The Impact Of Brexit On Clinical Trials

The level of uncertainty around the future of clinical trials is escalating, especially with the recent appointment of a new Prime Minister and the constant back and forth of Brexit negotiations. With no guarantee as to which deal will be executed, it is difficult to anticipate exactly how Brexit will influence and possibly limit the clinical trial industry for the UK.

Therefore, it is also difficult to prepare for these forthcoming changes. The relationship between the UK and EU is significant in this industry, as over 4500 UK-EU trials have been conducted between 2004 and 2016. A shift in this relationship will have both a direct and an indirect impact on the way clinical trials are conducted, in addition to short-term and long-term effects.

A report by Cancer Research UK, discusses the different potential deals that could be implemented along with what each could mean for the future of clinical trials in the UK. It focuses around 5 main themes; regulatory alignment, access to medicines, IMPs (Investigational Medicinal Product) and devices, data, funding and workforce. These themes are just a few of the many that will be affected by the repercussions of Brexit.

Regulatory alignment

The most direct and short-term impact Brexit will have, will be on the level of regulatory alignment between the UK and the EU. Although there have been some technical delays in launching and implementing the new regulation, the EU plans to change the way clinical trials are conducted. They intend to achieve this by putting into place the EU CTR (European Union Clinical Trial Regulation) which uses a Clinical Trials Information System (formerly known as the EU clinical trial portal and database) to harmonise the assessment and supervision process for clinical trials.

This new regulation will initiate several changes for clinical trials, including the sponsorship and the application and approval process. The concern is rooted from the extent to which the UK will be able to replicate these new changes. The UK government has made it clear that they plan to be as aligned as possible, however there is a chance that the UK may not be able to experience any of the advantages of the new portal and database, which, depending on how you looks at it, could be an opportunity to be innovative or have its challenges.

If the UK is restricted in collaboration and engagement in European trials, it could be detrimental to the UK’s attractiveness as a hosting country and research partner. The remaining themes are all subsequently impacted due to this issue. As soon as the new regulation is implemented, it is up to the UK to ensure that whatever regulation they choose to implement is as consistent with the EU CTR to avoid further consequences outside of the conduct of clinical trials.

border controls and data management

The UK’s access to medicines, IMPs and devices is also subject to being affected due to potential trade barriers. This relies upon the maintenance of the relationship between the MHRA and EMA and the EMA’s marketing authorisation to continue to apply to the UK. It is possible that the equivalence of regulation and standards of certification of IMPs and devices between the UK and EU may be influenced.

International trade also accounts for a significant percentage of the goods and services owned by the UK. With the possibility of new trade barriers, there is a risk of increased costs or interruptions in the movement of materials, which could in turn have a negative effect on patient care.

Border control, customs and regulatory checks between the EU and UK is also expected to be negatively impacted, regardless of the final Brexit decision. The efficiency and freedom of the movement of goods between the EU and the UK is predicted to be jeopardised, which raises a number of apprehensions, including the urgent delivery of drugs which may have short half-lives.

For a trial to be successful, the level of transparency and the ability to share data across borders is crucial. Following Brexit, it is likely that the MHRA will align its majority to the EU CTR and the UK will implement the rulings of GDPR. Lack of access to European data causes a great loss for the UK.

This affects the design and conduct of trials, the UK’s awareness of the real-world impact and effectiveness of their research and the patient’s access to treatments, to name a few. The pressing issue is the acceptance of UK data, both in the EU and internationally. It is imperative that the UK is able to effectively collect and share anonymised patient data internationally, whilst keeping the patient’s rights, safety and wellbeing protected.

funding and workforce

The UK government’s commitment to funding and the funding of UK trials are factors that have been considered to be critical to address within the clinical trials sector. Although short-term commitments may be easier to adhere to, the real cause for concern is the longer-term commitments as there are many factors that can determine and influence the UK’s stability, such as the economic status. In terms of the funds coming into the UK from the EU, the UK must ensure to be a full participant in the EU framework programmes, to protect the investment of UK trials and to secure collaboration amongst countries.

A strong workforce is central to a successful trial. A research team is made up of a range of individuals, with different backgrounds, skills and ideas. This is vital, not only for the efficient conduct of trials, but also for creating opportunities and initiating advances in technology and research. The talent of these workers significantly contributes to clinical trials in the UK and in some cases relies upon the ease of movement of workers and their families between the EU and UK.

The talks around Brexit have already influenced some people’s decision to remain or leave the UK and so decreasing the UK’s attractiveness as a destination for overseas researchers. Therefore, this not only impacts the recruitment of potential researchers but also the existing overseas researchers in presently ongoing trials. Even if migration of workers is still possible, it could lead to an administrative burden on the UK government. In all scenarios of Brexit, the movement of workers is bound to be affected.

Whether the government eventually decides for a ‘No deal’, ‘Hard Brexit’ or ‘Soft Brexit’, it is clear that there are significant changes in store for the UK Clinical Trial sector and that efforts must be made to ensure that the trials conducted are just as effective and beneficial for patients. It is also evident that regulatory alignment is not sufficient enough a means to ensure this.

The level of uncertainty around the future of clinical trials is escalating, especially with the recent appointment of a new Prime Minister and the constant back and forth of Brexit negotiations. With no guarantee as to which deal will be executed, it is difficult to anticipate exactly how Brexit will influence and possibly limit the clinical trial industry for the UK.

The UK government must direct its attentions to a number of factors, including those mentioned above, to protect the effectiveness of UK trials and more importantly patient safety. There is no doubt that this is a confusing and unclear time for the clinical trial sector, but addressing any potential issues from now could make the future of clinical trials a little more bright.

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