77 Amendments of Mathilde ANDROUËT related to 2022/0216(COD)
Amendment 118 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) In accordance with Article 1 of the Charter of Fundamental Rights of the European Union, which states that ‘human dignity is inviolable. It must be respected and protected,' and Article 3 of same, the quality and safety standards of SoHOs must respect the physical and mental integrity of the persons concerned, ensure SoHOs are donated with the free and informed consent of those persons and prohibit eugenic principles, financial gain from the human body or its parts and cloning,
Amendment 123 #
Proposal for a regulation
Recital 3
Recital 3
(3) As regards Article 168(4), point (a), TFEU, standards for the safety and quality of organs and SoHOs, blood and blood derivatives should ensure a high level of human health protection. Therefore, this Regulation aims at setting high standards by ensuring, amongst others, the protection of SoHO donors, taking into consideration their fundamental role in the provision of SoHOs and for recipients, as well as measures to monitor and support the sufficiency of the supply of SoHOs that are critical for the health of patients. In accordance with Article 3 of the Charter of Fundamental Rights of the European Union, these safety standards are based on the fundamental principle that the human body cannot be commercialised, which holds that no SoHO may be sold, as well as on the principle of the unavailability of the human body and the principle that the human body or parts thereof cannot be used for financial gain.
Amendment 126 #
Proposal for a regulation
Recital 4
Recital 4
(4) Directives 2002/98/EC16and 2004/23/EC17of the European Parliament and of the Council constitute the Union’s regulatory framework for blood and for tissues and cells, respectively. Although these Directives have harmonised to a certain degree the rules of Member States in the area of safety and quality of blood, tissues and cells, they include a significant number of options and possibilities for Member States to implement the rules they laid down. This results in divergences between national rules, which can create obstacles to cross-bordersharing ofthese substances. A fundamental revision of those Directives is needed for a robust, transparent, up-to-date and sustainable regulatory framework for these substances, which achieves safety and quality for all parties involved, enhances legal certainty and supports continuous supply, whilst facilitating innovation for the benefit of public health. In order to achieve a coherent application of the legal framework, it is appropriate to repeal Directives 2002/98/EC and 2004/23/EC and to replace them by a Regulation. _________________ 16 Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, p. 30). 17 Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (OJ L 102, 7.4.2004, p. 48).
Amendment 127 #
Proposal for a regulation
Recital 5
Recital 5
(5) Directives 2002/98/EC and 2004/23/EC are highly interconnected and contain very similar provisions for oversight and equivalent principles for safety and quality in the two sectors they regulate. In addition, many authorities and operators work across these sectors. As this Regulation aims to define high level principles that will be common to both the blood and of tissues and cells sectors, it would be appropriate that it replaces these Directives and merges the revised provisions into one legal act, with respect for the special characteristics of each of the substances recognised in the technical guidelines set out in this Regulation.
Amendment 129 #
Proposal for a regulation
Recital 6
Recital 6
(6) This Regulation should apply to blood and blood components, as regulated by Directive 2002/98/EC, as well as to tissues and cells, including haematopoietic peripheral blood, umbilical-cord blood and bone-marrow stem cells, reproductive cells and tissues, foetal tissues and cells and adult and embryonicderived solely from postnatal embryonic remnants and adult stem cells, as regulated by Directive 2004/23/EC. Since donation and human application of SoHOs other than blood, tissues and cells are increasingly common, it is necessary to extend the scope of this Regulation to any SoHO, regardless of whether it meets the definition of ‘blood’, ‘tissue’ or ‘cell’, to avoid that certain groups of donors or recipients are not protected by an appropriate Union level quality and safety framework. This will, for example, ensure the protection of donors and recipients of human breast milk, intestinal microbiota, blood preparations that are not used for transfusion, and any other SoHO that may be applied to humans in the future.
