Activities of Tilly METZ 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 (98)
Amendment 166 #
Proposal for a regulation
Recital 15
Recital 15
(15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and the means of achieving that aim are appropriate and necessary. In that regard, when selecting SoHO donors, Member States should use individual risk-based questions.
Amendment 176 #
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, pProgrammes promoting the donation of SoHOs should be founded on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient. Donor recruitment campaigns should never refer to compensation to avoid risk of incentivising donations. Voluntary and unpaid SoHO donation is also a factor which can contribute to high safety standards for SoHOs and therefore to the protection of human health. It is also recognised, including by the Council of Europe Committee on Bioethics24, that while financial gain should be avoided, it may also be necessaryacceptableto ensure that donors are not financially disadvantaged by their donation. Thus, compensation to remove any such risk is acceptable but should never constitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate more frequently than is allowed, posing risks to their own health and to that of prospective recipients. Such compensation should, therefore, be based on quantifiable and transparent criteriaset by national authorities, at a level appropriate in their Member State to reach such objectivesthe principle of financial neutrality. Any compensation regime should not serve as an inducement to donate nor lead to inappropriate financially-driven competition, including cross-border competition, between SoHO establishments and entities over donor recruitment. _________________ 24 Council of Europe Committee on Bioethics (DH-BIO). Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors (March 2018). Available at https://rm.coe.int/guide-financial- gain/16807bfc9a.
Amendment 190 #
Proposal for a regulation
Recital 20
Recital 20
(20) Competent authorities should be designated by the Member States for all the areas that fall within the scope of this Regulation. While Member States are best placed to identify the competent authority or authorities for each area, for example by geography, topic or substance, they should also be required to designate a single national authority that ensures appropriately coordinated communication with other Member States’ competent authorities and with the Commission. The SoHO National Authority should be considered the same as the designated competent authority in Member States where only one competent authority is designated. The list of all SoHO competent national authorities should be made publicly available.
Amendment 209 #
Proposal for a regulation
Recital 28
Recital 28
(28) Applicants requesting an authorisation of SoHO preparation should use the Euro GTP II methodologies or equivalent tools to assess the risk level of their SoHO preparation. Applicants should share the results of the risk assessments with competent authorities when requesting authorisation. With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. The most up-to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. In case of high risk, these should include a comparison with standard treatments, ideally in a study with subjects allocated to test and control groups in a randomised manner. The competent authority should approve the plans before they are implemented and should assess the outcome data as part of a SoHO preparation authorisation.
Amendment 232 #
Proposal for a regulation
Recital 35
Recital 35
(35) The EDQM is a structural part of the Council of Europe working under the European Pharmacopoeia Partial Agreement. The text of the Convention on the elaboration of a European Pharmacopoeia (ETS No. 050), accepted by Council Decision 94/358/EC26, is considered to be the text of the European Pharmacopoeia Partial Agreement. Member States of the Council of Europe that have signed and ratified the European Pharmacopoeia Convention are the member States of the European Pharmacopoeia Partial Agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement, including among others: the European Pharmacopoeia Commission, the European Committee on Organ Transplantation (CD-P-TO), the European Committee on Blood Transfusion (CD-P- TS) and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The European Pharmacopoeia Convention has been signed and ratified by the European Union and all its Member States, all of whom are represented in their intergovernmental bodies. In this context, the work of the EDQM on developing and updating guidelines on safety and quality of blood, tissues and cells, should be considered an important contribution to the field of SoHOs in the Union and should be reflected in this Regulation. The guidelines address issues of quality and safety beyond the risks of communicable disease transmission, such as donor eligibility criteria for the prevention of the transmission of cancer and other non- communicable diseases and the assurance of safety and quality during collection, processing, storage and distribution. It should therefore be possible to use those guidelines as one of the means to implement the technical standards provided for in this Regulation. In order to ensure impartiality and independence, and safeguard public interest, the Commission should establish a memorandum of understanding with the EDQM related to transparency of membership and outputs and conflict of interest rules for experts and stakeholders involved in drafting EDQM guidelines. _________________ 26 Council Decision 94/358/EC of 16 June 1994 accepting, on behalf of the European Community, the Convention on the elaboration of a European Pharmacopoeia (OJ L 158, 25.6.1994, p. 17).
