On Wednesday 21 March the House of Commons Health and Social Care Committee published a report titled "Brexit: medicines, medical devices and substances of human origins". The report emphasis that it is in the best interests of both citizens and the sector for there to be "the closest possible regulatory alignment" between the UK and EU post-Brexit. It also urges the Government to publish details of its contingency plans for the sector should a hard Brexit take place, to allow companies and health organisations to put in place the necessary plans.
The report is written on the basis that the Government is not prepared to remain either in the EU or in both the single market and customs union but is softly critical of this approach, noting that, given this position, "a course of harm reduction should be pursued". The overwhelming message of the report is the UK must seek as close regulatory alignment with the EU as possible in the life sciences sphere, stating that:
"The entire supply chain of pharmaceuticals, from research and development, timely licensing, production, quality control, through to the product being launched and available on a pharmacy shelf, will be adversely affected by regulatory divergence and seriously so in the event of a ‘no deal’ Brexit."
While the report is very much in favour of alignment with the EMA, it suggests that "a distant second-best option" would be to align with another large regulatory system, most likely to US Food and Drug Administration (FDA). However this would raise significant financial and patient safety issues, such as a delay in getting products to market, assessments being undertaken on the basis of a healthcare model very different to the UK's, and the risk of significant deregulation in the US (as recently mentioned by President Trump), affecting product availability in the UK without any input into the process. Creating an entirely separate regulatory system is not considered to be feasible, noting the wording from the UK Life Science Industrial Strategy that "the UK market is too small even with the fastest and most innovative regulatory system in the world to stand alone from a larger decision-making bloc". Any new regulatory system would require significant time and resources to develop, and would inevitably take time to 'bed in'.
Another theme of the report is concern around the lack of information available from the Government, and particularly the Department of Health and Social Care as to its plans in the event of a hard Brexit. It notes that the Government is currently refusing to release the details of its plans for a hard Brexit as to do so may impact on negotiations with the EU. However the report is highly critical of this position, noting that life sciences organisations are already having to prepare for the possibility of a hard Brexit with no information from the Government as to what this would look like. These businesses are now choosing between investing significantly in preparations for a hard Brexit that may not happen, or not preparing and running the risk of being unprepared in the event of a hard Brexit. Either option could have a significant negative impact on the UK life sciences sector.
Finally the report set out specific issues that would need to be considered while preparing for Brexit. These included joining international bodies such as the International Council on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH), preparing to collaborate with other nations for participation in clinical trials, and to replicate the role of Qualified Persons for the safety testing of batches of medicines. It noted that the UK's life sciences market was significant in the EU, for example contributing 20% of all EU pharmaceutical industry R&D. It was vital that preparations are undertaken to protect this industry post-Brexit.
The report makes very concerning reading for those concerned about life sciences regulation. It is clear that continued alignment with the EMA is vital for the UK life sciences industry to continue to thrive, while the Prime Minister has indicated she is in favour of regulatory alignment, this is no guarantee for the outcome of the negotiations. Companies should begin preparations for a hard Brexit, but will face hard choices on the significant resource investment this will require.