A look at the key developments across the sector this year

This time last year I wrote an article appearing in the December 2020 PharmaTimes ‘Review of the Year’. I reflected on 2020 as a landmark year and looked forward to a 2021 where the focus wasn’t on COVID-19. On reflection, a little naïve.

In that article, I also considered the opportunities that 2021 would bring for the life sciences sector and it seems fitting to spend some time looking back over the year and to contemplate whether the UK has grasped those opportunities or let them slip through our fingers.

The first opportunity I wrote about was the emergence of the UK’s accelerated licensing regime, including the Innovative Licensing and Access Pathway (ILAP) and Project Orbis. Billed as the government’s flagship programme to accelerate promising and innovative medicines through regulation and health technology assessment to benefit patients earlier, it presented (and still presents) a huge opportunity.

A year on, though, it’s clear that there remain some notable barriers to access, including manufacturers being encouraged to offer their medicines “on a cost neutral basis”. This seems counter-intuitive and will no doubt undo the good work of the MHRA to streamline its regulatory process. Nevertheless, the idea is a strong one and, as we move into a new year, it will be important that the government continues to look to evolve and adapt the process based on the experience of those manufacturers that have been through the process.

Another development which dominated the sector’s attention in 2021 was the NICE Methods and Process Review. At the time of writing, the sector is awaiting the final programme manual. Based on what we’ve seen from the proposals to date, there is a general feeling that this is one opportunity that has not been fully grasped, with the review really only tinkering at the edges. This is a shame. Consequently, NICE reform will continue to be a big feature of the sector’s advocacy efforts over the next 12 months to ensure that our health technology assessment landscape keeps pace with the revolutions we’re witnessing in medical science.

Finally, I also wrote with excitement about the prospect of the adoption of the Innovative Medicines Fund (IMF), promised in the government’s 2019 election manifesto and long called for by EMIG. Given the commitment to launch a new medicines fund was made two years ago, it seemed obvious when I was writing this time last year that 2021 would be the year it was introduced. Never underestimate the government’s ability to dither!

Despite the ongoing delays with adoption, the Cancer Drugs Fund-style funding arrangement presents an important step forward for the medicines access landscape and will afford both innovative cancer and non-cancer products alike the same opportunity to benefit NHS patients. Ultimately, time will tell how successful the fund will be, but I’m hopeful that it will become an important tool for improving the availability of medicines and, crucially, addressing the inequity that currently exists between cancer and non-cancer medicines.

Looking ahead at the forces and changes that are likely to shape the sector next year, 2022 is going to be an incredibly busy year for us all!

COVID-19 has continued to dominate the news cycle throughout 2021 and has had huge implications for the life sciences sector. While the UK’s economic recovery has been bullish, the NHS has not fared as well with activity levels tracking below pre-COVID averages.

In this context, the life sciences sector has had to adapt to working almost entirely remotely with the NHS, which has presented a challenge for our field teams and forced us to reconsider the way we partner with the NHS to deliver joint working projects.

Looking forward, as we find ourselves in the midst of another winter, traditionally the NHS’s most challenging season, there is a risk that a perfect storm of resurgent COVID rates, a bad flu season, normal winter pressures, staff shortages and rising inflation could further hinder and delay healthcare recovery. While I hope that we are nearing the end of the pandemic, it is clear that it will continue to cast a long shadow over healthcare in the UK across 2022 and probably beyond.

But there is also optimism, the government is currently taking new health legislation through Parliament which proposes the establishment of Integrated Care Systems (ICS). Backed by a new Health and Care Levy which should generate an additional £12 billion for the NHS and social care each year, these reforms are the biggest shake-up of the NHS since 2012 and offer the chance for the NHS to reset and begin delivering care in a more streamlined way. If done well, these reforms could be hugely important for patients. For my colleagues in industry, building relationships with these new NHS organisations will be critical over the next year, especially as responsibility for specialised services is increasingly transferred to them.

Beyond the NHS, there is also likely to be an increasing focus on the importance of the life sciences sector in the context of the UK’s recovery from the pandemic and long-term economic growth. The pandemic, and the successful roll-out of COVID-19 therapeutics and vaccines, has underlined the vital work of the sector and the transformative potential of industry-government collaboration. The Life Sciences Vision outlined an ambitious plan for the future and it will be critical that we continue to work closely with the government during its implementation to ensure that the sector continues to be seen as a priority industry for the UK in order to attract global investment. To do so, we must look to leverage our global leadership in scientific research and regulation while taking steps to address longstanding challenges associated with patient access.

There is also some light at the end of the Northern Ireland Protocol tunnel. While this is by no means resolved at the time of writing, I am optimistic that both sides are beginning to demonstrate pragmatism in the interests of patient safety and hopeful that a long-term resolution can be agreed that puts patients above the politics. I have been writing about the impact of Brexit for over five years now, and while I’m in no doubt that it will continue to be a regular feature in my musings about the state of UK life sciences, resolving the medicines issue in Northern Ireland will hopefully afford us all a break from this topic in 2022.

Looking a little further ahead, the renegotiation of the voluntary scheme (VPAS) is likely to dominate much of the sector’s attention over 2022. Despite not being operational until 2024, building intra-industry alignment on our negotiating stance will be a priority over the next year, ahead of formal negotiations with government in 2023. The 2024 scheme is made even more critical as the current VPAS has been somewhat underwhelming from an industry perspective. The allowed 2% growth rate, likely to be lower than the rate of inflation over the next two years, has operated as a straitjacket on the industry.

Nevertheless, while there are clear challenges ahead of us, I ended my article last year on a note of optimism and I remain hopeful that 2022 will prove to be a transformative year for the sector. The UK has retained its strong focus on becoming a ‘science superpower’ and, while delivering change is never easy, I am confident that the industry and government together, with our shared vision, can truly deliver for UK patients.

2021 has been a challenging and busy year for all of us and, with Christmas currently still going ahead as planned..., it’s important that we all take a moment over the holidays to pause and reflect on the important work we’ve all achieved for patients over the past 12 months and share a toast to a prosperous, or at least more normal, 2022.