Amendment 240 #
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. To ensure long-term sustainability, the campaigns should primarily focus on increasing the donor base for low-frequency donations. As there is a need to ensure the availability of SoHOs for medical treatments, Member States should support the establishment of public donation facilities and promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing the collection capacity and 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 259 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37 a) As recommended by the World Health Organisation (WHO), Member States should additionally support optimal clinical use of SoHOs, particularly where there are alternatives which can reduce the demand for SoHOs. In such fashion, Member States should ensure efficient implementation of the Patient Blood Management (PBM), which improves patients’ safety by minimising the risks associated with transfusion and improve patient outcomes, while at the same time ensuring sufficiency of blood supplies and reducing financial pressure on health system.
Amendment 263 #
Proposal for a regulation
Recital 37 b (new)
Recital 37 b (new)
(37 b) In order to ensure self-sufficiency and sustainability of supply of SoHOs, Member States should establish national SoHO emergency plans setting out measures when the supply situation for critical SoHOs presents or is likely to present a serious risk to human health. Such plans shall include measures, including optimisation of use, that impact demand of critical SoHOs, targets to ensure self-sufficiency of supply of critical SoHOs, donor recruitment and retainment strategy and ways of cooperation between competent authorities, experts and relevant stakeholders. National emergency plans should be further supplemented by the EU Strategy for critical SoHO supply sufficiency, primarily focusing on supply monitoring, reporting obligations and sharing of best practices within the EU.
Amendment 269 #
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 at Union level in the field of SoHOs. The SCB should adhere to high degree of transparency of its outputs and all it members, observers and experts should act independently, in the public interest and be free from any external influence that might affect the impartiality of their professional conduct.
Amendment 280 #
Proposal for a regulation
Recital 41
Recital 41
(41) In order to limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (the ‘EU SoHO Platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. The EU SoHO Platform should also serve as a reliable source of information for the general public regarding the work of the SoHO Coordination Board, national competent authorities and other expert bodies, including the EDQM, and SoHO entities and establishments.
Amendment 290 #
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 laid down in Article 5 of Regulation (EU) 2016/679. 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.
Amendment 291 #
Proposal for a regulation
Recital 44
Recital 44
(44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the integrity of the person, the protection of and the prohibition of making the human body and its parts as such a source of financial gain the protection of natural persons with regard to the processing of their personal data, the freedom of art and science and to conduct business, non-discrimination, the right to health protection and access to health care, and the rights of the child. To achieve these aims, all supervisory and SoHO activities should always be carried out in a manner that fully respects those rights and principles. The right for dignity and integrity of donors, recipients and of offspring born from medically assisted reproduction should always be taken into account, amongst others, by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material, that donor eligibility criteria are based on scientific evidence, that the use of SoHOs in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices, that activities are conducted in a transparent manner that prioritises the safety of donors and recipients, and that allocation and equitable access to SoHOs are defined in a transparent manner, on the basis of an objective evaluation of medical needs. This Regulation should therefore be applied accordingly.
Amendment 296 #
Proposal for a regulation
Recital 44 a (new)
Recital 44 a (new)
(44 a) Due to the high sensitivity of donor anonymity and taking into account the rights of offspring born from medically assisted reproduction with third party donation, SoHO entities should ensure donors of reproductive cells are duly informed about the possibility of ID release and the implication hereof, pursuant to provisions laid down in national legislation;
Amendment 299 #
Proposal for a regulation
Recital 45
Recital 45
(45) SoHOs, by definition, relate to natural 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 pseudonymised. 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 306 #
Proposal for a regulation
Recital 47 a (new)
Recital 47 a (new)
(47 a) In order to successfully implement this Regulation and ensure high quality and safety standards of SoHOs in the long-term, Member States should enhance education and provide appropriate training for medical personnel regarding SoHO collection, processing, storage, application, transfusion and procurement.
