International comparison of pharmaceutical industry payment disclosures in the UK and Japan: implications for self-regulation, public regulation, and transparency

Abstract

Background Self-regulation of payment disclosure by pharmaceutical industry trade groups is a major global approach to increasing transparency of financial relationships between drug companies and healthcare professionals and organisations. Nevertheless, little is known about the relative strengths and weaknesses of self-regulation across countries, especially beyond Europe. To address this gap in research and stimulate international policy learning, we compare the UK and Japan, the likely strongest cases of self-regulation of payment disclosure in Europe and Asia, across three dimensions of transparency: disclosure rules, practices, and data. Results The UK and Japanese self-regulation of payment disclosure had shared as well unique strengths and weaknesses. The UK and Japanese pharmaceutical industry trade groups declared transparency as the primary goal of payment disclosure, without, however, explaining the link between the two. The rules of payment disclosure in each country provided more insight into some payments but not others. Both trade groups did not reveal the recipients of certain payments by default, and the UK trade group also made the disclosure of some payments conditional on recipient consent. Drug company disclosure practices were more transparent in the UK, allowing for greater availability and accessibility of payment data and insight into underreporting or misreporting of payments by companies. Nevertheless, the share of payments made to named recipients was three times higher in Japan than in the UK, indicating higher transparency of disclosure data. Conclusions The UK and Japan performed differently across the three dimensions of transparency, suggesting that any comprehensive analysis of self-regulation of payment disclosure must triangulate analysis of disclosure rules, practices, and data. We found limited evidence to support key claims regarding the strengths of self-regulation, while often finding it inferior to public regulation of payment disclosure. We suggest how the self-regulation of payment disclosure in each country can be enhanced and, in the long run, replaced by public regulation to strengthen the industry’s accountability to the public.

Drug company methodologies used for reporting in the UK pharmaceutical industry payment transparency database between 2015-2019: A content analysis

“…This study adds to the literature showing major shortcomings of self-regulated payment disclosure systems from both the pharmaceutical 1,18,22,44,45 and medical device 46 industries. This study’s findings of opacity in several areas corresponds with issues outlined in other studies of disclosure systems, such as non-disclosure of certain payment areas, 27 and unnecessary aggregation of recipients. 18,46 Overall, it reinforces the conclusions of the 2021 analysis of European disclosure systems, that “self-regulation cannot address ‘the issues of perceived conflict of interest’, as promised by EFPIA.” 22 The shortcomings of self-regulation found here reflect issues with self-regulation generally, which can be seen in other areas of the pharmaceutical industry 47,48 and other industries including alcohol 49 and nutrition.…”

“…18 Also, in one methodological note, Thea pharmaceuticals described not obtaining consent from HCPs and aggregating all HCP payments. Given that the UK disclosure system is considered the most accessible self-regulated European system, 22,27 similar issues likely exist with methodological notes in other EFPIA pharmaceutical markets (e.g. Spain).…”

“…22,27 The Association of the British Pharmaceutical Industry (ABPI) requires that member companies publish details of their payment methodologies (‘methodological notes’), alongside details of payments, every year on its website Disclosure UK (full overview of Disclosure UK in Box 1). 28 22,27 The ABPI represent the vast majority of UK manufacturers of branded prescription pharmaceuticals 28 and in 2019 on Disclosure UK 130 companies disclosed £542.5 million in payments to HCPs and HCOs. 29 Issues have been highlighted with the UK disclosure system, for example, the misreporting/underreporting of payments.…”

Pharmaceutical industry payments to NHS trusts in England: A four-year analysis of the Disclosure UK database

“…Nevertheless, in most countries efficient analysis of payments to HCOs is precluded by the “closed” electronic formats of disclosures, published as portable document files (PDFs), and their dispersal on multiple drug company websites [ 24 , 25 ]. Further, even centralised databases, such as the industry-run Disclosure UK [ 29 ] or Irish transferofvalue.ie [ 30 ], suffer from the absence of built-in recipient categories and the lack of recipient disambiguation [ 24 , 26 , 31 , 32 ].…”

Pharmaceutical company sponsorship of doctors: is gender equity a concern?

“…For example, the industry trade association Medicines Australia has required member companies to disclose funding of sponsored events since 2007 3 and of payments to individual clinicians since 2015 4 . In the United States, the 2010 Sunshine Act , requiring public reporting since 2013, was famously announced by Senator Charles Grassley with the comment that it “sheds light on these hidden payments and obscured interests through the best disinfectant of all: sunshine.” 5 The European Union, Japan, and South Korea have since also introduced legislated or industry self‐regulatory transparency processes 6‐8 …”