years. We know from informal contacts with other researchers that things for some of them are even worse, bewildered by a new lexicon and showered with letters written in EMA bureaucratese.'
The system may be slow, but surely it's still better than what's available anywhere else?
Dr Jefferson agrees: ‘We are not trying to damage EMA with this paper. We are pointing out the current difficulties because we believe the EMA policy is the way forward.
'With evidence of reporting bias in the way studies are presented in journals and even suppressed studies when results don't support the desired outcome, open data is vital. As it stands, it is probably the only way forward for Evidence Based Medicine to regain credibility. Evidence based medicine only works properly when you can see all the evidence.
'Given the growing recognition of regulatory data as the key to unlocking reporting bias in the scientific literature, the EMA's system needs to be straightforward. Instead, we report that using it is more complex and convoluted than one might hope. There are also signs of a system that must throttle its output to cope with demands. In 2010, the EMA had a team of five people who handled these requests as just part of their job. At the end of 2014 there was a full-time team of 12. In the first two years, there were around 20 requests for data each month. In the six months after that, requests doubled, yet the number of pages of data released fell by more than a third.'
Now, the EMA has a new policy – 0070 – which aims to openly publish trials data, rather than respond to individual requests. However, the documents that appear will be redacted – that is, certain information will be blanked out – and Drs Doshi and Jefferson warn that such redaction may be excessive, meaning that the new policy may not deliver as well the current, albeit imperfectly operating, policy 0043.
Dr Peter Doshi concludes: 'The EMA is trying to do the right thing for science, for medicine and especially for the patients they serve. That is precisely why it is worth fighting to improve EMA practice, perhaps with more resources and regular open audits.'
Canada is now looking at a similar data access scheme and campaigners across the world are determined to get more regulators to be more transparent in an effort to make medicine safer and more effective for all. The lessons that the researchers have identified in their critique of the EMA's pioneering approach may be just as useful outside Europe as within it.