Amendment 332 #
Proposal for a regulation
Article 2 – paragraph 4 a (new)
Article 2 – paragraph 4 a (new)
4 a. This Regulations further establishes provisions on: (a) national emergency plans and the EU Strategy for critical SoHO supply sufficiency; (b) SoHo Coordination Board; (c) EU SoHO Platform.
Amendment 344 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘SoHO donor’ means any person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs, whether that donation is successful or living SoHO donor or a deceased SoHO donotr;
Amendment 347 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8 a) ‘living SoHO donor’ means a living person who has presented themselves to a SoHO entity, or been presented by a person granting consent on their behalf, in accordance with national legislation, with a view to making a donation of SoHOs, whether that donation is successful or not, for the purpose of application to a person other than themselves, and other than situations of within couple use as defined in point (63);
Amendment 351 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)
Article 3 – paragraph 1 – point 8 b (new)
(8 b) ‘deceased SoHO donor’ means a person who has been referred to a SoHO entity and for whom consent or authorisation, or absence of expressed refusal to donation is in place, in accordance with national legislation;
Amendment 354 #
Proposal for a regulation
Article 3 – paragraph 1 – point 9
Article 3 – paragraph 1 – point 9
(9) ‘SoHO recipient’ means the person to whom SoHOs are applied or such an application is envisaged;
Amendment 360 #
Proposal for a regulation
Article 3 – paragraph 1 – point 11
Article 3 – paragraph 1 – point 11
(11) ‘offspring from medically assisted reproduction’ means fetuses and children that are born following medically assisted reproduction;
Amendment 425 #
Proposal for a regulation
Article 3 – paragraph 1 – point 47 – introductory part
Article 3 – paragraph 1 – point 47 – introductory part
(47) ‘traceability’ means the ability to locate and identify SoHOs during any step from collection through processing and storage to distribuhuman application or disposal, including the ability to:
Amendment 426 #
Proposal for a regulation
Article 3 – paragraph 1 – point 51
Article 3 – paragraph 1 – point 51
(51) ‘imputability’ means the likelihood that a serious adverse occurrence, in a SoHO donor, is related to the donation process or, in a recipient or an offspring born from medically assisted reproduction , to the application of the SoHOs;
Amendment 435 #
Proposal for a regulation
Article 3 – paragraph 1 – point 62 a (new)
Article 3 – paragraph 1 – point 62 a (new)
(62 a) ‘ID release’ means disclosure of personal identifying information about reproductive cells donor to donor- conceived offspring;
Amendment 437 #
Proposal for a regulation
Article 3 – paragraph 1 – point 63
Article 3 – paragraph 1 – point 63
(63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction from two persons with an intimate physical relationship (‘partners’) , where one person supplies their own oocytes and the other person supplies their own sperm;
Amendment 439 #
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘compensation’ means making good of anyquantifiable losses associated with donation; such compensation shall respect the principle of financial neutrality and not be intended as an incentive to donate;
Amendment 451 #
Proposal for a regulation
Article 3 – paragraph 1 – point 64 a (new)
Article 3 – paragraph 1 – point 64 a (new)
(64 a) 'financial neutrality' means that no financial gain or loss will be incurred by compensated donors as a result of the donation;
Amendment 485 #
Proposal for a regulation
Article 5 – paragraph 4
Article 5 – paragraph 4
4. Each Member State shall designate a single SoHO National Authority, in conformity with Member States’ constitutional requirements, responsible for coordinating exchanges with the Commission and with other Member States’ SoHO National Authorities. The Commission shall make publicly available the list of SoHO National Authorities on the EU SoHO Platform.
Amendment 488 #
Proposal for a regulation
Article 7 – paragraph 2
Article 7 – paragraph 2
2. Competent authorities shall ensure that their personnel have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. All relevant personnel shall make an annual declaration of their interests, which shall be published on the authorities’ web-portal.
Amendment 503 #
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 2
Article 14 – paragraph 2 – subparagraph 2
The competent authorities may also indicate that they consider there is a need that the SCBSCB shall consults, in accordance with Article 68(1), point (b), with the equivalent advisory bodies established in other relevant Union legislation referred to in Article 2(3).
