Changes from report parliamentary committee draft to plenary report

RemovedArticle 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. It ensures a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring from medically assisted reproduction, and strengthens the continuity of supply of such substances. 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.

AddedRecital 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, quality and sustainability of SoHOs from a communicable disease threat perspective, should be considered an important contribution in the field of SoHOs in the Union and should be reflected in this Regulation. In addition, the ECDC established an expert network for the Microbial Safety of SoHOs, which ensures the implementation of the requirements on the ECDC’s relations with the Union Member States and EEA Member States stated in Regulation (EC) No 851/2004, regarding transparent strategic and operational collaboration on technical and scientific issues, surveillance, responses to health threats, scientific opinions, scientific and technical assistance, collection of data, identification of emerging health threats, and public information campaigns related to the safety of SoHOs. This SoHO expert network should provide information or advice in relation to relevant outbreaks of communicable diseases, including those exacerbated by climate change, in particular regarding the eligibility and testing of donors and the investigation of serious adverse occurrences involving suspected transmission of a communicable disease.

AddedRecital 37: (37) It is necessary and beneficial to all parties to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to ensure the broadest possible donor base, with a view to ensuring a more resilient supply system, and 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 and equal access to SoHOs for medical treatments, Member States and the Union should support the establishment of public donation facilities and promote the voluntary and unpaid donation of SoHOs of high quality and safety with a view to increasing the collection capacity and autonomy in the Union. Member States are also urged to take steps to encourage a strong involvement of all relevant sectors, in particular the public and non-profit sector, in the provision of SoHO services, in particular for critical SoHOs and the related research and development.

AddedRecital 37 a (new): (37a) The COVID-19 pandemic can be considered one of the biggest health crises to affect Europe. It had adverse effects on the resilience of the donor base in some countries whose collection systems rely on a small number of donors donating more frequently than elsewhere. This crisis highlighted the vulnerabilities of the Union in very different aspects, ranging from the lack of coordination between Member States, which is essential to addressing such situations, to the Union’s strong dependence on third countries for the production and supply of raw materials and active substances needed for the elaboration of medical treatments. In the case of SoHOs, the pandemic drastically reduced the number of donors and exports from third countries, putting the Union in a situation of shortages of some SoHOs and patients at serious risk due to a lack of adequate treatments. In this context, the initiatives for a strong European Health Union should work in favour of European autonomy, in particular as regards the supply of SoHOs and the ability to minimise the risk of shortages, especially of SoHOs for therapeutic use. The lessons learned and the resulting measures taken at Union level should serve as a reference for the prevention, detection and resolution of future health crises. Regulation (EU) 2022/2371 of the European Parliament and of the Council1a lays down the guidelines to be followed for that purpose. To increase European autonomy in terms of SoHOs, Member States should be urge…

AddedRecital 37 b (new): (37b) In order to ensure autonomy and sustainability of supply of SoHOs, Member States should establish national SoHO emergency and continuity of supply plans setting out measures for cases where the supply situation for critical SoHOs presents or is likely to present a serious risk to human health. Such plans should include measures, including optimisation of use, that impact demand for critical SoHOs, targets to ensure autonomy of supply of critical SoHOs, donor recruitment and retainment strategies and arrangements for cooperation between competent authorities, experts and relevant stakeholders. National SoHO emergency and continuity of supply plans should be further supplemented by the strategy for the promotion of European autonomy in terms of SoHO supply and the SoHO entity emergency and continuity of supply plans, primarily focusing on supply monitoring, reporting obligations and sharing of best practices within the Union. Moreover, Member States should be encouraged to establish certain areas, such as transfusion medicine, as an independent medical subject with structured training, including medical specialisation schools and programmes for continuous medical education for all medical staff. Providing training and better information for the prescribers would reduce the risk of unnecessary application of SoHOs. Furthermore, as recommended by the World Health Organization, Member States should additionally support optimal clinical use of SoHOs, in particular where there…

AddedRecital 37 c (new): (37c) In cases where the availability of SoHO preparations or SoHO-derived products depends on potential commercial interests, such as some plasma-derived products, there is a risk of not having the interests of patients and research at the forefront. There could even be situations in which some products with low profitability are no longer produced, thereby 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 voluntary and unpaid donations, should be fair and transparent. For certain products with low profitability, Member States should encourage research and innovation and should ensure that such products continue to be manufactured.

