194 Amendments of Nicolás GONZÁLEZ CASARES related to 2022/0216(COD)
Amendment 124 #
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 safety 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.
Amendment 125 #
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-border sharing of these 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 and cross-border cooperation. 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 128 #
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, taking into consideration the special characteristics of each type of substance.
Amendment 133 #
Proposal for a regulation
Recital 9
Recital 9
(9) All SoHOs that are intended to be applied to humans fall within the scope of this Regulation. SoHOs can be prepared and stored in a variety of ways, becoming SoHO preparations, which can be applied to recipients. In these circumstances, this Regulation should apply to all activities from donor recruitment to human application and outcome monitoring. SoHOs or SoHO preparations can also be used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in particular on medical devices, regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council19, on medicinal products, regulated by Directive 2001/83/EC of the European Parliament and of the Council20and by Regulation (EC) No 726/2004 of the European Parliament and of the Council21, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007 of the European Parliament and of the Council22, or on food, regulated by Regulation (EC) No 1925/2006 of the European Parliament and of the Council23. The criteria that define when SoHOs or SOHO preparations become products regulated under other Union legislation are not defined in this Regulation but are defined in those other acts. In case of products covered by other legislation of the Union, this Regulation shall only apply to those parts specified on it, without prejudice to other legislation of the Union.Inaddition, this Regulation should apply without prejudice to Union legislation on genetically modified organisms. _________________ 19 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1). 20 Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). 21 Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p. 1). 22 Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324, 10.12.2007, p. 121). 23 Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods (OJ L 404, 30.12.2006, p. 26).
Amendment 136 #
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 environmental contamination, loss of traceability or damage to the biological properties inherent to the substance, and necessary for efficacy and/or functionality in the recipient, also appear. Thus, the requirements for SoHO establishment authorisation should apply. Furthermore, in case of substances meant for autologous but non-homologous application, this Regulation shall apply without prejudice to Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Or. en (Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004)
Amendment 142 #
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, issuing, 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 158 #
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 on them 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 needthe possibility for donors to donate repeatedly. Donations of oocytes, bone marrow, peripheral blood stem cells and frequent donation of plasma should be considered to imply a significant risk.
Amendment 165 #
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 where necessary supported by scientific evidence, and the means of achieving that aim are appropriate and necessary.
Amendment 172 #
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, provided that they adhere to the Charter of Fundamental Rights of the European Union. 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.
Amendment 173 #
Proposal for a regulation
Recital 17
Recital 17
(17) This Regulation is not meant to cover research using SoHOs when that research does not involve application to the human body, for example in vitro research or research in animals. However, human substances used in research involving studies where they are applied to the human body should comply with the rules laid down in this Regulation, regarding clinical studies with SoHO.
Amendment 175 #
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, prticle 3 of the Charter of Fundamental Rights of the European Union prohibits the human body or parts of it from becoming a source of financial gain. Programmes promoting the donation of SoHOs shouldmust 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, and increases public trust in donation systems. 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, financially neutralcompensation to remove any such risk is acceptable but should never produce a financial gain for the donor orconstitute 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,in any way that could posingerisks to their own health and to that of prospective recipients.Compensation and reimbursements should under no circumstances be an incentive or a claim to recruit donors, should not expose vulnerable persons in society to exploitation and should not promote competition among SoHO entities for the recruitment of donors. Such compensation should, therefore, be set by national authorities, at a level justified andappropriate 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 189 #
Proposal for a regulation
Recital 19
Recital 19
(19) In order to maintain public trust in SoHO donation and use programmes, information that is given to prospective donors, recipients or physicians regarding the likely use and benefits of particular SoHOs or SoHO preparations when applied to recipients should accurately reflect reliable scientific evidence and under no circumstances attribute or imply levels of safety or efficacy not supported by scientific methods. This should ensure that donors, or their families, are not coerced to donate by exaggerated descriptions of benefits and prospective patrecipients are not given false hopes when making decisions on their options for treatment. The verification of compliance with this Regulation through supervisory activities is of fundamental importance to ensure that, across the Union, the objectives of the Regulation are effectively achieved. The responsibility to enforce this Regulation lies with the Member States, whose competent authorities should monitor and verify, through the organisation of supervisory activities, that relevant Union requirements are effectively complied with and enforced.
Amendment 193 #
Proposal for a regulation
Recital 21
Recital 21
(21) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities that act independently and impartially. It is therefore important that their function of oversight is separate and independent from the performance of SoHO activities. In particular, competent authorities should be free from undue political influence and from industry or other actors’ interference that might affect their operational impartiality.
Amendment 199 #
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 withe Clasification Advisory Council, defined in this Regulation and composed by representatives of the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, medical devices, organs or fooadvanced therapies, medical devices and the SoHO Coordination Board, 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 or the Classification Advisory Council, decide on the regulatory status of a particular substance, product or activity under this Regulation.
Amendment 208 #
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 and issuing, 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 offspring 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 210 #
Proposal for a regulation
Recital 28
Recital 28
(28) With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated, following the guidelines specified in this Regulation. The most up- to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end- points. In case of high risk, these should include a comparison with standard treatments, ideally in a study with subjects allocated to test and control groups in a randomised manner. The competent authority should approve the plans before they are implemented and should assess the outcome data as part of a SoHO preparation authorisation. (Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 AprilIf a conventional treatment or a control group is based on a medicinal product for human use, these studies shall be considered clinical trials that are covered by Regulation 536/2014. Or. en 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC)
Amendment 213 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
Amendment 214 #
Proposal for a regulation
Recital 28 b (new)
Recital 28 b (new)
(28 b) The commitment to publish the clinical results obtained should be a mandatory requirement for clinical studies with SoHO. The existence of a registry of SoHO clinical studies at EU level is critical to facilitate patient participation in clinical studies, to boost multi-centre studies and to foster collaboration to generate more robust results and conclusions, and to make the generated knowledge available to other researchers, healthcare professionals, participants themselves and the general public.
Amendment 215 #
Proposal for a regulation
Recital 29
Recital 29
(29) In the interests of efficiency, it should be permitted to conduct clinical outcome studies using the established framework in the pharmaceutical sector for clinical trials, as set out in Regulation (EU) No 536/2014 of the European Parliament and of the Council25, when operators wish to do so. Whilst applicants can choose to record the clinical data generated during the clinical outcome monitoring themselves, they should also be permitted to use existing clinical data registries as a means of such recording when those registries have been verified by the competent authority, or are certified by an external institution, in terms of the reliability of their data management procedures. _________________ 25 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).
Amendment 216 #
Proposal for a regulation
Recital 30
Recital 30
(30) In order to facilitate innovation and reduce administrative burden, competent authorities should share with each other information on the authorisation of new SoHO preparations and the evidence used for such authorisations, through the EU SoHO platform, 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. Competent authorities should also share with each other information on clinical studies with SoHO, via the EU SoHO Platform.
Amendment 221 #
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 a means to demonstrate compliance with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. Member States should be involved in both the drafting and voting of these guidelines and should follow a transparent process of consultation with other relevant EU authorities and stakeholders. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines are based on the most up-to-date scientific evidence and 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 234 #
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. The development of the guidelines should include stakeholder consultations to ensure their suitability and transparency.Member States should have an active role in the development of the guidelines, in cooperation with the EDQM. _________________ 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 246 #
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 and the Union should promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing self- sufficiency in the Unionthe autonomy of the Union, based on a wider donor base. Member States and the Union are also urged to take steps to encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 257 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
Amendment 264 #
Proposal for a regulation
Recital 37 b (new)
Recital 37 b (new)
(37 b) On the other hand, it is essential to take steps to achieve, as soon as possible, an EU autonomy in the area of SoHO, especially in the case of plasma, which shows an increasing demand due to new therapeutic applications of plasma- derived medicines. Nowadays, the Union suffers from chronic shortages of plasma, resulting in its dependence on imports from third countries. It is necessary to specify the measures to be taken to increase the donor base, always in line with the principles of voluntary and unpaid donation, as well as to improve the infrastructure to enable efficient collection of SoHO, in order to ensure the continued, adequate and safe supply, also in times of crisis.
