Race against time: Looking at the latest Brexit developments and their impact on pharma

With recent plans announced by the UK’s prime minister to remain part of the European Medicines Agency (EMA), which would be favourable for many in the pharma industry, I will look at these developments as well as how they will impact industry and the reactions from leaders in the field.

At the beginning of March, the prime minister, Theresa May, spoke about her plans to work with the European Union (EU) on terms that would mean the UK can remain part of the EMA. This announcement was met with guarded positivity from various bodies that represent the pharmaceutical and biotech industries, which have lobbied for cooperation from the initial outcome of the referendum back in 2016.

“It’s good to see the PM articulating the practical dynamics of our industry of the future, when she said in her speech that ‘membership of the EMA would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations’,” said the UK BioIndustry Association’s (BIA’s) CEO Steve Bates.

“Every month, 45 million packs of medicines move from the UK to the EU — and 37 million come the other way,” added chief executive of the ABPI, Mike Thompson. “That is why the Prime Minister’s commitment to seek cooperation on medicines regulation would be the best outcome for patients, not just in the UK but across Europe.”

Yet, the regulatory landscape is something that could be tricky to navigate. Currently, regulatory arrangements are very complex in nature and are managed by an EU-wide system.

Additionally, the UK has been a major influencer within the EU system, with the Medicines and Healthcare Products Regulatory Agency (MHRA) leading at least a fifth of new medicine evaluations for the EMA and having significant input into the development of GMP and product guidance. If there are changes to these arrangements, then the supply of medicines and devices may be affected across Europe. And, that is just the start of it, according to the ABPI…

“It’s now critical that both sides prioritise patient safety in phase two of the negotiations,” Thompson added. “Delivering close cooperation on the regulation of medicines is only one part of the challenge. Making sure the supply of medicines is uninterrupted is essential to ensure patients in the UK and EU can get the medicines they need from day one of Brexit.”

“By working in partnership, the EU and the UK have together achieved many research breakthroughs and developed pioneering systems of medicines regulation that have saved and improved countless lives. As the second phase of Brexit negotiations begins, it is vital that the concerns of patients are addressed with urgency,” agreed Aisling Burnand MBE, chief executive of the Association of Medical Research Charities (AMRC).“By taking healthcare and research into consideration, Brexit negotiators have the opportunity to ensure that no patient, whichever country they live in, faces unnecessary delays in accessing existing as well as new and better treatments.”

Negotiations are now in full swing with a conditional transitional period softening the blow on various sectors after 19 March 2019 (the official date the UK is set to leave the EU), it may be that a satisfactory outcome can be reached, but the clock is ticking.

As Bates concluded: “There is much work to be done but this is a positive step forward on the future of medicines regulation.”