26 Amendments of Jan HUITEMA related to 2022/0216(COD)
Amendment 167 #
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 science-based, appropriate and necessary.
Amendment 168 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
Amendment 181 #
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. 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 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 225 #
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 ae of the means to demonstrate compliance with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines achieve the same 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 255 #
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 strongly 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 285 #
Proposal for a regulation
Recital 42
Recital 42
(42) The processing of personal data under this Regulation should be subject to strict guarantees of confidentiality and should comply with the rules on the protection of personal data laid down in Regulation (EU) 2016/679 of the European Parliament and of the Council and in Regulation (EU) 2018/1725 of the European Parliament and of the Council . The Commission may also decide that information on SoHO donations are added to donors Electronic Health Records (EHRs).
Amendment 315 #
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) SoHO donor recruitment; except if the entity is not subject to further SoHO activites as listed in this paragraph.
Amendment 345 #
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 SoHOsliving SoHO donor or deceased SoHO donor, whether that donation is successful or not;
Amendment 350 #
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 any living person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs either for autologous use or for allogeneic use.
Amendment 353 #
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 any deceased person who donates SoHO after death.
Amendment 442 #
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 471 #
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 lawbased on scientific evidence, are compatible with Union law, do not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, and are proportionate to the risk to human health.
Amendment 596 #
Proposal for a regulation
Article 50 – paragraph 1
Article 50 – paragraph 1
1. SoHO establishments shall establish, maintain and update, as necessary, a quality management system achieving a high level of quality of SoHOs by followingtaking into account, in particular, the Good Practice Guidelines published by the EDQM and which are included in the technical guidelines referred to in Article 56(4), point (a), and Article 59(4), point (a).
Amendment 636 #
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 lossexpenses and inconveniences related to their participation in donations, for example, 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 687 #
Proposal for a regulation
Article 58 – paragraph 2 – introductory part
Article 58 – paragraph 2 – introductory part
2. In the procedures referred to in paragraph 1, SoHO entities shall mitigate the risks of communicable disease transmission from SoHO donors to recipients by combining, at least, the following measures: follow the latest technical guidelines from EDQM and ECDC to mitigate the following risks: (a) the risks of communicable disease transmission from SoHO donors to recipients; (b) the risks of non-communicable disease transmission, including genetic conditions and cancer, from donors to the recipients or to offspring from medically assisted reproduction; (c) the risks of communicable or non- communicable disease transmission to the recipients through cross-contamination of donations during collection, processing, storage and distribution; (d) risks arising from microbial contamination of SoHOs from the environment, the personnel, the equipment, materials or solutions coming into contact with SoHOs during collection, processing, storage or distribution; (e) the risks that any reagents and solutions added to SoHOs or coming in contact with SoHOs during collection, processing, storage and distribution might be transmitted to recipients and have a toxic, or other, detrimental effect on their health; (f) the risks that inherent properties of SoHOs, necessary for clinical efficacy, have been changed by any SoHO activity performed, in a manner that renders SoHO preparations ineffective or less effective when applied to recipients; (g) the risks that SoHOs cause an immune reaction in recipients; (h) any other risk to the health of SoHO recipients or of offspring from medically assisted reproduction arising from the application of SoHOs or SoHO preparations and not addressed in this paragraph.
Amendment 689 #
Proposal for a regulation
Article 58 – paragraph 2 – point a
Article 58 – paragraph 2 – point a
Amendment 691 #
Proposal for a regulation
Article 58 – paragraph 2 – point b
Article 58 – paragraph 2 – point b
Amendment 696 #
Proposal for a regulation
Article 58 – paragraph 2 – point c
Article 58 – paragraph 2 – point c
Amendment 709 #
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
Amendment 712 #
Proposal for a regulation
Article 58 – paragraph 4
Article 58 – paragraph 4
Amendment 715 #
Proposal for a regulation
Article 58 – paragraph 5
Article 58 – paragraph 5
Amendment 716 #
Proposal for a regulation
Article 58 – paragraph 6
Article 58 – paragraph 6
Amendment 718 #
Proposal for a regulation
Article 58 – paragraph 7
Article 58 – paragraph 7
Amendment 722 #
Proposal for a regulation
Article 58 – paragraph 8
Article 58 – paragraph 8
Amendment 724 #
Proposal for a regulation
Article 58 – paragraph 9
Article 58 – paragraph 9
Amendment 749 #
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
2. Member States shall make all reasonable efforts 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.