Amendment 266 #
Proposal for a regulation
Recital 37 c (new)
Recital 37 c (new)
(37 c) In order to reach an appropriate level of autonomy in the Union, it will be necessary to increase the collection of SoHO, but also to ensure its proper and efficient use. The factors and measures affecting SoHO’s demand play a critical role in ensuring the quality, safety and sustainability of the SoHO system. Suboptimal clinical practices and unnecessary use of SoHO compromises patient safety and limits the availability of SoHO for other patients in need. Member States should take measures to promote the optimal use of SoHO, taking into account alternatives that may reduce the demand, always following the most up-to- date scientific guidelines. The competent authorities should train healthcare professionals to make optimal use of SoHO. Member States should draw up national plans to ensure the supply of SoHO, as well as national emergency plans.
Amendment 267 #
Proposal for a regulation
Recital 37 d (new)
Recital 37 d (new)
(37 d) In cases where the availability of SoHO preparations or SoHO-derived products depend on profit-making entities, such as some plasma-derived products, there is a risk of altruistic donations turning into disproportionate profits and commercial interests taking precedence over the interests of patients and research. There could even be situations in which some low-profitable products are no longer produced, hampering their accessibility for patients. Similarly, investment in research and innovation for this type of products could be very small or non-existent. Prices of SoHO-derived products, which are obtained from altruistic and unpaid donations, should be fair and transparent. For certain low- profitable products, Member States should encourage research and innovation and should ensure, through negotiations, incentives or public service obligations, that they continue to be manufactured.
Amendment 271 #
Proposal for a regulation
Recital 38
Recital 38
(38) In order to promote a coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission should participate in its activities and chair it. The SCB should contribute to a coordinating the application of this Regulation throughout the Union, including by helping Member States to conduct SoHO supervisory activities. The SCB should be composed of persons designated by the Member States based on their role and expertise in their competent authorities, and should also involve experts that are not working for competent authorities, for specific tasks where access to necessary in-depth technical expertise in the field of SoHOs is required. In the latter case, appropriate consideration should be given to the possibility of involving European expert bodies such as the ECDC and the EDQM and existing professional, scientific, experts and donor and patrecipient representative groups at Union level in the field of SoHOs may also be invited.
Amendment 277 #
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 causes confusion among operators in the field, and the consequent legal uncertainty is a disincentive to professionals to develop new ways to prepare and use SoHOs. 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, the Classification Advisory Council 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 281 #
Proposal for a regulation
Recital 41
Recital 41
(41) In order to limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (the ‘EU SoHO Platform’) to facilitate timely submission of data and reports as well as improved transparency of national reporting and supervisory activities. and better communication, collaboration, coordination and exchange of SoHO between Member States. Member States should preferably use this new platform in their exchanges to limit the administrative burden.
Amendment 292 #
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 prohibition of making the human body and its parts a source of economic gain, 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 offspring born from medically assisted reproduction should always be taken into account, amongst others, by ensuring that consent for donation is freely given and donors or their representatives are informed with regards to the intended use of the donated material, that donor eligibility criteria are based on scientific evidence, that the use of SoHOs in humans is not promoted for commercial purposes or with false or misleading information regarding efficacy so that the donors and recipients can make well-informed and deliberate choices, that activities are conducted in a transparent manner that prioritises the safety of donors and recipients, and that allocation and equitable and non-discriminatory 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 297 #
Proposal for a regulation
Recital 45
Recital 45
(45) SoHOs, by definition, relate to persons, and there are circumstances where the processing of personal data relating to donors and recipients may be necessary to achieve the objectives and requirements of this Regulation, especially provisions relating to vigilance and communication between competent authorities. This Regulation should provide a legal basis under Article 6 and, where relevant, fulfil the conditions under Article 9(2), point (i), of Regulation (EU) 2016/679 for processing of such personal data. With respect to personal data processed by the Commission, this Regulation should provide a legal basis under Article 5 and, where relevant, fulfil the conditions under Article 10(2), point (i), of Regulation (EU) 2018/1725. Data on safety and efficacy of new SoHO preparations in recipients should also be shared, with appropriate protective measures and, where possible, anonymised, to allow aggregation at Union level for more robust evidence gathering on the clinical efficacy of SoHO preparations. For all data processing, such processing should be necessary and appropriate with a view to ensuring compliance with this Regulation in order to protect human health. Data on donors, recipients and offspring should hence be limited to the minimum necessary and pseudonymised, or anonymised, as appropiate in each case. dDonors, recipients and offspring should be informed of the processing of their personal data in line with the requirements of Regulations (EU) 2016/679 and (EU) 2018/1725, and in particular as provided for under this Regulation, including the possibility of exceptional cases where circumstances require such processing.
Amendment 303 #
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 objectiveThis Regulation will increase coordination between Member States and facilitate the cross-border exchange of SoHO.
Amendment 305 #
Proposal for a regulation
Recital 47 a (new)
Recital 47 a (new)
(47 a) 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 307 #
Proposal for a regulation
Recital 47 b (new)
Recital 47 b (new)
(47 b) In some cases such as bone marrow or haematopoietic stem cell transplants, the level of donor/recipient compatibility has to be extremely high. Therefore, excellent coordination is needed at a global level, beyond the Union level, so that each patient has more options of finding a compatible donor.
Amendment 310 #
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 reproduction, and for enhanced coordination between Member States to improve the availability and accessibility of SoHO across the Union. 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, recipients and offspring of medically assisted reproduction.
Amendment 318 #
(h a) issuing of SoHOs;
Amendment 321 #
Proposal for a regulation
Article 2 – paragraph 1 – point m a (new)
Article 2 – paragraph 1 – point m a (new)
(m a) clinical studies with SoHO.
