Divergent interests and transparency paradox

The UK government declares that it seeks to protect the public interest, including patient health, by ‘encouraging industry-led initiatives that meet the minimum statutory requirements’.2 However, this approach overlooks the fundamental divergence of interests between the public and industry regarding transparency.

Trade bodies governing self-regulation, such as the ABPI or its ‘parent’ organisation, the European Federation of Pharmaceutical Industries and Associations (EFPIA), use transparency primarily to protect the industry’s reputation (box 3). For them, making payments publicly available—but not necessarily accessible, analysable or meaningful—is sufficient to meet the reputational goals.

Conversely, the National Health Service (NHS),7 and the National Institute for Health and Care Excellence (NICE)8 recognise Disclosure UK’s potential role in detecting COIs—a crucial first step in preventing their associated harms.6 9 For example, NICE expects that an application to sit in an advisory committee will be followed by a review of Disclosure UK ‘to identify if any other interests need to be declared [beyond those declared by the applicant]’.8

Uncertainty in payment disclosure

To become a genuine tool in managing COIs, disclosure reporting must follow certain minimum quality standards that ensure reliable tracing of all payments from all companies. One of the most influential formulations of such standards includes the criteria of disclosure accuracy, consistency, completeness and searchability specified by Lo and Field.9

Nevertheless, Disclosure UK fails to meet these criteria, which we demonstrate by assigning industry payments to the four categories from the Rumsfeld Matrix, inspired by remarks made by the US Defence Secretary Donald Rumsfeld on the gaps in intelligence about alleged weapons of mass destruction in Iraq.10

• ‘Known knowns’—payments identifiable, at least theoretically, through Disclosure UK.

• ‘Unknown knowns’—payments whose existence is uncertain given the confusion in companies’ disclosure records.

• ‘Known unknowns’—payments made but not traceable in Disclosure UK.

• ‘Unknown unknowns’—payments that remain undetected because their existence is not deducible from companies’ records.

Cumulatively, these layers of uncertainty mean that the public only sees the ‘tip of the iceberg’ of payments, with an unknown share being obscured, hidden or completely untraceable (figure 1). The lack of full and reliable information about industry financial ties undermines—if not eliminates—possibilities for establishing the existence, extent and effects of any associated COIs.

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Figure 1

The iceberg of uncertainty in payment reporting in Disclosure UK. Source: own research. Figure created using Canva.

The uncertainty arises from an interplay between the imprecise disclosure rules from the ABPI Code, their inconsistent implementation by companies, and the poor quality of the Disclosure UK data.5 11 But the uncertainty is not unavoidable—it can be prevented using provisions from payment transparency legislation developed elsewhere (table 1).3 4

• Denmark—Health Act of 2014 and Executive Order No. 1153

• Estonia—Medicinal Products Act of 2005 (provisions from 2013)

• France—Law Number 2011–2012 (Loi Bertrand)

• Hungary—Act XCVIII of 2006 on the General Provisions Relating to the Reliable and Economically Feasible Supply of Medicinal Products and Medical Aids and on the Distribution of Medicinal Products (provisions from 2011)

• Latvia—Regulation no 378 on Advertising Medicinal Products Procedures for Advertising Medicinal Products and Procedures by Which a Medicinal Product Manufacturer is Entitled to Give Free Samples of Medicinal Products to Physicians

• Lithuania—Law on Pharmacy and Ministerial Order no V-1537/2000

• Portugal—Decree Law 20/2013 and 128/2013

• Romania—Ministerial Orders 194/2015 and 874/2015

• Slovakia—Act No. 362/2011 on Medicines and Medical Devices

• USA—Physician Payments Sunshine Act (Sunshine Act)

Known knowns

The ‘known knowns’ of payment disclosure encompass payments identifiable, at least theoretically, through Disclosure UK. They have been scrutinised across healthcare professionals,12 general practices,13 NHS Trusts14 and professional organisations,15 highlighting potential conflicts between industry funding and the imperative of high-quality patient care.

However, these disclosures are ‘known knowns’ only to those well-versed in the intricacies of Disclosure UK and capable of undertaking forensic research.

Consider NHS Trust A contributing to an NICE technology appraisal.14 One might expect that searching in Disclosure UK would reveal a complete picture of the trust’s drug company funding. Yet, without clear naming rules and unique recipient identifiers, such as those mandated by the US Sunshine Act (table 1), companies can use multiple names and abbreviations. Some can also identify the trust indirectly through its constituent hospitals, departments or clinics. Conversely, some payments may be misattributed, which becomes evident through cross-referencing Disclosure UK entries with the trust’s official address information.

