Activities of Joanna KOPCIŃSKA related to 2022/0216(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC
Amendments (55)
Amendment 171 #
Proposal for a regulation
Recital 16
Recital 16
(16) This Regulation should not interfere with nNational legislation in the health area with objectives other than quality and safety of SoHOs that is compatible with Union law, in particular legislation concerning ethical aspects, shall take precedence over the provisions of this Regulation. Such aspects arise due to the human origin of the substances, which touches upon various sensitive and ethical concerns for Member States and citizens, such as access to particular services that use SoHOs. This Regulation shouldall also not interfere with decisions of an ethical nature made by Member States. Such ethical decisions might, and, in particular, no provision of this Regulation may be construed as imposing an obligation on Member States to use types of SoHOs that are legally prohibited in that Member State. Decisions concerning the use, or limitation of the use, of specific types of SoHOs or specific uses of SoHOs, including reproductive cells and embryonic stem cells, are an exclusive competence of the Member States. When a Member State allows the use of such cells, this Regulation should apply in full with a view to ensuring safety and quality and to protecting human health.
Amendment 194 #
Proposal for a regulation
Recital 22
Recital 22
(22) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities that act in the public interest, are appropriately resourced and equipped, and offer guarantees of impartiality, professionalism and transparency. When infringements relate to direct health risks, and the publication of information regarding those infringements can contribute to risk mitigation and the protection of donors, recipients or offspring from medically assisted reproduction, competent authorities should, where necessary, be able to prioritise transparency of their enforcement activities over the protection of confidentiality of the party that has infringed the Regulation. Matters covered by trade secrecy or infringements of the law until such time as the competent court has issued a ruling may not be the subject of such public information.
Amendment 206 #
Proposal for a regulation
Recital 26
Recital 26
(26) Commission experts should be able to perform controls, including audits, in Member States to verify the effective application of the relevant requirements of competent authorities and of the supervisory activity systems. Commission controls should also serve to investigate and collect information on enforcement practices or probOfficial controls may only be carried out with the agreement of the Member State, in compliance with the organisational rulems, emergencies and new developments in Member Statfunctioning and powers of the national supervisory authorities. Official controls should be performed by personnel who are independent, free from any conflict of interest and in particular who are not in a situation which, directly or indirectly, could affect their ability to carry out their professional duties in an impartial manner.
Amendment 226 #
Proposal for a regulation
Recital 33
Recital 33
(33) With regards to standards concerning donor, recipient and offspring protection, this Regulation should provide for a hierarchy of rules for their implementation. As risks and technologies change, this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this Regulation. As part of that hierarchy, in the absence of Union legislation describing particular procedures to be applied and followed to meet the standards set out in this Regulation, following the guidelines of the European Centre for Disease Prevention and Control (ECDC) and the EDQM should be considered as a means to demonstratone of the means to be compliancet with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. Member States may decide that SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines achieve the samrecognised guidelines that are based on scientific evidence and achieve an appropriate level of quality, safety and efficacy. In cases of detailed technical issues for which neither Union legislation nor the ECDC and the EDQM have defined a technical guideline or rule, operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.
Amendment 249 #
Proposal for a regulation
Recital 37
Recital 37
(37) It is necessary to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to help European citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. As there is a need to ensure the availability of SoHOs for medical treatments, Member States should promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing self- sufficiency in the Union. Member States are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 270 #
Proposal for a regulation
Recital 38
Recital 38
(38) In order to promote a coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission should participate in its activities and chair it. The SCB should contribute to a coordinating the application of this Regulation throughout the Union, including by helping Member States to conduct SoHO supervisory activities. The SCB should be composed of persons designated by the Member States based on their role and expertise in their competent authorities, and should also involve experts that are not working for competent authorities, for specific tasks where access to necessary in-depth technical expertise in the field of SoHOs is required. In the latter case, appropriate consideration should be given to the possibility of involving European expert bodies such as the ECDC and the EDQM and existing professional, scientific and donor and patient representative groups and industry experts at Union level in the field of SoHOs. When seeking the input of expert bodies such as the ECDC and the EDQM, the SCB shall have due regard to their respective areas of expertise and avoid duplication.