Amendment 323 #
Proposal for a regulation
Article 2 – paragraph 2 – introductory part
Article 2 – paragraph 2 – introductory part
2. In cases of autologous use of SoHOs, excluding cases where the processing involves a substantial modification or where its application is non-homologous, where:
Amendment 333 #
(1) ‘blood’ means the liquid that circulates in arteries and veins carrying oxygen to and carbon dioxide from the tissues of the body. It consists of a liquid part, plasma, and a solid consisting of red blood cells, leucocytes and platelets;
Amendment 338 #
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 manner, whether it contains cells or not and whether those cells are living or not. For the purposes of this Regulation, SoHO does not include organs in the sense of Article 3, point (h), of Directive 2010/53/EU, but does include substances which can be extracted from them;
Amendment 339 #
Proposal for a regulation
Article 3 – paragraph 1 – point 6
Article 3 – paragraph 1 – point 6
(6) ‘human application’ means inserted, implanted, injected, infused, transfused, transplanted, ingested, transferred (as in transfer to the uterus or fallopian tube of a woman), inseminated or otherwise added to the human body in order to create a biological, mechanical or physiological interaction with that body;
Amendment 340 #
Proposal for a regulation
Article 3 – paragraph 1 – point 7
Article 3 – paragraph 1 – point 7
(7) ‘SoHO activity’ means an action, or series of actions, that has a direct impact on the safety, quality or, efficacy or functionality of SoHOs, as listed in Article 2(1);
Amendment 343 #
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, or a deceased person who has authorised, or on his/her behalf a family member or authorised person, the donation of parts of his/her body after death, whether that donation is successful or not;
Amendment 349 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8 a) ‘SoHO donation’ means a process by which a person – or on his/her behalf a relative or authorised person – voluntarily and altruistically gives parts of their own body to other people in need, or authorises their use after their death. It includes the necessary medical formalities, examinations and treatments and monitoring of the SoHO donor, whether that donation is successful or not;
Amendment 352 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)
Article 3 – paragraph 1 – point 8 b (new)
(8 b) ‘living 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;
Amendment 355 #
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, in vitro fertilisation or any other laboratory or medical intervention that promotes conception and uses SoHOs for the preservation of fertility through collection and storage of SoHO substances for subsequent human application;
Amendment 361 #
Proposal for a regulation
Article 3 – paragraph 1 – point 11
Article 3 – paragraph 1 – point 11
(11) ‘offspring from medically assisted reproduction’ means fetuses and children that are born following medically assisted reproduction;
Amendment 362 #
Proposal for a regulation
Article 3 – paragraph 1 – point 11 a (new)
Article 3 – paragraph 1 – point 11 a (new)
(11 a) ‘unborn offspring from medically assisted reproduction’ means embryos and foetuses conceived by medically assisted reproduction;
Amendment 364 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point b
Article 3 – paragraph 1 – point 12 – point b
(b) meets a pre-defined specification; and
Amendment 366 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point c
Article 3 – paragraph 1 – point 12 – point c
(c) is intended for application to a recipient for a specific and homologous clinical indication or is intended for distribution for manufacture of a product regulated by other Union legislation, or as the starting and raw material thereof; and
Amendment 368 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 – point c a (new)
Article 3 – paragraph 1 – point 12 – point c a (new)
(c a) has not been substantially modified, such as to be considered as a medicinal product or advanced therapy, and is not intended to be applied in a non- homologous manner to the recipient.
Amendment 370 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 a (new)
Article 3 – paragraph 1 – point 12 a (new)
(12 a) ‘competent authority’ means the body or bodies responsible for SoHO’s activities at national level, designated by each Member State;
Amendment 371 #
Proposal for a regulation
Article 3 – paragraph 1 – point 12 b (new)
Article 3 – paragraph 1 – point 12 b (new)
(12 b) ‘national authority’ means the reference competent authority, at national level, appointed by each Member State and responsible for coordinating exchanges with the Commission and with the national SoHO authorities of other Member States;
Amendment 374 #
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 and encouraging persons to become SoHO donors;
Amendment 378 #
Proposal for a regulation
Article 3 – paragraph 1 – point 15
Article 3 – paragraph 1 – point 15
(15) ‘processing’ means any operation involved in the handling of SoHOs, including washing, shaping, separation, fertilisation, decontamination, sterilisation, preservation and packaging. It does not include activities involving a substantial modification of SoHOs that would make it a medicinal product or an advanced therapy;
Amendment 383 #
Proposal for a regulation
Article 3 – paragraph 1 – point 16
Article 3 – paragraph 1 – point 16
(16) ‘quality control’ means severaldefined tests or checks to confirm that a SoHO activity or SoHO preparation meets pre- defined quality criteria;
Amendment 386 #
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 issuing;
Amendment 387 #
Proposal for a regulation
Article 3 – paragraph 1 – point 18
Article 3 – paragraph 1 – point 18
(18) ‘release’ means a process through which it is verified that a SoHO or a SoHO preparation meets defined safety and quality criteria and the conditions of any applicable authorisation before distribution, issuing, export or human application;
Amendment 393 #
Proposal for a regulation
Article 3 – paragraph 1 – point 21
Article 3 – paragraph 1 – point 21
(21) ‘export’ means distribution of SoHOs or SoHO preparations to third countries outside the Union;
Amendment 394 #
Proposal for a regulation
Article 3 – paragraph 1 – point 21 a (new)
Article 3 – paragraph 1 – point 21 a (new)
(21 a) ‘non-homologous use’ means a cell or tissue that, when applied to a recipient, ceases to have the same essential function, in the same anatomical or histological space as it had in its original environment in the donor;
Amendment 395 #
Proposal for a regulation
Article 3 – paragraph 1 – point 21 b (new)
Article 3 – paragraph 1 – point 21 b (new)
(21 b) ‘homologous use’ means a cell or tissue that when applied in a recipient mantains the same essential function, in the same anatomical or histological space as it had in its original environment in the donor;
Amendment 396 #
Proposal for a regulation
Article 3 – paragraph 1 – point 22
Article 3 – paragraph 1 – point 22
(22) ‘clinical outcome monitoring’ means evaluation of the health of a SoHO recipient for the purpose of monitoring the results of a SoHO preparation application, maintaining care and demonstrating safety and efficacy or functionality;
Amendment 397 #
Proposal for a regulation
Article 3 – paragraph 1 – point 23
Article 3 – paragraph 1 – point 23
(23) ‘autologous use’ means collection of SoHO from one individual for subequent application to the same individual, with or without further SoHO activities between collection and application;
Amendment 400 #
Proposal for a regulation
Article 3 – paragraph 1 – point 27
Article 3 – paragraph 1 – point 27
(27) ‘adverse occurrence’ means any incident associated with the donation or human application of SoHO that caused harm to a living SoHO donor, harm to a SoHO recipient or to offspring from medically assisted reproduction or that implied a risk of such harm;
Amendment 405 #
Proposal for a regulation
Article 3 – paragraph 1 – point 28 – point i a (new)
Article 3 – paragraph 1 – point 28 – point i a (new)
(i a) any other adverse ocurrence specified by the EDQM guidelines.
