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Government says no to sunshine legislation – a major setback for patient safety and transparency

Government says no to sunshine legislation – a major setback for patient safety and transparency

By Ruth MacLeod and Kath Sansom

Just two weeks after bowing to industry pressure on its pharma pricing deal, the government has now rejected calls for sunshine legislation – a move that would have forced industry to openly disclose the millions it gives to the health sector every year.

The announcement was made as Parliamentarians logged out for Christmas -a comms strategy clearly designed to minimise negative media coverage.

Without mandatory disclosure of financial ties – a key cause of scandals such as mesh, valproate and Primodos – these connections remain obscured, leaving patients at risk. Optional guidance will be ignored by industry. Again, we see the Government putting the interests of industry over those of patients.

It is deeply disappointing that five years after the Cumberlege review recommended a statutory requirement for industry to disclose payments to the healthcare sector, the government has chosen not to act. By rejecting sunshine legislation, the government has missed a vital opportunity to embed transparency and accountability in healthcare.

Instead, the Government have opted to create “guidance” corporations won’t have to follow.  

Industry payments

Evidence shows industry payments to doctors affects their choice of treatment for patients – and that studies sponsored by drug or device companies are more likely to find results favouring the company. Industry payments affect research integrity.

With this voluntary guidance recommendation response, the Government is saying no to Sunshine legislation that would have put the onus on the pharma and medical device industry to declare to an open database.

Timeline

  • 2020 –  following the First Do No Harm report into three women’s health scandals, the Cumberlege review recommended that transparency of payments made clinicians needed to improve, saying there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians. They specified that this should be a statutory requirement similar to the Physician Payments Sunshine Act 2010 in the US.
  • 2022 the relevant primary legislation to make this happen was laid down in the Health and Care Act 2022.  But it needed secondary legislation.
  • October 2023 the Conservative Government went out with a consultation on proposals for the relevant secondary legislation.
  • 2024 Labour wins the election and delayed responding to this consultation.  Sling the Mesh and other stakeholders were often told a response was soon coming and struggled to get the new Government to take proper interest in the First Do No Harm Cumberlege review.
  • December 2025 The Government say not to legislation, putting industry interests ahead of patient safety

Why does transparency matter? 

  • These opaque payments are a big hidden scandal in medicine.  There is limited transparency in the pharmaceutical sector with their self-regulated “Disclosure UK” database, but it misses payments
  • There is no database in the UK for the medical device industry showing its payments to the healthcare sector. 
  • Whilst the existence of a financial payment from industry does not carry an automatic assumption of bias, or wrongdoing, evidence shows industry payments to doctors can add prescribing bias and that studies sponsored by industry are more likely to find results favour the company.
  • With mesh –  women describe unrelenting chronic pain, job loss, marriage breakdown, suicide ideation. Without the influence of payments from mesh manufacturers on surgeon key opinion leaders, the professional societies, conferences and training days, and on the scientific literature cited in defence of mesh, Sling the Mesh don’t believe this institutional denial that led to the mesh scandal would have happened.
  • Payments can be to individual healthcare professionals, research organisations, professional societies, NHS Trusts – industry also sponsor training days, conferences.  It is against this background that the decades-overdue need for transparency is clear. The BMJ and many others have called for improved transparency for years. 
  • Evidence shows statutory transparency systems work best, like those used in the USA and France.  It shows that voluntary declaration doesn’t work well.  One paper used the US Sunshine Act to look at voluntary transparency declarations in studies on mesh surgery and found that 95% of the studies had at least one author who’d received industry funded near the time of publication, and that for 47/53 of these studies, the funding was not declared.
  • Legislative transparency would not have removed the risk of tragedies like the mesh scandal recurring. But it would have allowed for proper analysis of the role of industry in the healthcare sector in 2026.  For example, doctors on the boards for clinical guidelines may not always correctly declare their conflicts.  Statutory systems that put the onus on the companies can avoid this.
  • We question how effective this new Government guidance, to be developed with industry, will be, and how it will be enforced
  • This may be especially important with an apparent focus on industry collaborations in the NHS 10 year plan

Further reading

Healthsense

Why everyone should care

Health Service Journal

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