39 Amendments of Margarita DE LA PISA CARRIÓN related to 2022/0216(COD)
Amendment 119 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) In accordance with Article 168(1), first subparagraph, of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union, a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities.
Amendment 120 #
Proposal for a regulation
Recital 1 b (new)
Recital 1 b (new)
(1b) The scope of this regulation goes beyond the subject matters addressed in previous directives. Reproductive techniques and the use of SoHos as starting materials for medicinal products raise very complex questions that are tackled in a fragmented manner by the Member States in legal and ethical contexts. Both matters require ad hoc legislation that responds effectively to their specific nature.
Amendment 121 #
Proposal for a regulation
Recital 1 c (new)
Recital 1 c (new)
(1c) Reproductive techniques, tissue banks and pharmaceutical industries have specific characteristics that make it difficult to establish a common standard to provide the quality, safety and efficacy needed to ensure good practice in these areas.
Amendment 122 #
Proposal for a regulation
Recital 1 d (new)
Recital 1 d (new)
(1d) The development of legislation in the areas of reproductive techniques, tissue banks and pharmaceutical industries must reflect the importance of donation and the need for enhanced traceability because of their implications for health-related information and the existence of third parties.
Amendment 131 #
Proposal for a regulation
Recital 8 a (new)
Recital 8 a (new)
(8a) The EU shall further the development of a European SoHO sovereignty with a view to preventing dependency on third countries with regard to sectors and products of strategical importance for the EU.
Amendment 132 #
Proposal for a regulation
Recital 8 b (new)
Recital 8 b (new)
(8b) Every step must be taken to prevent the development or the EU playing a role in the development of a paid cell and tissue donation industry.
Amendment 145 #
Proposal for a regulation
Recital 12 a (new)
Recital 12 a (new)
(12a) The scope of this regulation shall have no effect on national assisted reproduction legislation. Sexual and reproductive rights are a national competence.
Amendment 159 #
Proposal for a regulation
Recital 13 a (new)
Recital 13 a (new)
(13a) This regulation has no bearing on the right of offspring conceived during fertility treatment to know their provenance under the legislation in force in the Member States.
Amendment 164 #
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, particularly in the area of conception by means of fertility treatment. 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.
Amendment 169 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
(15a) Human embryos and foetuses and their cells, tissues and organs must not be used for diagnostic, therapeutic, research or experimental purposes.
Amendment 186 #
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, programmes 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 and may help to ensure the traceability of the donor. Voluntary and unpaid SoHO donation is also a factor which can contribute to ensuring the traceability of the donor and 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 necessary to 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 set by national authorities, at a level appropriate in their Member State to reach such objectives. _________________ 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 231 #
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. _________________ 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).Does not affect the English version.)
Amendment 274 #
Proposal for a regulation
Recital 39
Recital 39
(39) Some substances, products or activities have been subject to different legal frameworks with different requirements in the Member States. This may sometimes causes confusion among operators in the field, and the consequent legal uncertainty ismay be a disincentive to professionals to develop new ways to prepare and use SoHOs. However, in the area of assisted reproduction, a number of technical and ethical circumstances justify differentiated treatment and the observance of the provisions in force at national level. The SCB should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHOs. The SCB should keep a compendium of the opinions issued by the SCB or the competent authorities and of decisions made at Member State level, so that competent authorities considering the regulatory status under this Regulation of a particular substance, product or activity may inform their decision-making process by referring to that compendium. The SCB should also document agreed best practices to support a common Union approach. It should also cooperate with similar Union level bodies established in other Union legislation with a view to facilitating coordinated and coherent application of this Regulation between Member States and across bordering legislative frameworks. These measures should promote a coherent cross-sectoral approach and facilitate SoHO innovation.
Amendment 308 #
Proposal for a regulation
Recital 48
Recital 48
(48) In order to be able to supplement this Regulation where necessary with additional standards concerning the protection of donors, recipients and offspring from medically assisted reproductionconceived by means of fertility treatment to take into account technical and scientific developments in the field of SoHOs, and with additional rules on the authorisation of importing SoHO entities, on obligations and procedures for importing SoHO entities, on the organisation of Union training and exchange programmes, on technical specifications concerning the EU SoHO Platform, and on data protection, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carries out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making29. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 29 OJ L 123, 12.5.2016, p. 1.
Amendment 312 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
This Regulation establishes measures setting high standards of quality and safety for all substances of human origin (‘SoHOs’) intended for human application and for activities related to those substances in order to ensure a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring from medically assisted reproductionconceived by means of fertility treatment. This Regulation is without prejudice to national legislation which establishes rules relating to aspects of SoHOs other than their quality and safety and the safety of SoHO donors.
Amendment 319 #
Proposal for a regulation
Article 2 – paragraph 1 – point m – point i (new)
Article 2 – paragraph 1 – point m – point i (new)
(i) promotion and coordination actions to ensure SoHO supplies and foster donation culture.