Amendment 273 #
Proposal for a regulation
Recital 38 a (new)
Recital 38 a (new)
(38 a) The Commission shall cooperate with the EDQM in relation to the guidelines issued by that body. Such cooperation is without prejudice to the autonomy of Union law and should take into account Union principles on transparency and stakeholder participation.
Amendment 288 #
Proposal for a regulation
Recital 43
Recital 43
(43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform should be limited to the extent necessary to carry out supervisory activities provided for in this Regulation. In addition, the personal data and curriculum vitae of the persons responsible for the release of SoHOs should not be made public.
Amendment 298 #
Proposal for a regulation
Recital 45
Recital 45
(45) SoHOs, by definition, relate to persons, and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this Regulation, especially provisions relating to vigilance and communication between competent authorities. This Regulation should provide a legal basis under Article 6 and, where relevant, fulfil the conditions under Article 9(2), point (i), of Regulation (EU) 2016/679 for processing of such personal data. With respect to personal data processed by the Commission, this Regulation should provide a legal basis under Article 5 and, where relevant, fulfil the conditions under Article 10(2), point (i), of Regulation (EU) 2018/1725. Data on safety and efficacy of new SoHO preparations in recipients should also be shared, with appropriate protective measures, to allow aggregation at Union level for more robust evidence gathering on the clinical efficacy of SoHO preparations. For all data processing, such processing should be necessary and appropriate with a view to ensuring compliance with this Regulation in order to protect human health. Data on donors, recipients and offspring should hence be limited to the minimum necessary and pseudonymisedrocessed in fully anonymised form, using a donor or donation number. dDonors, recipients and offspring should be informed of the processing of their personal data in line with the requirements of Regulations (EU) 2016/679 and (EU) 2018/1725, and in particular as provided for under this Regulation, including the possibility of exceptional cases where circumstances require such processing.
Amendment 309 #
Proposal for a regulation
Recital 51 a (new)
Recital 51 a (new)
(51a) In view of the significant systemic changes that will result from the entry into force of this draft Regulation, it is essential to give Member States sufficient time to redesign existing national solutions so that they can comprehensively, coherently and reliably amend national legislation in all areas covered by the Regulation;
Amendment 331 #
Proposal for a regulation
Article 2 – paragraph 4
Article 2 – paragraph 4
4. Where non-viable SoHOs or their derivatives, as defined in Article 2, point (17), of Regulation (EU) 2017/745, incorporate, as an integral part, a medical device, and where the action of the non- viable SoHOs or their derivatives is principal and not ancillary to that of the device, the non-viable SoHOs or their derivatives shall be governed by this Regulation. If the action of the non-viable SoHOs or their derivatives is ancillary to that of the device and not principal, the provisions of this Regulation, insofar as they concern donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, collection of SoHOs from donors or patients, shall apply. In the case of SoHOs whose donation is not regulated by national law, the relevant procedures under health policy programme agreements shall apply.
Amendment 356 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
Amendment 376 #
Proposal for a regulation
Article 3 – paragraph 1 – point 14
Article 3 – paragraph 1 – point 14
Amendment 381 #
Proposal for a regulation
Article 3 – paragraph 1 – point 15
Article 3 – paragraph 1 – point 15
Amendment 403 #
Proposal for a regulation
Article 3 – paragraph 1 – point 28 – point h a (new)
Article 3 – paragraph 1 – point 28 – point h a (new)
h a) the transfer of embryos other than those intended.
Amendment 430 #
Proposal for a regulation
Article 3 – paragraph 1 – point 60
Article 3 – paragraph 1 – point 60
Amendment 446 #
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘compensation’ means making good of any lossexpenses and inconveniences associated with donation;
Amendment 456 #
Proposal for a regulation
Article 3 – paragraph 1 – point 70 a (new)
Article 3 – paragraph 1 – point 70 a (new)
(70 a) ‘risk-based approach’ shall mean one that uses techniques to determine the areas of risk where ‘risk’ is identified as the probability of an event occurring that will have an impact on the achievement of objectives, taking into account the severity of its outcome and/or the likelihood of non-detection by other methods.
Amendment 473 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. Member States may maintain or introduce within their territories measures that are more stringent than the ones provided for in this Regulation on condition that those national measures are compatible with Union law, and are proportionate to the risk to human healththe law.
Amendment 475 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. Member States shallmay make available to the public details of measures put in place in accordance with paragraph 1 without undue delay, including on the internet. The SoHO National Authority shall submit the details of any more stringent measure to the EU SoHO Platform referred to in Chapter XI.
