Regulatory Professionals

“So the 31st of January 2020 is fast approaching and given the highly regulated nature of the Biopharma and Life Sciences sector the separation of the UK from the EU could have major ramifications for the industry and country. Beyond Brexit now with deadlines in place is a reality and the uncertainty of departure has now been replaced with accelerated preparation in the future arrangements for regulation of medicines and medical devices post-Brexit. With limited detail other than the December 2019 confirmation we are now definitely leaving the EU, there will be many, many questions and challenges ahead.

Our report tracks vacancies within regulatory across Europe, which can be seen as a heat map of how the market is adapting in the new, soon to be post Brexit world. Currently Germany (19%) and the UK (28%) have nearly half of all regulatory positions across the EU between them. We do however expect, at some point, to see a further spike in vacancies in the Netherlands with the European Medicines Agency (EMA) now firmly in place and organisations wishing to have regulatory teams closer to the HQ for EMA. However, and potentially alarmingly, in December 2019 the EMA reported a significant shortfall in its staffing numbers at its HQ in the Netherlands with projected staff requirements being 897 and actual current headcount standing at circa 775. Historically, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has been a major contributor and thought-leader for EMA. In a post Brexit world the MHRA is predicted to have a significant uplift in open roles within Regulatory Affairs (RA). With the EMA move to Amsterdam and the UK falling outside the jurisdiction of the EMA, the MHRA and the UK life sciences sector will need to clarify their future role in Europe and the world.

Our current report also indicates growth within Biotech. Medicines that require certainty in supply chain timelines, for example cell and gene therapies, require special consideration by MAHs when it comes to Brexit. The risk posed by Brexit requires careful assessment and there are no guarantees that border controls will operate smoothly immediately after Brexit. Many companies have chosen to alter their supply chain and agreements with their suppliers to ensure improved rigour in their supply chain.

Ian Hudson the last years outgoing chief executive of MHRA having left his post in September 2019 said of the UK’s drugs regulator’s “preferred option” was to continue working with the European regulator after Brexit. As we move ever closer to departure we can only hope our politicians see beyond politics and understand it is critical that post-Brexit the UK and the EU ensures patients are not disadvantaged, innovators can get their products to the UK market as quickly and simply as possible, and the UK/EU will and should continue to play a leading role in promoting public health.

As of the 31st January an update went onto www.gov.uk with MHRA guidance and publications about a possible no-deal Brexit. To add some context to the potential issues ahead it is worth considering that currently circa 45 million patient packs are supplied from the UK to the EU-27/EEA countries and over 37 million patient packs are supplied from the EU-27/EEA to the UK on a monthly basis. Taking the potential scale of this problem on board a plan for the starkest of outcomes of Brexit in order to avoid medicines supply disruption both inside and outside the UK is critical. This update from the UK government is of course a sensible and expected notification regarding our course of action, if not the preferred outcome.

There are 66 proprietary biologics due to come off-patent in the US between 2020 and 2025 and it is expected that an increasing number of biosimilar applications are expected across the established markets in the US and EU. A significant number of future biosimilar approvals are expected from companies based in Europe and Asia, especially China. considering the vast level of understaffing at EMA currently, who have a steady state to maintain alongside the challenges of Brexit, being so far below required headcount could have a profound effect on a smooth transition even in light of there being willingness on all parties to align and get to the optimum outcomes for patients. Collaboration with Europe when it comes to drug regulation would be the most sensible and preferable pathway and we in the UK and the remaining EU member states should never lose sight of what MHRA and the EMA are there for, which is first and foremost to protect the public, promote innovation, and make sure that the focus is on the patient and not politics. As we plunge to earth amidst the certainty that Brexit is now happening, let us all hope that politicians and decision makers across the UK and EU open their parachutes to steady both of our descents and their minds in tandem. “