Activities of Cornelia ERNST related to 2022/0031(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2021/953 on a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) to facilitate free movement during the COVID-19 pandemic
Amendments (7)
Amendment 21 #
Proposal for a regulation
Recital 4
Recital 4
(4) In particular in light of the emergence of new SARS-CoV-2 variants of concern, the continued development and study of COVID-19 vaccines is a crucial aspect in the fight against the COVID-19 pandemic. In this context, it is important to facilitate the participation of volunteers in clinical trials, that is, studies performed to investigate the safety or efficacy of a medicine, such as a COVID-19 vaccine. Clinical research plays a fundamental role in the development of vaccines, and voluntary participation in clinical trials should therefore be encouraged. Depriving volunteers from access to EU Digital COVID Certificates could constitute a major disincentive to participate, delaying the conclusion of clinical trials and negatively impacting public health more generally. In addition, the integrity of clinical trials, including in terms of data blinding and confidentiality, should be preserved to ensure the validity of their results. It should thus be clarified that Member States may issue EU Digital COVID Certificates to participants in clinical trials that have been approved by Member States’ ethical committees and competent authorities, regardless whether they have received the COVID-19 vaccine candidate or, to avoid undermining the studies, the dose administered to the control group. In addition, it should be clarified that other Member States mayshould accept vaccination certificates for COVID- 19 vaccines undergoing clinical trials in order to waive restrictions to free movement put in place, in accordance with Union law, in response to the COVID-19 pandemic. If a COVID- 19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/20045 , vaccination certificates for that vaccine fall, as of that moment, within the scope of the first subparagraph of Article 5(5) of Regulation (EU) 2021/953. To ensure a coherent approach, the Commission should be empowered to ask the Health Security Committee, the European Centre for Disease Prevention and Control (ECDC) or the European Medicines Agency (EMA) to issue guidance with regards to the acceptance of certificates issued for a COVID-19 vaccine undergoing clinical trials that has not yet received a marketing authorisation, which should take into account the ethical and scientific criteria necessary for carrying out clinical trials. _________________ 5 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1).
Amendment 38 #
Proposal for a regulation
Recital 8 d (new)
Recital 8 d (new)
(8d) In light of the above it is necessary to continuously evaluate which measures remain effective, necessary and proportionate as regards the purpose of the fight against the COVID-19 pandemic.
Amendment 43 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
Amendment 51 #
Proposal for a regulation
Article 1 – paragraph 1 – point 2 a (new)
Article 1 – paragraph 1 – point 2 a (new)
Regulation (EU) 2021/953
Article 4 – paragraph 2
Article 4 – paragraph 2
(2a) in Article 4, paragraph 2 is replaced by the following: “2. The trust framework shall be based on a public key infrastructure and allow for the reliable and secure issuance and verification of the authenticity, validity and integrity of the certificates referred to in Article 3(1). The trust framework shall allow for the detection of fraud, in particular forgery. In addition, it mayshall support the bilateral exchange of certificate revocation lists containing the unique certificate identifiers of revoked certificates. Such certificate revocation lists shall not contain any other personal data. The verification of the certificates referred to in Article 3(1) and, where applicable, certificate revocation lists shall not give rise to the issuer being notified of the verification.”
Amendment 57 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EU) 2021/593
Article 5 – paragraph 5 – subparagraph 3 a (new)
Article 5 – paragraph 5 – subparagraph 3 a (new)
Member States mayshall also issue vaccination certificates referred to in point (a) of Article 3(1) to persons participating in clinical trials that concern a COVID-19 vaccine and that have been approved by Member States’ ethical committees and competent authorities, regardless whether they have been administered the vaccine candidate or the dose administered to the control group. The information about the COVID-19 vaccine to be included in the vaccination certificate in accordance with the specific data fields set out in point 1 of the Annex shall not undermine the integrity of the clinical trial. Member States may accept vaccination certificates issued by other Member States in accordance with this paragraph in order to waive restrictions to free movement put in place, in accordance with Union law, to limit the spread of SARS-CoV-2.;
Amendment 65 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 a (new)
Article 1 – paragraph 1 – point 5 a (new)
Regulation (EU) 2021/953
Article 10 – paragraph 5
Article 10 – paragraph 5
(5a) in Article 10, paragraph 5 is replaced by the following: “5. Any certificate revocation lists exchanged between Member States pursuant to Article 4(2) shall not be retained after the end of period of the application of this Regulation.”;
Amendment 79 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EU) 2021/593
Article 17 – paragraph 2
Article 17 – paragraph 2
It shall apply from 1 July 2021 to 30 June 2023, or until the WHO has declared that the COVID-19 pandemic has ended, whichever is earlier.;