UK's drug payment disclosure system fails to protect patients and public trust

The UK's self-regulated system for disclosing payments from drug companies to healthcare professionals and organizations is failing to protect patients and public trust, according to a new analysis led by researchers at the University of Bath, UK and Lund University, Sweden published in BMJ Evidence-Based Medicine.

The study highlights the staggering shortcomings of the current system, known as Disclosure UK, which is managed by the pharmaceutical industry's membership body/trade body , the Association of the British Pharmaceutical Industry (ABPI). The report finds that Disclosure UK leaves critical gaps that obscure potential conflicts of interest and put patient care at risk.

Key findings:

1. Billions in untraceable research payments

Between 2015 and 2022, drug companies reported £3.3 billion in research-related payments, representing 72% of all disclosed transactions. These payments are lumped together in aggregate without naming recipients, making it impossible to assess where the money goes or how it might influence patient care. Companies such as AstraZeneca (UK and Sweden owned with HQ in Cambridge, United Kingdom), Allergan (US owned), and Bristol Myers Squibb (US owned) classified over 90% of their total payments as research-related, raising concerns about how the definition of "research" may be used to limit transparency.

2. Non-research payments lack clarity
Non-research payments, including sponsorships and consultancy fees, amounted to £1.1 billion over the same period. While under the Code of Practice these payments are supposed to name recipients, companies' practices vary widely. Some report nearly all recipients, while others, such as Allergan, disclose as little as 15%.

3. Significant breaches by major companies
Several companies have been found to violate transparency requirements. Novo Nordisk, the Danish company that manufactures the weight-loss jabs Wegovy and Ozempic, failed to report approximately £7.8 million in payments to over 150 UK healthcare professionals and organizations, which constituted a major breach of the self-regulatory Code of Practice.

1. The Iceberg of Uncertainty: Unveiling the "Unknowns"
   The study introduces a novel framework for understanding the "unknowns" of payment disclosure, inspired by the "Rumsfeld Matrix," which categorizes gaps in knowledge about drug companies' financial ties to the healthcare sector. Researchers identified four key layers of uncertainty in how payments are disclosed under Disclosure UK:
   • Known knowns: These are payments that are reported and can technically be identified, but it's tricky to trace them. For instance, the way NHS trusts or organizations are named by drug companies can cause records to be incomplete or misleading.
   • Known unknowns: These payments are acknowledged in the system, but their details – which are key for tracing potential conflicts of interest – are hidden from the public. For example, research payments worth £3.3 billion are lumped together without specific details like the names of recipients, the amounts, or the purposes-often hiding behind claims of "commercial sensitivity."
   • Unknown knowns: These payments exist but are reported incorrectly or wrongly assigned. This happens when there are inconsistent naming systems or duplicate entries. For example, more than 10% of payments to patient organisations between 2015 and 2018 were reported wrongly, making it nearly impossible to establish the extent and nature of their ties to drug companies.
   • Unknown unknowns: These payments are never reported at all-either because companies aren't required to disclose them (like Vertex Pharmaceuticals, which isn't part of the ABPI Code) or because they ignore reporting rules. These cases involve companies like Novo Nordisk failing to disclose payments altogether, which the industry's self-regulatory body viewed as indicative of failings in the company's corporate culture, and not just technical processes for payment reporting..

Dr. Piotr Ozieranski, lead author from the University of Bath, warns:

"Our analysis reveals that the public sees only the tip of the iceberg when it comes to drug company payments to healthcare professionals and organizations. Without strong legislation, conflicts of interest will remain hidden, undermining healthcare integrity and potentially putting patients at risk.

Sunlight is the best disinfectant, which is why we're calling for a UK version of the USA's Sunshine Act to ensure transparency in pharmaceutical spending."

Dr. Emily Rickard, co author from the University of Bath added:

"Why is one of the world's largest industries-directly impacting public health-allowed such lax transparency? If pharmaceutical companies are funnelling billions across the UK's health ecosystem in the name of public interest, the public deserves to know where this money goes and how it affects patient care.

The UK government must prioritise patients' health over pharmaceutical profits, ensuring economic incentives don't compromise wellbeing. Robust legislation for pharmaceutical payment transparency is essential to protect patients from the harmful effects of unchecked commercial influence."

The report calls for the UK government to move beyond Disclosure UK and introduce mandatory legislation, which can be modelled on the US Sunshine Act. Such laws would:

• Require all payments, including those for research, to disclose full recipient details and amounts.
• Mandate consistent reporting standards, including unique identifiers for payment recipients.
• Impose significant financial penalties for companies failing to comply with transparency rules.

The research authors believe the government's recent consultation on payment transparency is a step in the right direction. However, the report cautions that simply expanding Disclosure UK won't be enough. Only legislation backed by enforcement mechanisms can bring the clarity and accountability needed to protect public trust in healthcare.

Specific recommendations for improvement are detailed in a recent Policy Brief published by the Institute of Policy Research at the University of Bath in collaboration with UK-based patient advocates.