This article is part of the FERMA/AIRMIC joint Brexit Newsletter which is designed to give risk professionals unique insight into Brexit related risks and mitigation strategies.
Ipsen has a strong presence in the UK. Whilst based in France, it employs over 700 people across three different sites and has played a role in the UK pharmaceutical sector since 1981. Their Chief Risk Officer and AMRAE Board member, General Secretary Anne Piot d’Abzac explained how Ipsen have ensured their business continues to flourish.
At an industry level, 45m packs of medicine produced in the UK are supplied to EU countries every month. 37m travel in the other direction. Many of these drugs are exclusively produced on one side of the Channel whilst being consumed on both sides. Thus, any supply chain complications could lead to serious difficulties getting medication to patients. Ipsen is no exception as one of its drugs, Dysport is exclusively produced in the UK.
Notably, as Sir Michael Rawlins, Chair of the Medicines and Healthcare Products Regulatory Agency (MHRA), told The Pharmaceutical Journal, the UK does not produce some medicines that are critically important to the NHS, for example, insulin, the hormone required by the 3.5m diabetics in the UK (including Prime Minister Theresa May).
In the event that the UK’s MHRA were to remain closely aligned to the European Medicines Agency (EMA), the UK and the EU would share a system for drug safety monitoring, drug licences and clinical trials. However, in the event of no-deal, the UK would need to set up its own regulatory framework which could lead to delays in licencing and UK access to new medicines. Additionally, as explained by The Scientist, the UK has been instrumental in setting up the new EU Clinical Trials Regime (CTR), which aims to speed up clinical trials. However it may face significant delays using it post-Brexit
Furthermore, to sell medicinal products in the EU, businesses must be a market authorisation holder. One feature of this is they must be located in the EEA30 (members of the Single Market). In a no-deal scenario, product licences and sites for testing and drug certification would have to be located in an EU country for the products to be valid in the EU.
Ipsen’s Chief Risk Officer, Anne Piot d’Abzac, detailed Ipsen’s response to this uncertainty in an interview with French newspaper La Croix. She discussed how as it takes – due to regulation – months to transfer market authorisations and release tests from Ipsen’s UK site to another European site outside the UK. That’s why Ipsen began its Brexit preparations very early. In October 2016, just four months after the UK’s referendum and five months before the triggering of the Article 50 process, a Brexit task force composed of professionals working on regulation, quality control and institutional relations, to name just a few, began to meet to discuss the way forward.
For the past 2 years Ipsen has been preparing on the assumption of a hard Brexit, to ensure the continuity of medical supplies to patients who depend on them, both in the UK and the EU.
“For us, the most important thing is to do all we can to ensure there is no disruption to patient supply of medicines, particularly as we produce a medicine in the UK that goes to over 80 different countries. So, if a patient is on a medicine today, we need to do what we can to ensure they still have access to that same treatment post-Brexit” said Anne Piot d’Abzac
To ensure operational continuity, Ipsen has ensured that certain functions such as quality control and regulatory compliance will be carried out both in the UK and the EU to avoid disruption even if the mutual recognition of norms and standards does not materialise. Although it is noted that these steps, alongside the transfer of many records to the EU, has been a costly exercise.
On Ipsen’s future relationship with the UK the company is very clear. Writing in an article in the business publication Raconteur, Ipsen’s UK team stated:
“Ipsen continues to invest in a strong presence here, which is why we have research, development, commercial and corporate functions based in the country, not just supporting our UK operations, but our global businesses too. We have an ambition to bring one new medicine or indication to market every year. It is a partnership we want to continue for years to come.”
Whilst Brexit uncertainty remains strong, the case of Ipsen shows us one of the many ways in which risk managers can help drive value. Through the creation of a Brexit Task Force focussed on risks, Ipsen has managed to develop a comprehensive understanding of the threats arising from Brexit before implementing mitigation solutions.
Anne Piot d’Abzac engaged in a radio interview with BFM Business in which she discussed how Ipsen have responded to Brexit. It can be found here: https://bfmbusiness.bfmtv.com/mediaplayer/video/brexit-faut-il-se-preparer-au-pire-des-scenarios-33-1601-1132605.html
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