Broken beyond repair: self regulation of industry payments to clinicians and hospitals

On 5 July 2024 the Prescription Medicines Code of Practice Authority (PMCPA), the drug industry’s self regulatory body, announced a landmark ruling.1 It publicly reprimanded Novo Nordisk, the pharmaceutical company with the “85.4% share of the global obesity care market,”2 for multiple breaches of the industry’s Code of Practice relating to non-disclosure of payments to individual clinicians, health organisations, and others in a position of influence in healthcare.3

Between 2020 and 2022 the company failed to disclose approximately 500 payments worth £7.8m to over 150 recipients.3 These included health professionals and other NHS staff, healthcare and patient organisations, patients, and journalists. The undisclosed payments represented 10-14% of each year’s payment total made by Novo Nordisk to these recipient types in the UK.3

Novo Nordisk is not the only company failing to disclose payments,456 but this latest case demonstrates most clearly why the self regulation of disclosure, overseen by the PMCPA and the Association of the British Pharmaceutical Industry (ABPI), needs replacing with new “sunshine legislation.”78

How can Novo Nordisk’s blunder be explained? The PMCPA pointed to “inadequate training, processes and monitoring.”3 “This is not the first time that the PMCPA has called out Novo Nordisk’s “wide ranging systemic failings,”3 and the Danish giant has failed to address repeated adjudications against its inappropriate marketing activities.9 For example, the PMCPA voiced similar concerns “about the company’s compliance culture, … internal governance systems and processes, and a perceived naivety and lack of accountability,”10 in justifying its two year suspension from the ABPI, which started in 2023.

Failure to comply with such action undermines the integrity of the healthcare service. It is likely that the undisclosed payments obfuscated Novo Nordisk’s “large scale”10 promotion of its GLP-1-based treatments. Because NHS organisations11 and the National Institute for Health and Care Excellence (NICE)12 may use company disclosures to manage financial conflicts of interest, the missing payments might have biased policymaking, investment, commissioning, and clinical judgment. The public still awaits Novo Nordisk’s “corrective and preventative actions”3 to learn which payments were missing and to whom, including three healthcare organisations receiving a total of over £3m.3

Because the PMCPA does not monitor disclosures independently and proactively, the missing £7.8m is a “best estimate.”3 The PMCPA “queried the accuracy” of some of Novo Nordisk’s data and seemed perplexed by the discrepancy between the company’s (£6.4m) and its own calculations (£7.8m) of the undisclosed total, while using a spreadsheet submitted by Novo Nordisk.3 Since Novo Nordisk’s admission was “voluntary,” and reportedly prompted by a previous complaint, it fell to Novo Nordisk to determine the scope and timeframe of the investigation and provide evidence it considered relevant,3 consistent with the lenient self regulatory approach to pharmaceutical company misconduct.9

The challenges encountered by the PMCPA, and, indeed, Novo Nordisk’s mention of a “very manual and time-consuming”3 verification process, stem from the company’s poor compliance with the self regulatory disclosure standards but also the inherent weakness of the standards. By not mandating unique identifiers, clear and meaningful payment and recipient categories, high granularity, and contextual information on payments, the ABPI code allows significant ambiguity in identifying payments and their recipients.13141516 This effectively impedes accurate data organisation and analysis.

We didn’t have access to Novo Nordisk’s internal records, but, through triangulating publicly available data, we submitted a complaint,17 upheld by the PMCPA, which revealed undisclosed payments to two companies central to Novo Nordisk’s “disguised” and “misleading”10 promotion of Saxenda (liraglutide). Self regulation isn’t designed to capture undisclosed payments and the current system can only ever make these findings accidentally or in rare circumstances. This reflects Novo Nordisk’s claim that its “voluntary admission only came to light as a result of its own investigation into another complaint.”3

Transparency itself isn’t enough to address financial conflicts of interest and industry influence on healthcare.1819 However, it is a necessary condition, one that is currently unmet in the UK. Comprehensive, enforceable, and user-friendly disclosure can be most easily achieved through legislation modelled on the US Sunshine Act, which has allowed documenting payment influence on prescription,20212223 undisclosed payments,242526 or corruption.27 Part of its success is that failure to follow the legally mandated disclosure standards is met, not with reputational sanctions, such as public reprimands,92829 used by self regulation, but serious financial penalties. For example, in 2021, three settled cases totalled $2.2m, which was used to strengthen compliance further.30 The sunshine legislation should also cover the medical device industry, which has even more lax self regulatory standards than drug companies.31

The new UK government might be more open to this idea than its predecessors. It may even support the government’s plans to use the health sector to boost economic growth32 because it will facilitate genuinely innovative ties with the healthcare sector that withstand public scrutiny and generate competitive advantage.