60 Amendments of Susana SOLÍS PÉREZ related to 2022/0216(COD)
Amendment 135 #
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. When SoHOs qualify or are used in medicinal products regulated by EU legislations mentioned above, only the provisions of this Regulation related to donor protection should be applicable.The criteria that define when SoHOs or SOHO preparations becomareproducts regulated under other Union legislation are not defined in this Regulation but are defined in those other acts. In addition, 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 140 #
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 and (EU) No 536/2014, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, 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 151 #
Proposal for a regulation
Recital 13
Recital 13
(13) Given the special nature of SoHOs, resulting from their human origin, and the increasing demands for these substances for human application or for the manufacture of products regulated by other Union legislation, or as the starting and raw material thereof, it is necessary to ensure a high level of health protection for donors as well as for recipients. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue as a result of the donation. This Regulation should therefore includeaddress principles and technical rules to monitor and protect donors. As different types of donation imply different risks for donors, with varying levels of significance, the monitoring of donor health should be proportionate to those levels of risk. This is particularly important when donation involves some risk to the donor’s health due to a need for pre-treatment with medicinal products, a medical intervention to collect the substance or a need for donors to donate repeatedly. Donations of oocytes, bone marrow, peripheral blood stem cells and plasma should be considered to imply a significant riske respective risk-classifications shall be defined in the respective guidelines.
Amendment 167 #
Proposal for a regulation
Recital 15
Recital 15
(15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law. Member States should notify the Commission of any such measures. More stringent protective measures put in place by Member States should be evidence- based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and the means of achieving that aim are science-based, appropriate and necessary.
Amendment 168 #
Proposal for a regulation
Recital 15 a (new)
Recital 15 a (new)
Amendment 181 #
Proposal for a regulation
Recital 18
Recital 18
(18) As a matter of principle, programmes promoting the donation of SoHOs should be founded on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient. Voluntary and unpaid SoHO donation is also a factor which can contribute to high safety standards for SoHOs and therefore to the protection of human health. It is also recognised, including by the Council of Europe Committee on Bioethics24, that while financial gain should be avoided, it may also be necessary to ensure that donors are not financially disadvantaged by their donation. Thus, compensation to remove any such risk is acceptable but should never constitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate more frequently than is allowed, posing risks to their own health and to that of prospective recipients. Such compensation should, therefore, be set by national authorities, at a level appropriate in their Member State to reach such objectives. _________________ 24 Council of Europe Committee on Bioethics (DH-BIO). Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors (March 2018). Available at https://rm.coe.int/guide-financial- gain/16807bfc9a.
Amendment 198 #
Proposal for a regulation
Recital 24
Recital 24
(24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult with the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, medical devices, organs or food, with the aim of ensuring coherent procedures for the application of this Regulation. Competent authorities and other relevant EU legislations. When SoHOs or SoHO preparations meet the criteria to be defined as a medicinal products or an advanced therapy medicinal product, the classification as medicinal product or as advanced therapy medicinal product should prevail. National authority should inform the SoHO Coordination Board of the outcome of their consultations. When SoHOs or SoHO preparations are used to manufacture products regulated under other Union legislation, or as the starting and raw material thereof, competent authorities should cooperate with the relevant authorities on their territory. This cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for SoHO and for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHOs or the product manufactured from SoHOs. It should in principle be the responsibility of the Member States to decide on a case- by-case basis on the regulatory status of a substance, product or activity. However, in order to ensure consistent decisions across all Member States with regard to borderline cases, the Commission should be empowered to, on its own initiative or at the duly substantiated request of a Member State, decide on the regulatory status of a particular substance, product or activity under this Regulation. In case of doubt on the classification of a substance, product or activity as medicinal product, the Commission should consult the permanent panel composed of representatives of the European Medicine Agency and the SoHO Coordination Board (SCB) for advice and to implement the classification decision taken by the panel across all EU Member States.
