New EFSA independence policy likely rejects most Parliament demands

- This policy is the outcome of a very long drafting process for EFSA’s Management Board (9 months).

Previous rules were written in late 2011, with a very limited review in 2014. CEO welcomes the adoption of the new policy in time for the selection of the new 2018-2021 panels.

- The new independence policy is a modest improvement compared to the previous one. It does not close the current policy’s main loopholes, however. As a consequence, the improvements brought by this new policy (ban on consultancy contracts for, scientific advice to and managerial positions with regulated companies and organisations funded by them), while real, remain limited.

- As a consequence, since EFSA will apply this new policy to the experts it will recruit for the period 2018-2021, it means that the level of conflicts of interests, in particular financial ones, is likely to remain high among EFSA’s panels at least until 2021.

- The management board has expressed its strong desire to remain involved in the review of this policy (leaving open the possibility to review it sooner than in five years) and seems to have started discussing concrete cases before adopting this policy. This is of course welcome.

- EFSA’s press release announcing the adoption of its new independence policy seems misleading, as it apparently wrongly describes the new policy on its most sensitive aspect: the way the two-years cooling-off period on industry interests, demanded by the European Parliament for the past four years in a row, will be applied.

The press release emphasises “A comprehensive set of “cooling-off” rules: external experts will be automatically barred from joining EFSA’s scientific panels if in the preceding two years they have been employed by, acted as consultants to, or have offered scientific advice to organisations that work in areas covered by EFSA’s remit. The cooling-off rules also apply to experts who have received research funding from such organisations over the same period.”

The two key expressions here are: “organisations that work in areas covered by EFSA’s remit” and “rules also apply to experts who have received research funding from such organisations”.

If the press release described accurately what is in EFSA’s new indepedendence policy, this would be a major victory for the European Parliament, as these two demands, broadening the scope of the experts interests screening, and including research funding in the cooling-off period, are exactly what MEPs demanded.

Sadly, it looks like the release is way too optimistic.

First, the scope for screening declarations of interests. Contrary to what the release says, the text of EFSA’s new independence policy does not seem to use “EFSA’s remit”, which is what CEO has been asking for since 2013 and the European Parliament since 2014. On the contrary, it seems to stick to EFSA’s current approach: only screen experts’ interests in light of the specific mandate of the group the expert is applying to, and not “EFSA’s remit”:

“This is why having worked as a self-employed professional or as an employee for a legal entity pursuing private or commercial interests in the sphere of the relevant expert group is deemed incompatible with membership of the Scientific Committee, Scientific Panels and Working Groups for two years after the conflicting activity has ended. This cooling off period applies to all managerial roles, employment and consultancies, even of an occasional nature, membership in a scientific advisory body and research funding on matters falling under the mandate of the relevant EFSA scientific group.”

The definition of a “legal entity pursuing private or commercial interests in the sphere of the relevant expert group” could be understood relatively widely, which might explain the wording used in the press release. However, “the mandate of the relevant EFSA scientific group” is word for word the narrow scope used in EFSA's previous independence policy. How should this be interpreted? In their public discussion, the members of the Management Board evoked a “grey zone” on this point, which will need to be clarified in the implementing rules. But chances are that the scope of the interests assessment remains too narrow.

Second, the inclusion of research funding in the cooling-off period. At first sight, the inclusion of research funding in the scope of the cooling-off period reads as a significant improvement: “The cooling-off rules also apply to experts who have received research funding from such organisations over the same period”. Research funding had been excluded completely from the previous versions of the draft. But this was in itself a regression compared to the previous policy, which had caused anger in the European Parliament.

However, while the text of EFSA’s new independence policy does now say that the cooling-off period applies to research funding, it immediately adds in a footnote that this research funding is defined “as per § 3.4”. And this is how the relevant part of section 3.4 reads:

“EFSA considers that for actors contributing to its operations, the acceptable level of research directly funded by the private sector is 25% of the total budget of the expert and his/her research team, for the sector of relevance. Private funding includes also funding coming from private organisations representing industry interests, such as industry associations. Private contributions to projects funded by public actors, such as those financed under the EU Research and innovation Framework Programmes (e.g. Horizon 2020), or equivalent programmes funded by international, national, regional or local public actors, do not count for this purpose.”

With this footnote and restriction, EFSA is in fact grabbing back what it pretends to have given. Research funding by industry1 remains excluded from the cooling-off period as long as the amounts at stake do not rise above 25% of the total research budget managed by the expert and/or his research team. With such a high ceiling, hardly any expert would not be appointed.

This is exactly what foresees... EFSA’s current independence policy. This clause reproduces the current policy’s loopholes on the matter, such as the fact that it will also not prevent an expert receiving research funding from multiple companies from being appointed, as long as no single funding source is above 25% of the expert’s total research funding. Unless the implementing rules make clear that the 25% threshold applies to all private sector funding considered together?

Also, the fact that public-private partnerships (PPPs) are now considered as public funding  by EFA's policy is worse compared to the previous policy. While PPPs can be useful for product development, they are a threat to the independence of the risk assessment of industry’s products. For instance, recent cases of pesticides risk assessment methodologies adopted by EFSA come from EU-funded PPPs where the pesticide industry was strongly involved.

One can of course appreciate that the main regression contained in the draft submitted to public consultation was avoided, but an actual policy improvement would have been preferable to a continuation of the status quo. After all, what the Parliament was asking was a two-years cooling-off period on industry research funding, not on industry research funding only when this would be above 25% of the expert’s annual research budget. EFSA has rejected CEO's calls to extend the cooling-off period period to five years.

- As far as transparency is concerned, experts will need to declare the proportion of their annual earnings received from “entities with an interest in EFSA’s activities”. While this should have been accompanied with absolute figures in brackets, this is an improvement.

- Importantly, national experts sent by national administrations will now have to file a public declaration of interest, which was a large black hole in the current system. However, whether they will be covered or not by EFSA’s independence policy remains unclear, with the signature of Memoranda of Understanding between EFSA and national bodies being foreseen. Nevertheless, the improved transparency on the identity of experts representing national governments at EFSA, for instance in pesticides peer reviews, is significant (in the glyphosate case, 80% of them had refused to be identified).

- Importantly, EFSA has committed to commission a feasibility study on the publication of “all the decisions performing the ex-ante scrutiny of DoIs submitted by the concerned individuals.” In other words, EFSA would explain publicly how it evaluates the interests declared by the experts. This would be extremely interesting to the media, other public food safety agencies, CEO obviously and, more generally, anyone interested in how EFSA sees its own independence. It would also generate highly interesting information, and enable a learning process for EFSA officials in charge of implementing the independence policy. Of course, since this would deal with information pertaining to individuals, due consideration should be given to respecting individuals’ privacy. We suggest the information published focusses on the institutions.

- The remaining “grey zones” in the interpretation and implementation of this policy, in particular the scope of DoIs screening, will be clarified in the upcoming implementing rules for this policy, issued by EFSA’s Director. In which direction will err this clarification, more independence or the opposite? Given that EFSA’s management main preoccupation is operational efficiency, one can question whether leaving the implementation details of EFSA’s independence policy entirely to EFSA’s management is the best approach. Whichever way, this process will be very important and needs to be watched closely.

• 1. or organisations representing its interests, which is a small helpful precision added compared to the last draft we saw.