These challenges in accurately identifying payment recipients pervade the entire database.5 13 16

Unknown knowns

The ‘unknown knowns’ involve payments whose existence is uncertain due to reporting inconsistent with the disclosure rules.

Take, again, NHS Trust A—to check its ties comprehensively, NICE must account for potentially misreported payments, both within and outside of Disclosure UK.

One issue, also enabled by the lack of unique recipient identifiers, is payments misattributed to the wrong organisations or persons sharing the same name.5 14 16 Moreover, unlike in, for instance, France’s Loi Bertrand (table 1), recipients subject to reporting are not categorised. Consequently, payments to individuals are sometimes mistakenly reported in the database section covering organisations.16 Similarly, some payments to patient organisations are reported in Disclosure UK, although they belong in a separate system.16 Conversely, from 2015 to 2018, over 10% of payments listed under patient organisations should have been reported in Disclosure UK.17 Confusingly, some payments to the same organisation may be reported in both systems concurrently, creating uncertainty around potential duplication and totals received.

Known unknowns

The ‘known unknowns’ include ties whose existence is acknowledged in Disclosure UK, but where disclosure rules permit concealment, exacerbated by inconsistent company practices.

For instance, Consultant B, invited to an NICE appraisal, cannot have their COI declaration verified fully through Disclosure UK, as the database ‘discloses’ most payments ‘in aggregate’—without naming recipients (box 1).

Payments to healthcare professionals and organisations for participation in companies’ research, including clinical trials, are reported as annual lump sums without detailing recipients or activities (box 1).4 From 2015 to 2022, research payments exceeded non-research payments to named recipients threefold (£3.3 billion vs £1.1 billion), constituting 72% of all payments (figure 2). High shares of research payments, including those by Allergan, Bristol Myers Squibb, and AstraZeneca (at least 90% for the entire period), are claimed as genuine research investment, but may reflect a flexible interpretation of what qualifies as research and research-related payments, a practice permitted by the ABPI Code.4

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Figure 2

Trends in the value of ‘known knowns’ and ‘known unknowns’ in Disclosure UK. Aggregate – payments reported without named recipients. Payment values are adjusted for inflation using the CPI index obtained from the Office of National Statistics.The figure excludes payments worth £5.2m which some companies made to healthcare organisations without identifying them, a known unknown. The possibility of aggregate reporting of payments to healthcare organisations was removed by the ABPI in 2019. Source: Disclosure UK databases obtained from the Association of the British Pharmaceutical Industry website https://search.disclosureuk.org.uk/Public/DownloadFullDataSet. The data was analysed in Microsoft Excel and visualised in RStudio (version 2024.04.2).

Payment transparency legislation mandates the disclosure of research payments in several countries (table 1).4 However, the UK government endorses the industry’s stance that secrecy is vital for investment, proposing to exempt ‘commercially sensitive information’ from disclosure.2

Despite the size of unknowns generated by research payments, the ABPI highlights a different issue caused by healthcare professionals refusing consent for companies to disclose their non-research consultancies and event sponsorships. Yet, this form of aggregate reporting represented merely 4% of the total (£0.2 billion vs £4.5 billion) between 2015 and 2022 (figure 2). The ABPI’s explanation emphasises insufficient commitment to transparency from individual recipients,18 while downplaying the impact of varying company practices, as suggested by disclosure rates ranging from nearly 100% to 15% among major UK companies.12

Since 2020 the ABPI has recommended that companies do not actively seek consent from healthcare professionals, although they can still ‘raise objections’ to the disclosure of their non-research payments.19 20 By 2022, these aggregated payments had fallen to nearly £9 million, a considerable drop compared with 2019. While celebrated as a success by the ABPI,19 the new recommendation underscores two critical flaws in self-regulation—difficulty in enforcing non-mandatory guidance across companies and the fact that, in the European legal environment, individual non-disclosure can ultimately be eliminated through legislation or other government mandate over-riding data privacy rights.3

Additionally, Disclosure UK does not mention—and therefore implicitly excludes—non-research payments and other interests covered in some countries with payment transparency legislation (table 1). For example, the US Sunshine Act covers ownership and investments and small hospitality payments known to be widespread and influence prescribing.21

Further, while Disclosure UK includes recipients involved in prescribing or managing prescription medicines, France’s Loi Bertrand covers a broad set of ‘players in the health field’, including media organisations and media and social ‘influencers’. Combined with the user interface from the independent eurosfordocs.fr platform, this wide-ranging data has enabled tracing COIs which can interfere with both healthcare standard setting and delivery.3 4

Yet another known unknown is the lack of information on how the money is spent by recipients. Contrastingly, transparency legislation mandates brief payment descriptions in several European countries, including the names and/or dates of industry-sponsored meetings.

