On 31 January 2020, the United Kingdom (UK) withdrew from the European Union (EU). Alongside a number of repercussions, the most impactful to the drug discovery sector arguably relates to regulatory affairs on account of adjusting from the European Medicines Agency (EMA) to the Medicines and Healthcare products Regulatory Agency (MHRA). This is the second article in a two-part article where DDW’s Megan Thomas evaluates the current impact of Brexit on the UK drug discovery sector. Read Part 1 here.
An overview: Where does the UK stand?
A report by Imperial College Business School asked1: “Has the UK fulfilled its ambition to break free from Brussels and give patients faster access to new drugs as they emerge? Or has Brexit only increased red tape and made the UK a less attractive market for innovation?” In an attempt to answer this, the report investigated official records of drug approvals and drew comparisons between the performance of the MHRA, and its international counterparts in the EU, US and Switzerland.
Key takeaways from the report revealed1:
- Fewer novel drugs were authorised by the MHRA in 2021 – its first year of independence – than by the EMA, with 35 approved in the UK, compared to 40 in Europe and 52 in the US.
- Of five new drugs that were approved in Europe but not the UK in 2021, two were given the MHRA ‘green light’ in Spring and early Summer of 2022, while three had yet to be approved at the time of the report’s publication.
- In 2021, the MHRA said it would rely on EU medicine approval procedures for two years in order to maintain stability and continuity. This was then extended in January 2023 with the aim of introducing a new international recognition framework in 2024, taking into account EU regulatory decisions, as well as those of other international regulatory bodies. As such, nearly 70% of new drugs authorised by UK authorities relied upon the EU’s approval process.
- There are suggestions that pharmaceutical companies may judge it ‘not to be worth the effort to seek UK approval’, on account of the size of the national market (the UK makes up 2.4% of the global pharmaceutical market) and ‘doubts over approval and NHS commitment’.
The report explores whether Brexit has opened up an opportunity for innovation and name checks Project Orbis and the national Early Access to Medicines Scheme. Another programme making a positive impact on the sector is Innovate UK.
Initiatives for innovation
The FDA Oncology Center of Excellence (OCE) initiated Project Orbis in May 2019 to provide a framework for concurrent submission and review of oncology products among international partners, which includes the MHRA, which joined in January 20212. Alongside the MHRA, Project Orbis involves the regulatory authorities of:
- Australia (Therapeutic Goods Administration (TGA))
- Canada (Health Canada)
- Singapore (Health Sciences Authority (HSA))
- Switzerland (Swissmedic)
- Brazil (Agência Nacional de Vigilância Sanitária (ANVISA))
- Israel (Ministry of Health)
Dr June Raine CBE, Chief Executive, Medicines and Healthcare products Regulatory Agency said3: “With Project Orbis, we are working to ensure that patients receive earlier access to promising, life-saving cancer treatments. We know that the earlier we can treat patients, the better their outcomes. Through international cooperation, innovation in regulation, and working with others across the whole health system, the MHRA is cementing the UK’s global position at the centre of life sciences and healthcare access.”
According to NHS England, the Early Access to Medicines Scheme (EAMS) helps give early access to new medicines to people with life threatening or seriously debilitating conditions, that do not yet have a marketing authorisation but where there is a clear unmet medical need4. The scheme was launched in 2014.
In a case study by the NHS on treating advanced renal cell carcinoma, Dr Balaji Venugopal, Honorary Clinical Senior Lecturer at University of Glasgow, said5: “EAMS offers an excellent opportunity for patients to access drugs within the NHS in areas of unmet need. For patients with advanced kidney cancer, the clinical trial has shown that the combination of avelumab and axitinib significantly extends the time without worsening of cancer and shrinks the cancer when compared against available standards. A significant number of patients have benefited in this clinical trial and through EAMS patients can access this combination in routine clinical practice as quickly as possible.”
In terms of Innovate UK, which has been in action since July 2007, the impact in a post-Bexit climate on UK innovation and development has been consistent. In March 2021, as reported by DDW, Pathios, a biotech company focused on the development of first-in-class therapies for cancer, announced that it had been awarded £350K in the form of a Smart Grant from Innovate UK. Another DDW story revealed that NK:IO has been awarded £1.6m ($2.1m) in grant funding from Innovate UK’s New Cancer Therapeutics programme. Moreover, UK technology company FourPlus, along with collaborators Holosphere and the Cell and Gene Therapy Catapult, have been awarded funding from Innovate UK to create and test a mixed reality training platform that enables customised training delivery for pharmaceutical companies and healthcare.
Last, but hopefully not least, Access Consortium is another recognition framework for medicines that will be in place by the first quarter of 2024, according to the UK government6. The government claimed: “The new framework will allow the MHRA to make the most of the expertise and decision-making of trusted regulatory partners to streamline assessments of specific products. As a result, cutting-edge medicines that have been approved in other countries will get to UK patients more quickly, with cost reductions and streamlined regulatory processes for industry.”
Dr June Raine, MHRA Chief Executive, said: “By fast-tracking access to approved products from other countries, we’re ensuring that innovative healthcare solutions reach those in need without delay.
“The introduction of the new routes will complement the work being done through the MHRA’s Innovative Licensing and Access Pathway (ILAP), establishing an additional avenue for accelerated access to life-saving new medicines. Combining MHRA’s globally recognised high standards with improved flexibility and a sustained collaborative approach across the healthcare system, the ILAP is helping reduce the time to market for innovative treatments by developing medicines that are both regulatory and access ready.”
In a paper in the Journal of European Public Policity, Parallel, divergent or drifting? Regulating healthcare products in a post-Brexit UK, Mark Dayan, Brexit and Trade Programme Lead at the Nuffield Trust, Holly Jarman, Associate Professor of Health Management, Policy and Global Public Health within the University of Michigan School of Public Health, Tamara Hervey, Jean Monnet Professor of EU Law ad personam at the City Law School, City University, London, and Mark Flear, Reader in Law and Socio-Legal Studies, Queen’s University Belfast, argue UK government needs to recognise that they have not succeeded in finding or implementing sudden quick wins from post-Brexit deregulation, and that they need a robust strategy for NHS supplies and medical industries facing instability.7
In a blog written by the authors for the London School of Economics, they stated8: “As our new research shows, the ongoing fact of Brexit has created a real dilemma for the UK, long home to a strong pharmaceutical sector and an NHS which excelled in getting enough medicines, medical devices and equipment at low cost. In our recent article, we find that the UK has struggled to adopt either strategy, or to work out a competitive way forward. To understand how we got here, we assess why simple narratives do not explain post-Brexit challenges, and how the limitations of the UK’s new circumstances and the capabilities of its government confine its choices.”
According to the authors, the government need priorities not over-simplifying narratives, having clear alignment on medical devices and equipment, test possibilities of divergence in the regulation of medicines, and ensure there is enough capacity. They said8: “The narrative that depicts the UK as newly freed to diverge from a stationary EU is false – the reality is much more complex. What is needed is a robust, coherent strategy to ensure that the NHS can get the products that it needs, not ideology-driven rhetoric. People in the UK deserve a grown-up, honest conversation about the UK’s future, which takes into account a realistic assessment of its size in global markets, the needs of health services in its nations, and the special place of Northern Ireland, which is likely to continue.”
Perhaps the only conclusive point to come to on the topic of Brexit and the industry at large is that regulation, particularly relating to the MHRA, is not a conclusive subject. There are a number of moving parts, a lot of work still to do, teething problems, and variables to consider. While there seems to be a lot of promise and opportunity, time will tell what post-Brexit Britain looks like.