The topic of Brexit tends to generate more questions than answers, and I recently represented Medidata at the Association of Clinical Research Organizations (ACRO) and met with a key member of the UK Parliament to clarify the risks and opportunities that Brexit poses to clinical trials.
Each year, ACRO member companies conduct clinical trials for more than 700 research sponsors in over 100 countries.
ACRO has been actively engaging with the European Commission, the UK government and other bodies since the 2016 UK referendum. ACRO has also had interactions with the UK government’s Office of Life Sciences, the HRA and MHRA on the complex matters associated with Brexit.
ACRO’s goal is to ensure that the collective views of ACRO members are strongly represented within the ongoing Brexit negotiations between the UK government and the European Union. And, of course, ACRO wishes to ensure that the position of both the UK - and indeed, the EU as a whole - continues, without impediment, to be an attractive region for conducting clinical research.
ACRO invited Rt. Hon. Hilary Benn, the Member of Parliament for the Leeds Central constituency and chairman of the UK Parliament’s influential Select Committee on Exiting the European Union, to discuss the organization on the future of clinical development in UK post-Brexit.
Mr. Benn stressed the importance of making available new, innovative - and affordable - treatments to UK citizens as the country adapts to new realities. Here are some of his key takeaways from the meeting:
- Brexit is a given at this point. It’s going to happen in March 2019 and, in Mr Benn’s own view, it’s very unlikely that a second referendum or parliamentary debate outcomes will change that.
- Trade and movement of goods. Mr Benn noted that the UK exiting the EU customs union should not be allowed to create an impediment to trade and movement, specifically the movement and retention of scientific and medical talent so as to retain the UK’s preeminent position in groundbreaking research. Moreover, the movement of investigational products for clinical trials ought not be impeded either. This is, as we all know right now, a very hot topic with a spectrum of UK political viewpoints compounded by the Irish border challenge.
- Alignment of clinical research regulations During the transition period and post-Brexit, regulation—including data protection and data privacy regulations—will likely be aligned via mutual recognition agreements between UK and EU.
- UK patients could be impacted by the need for separate, higher-overhead (UK and EU) drug approvals by pharma/device/biotech companies being required. Given the relatively small size of the UK marketplace (compared with the EU), it’s possible that the UK would be “further down the list” for when such companies are seeking approvals.
During the meeting, ACRO members outlined the typical drug/device approval cycles in the EU and highlighted the current dichotomy between scientific assessments (a sizable fraction of which have been carried out by UK’s MHRA versus the mechanisms around adding those treatments to the UK National Health Service (NHS) formulary via NICE.
ACRO is planning for further such meetings with influential players involved in the Brexit negotiations, and we’ll make sure to share new updates as they surface.