Amendment 130 #
Proposal for a regulation
Recital 7
Recital 7
(7) Solid organs are excluded from the definition of SoHOs for the purposes of this Regulation and, thus, from its scope. Their donation and transplantation are significantly different and are regulated in a dedicated legal framework, set out in Directive 2010/53/EU18 of the European Parliament and of the Council18, with the exception of blood-type conversions for the purposes of organ transplants. Shortcomings have not been raised regarding the existing quality and safety provisions for organs. Nonetheless, when organs are removed from a donor for the purposes of separating tissues or cells for human application, for example heart valves from a heart or pancreatic islets from a pancreas, this Regulation should apply. _________________ 18 Directive 2010/53/EU of the European Parliament and of the Council of 7 July 2010 on standards of quality and safety of human organs intended for transplantation (OJ L 207, 6.8.2010, p. 14).
Amendment 139 #
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. 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 or contamination of caregivers, friends or family, 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 141 #
Proposal for a regulation
Recital 11
Recital 11
(11) When SoHOs are used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in order to ensure a high level of protection and contribute to legal clarity and certainty, this Regulation should apply to the extent that the activities to which they are subjected are not regulated by the other Union legislative framework. Without prejudice to other Union legislation, and in particular to Directive 2001/83/EC, Regulations (EC) No 726/2004, (EC) No 1925/2006, (EC) No 1394/2007 and (EU) 2017/745, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, dispensing, import and export when those activities concern SoHOs up to the point of their transfer to operators regulated by other Union legislation. This means that close interaction between this regulatory framework and other related frameworks is essential to ensure interplay and coherence between relevant legal frameworks, without gaps or overlaps.
Amendment 144 #
Proposal for a regulation
Recital 12
Recital 12
(12) SoHOs can also be combined with other regulated products before, exclusively, human application. In these circumstances, close interaction between this regulatory framework and other related frameworks is also necessary to ensure a high level of human health protection for all cases where these substances are used.
Amendment 156 #
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 resuthe donation will not have any short- or medium-term adverse effects on the health of the donationrecipient. This Regulation should therefore include 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 risk.
Amendment 157 #
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 exclusively for human application 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 include 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 risk.
Amendment 160 #
Proposal for a regulation
Recital 14
Recital 14
(14) When a harmful genetic condition is detected in the offspringchildren resulting from medically assisted reproduction with third party donation, the transmission of that information enables the prevention of further use of donations affected by that genetic risk. It is thus important that relevant information in such cases is effectively communicated between SoHO entities and acted upon appropriately.
Amendment 162 #
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 and founded on respect for human dignity, voluntary donation, and the principle that SoHOs cannot be used for financial gain. 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 170 #
Proposal for a regulation
Recital 16
Recital 16
(16) This Regulation should not interfere with national legislation in the health area with objectives other than quality and safety of SoHOs that is compatible with Union law, in particular legislation concerning ethical aspects. Such aspects arise due to the human origin of the substances, which touches upon various sensitive and ethical concerns for Member States and citizens, such as access to particular services that use SoHOs. This Regulation should also not interfere with decisions of an ethical nature made by Member States. Such ethical decisions might concern the use, or limitation of the use, of specific types of SoHOs or specific uses of SoHOs, including reproductive cells and embryonic stem cells. When a Member State allows the use of such cells, this Regulation should apply in full with a view to ensuring safety and quality and to protecting human health. The authorisation of the use of such SoHOs in one Member State in no way obliges another Member State to adopt the same provisions or to transpose them into its own legislation. Indeed, some Member States prohibit all use of embryos for scientific and medical purposes, including for research.
Amendment 187 #
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. Voluntary and unpaid SoHO donation is also a factor which can contributes 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, financially neutralcompensation 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 191 #
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 shouldall also be required to designate a single independent 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.
