ObjectivesTo examine the accessibility and quality of drug company payment data in Europe.DesignComparative policy review of payment data in countries with different regulatory approaches to disclosure.Setting37 European countries.ParticipantsEuropean 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 measuresRegulatory 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).ResultsOf 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 Santé, had the highest accessibility and quality, exceeding that of Disclosure UK.ConclusionsThe 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.
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.
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