European Commission Launches Structured Dialogue with Stakeholders in Medicine Manufacturing Chain

• 01/03/2021
• Articles

The European Commission (the Commission) launched on 26 February 2021 a “structured dialogue” with the stakeholders in the medicine manufacturing chain, thus rolling out a principal ingredient of its Pharmaceutical Strategy for Europe  (see, Van Bael & Bellis Life Sciences News Alert of 26 November 2020).  The structured dialogue involves, in addition to Commission officials, representatives of national health authorities, pharmaceutical firms, patient associations, health non-governmental organisations and the research community (see, attached list of participants for the launch event).
 
The stated goal of the structured dialogue is to strengthen the resilience of pharmaceutical supply chains and ensure the security of supply of medicines, without compromising the affordability of these medicines. The structured dialogue will be a two-stage process in which phase 1 will serve to gain a better understanding of the functioning of global pharmaceutical supply chains and identify the precise causes of various vulnerabilities. Building on the evidence gathered in phase 1, phase 2 will come up with concrete measures to tackle these vulnerabilities.
 
In phase 1 four workstreams will (i) define a robust supply chain; (ii) identify critical medicines and trace EU manufacturing capacity for those products; (iii) list vulnerabilities and gauge the cost of eliminating them; and (iv) instil a modicum of innovation by identifying the modernisation needs, including priority R&D areas, to make supply chains robust and resilient to satisfy the requirements of public health.
 
The structured dialogue has the ambitious goal to put forward, in phase 2, a set of policy recommendations by the end of the year.