Amendment 506 #
Proposal for a regulation
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
Amendment 507 #
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1
Article 14 – paragraph 4 – subparagraph 1
The Commission may, upon a duly substantiated request of a Member State following the consultation referred to in paragraphs 1 and 2, or on its own initiative after a consultation with the SCB and relevant advisory bodies established under Union legislation referred to in Article 2(3), by means of implementing acts, determine the regulatory status of a substance, product or activity under this Regulation, in case questions arise in that respect, notably when these questions cannot be resolved at the Member State level, or in discussions between the SCB and the advisory bodies established in other relevant Union legislation, in accordance with Article 68(1), point (b).
Amendment 516 #
Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 1
Article 14 – paragraph 7 – subparagraph 1
The Commission may, by means of implementingdelegated acts, lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant Union legislation referred to in Article 2(3).
Amendment 517 #
Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 2
Article 14 – paragraph 7 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred toprocedure laid down in Article 79(2)7.
Amendment 518 #
Proposal for a regulation
Article 16 – paragraph 1 – point a
Article 16 – paragraph 1 – point a
(a) have, or have access to, a sufficient number of personnel so that SoHO supervisory activities can be performed efficiently and effectively; the declarations shall be made publicly available on the authorities’ web-portal;
Amendment 547 #
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 1 – point a
Article 27 – paragraph 3 – subparagraph 1 – point a
(a) does not comply with the conditions of its authorisation or the provisions of this Regulation; and
Amendment 548 #
Proposal for a regulation
Article 27 – paragraph 3 – subparagraph 1 – point a a (new)
Article 27 – paragraph 3 – subparagraph 1 – point a a (new)
(a a) does not follow up on corrective or preventive action following an inspection by national authorities pursuant to Article 29(14); and
Amendment 554 #
Proposal for a regulation
Article 28 – paragraph 5 – point b
Article 28 – paragraph 5 – point b
(b) that this non-compliance, or suspected non-compliance, implies a risk to the safety of SoHO donors, recipients or offspring from medically assisted reproduction.
Amendment 566 #
Proposal for a regulation
Article 32 – paragraph 1 a (new)
Article 32 – paragraph 1 a (new)
1 a. All inspectors shall act in an impartial manner and be independent of any direct or indirect conflicts of interest. Inspectors shall declare such impartiality in writing; such declarations shall be made available on the authorities’ web- portal.
Amendment 569 #
Proposal for a regulation
Article 32 – paragraph 3 – point a
Article 32 – paragraph 3 – point a
(a) the inspection techniques and procedures to be followed, including practical exercises and conflict of interest rules;
Amendment 588 #
Proposal for a regulation
Article 44 – paragraph 4
Article 44 – paragraph 4
4. SoHO entities shall submit to the EU SoHO Platform an annual summary of the data collected pursuant to this Article. In cases where national or international registries collect activity data meeting the criteria defined in the SoHO platform and such registries have been verified by competent authorities as having in place data quality management procedures that ensure accuracy and completeness of data, SoHO entities may delegate the submission of the activity data referred to in this Article to such registries. National competent authorities shall ensure all data from national registries are submitted to the EU SoHO Platform in accordance with Article 18(4). The Commission shall aggregate the annual summaries of the SoHO entities, prepare and publish an Annual SoHO Activity Report.
Amendment 589 #
Proposal for a regulation
Article 45 – paragraph 2 – point c
Article 45 – paragraph 2 – point c
(c) does not directly reveal the identity of the donor;
Amendment 594 #
Proposal for a regulation
Article 47 – paragraph 3 a (new)
Article 47 – paragraph 3 a (new)
3 a. Where SAO notification concerns public health matters, competent authorities shall communicate essential information to the general public and the SCB without delay.
Amendment 601 #
Proposal for a regulation
Article 51 – paragraph 2 – point b
Article 51 – paragraph 2 – point b
(b) investigation of suspected adverse occurrences in SoHO donors and recipients, recipients and, where relevant, offspring from medically assisted reproduction;
Amendment 602 #
Proposal for a regulation
Article 51 – paragraph 3
Article 51 – paragraph 3
3. By derogation from paragraph 2, in the case of SoHO entities that are authorised as SoHO establishments in accordance with Article 25(3), the physician shall be responsible for those tasks that are relevant to the SoHO activities performed by the SoHO entities and that have a direct influence on the health of SoHO donors and recipients, recipients, and, where relevant, offspring from medically assisted reproduction.
