4.6 Review

Accessibility and quality of drug company disclosures of payments to healthcare professionals and organisations in 37 countries: a European policy review

期刊

BMJ OPEN
卷 11, 期 12, 页码 -

出版社

BMJ PUBLISHING GROUP
DOI: 10.1136/bmjopen-2021-053138

关键词

ethics (see medical ethics); health policy; protocols & guidelines

资金

  1. Swedish Research Council (VR) [2020-01822]
  2. Swedish Research Council [2020-01822] Funding Source: Swedish Research Council

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The study examined the accessibility and quality of drug company payment data in Europe and found that it is typically low, hindering investigation of financial conflicts of interest. Major regulatory changes are needed to reach the standards of the widely researched US Open Payments database.
Objectives To examine the accessibility and quality of drug company payment data in Europe. Design Comparative policy review of payment data in countries with different regulatory approaches to disclosure. Setting 37 European countries. Participants European Federation of Pharmaceutical Industries and Associations, its trade group and their drug company members; eurosfordocs.eu, an independent database integrating payments disclosed by companies and trade groups; regulatory bodies overseeing payment disclosure. Main outcome measures Regulatory approaches to disclosure (self-regulation, public regulation, combination of the two); data accessibility (format, structure, searchability, customisable summary statistics, downloadability) and quality (spectrum of disclosed characteristics, payment aggregation, inclusion of taxes, recipient or donor identifiers). Results Of 30 countries with self-regulation, five had centralised databases, with Disclosure UK displaying the highest accessibility and quality. In 23 of the remaining countries with self-regulation and available data, disclosures were published in the portable document format (PDF) on individual company websites, preventing the public from understanding payment patterns. Eurosfordocs.eu had greater accessibility than any industry-run database, but the match between the value of payments integrated in eurosfordocs.eu and summarised separately by industry in seven countries ranged between 56% and 100% depending on country. Eurosfordocs.eu shared quality shortcomings with the underlying industry data, including ambiguities in identifying payments and their recipients. Public regulation was found in 15 countries, used either alone (3), in combination (4) or in parallel with (8) self-regulation. Of these countries, 13 established centralised databases with widely ranging accessibility and quality, and sharing some shortcomings with the industry-run databases. The French database, Transparence Sante, had the highest accessibility and quality, exceeding that of Disclosure UK. Conclusions The accessibility and quality of payment data disclosed in European countries are typically low, hindering investigation of financial conflicts of interest. Some improvements are straightforward but reaching the standards characterising the widely researched US Open Payments database requires major regulatory change.

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