Britain’s impending departure from the EU has raised a host of concerns in the drug development industry. In particular, worries have been voiced over the UK’s possible exclusion from funding opportunities and regulatory bodies such as the European Medicines Agency (EMA).
Though the British government has made promises to implement a new EU Clinical Trials Regulation (CTR ) and has stated its commitment to “being as aligned with the new EU clinical trials regulation as we possibly can be” at a recent debate in the House of Lords, worries remain over the post-Brexit clinical trial landscape in the UK.
Eight experts give their opinion on what Brexit may bring for the drug development industry.
How will Brexit impact the funding and regulation of clinical trials?
Pablo Graiver, CEO, Antidote Technologies
The largest concern facing the clinical trial industry is the same as that facing most sectors: uncertainty. In particular, researchers are facing uncertainty in three key areas:
Funding. While many major pharma companies have voiced clear commitment to continued R&D investment in the UK post-Brexit (including UK-headquartered AstraZeneca and GSK ), it remains to be seen how this will play out in practice. The UK is a large target market with experienced staff and clinical trial infrastructure so it seems likely that funding for commercial trials in the UK will continue without major disruption, assuming no major regulatory hurdles arise.
Regulation. Until recently, it wasn’t clear how the UK would manage the approval of trials alongside the supply and manufacture of study drugs between the EU and UK border. If the new CTR is delivered as promised, this should smooth the way for regulation around multi-centre clinical trials running across the EU and UK.
Freedom of movement. Current freedom-of-movement laws make it easy to hire EU nationals, and it remains to be seen how this will be dealt with post-Brexit. A shortage of qualified clinical trial staff will clearly make the UK a less attractive market to run studies.
James Burt, executive vice president, Accord Healthcare
Despite concerns that the UK could be left behind as pharma companies look to conduct clinical research and approve new drugs in larger markets, there are reasons for optimism.
The global trend within medicines regulation is increasingly for the leading agencies to work more collaboratively and mutually recognise activities and approaches. The Medicines and Healthcare Products Regulatory Agency (MRHA) is currently responsible for 40% of the testing that the EMA undertakes. It is highly likely that some degree of mutual recognition will be achieved given the positive precedents between agencies such as USFDA, EMA, Swiss Medic etc.
Despite uncertainties, we conjecture that post Brexit, the MRHA will continue to be a beacon of scientific excellence and a juggernaut in setting up trade agreements with the US, Middle East and Asia, retaining the UK’s appeal as a key market for clinical research and drug development.
Andrew Rut, CEO, MyMeds&Me
I view Brexit as a real opportunity for the UK to shake off unnecessary bureaucratic restraints, showcase its excellence in both research and medicine, and use it to the benefit of bio-pharmaceutical and academic-driven research in the medical arena.
The UK may not be able to compete with the US and China in a purely patient numbers game in clinical trials, but the way medicine is practiced here, and the highly connected nature of our systems means we can offer something really appealing to a global marketplace in more complex trials – such as CAR-T Cell therapies, immuno-therapeutics or those requiring long-term patient follow up.
If Britain wants to play in the global field why not take this chance to rebuild global credentials, lose some of the shackles of bureaucracy, which have bedeviled both clinical trials and drug safety legislation in Europe, and do something creative while protecting patients?”
Paul McGrade, senior counsel on Brexit, Lexington Communications
A low-ambition, overly cautious Brexit deal on pharma would create serious legal barriers to continuing large-scale clinical trials in the UK. We could see investigational medicinal products delayed in getting to trial sites, the duplication of good clinical practice inspections, and UK-authorised medicines barred as EU reference products. That would lead to delays, extra costs and a serious fall in the contribution of UK clinical trials to R&D in Europe. To avoid that, the pharma industry and individual companies should engage with both the UK and the EU sides to urge a solution which provides for:
- Full regulatory alignment on medicines and medicinal products, so both sides can have confidence that standards are maintained;
- An ambitious agreement on the movement of people so the industry has access to the talent it needs within and across borders; and
- Frictionless trade.
Jane Summerfield, counsel, Hogan Lovells
Amongst the many regulatory implications for the life sciences sector, Brexit has created uncertainty about the future legal status of the new CTR in the UK. The CTR was adopted and entered into force back in 2014, but will not apply until 6 months after the European Commission confirms that the new EU clinical trials portal and database are fully functioning.
Currently the expected date of CTR application is March 2020. Had the application date been prior to Brexit, the CTR would have been automatically implemented into UK national law by the EU (Withdrawal) Bill. However, the UK cannot unilaterally legislate to have access to EU systems and structures, including the new EU clinical trials portal and database. Access will require agreement from the EU as part of the negotiations on the future trading relationship between the UK and EU.
If the EU CTR application date occurs after Brexit but before the end of the proposed transition period (30 March 2019 to 31 December 2020), under the current draft of the Withdrawal Agreement the UK would have access the portal and database. Beyond this, continued access would need to be agreed with the EU and the UK would have to pass separate legislation to implement the CTR into UK law.
Dr Graham Dixon, CEO, Neem Biotech
One of the biggest potential impacts of Brexit lies in the degree of overlap and compatibility of post-Brexit EMA and MHRA regulations.
In the worst-case scenario, a combination of different clinical trial requirements across regions, a relatively smaller UK market size, high payer thresholds in the UK and diminished funding availability to carry out clinical trials with a reduction in European funding sources could well translate into the UK losing its status as a clinical trials destination of choice.
With the UK clinical trials industry carrying 30% of the European clinical trials burden, it would be a shame to lose this reputational and economic advantage.
David Jeffrey, senior vice president, Eisai
Uncertainty remains as to how and whether CTR will be implemented in the UK as a result of Brexit. This uncertainty is impacting the allocation of global trials into the UK at a crucial time, and is particularly affecting long-duration trials.
Currently it seems that the UK cannot be a ‘lead Member State’ in the new procedure. Complex issues around the release and supply of clinical trial materials remain, as well as the matter of VAT recovery and tariffs for placebos used in trials should the UK be outside the Customs Union. With good will on both sides, these important questions and uncertainties can be resolved.
Helen Davies, head of public affairs, Alzheimer’s Research UK
Because the diseases that cause dementia progress slowly, it is difficult to identify people with key hallmarks of disease. This means clinical trials for dementia treatments can be lengthy and often require very large populations. Therefore, it’s vital we can continue collaborating and sharing data with our European colleagues post-Brexit.
Consistent regulation of clinical trials is a key part of being able to collaborate. We must also have protected avenues to share information across borders. This is particularly important in progressing research into the rarer forms of dementia, which have smaller population sizes and often require pooling samples or gathering people from multiple countries for studies.