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The regulatory shift: Laboratory services post-Brexit

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Chris Allen, CEO of UK-based analytical testing and scientific consultancy provider Broughton, explains the challenges — and opportunities — that Brexit holds for laboratory services.

Key insights:

Although the UK officially left the European Union (EU) over two and a half years ago, the impact of Brexit is still being felt by Britain's pharmaceutical industry. Since then, we've noticed that areas like Qualified Person (QP), batch release testing and product manufacturing have been impacted. Manufacturers' questions remain unanswered in the absence of a Mutual Recognition Agreement (MRA) between the UK and the EMA that would facilitate market access. .

We all remember the extensive negotiations that lasted several years after the 2016 referendum and, arguably, the pharmaceutical industry was one of the most important industries to come up in these discussions. And it's no wonder, Linklaters estimates that each month 37 million packs of medicines are supplied to the UK from European nations, with 45 million heading in the opposite direction. Patients, researchers, universities, businesses, and this pivotal trade flow have all been affected by the regulatory shift.

Fast-forward to 2022, and much uncertainty remains. This is true for both analytical testing services like QC batch testing and in how we can attract the skilled professionals our pharmaceutical industry needs.

Mutual recognition

Trade of medicines and pharmaceuticals has continued because the UK Medicines and Health Products Regulatory Agency (MHRA) remains aligned with many areas of the European Medicines Agency (EMA). Despite the UK still recognising European standards, the EU no longer accepts generic drugs and other drug products manufactured in the UK, unless they have been tested in an EU member state, or one where an MRA is in place.

It's no longer a level playing field; one area where this imbalance is clear is batch release testing. The UK has a mutual recognition of audits, but not a mutual recognition of batch release testing data or QP certification. Since the end of the Brexit transition period, the UK has continued to accept batch testing results from the European Economic Area (EEA) and will do so until December 31, 2022. What happens after that remains unknown, but if the UK Government does change its position, pharmaceutical firms in Europe will have two years to adapt to any legislative changes, potentially having to set up new batch testing operations in the UK so that they can continue selling into the UK.

However, we can take comfort in how quickly the UK scientific industry upscaled and adapted when faced with an unprecedented pandemic, rapidly launching the world's most comprehensive coronavirus testing service. While not knowing what will happen after January 1, 2023 is a concern for the pharmaceutical industry, the UK Scientific community has proven its ability to adapt to whatever changes come into force.

Accelerated pathways

Following Brexit on January 1, 2021, the UK MHRA introduced the UK Innovative Licensing and Access Pathway (ILAP) to deliver safe and financially sustainable accelerated patient access to innovative medicines.  A new rolling review framework has also enabled the modular evaluation of treatments as data becomes available to simplify and accelerate their UK approval. The first COVID-19 vaccines underwent rolling reviews, speeding up patient access compared with other European countries.

As an analytical testing services provider, Broughton has predominantly been working with manufacturers selling into the UK, and we've seen the advantage that these accelerated pathways can provide. In the past, UK manufacturers benefited from funding such as the EMA's Horizon Europe program, but, since Brexit, EU funding has reduced significantly. We'd like to see the UK Government not just matching the funding lost through leaving the EU but increasing manufacturers' access to funding at both the national and local level so companies like ours can take full advantage of working within a more flexible MHRA framework.

Skills and training

Although access to technical skills and training was a cornerstone of Brexit negotiations, there are still signs of a scientific skills gap in the UK. In May 2021, the Home Office even placed specialist pharma roles on a business shortfall list, making it easier for foreign specialists to apply for post-Brexit skilled worker visas. For analytical testing companies, a skills gap could manifest in a shortage of experience across multiple areas such as quality control, quality assurance or product manufacturing.

Analytical testing and scientific consultancy companies like Broughton are not working in isolation ― they're an essential part of the pipeline feeding other parts of the UK pharmaceutical industry. Without this pipeline, there will be fewer people to step into technical research and development (R&D) roles, undermining future growth opportunities for manufacturers.

We have fantastic scientific skills in this country and need to make the most of them. At Broughton, we benefit from being close to many northern science universities, meaning we can tap into a wide talent pool without being part of the Oxbridge-London triangle. We also noticed that more young people are looking at alternatives to university, so we expanded our apprenticeship programmes as a way of promoting careers in analytical science. I also participated in the Government's apprenticeship trailblazer scheme, which focuses on gaining a better understanding of the industry's skills. This insight helps develop apprenticeships that train young people with the right expertise, helping to close skill gaps for businesses like ours. 

Final thoughts

No one can deny that Brexit profoundly impacted the UK's pharmaceutical industry, and analytical testing services are on the frontline. While much uncertainty remains, especially in the run-up to January 1, 2023, there are many reasons for hope. If we can continue feeding the industry pipeline with strong home-grown technical skills and the UK Government provides the necessary level of investment, the pharmaceutical industry could harness immense benefits from working within a more flexible regulatory environment.

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