Brexit: What’s next for UK pharma?

The UK’s official exit from the EU on January 31st marked the start of a year-long transition period, with a temporary deal agreed with the EU to keep the terms of trade relatively stable, at least for now. The European Union (Withdrawal Agreement) Act 2020 contains provisions to conserve mostly all EU law (as laid out in the “Acquis Communautaire”) so that it is still applicable in the UK until 31 December 2020. The lead-up to the departure has meant that pharmaceutical companies have actively been making any necessary changes to ensure their UK authorised medicines comply with EU law so that they can continue to be distributed in the European market.

With the industry still awaiting further post-Brexit related guidance from the EMA, what does the transition period really mean for UK pharmaceutical manufacturers?

Due to the lack of indication around procedures beyond this, many pharmaceutical companies have been left struggling to understand how the pharmaceutical supply chain will operate after December 2020. This has led to rising levels of uncertainty about the potential impact it could have on the supply chain and patients.

Considering the lack of clarity, manufacturers are still advised to continue to strengthen and support their regulatory workforces to ensure a smooth transition. Companies that have strong regulatory resources and expertise will be much better prepared to optimise outcomes whatever they may be. These well-prepared companies will also no doubt be able to position themselves with a competitive edge in the European market.

To this end, Recipharm has a well-established Brexit taskforce in place with the aim of closely monitoring all developments as we move further towards the completion of the transition period. The team continues to be responsible for preparing the company across the transition period, including investment in the necessary expertise and capabilities, with the overall objective being to minimise the impact of Brexit for customers.

Many in the industry hope that the UK and EU will be able to adopt a shared pragmatic approach and be open to exploring continued cooperation and collaboration in the interest of patient health and safety. Preserving the mutual recognition of regulations and institutions, such as the Medicines and Healthcare Products Regulatory Agency (MHRA), is deemed to be critical by many of the UK’s drug manufacturers. Through the MHRA, the UK plays a significant role in drug regulation in the EU and it will be a challenging task to replace its capacity and expertise.

As things stand, the EMA has specified that the UK will no longer participate in EU institutions and their decision-making following its departure in January 2020. The EMA states that this means that as of 1st February 2020, no representative of the UK can participate in meetings of the EMA’s scientific committees.

As the UK has now left the EU, attention is shifting to the negotiation of a free trade relationship. While the potential of the UK striking a ‘no-deal’ Brexit remains, it is still to be seen where the regulation of pharmaceutical products will fit into this process. Some aspects of a trade deal may be completed while other lower priority issues are still ongoing as deal negotiations progress.

While the fear of drug shortages associated with a ‘no-deal’ is, for now, out of the picture, the concerns surrounding drug supply still exist. If the UK decides to leave the EMA drug approval system and establishes its own, a very real risk of delayed access to new medicines is created in the short-term.