Amendment 606 #
Proposal for a regulation
Article 52 – paragraph 2 a (new)
Article 52 – paragraph 2 a (new)
2 a. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation.
Amendment 629 #
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. SoHO entities that collect SoHOs from donors that are subjected to a surgical procedure in order to donate, that are treated with hormones to facilitate donation, or that donate SoHOs that can be donated on a frequent and repeated basis, shall register such donors and the results of their donor health evaluations in a cross-entity registry that allows interconnection with other such registries, as referred to in paragraph 1, point (j). SoHO entities that manage such registries shall ensure interconnectivity between them.
Amendment 635 #
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for losses related to their participation in donations through fixed rate allowances. In such case, Member States shall establish the conditions for such allowances in national legislation, including the setting of an upper limit and transparent criteria based on quantifiable elements that ensures that allowances are financially neutral and consistent with the standards laid down in this Article. They may delegate the setting of conditions for such allowances to independent bodies that are established in accordance with national legislation.
Amendment 646 #
Proposal for a regulation
Article 54 – paragraph 2 a (new)
Article 54 – paragraph 2 a (new)
2 a. Any compensation regime shall not lead to inappropriate financially- driven competition, including cross- border competition, between SoHO establishments and entities over donor recruitment.
Amendment 649 #
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
3. SoHO entities may compensate or reimburse donors as provided for by their competent authorities pursuant to paragraph 2. Any compensation or reimbursement must never serve as an inducement to donate.
Amendment 652 #
Proposal for a regulation
Article 54 – paragraph 3 a (new)
Article 54 – paragraph 3 a (new)
3 a. Member States shall submit to the Commission and the SCB national provisions setting up the rules for compensation based on financial neutrality and consistent with standards set in this Article.
Amendment 656 #
Proposal for a regulation
Article 55 – title
Article 55 – title
55 Standards concerning information to be provided prior to consent or authorisation to donate SoHOs
Amendment 660 #
Proposal for a regulation
Article 56 – paragraph 1 – subparagraph 1
Article 56 – paragraph 1 – subparagraph 1
When the Commission deems it necessary to provide binding rules on the implementation of a particular standard or element of a standard referred to in Articles 53, 54 or 55, in order to ensure convergent and high levels of donor safety, the Commission may adopt implementingdelegated acts describing particular procedures to be followed and applied to meet such standard, or element thereof.
Amendment 661 #
Proposal for a regulation
Article 56 – paragraph 1 – subparagraph 2
Article 56 – paragraph 1 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 79(2)7.
Amendment 662 #
Proposal for a regulation
Article 56 – paragraph 3
Article 56 – paragraph 3
3. In order to apply the standards concerning donor protection or elements thereof, referred to in Articles 53, 54 and 55, SoHO entities shall follow the procedures laid down in any delegated and implementing act adopted in accordance with paragraphs 1 and 2 of this Article.
Amendment 677 #
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
SoHO entities shall protect the health of SoHO recipients and offspring from medically assisted reproduction from risks posed by SoHO preparations and their application. They shall do so by identifying, minimising or eliminating those risks.
Amendment 683 #
Proposal for a regulation
Article 58 – paragraph 1
Article 58 – paragraph 1
1. SoHO entities shall, based on latest technical guidelines from the EDQM and the ECDC, establish procedures with measures, and, where necessary, combinations of measures, that ensure high levels of safety and quality and demonstrate benefits for SoHO recipients and offspring from medically assisted reproduction that outweigh any risks. They shall, in particular, achieve a high level of assurance that pathogens, toxins or genetic conditions are not transmitted to recipients or offspring from medically assisted reproduction.
Amendment 694 #
Proposal for a regulation
Article 58 – paragraph 2 – point b
Article 58 – paragraph 2 – point b
(b) testing of donors for communicable diseases using certified and validated testing methods or other methods deemed adequate by EDQM and ECDC guidelines;
Amendment 697 #
Proposal for a regulation
Article 58 – paragraph 2 – point c
Article 58 – paragraph 2 – point c
(c) when feasible and deemed appropriate by the relevant technical guidelines, using processing technologies that reduce or eliminate any potential communicable pathogens.
