We’re now somewhere between the second and third attempt at the UK leaving the EU. Yet, as we approach the turn of the year, the future remains opaque. As with the last two attempts the incumbent government has committed to “absolutely no further delay”, this time past January 31, 2020. But with the general election results only days away this is far from certain – ambiguity and surprise at what unfolds seem to have become normalized states.
When it comes to the life sciences sector, we’ve seen particular turbulence – some real, some perceived. This has been accentuated as the NHS has continually been used as a pawn in party campaigns, either as a scare story or as safeguarding the future of UK plc., depending on which side of the political fence you sit. Away from politics, despite millions invested by the government in stock piling activities, a document leaked from the Department of Health and Social Care (DHSC) revealed shortages of 86 drugs including those for cancer, Parkinson’s disease and mental health conditions, as well as other more common conditions including antibiotics, hepatitis vaccines and anti-epilepsy drugs. However, drug shortages in some degree are not uncommon and this particular issue is arguably linked to global supply chain issues and not necessarily a linear consequence of Brexit. Shortages have also been reported in the United States and in a number of other European countries.
Brexit: The best- and worst-case scenario
These headline-making stories are the tip of an uncertainty iceberg for the life sciences industry. Whatever the outcome of Brexit, it is likely to impact everything from workforce, supply chains, movements of goods (export and import), regulatory activity, clinical trials (both ongoing and future), batch testing, release of product, inventory stockpiling and the list goes on. There have been a series of dialogues and technical notices about the potential impact of a "no deal" Brexit communicated from the UK Government to GPs, pharmaceutical companies and industry academics, which have been accepted by the life sciences and healthcare sectors. What is certain is that most sectors have recognized the need to adapt to whatever situation is ahead of us. The ongoing uncertainty (that has now lasted for years) can make making business decisions challenging and future planning quite crippling.
After decades of harmonizing the life science and healthcare sector across the EU, it seems incredulous that the UK will potentially become decoupled from the European system and network for the development and monitoring of medicines. However, if we do leave the EU on January 31, 2020, then the UK must embrace the change and turn it into a national and global opportunity and maintain its world-leading position in this sector and further accelerate advances in research for the benefit of patients and citizens.
The life sciences industry in the UK represents one of the most dominant economic sectors, contributing to over 70 billion to the UK economy and employing over 240,000 people. The UK government and industry has committed millions to the highly visionary Life Sciences Industrial Strategy, which places an emphasis on putting the UK in a world-leading position to take advantage of the health and digital technology trends of the next 20 years. The strategy aims to address a series of challenges within the life sciences and healthcare arena, such as continued support for innovation in science, encouragement in growth and manufacturing, making use of the data we have via leveraging digital tools, increased availability of talent in the sector, and cross industry collaboration – all to facilitate better patient care and support new innovative treatments and technologies. The strategy outlines three key areas within life sciences which the UK has committed long term and significant investment - genomics, digital health and early diagnosis. Science and technology advancements requires regulatory innovation in parallel to allow and ensure new treatments and techniques are controlled, safe and efficacious.
One of the “jewels in the crown” of the UK government is the UK regulator, the Medicines and Healthcare Regulatory Agency (MHRA). The MHRA is recognized as one of the largest and most innovative regulators in the EU and worldwide. If the MHRA (with Brexit) becomes an independent regulator then there is an opportunity to develop advancements in new regulatory frameworks for the new science and technology innovations, in an accelerated agile manner and essentially speed up drug research and development for the benefit of patients. This would be a significant undertaking and will require continued collaboration, investments in resources and training in the new complex science and technology (one example in the validation of artificial intelligence and machine learning algorithms). The MHRA will be crucial to the ability to execute on the UK’s Life Sciences Industrial Strategy and drive efficiency across the research and development ecosystem. The UK also has a huge asset in the diverse data set, intelligence and information stored within the NHS. This is something that is unique and doesn't exist anywhere else in the world. But right now, the industry faces much more risk than reward.
The flip side of a no-deal Brexit is that the UK doesn’t become a global beacon for clinical excellence. That it actually becomes marginalized in the context of EU regulations and unless equivalence is recognized, the UK would be decoupled from the current EU regulatory regime. If UK regulations do completely diverge from those of the EU, there would need to be a duplication of processes (UK and EU) and a need for additional resources to manage Brexit-related activities.
Of course, a Brexit transition is not so clearly defined. Just as other industries will encounter, there are many facets being faced by the life sciences sector on the brink of Brexit.
