BGMA reaction to the Health and Social Care Committee’s Report on Brexit: medicines, medical devices and substances of human origin

Warwick Smith, Director General of the British Generic Manufacturers Association, said: “The Committee’s report rightly highlights the utmost importance of maintaining the close ties with the EU after Brexit. Continued regulatory alignment, along with free and frictionless trade, will be the best way of ensuring that UK patients can continue to access a safe and secure supply of generic and biosimilar medicines.

We strongly support the Committee’s recommendations of maintaining regulatory alignment with the European Medicines Agency, and of seeking mutual recognition of standards and pharmacovigilance arrangements and Qualified Persons. Any divergence from current arrangements or additional costs of bringing medicines to market are likely to result in delays in the NHS and UK patients accessing generic medicines. This is especially crucial for biosimilar medicines, as if the UK was to cease to be part of the EU regulatory framework a new route of authorisation would be need to be created to allow UK patients to benefit from these medicines. These have the potential to save hundreds of millions of pounds from the NHS medicine bill, estimated to be up to £300m a year by 2021[1]  thus  increasing patient access to vital medicines.

“However, the Committee is right to consider the consequences of a ‘no-deal’ scenario and it is vital that the UK has sufficient contingency plans in place. The BGMA will continue to work with the Government to minimise the risk of any negative impact on patients.”

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^[1] Figure identified by Simon Stevens, NHS England Chief Executive – 12 September 2017. Please click here more more information.