Amendment 734 #
Proposal for a regulation
Article 58 – paragraph 14 – subparagraph 2 – point a a (new)
Article 58 – paragraph 14 – subparagraph 2 – point a a (new)
(a a) donor anonymity and the possibility of ID release and the implication hereof for medically assisted reproduction with third party donation of reproductive cells, pursuant to provisions laid down in national legislation;
Amendment 746 #
Proposal for a regulation
Article 62 – paragraph 1 a (new)
Article 62 – paragraph 1 a (new)
1 a. The Commission and the SCB shall provide guidance and support to the Member States when establishing national emergency plans and promote best-practice sharing within the Union.
Amendment 748 #
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. Member States shall make all reasonable efforts, in line with voluntary unpaid principle established in this Regulation, to promote public participation in SoHO donation activities, in particular for critical SoHOs, with a view to ensuring a resilient supply and responsive increases in donation rates when risks of shortage are detected. In so doing, they shall encourage the collection of SoHO with a strong public and non- profit sector involvement.
Amendment 766 #
Proposal for a regulation
Article 62 – paragraph 3 – point a a (new)
Article 62 – paragraph 3 – point a a (new)
(a a) evidence-based measures that impact demand of critical SoHOs;
Amendment 767 #
Proposal for a regulation
Article 62 – paragraph 3 – point a b (new)
Article 62 – paragraph 3 – point a b (new)
(a b) quantitative targets to ensure self- sufficiency of supply of critical SoHOs;
Amendment 768 #
Proposal for a regulation
Article 62 – paragraph 3 – point a c (new)
Article 62 – paragraph 3 – point a c (new)
(a c) strategy on optimisation of use of critical SoHOs;
Amendment 769 #
Proposal for a regulation
Article 62 – paragraph 3 – point a d (new)
Article 62 – paragraph 3 – point a d (new)
(a d) critical SoHO donor recruitment and retainment strategy, including communication campaigns and education programmes;
Amendment 770 #
Proposal for a regulation
Article 62 – paragraph 3 – point c a (new)
Article 62 – paragraph 3 – point c a (new)
(c a) stakeholder engagement;
Amendment 774 #
Proposal for a regulation
Article 62 – paragraph 3 a (new)
Article 62 – paragraph 3 a (new)
3 a. Member States shall submit their emergency plans to the Commission and the SCB within 2 years after entry into force of this Regulation.
Amendment 775 #
Proposal for a regulation
Article 62 – paragraph 6
Article 62 – paragraph 6
6. Member States shall review regularly their national SoHO emergency plans to take into account changes in the organisation of competent authorities and experience gained from implementing the plans and simulation exercises. Member States shall inform without delay the Commission and the SCB of any substantial revision of the national plans.
Amendment 778 #
Proposal for a regulation
Article 62 – paragraph 7 – subparagraph 1 – introductory part
Article 62 – paragraph 7 – subparagraph 1 – introductory part
The Commission may adopt implementingdelegated acts describing:
Amendment 779 #
Proposal for a regulation
Article 62 – paragraph 7 – subparagraph 1 – point b
Article 62 – paragraph 7 – subparagraph 1 – point b
(b) the role of stakeholders and the supportive role of the ECDC and the EDQM in the establishment and operation of national SoHO emergency plans.
Amendment 780 #
Proposal for a regulation
Article 62 – paragraph 7 – subparagraph 2
Article 62 – paragraph 7 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 79(2)7.
Amendment 783 #
Proposal for a regulation
Article 62 a (new)
Article 62 a (new)
Amendment 789 #
Proposal for a regulation
Article 63 – paragraph 3
Article 63 – paragraph 3
3. The SoHO National Authorities mshall without undue delay submit to the EU SoHO Platform the SoHO supply alert received in cases where the supply interruption might affect other Member States or where such interruption might be addressed through cooperation between Member States pursuant to Article 62(3), point (d).
