Health campaigners are threatening to bring the British government to court over its drug-pricing deal with Donald Trump, in a legal fight that risks undermining a key pillar of the U.S.-U.K. trade deal.

The core of the dispute centers on a change in how drug treatments are approved for use by the NHS, which critics argue could result in the health service paying substantially higher prices for medicines.

Campaigners label this move an “unlawful power grab” that could enable the health secretary to override the independent judgment of the National Institute for Health and Care Excellence (NICE).

NICE is an internationally respected body renowned for its independence from ministerial control, tasked with deciding which drugs the NHS in England and Wales should purchase based on clinical effectiveness and cost-effectiveness.

The perceived loss of NICE’s longstanding autonomy forms a key part of the government’s medicines agreement, initially announced in December.

Campaign groups Global Justice Now and Just Treatment have formally warned the Department of Health and Social Care (DHSC) that they are prepared to seek a judicial review in the high court.

They demand the revocation of a statutory instrument – secondary legislation – that came into force last month, which grants ministers the power to overrule NICE’s recommendations.

Nick Dearden, director of Global Justice Now, strongly condemned the government's actions, stating, “This is a government gambling with NHS patients’ lives in a geopolitical game with Donald Trump.”

He further criticized the potential sabotage of the mechanism designed to control pharmaceutical prices, particularly given the lack of parliamentary debate.

Lawyers from Leigh Day have already dispatched a nine-page “letter before claim” to the DHSC on behalf of the protesting groups, underscoring the seriousness of their legal intent.

Concerns about the legality and transparency of the deal extend beyond campaign groups.

Andrew Lansley, a former Conservative health secretary, has asserted that the statutory instrument is unlawful, citing a clash with the Health and Social Care Act 2012.

Furthermore, MPs from various parties, including Labour, have voiced profound concern over the secrecy surrounding the deal.

They highlight the government’s refusal to release an impact assessment of the decade-long deal's long-term cost, provide details in parliamentary replies, or allow a debate in the House of Commons.

Diarmaid McDonald, director of Just Treatment, emphasized their determination to defend NHS patients and democracy, stating, “But we believe the process they have followed is unlawful and we are ready to take them to court to defend NHS patients and our democracy.”

In response to these criticisms, ministers have defended the deal, asserting it will provide more NHS patients with access to innovative medicines and ensure that UK drug exports to the US remain tariff-free for three years.

A spokesperson for the DHSC explicitly denied that the change overrides NICE’s independence. They clarified that “Nice’s independence will always be protected.

It will continue to set out guidance and make recommendations entirely free from political interference, balancing clinical effectiveness with making sure taxpayers get a good deal.”

The department emphasized its commitment to bringing innovative medicines to the NHS, citing recent approval of a brain cancer drug for young patients as an example of benefiting from advances in medical science.

A DHSC source further elaborated on NICE’s legal framework, stating that “Nice’s legal framework states that ministers are not able to direct Nice as to the substance of its recommendations.

Nice remains responsible for independently deciding whether a medicine can be recommended as a clinically and cost-effective use of NHS resources.”

This ongoing battle highlights a deep division between government policy and public health advocacy, with the ultimate implications for NHS patients and drug pricing still unfolding.