Amendment 211 #
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. 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. In case the standard treatment or control group is based on medcinal products, the studies are considered as clinical trials as defined and regulated by Regulation 536/2014. The competent authority should approve the plans before they are implemented and should assess the outcome data as part of a SoHO preparation authorisation.
Amendment 218 #
Proposal for a regulation
Recital 30
Recital 30
(30) In order to facilitate innovation and reduce administrative burden, competent authorities shouldmust share with each other information on the authorisation of new SoHO preparations and the evidence used for such authorisations, including for the validation of certified medical devices used for SoHO collection, processing, storage or application to patients. Such sharing could allow authorities to accept previous authorisations granted to other entities, including in other Member States and to thus significantly reduce the requirements to generate evidence.
Amendment 224 #
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 based on scientific evidence for implementing the standards set out in this Regulation. As part of that hierarchy, in the absence of Union legislation describing particular procedures to be applied and followed to meet the standards set out in this Regulation, following the guidelines of the European Centre for Disease Prevention and Control (ECDC) and the EDQM should be considered as ae of the means to demonstrate compliance with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines achieve the same level of quality, safety and efficacy. In cases of detailed technical issues for which neither Union legislation nor the ECDC and the EDQM have defined a technical guideline or rule, operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.
Amendment 225 #
Proposal for a regulation
Recital 33
Recital 33
(33) With regards to standards concerning donor, recipient and offspring protection, this Regulation should provide for a hierarchy of rules for their implementation. As risks and technologies change, this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines for implementing the standards set out in this Regulation. As part of that hierarchy, in the absence of Union legislation describing particular procedures to be applied and followed to meet the standards set out in this Regulation, following the guidelines of the European Centre for Disease Prevention and Control (ECDC) and the EDQM should be considered as ae of the means to demonstrate compliance with the standards laid down in this Regulation to ensure high level of quality, safety and efficacy. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines achieve the same level of quality, safety and efficacy. In cases of detailed technical issues for which neither Union legislation nor the ECDC and the EDQM have defined a technical guideline or rule, operators should apply a locally defined rule that is in line with relevant internationally recognised guidelines and scientific evidence and is appropriate to mitigate any risk identified.
Amendment 237 #
Proposal for a regulation
Recital 36
Recital 36
(36) The ECDC, established by Regulation (EC) No 851/2004 of the European Parliament and of the Council27, is a Union agency with the mission of strengthening Europe's defences against communicable diseases. The work of the ECDC on developing and updating guidelines on safety andqua,quality and susainability of SoHOs from a communicable disease threat perspective, should be considered an important contribution in the field of SoHOs in the Union and should be reflected in this Regulation. In addition, the ECDC established an expert network for the Microbial Safety of SoHOs, which ensures the implementation of the requirements on the ECDC’s relations with the Union Member States and EEA Member States stated in Regulation (EC) No 851/2004, regarding strategic and operational collaboration on technical and scientific issues, surveillance, responses to health threats, scientific opinions, scientific and technical assistance, collection of data, identification of emerging health threats, and public information campaigns related to the safety of SoHOs. This SoHO expert network should provide information or advice in relation to relevant outbreaks of communicable diseases, in particular regarding the eligibility and testing of donors and the investigation of serious adverse occurrences involving suspected transmission of a communicable disease. _________________ 27 Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004, establishing a European centre for disease prevention and control (OJ L 142, 30.4.2004, p. 1).
Amendment 255 #
Proposal for a regulation
Recital 37
Recital 37
(37) It is necessary to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to help European citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. As there is a need to ensure the availability of SoHOs for medical treatments, Member States should promote the donation of SoHOs, including plasma, of high quality and safety, thereby also increasing self- sufficiency in the Union. Member States are also urged to take steps to strongly encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.
Amendment 262 #
Proposal for a regulation
Recital 37 a (new)
Recital 37 a (new)
(37 a) To ensure the capacity to better collect more plasma, Member States are encouraged to develop or strengthen their respective plasmapheresis programs. The Commission shall aid them through guidance and the exchange of best practices.