Amendment 795 #
Proposal for a regulation
Article 65 – paragraph 1
Article 65 – paragraph 1
Member States may take additional measures to the ones set out in their national SoHO emergency plans to ensure critical SoHOs supply in case of shortages on their territory, on a case-by-case basis. Member States taking such measures shall inform the other Member States, the SCB and the Commission without undue delay and give reasons for the measures taken.
Amendment 808 #
Proposal for a regulation
Article 67 – paragraph 2 a (new)
Article 67 – paragraph 2 a (new)
2 a. Permanent and alternate members of the SCB shall act independently, in the public interest and free from any external influence. SCB permanent and alternate members shall have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. Permanent and alternate members of the SCB shall make an annual declaration of their interests, which shall be available in the EU SoHO Platform.
Amendment 810 #
Proposal for a regulation
Article 67 – paragraph 3
Article 67 – paragraph 3
3. Member States shall submit the names and affiliation of their nominated members to the Commission, who shall publishmake the membership list publicly available in the EU SoHO Platform.
Amendment 811 #
Proposal for a regulation
Article 67 – paragraph 3 a (new)
Article 67 – paragraph 3 a (new)
3 a. The Commission shall make publicly available SCB agendas, minutes and guidance documents on the EU SoHO Platform.
Amendment 813 #
Proposal for a regulation
Article 67 – paragraph 6 – point j
Article 67 – paragraph 6 – point j
(j) the rules for declarations regarding conflict of interests of SCB members, alternates, observers and invited experts;
Amendment 815 #
Proposal for a regulation
Article 67 – paragraph 7 – subparagraph 1
Article 67 – paragraph 7 – subparagraph 1
The Commission shall, by means of implementingdelegated acts, adopt the necessary measures for the establishment, management and functioning of the SCB.
Amendment 816 #
Proposal for a regulation
Article 67 – paragraph 7 – subparagraph 2
Article 67 – paragraph 7 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 79(2)7.
Amendment 824 #
Proposal for a regulation
Article 68 – paragraph 1 – point f a (new)
Article 68 – paragraph 1 – point f a (new)
(f a) ensuring coordination regarding supply continuity and sufficiency of critical SoHOs;
Amendment 831 #
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. In order to ensure impartiality and independence and safeguard public interest, the Commission shall establish a memorandum of understanding with the EDQM related to high standards of transparency of membership and outputs and conflict of interest rules for experts and stakeholders involved in drafting of EDQM guidelines. The Commission shall make publicly available in the EU SoHO Platform a list of all members, experts and stakeholders involved in EDQM committees and their conflict of interest declarations.
Amendment 841 #
Proposal for a regulation
Article 73 – paragraph 1
Article 73 – paragraph 1
1. The Commission shall establish, manage and maintain the EU SoHO Platform to facilitate effective and efficient exchange of information concerning SoHO activities and supply of critical SoHOs in the Union, as provided for in this Regulation.
Amendment 857 #
Proposal for a regulation
Article 74 – paragraph 3 – subparagraph 1
Article 74 – paragraph 3 – subparagraph 1
The Commission shall adopt implementingdelegated acts laying down technical specifications for the EU SoHO Platform, including its functions, the roles and responsibilities of each of the parties listed in paragraph 1, the retention periods for personal data and the technical and organisational measures to ensure the safety and security of personal data processed.
Amendment 858 #
Proposal for a regulation
Article 74 – paragraph 3 – subparagraph 2
Article 74 – paragraph 3 – subparagraph 2
Those implementingdelegated acts shall be adopted in accordance with the examination procedure referred to in Article 79(2)7.
Amendment 859 #
Proposal for a regulation
Article 75 – paragraph 1 – introductory part
Article 75 – paragraph 1 – introductory part
1. Unless otherwise provided for in this Regulation or in national legislation on confidentiality, and without prejudice to Regulation (EC) No 1049/2001 of the European Parliament and of the Council33, each party involved in the application of this Regulation shall respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the following: _________________ 33 Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
Amendment 860 #
Proposal for a regulation
Article 75 – paragraph 1 – point a
Article 75 – paragraph 1 – point a
(a) natural persons with regard to the processing of personal data in accordance with Article 76;
Amendment 861 #
Proposal for a regulation
Article 75 – paragraph 3
Article 75 – paragraph 3
3. Paragraphs 1 and 2 shall not affect the rights and obligations of the Commission, Member States and competent authorities with regard to the exchange of information and the dissemination of alerts, nor the obligations of persons to provide information under national criminal law or other applicable law, including on access to information.
