Concern over how Brexit will affect clinical trials and future pharmaceutical regulations seems to be making companies hesitant when it comes to conducting studies in Britain. The number of new clinical trials that took place in Britain in 2017 was 25% lower than the average for 2009-2016.
After Brexit, regulations on clinical trials in the UK will depend on negotiations with the EU. Manufacturers are anxious that British research data may no longer be accepted by the European Medicines Agency (soon to be relocated from London to Amsterdam) once Brexit has happened on March 29th next year. No-one is yet sure how any UK clinical studies would be treated by the EMA, and a no-deal scenario would mean that the Medicines and Healthcare products Regulatory Agency, formerly affiliated to the EMA, would have to stand alone. This notion is currently part of an industry and public consultation process, and the government is preparing for all eventualities.
Disruption to drug research and supply
The NHS, known internationally for high-level research and key pharmaceutical development, could end up suffering through lack of overseas investment. Worries over Brexit are already having an impact – American biotech company, Recardio, has halted its British trials of a new heart drug dutogliptin, citing the instability caused by Brexit as the reason for its decision. The government is encouraging UK organisations that conduct clinical trials to evaluate their supply chains ahead of March 2019, and drug manufacturers have begun stockpiling pharmaceuticals. However, the UK health secretary is optimistic about the future, advising hospitals, GPs and pharmacies not to hoard additional drugs beyond their usual levels.
Indecision around Brexit is continuing to cause tension for many in the life sciences sector. UK research organisations that conduct adaptive phase 1 clinical studies, such ashttps://www.richmondpharmacology.com/specialist-services/adaptive-phase-i-studies, are closely monitoring the situation to assess the possible long-term impact on their industry.
Preparing for all possible outcomes
The Department of Health and Social Care has said that it is confident that a deal will be struck. Dr Ian Hudson, CEO of the UK’s Medicines and Healthcare products Regulatory Agency, has stated that the MHRA wants to retain a close working partnership with the EU, but in the event of a no-deal situation, the UK will strive to continue be at the forefront of public health promotion and clinical research.
Leave a Reply