Campaigners launch legal challenge to ‘unlawful powergrab’ over NHS drug price control changes demanded by Trump

  • Legislation used to end NICE’s independence was unlawful and undemocratic

  • Changes part of wider pro-industry concessions made by UK under pressure from White House and pharmaceutical industry

  • Experts say hundreds of thousands of lives put at risk

Patient-led campaign group Just Treatment, and social justice organisation, Global Justice Now, have written to the UK Government setting out why they believe the government has acted unlawfully in pushing through changes to the NHS’ drug price control frameworks, in the first stage of a legal challenge to a central pillar of the US-UK trade deal on pharmaceuticals.

A statutory instrument, which passed into law last month, gives ministers direct control over the key cost effectiveness threshold NICE uses to determine which medicines are made routinely available on the NHS. This change was required to enable the government to deliver on the promises made to Donald Trump under the trade deal on pharmaceuticals announced in December 2025. It is part of a package of changes that commits the UK to dramatically increasing spending on patented medicines by the NHS over the next ten years.

But the letter to the government (available here) sets out why the changes are unlawful, and asks the government to revoke the legislation or face a court battle on the changes. The claimants believe that the changes effectively end NICE’s independence from political interference, leaving medicine prices subject to political lobbying by Big Pharma corporations and the US government. They say this poses an existential risk to the UK’s careful framework of safeguards designed to protect patients and the NHS from the excessive pricing demands of the industry. Changes the government has committed to under the Trump deal are estimated to cost the NHS billions of pounds a year by 2035, and have been widely criticised by health experts.

Diarmaid McDonald, Director of Just Treatment said:

“The government caved in to threats from Donald Trump and the pharmaceutical industry and signed a deal that experts say could cost the lives of over 300,000 NHS patients. That’s more excess deaths than COVID. Worse still, they’ve refused to publish their own assessments of the damage the deal will do to the NHS, and they’ve used a parliamentary process designed to make it extremely difficult for MPs to properly scrutinise what they are up to. 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.”

Nick Dearden, Director of Global Justice Now said:

“The government has tried to claim this is about improving outcomes for patients and accelerating access to medicines, but everyone knows this is a move forced on the government by Donald Trump and Big Pharma. This is a government gambling with NHS patients’ lives in a geo-political game with Donald Trump. They risk sabotaging our carefully worked out mechanism for keeping a lid on Big Pharma’s overinflated prices, and they have done so without so much as a debate in parliament.”

Rowan Smith, Lawyer at Leigh Day, said:

“Our clients are deeply concerned about the impact the UK's pharmaceuticals trade deal with the US could have on the price and availability of drugs and medicines. They argue that new powers giving the Health Secretary direction over NICE in matters regarding cost effectiveness risk undermining an important and globally recognised health body, and could materially impact what drugs and medicines are available on the NHS. In submitting this legal letter, our client hopes that the Health Secretary will consider revoking the new regulations enforcing this change.”

Parliamentarians have been trying to force a public debate on these changes, but the mechanism the government used to enact them - known as a negative statutory instrument - is designed to make that kind of independent scrutiny almost impossible. Nonetheless MPs and peers from Labour, Conservatives, SNP, Lib Dems, Greens, and Plaid Cymru - as well as two cross party committees - have raised concerns.

NICE was established to be independent of ministerial control, but the deal the UK signed with Trump included commitments to increase the cost-effectiveness thresholds it uses to determine if medicines are deemed to be good value for money and so made available for use on the NHS. That required the government to legislate to give themselves the power to force that change on NICE, and they have already used it to adjust the thresholds. But, the letter asserts that the intention of the changes directly contradicts the primary legislation being amended, and therefore should only be made using a new primary legislative process.

John McDonnell MP, has been leading parliamentary efforts to secure scrutiny of the US-UK trade deal, and started a motion opposing the legislation enacting changes in NICE. He said:

“The government has ridden roughshod over the democratic process, the views of MPs and Peers, and the lives of NHS patients to force through a deal with Trump that they claim is in the interests of the UK. But they won’t publish anything to evidence their claims, and they won’t enable time for proper parliamentary debate on this. It is an extremely dangerous precedent and I hope the government backs down or the courts re-establish the democratic principles our parliament relies upon.”

The campaigners have set up a crowdfunder to cover the legal costs required to take the case, which needs to be heard within three months of the legislation being laid before parliament.

ENDS

Notes to editors:

  • The US-UK agreement on drug pricing secured a temporary US commitment not to place tariffs on pharmaceutical exports from the UK to the US. In return the UK has committed to a raft of permanent and far-reaching reforms of the price control mechanisms and a rapid acceleration in NHS spending on patented medicines - a doubling over ten years with no additional Treasury funds to offset the cost.

  • The agreement came after months of sustained pressure from the pharmaceutical industry and the White House, and according to experts at the University of York risks the lives of over 328,000 NHS patients over the 19 year lifetime of the deal.

  • NICE - a pioneering health technology appraisal agency, respected and replicated across the world - is the lynchpin of the UK’s complex matrix of instruments designed to control prices and spending on patent medicines medicines, where monopoly holding drug companies are able to unilaterally set their prices and exert significant power over the health system. The move to end NICE’s independence has been sharply criticised by experts, with NICE’s founding clinical and public health director describing it as “the greatest threat yet to its existence”.

  • The letter asserts the government has acted unlawfully on three grounds: using a parliamentary process that does not give them the authority to enact the changes they wish to make (the changes directly contradict the intent of the primary legislation it was seeking to amend, and therefore should only be changed using primary legislative process); failing to carry out and publish appropriate impact assessments of the effect these changes will have on different communities in the UK; and acting contrary to the true purpose of the act.

  • The letter gave the government until 15th May to respond, asking that the Secretary of State commits to revoking the unlawful legislation. If that does not happen the campaigners will take the government to court. The government asked for additional time to respond, and the claimants are awaiting that response. The case needs to be filed with the courts by 2nd June.

Hope Worsdale