Amendment 862 #
Proposal for a regulation
Article 75 – paragraph 5 – introductory part
Article 75 – paragraph 5 – introductory part
5. Competent authorities mayshall publish or make otherwise available to the public the outcome of SoHO supervisory activities regarding individual SoHO entities provided that the following conditions are met:
Amendment 863 #
Proposal for a regulation
Article 75 – paragraph 6 – point b
Article 75 – paragraph 6 – point b
(b) the information or data made available to the public does not unnecessaridisproportionately undermine the protection of commercial interests of a SoHO entity or any other natural or legal person;
Amendment 864 #
Proposal for a regulation
Article 76 – paragraph 3
Article 76 – paragraph 3
3. Personal data, including data concerning health, required for the application of Articles 35, 36, 41 and 47, Article 53(1), points (f) and (g), Article 53(3), and Article 58(11), (13) and (14), shall only be processed for the purpose of ensuring safety and quality of SoHOs and protecting the concerned SoHO donors, SoHO recipients and offspring from medically assisted reproduction. Those data shall be directly related to the performance of the supervisory activities and SoHO activities concerned and be limited to the extent necessary and proportionate for that purpose. The Commission shall adopt implementing acts laying down categories of personal data necessary to fulfilling the above listed obligations. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).
Amendment 865 #
Proposal for a regulation
Article 76 – paragraph 3 a (new)
Article 76 – paragraph 3 a (new)
3 a. Any re-use of personal data of SoHO donors, recipients and offspring born from medically assisted reproduction shall be provided in an anonymised format. Where, in duly justified cases, the purpose of the data processing cannot be achieved with anonymised data, pseudonymised data format may be used.
Amendment 866 #
Proposal for a regulation
Article 76 – paragraph 6
Article 76 – paragraph 6
6. In relation to their responsibilities to process personal data to comply with the obligations of this Regulation, the SoHO entities and competent authorities of the Member States shall be regarded as controllers as defined in Article 4, point (7), of Regulation (EU) 2016/679 and they are bound by the rules of that Regulation. The same provisions shall apply to any third party contracted by a SoHO entity for the processing of personal data, who shall be considered a processor as defined in Article 4, point (8) of the GDPR.
Amendment 867 #
Proposal for a regulation
Article 77 – paragraph 2
Article 77 – paragraph 2
2. The power to adopt delegated acts referred to in Articles 14(7), 28(10), 42(3), 53(6), 56(1), 58(15), 62(7), 62a(4), 67(7), 69(6), 73(4), 74(3) 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 869 #
Proposal for a regulation
Article 77 – paragraph 3
Article 77 – paragraph 3
3. The delegation of power referred to in Articles 14(7), 28(10), 42(3), 53(6), 56(1), 58(15), 62(7), 62a(4), 67(7), 69(6), 73(4), 74(3)and 76(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
Amendment 870 #
Proposal for a regulation
Article 80 – paragraph 1
Article 80 – paragraph 1
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by … [OP please insert the date = 32 years after the date of entry into force of this Regulation], notify the Commission and the SCB of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them. The Commissions shall make those provisions on penalties and their use publicly available on the EU SoHO Platform.
Amendment 871 #
Proposal for a regulation
Article 84 – paragraph 1
Article 84 – paragraph 1
Without prejudice to the dates of application referred to in Article 87 and the transitional provisions provided for in this Chapter, the Commission is empowered to adopt the delegated acts referred to in Articles 42(3), 67(7) and 73(4) and the implementing acts referred to in Articles 26(4), 43(6), 44(3), 46(3), 67(7) and 74(3) as from … [OP please insert the date = one day after the date of entry into force of this Regulation]. Such acts shall apply from the date of application in accordance with Article 87(1), second subparagraph, without prejudice to any transitional rules provided for in this Chapter.