Finally, Disclosure UK does not cover medical device companies, which use a separate self-regulatory system.22 However, they are often covered by transparency legislation, including Loi Bertrand, which also extends to manufacturers of veterinary products and cosmetics.

Unknown unknowns

The ‘unknown unknowns’ represent financial connections that may exist but remain unreported because the companies involved either do not subscribe to or breach the ABPI’s disclosure rules.

For example, when using Disclosure UK to assess the COIs of NHS Trust A or Consultant B, NICE must consider potential undisclosed ties, which are nearly impossible to trace even when triangulating with institutional disclosures.

One concern is payments potentially made by companies not signing up to the ABPI Code and therefore not obligated to disclose their payments.5 Despite the ABPI’s claims of few such companies, notable exceptions, like Vertex, exist.5

Further, the Prescription Medicines Code of Practice Authority (PMCPA), the ABPI’s self-regulatory body, ruled that since 2016 seven companies breached the ABPI Code by failing to report some of their payments in Disclosure UK. The most egregious was Novo Nordisk’s failure to report around 500 payments worth £7.8 million to over 150 UK healthcare professionals and organisations.23 Companies typically highlight that unreported payments arise from human error, internal process failures or misunderstanding of the disclosure rules.

As companies often struggle to trace all missing payments, the PMCPA rulings reveal only a minimum extent of unreporting.5 23 The possibilities for discovering unreporting are constrained by the PMCPA lacking independent investigative powers,23 relying instead on voluntary admissions by companies or evidence presented by complainants, typically healthcare professionals and industry whistleblowers.24

Redefining disclosure and addressing uncertainty

The fact that the government is considering expanding Disclosure UK reflects its acceptance of an industry-driven discourse that conceals the divergence of interests between the industry and the public regarding transparency. This discourse does not prioritise exposing COIs but protecting the industry’s reputation through the paradoxical concept of ‘aggregate disclosure’3 4 and the silence around donors, payments, and recipients disclosed elsewhere.

Once this discourse is recognised, it becomes clear that the uncertainty can only be addressed with transparency legislation using the international experience (table 1). Responding to the ‘known unknowns’ of Disclosure UK requires expanding disclosure rules to new payments, recipients, and industries. New rules regarding recipient identifiers, categories and payment descriptions are necessary to eliminate the ambiguities generating the ‘known knowns’ and ‘unknown knowns’.

A bespoke Sunshine Act would likely eliminate the uncertainty most comprehensively (table 1), while offering awareness-raising and educational opportunities across stakeholders involved in industry collaborations. However, the alternative route of extending the existing healthcare legislation might be more pragmatic politically. Notably, the transparency provisions included in the Health and Care Act 2022 following the Cumberlege Review could inform policy solutions more quickly and without triggering industry opposition that would likely surround a Sunshine Act proposal.

Irrespective of the chosen approach, it should be combined with standardising company disclosure practices through precise and regularly updated implementation guidelines. This needs to be reinforced through continual and transparent monitoring, supported by companies funding independent disclosure research, similar to the Truth Tobacco Industry Documents database.25 Heavy fines are also needed to deter substandard reporting, with any collected fines supporting compliance efforts.

These transparency gains cannot be achieved under ‘mixed’ legislative/self-regulatory systems (box 2). Most notably, they lack mandated disclosure of research payments and, like in self-regulation, leave the implementation and oversight in the industry’s hands, potentially leading to levels of uncertainty similar or even exceeding those characterising Disclosure UK.3 4

Nevertheless, even enhanced transparency cannot itself address COIs26 and may generate unintended consequences—‘moral licensing’,27 unjustified decrease in trust in physicians,28 or industry surveillance of prescribers.29 Therefore, it should be combined with reducing—or eliminating—industry interactions in professional training, continuing medical education, guideline and policy development.26