Amendment 268 #
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 agencies and bodies such as the ECDC and the EDQM and existing professional, scientific and donor and patient representative groups at Union level in the field of SoHOs. , the EMA, the Health Emergency Preparedness and Response Authority (HERA) established as a Commission service by Commission Decision of 16 September 2021 and the EDQM and existing professional, scientific and donor and patient representative groups at Union level in the field of SoHOs. Other Union institutions, bodies, offices and agencies should have an observer role. A representative designated by the European Parliament should be able to participate in the SoHO Coordination Board (SCB) as an observer. All members of the SCB should provide declarations of interest.
Amendment 275 #
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. In case a product could be classified both as SoHO or SoHO preparation and medicinal product, the classification as medicinal product should prevail.The SCB should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHOs. The SCB should keep a compendium of the opinions issued by the SCB or the competent authorities and of decisions made at Member State level, so that competent authorities considering the regulatory status under this Regulation of a particular substance, product or activity may inform their decision-making process by referring to that compendium. The SCB should also document agreed best practices to support a common Union approach. It should also cooperate with similar Union level bodies established in other Union legislation with a view to facilitating coordinated and coherent application of this Regulation between Member States and across bordering legislative frameworks. These measures should promote a coherent cross-sectoral approach, ensure high protection of public health, and facilitate SoHO innovation.
Amendment 279 #
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. The EU SoHO Platform might also be utilized by Member States as a channel for national initiatives and campaigns to encourage the exchange of best practices. Said national campaigns and campaigns shall, in close cooperation with patient organizations, aim to promote donation and sustainable supplies of SoHO products.
Amendment 285 #
Proposal for a regulation
Recital 42
Recital 42
(42) The processing of personal data under this Regulation should be subject to strict guarantees of confidentiality and should comply with the rules on the protection of personal data laid down in Regulation (EU) 2016/679 of the European Parliament and of the Council and in Regulation (EU) 2018/1725 of the European Parliament and of the Council . The Commission may also decide that information on SoHO donations are added to donors Electronic Health Records (EHRs).
Amendment 289 #
Proposal for a regulation
Recital 43
Recital 43
(43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform should, once it is established, be granted within the framework of the European Health Data Space and otherwise be limited to the extent necessary to carry out supervisory activities provided for in this Regulation.
Amendment 301 #
Proposal for a regulation
Recital 46
Recital 46
(46) In order to enable better access to health data in the interests of public health, Member States should entrust competent authorities as data controllers within the meaning of Regulation (EU) 2016/679 with powers to take decisions on the access to and re-use of such data. Furthermore, access to secondary data for reseach purposes should be made available via the European Health Data Space, once it is established.
Amendment 311 #
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. This Regulation is without prejudice to national legislation which establishes rules relating to aspects of SoHOs other than their efficacy, quality and safety and the safety of SoHO donors.
Amendment 313 #
Proposal for a regulation
Article 2 – paragraph 1 – introductory part
Article 2 – paragraph 1 – introductory part
1. This Regulation shall apply to SoHOs intended for human application, to SoHO preparations, to products manufactured from SoHOs and intended for human application, to SoHO donors and recipients, and to the following SoHO activities that have a direct impact on the safety, quality or efficacy of SoHOs :
Amendment 315 #
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) SoHO donor recruitment; except if the entity is not subject to further SoHO activites as listed in this paragraph.