Amendment 195 #
Proposal for a regulation
Recital 22
Recital 22
(22) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities – whose induction training they shall ensure – that act in the public interest, are appropriately resourced and equipped, and offer guarantees of impartiality, professionalism and transparency. When infringements relate to direct health risks, and the publication of information regarding those infringements can contribute to risk mitigation and the protection of donors, recipients or offspringchild from medically assisted reproduction, competent authorities should, where necessary, be able to prioritise transparency of their enforcement activities over the protection of confidentiality of the party that has infringed the Regulation.
Amendment 201 #
Proposal for a regulation
Recital 24
Recital 24
(24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult with the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, medical devices, organs or food, with the aim of ensuring coherent procedures for the application of this Regulation. Competent authorities should inform the SoHO Coordination Board of the outcome of their consultations. When SoHOs or SoHO preparations are used to manufacture products regulated under other Union legislation, or as the starting and raw material thereof, competent authorities should cooperate with the relevant authorities on their territory. This cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for SoHO and for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHOs or the product manufactured from SoHOs. It should in principle be the responsibility of the Member States to decide on a case- by-case basis on the regulatory status of a substance, product or activity. However, in order to ensure consistent decisions across all Member States with regard to borderline cases, the Commission should be empowered to, on its own initiative or at the duly substantiated request of a Member State, decide on the regulatory status of a particular substance, product or activity under this Regulation.
Amendment 204 #
Proposal for a regulation
Recital 24 a (new)
Recital 24 a (new)
(24a) Given the World Health Organization's1 a recommendation that health-care personnel should be informed about, and trained in, patient blood management, prescribers should be made more aware of therapeutic alternatives to the application of this SoHO Regulation. This practice is also liable to limit the flow of SoHOs and ensure security of supply. _________________ 1 a World Health Organization Resolution WHA 63.12, ‘Availability, safety and quality of blood products’, 21.5.2010.
Amendment 207 #
Proposal for a regulation
Recital 27
Recital 27
(27) Since SoHO preparations are subjected to a series of SoHO activities prior to their release and distribution, competent authorities should assess and authorise SoHO preparations to verify that a high level of safety, quality and efficacy is achieved consistently by the application of that specific series of activities, performed in that specific manner. When SoHOs are prepared with newly developed and validated collection, testing or processing methods, consideration should be given to the demonstration of safety and efficacy in recipients by means of requirements for clinical outcome data collection and review. The extent of such required clinical outcome data should correlate with the level of risk associated with the activities performed for that SoHO preparation and use. Where a new or modified SoHO preparation poses negligible risks for recipients (or offspringfoetuses, newborns or children in the case of medically assisted reproduction), the vigilance reporting requirements provided for in this Regulation should be adequate to demonstrate safety and quality. This should apply for well-established SoHO preparations that are introduced in a new SoHO entity but have been robustly demonstrated as safe and effective by their use in other entities.
Amendment 235 #
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 if, and only if, they respect the interests of the Member States and include consultation with specialised stakeholders to ensure the transparency of the process. _________________ 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 238 #
Proposal for a regulation
Recital 36
Recital 36
(36) The ECDC, established by Regulation (EC) No 851/2004 of the European Parliament and of the Council 27, is a Union agency with the mission of strengthening Europe'’s defences against communicable diseases. The work of the ECDC on developing and updating guidelines on safety and quality of SoHOs from a communicable disease threat perspective, should be considered an important contribution in the field of SoHOs in the Union and should be reflected in this Regulation. In addition, the ECDC established an expert network for the Microbial Safety of SoHOs, which ensures the implementation of the requirements on the ECDC’s relations with the Union Member States and EEA Member States stated in Regulation (EC) No 851/2004, regarding transparent,strategic and operational collaboration on technical and scientific issues, surveillance, responses to health threats, scientific opinions, scientific and technical assistance, collection of data, identification of emerging health threats, and public information campaigns related to the safety of SoHOs. This SoHO expert network should provide information or advice in relation to relevant outbreaks of communicable diseases, in particular regarding the eligibility and testing of donors and the investigation of serious adverse occurrences involving suspected transmission of a communicable disease. _________________ 27 Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004, establishing a European cCentre for dDisease pPrevention and cControl (OJ L 142, 30.4.2004, p. 1).
