Its expertise activity is based on several foundations: the French standard for "Quality in expertise", ANSES's own Guide to Good Practice and Code of Ethics, the Committee for ethical(1) standards and prevention of conflicts of interest, and finally the whole foundation as found in the current legal rules and regulations.
Good practices for collective expert assessment
The reliance on collective expert assessment for evaluating health risks is one of the basic principles set down in the founding charter on which ANSES is based. For this activity the Agency applies the French standard NF X 50-110 on "Quality in expertise activities - general requirements of competence for an expertise activity" and is drawing up its own good practice guide.
Collective expert assessment is organised according to a procedure for selecting and bringing together experts from various fields to consider a particular issue, take into account all of the available scientific knowledge, organise collective hearings and debate for all of the experts' opinions and hypotheses and then to issue opinions and/or recommendations which are systematically made public.
These principles have been set down in 2 framework documents that were adopted by the Board of Administration in 2010: Basic principles and key points for expert appraisal and ANSES’s own Code of ethical standards.
Collective expert assessment thus guarantees that all of the knowledge and data on a particular issue are taken into account in order to be able to issue an independent opinion after considering all hypotheses.
In practice ANSES recruits most of its experts through public calls for candidates. All potential candidates have to sign a commitment to respect the Agency's ethical rules and they are only appointed once their public declarations of interests (which are mandatory and must be kept up-to-date) have been examined.
- The expert appraisal must be conducted collectively at all stages, from the initial presentation of data, through successive discussion and debate to the final conclusions.
The Committee for ethical standards and prevention of conflicts of interests
In order to guarantee the quality of its expertise, ANSES has an audit mechanism and a specific body, the Committee for ethical standards and prevention of conflicts of interests, which is responsible for dealing with particularly complex situations and evaluating choices which have been brought into question or raised doubts.
The Committee for ethical standards can intervene in the areas covered by collective expert assessment as well as in scientific and technical support, research applied to the Agency’s missions, reference activities, surveillance, vigilance, training and public information initiatives.
Based on specific requests, it examines the way in which the Agency implements all of the principles, rules and procedures that it has established for itself with regard to compliance with its ethical standards for ensuring independent expertise.
The Committee for ethical standards and prevention of conflicts of interest issues opinions on:
- any issue concerning the breach of an ethical obligation it has been requested to handle;
- all basic ethical topics. It issues general recommendations which may clarify certain practices or rules, and prevent non-compliance with independence requirements in expertise, by suggesting when necessary improvements to the applicable ethical standards;
- the Agency’s basic rules with regard to the independence of its work, its partnership policy, and changes in ethical standards, etc.
- special cases, such as when a situation is particularly complex (determining the level of risk of a conflict of interest for an expert or employee and its possible consequences for participation in an expertise mission with regard to the affair in question).
The Committee for ethical standards and prevention of conflicts of interests is a significant innovation in ANSES's governance structure, which is defined in the Agency's founding charter. It can intervene in all circumstances and all stages of collective expert assessment from a formal request through to an ANSES opinion.
The Committee for ethical standards and prevention of conflicts of interests can be petitioned by a member of the Board of Administrators, of the Scientific Board, of the Expert Committees or by the Director General or an ANSES employee.
It is empowered to collect all the necessary documents for its investigation and to hear third parties which might inform its decision.
The Committee has access to all the information the Agency possesses and the means necessary to function. It sends its opinions and recommendations to the petitioning individual or organisation as well as to the Agency's Board of Administrators and Director General. The latter informs the Agency's supervisory ministries of this and makes the decisions necessary for applying its Opinions and recommendations.
The Committee for ethical standards and prevention of conflicts of interest is made up of six members, all with acknowledged expertise and experience in ethical matters:
Appointed for a five-year mandate by the ministerial order of 11 April 2016, these committee members may not participate in any other ANSES bodies or activities.
An ethics officer at ANSES
The French law of 26 January 2016 on the modernisation of the health care system specifies that an ethics officer must be appointed for each public health organisation and Manuelle Vertot, Director of the Legal Affairs Unit, has been appointed in this capacity for the Agency.
She will conduct her ethical officer activities for a three-year period with the support of all the Agency's departments, while taking into consideration the opinions and recommendations of ANSES's Committee for ethical standards and prevention of conflicts of interest.
(1)Ethics is understood as the "moral code of rules specific to a profession" - L.-M Morfaux, Vocabulaire de la philosophie et des sciences humaines, Paris, Armand Colin. 1980.