I was heartened to read in the report “Maintaining and growing the UK’s world leading Life Sciences sector in the context of leaving the EU” from the UK EU Life Sciences Steering Group that there was emphasis on the importance of keeping a common European regulatory system after Brexit. This will be key to the future success of Ortheia and its start-ups.
This is not an unrealistic expectation after all The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has not only been of the most important regulators within the European system, but has also been instrumental in building the framework and without the MHRA the European system lack both capacity and expertise. Also the loss of the UK Notified Bodies would also have a major impact the EU system.
Today the combined regulatory system in the UK and EU is highly sophisticated, spanning as it does medicines, devices and in-vitro diagnostic devices, which have been built jointly over the past 50 years. This system is world leading and provides industry with the scale and certainty to bring innovative, effective and safe medical technologies to patients.
For the UK to reconstruct its own stand-alone regulatory model would take significant resources, time and expertise – and would simply not by in the interests of UK patients or our industry.
No longer being within a combined European regulatory system could result in:
- Delays (relative to European patients) in regulatory approvals and launch od new devices and the UK effectively becoming a “B list” launch market
- Disruption in new medical technologies as a result of border inspections for products going to or from Europe
- There are grave fears over falsified medical products reaching UK patients if the UK is not part of EU-wide monitoring systems
I do strongly support the belief that, because of the potential impact on public health, it is in the mutual interests of both the UK and EU to reach agreement on maintaining regulatory alignment.
I agree that this could be achieved through a regulatory cooperation agreement, under which the UK continue to be an active participant in European regulatory procedures and decisions. This will be critical to the continuing success of SMEs like Ortheia and its planned start-ups.
Prof Edward Draper