16 Amendments of Nicolaus FEST related to 2022/0031(COD)
Amendment 8 #
Proposal for a regulation
–
–
The European Parliament rejects the Commission proposal.
Amendment 9 #
Proposal for a regulation
–
–
The European Parliament rejects the Commission proposal.
Amendment 11 #
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, even though there have been operational issues with the digital certificate that have reduced its effectiveness, particularly involving fraudulent use of secret cryptographic keys. It is also to contribute to facilitating the gradual 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.
Amendment 16 #
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. Tests confirming the presence of COVID-19 antibodies should also enable a Digital COVID Certificate to be obtained for a renewable period of 90 days in order to facilitate free movement, as is the case in Switzerland, a member of the Schengen Area. 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. _________________ 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).
Amendment 17 #
Proposal for a regulation
Recital 2 a (new)
Recital 2 a (new)
(2a) Notes a blind spot in the application of Regulation (EU) 2021/953 regarding the validity period of the COVID certificate after the booster dose (3rd dose).
Amendment 18 #
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 and drug treatments 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 or drug treatment. Clinical research plays a fundamental role in the development of vaccines and treatments, and voluntary participation in clinical trials should therefore be encouraged. Depriving vaccine trial 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. 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. It would, however, be irresponsible if volunteers who have participated in clinical trials, whose certificate is deactivated due to non-authorisation of the trialled vaccine, were forced to be re- vaccinated with an authorised product whose possible short-, medium- or long- term interactions with the trialled vaccine have not been evaluated, particularly given the proximity in time of the vaccine administration. Following the precautionary principle, their certificates should therefore be valid for life. _________________ 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 23 #
Proposal for a regulation
Recital 5
Recital 5
(5) Since the adoption of Regulation (EU) 2021/953, the epidemiological situation with regard to the COVID-19 pandemic has evolved considerably. On the one hand, by 31 January 2022, more than 80% of the adult population in the Union have completed their primary vaccination cycle, and more than 50% have received a booster dose, despite significant differences between Member States6. Increasing vaccine uptake remains a crucial objective in the fight against the pandemic, given the increased protection against hospitalisation and severe disease afforded by vaccination, and thus plays an important role in ensuring that restrictions to the free movement of persons can be lifted. It would be appropriate to review the legitimacy of the COVID Certificate in the light of the number of vaccinated people in the EU and the lower risk presented by the new variants, as restricting the free movement of persons within the Union should remain an exception. _________________ 6 https://vaccinetracker.ecdc.europa.eu/publi c/extensions/COVID-19/vaccine- tracker.html
Amendment 25 #
Proposal for a regulation
Recital 6
Recital 6
(6) On the other hand, the spread of the SARS-CoV-2 variant of concern ‘Delta’ in the second half of 2021 caused an increase in the number of infections, hospitalisation and deaths, requiring Member States to adopt strict public health measures in an effort to protect healthcare system capacity, which is often under pressure as a result of budget cuts due mainly to austerity policies, promoted by the European Commission in its recommendations to Member States as part of the European Semester. In early 2022, the SARS-CoV-2 variant of concern ‘Omicron’ caused sharp increases in the number of COVID-19 cases, rapidly replacing Delta and reaching an unprecedented intensity of community transmission across the Union. As noted by ECDC in its Rapid Risk Assessment of 27 January 20227, Omicron infections appear less likely to lead to a severe clinical outcome that requires hospitalisation or admission to intensive care units, and notes that some Member States have decided to consider COVID- 19 an endemic disease. Although the reduction in severity is partially due to inherent characteristics of the virus, results from vaccine effectiveness studies have shown that vaccination plays a significant role in preventing severe clinical outcomes from Omicron infection, with effectiveness against severe illness increasing significantly among people having received three vaccine doses. However, the vaccine’s efficacy against infectiousness has proven to be limited. Furthermore, given the very high levels of community transmission, leading to many people being sick at the same time, Member States are likely to undergo a period of substantial pressure on their healthcare systems and on the functioning of the society as a whole, mainly through absence from work and education. Member States should therefore be encouraged to maintain or increase their budgetary provisions such that the number of hospital beds is at least equal to the number prior to the pandemic. In the light of the shortage of healthcare workers, Member States should exempt such workers from the obligation to be vaccinated, since vaccination has been shown not to prevent transmission. _________________ 7 https://www.ecdc.europa.eu/sites/default/fil es/documents/RRA-19th%20update-27- jan-2022.pdf
Amendment 27 #
Proposal for a regulation
Recital 7
Recital 7
(7) After a peak in Omicron cases, a high proportion of the population is expected to enjoy, at least for a certain period, protection from COVID-19 either due to vaccination or prior infection, or both. However, it is not possible to predict the impact of a possible increase in infections in the second half of 2022. In addition, the possibility of a worsening, or not, of the pandemic situation because of the emergence, or non-emergence, of new SARS-CoV-2 variants of concern cannot be ruled out. As also noted by ECDC, significant uncertainties remain at this stage of the COVID-19 pandemicregarding the evolution of COVID-19.
