Public Declarations of Interests
What is the PDI?
The public declaration of interests (PDI) refers to relationships of interest of any kind, direct or indirect, that the individual concerned has had with public or private organisations involved in the Agency’s field of competence or the collegial body of which they are a member. The disclosure requirements imposed by this declaration cover all interests, relationships or facts likely to give rise to a potential conflict of interest or incompatibility between the duties of the individual contributing to the expert assessment for the Agency and their outside activities.
The French Act No. 2011-2012 of 29 December 2011 on the strengthening of health protection with respect to medicinal and health products (in French) and its subordinate legislation (French Decree No. 2012-745 of 9 May 2012 on public declaration of interests and transparency with regard to public health and safety (in French) and the Ministerial Order of 5 July 2012 then the Ministerial Order of 31 March 2017 laying down the standard document for the public declaration of interests mentioned in Article L. 1451-1 of the French Public Health Code (in French) standardised the DPI in a single form that is binding on all health agencies and competent authorities in matters of public health. All PDIs are collected and made public on the single DPI-Santé website.
Scope of the PDI
The PDI covers activities performed over the previous five years related to:
- the scope of ANSES’s missions for its relevant officials, members of its Board of Administrators, its Scientific Board, and its Committee for Ethical Standards and the Prevention of Conflicts of Interest,
- the field of competence of the committee or working group concerned, for the members of its expert groups and individuals invited to contribute their expertise without being members (expert rapporteurs on a given issue).
Who must complete a PDI?
Members of expert bodies, ANSES officials whose functions are directly related to expert assessment, and individuals invited to contribute their expertise to collegial bodies without being a member must complete a written public declaration of interests, using the standard document.
In accordance with Article L.1451-1 of the Public Health Code, experts may only take part in the work, deliberations and voting of bodies in which they serve, once their PDI has been submitted to ANSES.
When is it necessary to complete a PDI?
All individuals described above are required to submit a PDI, at the time they take office.
The PDI is then updated, at the initiative of the person concerned, on the occasion of any event likely to give rise to changes in its content. It should be updated at least annually.
Main items in the PDI
- 1.Main activity
2.Secondary activities undertaken
- 2.1. Participation in governing bodies of another organisation
- 2.2. Business consultancy, advisory or expert activity
- 2.3. Participation in scientific research, testing, studies
- 2.4. Articles, conferences, seminars, training
- 2.5. Inventions, holding of a patent or intellectual property rights
- 3.Management of activities benefiting from funding from a for-profit organisation
- 4.Financial interest in the capital of a company
- 5.Close relatives (parents, spouse, children or stepchildren) that are employees and/or have a financial interest in an organisation in the relevant field
- 6. Elective offices and mandates currently held
- 7.Other relationships of interest
Prevention of risks of conflicts of interest
Anyone contributing expertise is subject to the principle of impartiality. They may not be involved with an issue in which they might have an indirect or direct private or personal interest to uphold, which would then be regarded as having a “conflict of interest”. It is therefore their responsibility to declare all their “relationships of interest” in their PDI and update it as necessary, from the time of their application for a role with the expert group until the end of their tenure with ANSES.
ANSES conducts analyses of relationships of interest with respect to topics covered and thus institutes measures to ensure the principle of impartiality.
ANSES addresses conflicts of interest at two successive levels:
- During selection of expert group members, by reviewing the relationships reported in the PDI in the field covered by the expert body. A candidate will not be selected if the relationships of interest reported are liable to automatically give rise to a conflict of interest concerning the subjects addressed by the group;
- At each meeting of an expert group, by comparing the relationships reported in each participant’s PDI with the issues on the agenda. In this case, the participant(s) concerned will be subject to management or disqualification measures regarding the dossiers and subjects that pose a specific problem. In accordance with the terms of Article L.1451-1 of the Public Health Code, this expert or these experts may not take part in any work, deliberations and voting of bodies in which they serve. Work conducted by an expert with a conflict of interest may be taken into account, under the terms established by the Agency, especially by means of a hearing, however, this expert may not participate in any phase of the examination of the issue.
In order to ensure the transparency and traceability of decisions, and in accordance with Articles L.1451-1 and R.1451-2 of the Public Health Code, the public declarations of interests submitted to ANSES are published on the DPI-Santé website implemented by the Ministry of Health, with the exception of specific details involving family relationships and financial interests reported for close family members.
Where should a PDI be submitted or updated?
The single DPI-Santé website implemented by the Ministry of Health enables external experts, members of the Agency's governance bodies and any employees subject to this requirement to submit or update their PDI.