Amendment 407 #
Proposal for a regulation
Article 3 – paragraph 1 – point 29
Article 3 – paragraph 1 – point 29
(29) ‘SoHO rapid alert’ means a communication regarding a SAO, a communicable disease outbreakn adverse ocurrence or other information that might be of relevance to the safety and quality of SoHOs in more than one Member State and is to be transmitted rapidly between competent authorities and the Commission to facilitate the implementation of preventive or mitigating measures;
Amendment 408 #
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 and managed by the Commission tofor the exchange of information concerning SoHO activities at Union level, between competent authorities, the Commission, SoHO entities and other relevant entities, and to facilitate coordination and cross-border cooperation, between Member States, on SoHO;
Amendment 412 #
Proposal for a regulation
Article 3 – paragraph 1 – point 33
Article 3 – paragraph 1 – point 33
(33) ‘the compendium of SoHO’ means a list kept up-to-date by the SoHO Coordination Board of decisions, taken at Member State level, and opinions, issued by competent authorities and by the SCB and the Classification Advisory Council, on the regulatory status of specific substances, products or activities and published on the EU SoHO platform;
Amendment 414 #
Proposal for a regulation
Article 3 – paragraph 1 – point 38
Article 3 – paragraph 1 – point 38
(38) ‘Union training’ means training activities for the personnel of competent authorities and, where appropriate, for personnel of delegated bodies performing SoHO supervisory activities;
Amendment 416 #
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 418 #
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 420 #
Proposal for a regulation
Article 3 – paragraph 1 – point 42 a (new)
Article 3 – paragraph 1 – point 42 a (new)
(42 a) ‘Classification Advisory Council’ means a body composed of representatives of the SoHO Coordination Board, the European Medicines Agency and the Medical Device Coordination Group with the responsibility of assisting the Member States and the Commission in determining the regulatory status of a substance, product or activity covered by this Regulation;
Amendment 421 #
Proposal for a regulation
Article 3 – paragraph 1 – point 42 b (new)
Article 3 – paragraph 1 – point 42 b (new)
(42 b) ‘SoHO Coordination Board (SCB)’ means a body set up by this Regulation to promote coordination between Member States on SoHO;
Amendment 423 #
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, updated in accordance with the latest scientific evidence, 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;
Amendment 424 #
Proposal for a regulation
Article 3 – paragraph 1 – point 47 – introductory part
Article 3 – paragraph 1 – point 47 – introductory part
(47) ‘traceability’ means the ability to locate and identify SoHOs during any step from collection through processing and storage to, distribution or issuing, to human application or disposal, including the ability to:
Amendment 427 #
Proposal for a regulation
Article 3 – paragraph 1 – point 51
Article 3 – paragraph 1 – point 51
(51) ‘imputability’ means the likelihood that a seriousn adverse occurrence, in a SoHO donor, is related to the donacollection process or, in a recipient, to the application of the SoHOs;
Amendment 433 #
Proposal for a regulation
Article 3 – paragraph 1 – point 61
Article 3 – paragraph 1 – point 61
(61) ‘SoHO for reproductive cellson’ means all cells intended to be used for the purpose of medically assisted reproduction and embryos resulting from fertilisation;
Amendment 434 #
Proposal for a regulation
Article 3 – paragraph 1 – point 62
Article 3 – paragraph 1 – point 62
(62) ‘third party donation’ means a donation of SoHO for reproductive cellson by a person to a personrecipient or a couple with whom the donor does not have an intimate physical relationship;
Amendment 436 #
Proposal for a regulation
Article 3 – paragraph 1 – point 63
Article 3 – paragraph 1 – point 63
(63) ‘within couple use’ means use of reproductive cells for medically assisted reproduction frombetween two persons with an intimate physical relationship, where one person supplies their own oocytes and the other person supplies their own sperm. Such gametes shall under no circumstances be applied to third parties;
Amendment 441 #
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, without any net gain or loss;
Amendment 452 #
Proposal for a regulation
Article 3 – paragraph 1 – point 64 a (new)
Article 3 – paragraph 1 – point 64 a (new)
(64 a) ‘reimbursement’ means the reimbursement of costs incurred by the donor associated with the donation process;
Amendment 454 #
Proposal for a regulation
Article 3 – paragraph 1 – point 64 b (new)
Article 3 – paragraph 1 – point 64 b (new)
(64 b) ‘financial neutrality’ means a situation in which the donor does not experience net economic gains or losses associated with a donation;
Amendment 461 #
Proposal for a regulation
Article 3 – paragraph 1 – point 70 a (new)
Article 3 – paragraph 1 – point 70 a (new)
(70 a) ‘informed consent’ means consent by the donor to make a free and non- coercive donation or consent by the recipient to accept a treatment with a SoHO, after receiving clear, comprehensive and comprehensible information;
Amendment 465 #
Proposal for a regulation
Article 3 – paragraph 1 – point 70 b (new)
Article 3 – paragraph 1 – point 70 b (new)
(70 b) ‘European autonomy’ means the situation where the Union has the capacity to self-supply SoHO, being self- sufficient from third countries to cover most of the demand, with the exception of those SoHOs which require global management due to their intrinsic characteristics.
Amendment 468 #
Proposal for a regulation
Article 3 – paragraph 1 – point 70 c (new)
Article 3 – paragraph 1 – point 70 c (new)
(70 c) ‘SoHO clinical study’ means an experimental evaluation of a SoHO or a SoHO preparation in humans, with the objective of drawing conclusions regarding its efficacy and safety.
Amendment 470 #
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 law, and are proportionate to the risk to human health. In particular, Member States may introduce requirements for donations, including the prohibition or restriction of imports of SoHO, to ensure a high level of health protection and to achieve the objective defined in Article 54, provided that the conditions of the Treaties are met. Such measures shall not hinder coordination between Member States or European autonomy.
Amendment 491 #
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 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. They shall also be transparent about the criteria used for the assessment and authorisation of SoHO preparations and SoHO entities.
Amendment 493 #
Proposal for a regulation
Article 9 – paragraph 1
Article 9 – paragraph 1
1. Competent authorities shall be responsible for the SoHO supervisory activities referred to in Chapter III in order to verify the effective compliance of SoHO entities and SoHO preparations authorised in their territory with the requirements set out in this Regulation.
Amendment 495 #
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) procedures to ensure the independence, impartiality, transparency, effectiveness, quality, suitability for purpose and consistency of their SoHO supervisory activities;
Amendment 496 #
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 efficiently, safely and effectively;
Amendment 499 #
Proposal for a regulation
Article 14 – paragraph 1
Article 14 – paragraph 1
1. In all cases where questions arise as to the regulatory status of a substance, product or activity, competent authorities shall consult with authorities established in other relevant Union legislation referred tothe Classification Advisory Council, defined in Aarticle 2(3), as relevant.67(a) In such cases, competent authorities shall also consult the compendium referred to Article 3 point (33).
Amendment 500 #
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 1
Article 14 – paragraph 2 – subparagraph 1
Amendment 502 #
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 2
Article 14 – paragraph 2 – subparagraph 2
Amendment 505 #
Proposal for a regulation
Article 14 – paragraph 3
Article 14 – paragraph 3
3. The competent authorities shall inform the SCBClassification Advisory Council of the subsequent decision taken in their Member State, following the consultations referred to in paragraph 1 of this Article, regarding the regulatory status of the substance, product or activity concerned under this Regulation and on any consensus reached as a result of those consultations for publication in the compendium by the SCB. To the extent possible, Member States shall accept the opinion of the Classification Advisory Council. Otherwise, they shall inform the Classification Advisory Council as soon as possible of the decision taken and its justification.
Amendment 509 #
Proposal for a regulation
Article 14 – paragraph 4 – subparagraph 1
Article 14 – paragraph 4 – subparagraph 1
The Commission may, upon a duly substantiated request of a Member State or the Classification Advisory Council, following the consultation referred to in paragraph 1, or on its own initiative, by means of implementing acts, determine the regulatory status of a substance, product or activity under this Regulation, in case questions arise in that respect, notably when these questions cannot be resolved at the Member State level, or in discussions between the SCB and the advisory bodies established in other relevant Union legislation, in accordance with Article 68(1), point (b)in the Classification Advisory Council. This decision shall be based on the most up-to- date scientific evidence.
Amendment 510 #
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
Amendment 513 #
Proposal for a regulation
Article 14 – paragraph 6
Article 14 – paragraph 6
6. The consultation and cooperation referred to in paragraphs 1, 2 and 5 may also be initiated on the basis of a request for advice from a SoHO entity, as referred to in Article 40.
Amendment 515 #
Proposal for a regulation
Article 14 – paragraph 7 – subparagraph 1
Article 14 – paragraph 7 – subparagraph 1
The Commission may, by means of implementing acts, lay down rules concerning procedures for consultation referred to in paragraph 1 and cooperation referred to in paragraph 5 by the competent authorities when they consult the authorities established in other relevant Union legislation referred to in Article 2(3).
Amendment 524 #
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. SoHO preparation 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. Where a Member State has adopted a more stringent measure, in accordance with Article 4, which relates to a specific SoHO preparation, that Member State may decline to recognise the validity of the SoHO preparation authorisation of another Member State pending verification that the more stringent measure has been met. This information shall be notified, without undue delay, in the EU SoHO Platform.