Amendment 260 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37a) Given the negative effects of the COVID-19 pandemic on the frequency and quantity of plasma donation in some countries, Member States are invited to develop plasmapheresis programmes to increase their collection capacity and donor base.
Amendment 283 #
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, to make it possible to share the elements used to determine the regulatory status of a substance and to improved the transparency of national reporting and supervisory activities.
Amendment 294 #
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 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 offspringpersons 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 302 #
Proposal for a regulation
Recital 47
Recital 47
(47) The exchange of SoHOs between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages. For certain SoHOs that need to be matched between the donor and the recipient, such exchanges are essential to allow patients to receive the treatment they need. In this context, the objective of this Regulation, namely to ensure quality and safety of SoHOs and a high level of protection of donors, needs to be achieved at Union level, by establishing high standards of quality and safety for SoHOs, based on a common set of requirements that are implemented in a consistent manner across the Union. Thus, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
Amendment 314 #
Proposal for a regulation
Article 2 – paragraph 1 – introductory part
Article 2 – paragraph 1 – introductory part
1. This Regulation shall apply exclusively to SoHOs intended for human application, to SoHO preparations, to products manufactured from SoHOs and intended for human application, to SoHO donors and recipients who have not been duly declared dead, and to the following SoHO activities:
Amendment 317 #
Proposal for a regulation
Article 2 – paragraph 1 – point h a (new)
Article 2 – paragraph 1 – point h a (new)
(ha) SoHO dispensing;
Amendment 320 #
Proposal for a regulation
Article 2 – paragraph 1 – point m a (new)
Article 2 – paragraph 1 – point m a (new)
(ma) The exchange and sharing of data or information on quantities or stocks of SoHOs, and the promotion of activities related to security of supply;
Amendment 328 #
Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 1
Article 2 – paragraph 3 – subparagraph 1
For SoHOs that are used to manufacture products in accordance with Union legislation on medical devices, regulated by Regulation (EU) 2017/745, on medicinal products, regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, or on food, regulated by Regulation (EC) No 1925/2006, or as the starting and raw material thereof, the provisions of this Regulation applicable to the activities of SoHO donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, and collection of SoHOs from donors or patients, as well as continuity of SoHO supply, shall apply. Insofar as the activities of SoHO release, distribution, import and export relate to SoHOs prior to their distribution to an operator regulated by the other Union legislation referred to in this subparagraph, the provisions of this Regulation shall also apply.
Amendment 342 #
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 freely and voluntarily to a SoHO entity with a view to making a donation of SoHOs, whether that donation is successful or not; donors will have a guarantee that their donations are anonymous to recipients, and they will be unpaid;
Amendment 348 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8a) 'donation' means a philanthropic act by a person of freely and voluntarily agreeing to provide a third party with a SoHO from that person's own body. Donations are deemed to be unpaid-for. Donations of reproductive cells are not covered by this Regulation in the case of post-mortem usage, which should be prohibited in all Member States.
Amendment 357 #
Proposal for a regulation
Article 3 – paragraph 1 – point 10
Article 3 – paragraph 1 – point 10
(10) ‘medically assisted reproduction’ means the facilitation of conception by intra-uterine insemination of sperm, or in vitro fertilisation or any other laboratory or medical intervention that promotes conceptionwhere conception meets the ethical rules laid down by the competent authorities of each Member State;
Amendment 373 #
Proposal for a regulation
Article 3 – paragraph 1 – point 13
Article 3 – paragraph 1 – point 13
(13) ‘donor recruitment’ means any activity aimed at informing the public and encouraging persons to become SoHO donors;
Amendment 375 #
Proposal for a regulation
Article 3 – paragraph 1 – point 14
Article 3 – paragraph 1 – point 14
(14) ‘'collection’' means a process by which SoHOs are removed, procured, excreted, secreted or obtained by any other manner, including any preparatory steps, such as hormone treatment, needed to facilitate the process; SoHOs cannot be procured from a donor who has not expressly requested that and whose state of health does not permit an informed choice to be made. Collection of SoHOs shall be strictly prohibited in connection with medically assisted suicide by a donor, since the substances injected may impair the quality of the donation.
