8 Amendments of Pascal CANFIN related to 2022/0031(COD)
Amendment 14 #
Proposal for a regulation
Recital 2
Recital 2
(2) According to Regulation (EU) 2021/953, test certificates are to be issued based on two types of tests for SARS-CoV- 2 infection, namely molecular nucleic acid amplification tests (‘NAAT’), including those using reverse transcription polymerase chain reaction (‘RT-PCR’), and rapid antigen tests, which rely on detection of viral proteins (antigens) using a lateral flow immunoassay that gives results in less than 30 minutes, provided they are carried out by health professionals or by skilled testing personnel. However, Regulation (EU) 2021/953 does not cover antigenic assays, such as enzyme-linked immunosorbent assays or automated immunoassays, which test for antigens in a laboratory setting. As of July 2021, the technical working group on COVID-19 diagnostic tests2, responsible for preparing updates to the common list of COVID-19 rapid antigen tests3 agreed by the Health Security Committee established by Article 17 of Decision No 1082/2013/EU of the European Parliament and of the Council4 , also reviews proposals put forward by Member States and manufacturers for COVID-19 laboratory-based antigenic assays. Those proposals are assessed against the same criteria as those used for rapid antigen tests, and the Health Security Committee has established a list of the laboratory-based antigenic assays that meet those criteria. As a result, and in an effort to enlarge the scope of the different types of diagnostic tests that may be used as the basis for the issuance of an EU Digital COVID Certificate, the definition for rapid antigen tests should be adapted to include laboratory-based antigenic assays. It should thus be possible for Member States to issue test certificates on the basis of the antigen tests included in the EU common list agreed, and regularly updated, by the Health Security Committee as meeting the established quality criteria. The use of antigen tests for the issuance of certificates of recovery pursuant to Commission Delegated Regulation (EU) 2022/2564a entails an increased risk for the issuance of such certificates for false positive tests. The possibility for Member States to use antigen tests for the issuance of such certificates should hence be understood as a possibility when the availability of NAAT tests is scarce due to a high number of infections in the area concerned or another reason. _________________ 2 https://ec.europa.eu/health/health- security-and-infectious-diseases/crisis- management/covid-19-diagnostic-tests_en 3 https://ec.europa.eu/health/system/files/202 2-01/covid-19_rat_common-list_en.pdf 4 Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1). 4a Commission Delegated Regulation (EU) 2022/256 of 22 February 2022 amending Regulation (EU) 2021/953 of the European Parliament and of the Council as regards the issuance of certificates of recovery based on rapid antigen tests (OJ L 42, 23.2.2022, p. 4).
Amendment 19 #
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 may 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. The validity of such vaccination certificates should not be longer than that of the certificates issued based on products approved by the European Medecines Agency (EMA). In this regard, the issuance of vaccination certificates to participants in clinical trials for COVID-19 vaccines and acceptance of such certificates is a Member States’ competence. 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. In case of a negative evaluation of an application for marketing authorisation, or if the pharmaceutical company in question states that it does not intend to apply for a marketing authorisation pursuant to Regulation (EC) No 726/2004, the validity of the certificate should be discontinued. _________________ 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 30 #
Proposal for a regulation
Recital 8
Recital 8
(8) As a result, it cannot be excluded that Member States continue to require Union citizens exercising their right to free movement to present proof of COVID-19 vaccination, test or recovery beyond 30 June 2022, the date when Regulation (EU) 2021/953 is set to expire. It is thus important to avoid that, in the event that certain restrictions to free movement based on public health are still in place after 30 June 2022, Union citizens and their family members are deprived of the possibility to make use of their EU Digital COVID Certificates, which are an effective, secure and privacy-preserving way of proving one’s COVID-19 status. At the same time, gThe use of EU Digital COVID Certificates should be proportionate to the epidemiological situation and associated public health risk. Given that any restrictions to the free movement of persons within the Union put in place to limit the spread of SARS-CoV- 2, including the requirement to present EU Digital COVID Certificates, should be lifted as soon as the epidemiological situation allows, the extension of the application of Regulation (EU) 2021/953 should be limited to 12 months and subject to a mid-term evaluation after six months, with a possibility of repeal of that Regulation on the basis of a recommendation of the ECDC and the Health Security Committee. In addition, the extension of that Regulation should not be understood as requiring or encouraging Member States, in particular those that lift domestic public health measures, to maintain or impose free movement restrictions. The power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union delegated to the Commission pursuant to Regulation (EU) 2021/953 should be equally extended. It is necessary to ensure that the EU Digital COVID Certificate system can adapt to new evidence on the efficacy of COVID-19 health technologies and to scientific progress in containing the COVID-19 pandemic.