Amendment 337 #
Proposal for a regulation
Article 3 – paragraph 1 – point 5
Article 3 – paragraph 1 – point 5
(5) ‘substance of human origin’ (SoHO) means any substance collected from the human body in whatever mannerfor health and medical purposes, respecting its human dignity and being able to form a new individual, whether it contains cells or not and whether those cells are living or not. F; for the purposes of this Regulation, SoHO does not include organs in the sense of Article 3, point (h), of Directive 2010/53/EU;
Amendment 341 #
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 not;, freely and voluntarily, alive or deceased, has with informed prior consent and in the presence of a medical practitioner authorised the donation of SoHO for altruistic medical purposes to a SoHO organisation that respects human dignity. If the donor is a minor, the consent of the parents shall be required.
Amendment 359 #
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 reproductionfertility treatments’ means embryos, foetuses and children resulting from conception through fertility treatments;
Amendment 432 #
Proposal for a regulation
Article 3 – paragraph 1 – point 61
Article 3 – paragraph 1 – point 61
(61) ‘'reproductive cells’' means all cells intended to be used for the purpose of medically assisted reproductionsexually reproductive haploid cells, a female and a male gamete that unite to form a new individual, whose genetic load is unique and unrepeatable;
Amendment 438 #
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘'compensation’' means making good of any losses and expenses associated with donation; such compensation should help facilitate matters and remove obstacles for donors. It must be ensured that throughout the entire SoHO treatment, from donation to implantation in the recipient, the principle of compensation rather than that of profit-making is followed.
Amendment 472 #
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 in order to comply with national provisions in this field on condition that those national measures are compatible with Union law, and are proportionate to the risk to human health.
Amendment 501 #
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 1
Article 14 – paragraph 2 – subparagraph 1
In the course of the consultation referred to in paragraph 1, the competent authorities may alsoshall submit a request to the SCB for its opinion on the regulatory status of the substance, product or activity under this Regulation and shall do so in all cases where the competent authorities, after the consultations referred to in paragraph 1, are not in a position to take a decision in that respect.
Amendment 536 #
Proposal for a regulation
Article 25 – paragraph 4
Article 25 – paragraph 4
Amendment 538 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. Competent authorities shall establish and maintain a system for receiving and processing requests for the authorisation of importing SoHO entities. SoHO entities shall ensure that SoHOs and their preparations are imported where European supply management and the domestic supply chain are not compromised.
Amendment 540 #
Proposal for a regulation
Article 26 – paragraph 4 – subparagraph 1
Article 26 – paragraph 4 – subparagraph 1
The Commission shall adopt implementing acts to specify uniform procedures and working methods for establishing and maintaining an importing SoHO entity authorisation system. Such entities shall comply with the technical and ethical specifications in force within the Union in order to maintain an optimal level of quality, safety and efficiency.
Amendment 571 #
Proposal for a regulation
Article 34 – paragraph 1
Article 34 – paragraph 1
1. Competent authorities shall verify that SoHO entities have appropriate procedures in place to ensure traceability and coding of SoHOs as referred to in Article 45. The authorities shall ensure that enhanced traceability is put in place for donations where the medical, bioethical and legal implications are of particular relevance. In such cases, access to information and traceability shall be guaranteed for the recipient and the offspring conceived following fertility treatment.
Amendment 644 #
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 and expenses 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 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 663 #
Proposal for a regulation
Article 56 – paragraph 4 – introductory part
Article 56 – paragraph 4 – introductory part
4. For those standards concerning donor protection or elements thereof for which no implementing act has been adopted, in order to apply such standards or elements thereof in accordance with what has been decided by the Member State, SoHO entities shall follow:
Amendment 675 #
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 reproductionconceived following fertility treatment from risks posed by SoHO preparations. They shall do so by identifying, minimising or eliminating those risks, guaranteeing the right of individuals to know their genetic origin.
Amendment 680 #
Proposal for a regulation
Article 58 – title
Article 58 – title
58 Standards concerning protection of SoHO recipients and of offspring protectionconceived following fertility treatment
Amendment 686 #
Proposal for a regulation
Article 58 – paragraph 1
Article 58 – paragraph 1
1. SoHO entities shall 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 729 #
(ca) undermine the requirements of traceability and the right of individuals to know their genetic origin.
Amendment 733 #
Proposal for a regulation
Article 58 – paragraph 14 – subparagraph 2 – point a
Article 58 – paragraph 14 – subparagraph 2 – point a
(a) the safeguards intended to protect their data and the data of the offspring in the case of medically assisted reproductionconceived following fertility treatment;
Amendment 737 #
Proposal for a regulation
Article 58 – paragraph 16
Article 58 – paragraph 16
16. Where, in the case of risk to SoHO recipients and offspring from medically assisted reproductionconceived following fertility treatment arising from inadequate levels of safety and quality of SoHOs, imperative grounds of urgency so require, the procedure provided for in Article 78 shall apply to delegated acts adopted pursuant to this Article.
Amendment 743 #
Proposal for a regulation
Article 62 – title
Article 62 – title
Establishment of national SoHO emergency plans
Amendment 745 #
Proposal for a regulation
Article 62 – paragraph 1
Article 62 – paragraph 1
1. Member States, in collaboration with National SoHO Authorities, shall draw up national SoHO emergency plans setting out measures to be applied without undue delay when the supply situation for critical SoHOs presents or is likely to present a serious risk to human health.
Amendment 792 #
Additional emergency measures by Member States
Amendment 793 #
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 and the Commission without undue delay and give reasons for the measures taken. Member States may also exercise their powers to develop national plans to increase donations or ensure the quality supply of SoHOs.