Amendment 384 #
Proposal for a regulation
Article 3 – paragraph 1 – point 17
Article 3 – paragraph 1 – point 17
Amendment 385 #
Proposal for a regulation
Article 3 – paragraph 1 – point 17
Article 3 – paragraph 1 – point 17
(17) ‘'storage’' means the maintenance of SoHOs under appropriate controlled conditions until distribution or dispensing;
Amendment 388 #
Proposal for a regulation
Article 3 – paragraph 1 – point 18
Article 3 – paragraph 1 – point 18
Amendment 389 #
Proposal for a regulation
Article 3 – paragraph 1 – point 18 a (new)
Article 3 – paragraph 1 – point 18 a (new)
(18a) 'disposal' means completely destroying SoHOs for whatever reason. Strict monitoring rules must be complied with so as to ensure that the ultimate purpose of the disposal process is achieved.
Amendment 390 #
Proposal for a regulation
Article 3 – paragraph 1 – point 18 a (new)
Article 3 – paragraph 1 – point 18 a (new)
(18a) 'dispensing' means the provision of SoHOs or SoHO preparations, possibly following a medical prescription, for application to a specific recipient;
Amendment 391 #
Proposal for a regulation
Article 3 – paragraph 1 – point 20
Article 3 – paragraph 1 – point 20
(20) ‘import’ means activities carried out to bring SoHOs or SoHO preparations into the Union from a third country, including the organisation of such activities and physical verification of coherence with associated documentation, the appropriateness of transport conditions, the integrity of packaging and the adequacy of labelling before release; each Member State will remain free to accept or reject SoHOs imported from a third country;
Amendment 401 #
(a) death, i.e. the irreversible cessation of an individual's vital functions by natural causes or as a result of medically assisted suicide;
Amendment 404 #
Proposal for a regulation
Article 3 – paragraph 1 – point 28 – point i
Article 3 – paragraph 1 – point 28 – point i
(i) prolonged sub-optimal health of a SoHO donor following single or multiple donations;after stating a willingness to donate, or following single or multiple donations, or after detection of contagious or chronic diseases or infections that are or may be communicable.
Amendment 415 #
Proposal for a regulation
Article 3 – paragraph 1 – point 40
Article 3 – paragraph 1 – point 40
(40) ‘SoHO establishment’ means a SoHO entity that carries out both processing and storage or processing and release or storage and release of SoHOs;
Amendment 417 #
Proposal for a regulation
Article 3 – paragraph 1 – point 41
Article 3 – paragraph 1 – point 41
(41) ‘'critical SoHO’' means a SoHO for which an insufficient supply will result in serious harm or risk of harm to patrecipients;
Amendment 419 #
Proposal for a regulation
Article 3 – paragraph 1 – point 42
Article 3 – paragraph 1 – point 42
(42) ‘critical SoHO entity’ means a SoHO entity that carries out activities contributing to the supply of critical SoHOs and the scale of those activities is such that a failure to carry them out cannot be compensated by activities of other entities or alternative substances or products for patrecipients;
Amendment 422 #
Proposal for a regulation
Article 3 – paragraph 1 – point 45
Article 3 – paragraph 1 – point 45
(45) ‘'technical guidelines’' means a description of a series of methodological procedures and parameters that, if followed, achieve a level of quality and safety of a SoHO activity or a SoHO preparation that is considered to be acceptable as a means to comply with regulatory standards in line with the criteria laid down by the Member States' competent authorities;
Amendment 440 #
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘'compensation’' means making good of any quantifiable losses associated with donation; such compensation should never be intended or provided with a view to encouraging donations;
Amendment 453 #
Proposal for a regulation
Article 3 – paragraph 1 – point 64 a (new)
Article 3 – paragraph 1 – point 64 a (new)
(64a) 'financial neutrality of a donation' means that there will be no financial gains or losses for a donor as a result of a donation;
Amendment 464 #
Proposal for a regulation
Article 3 – paragraph 1 – point 70 a (new)
Article 3 – paragraph 1 – point 70 a (new)
