Changes from plenary report to adopted text

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. 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.

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

Article 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;

Article 2 – paragraph 1 – point m a (new): (ma) SoHO clinical studies.

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

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 (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 patients, quality control testing of SoHOs, and the continuity of supply of SoHOs, 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.

Article 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.

Article 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.

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 body and its constituent parts;

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 includes substances which can be extracted from them;

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, efficacy or functionality of SoHOs, as listed in Article 2(1);

Article 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;

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

Article 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;

Article 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;

Article 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;

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

Article 3 – paragraph 1 – point 11 a (new): (11a) ‘unborn offspring from medically assisted reproduction’ means embryos and foetuses conceived by medically assisted reproduction;

Article 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;

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

Article 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;

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 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;

Article 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;

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

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

Article 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;

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

Article 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;

Article 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;

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;

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;

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 SoHO recipients;

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 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:

Article 3 – paragraph 1 – point 51: (51) ‘imputability’ means the likelihood that an adverse occurrence, in a SoHO donor, is related to the collection process or, in a SoHO recipient or offspring from medically assisted reproduction, to the application of the SoHOs;

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;

Article 3 – paragraph 1 – point 61: (61) ‘SoHO for reproduction’ means all cells intended to be used for the purpose of medically assisted reproduction, and embryos resulting from fertilisation;

Article 3 – paragraph 1 – point 62: (62) ‘third party donation’ means a donation of a SoHO for reproduction by a person to a recipient or a couple with whom the donor does not have an intimate physical relationship;

Article 3 – paragraph 1 – point 62 a (new): (62a) ‘ID release’ means the disclosure of information that permits the identification of donors of a SoHO for reproduction to donor-conceived offspring or their legal parents, as provided for in national legislation;

Article 3 – paragraph 1 – point 63: (63) ‘within relationship use’ means use of reproductive cells for medically assisted reproduction between persons with an intimate physical relationship, where a person provides their own oocytes and another person supplies their own sperm for the human application to a person within the relationship;

Article 3 – paragraph 1 – point 64: (64) ‘compensation’ means making good of any quantifiable losses and reimbursement of expenses associated with donation;

Article 3 – paragraph 1 – point 64 a (new): (64a) ‘financial neutrality of donation’ means that no financial gain or loss will be incurred by the donor as a result of the donation;

Article 3 – paragraph 1 – point 70 a (new): (70a) ‘donor base resilience’ means the capacity of the donation collection system to rely on a large number of donors for a given SoHO category;

Article 3 – paragraph 1 – point 70 b (new): (70b) ‘informed consent’ means that the donor’s agreement has been obtained freely without coercion and after the donor has been provided with access to clear, comprehensive information in line with the donor’s capacity to understand, for SoHO donation or use;

Article 3 – paragraph 1 – point 70 c (new): (70c) ‘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;

Article 3 – paragraph 1 – point 70 d (new): (70d) ‘European autonomy’ means the Union’s degree of independence from third countries in relation to the collection of SoHOs, the manufacture of SoHO preparations and any other SoHO activities.

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 based on scientific evidence, are compatible with Union law, and are proportionate to the risk to human health. / Such measures: / (a) shall not directly or indirectly constitute discrimination between SoHO donors based on any of the grounds recognised by Article 21 of the Charter of Fundamental Rights of the European Union, in particular discrimination based on sexual orientation. Member States shall report to the Commission any restrictions that they or SoHO entities in their territory impose that can reasonably be considered to constitute such discrimination and provide a summary of the scientific evidence used to justify these measures to protect SoHO donors, SoHO recipients or offspring from medically assisted reproduction; / (b) may contribute to setting up a European supply chain and to achieving the objective of European autonomy and coordination between Member States; they may also be aimed at reinforcing the principle of voluntary and unpaid donation.

Article 5 – paragraph 3 – point a: (a) have the autonomy to act and make decisions independently and impartially while respecting the internal administrative organisational requirements determined in national legislation;

Article 5 – paragraph 3 – point c: (c) have sufficient human and financial resources, operational capacity, and expertise, including technical expertise, to achieve the aims of, and fulfil their obligations under, this Regulation;

Article 5 – paragraph 4: 4. Each Member State shall designate a single SoHO National Authority, in conformity with Member States’ constitutional requirements, responsible for coordinating exchanges with the Commission and with other Member States’ SoHO National Authorities. The Commission shall make publicly available the list of SoHO National Authorities on the EU SoHO Platform.

Article 7 – paragraph 1: 1. Competent authorities and members of the SCB shall act independently, in the public interest and free from any external influence.

Article 7 – paragraph 2: 2. Competent authorities shall ensure that their personnel have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. All relevant personnel shall make an annual declaration of their interests, which shall be published on the competent authorities’ website.

Article 7 – paragraph 2 a (new): 2a. Paragraph 2 shall also apply to the previous activities of staff members for a reasonable period prior to them being recruited by the competent authorities, to be determined and made public by the competent authorities.

Article 8 – paragraph 1: 1. Without prejudice to Article 75, competent authorities and members of the SCB 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, including decisions to revoke, suspend or reinstate an authorisation for SoHO activities. Competent authorities shall also be transparent about the criteria used for the assessment and authorisation of SoHO preparations and SoHO entities.

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.

Article 9 – paragraph 2 – point a: (a) human and financial resources, operational capacity, and expertise, including technical expertise, to carry out the supervisory functions provided for in this Regulation;