42 Amendments of Andreas GLÜCK related to 2022/0216(COD)
Amendment 137 #
Proposal for a regulation
Recital 10
Recital 10
(10) When SoHOs are used in the autologous setting without any manipulation, processing or storage, the application of this Regulation would not be proportionate to the limited quality and safety risks arising in such a setting. Furthermore, if minimal processing is needed to restore applicability during a surgical procedure or the manipulation is done within a closed system, the Regulation should not apply as well. When autologous SoHOs are collected and processed before being re-used in the same person, risks appear that should be mitigated. Thus, there needs to be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the recipient. When autologous SoHOs are collected to be processed and also stored, risks of cross-contamination, loss of traceability or damage to the biological properties inherent to the substance, and necessary for efficacy in the recipient, also appear. Thus, the requirements for SoHO establishment authorisation should apply.
Amendment 151 #
Proposal for a regulation
Recital 13
Recital 13
(13) Given the special nature of SoHOs, resulting from their human origin, and the increasing demands for these substances for human application or for the manufacture of products regulated by other Union legislation, or as the starting and raw material thereof, it is necessary to ensure a high level of health protection for donors as well as for recipients. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation. This Regulation should therefore includeaddress principles and technical rules to monitor and protect donors. As different types of donation imply different risks for donors, with varying levels of significance, the monitoring of donor health should be proportionate to those levels of risk. This is particularly important when donation involves some risk to the donor’s health due to a need for pre-treatment with medicinal products, a medical intervention to collect the substance or a need for donors to donate repeatedly. Donations of oocytes, bone marrow, peripheral blood stem cells and plasma should be considered to imply a significant riske respective risk-classifications shall be defined in the respective guidelines.
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 218 #
Proposal for a regulation
Recital 30
Recital 30
(30) In order to facilitate innovation and reduce administrative burden, competent authorities shouldmust share with each other information on the authorisation of new SoHO preparations and the evidence used for such authorisations, including for the validation of certified medical devices used for SoHO collection, processing, storage or application to patients. Such sharing could allow authorities to accept previous authorisations granted to other entities, including in other Member States and to thus significantly reduce the requirements to generate evidence.
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 289 #
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, once it is established, be granted within the framework of the European Health Data Space and otherwise be limited to the extent necessary to carry out supervisory activities provided for in this Regulation.
Amendment 301 #
Proposal for a regulation
Recital 46
Recital 46
(46) In order to enable better access to health data in the interests of public health, Member States should entrust competent authorities as data controllers within the meaning of Regulation (EU) 2016/679 with powers to take decisions on the access to and re-use of such data. Furthermore, access to secondary data for reseach purposes should be made available via the European Health Data Space, once it is established.
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 324 #
Proposal for a regulation
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
(c) SoHOs are not processedor minimally processed to maintain or establish their applicability during medical treatment and surgeries and not stored before application, this Regulation shall not apply.
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 363 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point a
Article 3 – paragraph 1 – point 12 – point a
(a) has been subjected to one or more SoHO activities, including processing, in accordance with defined quality and safety parameters;
Amendment 377 #
Proposal for a regulation
Article 3 – paragraph 1 – point 15
Article 3 – paragraph 1 – point 15
(15) ‘processing’ means any operation involved in the non-autologous handling of SoHOs, including washing, shaping, separation, fertilisation, decontamination, sterilisation, preservation and packaging; in autologous use it means only handling beyond minimal operations including immediate application of SoHO within a closed system;
Amendment 410 #
Proposal for a regulation
Article 3 – paragraph 1 – point 31
Article 3 – paragraph 1 – point 31
(31) ‘EU SoHO Platform’ means the digital platform established by the Commission to exchange information concerning SoHO activities which should be interoperable with existing and upcoming frameworks;
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 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 617 #
Proposal for a regulation
Article 53 – paragraph 1 – point j
Article 53 – paragraph 1 – point j
(j) for donations referred to in paragraph 3, verify, by means of ainterconnected registryies, 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 621 #
Proposal for a regulation
Article 53 – paragraph 1 – point k
Article 53 – paragraph 1 – point k
(k) develop and implement a plan for monitoring the donor’s health after the donation in cases where the SoHO donations imply a significant risk to a donor as referred to in paragraph 3;
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 670 #
Proposal for a regulation
Article 56 – paragraph 5
Article 56 – paragraph 5
5. In those cases referred to in paragraph 4, point (a) and (b), for the purpose of Article 30 in conjunction with Article 29, SoHO entities shall be able to demonstrate to their competent authorities, for each of the standards or elements thereof, which and to what extent they follow the respective guidelines referred to in paragraph 4, point (a) and point (b).
Amendment 672 #
Proposal for a regulation
Article 56 – paragraph 6
Article 56 – paragraph 6
Amendment 682 #
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. In the case of medically assisted reproduction, the option of the respective persons refusing genetic screening should be retained and the procedure is subject to national legislation according to the principle of subsidiarity hence with regard to the transmission of genetic diseases to offspring, the provisions apply only if Member States decide to allow this technology, and subsequently if it corresponds to the wish of the donor or the recipient
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 711 #
Proposal for a regulation
Article 58 – paragraph 3 – point b – point ii
Article 58 – paragraph 3 – point b – point ii
(ii) testing prospective recipients to identify any relevant genetic risk, combined with testing donors for such identified genetic conditions to ensure matching that will prevent the concerned condition in the offspring. In the case of medically assisted reproduction, the option of the respective persons refusing genetic screening should be retained and the procedure is subject to national legislation according to the principle of subsidiarity hence with regard to the transmission of genetic diseases to offspring, the provisions apply only if Member States decide to allow this technology, and subsequently if it corresponds to the wish of the donor or the recipient.
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 725 #
Proposal for a regulation
Article 58 – paragraph 10 – point a
Article 58 – paragraph 10 – point a
(a) apply SoHO preparations to recipients without proven benefit, except in the context of a clinical investigation approved in the context of a conditional authorisation of the SoHO preparation by their competent authority pursuant to Article 41(4) or compassionate use and experimental therapy as described in Article 61;
Amendment 731 #
Proposal for a regulation
Article 58 – paragraph 11 – subparagraph 1
Article 58 – paragraph 11 – subparagraph 1
For the measures referred to in paragraphs 2, point (a) and 3(b), SoHO entities shall verify the eligibility of a donor by means of an interview with him/her, his/her legal guardian or, in case of a donation after death, a relevant individual that is informed regarding the donor’s health and lifestyle history. The interview may be combined with any interview conducted as part of the evaluation referred to in Article 53(1), point (f).
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.
Amendment 785 #
Proposal for a regulation
Article 62 a (new)
Article 62 a (new)
Article 62 a Public Service Obligation SoHO entities collecting or processing blood or blood components in a Member State are, within the limits of their responsibilities, obliged to ensure an appropriate and continuous supply of these SoHOs and SoHO preparations in that Member State in order to meet the needs of patients.
Amendment 807 #
Proposal for a regulation
Article 67 – paragraph 2
Article 67 – paragraph 2
2. Each Member State shall nominate two permanent members and two alternates representing the SoHO National Authority and, where the Member State chooses, the Ministry of Health. The SoHO National Authority may nominate members from other competent authorities, but those members shall ensure that the views and suggestions they make are endorsed by the SoHO National Authority. The Board may also invite experts, stakeholders and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, particularily the ones defining boardelines with other legislation, shall have an observer role.