Amendment 322 #
Proposal for a regulation
Article 2 – paragraph 2 – introductory part
Article 2 – paragraph 2 – introductory part
2. In cases of autologous use of SoHOs, with the exception of processes involving a substantial manipulation or application intended for a non- homologous use, where:
Amendment 327 #
Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 1
Article 2 – paragraph 3 – subparagraph 1
For SoHOs that are used to manufacture products in accordance with Union legislation on medical devices, regulated by Regulation (EU) 2017/745, on medicinal products, regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007, on investigational medicinal products regulated by Regulation 536/2014, or on food, regulated by Regulation (EC) No 1925/2006, or as the starting and raw material thereof, the provisions of this Regulation applicable to the activities of SoHO donor recruitment, donor history review and eligibility assessment, testing of donors for eligibility or matching purposes, and collection of SoHOs from donors or patients shall apply. Insofar as the activities of SoHO release, distribution, import and export relate to SoHOs prior to their distribution to an operator regulated by the other Union legislation referred to in this subparagraph, the provisions of this Regulation shall also apply.
Amendment 330 #
Proposal for a regulation
Article 2 – paragraph 3 – subparagraph 2
Article 2 – paragraph 3 – subparagraph 2
By way of derogation from the first subparagraph, in cases where SoHOs, SoHO preparations, or products manufactured from SoHO, as referred to in that subparagraph, are exclusively for autologous use, only those provisions of this Regulation that concern the collection and testing of SoHOs from patients shall apply.
Amendment 334 #
Proposal for a regulation
Article 3 – paragraph 1 – point 1
Article 3 – paragraph 1 – point 1
(1) ‘“blood’ means the liquid that circulates in arteries and veins carrying oxygen to and carbon dioxide from the tissues of the bodywhole blood collected from a donor and processed either for transfusion or for further manufacturing;
Amendment 335 #
Proposal for a regulation
Article 3 – paragraph 1 – point 3
Article 3 – paragraph 1 – point 3
(3) ‘cell’ means a mass of cytoplasm with or without a nucleus,A typical cell is the smallest unit of an organism that ihas bound externally by a cell membrane. Usually microscopic in size, cells are the smallest structural and functional unit of an organism;een generated directly through mitosis. A cell comprises a nucleus (eukaryotic cells) or nucleoid material (prokaryotic cells) and cytoplasma enclosed by a cell membrane.
Amendment 336 #
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, medicinal products regulated by Regulation (EC) No 726/2004 and Directive 2001/83/EC and investigational medicinal products regulated by Regulation (EC) No 536/2014;
Amendment 345 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8
Article 3 – paragraph 1 – point 8
(8) ‘SoHO donor’ means any person who has presented themselves to a SoHO entity with a view to making a donation of SoHOsliving SoHO donor or deceased SoHO donor, whether that donation is successful or not;
Amendment 350 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 a (new)
Article 3 – paragraph 1 – point 8 a (new)
(8 a) ‘Living SoHO donor’ means any living person who has presented themselves to a SoHO entity with a view to making a donation of SoHOs either for autologous use or for allogeneic use.
Amendment 353 #
Proposal for a regulation
Article 3 – paragraph 1 – point 8 b (new)
Article 3 – paragraph 1 – point 8 b (new)
(8 b) ‘Deceased SoHO donor’ means any deceased person who donates SoHO after death.
Amendment 369 #
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) does not involve a substantial manipulation or is intended for a non- homologous application.
