Will fast-tracking medicines improve affordability?

According to the European Medicines Agency, adaptive pathways aim to improve timely access to new medicines “primarily in areas of high medical need.” The eligible products would be put on the market earlier for small subsets of patients and their use would gradually be expanded based on additional data generated.

The public health community has voiced a series of concerns ranging from the questionable innovative value of these medicines to fears about patient safety and the affordability of these products. Therefore, it is essential for the public health community to see the evaluation of the pilot project, which must include the impact on affordability.

Yannis Natsis, policy coordinator universal access and affordable medicines, at the European Public Health Alliance (EPHA), issued a briefing in response to an article published earlier this month by four influential European regulators including the leadership of the EMA, ie, its executive director Guido Rasi, and senior medical officer Hans-Georg Eichler, as well as the Director of the Dutch Medicines Agency, addressing the issue of the  affordability of new drugs.