As the UK prepares to leave the European Union in March 2019, stakeholders across the European life sciences industry are busy preparing for Brexit’s potential impact on their operations. In France, the Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) – the country’s drug regulator – is seeing Brexit as an opportunity to gain a more prominent position in European medicine regulation.
With the European Medicines Agency (EMA) having announced its relocation from London to Amsterdam, the British regulator – the Medicines and Healthcare Products Regulatory Agency (MHRA) – stands to lose some of its influence within Europe.
This may present an opportunity for the French regulatory system to increase its European standing, as Dominique Martin, CEO of the ANSM, notes. “[Brexit] is a big opportunity for us, we have modified our indicators and have become more active in giving scientific advice.”
Regardless [of whether it is a ‘hard’ or ‘soft’ Brexit], a window of opportunity is opening.
However, Martin is keen to note that the nature and level of opportunity available to ANSM will depend on the type of Brexit that the UK chooses. He explains, “Will it be a hard Brexit, in which the UK is left completely out of the EU and Europe will have to fill the void left by the prominent British regulatory bodies? Or will it be a soft Brexit, wherein the UK will essentially re-join the EU in a matter of years? Regardless, a window of opportunity is opening.”
In order to step through this window of opportunity, Martin feels that the ANSM needs to draw from the experience of other European nations to better access EMA funding. He admits that “It may be in our interest to follow the lead of our Spanish colleagues, who have a system in which the EMA gives them funding for their portfolio of projects. The French system, as it stands, is not designed for such financial cooperation, but I think it could be beneficial as we regain footing in the European regulatory ecosystem. We need to create a ‘virtuous circle’ in which we can increase our access to financing, use the funds to invest in the quality of our regulatory work, and so on.”
Furthermore, Martin points out that, as part of its Brexit strategy, the ANSM will have to work closely with other stakeholders to share knowledge and bolster expertise. He points out that “In order to prepare ourselves for our Brexit strategy, we will need to work with the other government ministries. We may also need to consider having special ‘additional’ terms for certain members of the government; these additional terms are special extensions to specific mandates, implemented to help navigate the Brexit process. We may have to reorganize certain roles, focusing on our strengths. For instance, we are very good at oncology and vaccines. We need to fortify and prioritize our strengths in these fields, regardless if they are in industry, academia, or wherever.”