On marketing authorisations for plant protection products
In July 2015, ANSES was given responsibility for issuing, amending or withdrawing marketing authorisations (MAs) for plant protection products, and tasked with setting up a phytopharmacovigilance scheme.
After consulting all the stakeholders, the Agency set up a new organisation enabling it to fulfil these missions in accordance with its founding principles: scientific expertise, independence, openness and transparency, while paying particular attention to the separation between risk assessment and marketing authorisation activities.
The complexity of the scheme managed by the Agency and its alignment with the tasks carried out by other national players (Ministries, INRAE, French Agency for Biodiversity, Santé Publique France, etc.) and the European framework need to be explained to the various stakeholders.
Furthermore, the constant development of scientific knowledge and regulatory requirements, as well as the work conducted in phytopharmacovigilance, call for a regular flow of information to the relevant players.
After a meeting in 2017 to prepare the groundwork, ANSES decided to set up a permanent platform in 2018 for dialogue with stakeholders on activities related to plant protection products, in order to improve information and provide a regular framework for multi-stakeholder exchange.
The purpose of this dialogue forum is to discuss the state of knowledge, health risk assessment methodologies and current scientific debates on plant protection products, in order to:
- improve understanding of how opinions are formulated and the different stages of the process;
- help increase the visibility of the Agency's work and the clarity of the decisions taken and opinions issued;
- facilitate access to data;
- provide information on the scientific work and publications likely to be taken into account in the assessment of products and issuing of MAs;
- provide context on the assessment methods and the national and EU regulatory framework;
- encourage feedback from the field that could enhance phytopharmacovigilance work or provide guidance on the direction of research projects;
- promote scientific work likely to answer questions on plant protection substances and products and their uses, especially with regard to alternatives and biocontrol products;
- help clarify stakeholders' expectations and questions, and identify the most suitable methods/players/places for taking them into account;
- provide answers to stakeholders' questions, encourage and develop exchanges between participants.
This platform is open to various stakeholders working in the field of plant protection products, who have expressed an interest in taking part in and contributing to the discussions:
- industrial companies or company federations;
- associations for environmental or consumer protection, environmental health, and victim or patient support;
- technical institutes and professional federations;
- employee trade unions;
- agricultural unions.
Given the multitude of organisations interested in the impact and uses of plant protection products, this platform is open to more than 150 organisations that are regularly invited to participate in the debates. The configuration of this dialogue forum varies according to the topics discussed, but each meeting brings together on average around 60 people from the stakeholders concerned, who represent diverse viewpoints and interests.
The composition of this platform evolves regularly as new players express an interest in taking part in this dialogue forum.
Bernard Chevassus-au-Louis, former Research Director at INRA and Chair of the Humanité & Biodiversité association, was appointed Chair of this dialogue forum by the Agency's Director General.
This body meets two to three times a year, depending on the needs expressed by the stakeholders, current events and the Agency's work.
To preserve the equanimity of the debates, participants commit to listen, exercise restraint and respect the points of view expressed by other stakeholders, in the interests of equitable access and freedom of speech. Remarks made during the meetings must not be used or quoted outside this forum. A summary of the topics discussed is sent to all participants.
ANSES reserves the right to exclude any person who does not comply with the above operating rules.
This Committee is coordinated and managed by Régine Fraysse-Boutrais, who is responsible for openness to society within the Social Sciences, Expertise & Society Unit (MiSSES) of ANSES's Science for Expertise Division.