Amendment 52 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point a
Article 1 – paragraph 1 – point 3 – point a
Regulation (EU) 2021/953
Article 5 – paragraph 2 – point b
Article 5 – paragraph 2 – point b
(b) information about the COVID- 19 vaccine and the number of doses of COVID-19 vaccines administered to the holder, regardless of the Member State in which they have been administered;;
Amendment 54 #
Proposal for a regulation
Article 1 – paragraph 1 – point 3 – point b
Article 1 – paragraph 1 – point 3 – point b
Regulation (EU) 2021/953
Article 5 – paragraph 5 – subparagraph 3 a (new)
Article 5 – paragraph 5 – subparagraph 3 a (new)
Member States may 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.; The validity of such vaccination certificates, issued by Member States, shall not be longer than that of the vaccination certificates issued pursuant to the second subparagraph of this paragraph. Such certificates shall include information regarding the phase of the clinical trial and the status 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. If a COVID-19 vaccine undergoing clinical trials is subsequently granted a marketing authorisation pursuant to Regulation (EC) No 726/2004, vaccination certificates for that vaccine fall, as of that moment, within the scope of the first subparagraph of this paragraph. In the case of a negative evaluation of marketing authorisation application for the specific product, or in case the incumbent pharmaceutical company states it does not intend to apply for a marketing authorisation, the validity of the certificate shall be discontinued.;
Amendment 64 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5
Article 1 – paragraph 1 – point 5
Regulation (EU) 2021/953
Article 7 – paragraph 4
Article 7 – paragraph 4
4. On the basis of guidance received pursuant to Article 3(11), recommendations by the ECDC and where relevant other Union agencies, based on the latest scientific evidence, the Commission is empowered to adopt delegated acts in accordance with Article 12 to amend paragraph 1 of this Article and point (c) of Article 3(1) to allow for the issuance of the certificate of recovery on the basis of a positive antigen test, antibody test, including a serological test for antibodies against SARS-CoV-2, or any other scientifically validated method. Such delegated acts shall also amend point 3 of the Annex by adding, modifying or removing the data fields falling under the categories of personal data referred to in points (b) and (c) of paragraph 2 of this Article.;
Amendment 75 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 d (new)
Article 1 – paragraph 1 – point 7 d (new)
Regulation (EU) 2021/953
Article 16 – paragraph 2
Article 16 – paragraph 2
(7d) In Article 16, paragraph 2 is replaced by the following: "2. By 31 MarchDecember 2022, the Commission shall submit a report to the European Parliament and to the Council on the application of this Regulation. The report shall contain, in particular, an assessment of the proportionality and the impact of this Regulation on the facilitation of free movement, including on travel and tourism and the acceptance of the different types of vaccine, fundamental rights and non- discrimination, as well as on the protection of personal data during the COVID-19 pandemic. The report mayassessment shall be accompanied by legislative proposals, in particular to extend the period of application of this Regulation, taking into account a recommendation of the ECDC and the Health Security Committee to either repeal this Regulation after the initial six monthes evolution of the epidemiological situation with regard to the COVID-19 pandemic.xtension or to extend the period of application of this Regulation up to 12 months;"
Amendment 78 #
Proposal for a regulation
Article 1 – paragraph 1 – point 8
Article 1 – paragraph 1 – point 8
Regulation (EU) 2021/953
Article 17 – paragraph 2
Article 17 – paragraph 2
It shall apply from 1 July 2021 to 30 June 2023., with a possibility of its repeal after six months pursuant to the evaluation and recommendation of the ECDC and the Health Security Committee;