9 Amendments of Tineke STRIK related to 2022/0031(COD)
Amendment 10 #
Proposal for a regulation
Recital 1
Recital 1
(1) Regulation (EU) 2021/953 of the European Parliament and of the Council1 lays down a framework for the issuance, verification and acceptance of interoperable COVID-19 vaccination, test and recovery certificates (EU Digital COVID Certificate) for the purpose of facilitating the holders’ exercise of their right to free movement during the COVID- 19 pandemic. It is also to contribute to facilitating the gradualRegulation (EU) 2021/953 has never represented and will never constitute legal basis to introduce additional requirements for the exercise of the right to free movement and to derogate from the provisions of Directive 2004/38/EC of the European Parliament and of the Council1a. Rather, it aims to facilitate the lifting of restrictions to free movement put in place by the Member States, in accordance with Union law, to limit the spread of SARS- CoV-2, in a coordinated manner. _________________ 1 Regulation (EU) 2021/953 of the European Parliament and of the Council of 14 June 2021 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 (OJ L 211, 15.6.2021, p. 1). 1a Directive 2004/38/EC of the European Parliament and of the Council of 29 April 2004 on the right of citizens of the Union and their family members to move and reside freely within the territory of the Member States amending Regulation (EEC) No 1612/68 and repealing Directives 64/221/EEC, 68/360/EEC, 72/194/EEC, 73/148/EEC, 75/34/EEC, 75/35/EEC, 90/364/EEC, 90/365/EEC and 93/96/EEC (OJ L 158, 30.4.2004, p. 77).
Amendment 13 #
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 recovery certificates pursuant to Commission Delegated Regulation (EU) 2022/2564a entails an increased risk for the issuance of recovery certificates for false positive tests. The possibility for Member States to use antigen tests for the issuance of recovery 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 20 #
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 certificate should not be longer than that of the certificate issued based on European Medicines Agency (EMA)-approved products. In this regard, the issuance of vaccination certificates to participants in clinical trials for COVID-19 vaccines and acceptance of those 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 marketing authorisation application, or in case the pharmaceutical company in question states that it does not intend to apply for 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 29 #
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, where required by Member States to exercise their right to free movement, 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 strictly necessary and 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. In additiona maximum period of 12 months and subject to a mid-term evaluation after six months, accompanied by an opinion and recommendation of the ECDC and of the Health Security Committee regarding the necessity and proportionality of maintaining the application of the EU Digital COVID Certificates. The mid-term evaluation might be accompanied by a legislative proposal to shorten the period of application of Regulation (EU) 2021/953 or to repeal that Regulation. As general rule, Member States should not introduce any free movement restriction if not warranted by the epidemiological situation with regard to the COVID-19 pandemic and where strictly necessary and proportionate for public health reasons based on the latest available scientific evidence. In this regard, the extension of that Regulation should not be understood nor be a justification as requiring Member States, in particular those that lift domestic public health measures, to maintain or impose free movement restrictions or request additional formalities to exercise the right to free movement, including the requirement to present the EU Digital COVID Certificates. 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 technologies and scientific progress in containing the COVID-19 pandemic.