AddedRecital 38: (38) In order to promote a coordinated and coherent 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 European Medicines Agency (EMA). The European Parliament, the EDQM and existing professional, scientific experts and donor and recipient patient representative groups and stakeholders at Union level in the field of SoHOs could also be invited. Other Union institutions, including the European Parliament, expert bodies, offices and agencies such as the EMA, ECDC and the EDQM, should have an observer role. All members of the SCB should provide declarations of interest, adhering to a high degree of transparency concerning its outputs. Members of the SCB, observers and experts should act independently, in the public interest and be free from…

AddedRecital 39: (39) Some substances, products or activities have been subject to different legal frameworks with different requirements in the Member States. This can sometimes cause confusion among operators in the field, and the consequent legal uncertainty can be a disincentive to professionals to develop new ways to prepare and use SoHOs. The SCB should receive on an ongoing basis relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHOs. The SCB should monitor those opinions in order to react quickly and in an informed manner to further requests for opinions from other Member States, 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 a high level of protection of public health, and facilitate SoHO innovation.

AddedRecital 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, to make it possible to share the elements used to determine the regulatory status of a substance, to improve the transparency of national reporting and supervisory activities and ensure better communication, collaboration and coordination in relation to, and exchange of, SoHOs between Member States. The national competent authorities should be encouraged to use the EU SoHO Platform instead of maintaining national registers, in particular to limit the administrative burden. Member States should also be able to utilize the EU SoHO Platform as a channel for national initiatives and campaigns to encourage the exchange of best practices. Such national initiatives and campaigns should be established in close cooperation with patient organisations, and aim to promote the need to maintain sustainable supplies of SoHO products. The EU SoHO Platform should also serve as a reliable source of information for the general public regarding the work of the SCB, national competent authorities and other expert bodies, including the EDQM, and SoHO entities and establishments. The online platform could be further used for the sharing of best practices between Member States with regard to initiatives, such as campaigns, to support the supply of SoHOs.

AddedRecital 43: (43) As the EU SoHO Platform requires the processing of personal data, it will be designed respecting the principles of data protection laid down in Article 5 of Regulation (EU) 2016/679. Any processing of personal data should be limited to achieving the objectives and obligations of this Regulation. Access to the EU SoHO Platform should be limited to the extent necessary to carry out supervisory activities provided for in this Regulation.

AddedRecital 44: (44) This Regulation respects the fundamental rights and observes the principles recognised in particular by the Charter of Fundamental Rights of the European Union and in particular human dignity, the integrity of the person and the prohibition of making the human body and its parts a source of financial gain, the protection of natural persons with regard to the processing of their 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 and criteria of compatibility between donors and recipients, 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 …

AddedRecital 44 a (new): (44a) Due to the high sensitivity of donor anonymity and taking into account the rights of offspring from medically assisted reproduction following third party donation, SoHO entities should ensure donors and recipients of reproductive cells are duly informed about the possibility of ID release and the implications thereof, pursuant to provisions laid down in national legislation.

AddedRecital 45: (45) SoHOs, by definition, relate to natural 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, 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 processed in pseudonymised or anonymised form, as appropriate in each case. Donors, 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) 201…

AddedRecital 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 research purposes should be provided via the European Health Data Space, once it is established.

AddedRecital 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 the optimal timeframe. This Regulation should serve to increase coordination between Member States and facilitate the cross-border exchange of SoHOs.

AddedRecital 47 a (new): (47a) The objectives of this Regulation, namely to ensure that SoHOs are of high quality and safe and to provide a high level of protection for donors, need 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 those objectives. Member States in turn should enhance education and provide appropriate training for medical personnel regarding SoHO collection, processing, storage, application, transfusion and procurement.