Amendment 492 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Without prejudice to Article 75, competent authorities shall carry out their supervisory activities in a transparent manner and they shall make accessible and clear to the public decisions taken in cases where a SoHO entity has failed to comply with an obligation under this Regulation and where such failure causes or may cause a serious risk to human healtho revoke, suspend or reinstate authorisation for SoHO activities.
Amendment 512 #
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The consultation and cooperation referred to in paragraphs 1, 2 and 5 may also be initiated on the basis of a request for advice from a SoHO entity, as referred to in Article 40.
Amendment 519 #
Proposal for a regulation
Article 16 – paragraph 2 – point a
Article 16 – paragraph 2 – point a
(a) before any inspection procedure is initiated, declare in writing any direct or indirect interests referred to in Article 7(2) and update that declaration yearly and whenever the declared information changes or any new interest arisesrelating to inspection activities of the entity concerned;
Amendment 522 #
Proposal for a regulation
Article 17
Article 17
Amendment 523 #
Proposal for a regulation
Article 18 – paragraph 3 – point e
Article 18 – paragraph 3 – point e
Amendment 537 #
Proposal for a regulation
Article 25 – paragraph 6 – subparagraph 1 a (new)
Article 25 – paragraph 6 – subparagraph 1 a (new)
Amendment 542 #
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Competent authorities shall provide guidelines and templto facilitates to allow thathe submission of applications from SoHO entities for their authorisation as SoHO establishments are submitted in accordance with Article 49. When developing these guidelines and templates, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).
Amendment 543 #
Proposal for a regulation
Article 27 – paragraph 2 – point a
Article 27 – paragraph 2 – point a
Amendment 544 #
Proposal for a regulation
Article 27 – paragraph 2 – point b
Article 27 – paragraph 2 – point b
(b) assess the application on the basis of the provisions of national administrative law;
Amendment 551 #
Proposal for a regulation
Article 28 – paragraph 2 – point a
Article 28 – paragraph 2 – point a
Amendment 552 #
Proposal for a regulation
Article 28 – paragraph 2 – point b
Article 28 – paragraph 2 – point b
(b) assess the application on the basis of the provisions of national administrative law;
Amendment 557 #
Proposal for a regulation
Article 29 – paragraph 5 – introductory part
Article 29 – paragraph 5 – introductory part
5. By derogation from paragraph 4, competent authorities may conduct inspections, in full or in part, by means of a remote document reviewinspection, provided that:
Amendment 562 #
Proposal for a regulation
Article 29 – paragraph 16
Article 29 – paragraph 16
16. For the purpose of standardised inspections referred to in paragraph 1 of this Article, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c), provided that they do not contravene the national legal provisions in force in the Member State concerned.
Amendment 563 #
Proposal for a regulation
Article 31 – paragraph 4 – subparagraph 2 a (new)
Article 31 – paragraph 4 – subparagraph 2 a (new)
The inspection shall be conducted in the official language of the country concerned, including the inspection report. Forms in all the official languages of the European Union shall be acceptable during the submission of an inspection application.
Amendment 564 #
Proposal for a regulation
Article 31 – paragraph 6 a (new)
Article 31 – paragraph 6 a (new)
6 a. 7. In exceptional cases, an inspection request may be refused or dismissed if it has not been justified.
Amendment 568 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. Competent authorities shall provide inspectors with amay organise specific induction training before inspectors before they take up their duties. For the specific induction training, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).
Amendment 574 #
Proposal for a regulation
Article 35 – paragraph 1
Article 35 – paragraph 1
1. Competent authorities shall be responsible for the management of vigilance associated with SoHO activities. They shall provide guidance and templates for the submission of SAO notifications and of SAO investigation reports as referred to in Article 47.
Amendment 575 #
Proposal for a regulation
Article 35 – paragraph 10
Article 35 – paragraph 10
10. Competent authorities shall submit to their SoHO National Authorities an annual summary of the SAO notifications and SAO investigation reports received in accordance with the provisions of the national law of the Member State concerned. The SoHO National Authorities shall submit an annual summary of those SAO notifications and investigation reports to the EU SoHO Platform referred to in Chapter XI before 31 May of the subsequent year and shall make an aggregated version of that summary available to the public in their Member State, including on the internet. They shall include in the annual summary the numbers and types of those SAO reported to them that meet thresholds of seriousness and imputability that are agreed at Union level within the SCB.
