Medicinal products

Structured Dialogue initiative - 2nd Event

16 June 2021

The purpose of the second high level meeting of the structured dialogue, organised on 16 June, was to reiterate the importance of the dialogue and provide further political and high level steer, as the end of Phase 1 approaches on 20 July, when the workstream reports will be submitted.

Vice President Schinas opened the event showing political support building up to this ongoing crucial work. He noted the link to the Commission adopted communication on lessons learned from the Covid-19 crisis and remedial actions to address and improve European public health policy. He reiterated that health security, including security of supply of medicines, is one of key elements of a resilient Europe, is a fundamental stone of a European Health Union and  noted the importance of strategic autonomy, while building international co-operation to achieve sufficiently diversified supply chains.

Commissioner Breton noted the importance of identifying weaknesses and dependencies in medicines supply chains to increase security of supply and manufacturing capacity and to achieve strategic autonomy. He reflected on the importance of the collaborative dialogue to ensure preparedness for future crises.

Commissioner Kyriakides commented the inclusive collaboration, trustful partnership and the commitment of participants in the process, particularly patient representatives. She presented the structured dialogue as an opportunity for all to ensure the EU is prepared to address the current issues with supply chains but also to anticipate future challenges. Better prepared and more responsive. Finally, she noted the importance of considering a long-term strategic perspective.
The representative of the Portuguese Presidency, Secretary of State (Health) Diego Serras Lopes, draw attention to Portuguese Presidency Council Conclusions, adopted on 15 June stressing the need to align industrial and health policy. Ms Forte, Secretary of State (Health) from Slovenia, representing Slovenian Presidency, highlighted the need for understanding of the reasons for supply chain challenges and called for greater transparency.

The rapporteurs presented the progress of the work of their respective workstreams (please see below detailed summary). Overall, good progress have been achieved although some issues are still outstanding (criteria to establish the list of critical medicines, documentation of vulnerabilities) and there is  a need to ensure good alignment between the workstreams. Additional challenges present the strongly stressed by VP and Commissioners data gathering exercise.

The presentation of workstreams reports was followed by the reactions from the stakeholders. Overall, all speakers recognized the importance of the objective. Industry representatives stress the importance of pharmaceutical and industrial policies to support the robustness of the supply chains and necessity to create the market conditions rewarding the security of supply as well as need for more regulatory flexibility. Chemical industry underline the need of strong industrial base in the EU and wholesalers, the importance to take into account the distribution aspects. Patients and health professionals representatives stressed the relevance of the subject to the patients and called for more transparency from industry and careful assessment of an impact of all potential measures, taken in order to ensure the supply of medicines, on the patients and affordability. They also stressed the difficulties they have in contributing to discussions and necessity to ensure that all voices are represented in the final report. The representatives of the regulators stressed that the impact of the regulatory environment on the supply issues should be carefully assessed and not over stated. The dialogue between the regulators and industry is necessary to ensure supply security and safety, quality and efficacy at the same time.