BAKGRUNN (fra europaparlaments- og rådsforordningen)

(1) According to Article 168(1), first subparagraph, of the Treaty on the Functioning of the European Union (TFEU) and Article 35 of the Charter of Fundamental Rights of the European Union (the ‘Charter’), a high level of human health protection is to be ensured in the definition and implementation of all Union policies and activities.

(2) Article 168(4), point (a), TFEU provides that the European Parliament and the Council is to adopt measures setting high standards of quality and safety for organs and substances of human origin (SoHO), blood and blood derivatives. Furthermore, Member States are not to be prevented from maintaining or introducing more stringent protective measures.

(3) According to Article 168(7) TFEU, Union action is to respect the responsibilities of the Member States for the definition of their health policy and for the organisation and delivery of health services and medical care. Measures adopted pursuant to Article 168(4), point (a), TFEU are not to affect national provisions on the donation or medical use of organs and blood.

(4) As regards Article 168(4), point (a), TFEU, high standards for the quality and safety of organs and SoHO, blood and blood derivatives are to ensure a high level of human health protection. Therefore, this Regulation aims at setting high quality and safety standards by ensuring, inter alia, the protection of SoHO donors, taking into consideration their fundamental role in the provision of SoHO, and of SoHO recipients and offspring from medically assisted reproduction, as well as by providing for measures to monitor and support the sufficiency of the supply of SoHO that are critical for the health of patients. In accordance with Article 3 of the Charter, those safety standards are to be based on the fundamental principle that the human body or its parts as such are not to be a source of financial gain.

(5) Directives 2002/98/EC (3) and 2004/23/EC (4) of the European Parliament and of the Council constitute the Union’s regulatory framework for blood and blood components and for tissues and cells, respectively. Although those Directives have harmonised to a certain degree the rules of Member States in the area of quality and safety 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 has resulted in divergences between national rules, which can create obstacles to cross-border sharing of such substances. A fundamental revision of those Directives is needed for a robust, transparent, up-to-date and sustainable regulatory framework for such substances, which achieves quality and safety of all SoHO, enhances legal certainty for patients and stakeholders involved and supports continuous supply, including the cross-border exchange of SoHO, whilst facilitating innovation for the benefit of public health. In order to achieve a coherent application of the legal framework, it is appropriate to repeal Directives 2002/98/EC and 2004/23/EC and to replace them by a Regulation.

(6) Directives 2002/98/EC and 2004/23/EC are highly interconnected and contain very similar provisions on oversight and equivalent principles on quality and safety in the sectors they regulate. In addition, many authorities and operators work across those sectors. As this Regulation aims to define high level standards that will be common to blood, tissues and cells, it would be appropriate that it replaces those Directives and merges the revised provisions into one legal act, taking into consideration the special characteristics of each type of substance, as recognised by the technical guidelines referred to in this Regulation.

(7) This Regulation should apply to blood and blood components, as regulated by Directive 2002/98/EC, as well as to tissues and cells, including haematopoietic stem cells from peripheral blood, from umbilical-cord blood or from bone marrow, reproductive cells and tissues, embryos, foetal tissues and cells and adult and embryonic stem cells, as regulated by Directive 2004/23/EC. Since donation and human application of SoHO other than those regulated by Directives 2002/98/EC and 2004/23/EC are increasingly common, it is necessary to extend the scope of this Regulation to any SoHO, in order to prevent a situation in which certain groups of SoHO donors or SoHO recipients and offspring from medically assisted reproduction are not protected by an appropriate Union level quality and safety framework. This will, for example, ensure the protection of SoHO donors and SoHO recipients of human breast milk, intestinal microbiota, blood preparations that are not used for transfusion, and any other SoHO that might be applied to humans in the future.

(8) Ensuring the quality and safety of SoHO is crucial when such substances biologically interact with the body of the SoHO recipient or of recipients receiving products manufactured from SoHO regulated by other Union legislation. However, this Regulation should not cover the placing of a substance on the body when it does not have any biological interaction with that body, such as in the case of wigs made from human hair.

(9) All SoHO that are intended to be applied to humans fall within the scope of this Regulation. SoHO can be processed and stored in a variety of ways, becoming SoHO preparations, which can be applied to SoHO recipients. In those circumstances, this Regulation should apply to all activities from SoHO donor registration to human application and clinical-outcome registration. SoHO can also be used to manufacture products regulated by other Union legislation, namely medical devices, regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council (5), medicinal products, regulated by Directive 2001/83/EC of the European Parliament and of the Council (6), advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007 of the European Parliament and of the Council (7), and investigational medicinal products, regulated by Regulation (EU) No 536/2014 of the European Parliament and of the Council (8). This Regulation should apply without prejudice to Union legislation on genetically modified organisms.