Amendment 525 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
1. Competent authorities shall have procedures in place to allow that applications for the authorisation of SoHO preparations are submitted in accordance with Article 41. They shall provide guidelines and templates for the submission of applications for SoHO preparation authorisation. When developing these guidelines and templates, competent authorities shall consultfollow the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c). Competent authorities may establish simplified procedures for applications concerning modifications to previously authorised SoHO preparations.
Amendment 531 #
Proposal for a regulation
Article 21 a (new)
Article 21 a (new)
Article 21 a Conditional authorisation of SoHO preparations in exceptional situations 1. In exceptional cases, and subject to a medical prescription, the competent authorities may consult the best practices approved and documented by the SCB in accordance with Article 68(1)(c) and authorise the conditional and temporary use of certain SoHOs preparations in cases where: (a) the potential recipient of those SoHO preparations is at vital risk, has no available therapeutic alternatives and their treatment cannot be postponed; (b) available clinical data indicate that the SoHO preparation will be safe and effective. 2. The competent authorities shall, without undue delay, enter information on conditional authorisations of SoHO preparations into the EU SoHO Platform referred to in Chapter XI. 3. After receiving conditional and temporary authorisation for a SoHO preparation, the SoHO entity shall, in parallel, initiate a regular authorisation procedure for that SoHO preparation in accordance with Article 21.
Amendment 533 #
Proposal for a regulation
Article 22 – paragraph 5
Article 22 – paragraph 5
5. When assessing the SoHO preparation pursuant to paragraph 4, points (e) and (g), competent authorities shall consider, in the cases where the applicant has proposed to record, and recorded,verify that the clinical studies and their results of the clinical outcome monitoring in an existing clinical registry, that this is an acceptable method, provided that those competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of datahave been correctly recorded in the EU SoHO Platform.
Amendment 556 #
Proposal for a regulation
Article 28 – paragraph 9
Article 28 – paragraph 9
9. By derogation from paragraph 1, in case of emergencythe exceptional situations described in Article 21(a) or in case of emergency, as described in Article 64, competent authorities may authorise imports of SoHOs for immediate application to a specific recipient when justified by the clinical circumstances on a case-by-case basis.
Amendment 565 #
Proposal for a regulation
Article 32 – paragraph 1 – subparagraph 2
Article 32 – paragraph 1 – subparagraph 2
In exceptional cases, competent authorities may consider that a person’s considerable and relevant experience may exempt this person from the requirement set out in the first subparagraph. They shall also perform their duties impartially, transparently and free from conflicts of interest.
Amendment 567 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. Competent authorities shall provide inspectors with a specific induction training before inspectors take up their duties. For the specific induction training, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c). The designation criteria shall be clear and transparent.
Amendment 572 #
Proposal for a regulation
Article 34 – paragraph 2
Article 34 – paragraph 2
2. Competent authorities shall establish procedures for the unique identification of SoHO establishments that are subject to the provisions on the Single European Code in Article 46. Competent authorities shall ensure that such identification complies with the technical standards defined for that coding system. For this purpose, competent authorities may preferably use a SoHO establishment identification code generated by the EU SoHO Platform.
Amendment 573 #
Proposal for a regulation
Article 34 a (new)
Article 34 a (new)
Article 34 a Monitoring of SoHO availability and continuity of supply 1. As part of the national plans to ensure the continuity of SoHO supply referred to in Article 61(a), the competent authorities shall establish a digital platform through which they can exchange information on the availability of SoHO in the national territory in a fast and efficient manner. Through this system, competent authorities may request national SoHO entities to provide information on the availability of a certain SoHO product in specific situations of need. They shall also take into account alerts sent by national SoHO entities concerning the availability of SoHO and potential shortages. The competent authorities shall ensure that this digital platform is available no later than two years after the entry into force of this Regulation. 2. The competent authorities shall be responsible for monitoring the availability of SoHO at national level. They shall provide guidance to SoHO entities to facilitate the exchange of information on the availability of SoHO referred to in Article 46(a). 3. The competent authorities shall store and analyse information on the availability of SoHO and its fluctuations over time, as well as trends in demand and potential shortages of SoHO and shall draw up reports containing that information which may be made available to other Member States through the EU SoHO Platform as defined in Article 73 (Article 35).
Amendment 576 #
Proposal for a regulation
Article 36 a (new)
Article 36 a (new)
Amendment 577 #
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. The responsible person for release of SoHOs shall be in possession of a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned and shall have at least 2 years of experience in the relevant field. The SoHO entity shall ensure that the person responsible for the release of SoHO receives adequate and up-to-date training, appropriate to their job and responsibilities, including specific training on those SoHOs that require it.
Amendment 579 #
Proposal for a regulation
Article 40 – paragraph 3
Article 40 – paragraph 3
3. SoHO entities may request to their competent authorities a derogation from the requirement for a SoHO preparation authorisation in the exceptional circumstances referred to in Articles 21(a) 64.
Amendment 582 #
Proposal for a regulation
Article 41 – paragraph 4
Article 41 – paragraph 4
4. SoHO entities shall perform the clinical outcome monitoring once a conditional authorisation has been granted pursuant to Article 21(2), point (c), and submit the results to their competent authorities. In conducting the clinical investigation study as referred to in paragraph 3, points (b) and (c), for the SoHO preparation concerned, the applicant may use an existing clinical registry to record its results provided that their competent authorities have verified that the registry has data quality management procedures in place that ensure accuracy and completeness of datashall register that study and the results obtained in the SoHO EU Platform in accordance with Article 36 (a).
Amendment 585 #
Proposal for a regulation
Article 41 a (new)
Article 41 a (new)
Article 41 a Clinical studies with SoHO 1. SoHO entities may conduct clinical studies with SoHO, in the context of the monitoring plans defined in Article 41 or beyong it, with the aim of comparing or improving treatments. 2. Clinical studies shall always have the safety and well-being of the participants in the study as a priority and they shall respect the provisions of Articles 53, 54, 55, 56, 58 and 59 of this Regulation, concerning the protection of donors and recipients. SoHO entities intending to start a clinical study shall seek to obtain more robust and reliable data, through collaboration with other SoHO entities, if necessary. 3. SoHO entities must apply for a favorable opinion from the Research Ethics Committee before starting any clinical study. The Committee shall assess the ethical, legal and methodological aspects of the study, to determine the capacity of the study design to draw robust conclusions, as well as well-being and safety-related aspects of the participants, before issuing a favorable opinion for the study. 4. The person responsible for the clinical study shall be adequately trained. 5. Before starting the clinical study, SoHO entities shall register it on the EU SoHO Platform, where they shall also record the results after the end of the study, in accordance with Article 36 (a). 6. SoHO entities shall request approval of the clinical study to competent authorities before starting a clinical study with SoHO, in accordance with Article 36(a). SoHO entities may request assistance regarding administrative, technical and ethical aspects of the clinical study to the competent authorities, in accordance with Article 36(a).
Amendment 591 #
Proposal for a regulation
Article 46 a (new)
Article 46 a (new)
Amendment 592 #
Proposal for a regulation
Article 47 – paragraph 1
Article 47 – paragraph 1
1. SoHO entities shall maintain a system for detecting, investigating and recording information concerning adverse occurrences, including adverse occurrences detected during clinical outcome monitoring as part of a SoHO preparation authorisation application as referred to in Article 41 or as part of a clinical study with SoHO, as referred to in Article 41(a).
Amendment 595 #
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
1. SoHO establishments shall not carry out any SoHO activities without prior SoHO establishment authorisation. This shall apply whether all activities are carried out by the establishment itself or one or more are contracted to another SoHO entity.
