Public contributions to R&D of medical innovations: A framework for analysis.

Abstract

Background and objective: Article 57 of the proposed European Union (EU) Pharmaceutical Legislation (PL, Directive) will require market authorization applicants to publicly declare any direct financial support for R&D received from public authorities. Our research aims to identify the categories needed to capture direct or indirect public contributions to R&D, provide a framework for standardized reporting of public contributions, and reduce ambiguity in the interpretation of "direct" and "indirect" public contributions.

Methods: An iterative mixed-methods approach is applied: a targeted literature review was conducted, complemented by interviews with representatives of different stakeholder groups to identify categories of public contributions to R&D, followed by searches for relevant data sources.

Results: 26 publications on primary data relevant to analyses of public contributions were identified, finding that between half of all drugs approved and >90 % of drug targets are associated with public sector institutions and/ or their spin-outs. Eight categories of public contributions to medical innovations were identified along the value chain (from basic research to post-market surveillance).

Discussion and conclusion: The framework offers a structured and systematic approach for identifying data on public and philanthropic contributions to developing medical products (medicines and devices). This information is often not comprehensively documented. Therefore, aligned public policies enforcing transparent and standardized reporting in sufficient granularity on R&D investments and conditions are key.