(10) Many activities that are carried out, from the moment of the registration of a potential SoHO donor to the use of SoHO in a recipient, or from the moment of collection of SoHO from a person for human application to themselves or from persons as part of their own current or future medically assisted reproduction treatment or as part of such treatment in the context of within-relationship use, have an impact on the safety, quality or effectiveness of SoHO or the safety of SoHO donors.

(11) Entities that register prospective living SoHO donors, recording the information needed to identify a match with prospective SoHO recipients in the same Member State or internationally, should be considered as SoHO entities. The registering of persons that indicate their consent to donate tissues after death, or from whom donation is permitted in accordance with national legislation, should not be considered as SoHO donor registration within the meaning of this Regulation and should not, therefore, require the entity carrying out that activity to register as a SoHO entity.

(12) The review of SoHO donor history, together with the conduct of medical examinations to establish the eligibility of a prospective SoHO donor, is an activity that can have an impact on the quality and safety of SoHO and, as such, should be considered as a SoHO activity.

(13) Testing for communicable disease status, or for the purpose of matching a SoHO donor with a specific SoHO recipient, is an activity with a high degree of impact on the safety of SoHO and, as such, it should be considered as a SoHO activity. Laboratories that carry out such testing should therefore be registered as SoHO entities. While such testing is generally for the purpose of protecting the SoHO recipient, communicable disease testing of persons prior to the storage of SoHO collected from them, for the purpose of subsequent re-application to them, is important to prevent cross-contamination between such SoHO while in storage. Therefore, such testing should include the allogeneic, autologous and within-relationship use contexts.

(14) Collection of SoHO involves risks both to SoHO donors and to persons from whom SoHO are being collected for subsequent re-application to those same persons as well as to persons from whom SoHO are collected as part of their own current or future medically assisted reproduction treatment or as part of such treatment in the context of within-relationship use. As such, collection of SoHO should be considered as a SoHO activity. For the purposes of this Regulation and to ensure comprehensive SoHO donor protection, that activity should be understood to include the pre-treatment of persons with hormones, growth factors or other medicinal products that is required to make the collection possible.

(15) SoHO are frequently processed prior to distribution or, in the autologous context, prior to human application. Processing can have objectives such as: preservation by, for example, cooling, freezing or freeze-drying; pathogen inactivation by, for example, washing, antibiotic decontamination or sterilisation; or physical separation or purification into selected elements by, for example, centrifugation of blood to prepare red blood cell concentrates, platelet concentrates and plasma as separate components. If not performed correctly and in a consistent manner, processing steps carry risks of contamination or of changing the inherent properties of SoHO in a manner that might reduce their effectiveness. Therefore, processing of SoHO should be considered as a SoHO activity and any entity performing SoHO processing should be subject to appropriate oversight, including an obligation to obtain an authorisation for any SoHO preparation they distribute or apply. In cases where a surgical team prepares distributed SoHO for human application, without removal from the surgical field and immediately prior to the human application, such preparatory handling should not be considered as processing for the purposes of this Regulation. Such preparatory handling might include rinsing or rehydration, in accordance with the instructions provided with the SoHO, or cutting and shaping to render the SoHO suitable for the intended use in the SoHO recipient, for allogeneic or autologous use. In addition, in the autologous context, the preparation of SoHO during and for the purpose of human application as part of the same surgical intervention in which they were collected and without removal from the surgical field should not be considered as processing for the purposes of this Regulation. The necessary procedures to be carried out, in accordance with the instructions provided with the SoHO preparation, immediately prior to human application, of released and distributed SoHO should not be considered as processing for the purposes of this Regulation. Mixing of released human breast milk with medication before human application should also not be considered as processing.

(16) Quality control is a key element of a quality management system that is critical for the safe release of SoHO for human application, distribution or export, and therefore quality control should be considered as a SoHO activity. The tests and checks performed as part of quality control are sometimes carried out in dedicated quality control laboratories or departments. In order to allow appropriate oversight, such laboratories or departments should be registered as SoHO entities.

(17) SoHO are stored in SoHO establishments prior to their release. For the purposes of this Regulation, storage refers to maintaining SoHO under particular environmental conditions, such as temperature, that were established during the preservation step of processing and that ensure that the quality of SoHO will be maintained. The storage of released and distributed SoHO in a hospital, for example, should also be considered as a SoHO activity.

