The October transparency debate at EFSA’s Parma, Italy, HQ raised many questions about how to make data available to the public, while protecting business and research interests. It has also provoked conversation about conflicts of interest and how best to separate risk management and risk assessment in the European Union.
At the meeting, the question was asked whether the European Food Safety Authority (EFSA, risk assessor) and the European Commission (risk manager) needed to be less independent of each other, essentially to add a more political element and context to EFSA’s output.
EFSA’s Per Bergman, director of Scientific Evaluation of Regulated Products, said independence did not necessarily mean operating in a contextual vacuum.
“It is important that EFSA as risk assessor understands the context of its scientific opinions – we cannot work in isolation,” said professor Bergman.
“There are some who say that the Commission and EFSA do not understand each other but I would turn it around and say that the separation of risk management and risk assessment has been a success.”
“All parties have benefitted from this because we have specialised in our respective roles. We have taken real measures to clarify not only the role but also what is expected of us. I think we have done a good job of this. But if we stop interacting then it will not work.”
So a fine line then.
Separation of powers
A good example of this ‘separation of powers’ was a recent EFSA positive opinion on the role of carbohydrates for brain health, which was subsequently rejected by the European Parliament as not useful to European populations.
Even some of the Strasbourg parliamentarians that rejected the NDA panel opinion, agreed it was scientifically valid, but they felt the claim would not benefit public health. So it was kiboshed. EFSA had done its scientific work, the Parliament its political work. For many, a fine example of a functioning and healthy system that gives disparate parties equal opportunity to exert influence on the end decision.
“No one can deny that glycaemic carbohydrates are important for the function of the brain- it is well-established science,” professor Bergman said.
“Then it moves to the authorisation process where EFSA is not involved at all and then the member states, the Commission, the Parliament have to take into account the EFSA opinion but also other factors.”
“At that level it is possible – like caffeine – that some claims will be blocked. I think that is a good thing. The panel always considers the limit of its mandate - to stay within the science and not get into the risk management.”
Observation observations
Back on the subject of transparency, Valeriu Curtui, head of the Nutrition Unit, agreed with EFSA management board chair Sue Davies in the push for more open panels with more observers.
“We will continue to open panels to observers,” Curtui said. “We welcome observers to the panels but of course there are certain subjects that cannot be opened to the public like certain claims. So we can only open those sessions where we discuss non-confidential issues.”
“Working groups are more sensitive because the working group needs to discuss subjects more openly.”
More broadly Bergman suggested many of the commercial sector’s concerns about data protection were already met in existing laws and guidelines, even as the agency recognised the need for ongoing evolution in certain areas.
“EFSA has to adhere to the legislation as it stands today both in terms of protection of business and the public right to information. We simply adhere to the decision taken most of the time by the European Commission.”
“Question is: Why is anything confidential in the dossiers? The answer is that the names of the study directors, contact details, gene sequences, production processes etc. sometimes need to be protected either for privacy or business interests.”