(70a) 'patient blood management' means an innovative organisational approach for the best possible management of patients undergoing surgery at risk of bleeding, based on the following three pillars: (a) optimising the patient's blood mass; (b) minimising blood loss; (c) improving the patient's tolerance to anaemia;
Amendment 466 #
Proposal for a regulation
Article 3 – paragraph 1 – point 70 b (new)
Article 3 – paragraph 1 – point 70 b (new)
(70b) ‘donor base resilience’ means the capacity of the donation collection system to rely on a large number of donors to address the emergence of a health crisis;
Amendment 467 #
(70c) ‘free and informed consent’ means that the donor’s agreement has been obtained freely without coercion and after access to clear, comprehensive information in line with his or her capacity to understand;
Amendment 469 #
Proposal for a regulation
Article 3 – paragraph 1 – point 70 d (new)
Article 3 – paragraph 1 – point 70 d (new)
(70d) 'national self-sufficiency' means Member States' lack of dependence on another State as regards the collection and manufacture of SoHOs, the transport of those substances and any other SoHO activity.
Amendment 474 #
Proposal for a regulation
Article 4 – paragraph 1 a (new)
Article 4 – paragraph 1 a (new)
1a. Member States may introduce additional measures to help set up a national and European supply chain and to achieve the objective of national self- sufficiency. Such measures may also aim to reinforce the principle of voluntary and unpaid donation.
Amendment 476 #
Proposal for a regulation
Article 5 – paragraph 3 – point a
Article 5 – paragraph 3 – point a
(a) have the autonomy to act and make decisions independently and impartially while respecting the internal administrative organisational requirements determined by the Constitutions of the Member Stateseach Member State's own legislation;
Amendment 487 #
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. Personnel shall not have engaged in any activity, beyond an appropriate point in time prior to working for the competent authorities concerned, which may detract from their independence.
Amendment 490 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. Without prejudice to Article 75, competent authorities shall carry out their supervisory activities in a transparent manner, including in connection with the application of contracts for the supply of medicinal products all or some of whose active substances are derived from SoHOs, and they shall make accessible and clear to the public decisions taken in cases where a SoHO entity has failed to comply with an obligation under this Regulation and where such failure causes or may cause a serious risk to human health.
Amendment 497 #
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) appropriate and properly maintained facilities and equipment to ensure that personnel can perform their SoHO supervisory activities safely, efficiently and effectively;
Amendment 530 #
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Article 21a Exceptional derogation from the obligation to authorise SoHO preparations in situations where there is no therapeutic alternative 1. By way of derogation from Article 21 of this Regulation, and after consulting the relevant best practices approved and documented by the SCB in accordance with Article 68(1)(c), the competent authorities may authorise, on an exceptional basis and at the request of a prescribing doctor within a SoHO entity, SoHO preparations in situations where the procedures referred to in Article 21 have not been followed, provided that: (a) provision has been made for the use of such preparations for a given patient, in cases where that patient has no therapeutic alternative, when treatment cannot be postponed or when his or her condition is life-threatening; (b) the preparation is deemed to be safe and effective on the basis of the available clinical data. 2. The competent authorities shall inform the national SoHO authority of the authorised derogation. The national SoHO authority shall inform the Commission and the other Member States of any decision to authorise the distribution or preparation for immediate application of SoHOs in accordance with paragraph 1.