Amendment 603 #
Proposal for a regulation
Article 52 – paragraph 2
Article 52 – paragraph 2
2. SoHO entities shall protect the physical and mental health of living donors before, during and after the donation.
Amendment 604 #
Proposal for a regulation
Article 52 – paragraph 2 a (new)
Article 52 – paragraph 2 a (new)
2 a. SoHOs from living donors shall be obtained from individuals whose state of health is such that no adverse effects on their health are expected/likely as a result of donation.
Amendment 607 #
Proposal for a regulation
Article 53 – paragraph 1 – point a a (new)
Article 53 – paragraph 1 – point a a (new)
(a a) ensure that donors are not discriminated on grounds not specified in the technical guidelines listed in Article 56, based on scientific evidence, and intended to avoid potential risks to the health of SoHO recipients or donors;
Amendment 608 #
Proposal for a regulation
Article 53 – paragraph 1 – point b
Article 53 – paragraph 1 – point b
(b) provide donors or their relatives or any persons granting authorisation on their behalf, in accordance with national legislation, with the information referred to in Article 55 and in a way that is adequate in view of their capacity to understand it, so that they can give free and informed consent;
Amendment 609 #
Proposal for a regulation
Article 53 – paragraph 1 – point f
Article 53 – paragraph 1 – point f
(f) verify the eligibility of the donor on the basis of a donor health evaluation, including mental health-related aspects that could be altered by the donation process, that aims to minimise any risk that the donation might pose to the donor’s health;
Amendment 626 #
Proposal for a regulation
Article 53 – paragraph 2
Article 53 – paragraph 2
2. In the course of the donor health evaluations referred to in paragraph 1, point (f), SoHO entities shall conduct interviews with the donors and gather information concerning the donors’ present and recent state of physical and mental health and their health histories to assure the safety of the donation process for those donors. SoHO entities may perform laboratory tests as part of the donor health evaluations. They shall perform such tests in cases where evaluations indicate that laboratory tests are necessary to establish the eligibility of those donors from the perspective of their own protection. The physician, as referred to in Article 51, shall approve the procedure and criteria for donor health evaluations.
Amendment 627 #
Proposal for a regulation
Article 53 – paragraph 3
Article 53 – paragraph 3
3. SoHO entities that collect SoHOs from donors that are subjected to a surgical procedure in order to donate, that are treated with hormones to facilitate donation, or that donate SoHO that can be donated on a frequent and repeated basis, shall register such donors and the results of their donor health evaluations in a cross- entity registry that allows interconnection with other such registries at Union level, as referred to in paragraph 1, point (j). SoHO entities that manage such registries shall ensure interconnectivity between them.
Amendment 643 #
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 living donors for losses related to their participation in donations through fixed rate allowances. In such case, Member States shall establish the conditions for such allowances in national legislation, including the setting of an upper limit that ensures that allowances are transparent, 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 648 #
Proposal for a regulation
Article 54 – paragraph 3
Article 54 – paragraph 3
3. SoHO entities may compensate or reimburse living donors as provided for by their competent authorities pursuant to paragraph 2. SoHO entities shall report transparently to the competent authorities on the compensation used, and on any changes made in this respect.
Amendment 651 #
Proposal for a regulation
Article 54 – paragraph 3 a (new)
Article 54 – paragraph 3 a (new)
3 a. Compensation may under no circumstances be used for promotion or as a claim for recruitment, shall not be an incentive to donate and shall not lead to exploitation of the most vulnerable persons in society or to situations of inappropriate competition for the recruitment of donors.
Amendment 653 #
Proposal for a regulation
Article 54 – paragraph 3 b (new)
Article 54 – paragraph 3 b (new)
3 b. The Commission shall assess the ethical aspects of voluntary and unpaid donation and verify that Member States’ compensation and reimbursement systems follow the guidelines specified in this Regulation. This assessment shall determine, inter alia, that such compensations and reimbursements under no circumstances constitute an incentive or a claim to recruit donors, that they do not expose vulnerable people in society to exploitation activities, that they do not undermine public confidence in the donation system or that they do not promote competition between SoHO entities for the recruitment of donors. Member States shall provide the Commission with the information requested to perform this assessment. By [one year after the entry into force of this Regulation], and every three years, the Commission shall submit a report to the Council and the European Parliament assessing the compensation and reimbursement systems in the Member States and, where appropriate, making recommendations to the Member States on how they can be improved. These reports shall be made available to the public.
Amendment 658 #
Proposal for a regulation
Article 55 – paragraph 3 – point d
Article 55 – paragraph 3 – point d
(d) the intended use of the donated SoHO, in particular covering proven benefits for the future recipients and any possible research or commercial uses to which the donor should give an informed consent;
Amendment 671 #
Proposal for a regulation
Article 56 – paragraph 6
Article 56 – paragraph 6
Amendment 676 #
Proposal for a regulation
Article 57 – paragraph 1
Article 57 – paragraph 1
SoHO entities shall protect the health of SoHO recipients and offspring from medically assisted reproduction from risks posed by SoHO preparations and their application. They shall do so by identifying, minimising or eliminating those risks.
Amendment 679 #
Proposal for a regulation
Article 57 – paragraph 1 a (new)
Article 57 – paragraph 1 a (new)
SoHO entities shall ensure that recipients are not discriminated on grounds not specified in the technical guidelines listed in Article 56, based on scientific evidence and intended to avoid potential risks to the health of donors or recipients;
Amendment 688 #
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,follow the scientific and technical specifications defined in Article 59 to mitigate the following measurerisks:
Amendment 690 #
Proposal for a regulation
Article 58 – paragraph 2 – point a
Article 58 – paragraph 2 – point a
Amendment 692 #
Proposal for a regulation
Article 58 – paragraph 2 – point b
Article 58 – paragraph 2 – point b
Amendment 695 #
Proposal for a regulation
Article 58 – paragraph 2 – point c
Article 58 – paragraph 2 – point c
Amendment 699 #
Proposal for a regulation
Article 58 – paragraph 2 a (new)
Article 58 – paragraph 2 a (new)
2 a. of communicable disease transmission from SoHO donors to recipients by combining, at least, the following measures: (i) reviewing and evaluating the donors’ current and past health, travel and relevant behavioural histories to allow the application of temporary or permanent deferrals when risks cannot be fully eliminated by donor testing; (ii) testing of donors for communicable diseases using certified and validated testing methods, or other methods considered appropriate in accordance with the guidelines defined in Article 59; (iii) when feasible and suitable according to the guidelines defined in Article 59, using processing technologies that reduce, inactivate or eliminate any potential communicable pathogens.
Amendment 701 #
Proposal for a regulation
Article 58 – paragraph 2 b (new)
Article 58 – paragraph 2 b (new)
2 b. of non-communicable disease transmission, including genetic conditions and cancer, from donors to the recipients or to offspring from medically assisted reproduction by combining, at least, the following measures: (i) reviewing the donors’ current and past health to allow temporary or permanent deferral of donors that carry a risk of transmitting cancerous cells or other non- communicable diseases that might be passed to a recipient by SoHO application; (ii) where the transmission of genetic conditions is an identified risk, and in particular in the case of medically assisted reproduction with third party donation: - testing donors for those conditions, as indicated by prevalence or severity as presenting the highest risk;or - 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.