AddedRecital 47 b (new): (47b) In some cases, such as bone marrow or haematopoietic stem cell transplants, the level of donor/recipient compatibility has to be extremely high. Therefore, coordination is needed at a global level, so that each patient has as many options as possible as regards finding a compatible donor.

AddedArticle 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. It ensures a high level of human health protection, in particular for SoHO donors, SoHO recipients and offspring from medically assisted reproduction and serves to strengthen the continuity of supply of SoHOs. 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, SoHO recipients and offspring from medically assisted reproduction.

AddedArticle 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, SoHO recipients and offspring from medically assisted reproduction, and to the following SoHO activities:

AddedArticle 2 – paragraph 1 – point a: (a) SoHO donor recruitment, except if that is the sole SoHO activity of the entity in which case only Article 54(3b) shall apply;

Article 2 – paragraph 1 – point h a (new): (ha) issuing of SoHOs;

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ChangedArticle 2 – paragraph 1 – point m a (new): (ma) exchange of information on availability and stocks, and promotion of actions relating to the security of SoHO supply;clinical studies.

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RemovedArticle 2 – paragraph 1 – point m b (new): (mb) coordination of the competent authorities with the Commission and EU agencies in the event of the emergence of a disease transmissible via SoHOs.

AddedArticle 2 – paragraph 1 a (new): 1a. Articles 53, 54, 55 and 56 shall apply also to SoHO donations intended for research.

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ChangedArticle 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 (EU) No 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, collection of SoHOs from donors or patientspatients, quality control testing of SoHOs, and the continuity of supply of these substancesSoHOs, 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.

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RemovedArticle 3 – paragraph 1 – point 8: 8) ‘SoHO donor’ means any person living or dead under the care of a SoHO entity for the purposes of making a donation of SoHOs; the person providing sperm for use within the couple shall not deemed to be a donor of SoHOs, but rather a partner;

AddedArticle 2 – paragraph 4 a (new): 4a. This Regulation also establishes provisions on: / (a) exchange of information on availability and stocks of SoHOs, and promotion of actions relating to the security of SoHO supply; / (b) coordination between competent authorities and the Commission and Union agencies in the event of SoHO-related health emergencies.

AddedArticle 2 – paragraph 4 b (new): 4b. This Regulation does not apply to breast milk that is expressed by a mother solely for the purpose of feeding her own child.

AddedArticle 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 body and its constituent parts;

AddedArticle 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 includes substances which can be extracted from them;

AddedArticle 3 – paragraph 1 – point 7: (7) ‘SoHO activity’ means an action, or series of actions, that has a direct impact on the safety, quality, efficacy or functionality of SoHOs, as listed in Article 2(1);

AddedArticle 3 – paragraph 1 – point 7 a (new): (7a) ‘SoHO donation’ means a process by which a person voluntarily and altruistically gives SoHOs from their own body to people in need, or authorises their use after their death; it includes the necessary medical formalities, examination and treatments and monitoring of the SoHO donor, irrespective of whether that donation is successful or not; it also includes when consent is given by an authorised person in accordance with national legislation;

AddedArticle 3 – paragraph 1 – point 8: (8) ‘SoHO donor’ means a living or deceased SoHO donor;

AddedArticle 3 – paragraph 1 – point 8 a (new): (8a) ‘living SoHO donor’ means a living person who has presented themselves to a SoHO entity, or has been presented by a person granting consent on their behalf, in accordance with national legislation, with a view to making a SoHO donation, except donors of SoHOs for reproduction within relationship use;

AddedArticle 3 – paragraph 1 – point 8 b (new): (8b) ‘deceased SoHO donor’ means a deceased person who has been referred to a SoHO entity and for whom consent or authorisation, or an absence of express refusal, to donation is in place, in accordance with national legislation;