Amendment 535 #
Proposal for a regulation
Article 25 – paragraph 2
Article 25 – paragraph 2
2. Competent authorities shall authorise as SoHO establishments the SoHO entities that both process and store or process and release or store and release SoHOs in accordance with Article 27.
Amendment 539 #
Proposal for a regulation
Article 26 – paragraph 3
Article 26 – paragraph 3
3. Importing SoHO entity authorisations shall be valid throughout the Union for the period defined in the terms of the authorisation, when such a time period has been defined, or until a competent authority has suspended or withdrawn the authorisation or the entity has ceased to conduct SoHO activities. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific importing SoHO entity authorisation, that Member State may decline to recognise the validity of the importing SoHO entity authorisation of another Member State pending verif. That refusal shall end once the Member State which has adopted a more stringent measure has verified that the correct application of that the more stringent measure has been metmeasure by the Member State which granted the authorisation has been met. It may be based on the principle of voluntary and unpaid donation, in accordance with Article 4(1)(a) of this Regulation.
Amendment 570 #
Proposal for a regulation
Article 32 – paragraph 5
Article 32 – paragraph 5
5. Inspectors may be assisted by technical experts provided that the competent authorities ensure that those experts comply with the requirements of this Regulation, in particular with the obligations set out in Articles 7 and 76. Competent authorities shall ensure that inspectors have not worked as assessors as defined in Article 24 of this Regulation for at least one year.
Amendment 590 #
Proposal for a regulation
Article 46 – paragraph 2 – point d
Article 46 – paragraph 2 – point d
(d) SoHOs imported into the Union in case of emergency authorised directly by competent authorities pursuant to Article 28(9);
Amendment 610 #
Proposal for a regulation
Article 53 – paragraph 1 – point g
Article 53 – paragraph 1 – point g
(g) document the results of the donor health evaluation referred to in point (f), including donor vaccination schedules;
Amendment 657 #
Proposal for a regulation
Article 55 – paragraph 3 – point c a (new)
Article 55 – paragraph 3 – point c a (new)
(ca) the regular renewal of their consent to the donation at the end of a period set by each Member State;
Amendment 673 #
Proposal for a regulation
Chapter VII – title
Chapter VII – title
VII SOHO RECIPIENT AND OFFSPRING PROTECTION
Amendment 674 #
Proposal for a regulation
Article 57 – title
Article 57 – title
Objectives regarding SoHO recipient and offspring protection
Amendment 678 #
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
SoHO entities shall protect the health of SoHO recipients and offspringchildren from medically assisted reproduction from risks posed by SoHO preparations. They shall do so by identifying, minimising or eliminating those risks.
Amendment 681 #
Proposal for a regulation
Article 58 – title
Article 58 – title
Standards concerning SoHO recipient and offspring protection
Amendment 684 #
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 685 #
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 698 #
Proposal for a regulation
Article 58 – paragraph 2 – point c a (new)
Article 58 – paragraph 2 – point c a (new)
(ca) a list of contagious or chronic diseases or infections that are or may be communicable, which must be explicitly formalised and shared between Member States.
Amendment 738 #
Proposal for a regulation
Article 59 – title
Article 59 – title
Implementation of the standards concerning recipient and offspring protection
Amendment 771 #
Proposal for a regulation
Article 62 – paragraph 3 – point f a (new)
Article 62 – paragraph 3 – point f a (new)
Amendment 830 #
Proposal for a regulation
Article 70 – paragraph 1 – introductory part
Article 70 – paragraph 1 – introductory part
1. The Commission shallmay perform controls, including audits, inat the request of Member States to verify the effective application of the requirements relating to:
Amendment 835 #
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
The Commission shallMember States may establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM.
Amendment 836 #
Proposal for a regulation
Article 71 – paragraph 1 a (new)
Article 71 – paragraph 1 a (new)
The Commission shall ensure that those guidelines reflect the interests of Member States and, where appropriate, may adopt implementing acts laying down standards in line with those interests.