On 15 December 2011, the European Food Safety Authority (EFSA) Management Board adopted its Authority’s Policy on independence and scientific decision-making processes. A few months later EFSA’s Executive Director signed off a set of implementing rules on Declarations of Interests (DoIs). These rules regulate the way EFSA should process DoIs and prevent the occurrence of conflicts of interests.
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Background
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The current system of declarations of interests and their subsequent screening and evaluation needs to be monitored and regularly reviewed to ensure that it is comprehensive enough for the prevention of the occurrence or the mitigation of potential conflicts of interests, and to assess whether the current measures taken are proportionate to the potential risks.
A 2013 report published by the Corporate Europe Observatory states that following controversy over its close ties with industry, EFSA has implemented a new policy designed to ensure the independence of its scientific panels. As a result of its new independence policy (instituted in 2011/2012), EFSA banned 85 experts from joining its panels, so there was some improvement in this regard.
EFSA has initiated an internal review of the completeness and proportionality of the current rules on DoIs. This review focuses on whether the measures currently in place are adequate in view of the risks they address, while also considering the suggestions, findings and conclusions received from EFSA’s institutional stakeholders and other interested parties. The outcome of the meeting will provide input to the on-going review of EFSA’s 2012 implementing rules of the Declaration of Interests Policy.
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EPHA’s contribution
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1. Are all relevant elements for the detection and mitigation of possible conflicts covered in the independence implementation rules? As the leading voice of the European public health community, the European Public Health Alliance (EPHA) recognises the efforts made by EFSA towards improved processes and rules for dealing with conflict of interests and independence rules. Having analysed the reviewed rules of DoI, we feel that some crucial elements necessary for effective detection and mitigation of possible conflict of interests are missing. Notably, as the sole source of information on scientists’ potential conflict of interests available to EFSA is these persons’ self-assessment (subject to ‘personal interpretation’), some potentially crucial data might remain unchecked. We recommend that public third parties information (independent and potentially more ‘objective’), such as from national agencies, must be used for checks by EFSA while assessing scientists’ DoIs. Furthermore, the Commission’s experts coming from the industry (in the past and currently) should figure in the Transparency Register. The Transparency register has been set up and is operated by the European Parliament and the European Commission, with support from the Council of the European Union. By its code of conduct the register would serve as a ‘double check’ on EFSA experts’ industry activities vis-à-vis EU decision-making processes.
In addition, ‘gifts and invitations‘ policies and procedures should be better highlighted under the DoIs for the entire Agency. It seems that EFSA’s independence rules themselves are too narrow and embrace only considerations that fall inside the thematic mandate of the Scientific Panel or working group the expert is applying to. Given that borders between food, nutrition, chemicals, pesticides, animal health and welfare and other areas covered by EFSA have recently been fast disappearing, it is almost impossible, nowadays, to work in silos and not include other areas.
2. Are the current elements for the detection and mitigation of possible conflicts clearly and transparently described in the independence implementation rules? In our view more clarity, transparency and consistency are needed. Current rules have already improved significantly in recent years, but we think it is of paramount importance that declared conflicts of interests with industry and industry-sponsored activities are stopped. Only this provision would ensure true independence of science-based recommendations and opinions. It would also improve public trust towards EFSA and its work. Scientists with CoIs whose contribution would be seen as obligatory (as sometimes happen) could always be invited for hearings by the panel, without them being involved in any decision-making processes.
3. Are the measures effective in detecting and mitigating conflicts of interests and do they effectively address breaches of trust? In our view, the responsibility of the institution’s independence, detection and mitigation of CoIs be internalised, rather than putting the onus on external individuals who may or may not be able to implement and sustain independent high scientific standards at all times. Also, as the administrative burden involved in checking individual DoIs is immense and at times unmanageable, it would be advisable to strengthen EFSA’s capacity for pro-active and consistent checking of CoIs, with experience and knowledge of food and drink industry influencing tactics. EPHA analysed specific articles of EFSA’s policy document related to its scientific committees. We have the following further considerations that may challenge EFSA’s effort for an ambitious and comprehensive policy:
– ‘Cooling-off’ periods insufficient or non-existent:
- Application for membership to EFSA’s Scientific Committee, Scientific Panels or Working Groups are to be rejected when a CoI activity happens in the present or in the past.
- These periods seem to be either too short- 2 years in case of an activity falling under the category of employment with a body other than a food safety organisations (FSOs) that is ongoing at the moment of the screening shall be considered in CoI with membership of that group.
- Membership shall also be prevented for activities that have been terminated in the two years preceding the submission of the ADoI – 1 year in the case of “for category research funding the assessment is to be made on the basis of whether the (co-)funding for research or developmental work received from the private sector during the year preceding the submission of the DoI exceeds 25% of the annual budget (…)”) or non-existent.
- Effectively, among litererally all activities undertaken by a potential member, such as “member of a management body or equivalent other than a management body of a FSO”, “ad hoc or occasional consultancy to bodies other than FSO”, “member of a scientific advisory body other than scientific groups of a FSO”, experts having interests related to other organisations for “economic interests” and “intellectual property rights” – only activities that are “ongoing at the moment of the screening shall be considered in CoI”.
- Those conditions equally apply to eligibility criteria for chairmanship of an EFSA’s Scientific Committee, Scientific Panels or working groups (a slightly stricter 2 year cooling-off period for being a “member of a management body or equivalent other than a management body of a FSO”, and a 5 year cooling-off period for “employment with a body other than a FSO or ad hoc occasional consultancy to bodies other than FSO” apply.
– Private-funds proportion to overall budget inadequate: the proportions of the economic operator funds to the overall budget seem too high (25% in the case above).
– Breach of trust: it is imperative to look into the occurrence, but also frequency of ‘omissions’ from DoI, especially if the omission happens on a regular basis. As regards Article 14: “In case of a breach of trust, EFSA shall propose to the Management Board the dismissal of the concerned member from membership of EFSA’s SC and/or Scientific Panels. The Executive Director may ask the Internal Audit Capability to perform a review of the scientific outputs adopted by the scientific body to which that expert contributed.” An individual found in breach of trust should also be prevented from re-applying in the future with this and any other EU agency. A review of the scientific outputs should be always performed.
4. Are the mechanisms effective to ensure expert compliance and EFSA staff compliance with the rules? It is an important development to see under CoI an item related to “negotiations with a prospective employer having a vested interest in EFSA or in its activities (provided the staff member has received an offer and the tasks assigned to the staff member have an impact on EFSA’s decision making process)”. In addition, post-employment issues in coordination with all the appointing bodies involved should be duly and adequately addressed.
5. Overall consideration on the balance: absence of bias and scientific excellence? Bias-free decision-making and scientific excellence do not exclude each other. It is perfectly possible to appoint scientific experts coming from the public field provided a long-term policy of building in-house excellence is implemented. Therefore, such systemic changes should go in parallel to other process-oriented changes. Public health agencies relying on industry-linked experts undermine their purpose, lose public trust and can potentially increase public health problems (eg. through giving misguided dietary advice).
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EPHA related articles
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