ANSM et ANSES, together in a "one health" approach

Joint interview with Jean-Pierre Orand, Director of the French Agency for Veterinary Medicinal Products (ANMV) within ANSES, and Caroline Semaille, Deputy Director General in charge of Operations at the French Health Products Safety Agency (ANSM).

In France, two health agencies are responsible for medicines. How do the ANSM, which oversees human medicines, and the ANMV, responsible for veterinary medicines, coordinate their actions?

CAROLINE SEMAILLE. The ANSM and the ANMV have been working together for a very long time, mainly in the inspection of pharmaceutical establishments with combined human and veterinary activities. We poolour resources in this area, and coordinate our efforts: in 2021, we conducted five joint inspections for non-clinical studies. Our agencies also work together during major problem situations. This was the case with the shortages of human medicines and the possibilities of supplementing
them with veterinary medicines if needed during the COVID-19 crisis. We will be extending this cooperation to the assessment of marketing authorisation applications in order to capitalise on our respective expertise. 

JEAN-PIERRE ORAND. We also work together at European level. The ANSM and ANMV represent France's position at the European Medicines Agency and take part in the network of European Heads of Medicines Agencies, which addresses health policy and management issues. We co-chaired the two meetings of this network during the French Presidency of the European Union, by video conference and in Saint-Malo. 

On which subjects, historical or new, do you work together? And what do you get out of these collaborations?

JEAN-PIERRE ORAND. Of course, we are still heavily involved in the issue of antimicrobial resistance, one of our longest-standing areas of collaboration. We also see other issues emerging. For example, the use of herbal veterinary medicinal products is becoming increasingly popular among farmers and veterinarians. In 2021, the ANMV produced a consumer risk assessment in which ANSM staff participated, as this is also a well-known topic in human medicine. While each agency has its own tasks and assessors, there is a clear benefit in working together, particularly on the assessment of environmental risks associated with the use of medicines. 

CAROLINE SEMAILLE. In some areas, such as herbal and homeopathic medicines, skills are scarce. It is therefore in both our interests to exchange our respective expertise. The ANSM's toxicology experts participate in the ANMV's work and, in parallel, their experts are associated with the French Pharmacopoeia Commission. In addition, the ANMV, and ANSES more
generally, has developed environmental health expertise from which we can also benefit. With the new European policies
related to the Green Deal, we are moving towards a greater consideration of environmental impacts, including for human
medicines. 

What future collaborations have you planned?

JEAN-PIERRE ORAND. In animal health, we are seeing the emergence of new therapies, such as gene therapy or the use of stem cells, which already exist in human medicine. This encourages us to strengthen our exchanges with the ANSM on these innovations by taking the overall "one health" approach even further. The subjects are increasingly cross-cutting and call for
closer links. For example, the two agencies are partners, along with the Ministries of Health and Agriculture, in the WHO-led,
EU-funded PARS project. This is designed to support structural reforms in the Member States regarding antibiotic availability. We
are also jointly supporting a project to assess a European dossier on a human vaccine for avian influenza.

CAROLINE SEMAILLE. To put into action our desire to break down barriers in public health activities, we are launching the construction of the future joint ANSM-ANSES facility, whose first stone will be laid in Lyon in July. The teams of our two Lyon agencies will be grouped together in a single building: they will share a single laboratory offering a high level of biosafety and
advanced technologies. This facility will thus enable us to pool our skills, which will focus primarily on one of the pioneering topics of our collaboration: antimicrobial resistance, for which the "one health" approach is of great importance. This is a
great achievement in our cooperation.