Health Secretary discusses impact of Brexit on regulation of medicines and medical devices

Jeremy Hunt, Secretary of State for Health and Social Care, has given evidence to the Commons Health Select Committee as part of their inquiry, ‘Brexit: the regulation of medicines, medical devices and substances of human origin’. Hunt, alongside Lord O’Shaughnessy, Parliamentary Under-Secretary of State for Health, Department of Health and Social Care (DHSC) and Dr Ian Hudson, Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), discussed the analyses that have been made of the risks that Brexit poses for patients and for the life sciences industry, how health ministers were preparing for a ‘disruptive Brexit, and what preparations have been put in place to minimize these risks and build on any opportunities that Brexit presents for the sector.

Contingency planning was confirmed to be in progress across government to ensure that a no deal scenario does not interfere with the medicines supply chain and impact patient access to treatments, but detail of the plans could not be shared at present. When pressed, the minister suggested that a ‘summary’ may be provided in due course. External research has been commissioned to examine the potential effects of a no deal scenario on the supply chain of medicines, but the minister was unsure as to whether medical devices were included within the research brief. It was also emphasized by the committee that there would be no sector-by-sector deals, meaning that if negotiations fail in other areas, then the life sciences sector could be threatened. The MHRA are preparing for a no deal scenario, including by ensuring availability of training programmes for training Qualified Persons to maintain pharma vigilance.

Assurances were received that the detail of the transitional phase would be agreed by the end of March, and that the health-related products sector is being considered in all discussions through inclusion of the DHSC in all industry discussions and the UK-EU life sciences steering group ensuring engagement between the public and private sectors.

Hunt stated that permanent regulatory alignment was the solution to the uncertainty under discussion that the UK was seeking, as the second best option to continued membership of the single market and customs union. However, it was acknowledged that any agreement could not bind future parliaments, therefore a process of arbitration would need to be agreed and legally underpinned to prevent the UK being forced to unilaterally amend regulations in responses to changes from the EU. The committee questioned whether this hope for the EU to agree a separate system of arbitration for regulations just for the UK was overly optimistic, and despite stating that this was the case for other trade deals, Hunt did not answer this query.

Both health ministers asserted that access to treatments did not need to be affected by Brexit since the UK imports medicines as a ‘customer’, therefore the UK Government should ensure that delays do not occur. They also denied that Brexit did not impact the progress of the Accelerated Access Review, with the first meeting of the Accelerated Access Collaborative happening next week, and the first set of products to be identified in April. The UK was also stated to be in a position to draw up a new licensing scheme by 2019.

Addressing concerns about the future of pan-European clinical trials, Hudson said that as long as UK standards remained aligned with others, it would still be possible to be part of multi-centre trials even in a hard Brexit scenario. Lord O’Shaughnessy stated that the government’s continued desire for a close working relationship with the EU included a continued desire to take part in the new clinical trials regulations coming into force post-2019. However, concerns were expressed by the committee that, despite the attractiveness of the UK as a place to conduct trials due to its high quality, national data, strong universities sector, and high levels of investment, the UK risked being side-lined if separate trial applications needed to be submitted for the UK and EU.

Click here to watch the full evidence session.

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Published 24. January 2018 in News UK