Tip of the iceberg? Country- and company-level analysis of drug company payments for research and development in Europe

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 countryregulatory 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 selfregulation 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.