The UK risks becoming a “backwater” supply market for medicines – potentially jeopardising £18 billion of NHS savings from new off-patent drugs in the next five years – unless a more supportive policy environment is introduced. So says the British Generic Manufacturers Association (BGMA) in its election manifesto, published today (March 25).

Despite the off-patent market representing four out of five NHS prescription items dispensed, contributing to the UK having the lowest medicine prices in Europe, there is no dedicated policy framework to support the sector, the BGMA points out. Generics or biosimilars are not even mentioned in the Government’s Life Sciences Vision, it says – and this at a time when the operating environment has become increasingly challenging.

Issues include significant MHRA licensing delays, a volatile pricing regime and changes emanating from the EU-UK Trade and Cooperation Agreement that have “hurt domestic manufacturing capacity”.

The culmination of these issues has seen a doubling in the number of medicines shortages, as manufacturers find the UK a commercially unsustainable market to supply, says the trade body. 

Mark Samuels, chief executive, said: “The generic and biosimilar medicine sector has been largely ignored from a policy perspective. The EU-UK Trade and Cooperation Agreement has hurt the UK’s medicines supply resilience, adding regulatory and logistical complexity to an industry that relies on simplicity to survive.

“Our sector supplies the NHS with high volumes of medicines but with razor-thin margins. Throw in a volatile Government pricing system over the past five years alongside a doubling of domestic regulatory delays, then the UK is becoming an increasingly unattractive market for international companies.

“The sustained high period of drug shortages we are currently seeing is the evidence of a complacent policy approach to the UK’s off-patent sector.

“With a General Election looming, we urge whoever forms the next Government to create a dedicated and targeted set of policies to support this critical sector’s survival and economic growth. Without specific support, there is a significant risk that the £18 billion of NHS savings on offer from generics and biosimilars over the next five years will not be realised.”

The BGMA’s manifesto calls for, among other things: a dedicated national strategy for biosimilars for England and the Government to use at least half of the £520m announced in the 2023 Autumn Statement to support UK manufacturing of generic and biosimilar medicines and improve security of supply.

Mark Samuels added: “Our manifesto lays out a range of areas where real progress could be achieved. These would drive economic growth, restore medicine supply resilience, increase the savings the NHS makes and, importantly, allow more patients to access vital medicines.”