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)

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Series Details L 231, Pages 12-16
Publication Date 17/07/2020
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Summary:

Legislative initiative put forward by the European Commission on 17 June 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.

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.

The proposed Regulation aims to ensure that clinical trials with products for human use that contain or consist of GMOs and are intended to treat or prevent the coronavirus can start swiftly and without a prior environmental risk assessment and/or consent under existing GMO legislation, in so far as there is a valid declaration of pandemic or if COVID-19 is declared an emergency situation and remains so (temporary derogation). The European Commission tabled the proposal 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.

Source Link http://data.europa.eu/eli/reg/2020/1043/oj
Related Link(s)
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 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/

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