Medicine availability: As mentioned, this is one of the more well-covered topics in the press with frequent, if irregular, stories breaking relating to drug shortages. Despite reports, many of the headlines are extreme and while there is the possibility of drug supply issues, stockpiling of critical drugs is one area that pharmaceutical organizations and healthcare bodies have been preparing for, for some time.
Clinical Trials in the UK and EU: There is concern that with Brexit the UK becomes a less attractive market destination for conducting clinical trials. Some companies have been looking at suspending trials at least until there is more clarity around the regulatory landscape. It will be critical to make sure that patients who are participating in trials at the time of Brexit (both UK and EU) will be able to still access the same investigational drug they have been receiving. A “no deal” scenario could have a massive impact on the conduct of multi-geographic clinical trials in the UK and EU in the short and longer term and needs to seriously be addressed and mitigated against.
Increased costs: Having a divergent regulatory framework adds burdening costs to the industry and authorities. To date, the amount of resources and finances that have been deployed have not been insignificant in preparing for Brexit. Brexit has been an additional source of revenue to management consultants and companies providing specialist Brexit consulting services. There is also a concern that health organizations may not have complete accessibility to a broad range of supply of medicines at current prices, which puts additional costs on the NHS. Most probably, the costs will be borne downstream by the patient and taxpayers through higher cost medicinal drug and medical devices products.
Recognition of professional qualifications: The EU operates under the directive on mutual recognition of professional healthcare which facilitates the free movement of EU citizens by permitting professionals qualified in one-member state to practise in another EU jurisdiction. A significant proportion of doctors working in the UK gained their professional qualification outside of the UK. A mutual recognition of qualifications is a particularly critical issue especially in Northern Ireland/Ireland where clinicians move freely across the border. A potential lack of clinicians could impact ongoing clinical trials and the entire healthcare system in the UK.
Pharmacovigilance: EU Pharmacovigilance legislation came into force in 2012 and the provisions allowed for centralized reporting of safety reports and Suspected Unexpected Serious Adverse Events (SUSARs) to a database (EudraVigilance) which is managed and governed by the European Medicines Agency. It ensures the effective coordination, evaluation of risk, and provides data to the network for collaborative decision making around products. Upon a "no deal" scenario it is assumed that the UK will no longer have access to the systems and services the EMA provide around pharmacovigilance. The UK would have vastly smaller data sets with which to develop clinical safety and efficacy intelligence. EudraVigilance would not receive UK data and the UK will not be party to EU data, both being deprived of meaningful information from which to derive decisions around clinical trials and authorized products being monitored on the market. In general, the outcome will be a less efficient pharmacovigilance system, directly impacting the ability to make decisions around medicines.
Clinical research resources and funding: The EU provides a unique and thriving ecosystem for clinical research, by the provision of significant funding, sharing of expertise, development of world class facilities and international collaboration. Brexit will increase the burden of performing multi-center trials and could create obstacles to future collaborations and sharing of data sets. A "no deal" scenario could lead to the research community facing significant uncertainty about future funding sources and opportunities for collaboration. This would potentially lead to the UK losing academic expertise and a decline in demand from researchers to work in the UK, thereby damaging the UK’s research outputs and reputation.
Will pragmatism win the day?
The only thing that is certain, is that the life sciences industry is facing a huge amount of uncertainty and has had to invest significantly and has been preparing as best it can and carrying on as normal in the meantime until the future becomes clear. It’s a sufficient approach in the short term but, looking further ahead, one would hope that pragmatism will win the day. Europe and the life sciences industry has come so far in terms of drug development and supply, collaboration, patient care and improving the quality of life, to name a few areas. It is imperative that this is not all thrown away or lost in a divorce from the EU because if it is, nobody will win.
Regardless of what happens politically in the UK, the ambitious Life Sciences Industrial Strategy will move forward and independently of Brexit. The strategy for the UK is cutting edge in all aspects and puts in place the foundations for future growth of life sciences in the UK. As it is executed, it will deliver huge benefits to the citizens through advancement of science and the use of the latest digital health technologies to, ultimately, create a stronger economy and a stronger NHS. The MHRA, as one of the world's most innovative regulators, together with continued collaborations across its diverse stakeholder groups, will be a fundamental foundation to the advancement and success of the strategy in this sector.
Article author: Fiona Maini,
Principal Global Compliance and Strategy,