Amendment 379 #
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 with the exception of activities requiring substantial manipulation;
Amendment 380 #
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 packagingdifferent steps of preparation processes of SoHOs;
Amendment 410 #
Proposal for a regulation
Article 3 – paragraph 1 – point 31
Article 3 – paragraph 1 – point 31
(31) ‘EU SoHO Platform’ means the digital platform established by the Commission to exchange information concerning SoHO activities which should be interoperable with existing and upcoming frameworks;
Amendment 413 #
Proposal for a regulation
Article 3 – paragraph 1 – point 34 a (new)
Article 3 – paragraph 1 – point 34 a (new)
(34 a) "Quality risk management system" : means a systematic process for the assessment, control, communication and review of the quality risks of a SoHo or SoHO preparation throughout its life cycle;
Amendment 431 #
Proposal for a regulation
Article 3 – paragraph 1 – point 60
Article 3 – paragraph 1 – point 60
(60) ‘Annual SoHO Activity Report’ means the annual report published by the Commission aggregating the data reports from SoHO entities carrying out the following activities: donor recruitment, collection, storage, distribution, import, export and human application of SoHOs;
Amendment 442 #
Proposal for a regulation
Article 3 – paragraph 1 – point 64
Article 3 – paragraph 1 – point 64
(64) ‘compensation’ means making good of any lossexpenses and inconveniences associated with donation;
Amendment 483 #
Proposal for a regulation
Article 5 – paragraph 3 – point c
Article 5 – paragraph 3 – point c
(c) have sufficient resources, operational capacity, and subject matter expertise to achieve the aims of, and fulfil their obligations under, this Regulation;
Amendment 504 #
Proposal for a regulation
Article 14 – paragraph 2 – subparagraph 2 a (new)
Article 14 – paragraph 2 – subparagraph 2 a (new)
2 a.In deviation from paragraphs 1 and 2, the following procedure shall apply when a substance or product may possibly be considered a medicinal product: (a) The question shall automatically be referred to the EMA and the SCB and the full dossier shall be made available. (b) The EMA and the SCB shall establish a permanent panel for reviewing such questions.The panel shall, where relevant, also consult other authorities mentioned in paragraph 1, such as the Medical Devices Coordination Group. (c) The panel shall seek to reach an opinion by consensus.An opinion adopted by consensus shall be implemented by the competent authorities.If no consensus can be reached, the question shall be referred to the Commission for a decision in accordance with paragraph 4. The members of the panel shall be appointed by the EMA and the SCB based on their specific expertise, including for the EMA in particular expertise in the area of advanced therapy medicinal products. The EMA shall ensure the secretariat of the panel and collaborate with the SCB in maintaining the compendium.
Amendment 508 #
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 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), or in accordance with paragraph 2a (c).
Amendment 511 #
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, or in the case of paragraph 2a, the EMA.
Amendment 514 #
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). The Commission may also lay down rules concerning the procedure referred to in paragraph 2a and the operation of the permanent panel in coherence with the specific provisions foreseen in Regulation (EC) 726/2004, Directive 2001/83/EC and Regulation (EU) 2017/745.
Amendment 541 #
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. Competent authoritiesThe SoHO coordination Board shall provide guidelines and templates to allow that applications from SoHO entities for their authorisation as SoHO establishments are submitted in accordance with Article 49. When developing these guidelines and templates, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).
Amendment 550 #
Proposal for a regulation
Article 28 – paragraph 1
Article 28 – paragraph 1
1. Competent authoritiesThe SoHO Coordination Board shall provide guidelines and templates to allow that applications from SoHO entities for their authorisation as importing SoHO entities are submitted in accordance with Article 43. In developing these guidelines and templates, competent authorities shall consult the relevant best practices agreed and documented by the SCB as referred to in Article 68(1), point (c).
Amendment 587 #
Proposal for a regulation
Article 43 – paragraph 4
Article 43 – paragraph 4
4. The importing SoHO entity authorisation holder shall be based in the Union, and be responsible for the physical reception and visual examination and verification of imported SoHOs prior to their release. The importing SoHO entity shall verify coherence between the SoHO received and the associated documentation and conduct an examination of the integrity of packaging and the compliance of labelling and transport conditions with the relevant standards and technical guidelines as referred to in Articles 57, 58 and 59. The importing SoHO entity shall make sure and certify that the imported SoHOs are of equivalent quality to what is required by European regulations.