Amendment 593 #
Proposal for a regulation
Article 47 – paragraph 2
Article 47 – paragraph 2
2. Where applicable, SoHO entities shall make all reasonable efforts to encourage prospective parents of children born from third party donation to commit to communicate information concerning any genetic conditions that emerge, as those children grow up, to the SoHO entity where they were treated. That entity shall communicate, without undue delay, the information to the SoHO entity that distributed or applied the reproductive cells with a view to preventing further distribution of SoHO from the implicated SoHO donor.
Amendment 597 #
Proposal for a regulation
Article 51 – title
Article 51 – title
51 Physicians and embryologists
Amendment 598 #
Proposal for a regulation
Article 51 – paragraph 1 – introductory part
Article 51 – paragraph 1 – introductory part
1. Each SoHO establishment shall designate a physician or embryologist who resides and carries out its tasks in the same Member State and who shall at least fulfil the following conditions and have the following qualifications:
Amendment 599 #
Proposal for a regulation
Article 51 – paragraph 1 – point a
Article 51 – paragraph 1 – point a
(a) possession of formal qualification as a physician or have a degree in biology, biotechnology or medical analytics;
Amendment 600 #
Proposal for a regulation
Article 51 – paragraph 2 – introductory part
Article 51 – paragraph 2 – introductory part
2. The physiciaerson referred to in paragraph 1 shall be responsible for at least the following tasks:
Amendment 612 #
Proposal for a regulation
Article 53 – paragraph 1 – point j
Article 53 – paragraph 1 – point j
(j) verify, where justified, by means of a registry, that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in Article 56 and demonstrate that their health is not compromised;
Amendment 630 #
Proposal for a regulation
Article 53 – paragraph 6
Article 53 – paragraph 6
Amendment 710 #
Proposal for a regulation
Article 58 – paragraph 3 – point b – introductory part
Article 58 – paragraph 3 – point b – introductory part
(b) where the transmission of genetic conditions is an genuinely identified risk, and in particular in the case of medically assisted reproduction with third party donation:
Amendment 736 #
Amendment 765 #
Proposal for a regulation
Article 62 – paragraph 2 a (new)
Article 62 – paragraph 2 a (new)
Amendment 823 #
Proposal for a regulation
Article 68 – paragraph 1 – point e
Article 68 – paragraph 1 – point e
(e) liaising for the exchange of experience and good practices, as relevant, with the EDQM and the ECDC regarding technical standards within their respective areas of expertise, and with the EMA on authorisations and supervisory activities concerning the implementation of the PMF certification pursuant to Directive 2003/63/EC, to support the harmonised implementation of standards and technical guidelines;
Amendment 829 #
Proposal for a regulation
Article 70 – paragraph 1 – introductory part
Article 70 – paragraph 1 – introductory part
1. The Commission, with the agreement of the Member State and in duly justified cases, shall perform controls, including audits, in the Member States to verify the effective application of the requirements relating to:
Amendment 834 #
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
The Commission shall establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM. Such cooperation is without prejudice to the autonomy of Union law and should take into account Union principles on transparency and stakeholder participation.
Amendment 850 #
Proposal for a regulation
Article 73 – paragraph 4
Article 73 – paragraph 4
Amendment 868 #
Proposal for a regulation
Article 77 – paragraph 2
Article 77 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 28(10), 42(3), 53(6), 58(15), 69(6), 73(4),69(6) and 76(8) shall be conferred on the Commission for an indeterminate period of time from … [OP please insert the date = date of entry into force of this Regulation].
Amendment 873 #
Proposal for a regulation
Article 87 – paragraph 1 – subparagraph 2
Article 87 – paragraph 1 – subparagraph 2
Unless otherwise provided for in paragraph 2, it shall apply from … [OP please insert the date = twohree years after the date of entry into force of this Regulation].
Amendment 874 #
Proposal for a regulation
Article 87 – paragraph 2 – subparagraph 1
Article 87 – paragraph 2 – subparagraph 1
Article 81(3) to (6) and Article 82(3) shall apply from … [OP please insert the date = threefour years after the date of entry into force of this Regulation].