Amendment 702 #
Proposal for a regulation
Article 58 – paragraph 2 c (new)
Article 58 – paragraph 2 c (new)
2 c. of communicable or non- communicable disease transmission to the recipients through cross-contamination of donations during collection, processing, storage and distribution by measures that ensure that physical contact between SoHOs from different donors is avoided or, in cases where combining donations is necessary for efficacy of the SoHO preparation, is minimised.
Amendment 703 #
Proposal for a regulation
Article 58 – paragraph 2 d (new)
Article 58 – paragraph 2 d (new)
Amendment 704 #
Proposal for a regulation
Article 58 – paragraph 2 e (new)
Article 58 – paragraph 2 e (new)
2 e. 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 by combining, at least, the following measures: (i) specifying such reagents and solutions prior to their purchase; (ii) verifying any required certifications of such reagents and solutions; (iii) demonstrating the removal of such reagents and solutions, when necessary, prior to distribution.
Amendment 705 #
Proposal for a regulation
Article 58 – paragraph 2 f (new)
Article 58 – paragraph 2 f (new)
Amendment 706 #
Proposal for a regulation
Article 58 – paragraph 2 g (new)
Article 58 – paragraph 2 g (new)
2 g. that SoHOs cause an immune reaction in recipients by combining, at least, the following measures: (i) accurately typing and matching of patients to donors, when such matching is necessary; (ii) correctly distributing SoHOs to the correct recipients pursuant to Article 45.
Amendment 707 #
Proposal for a regulation
Article 58 – paragraph 2 h (new)
Article 58 – paragraph 2 h (new)
Amendment 708 #
Proposal for a regulation
Article 58 – paragraph 3
Article 58 – paragraph 3
Amendment 713 #
Proposal for a regulation
Article 58 – paragraph 4
Article 58 – paragraph 4
Amendment 714 #
Proposal for a regulation
Article 58 – paragraph 5
Article 58 – paragraph 5
Amendment 717 #
Proposal for a regulation
Article 58 – paragraph 6
Article 58 – paragraph 6
Amendment 719 #
Proposal for a regulation
Article 58 – paragraph 7
Article 58 – paragraph 7
Amendment 721 #
Proposal for a regulation
Article 58 – paragraph 8
Article 58 – paragraph 8
Amendment 723 #
Proposal for a regulation
Article 58 – paragraph 9
Article 58 – paragraph 9
Amendment 726 #
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 a clinical study referred to in Article 41(a);
Amendment 727 #
Proposal for a regulation
Article 58 – paragraph 10 – point b
Article 58 – paragraph 10 – point b
(b) apply SoHO preparations to recipients unnecessarily. SoHO entities shall make an optimal use of SoHO, taking into account therapeutic alternatives, and following the most up-to- date scientific guides specified in Article 59 ;
Amendment 728 #
Proposal for a regulation
Article 58 – paragraph 10 – point c a (new)
Article 58 – paragraph 10 – point c a (new)
(c a) prioritise cosmetic uses over clinical uses, especially in the event of a possible shortage of SoHO.
Amendment 730 #
Proposal for a regulation
Article 58 – paragraph 11 – subparagraph 1
Article 58 – paragraph 11 – subparagraph 1
Amendment 732 #
Proposal for a regulation
Article 58 – paragraph 11 – subparagraph 2
Article 58 – paragraph 11 – subparagraph 2
For donors that donate repeatedly, the interviews referred to in the first subparagraph may be limited to aspects that might have changed and may be replaced with questionnaires.
Amendment 741 #
Amendment 742 #
Proposal for a regulation
Article -62 (new)
Article -62 (new)
Amendment 747 #
Proposal for a regulation
Article 62 – paragraph 2
Article 62 – paragraph 2
Amendment 773 #
Proposal for a regulation
Article 62 – paragraph 3 – point f a (new)
Article 62 – paragraph 3 – point f a (new)
(f a) communication strategy for the general public.
Amendment 776 #
Proposal for a regulation
Article 62 – paragraph 6
Article 62 – paragraph 6
6. Member States shall review regularly their national SoHO emergency plans at least every 3 years and whenever necessary to take into account changes in the organisation of competent authorities and, experience gained from implementing the plans and simulation exercises and the recommendations issued by the Commission, as referred to in Article 62(a).
Amendment 786 #
Proposal for a regulation
Article 62 b (new)
Article 62 b (new)
Article 62 b European SoHO autonomy 1. By two years after the entry into force of this Regulation, the Commission shall submit a report to the Council and the European Parliament assessing the different measures applicable to secure the SoHO supply at national level, in the Member States, and at Union level. This report shall include measures to promote donation, in a manner compatible with the principles of voluntary and unpaid donation defined in paragraph 54 – such as informative and awareness-raising campaigns for citizens on the benefits of donation, as well as measures for the efficient use of SoHO. Based on the results of this report, the Commission shall develop a plan to promote European SoHO autonomy and give recommendations to Member States to implement measures in this regard in their national plans, described in Article 61 (a). 2. The plan for a European autonomy proposed by the Commission shall be reviewed every 5 years. 3. The Commission shall work with Member States to promote public participation in SoHO donation activities, in particular with regard to critical SoHO, with a view of ensuring resilient supply and a significant increase in donation rates where risks of shortages are identified. In doing so, it shall encourage the collection of SoHO through strong public and non-profit sector participation.
Amendment 787 #
Proposal for a regulation
Article 63 – paragraph 1
Article 63 – paragraph 1
1. Critical SoHO entities shall without undue delay launch a SoHO supply alert to their competent authorities in case of a significant interruption, indicating the underlying reason, the expected impact on patients and any mitigating actions taken including possible alternative supply channels if appropriate. Interruptions shall be considered significant when the application of critical SoHO is cancelled or postponed due to unavailability and this poses a serious risk to human health.
Amendment 788 #
Proposal for a regulation
Article 63 – paragraph 1 a (new)
Article 63 – paragraph 1 a (new)
Amendment 790 #
Proposal for a regulation
Article 63 – paragraph 3
Article 63 – paragraph 3
3. The SoHO National Authorities mayshall submit to the EU SoHO Platform the SoHO supply alert received, especially in cases where the supply interruption might affect other Member States or where such interruption might be addressed through cooperation between Member States pursuant to Article 62(3), point (d).
Amendment 791 #
Proposal for a regulation
Article 64 – title
Article 64 – title
Derogation from the obligations to authorise SoHO preparations in public health emergency situations
Amendment 794 #
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 suppontinuity of SoHO supply, as well as in the national SoHO emergency plans to secure SoHO supply, especially 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.
Amendment 797 #
Proposal for a regulation
Article 65 a (new)
Article 65 a (new)
Article 65 a Plans to ensure continuity of supply to SOHO entities SoHO entities carrying out SoHO activities related to critical SoHOs shall have in place a plan to ensure continuity of supply of its own entity that supports the implementation of the national SoHO continuity of supply plan referred to in Article 61 (a).
Amendment 806 #
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 and observers to attend its meetings, and may cooperate with other external experts as appropriate, in order to ensure a multidisciplinary and diverse representation of stakeholders in the SoHO sector. Other Union institutions, bodies, offices and agencies shall have an observer role.
Amendment 812 #
Proposal for a regulation
Article 67 – paragraph 4
Article 67 – paragraph 4
4. The Commission shall chair the meetings ofBoard shall be co-chaired by a representative of the Commission and by one rotating representative of the Member States, who shall be elected by and from among the representatives of the Member States in the SCB. The chair shall not take part in votes of the SCB.
Amendment 814 #
Proposal for a regulation
Article 67 – paragraph 6 – point k a (new)
Article 67 – paragraph 6 – point k a (new)
(k a) make available to the public a summary of the topics discussed at the meetings.