Amendment 37 #
Proposal for a regulation
Recital 8 c (new)
Recital 8 c (new)
Amendment 53 #
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.; Validity of such vaccination certificate issued by a Member State shall not be longer than that of the vaccination certificates issued pursuant to the second subparagraph of this paragraph. A certificate provided according to this criteria, 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 marketing authorisation, validity of the certificate shall be discontinued.;
Amendment 66 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 b (new)
Article 1 – paragraph 1 – point 5 b (new)
Regulation (EU) 2021/953
Article 11
Article 11
(5b) Article 11 is replaced by the following: “Article 11 Restrictions to free movement and information exchange 1. Without prejudice to Member States’ exclusive competence to impose restrictions to free movement on grounds of public health, where Member States accept vaccination certificates, test certificates indicating a negative result or certificates of recovery, they shall refrain from imposing additional restrictions to free movement, such as additional travel-related testing for SARS- CoV-2 infection or travel-related quarantine or self-isolationshall refrain from introducing restrictions or additional requirements to the exercise of the right to free movement, including the requirement to present the EU Digital COVID Certificates, unless they are strictly necessary and proportionate for the purpose of safeguarding public health in response to the COVID-19 pandemic, also taking fully into account available scientific evidence, including epidemiological data published by the ECDC on the basis of Recommendation (EU) 2020/1475. 2. Where a Member State requires, in accordance with Union law, in view of the pandemic situation, introduces measures limiting free movement, it shall refrain from imposing additional travel restrictions or further restrictive measures for holders of certificates referred to in Article 3. deleted deleted deleted 3. Where a Member State requires, by way of exception, and only where strictly necessary and proportionate for public health reasons based on the latest available scientific evidence, holders of the certificates referred to in Article 3(1) to undergo, after entry into its territory, quarantine or self-isolation or to be tested for SARS-CoV-2 infection, or if it imposes other restrictions on the holders of such certificates because, for example, the epidemiological situation in a Member State or in a region within a Member State worsens quickly, in particular as a result, in full compliance with Union law and avoiding direct or indirect discrimination, as a result, for instance, of a SARS-CoV-2 variant of concern or interest, it shall inform the Commission and the other Member States accordingly, if possible 48 hours in advance of the introduction of such new restrictions. To that end, the Member State shall provide the following information: (a) the reasons for such restrictions; , including all relevant epidemiological data and scientific evidence supporting such restrictions; (b) the scope of such restrictions, specifying which certificate holders are subject to or exempt from such restrictions; (c) the date and duration of such restrictions. 34. Member States shall inform the Commission and the other Member States of the issuance and the conditions of acceptance of the certificates referred to in Article 3(1), including the COVID-19 vaccines they accept pursuant to the second subparagraph of Article 5(5). 45. Member States shall provide the public with clear, comprehensive and timely information with regard to paragraphs 2 and 3. As a general rule, Member States shall make that information publicly available 24 hours before new restrictions come into effect, taking into account that some flexibility is required for epidemiological emergencies. In addition, the information provided by the Member States may be made publicly available by the Commission in a centralised manner.”;
Amendment 72 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 a (new)
Article 1 – paragraph 1 – point 7 a (new)
Regulation (EU) 2021/953
Article 16
Article 16
(7a) Article 16 is replaced by the following: “Article 16 Commission report 1. By 31 OctoDecember 20212, the Commission shall submit a report to the European Parliament and to the Council. The report shall include an overview of: (a) the number of certificates issued pursuant to this Regulation; (b) guidance requested pursuant to Article 3(11) on the available scientific evidence and level of standardisation regarding the possible issuance of certificates of recovery based on antibody tests, including serological testing for antibodies against SARS-CoV-2, taking into account the availability and accessibility of such tests; and (c) the information received pursuant to Article 11. 2. By 31 March 2022, the Commission shall submit a report to the European Parliament and to the Council on the application of on the application of this Regulation. deleted deleted deleted deleted The report shall contain, in particular, an assessment of the necessity, proportionality and impact of this Regulation on the facilitation of free movement, including on travel and tourism and the acceptance of the different types of vaccine, on fundamental rights and non- discrimination, as well as on the protection of personal data during the COVID-19 pandemic. It shall also assess any domestic use by Member States of the EU Digital COVID Certificates for purposes other than freedom of movement, and shall put those in relation to the use for purposes under this Regulation. The report shall contain, in particular, an assessment of 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- discriminassessment shall be accompanied by an opinion and recommendation of the ECDC and of the Health Security Committee regarding the necessity and proportionality of maintaining the application of the EU Digital COVID Certificates in view of the pandemic situation, as well as on the protection of personal data during the COVID-19 pandemicnd the latest available scientific evidence. The report mayight be accompanied by legislative proposals, in particular to ex to shortend the period of application of this Regulation, taking into account the evolution of the epidemiological situation with regard to the COVID-19 pandemic. or to repeal this Regulation.”;
Amendment 80 #
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, without prejudice to Article 16.;