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(33) Although individual research entities may agree with each other or with another party to act as a sponsor in order to prepare a single harmonised Union-wide clinical trial protocol, experience during the COVID-19 pandemic has shown that initiatives to set up large multinational trials struggle to materialise due to the lack of a single entity that is able to take up all the responsibilities and activities of a sponsor within the Union as well as interact with multiple Member States. To address that problem, a new Union-wide and Union-funded vaccine trial network called VACCELERATE was launched following the Commission communication of 17 February 2021 entitled ‘HERA Incubator: Anticipating together the threat of COVID-19 variants’. The Agency should identify and facilitate such initiatives by giving advice on the possibilities for acting as a sponsor or, where applicable, for allocating respective responsibilities as co-sponsors in accordance with Article 72 of Regulation (EU) No 536/2014 and coordinate the development of clinical trial protocols. Such an approach would strengthen the research environment in the Union, would promote harmonisation and would avoid subsequent delays in availability of results of research for marketing authorisation files. A Union sponsor could benefit from Union research funding available at the time of the public health emergency as well as from existing clinical trial networks to facilitate the development, application, submission, and running of trials. This may be particularly valuable for trials established by Union or international public health or research organisations.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.