Background: In 2021, France effectively implemented transparency measures for public subsidies in the research and development of new medicines, setting a precedent in Europe.
This policy fostered hope for fairer negotiations between the State and the pharmaceutical industry and enhanced treatment accessibility. However, regulatory provisions introduced by the Government compromised the framework of the measure crafted by civil society and parliamentarians.
Description: In 2020, our organizations advocated towards the Ministry of Health and parliamentarians to ensure the translation of the 2019 World Health Assembly resolution on improving the transparency of markets for health products in national legislation. In the fall of the same year, an amendment was adopted in the 2021 Social Security Financing Bill stating that of the amount of public subsidies received for the research and development (R&D) of new medicines is public. Our organizations urged the Ministry of health to publish an implementing decree that would secure exhaustive, readable and diachronic information on public R&D subsidies. However, our demands remained unanswered.
The published decree states that pharmaceutical companies should only declare direct public investments they have received during the previous year. The text does not provide for penalties, relying on companies’ goodwill to disclose this information to price-setting authorities and the public.
Lessons learned: In 2021, out of 111 respondents, only 7 companies declared having received public subsidies totaling 3,082 million euros. In 2022, 2 out of 87 companies declared having received public subsidies amounting to 194 202€. In contrast, the Leem (the French Pharmaceutical Companies Association) published an estimate of 47 million euros of public subsidies received for R&D in France in 2017. These figures are proof of significant under-reporting.
They undermine French public R&D efforts, put the French government at a disadvantage in price negotiations for health products, and thus call for a firm political response.
Conclusions/Next steps: Efficient transparency measures of R&D funding must cover direct and indirect public subsidies, with explicit penalties in case of failure to meet the obligation to declare. Involving patient and health organizations at every legislative and regulatory stage is crucial for effective design and implementation by governments.