Tip of the Iceberg? Country- and Company-Level Analysis of Drug Company Payments for Research and Development in Europe

Abstract

Background: Creating new therapies often involves drug companies paying healthcare professionals and institutions for research and development (R & D) activities, including clinical trials. However, industry sponsorship can create conflicts of interests. We analysed approaches to drug company R & D payment disclosure in European countries and the distribution of R & D payments at the country and company level. Methods: Using documentary sources and a stakeholder survey we identified country-regulatory approaches to R & D payment disclosure. We reviewed company-level descriptions of disclosure practices in the UK, a country with a major role in Europe’s R & D. We obtained country-level R & D payment data from industry trade groups and public authorities and company-level data from eurosfordocs.eu, a publicly available payments database. We conducted content analysis and descriptive statistical analysis. Results: In 32 of 37 studied countries, all R & D payments were reported without named recipients, following a self-regulatory approach developed by the industry. The methodological descriptions from 125 companies operating in the UK suggest that within the self-regulatory approach companies had much leeway in deciding what activities and payments were considered as R & D. In five countries, legislation mandated the disclosure of R & D payment recipients, but only in two were payments practically identifiable and analysable. In 17 countries with available data, R & D constituted 19%-82% of all payments reported, with self-regulation associated with higher shares. Available company-level data from three countries with self-regulation suggests that R & D payments were concentrated by big funders, and some companies reported all, or nearly all, payments as R & D. Conclusion: The lack of full disclosure of R & D payments in countries with industry self-regulation leaves considerable sums of money unaccounted for and potentially many conflicts of interests undetected. Disclosure mandated by legislation exists in few countries and rarely enhances transparency practically. We recommend a unified European approach to R & D payment disclosure, including clear definitions and a centralised database.

Payments to healthcare organisations reported by the medical device industry in Europe from 2017 to 2019: an observational study

“…41 Also, many pharmaceutical industry disclosure websites disclose research and development payments to healthcare professionals and healthcare organisations, and these make up a large proportion of payments (though in Europe this is usually presented as an aggregated value for each company). 42 Nonetheless, these areas are not covered by the transparentmedtech.eu database. 22 Another major area that is not covered by transparentmedtech.eu, but is covered by US Open Payments, is ownership or shares in medical device companies.…”

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

“…A complementary explanation might be that the non-R&D payments, especially grants and donations, were overtaken by R&D payments, which constitute around two-thirds of all payments reported by drug companies in the UK [ 83 ]. The ABPI Code allows for R&D payments to be reported without mentioning any organisational- or individual-level recipients [ 83 ].…”

“…Between 2015 and 2018, 116 companies, representing 71.17% of all companies committing to report their payments in Disclosure UK, made non-R&D payments to NHS trusts in England. Over this period, the number of companies making payments increased from 83 [75], 90.53% (2016) [76], 91.45% (2017) [77], 91.70% (2018) [78] of the total number of NHS trusts in the respective years.…”

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

“…18 Such inconsistencies create several issues, [32][33][34] for example, making it difficult to compare companies' payment values. 32 However, the Irish study 18 and others 1,18,35 of methodological notes have been limited in scope, only analysing a limited number of years and a limited number of aspects of the notes. 1,18,35 This study aimed to comprehensively analyse the content of methodological notes of companies reporting payments on the ABPI payment disclosure website for 2015-2019 and their adherence to the relevant codes of conduct and guidance.…”

“…32 However, the Irish study 18 and others 1,18,35 of methodological notes have been limited in scope, only analysing a limited number of years and a limited number of aspects of the notes. 1,18,35 This study aimed to comprehensively analyse the content of methodological notes of companies reporting payments on the ABPI payment disclosure website for 2015-2019 and their adherence to the relevant codes of conduct and guidance. Specifically, we aimed to assess a) whether methodologies varied between companies and years, b) whether methodologies adhered to the ABPI code of practice and other regulatory advice, and c) what methodologies companies used in key areas (e.g.…”