An important piece of the new Pharmaceutical Strategy adopted in November 2020 by the von der Leyen Commission is represented by the structured dialogue with the actors of the pharmaceuticals manufacturing chain in order to better identify causes and drivers of vulnerabilities and to prevent shortages of medicines in the market. Reinforcement of the EU’s strategic autonomy of pharmaceutical production may greatly impact avoidance of bottlenecks (deriving from stops to import from non-EU countries). The structured dialogue initiative will focus on how to ensure enough manufacturing capacity for critical active ingredients, raw materials and medicines in the EU. The initiative was launched on 26 February 2021 with a high-level event, followed by an operational meeting on 25 Mar 2021.
The structured dialogue will be coordinated by the Commission, and it articulates in two distinct phases. The first one is divided into four different workstreams, and will focus on identifying current knowledge gaps, and on confirming priority areas of action. Some topics of attention have been raised during the launch event, e.g. the need for regulatory flexibility, the support to public-private collaborations and investments and the avoidance of protectionism.
The second phase will examine in deeper detail the identified issues, and it will propose a set of measures for the attention of the European Commission.
The process is expected to close by the end of 2021; conclusions will be presented in the form of written documents.