Amendment 819 #
Proposal for a regulation
Article 68 – paragraph 1 – point a
Article 68 – paragraph 1 – point a
(a) in collaboration with other authorities designated in other relevant Union legislation, preparing opinions at the request of competent authorities in accordance with Article 14(2) first sub-paragraph1), on the regulatory status under this Regulation of a substance, product or activity and transmitting its opinions to the compendium;
Amendment 820 #
Proposal for a regulation
Article 68 – paragraph 1 – point b
Article 68 – paragraph 1 – point b
(b) when preparing the opinions referred to in point (a) of this paragraph, initiating, at Union level, a consultation with equivalent advisory bodies establishedparticipate in other relevant Union legislation in accordance with Article 14(2) second sub-paragraph, and including in the compendium the opinions concerning the Union legislation to be applied in cases where there is agreement with the equivalent advisory bodies Classification Advisory Council as defined in Article 68 (a);
Amendment 822 #
Proposal for a regulation
Article 68 – paragraph 1 – point d
Article 68 – paragraph 1 – point d
(d) recording information notified in accordance with Article 14(32), and including such information in the compendium;
Amendment 825 #
Proposal for a regulation
Article 68 – paragraph 1 – point g a (new)
Article 68 – paragraph 1 – point g a (new)
Amendment 826 #
Proposal for a regulation
Article 68 a (new)
Article 68 a (new)
Amendment 828 #
Proposal for a regulation
Article 69 – paragraph 1 – subparagraph 1
Article 69 – paragraph 1 – subparagraph 1
The Commission shall organise Union training in cooperation with the Member States concerned.
Amendment 832 #
Proposal for a regulation
Article 71 – paragraph 1
Article 71 – paragraph 1
The Commission shall establish and maintain cooperation with the EDQM in relation to the guidelines published by the EDQM. Such cooperation shall be based on the highest scientific standards, be proactive in identifying future needs and be transparent, involving the relevant stakeholders in consultations related to the development of the technical guidelines.
Amendment 837 #
Proposal for a regulation
Article 71 – paragraph 1 a (new)
Article 71 – paragraph 1 a (new)
The Commission shall evaluate the transparency in the procedures and development of the technical guidelines by the EDQM and their suitability to the needs and interests of the Member States.
Amendment 838 #
Proposal for a regulation
Article 72 – paragraph 1 – point a
Article 72 – paragraph 1 – point a
(a) providing secretariat and technical, scientific and logistic support to the SCB and its working groups and to the Classification Advisory Council;
Amendment 839 #
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
2. With regard to the support referred to in paragraph 1, point (a), the Commission shall, in particular, organise the meetings of the SCB and its working groups, the travel of members of the SCB, and of the Classification Advisory Council, the travel of members of the SCB and the Classification Advisory Council reimbursement and special allowances for scientific experts that participate in those meetings, and ensure the appropriate follow-up.
Amendment 840 #
Proposal for a regulation
Article 73 – paragraph 1
Article 73 – paragraph 1
1. The Commission shall establish, manage and maintain the EU SoHO Platform to facilitate effective and efficient exchange, registration and storage of information concerning SoHO activities in the Union, as provided for in this Regulation. To ensure optimal use of the EU SoHO Platform, the Commission shall:
Amendment 842 #
Proposal for a regulation
Article 73 – paragraph 1 – point a (new)
Article 73 – paragraph 1 – point a (new)
(a) develop the technical and functional specifications of the EU SoHO Platform, including the data exchange mechanism for the exchange with existing national systems and the format for electronic submission;
Amendment 843 #
Proposal for a regulation
Article 73 – paragraph 1 – point b (new)
Article 73 – paragraph 1 – point b (new)
Amendment 844 #
Proposal for a regulation
Article 73 – paragraph 1 – point c (new)
Article 73 – paragraph 1 – point c (new)
(c) develop relevant guidance for reporting through the EU SoHO Platform;
Amendment 845 #
Proposal for a regulation
Article 73 – paragraph 1 – point d (new)
Article 73 – paragraph 1 – point d (new)
(d) ensure data interoperability between the EU SoHO Platform, Member States’ IT systems and other relevant IT systems and databases, such as the EMA’s European Shortages Monitoring Platform or systems defined in the European Health Data Space, without duplication of reporting;
Amendment 846 #
(e) ensure that the Commission, national authorities and competent authorities, SoHO entities, SCB, ECDC, EMA, EDQM and other relevant bodies have adequate levels of access to the information contained in the EU SoHO Platform to carry out their tasks;
Amendment 847 #
Proposal for a regulation
Article 73 – paragraph 1 – point f (new)
Article 73 – paragraph 1 – point f (new)
(f) ensure that confidential information sent to the system is protected from unjustified disclosure;
Amendment 848 #
Proposal for a regulation
Article 73 – paragraph 1 – point g (new)
Article 73 – paragraph 1 – point g (new)
(g) ensure that the EU SoHO Platform is fully operational at the latest 2 years after the entry into force of this Regulation, and develop an implementation plan for the Platform.
Amendment 849 #
Proposal for a regulation
Article 73 – paragraph 1 a (new)
Article 73 – paragraph 1 a (new)
1 a. Information collected through the EU SoHO Platform on SoHO shortage alerts, SoHO shortages and demand trends, cross-border SoHO requests and resolutions, or import and export of SoHO to third countries outside the EU will be used for the monitoring, prevention and management of SoHO shortages in the EU, as well as to enhance the EU SoHO autonomy, as part of the plan defined in Article 62 (a).
Amendment 851 #
Proposal for a regulation
Article 74 – paragraph 2
Article 74 – paragraph 2
2. The EU SoHO platform shall also provide a secure environment for the exchange of information between competent authorities and, the Commission and the EMA, the ECDC, the SCB and EDQM, in particular in relation to SAO and rapid alerts. It shall also provide public access to information regarding the registration and authorisation status of SoHO entities and shall indicate the applicable guidelines to be followed to meet the technical standards laid down in Articles 56 and 59.
Amendment 852 #
Proposal for a regulation
Article 74 – paragraph 2 a (new)
Article 74 – paragraph 2 a (new)
2 a. The EU SoHO Platform shall also be the main intermediary for reporting SoHO shortages and for cross-border requests of SoHO. National authorities shall issue and receive shortage alerts that cannot be resolved at Member State level, as well as SoHO cross-border requests and shall be able to respond to them. National authorities, aware of the national availability of SoHO, as referred to in Article 34(a), shall use the EU SoHO Platform to report any SoHO shortages that may lead to a public health emergency or severe ocurrence.
Amendment 853 #
Proposal for a regulation
Article 74 – paragraph 2 b (new)
Article 74 – paragraph 2 b (new)
2 b. In the event of a SoHO-related health emergency or for the purpose of preventing potential threats, alerts issued through the EU SoHO Platform shall allow for rapid situational awareness by the Commission, competent authorities and other relevant bodies so that action can be taken as soon as possible as set out in Regulation (EU) 2022/2371 on serious cross-border threats to health.
Amendment 854 #
Proposal for a regulation
Article 74 – paragraph 2 c (new)
Article 74 – paragraph 2 c (new)
2 c. It shall also provide public access to information regarding the registration and authorisation status of SoHO entities and shall indicate the applicable guidelines to be followed to meet the technical standards laid down in Articles 56 and 59.
Amendment 855 #
Proposal for a regulation
Article 74 – paragraph 2 d (new)
Article 74 – paragraph 2 d (new)
2 d. The EU SoHO Platform shall contain a record of clinical studies with SoHO and their results, as referred to in Article 36 (a).