Amendment 617 #
Proposal for a regulation
Article 53 – paragraph 1 – point j
Article 53 – paragraph 1 – point j
(j) for donations referred to in paragraph 3, verify, by means of ainterconnected registryies, that donors are not donating more frequently than indicated as safe in technical guidelines as referred to in Article 56 and demonstrate that their health is not compromised;
Amendment 621 #
Proposal for a regulation
Article 53 – paragraph 1 – point k
Article 53 – paragraph 1 – point k
(k) develop and implement a plan for monitoring the donor’s health after the donation in cases where the SoHO donations imply a significant risk to a donor as referred to in paragraph 3;
Amendment 636 #
Proposal for a regulation
Article 54 – paragraph 2
Article 54 – paragraph 2
2. Member States may allow for the compensation or reimbursement from the SoHO entities to donors for lossexpenses and inconveniences related to their participation in donations, for example, through fixed rate allowances. In such case, Member States shall establish the conditions for such allowances in national legislation, including the setting of an upper limit that ensures that allowances are financially neutral and consistent with the standards laid down in this Article. They may delegate the setting of conditions for such allowances to independent bodies that are established in accordance with national legislation.
Amendment 665 #
Proposal for a regulation
Article 56 – paragraph 4 – point a – introductory part
Article 56 – paragraph 4 – point a – introductory part
(a) the most recent technical guidelines, established through a transparent and comprehensive consultation process with a broad selection of stakeholders based on latest scientific knowledge and relevant expertise , and as indicated on the EU SoHO Platform referred to in Chapter XI, as follows:
Amendment 670 #
Proposal for a regulation
Article 56 – paragraph 5
Article 56 – paragraph 5
5. In those cases referred to in paragraph 4, point (a) and (b), for the purpose of Article 30 in conjunction with Article 29, SoHO entities shall be able to demonstrate to their competent authorities, for each of the standards or elements thereof, which and to what extent they follow the respective guidelines referred to in paragraph 4, point (a) and point (b).
Amendment 672 #
Proposal for a regulation
Article 56 – paragraph 6
Article 56 – paragraph 6
Amendment 725 #
Proposal for a regulation
Article 58 – paragraph 10 – point a
Article 58 – paragraph 10 – point a
(a) apply SoHO preparations to recipients without proven benefit, except in the context of a clinical investigation approved in the context of a conditional authorisation of the SoHO preparation by their competent authority pursuant to Article 41(4) or compassionate use and experimental therapy as described in Article 61;
Amendment 784 #
Proposal for a regulation
Article 62 a (new)
Article 62 a (new)
Article 62 a European autonomy in the supply of SoHO The Commission shall, within two years of the entry into force of this Regulation, publish a strategy for promoting increased European autonomy in the provision of SoHOs. The strategy shall contain specific objectives and an accompanying calendar to be defined jointly by the European Commission in consultation with relevant national authorities, the European Parliament and relevant proffessional, scientific, industry, donor and patient representative groups.
Amendment 785 #
Proposal for a regulation
Article 62 a (new)
Article 62 a (new)
Article 62 a Public Service Obligation SoHO entities collecting or processing blood or blood components in a Member State are, within the limits of their responsibilities, obliged to ensure an appropriate and continuous supply of these SoHOs and SoHO preparations in that Member State in order to meet the needs of patients.
Amendment 802 #
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. Other Union institutions, agencies, bodies, offices and agencior services shall have an observer role. The European Parliament shall designate a technical representative to participate in the SoHO Coordination Board as an observer.
Amendment 809 #
Proposal for a regulation
Article 67 – paragraph 3
Article 67 – paragraph 3
3. Member States shall submit the names and affiliation of their nominated members to the Commission, who shall publish the membership list in the EU SoHO Platform. The list setting out the authorities, organisations or bodies to which the SoHO Coordination Board participants belong shall be published on the Commission's website.
Amendment 817 #
Proposal for a regulation
Article 67 – paragraph 7 a (new)
Article 67 – paragraph 7 a (new)
7 a. The rules of procedure, guidance, agendas and minutes of the meetings of the the SoHO Coordination Board shall be published on the Commission's website unless such publication undermines the protection of a public or private interest, as defined in Article 4 of Regulation (EC) No 1049/2001.
Amendment 821 #
Proposal for a regulation
Article 68 – paragraph 1 – point b a (new)
Article 68 – paragraph 1 – point b a (new)
(b a) participating in the permanent panel referred to in Article 14(2 a) and in the procedure referred to in that paragraph.