How has Sanofi been preparing for Brexit?

Our main priority all along has been to ensure that people in the UK and Europe continue to have access to the vaccines and medicines we produce, when they need them. We are now in good shape, whatever the outcome of the negotiations.

We’ve been planning for a no-deal Brexit for nearly 2 years. We focused our planning on this scenario as we believed this would cause the greatest level of disruption to the UK’s pharmaceutical industry. Our aim was to ensure we are prepared for the worst; whilst hoping for the best. So we had already initiated activity to increase our stockpile, based on our own projections over the potential disruption that a no-deal agreement could pose. However, we welcomed the Governments guidance in August and adapted our planning in line with their guidance to increase stockpiles by a further 6 weeks over existing arrangements. Put simply, we are stockpiling treatments so that patients do not have to.

We have also validated alternative supply routes to mitigate against any delays at the Calais-Dover border and duplicated necessary processes; such as moving Qualified Person (QP) release, Quality Control (QC) testing and Label and Packaging for all medicines destined for the EU from our UK site to a European site.

How much has the firm spent on these preparations?

Given the amount of variables at play, it is difficult to put an exact figure on how much Sanofi UK has spent on preparations for Brexit.

We have concentrated a lot of effort on our preparations and the figure is likely to be in the millions – a cost that we are absorbing to ensure people have access to the medicines and vaccines they need, when they need them.

How do you expect Brexit to impact on Sanofi’s operations in Europe?

In terms of the UK, we want to ensure the UK remains a hotbed for medical innovation and collaboration between government, businesses and academia. We want to ensure that Brexit does not disrupt international research collaboration.

We are, however, confident that the UK will continue to be an attractive destination for investment and the future growth of the pharmaceuticals sector in tandem with the rest of Europe.

Do you expect the UK’s departure from the EU to impact on Sanofi’s presence and investment in the UK?

However the deal may look after March 29, we are confident that the UK will remain an attractive location for investment. At present, Sanofi UK employs 1,200 people and, with its world leading universities and highly-skilled workforce, we remain committed to the UK and investing in the development of our workforce. We have a substantial manufacturing facility in Haverhill, Suffolk and, as a signal of our future intentions, we have recently announced an investment in a new head office in Reading.

Collaboration remains at the heart of our work in the United Kingdom, with 63 research collaborations currently in place, a number which we expect to increase in the coming years.

Are you concerned about customs delays and disruptions at the UK’s entry points and, if so, how to you plan to overcome these potential issues?

We have stockpiled medicines and vaccines, and feel we are well prepared for any eventuality, including delays at the Calais-Dover border. But we have also validated alternative supply routes to mitigate the possibility of delays to our treatments coming into the country.

Should patients be worried about access to medicines, if Brexit occurs under a ‘no-deal’ scenario?

We have worked really hard to reassure patients that we, and other companies like us, have robust contingency plans in place. We hope that people will not feel the need to stockpile medicines in their own cabinets.

Patient safety is our main priority and we have devised a range of back-up plans and alternative logistical arrangements to do everything we can to ensure minimal disruption from Brexit.

Do you think Brexit poses a significant threat to future timely access to innovative medicines in the UK?

We welcome the updated MHRA guidance published on 3rd January. It is clear the MHRA are thinking creatively on how to be a fast, light touch, regulator and it looks like there could be some exciting and encouraging regulatory processes in place.

We have been working with the MHRA on a fast-track national review for a new UK influenza vaccine, using a dossier based on the documents submitted in Australia, adapted to meet MHRA requirements. This expedited process shows that MHRA can be flexible and agile in their ways of working, and could provide opportunities for faster product approvals when the UK leaves the European Union. The process took just seven months, compared with a standard review time of 12 months for national approvals. However, such processes must be backed up with action from the wider health system.

What are your views on how the Brexit process has been handled, from an industry standpoint?

Our priority is to ensure there is no negative impact on the regulatory capacity, processes and timeframes for new and existing medicines and vaccines reaching patients and citizens in the UK from mainland Europe.

We have met with relevant government advisers and officials as part of delegations representing various trade associations which we are members of and have voiced our concerns around future access to medicines and treatments post-Brexit.

We are confident that through our contingency that people in the UK and Europe will have access to the Sanofi treatments they need whatever the outcome of Brexit.