Regulation (EU) 2020/1043 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19)

Summary:

Regulation (EU) 2020/1043 - adopted by the co-legislators on 15 July 2020 - introducing a temporary derogation for certain rules on clinical trials involving genetically modified organisms (GMOs) in the framework of the development of a vaccine or treatment for COVID-19 (coronavirus). This is a text with EEA relevance.

Further information:

The environmental risks of all medicinal products are assessed as part of the marketing authorisation procedures, including for medicinal products that contain or consist of genetically modified organisms (GMOs). The purpose of existing EU legislation on GMOs is to protect human health and the environment. However, the specific characteristics of the setting of clinical trials in a situation of public health emergency are not foreseen within it.

The public health emergency caused by the COVID-19 (coronavirus) pandemic required the need for development of vaccines and therapies which are safe, efficacious as soon as possible. Due to the sort of some of the vaccines under development, there is also a need to adapt the regulatory framework on GMOs so so that the conduct of clinical trials with these vaccines can start within the shortest possible timelines while ensuring the rights, safety, dignity and well-being of those individuals that take part in a clinical trial, as well as the reliability and robustness of the data generated and adequate protection of the environment and of human health via the environment.

This Regulation therefore provides for a temporary derogation from EU legislation on GMOs to ensure that the conduct of clinical trials in the territory of several Member States with investigational medicinal products containing or consisting of GMOs intended to treat or prevent COVID-19 (coronavirus) is not delayed.

The draft law was adopted by the European Commission on 17 June 2020 in the framework of its EU Strategy for COVID-19 vaccines. The plenary of the European Parliament endorsed it on 10 July, followed by the Council of the European Union on 14 July. The Act was signed by the co-legislators on the following day and published in the Official Journal on 17 July 2020.

On 6 March 2024, the European Commission published a Notice stating that the conditions for the application of Regulation (EU) 2020/1043 are no longer fulfilled.

• Primary Source

Official

EUR-Lex: COM(2020)261: Proposal for a Regulation on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=COM:2020:261:FIN

European Parliament: Legislative Observatory: Procedure File for Proposal on Conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (2020/0128(COD)) https://oeil.secure.europarl.europa.eu/oeil/popups/ficheprocedure.do?reference=2020/0128(COD)

European Parliament: Legislative Train Schedule: Conduct of Clinical Trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease https://www.europarl.europa.eu/legislative-train/theme-coronavirus-and-eu-action/file-clinical-trials-medicinal-products-containing-gmos-intended-to-treat-covid-19/06-2020

European Parliament: Press Release, 10/07/2020: Parliament to allow COVID-19 vaccines to be developed more quickly https://www.europarl.europa.eu/news/en/press-room/20200706IPR82731/

Council of the European Union: Press Release, 14/07/2020: Vaccine against COVID-19: Council adopts measures to facilitate swift development https://www.consilium.europa.eu/en/press/press-releases/2020/07/14/vaccine-against-covid-19-council-adopts-measures-to-facilitate-swift-development/

EUR-LEX: C Series, 06/03/2024: Notice from the Commission on the fulfilment of the conditions for the application of Regulation (EU) 2020/1043 on the conduct of clinical trials with and supply of medicinal products for human use containing or consisting of genetically modified organisms intended to treat or prevent coronavirus disease (COVID-19) http://data.europa.eu/eli/C/2024/1960/oj

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