Life sciences industry and the post-Brexit route to market

Claudia Rubin takes a look at the life sciences industry and the post-Brexit route to market

It is hard to imagine what Brexit might have brought if it weren’t for the pandemic. However, five years on from the UK’s vote to leave the European Union (EU), we can take stock of the post-Brexit life sciences industry; whether our hopes or fears have been realised and where the industry should turn its gaze to from here.

Top 5 takeaways
1. The jury is out as to whether the UK is turning Brexit into a transformative opportunity for access to healthcare innovation for UK patients.
2. The Life Sciences Vision sets a goal for the UK to be ‘the leading global centre for innovative research, design and delivery’.
3. The new Innovative Licensing and Access Pathway (ILAP) pathway aims to bring innovative products through the licensing process faster.
4. Covid-19 pandemic has demonstrated the necessity of a truly symbiotic relationship between science and healthcare.
5. A highly aligned clinical trials, licensing and reimbursement programme is essential to seizing the post-pandemic opportunity.

The new Life Sciences Vision, published by the government in July, is the third iteration of the UK’s strategy and is emphatic about how critical the industry is to the future of UK plc. It also presents the strongest case yet, not only for how essential it is for the economy, but also how intertwined it is with transforming the health, and healthcare, of the nation.

Unquestionably, the biggest tangible life sciences success attributed to Brexit is the COVID-19 vaccination scheme. The rapid roll out of vaccines has made household names of the likes of Pfizer and AstraZeneca. The celebration of the vaccine programme’s Britishness – in the science, the commercialisation and in the rollout – has certainly served to paint a picture of what post-Brexit Britain can achieve.

In reality, Britain’s vaccine programme was not a by-product of Brexit. The UK could have gone its own way as a member of the EU, as well. It is not because of Brexit that the UK was able to procure its own vaccine supplies.1

However, arguably the vaccine scheme has illustrated the real and tangible benefits of reclaiming sovereignty over our medicine regulations, clinical trials, approvals and procurement. It is certainly the best, if not the only, visible example of this impact so far, though that is the crux of the problem; to date, we have little evidence of meaningful step-change from anywhere else.

Taking a critical look at the three major stages in medicines and medical technology access – clinical trials, licensing and reimbursement – leads us still to conclude that the jury is out, at best, as to whether the UK is turning Brexit into a transformative opportunity for access to healthcare innovation for UK patients.

On clinical trials
The last 18 months of Covid trials have shown what is possible if we move with great agility. Building on these experiences to be more dynamic and using more digital technology in research delivery features strongly in the Life Sciences Vision, which sets a goal for the UK to be ‘the leading global centre for innovative research design and delivery’. However, a very real and ongoing issue for many scientific institutions is the PhD student brain drain; straining human resources and hampering research for over five years now. With further uncertainty surrounding the post-Brexit immigration system, the renewed positivity underpinning our clinical trial infrastructure remains somewhat hindered.

“There is no shortage of innovative ideas, entrepreneurial clinicians or promising pilots across the NHS, but successful adoption and scale at a national level remains a key weakness”

On regulation
Another perceived strength of post-Brexit Britain is in our ambition to become a global regulator of choice for the rapidly growing digital health sector, as well as transformative pharma and medical technology. The Medicines and Healthcare products Regulatory Agency (MHRA) has implemented some welcome post-Brexit reforms, signalling both its intention, as well as some practical steps, through the new Innovative Licensing and Access Pathway (ILAP) pathway, to bring innovative products through the licensing process faster.

The MHRA also has the intention of attracting a wider variety of biosimilar products through accelerated UK market entry, prior to the European Medicines Agency (EMA) process. The difference here is not so much about timelines – for these are broadly similar – but rather less burdensome efficacy trial data and an acceptance of real-world evidence. Therefore, whilst the regulatory approval timelines are very similar, the less demanding MHRA process can offer a route to market that may involve significantly lower investment on behalf of the submitting company.

But a comprehensive new regulatory regime, for which the scene has been set by the new Medicines and Medical Devices Act, is yet to unfold. Undoubtedly, the additional administrative burden from new regulatory frameworks, the need to track changes to legislation between the EU and the UK, monitoring the Northern Ireland protocol, as well as the new Trade and Cooperation Agreement, will all need to be offset by some tantalising incentives for pharma.

On reimbursement
The third piece, the one that would truly lift the UK above its competitors in this sector, is whether we can leverage the gift to innovation uptake presented by our National Health Service; finally realising the promise of the NHS developing into the world’s largest testbed for life sciences innovation.

Traditionally uncomfortable bedfellows, the pandemic has demonstrated emphatically the necessity of a truly symbiotic relationship between science and healthcare. There is no shortage of innovative ideas, entrepreneurial clinicians or promising pilots across the NHS, but successful adoption and scale at a national level remains a key weakness. After all, it is only when innovation becomes standard of care, that transformative healthcare makes a real difference to patients’ lives. Without a realistic prospect of widespread reimbursement, a world-leading trials infrastructure that feeds into an efficient licensing pathway becomes rather a road to nowhere if rapid reimbursement remains elusive and the UK health system and its patients fail to benefit.

Since Brexit, some proposed developments such as the Innovative Medicines Fund, the reforms from the National Institute for Health and Care Excellence (NICE) Methods Review, a firmer framework for commercial agreements and conditional approvals do offer some promise. They point towards a recognition that we will be unable to realise the benefits of a sovereign regime, if companies are put off from launching products here. But these iterative developments do not go far enough and have been subject to much delay. Being outside the EMA is still a real risk, and anecdotally at least, it instinctively feels that the UK’s position as a priority market is still questionable. A deeper look at the evidence around this would be welcome.

The new Life Sciences Vision tackles this weakness in our value chain, with the promise of creating a task force to address the structural ‘scale-up and adoption’ problem head-on, but bold thinking, akin to the establishment of NICE and the National Institute for Health Research (NIHR), 20 and 15 years ago respectively, is still lacking.

If we are to seize the post-Brexit, post-pandemic opportunity, we need a highly aligned clinical trials, licensing and reimbursement programme that will do justice to the raft of exciting and novel advanced therapies and digital health technologies making their way into the world’s advanced healthcare systems.

Claudia Rubin is Senior Director at Newmarket Strategy. Go to www.newmarket-strategy.com