Amendment 31 #
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, 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 123 months. In addition, the extension of that Regulation should not be understood as requiring Member States, in particular those thatMember States should 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 scientific progress in containing the COVID-19 pandemichat restrict freedoms. It is necessary to ensure that the EU Digital COVID Certificate system is a tool to be used only in exceptional circumstances and is not to be used permanently.
Amendment 47 #
Proposal for a regulation
Article premier – paragraph 1 – point 2 – point a – point i
Article premier – paragraph 1 – point 2 – point a – point i
Regulation (EU) 2021/953
Article 3 – paragraph 1 – point b
Article 3 – paragraph 1 – point b
(b) a certificate confirming that the holder has been subject to a NAAT test, or an antigen test listed in the EU common list of COVID-19 antigen tests agreed by the Health Security Committee, or an immunological test showing the presence of antibodies, carried out by health professionals or by skilled testing personnel in the Member State issuing the certificate and indicating the type of test, the date on which it was carried out and the result of the test (test certificate);
Amendment 60 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 – point –a (new)
Article 1 – paragraph 1 – point 5 – point –a (new)
Regulation (EU) 2021/953
Article 7 – paragraph 1
Article 7 – paragraph 1
(-a) In Article 7, paragraph 1 is replaced by the following: "1. Each Member State shall issue, upon request, certificates of recovery referred to in point (c) of Article 3(1) following a positive result of a NAAT test carried out by health professionals or by skilled testing personnel. A Member State may also issue, upon request, certificates of recovery referred to in point (c) of Article 3(1) following a positive result of a rapid antigen test listed in the EU common list of COVID-19 antigen tests agreed by the Health Security Committee carried out by health professionals or by skilled testing personnel. Member States may issue certificates of recovery based on rapid antigen tests carried out by health professionals or by skilled testing personnel on or after 1 October 2021, provided that the rapid antigen test used was included in the EU common list of COVID-19 antigen tests agreed by the Health Security Committee at the time the positive test result was produced. A Member State may also issue certificates of recovery referred to in point (c) of Article 3(1) following a positive result of an antibody test carried out by health professionals or by skilled testing personnel, provided that the antibody test used was included in the EU common list of COVID-19 antibody tests agreed by the Health Security Committee at the time the positive test result was produced. Certificates of recovery shall be issued at the earliest 11 days after the date on which a person was first subject to a NAAT test or rapid antigen test that produced a positive result, or the day after the date on which a person was subject to an antibody test that produced a positive result. The Commission is empowered to adopt delegated acts in accordance with Article 12 to amend the number of days after which a certificate of recovery is to be issued, on the basis of guidance received from the Health Security Committee in accordance with Article 3(11) or on scientific evidence reviewed by ECDC."
Amendment 68 #
Proposal for a regulation
Article 1 – paragraph 1 – point 5 d (new)
Article 1 – paragraph 1 – point 5 d (new)
Regulation (EU) 2021/953
Article 11 – paragraph 4 a (new)
Article 11 – paragraph 4 a (new)
(5d) In Article 11, the following paragraph is added: “4a. Member States shall not make use of the EU Digital COVID Certificate as a tool to implement domestic restrictions.”;
Amendment 70 #
Proposal for a regulation
Article 1 – paragraph 1 – point 6
Article 1 – paragraph 1 – point 6
Regulation (EU) 2021/953
Article 12 – paragraph 2
Article 12 – paragraph 2
Amendment 76 #
Proposal for a regulation
Article 1 – paragraph 1 – point 7 e (new)
Article 1 – paragraph 1 – point 7 e (new)
Regulation (EU) 2021/953
Article 16 – paragraph 3 (new)
Article 16 – paragraph 3 (new)
Amendment 82 #
Proposal for a regulation
Article premier – paragraph 1 – point 8
Article premier – 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 20232.;