Whilst Prime Minister Rishi Sunak and Labour party leader Keir Starmer, centre attention on migration and tax policies, the UK healthcare industry awaits a new government that will tackle Brexit’s effects on the life sciences sector and a labyrinthine regulatory process.
As the UK heads towards a 4 July general election, recent YouGov polls, suggest that the battle for leadership will be fought primarily between the Labour and Conservative parties. In its manifesto, the Conservative Party has pledged to increase NHS spending above inflation, recruit more staff to the NHS and expand the Pharmacy First system. On the other side, the Labour Party has committed to “end regulatory backlogs” in the Medicines and Healthcare products Regulatory Agency (MHRA), and quicken treatment timelines. It has also promised to create a new “pro-innovation body” that will be responsible for setting new targets for regulators.
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During a recent clinical trials-focused event, industry leaders highlighted problems with regulatory timelines, citing significant backlogs in the MHRA and National Institute for Health and Care Research’s (NIHR) review processes as key challenges in the country.
Moreover, some attendees at the Outsourcing in Clinical Trials (OCT) UK and Ireland conference, also stated that there still exist unresolved regulatory issues related to Brexit, which require more clarity. Pharmaceutical professionals said they will be voting for a sleeker system that addresses the pitfalls of Brexit and regulatory uncertainties.
Last year, Lord James O’Shaughnessy, the former health minister, conducted a review of the UK commercial clinical landscape. The investigation identified several areas to improve as the UK has fallen down the rankings as a life sciences hub following Brexit and the Covid-19 pandemic.
Not enough has been done to bolster the life sciences industry again, says a site manager at a major international pharmaceutical company with several UK sites. He tells Pharmaceutical Technology that Lord James O’Shaughnessy’s review was “great”, but we need to continue the momentum. It would be helpful if the National Health Service (NHS) created a unified platform to work with vendors to run clinical studies, so the two sides can “speak freely,” he says.
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By GlobalDataA site manager at a major UK clinical research organisation tells this publication that the UK needs to attract more clinical trial activity to the country, lamenting a dip in activity over recent years.
The Association for the British Pharmaceutical Industry (ABPI) reports that the number of commercial clinical trials in the UK fell from 667 initiated trials in 2017, decreasing by 34% (excluding Covid-19 clinical trials) in 2020. Additionally, there needs to be more investment into patient recruitment, says an executive from a prominent pharmaceutical consultancy company, adding that this could strengthen the company’s clinical landscape.
A streamlined regulatory system
O’Shaughnessy’s May 2023 review found that 55% of clinicians want to be involved in research, but that 53% labelled time constraints as the biggest barrier. Moreover, delays and unnecessary barriers in several areas of the regulatory process make this even tougher, say clinical trial experts. Nasim Patel, the research and business director at 4 Medical Clinical Solutions, says that the UK “needs to bring back appeal” by working on MHRA timelines.
In September 2023, the agency set out a goal to increase its target for the proportion of medicines it assesses from 50% within 210 days under the old plan, to 90% in the same timeframe for the 2024 – 25 period. While the goal is admirable, the site manager says this would only be possible if the agency receives extra financial backing from the new government.
Jamie Cole, the director of life sciences at EMIS Health, stated that his clinical trial recruitment company would benefit from more collaboration between the public and private sector. He says an investment in data sharing would make a massive improvement in his day-to-day work, considering currently the company needs to get permission from individual general practices to access NHS data. A platform to request this data and share it in a more streamlined manner would speed up clinical trial recruitment pathways, he adds.
In a 13 June statement, the ABPI echoed this sentiment, asserting its hopes for more collaboration between the NHS and the commercial pharmaceutical industry to run clinical trials. The need for life science and healthcare collaboration was also highlighted at the recent NHS Confed Expo conference. “We really need a national strategy that focuses on all the different [government] departments, on how do we actually work together on common goals to improve not just healthcare, but health overall,” said Dr. Layla McCay, the director of policy at the NHS Confederation, at one of the conference’s keynote sessions.
The aftermath of Brexit
At the 26 June BBC Prime Ministerial Debate, when asked, “how can we mend our broken trading relationship with Europe?” Prime Minister Rishi Sunak said the Conservative party would cut taxes on business rates for small businesses. On the other hand, Keir Starmer, the leader of the Labour Party said, “I do not accept that we cannot get a better [trade] deal than the one that we’ve got [with the EU]”. He added that the Labour Party would aim to improve agreements with the EU surrounding research and development.
Following Brexit, the EU exerted full customs requirements and checks on UK exports. To partially mitigate this, in 2024, the government implemented the Windsor Framework which aimed to address supply chain delays when it came to trade in and out of Northern Ireland. Additionally, over the years, the UK has strengthened its own drug approval and health technology assessment procedures, separate from the EU. However, Patel says that the system still requires an overhaul. Since Brexit, the additional paperwork for import and export businesses trading with European companies has become “unnecessarily tedious,” causing delays in UK clinical services, he adds.
Patel says the life sciences sector should also be considered for future tax breaks to attract more business to the UK. During a presentation at the OCT conference, Dr. Yooni Kim, the vice president of clinical services at Novotech, highlighted Australia as a good example of this, given the country’s system of offering companies up to 43.5% in cash refunds through its research and development (R&D) refund scheme. Pharmaceutical companies may find the UK to be a more expensive location for the clinical development of their assets, says Patel.
Furthermore, the MHRA needs to provide further clarity on the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) guidelines, a pharmaceutical consultant tells Pharmaceutical Technology. ICH guidelines cover several parts of the drug development life cycle including marketing authorisation applications, biological medicinal products, and medical devices.
Before Brexit, the MHRA was under ICH in the EU system but has now become a full member of the ICH since 2022. In this post-Brexit transition, the MHRA has not yet provided full clarity on the specific changes in its ICH guidelines, leaving the industry in slight confusion, says the pharmaceutical consultant. While the MHRA did launch a public consultation on ICH Good Clinical Practice guidelines in May 2023, more direct counsel on the guidelines is still needed. Many people in the industry are still uncertain about how the transition from the EU has affected our current system in the UK and regulators have yet to explain this to the sector, the consultant adds.
