Overview

This policy brief from the European Observatory on Health Systems and Policies is one of a series on addressing market and policy failures in the pharmaceutical sector that was prepared for the Austrian EU Presidency. It aims to inform discussions about stimulating more meaningful productivity in terms of R&D. More specifically, it explores how R&D efforts can be steered to areas of unmet clinical needs and how efficiency in the R&D process can be increased. It also explicitly considers concrete options for strengthening cooperation between EU Member States in this context.

This policy brief notes that a comprehensive approach encompassing initiatives to guarantee funding, optimize evidence generation and reconsider regulatory requirements will be necessary if Europe is to address the paucity of true innovation observed among newly approved medicines, particularly in the context of unmet needs. Despite a number of promising initiatives that are ongoing at different levels for each of these areas, no individual measure would produce the same level of results as an overarching vision backed by strong political commitment. Having looked at the different elements related to stimulating the right innovation to ensure patient benefit where it is most needed, it seems that the one crosscutting theme is the need for information. Lack of transparency regarding R&D costs, medicines in the pipeline, and research already commissioned and/or funded by different sources – but also information on unmet needs in their dynamic nature as well as the willingness of public funders to support related work – have been compounding progress in the area.