The European Food Safety Authority (EFSA) has published implementing rules related to Declarations of Interest (DOIs), one of the cornerstones of its recently adopted Policy on Independence and Scientific Decision-Making Processes. The rules related to Declarations of Interest (DOIs) continue to strengthen the procedures in place for screening and managing interests declared by those involved in EFSA’s activities. The new rules provide a clearer and more transparent set of general principles applicable to all those engaging in EFSA’s work – scientific experts, staff, members of the Management Board and third party organisations, including external contractors. The implementing rules allow EFSA to tap into the best scientific expertise available while ensuring – for both the organisation and its experts - independence and integrity throughout all areas of the Authority’s governance and work. The rules will be presented publicly for the first time today at an information session in Brussels for stakeholders and interested parties. EFSA has utilised the new rules in the ongoing re-establishment of its Scientific Committee and eight of its Scientific Panels. For all other individuals and processes concerned, the rules will enter into force as of 1 July 2012, with a 4-month transition period.
Speaking ahead of the information session, EFSA Executive Director Catherine Geslain-Lanéelle, said: “EFSA understands that, notwithstanding the high caliber of its scientific work, the value of its scientific advice is directly linked to the level of trust held in it by the public and therefore seeks to guarantee independence in all aspects of its governance and scientific activities. The new Implementing Rules provide clearer guidance for experts submitting Declarations of Interest to EFSA and increase the level of scrutiny and number of safeguards in place to guarantee independence throughout all our activities. Importantly, these improvements also provide an additional layer of protection for EFSA’s scientific experts in recognition of their commitment to support the organisation in fulfilling its public health mission. ”
The new rules lay down in detail the criteria EFSA uses for assessing interests declared by scientific experts and other individuals involved in its work. Different types of interests are listed with guidance about whether or not they constitute potential conflicts of interest. Where a potential conflict of interest is identified, the scientific expert or individual is prohibited from participating in EFSA’s scientific work or taking up certain roles. For example, scientists currently employed by industry (including full-time consultancy) in areas relevant to EFSA’s work (such as the food and feed industry) are categorically excluded from becoming a member of any of EFSA’s scientific groups, including the Scientific Committee, its Panels and their Working Groups. In other instances, and depending on the interests concerned, an expert may be allowed to become a member of a Scientific Panel but not be eligible for consideration as Chair.
The rules are also more inclusive of experts with interests in public organisations with a similar remit to EFSA and facilitate in particular the involvement of scientists from national food safety agencies in EFSA’s work. Scientists from organisations carrying out tasks within EFSA’s mission and pursuing public interest objectives such as national food safety agencies, universities or international organisations have expertise that is valuable to the Authority’s work. EFSA actively seeks to foster real and effective networks with these experts and the rules are designed to reflect this.
The rules provide definitions of interests and general principles for the declaration and assessment of interests which apply to a wide range of individuals and organisations which are involved in EFSA’s governance, such as its Management Board, or that have a role to play in the delivery of its scientific work. These include scientific experts, such as members of its Scientific Committee, Scientific Panels, working groups and EFSA Networks, members of the Management Board and the Advisory Forum, the Executive Director and EFSA staff. For the first time, it is made explicit that the rules also apply to external organisations, such as contractors or grant beneficiaries which contribute to EFSA’s scientific work.
EFSA confirms its commitment to defend the reputation of its experts should unfounded allegations be put forward by third parties. Recognising that the responsibility for complete and truthful DoIs lies with the person filling in the declaration, under the new rules EFSA has introduced an additional level of scrutiny in support of the integrity of both the process and its experts. As part of the overall verification of its declarations of interests procedures, EFSA will carry out random sampling of declarations of scientific experts to monitor for completeness and coherence with EFSA’s rules.
The rules implement EFSA’s recently adopted Policy on Independence and Scientific Decision-Making Processes. The policy integrates in one document the wide range of initiatives EFSA has put in place to uphold its core values of scientific excellence, openness, independence, transparency and responsiveness. It not only covers issues related to interests and independence but also sets out the internal mechanisms and processes which EFSA follows to ensure good governance within the organisation. The policy was subject to a public consultation and was also discussed with stakeholders and interested parties at a conference in Brussels in October 2011 before being adopted by EFSA’s Management Board in December of the same year.
In recognition of the interest of stakeholders in the implementation of the policy, EFSA is holding an information session in Brussels on 5 March 2012 to explain how the Authority will assess interests and make decisions regarding the interests of experts under the new rules. Through the use of practical illustrations, stakeholders will be able to gain a better understanding of the factors that EFSA will consider when screening Declarations of Interest.
The main new features of the Implementing Rules compared with those that preceded them are:
1. Greater scrutiny and more safeguards:
- Definitions and principles apply to all those engaging in EFSA’s work – staff, experts, members of the Management Board or third party organisations, including external contractors
With respect to EFSA’s scientific work:
- stronger measures concerning industry-related interests eg scientific experts previously employed by industry must wait 2 years before being allowed to be a member of one of EFSA’s scientific groups
- stronger measures concerning funding-related interests eg scientific experts managing research funding, 25% or more of which comes from the private sector in the year preceding the submission of their DoI, have restrictions placed on their ability to take part in EFSA’s scientific groups
- introduction of random sampling of DoIs to monitor for completeness and coherence with EFSA’s rules
- creation of the Committee on Conflicts of Interests, a body that will review decisions on interests subject to possible complaint or questioning
2. Greater clarity and transparency
- a clear definition of ‘conflicts of interest’ compatible with OECD guidelines
- a clear definition for organisations deemed to carry out tasks within EFSA’s remit (also known as ‘Food Safety Organisations’) and from which the Authority actively seeks participation from scientific experts
- an explicit reference to the requirements of external contractors and grant beneficiaries (and in some cases the staff working for those organisations) regarding DoIs
- rules clearly state that scientific experts cannot assess, review or rate their own work
- a clearer set of definitions of relevant activities which have to be declared by all persons
- a simplified table (Annex IV of the Implementing Rules) clarifying which declared interests would lead to a scientific expert being allowed or disallowed to take part in EFSA’s scientific groups and in what role (e.g. chair, vice-chair or member).
- rules increase transparency of preventive and remedial measures ensuing from each interest and activity; all decisions are recorded in meeting minutes including how decisions were assessed
3. Access to the best scientific expertise while ensuring impartiality
- Interests are a consequence of attaining high-level scientific recognition at international level; clearer criteria for screening and managing possible interests allowing EFSA access to top scientists
- Rules are more inclusive of experts with interests in Food Safety Organisations
- New rules on research interests allow EFSA to include top scientists involved in the European Commission’s Horizon 2020, and to support its objectives to stimulate growth and innovation
- Rules provide more comprehensive framework for declarations of interests to support EFSA’s scientific experts who dedicate their time, knowledge and expertise to the Authority’s work
 Members of EFSA’s Scientific Panels and the Scientific Committee are nominated for 3 years. The terms of the Scientific Committee and eight Scientific Panels (Animal Health and Welfare; Biological Hazards; Contaminants in the Food Chain; Feed Additives and Products or Substances used in Feed; Genetically Modified Organisms; Dietetic Products, Nutrition and Allergies; Plant Health; and Plant Protection Products) will expire in July 2012. The EFSA Management Board will consider at their March meeting a list of candidates for possible appointment to these panels drawn up by EFSA following an open call for expression of interest and a rigorous evaluation procedure.