Session 5

Transparency of public contributions to drug development

Exploring policy options for fair pricing

Organised by HI PRIX & the Austrian Institute for Health Technology Assessment, Austrian Federal Ministry of Labour, Social Affairs, Health, Care and Consumer Protection, Österreichische Gesundheitskasse, and Drugs for Neglected Diseases initiative

Article 57 of the revision of EU pharmaceutical legislation will require market authorisation applicants to publicly declare any direct financial support for research and development (R&D) activities received from public authorities. Public contributions to drug research R&D are manifold but not well documented. Aligned public policies enforcing transparency on R&D investments are key for implementing the transparency clause: for example, standardisation of reporting and conditions attached to public support are under consideration. While frameworks and methodologies for searching and documenting public contributions to R&D of products have been developed and applied in multiple case studies (in the EC-project HI-PRIX, GA 101,095,593), using such data in price-setting and in price negotiations is still up for debate. This session will explore policy options to inform the ongoing discussions about fair pricing under the revision of the EU pharmaceutical legislation.