AddedArticle 3 – paragraph 1 – point 9: (9) ‘SoHO recipient’ means the person to whom SoHOs are applied or for whom such an application is envisaged;

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 involves the use of SoHOs;

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RemovedArticle 3 – paragraph 1 – point 13: (13) ‘donor recruitment’ means any activity aimed at informing persons about activities related to the donation of SoHOs or encouraging them to donate;

AddedArticle 3 – paragraph 1 – point 11: (11) ‘offspring from medically assisted reproduction’ means children that are born following medically assisted reproduction;

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ChangedArticle 3 – paragraph 1 – point 17:11 (17)a ‘storage’(new): means(11a) the‘unborn maintenanceoffspring offrom SoHOsmedically underassisted appropriatereproduction’ controlledmeans conditionsembryos untiland distributionfoetuses orconceived issuing;by medically assisted reproduction;

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AddedArticle 3 – paragraph 1 – point 12 – point a: (a) has been subjected to processing and, where relevant, one or more other SoHO activities in accordance with defined quality and safety parameters;

AddedArticle 3 – paragraph 1 – point 12 – point b: (b) meets a pre-defined specification;

AddedArticle 3 – paragraph 1 – point 13: (13) ‘donor recruitment’ means any activity aimed at informing persons about activities related to SoHO donation or at encouraging them to donate SoHOs;

AddedArticle 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 the handling of SoHOs within the same sterile field during a surgical intervention or within a closed-system medical device, where those SoHOs are either released or for autologous application;

AddedArticle 3 – paragraph 1 – point 17: (17) ‘storage’ means the maintenance of SoHOs under appropriate controlled conditions until distribution, issuing, export or human application;

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 or until issuing;

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ChangedArticle 3 – paragraph 1 – point 18 a (new): (18a) ‘issuing’ means the provision of SoHOs or preparations basedSoHO onpreparations, SoHOs,where possiblyrelevant following a medical prescription, for application to a specific recipient;

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RemovedArticle 3 – paragraph 1 – point 31: (31) ‘EU SoHO platform’ means the digital platform interoperable with other existing EU platforms set up by the Commission to exchange information concerning SoHO activities between the competent authorities, EU agencies and the Commission;

AddedArticle 3 – paragraph 1 – point 23: (23) ‘autologous use’ means collection of SoHO from one individual for subsequent application to the same individual;

AddedArticle 3 – paragraph 1 – point 27: (27) ‘adverse occurrence’ means any incident associated with the donation or human application of SoHOs, which caused harm to a living SoHO donor, harm to a SoHO recipient, to offspring from medically assisted reproduction or to unborn offspring from medically assisted reproduction or that implied a risk of such harm;

AddedArticle 3 – paragraph 1 – point 28 – point h a (new): (ha) the transfer of embryos to a person other than the person intended;

AddedArticle 3 – paragraph 1 – point 29: (29) ‘SoHO rapid alert’ means a communication regarding an adverse occurrence, a communicable disease outbreak 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 preventing or mitigating measures;

AddedArticle 3 – paragraph 1 – point 33: (33) ‘the compendium of SoHOs’ 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, on the regulatory status of specific substances, products or activities and published on the EU SoHO platform;

AddedArticle 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;

Article 3 – paragraph 1 – point 40: (40) ‘SoHO establishment’ means a SoHO entity that carries out processing and storage or processing and release or storage and release of SoHOs;

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ChangedArticle 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 SoHO recipients;

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ChangedArticle 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 SoHO recipients;

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 human application or disposal, including the ability to:

Change 16

ChangedArticle 3 – paragraph 1 – point 64:51: (64)(51) ‘compensation’‘imputability’ means makingthe goodlikelihood ofthat anyan quantifiableadverse lossesoccurrence, associatedin witha donation;SoHO suchdonor, compensationis shouldrelated neverto bethe intendedcollection orprocess providedor, within a viewSoHO recipient or offspring from medically assisted reproduction, to encouragingthe donations;application of the SoHOs;

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AddedArticle 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;