Legal challenge mounted over UK-US drug pricing deal and NICE independence

Two campaign organisations, Global Justice Now and Just Treatment, have issued a letter before claim to the Department of Health and Social Care (DHSC), threatening legal action over a UK-US agreement on NHS drug pricing. The groups argue that a statutory instrument allowing ministers to override the National Institute for Health and Care Excellence (NICE) constitutes an unlawful power grab. They are demanding the revocation of the legislation or they will proceed with a judicial review in the High Court.

The statutory instrument, which came into force last month, is part of a medicines agreement with the Trump administration announced in December. It grants the health secretary the power to overrule NICE’s independent judgment on the prices the NHS should pay for certain medicines. Campaigners claim this mechanism risks higher drug costs for the health service and undermines the institute’s longstanding independence, a body respected globally for its role in determining which drugs the NHS in England and Wales should purchase.

Nick Dearden, director of Global Justice Now, described the move as a government gambling with patient lives in a geopolitical contest. Lawyers Leigh Day delivered the nine-page letter on behalf of the groups, highlighting concerns that the deal was advanced without parliamentary debate. The DHSC has defended the agreement, stating it ensures UK drug exports to the United States remain tariff-free for three years and improves patient access to innovative treatments, such as a recently approved brain cancer drug for children aged 12 and over.

Former Conservative health secretary Andrew Lansley has stated the statutory instrument is unlawful because it clashes with the Health and Social Care Act 2012. MPs from multiple parties, including Labour, have expressed concern over the secrecy surrounding the deal, noting the government’s refusal to release its impact assessment or allow a Commons debate. Diarmaid McDonald, director of Just Treatment, criticised the use of a parliamentary process designed to limit scrutiny, asserting the process is unlawful and that they are prepared to defend NHS patients and democracy in court.

A DHSC spokesperson denied that NICE’s independence is compromised, asserting that ministers cannot direct the substance of its recommendations. The department maintained that NICE will continue to set guidance and make recommendations free from political interference, balancing clinical effectiveness with value for taxpayers. The government argues the deal is necessary to keep pace with a revolution in medical science and ensure thousands of patients access life-changing new treatments.