As of January this year any clinical trials used in applications submitted to the EMA for new pharmaceuticals will be made public.
EMA senior medical officer Hans-Georg Eichler said this move would likely put pressure on its food safety counterpart to follow suit - and joked that he had to apologise to EFSA colleagues if this was the case.
Eichler was invited to talk about the new policy at EFSA's second scientific conference at the Milan Expo this week.
Chair Ana Canal, executive advisor of the scientific co-ordination unit of the Spanish Agency for Consumer Affairs, Food Safety and Nutrition, commented: "I think this puts even more pressure on EFSA - if the medicines agency can do it, EFSA can do it."
On the transition to the new policy, Eichler said:“In the past, the position of industry had been: ‘We spend a lot of money to generate this data, so we’ll only share it with the regulator.’ But there has been a stronger and stronger political push on this.”
Tackling transparency
At the policy's inception it was argued that EMA decisions were a matter of public interest, therefore the data that formed a basis of those decisions should be made public. There was a concern that pharma was only publishing papers that were favourable to its products.
This was met with tremendous industry resistance and the EMA became embroiled in various legal cases against it.
"It was confrontational to say the least," he said. "We understood after a certain point in time that we cannot duck this issue [of transparency] and we have to do something, but the industry still for a long, long time continued to think that if I just duck the storm will blow over and it will all be good. But that was a misjudgment, the storm did not go away."
In its blurb for the presentation, EFSA said: “The environment in which [EFSA] operates has evolved significantly since its foundation. [...] The ‘open data’ movement, which has entered the sphere of EU institutions, is unleashing the potential for reuse of data.”
EFSA is developing a roadmap on its ambitions for big and open data, but it remains unclear whether it will echo the EMA on this policy.
One attendee, Martin Dermine of the NGO Pesticide Action Network (PAN) Europe, told us this was exactly the kind of policy it would like to see enforced by EFSA but it had its doubts whether the authority would be willing to go this far with its concept of openness.
See you in court
EMA’s policy was met by resistance from the pharma industry because of concerns over unfair competitive advantages this may give to those downloading the files.
US-based biopharma giant AbbVie and InterMune UK took the EMA to the European Court of Justice for sharing their trial data on drugs.
Yet the companies dropped their cases when they realised they "couldn't survive it politically", Eichler said.
The decisions came after a vote in favour of the European Clinical Trials Regulation in the European Parliament.
"In the pharmaceutical industry there are still some who want to drag their feet but the majority have understood that the train has left the station."
A story of push and pull
The EMA responded to these commercial concerns initially by saying papers could be seen but not downloaded or printed. However transparency advocates claimed this would hinder their ability to run checks.
As a compromise it opted for a two-tiered approach whereby anybody could view the papers with print and download disabled, but to download the documents users had to enter their details and agree to certain terms and conditions that the information would not be used in unfair competitive practices or to reveal identities of patients figured in the papers.
Asked what would happen if these terms and conditions were violated, Eichler said the EMA had made clear from the beginning that it was not its responsibility to
take abuses of data to court and this would likely fall to the pharma firms themselves.
A rising tide lifts all boats
He added that the push for this policy had started with a concept of 'catching out' big pharma but had since evolved into a much more "productive, forward-thinking" use of access that was about learning from others.
"If all the data in all the world were made available, we would have better trial designs in the future because you could learn from the mistakes that your competitors made two years ago. Is that a competitive advantage? Yes of course it is. Is it an unfair competitive advantage? No, it's not. It's a rising tide that lifts up all the boats.”
Medical union the British Medical Association (BMA) was one advocate of this ability to learn from others’ trials and errors.
In the past it said: “Openness in clinical trials will benefit doctors, researchers, pharmacists, regulators, and, most importantly, our patients. It will also help make the most of scarce resources if trials are not being duplicated because data has been withheld.”
Concluding his talk, Eichler said: "What started out as a rather nasty story, I think may have a very happy ending."