(18) As the release of SoHO is a critical step that allows SoHO to be moved from a ‘quarantined’ to an ‘available for use’ status, it should be considered as a SoHO activity. Any SoHO entity carrying out release should be authorised as a SoHO establishment. SoHO that are distributed or exported should first have been subjected to a release step. In cases where the receiving SoHO entity carries out a further processing step on released and distributed SoHO, those SoHO should be subjected to a second release step prior to re-distribution. In the case of autologous, bedside or in-surgery processing of SoHO without storage, it would be impractical to require a release step prior to the re-application of the SoHO preparation to the SoHO recipient. In such cases, quality control tests and checks should instead be incorporated in the processing steps that have been authorised. This should allow consistent quality criteria to be achieved without the need for a release activity in those circumstances.

(19) SoHO distributed for human application might be intended for an individual SoHO recipient on the basis of a medical prescription. Alternatively, SoHO might be distributed in batches to be stored as a local stock to be used, as required, in a SoHO entity carrying out human application. In such cases, the distributed SoHO should not be released a second time but their provision to individual SoHO recipients, in some cases involving a biological matching step, should be considered as another distribution step.

(20) The import of SoHO should include a formal verification that the quality, safety and effectiveness of the imported SoHO are equivalent to those of SoHO provided in the Union in accordance with this Regulation. As such, import should be considered as a SoHO activity with a significant impact on the quality and safety of SoHO and entities performing import should be authorised as importing SoHO establishments. Following import, SoHO should be subject to release, prior to distribution within the Union. In certain cases, and in particular in the case of haematopoietic stem cells, national and international donor registries play a key role in the organisation of the import of matching stem cells for individual SoHO recipients in the Union. Such registries verify equivalence of quality and safety with the standards of this Regulation. As such, registries organising import of SoHO should be authorised as importing SoHO establishments. In those cases, it should be possible for the SoHO to be received by the transplanting centres and it should be possible for the authorised registry to delegate the steps of physical checking of the imported SoHO and their documentation to the SoHO entity receiving and applying the SoHO to the SoHO recipient.

(21) All SoHO being exported from the Union should first require a release to confirm compliance with the quality and safety provisions of this Regulation. Export, which should be considered as a SoHO activity, can have an impact on SoHO supply within the Union. Therefore, entities exporting SoHO should be authorised as SoHO establishments.

(22) In the context of this Regulation, any reference to effectiveness should be considered to include an expected response in a SoHO recipient that is measurable in terms of degree, such as an engraftment of bone marrow cells after transplant, or if an expected result in a SoHO recipient that is successful or not, but cannot be measured in terms of degree, such as the success or failure of a cornea or bone transplant, and which is evaluated in accordance with a previously approved clinical-outcome monitoring plan, when such a plan is required.

(23) Human application of SoHO is a SoHO activity that falls within the scope of this Regulation, but that activity is only subject to a limited number of provisions. Entities applying SoHO to SoHO recipients are subject to provisions concerning traceability, reporting activity data and notifying adverse reactions or events, where relevant, and provisions concerning monitoring clinical outcomes when applying SoHO in the context of a plan for SoHO preparation authorisation. There are also obligations not to apply SoHO unnecessarily and to obtain SoHO recipient consent. However, the clinical decisions and the clinical procedures relating to human application of SoHO fall outside the scope of this Regulation and are governed by national legislation on the organisation of the healthcare systems of Member States.

(24) Most aspects of the monitoring of SoHO recipients, following surgical and other interventions, are outside the scope of this Regulation and fall under healthcare responsibilities. However, certain obligations of this Regulation should apply to SoHO recipient-outcome monitoring in the context of the human application of SoHO to SoHO recipients as part of a plan to generate evidence for SoHO preparation authorisation. Clinical registries to record the clinical data generated during the clinical-outcome monitoring are useful tools that allow for more efficient data collection from aggregated groups of SoHO recipients, applying standardised outcome measurements and reflecting outcomes in the ‘real world’ setting. Managing such registries should be considered as a SoHO activity, as it ensures that data quality and data management procedures are robust and allow for the data to be used for the purpose of SoHO preparation authorisation. The transfer of such outcome data from local or national registries to international registries should be promoted as it facilitates the aggregation and analysis of significantly larger data cohorts of SoHO recipients and can contribute to earlier SoHO preparation authorisations and access to SoHO therapies.

(25) Persons from whom SoHO are collected for subsequent human application as part of their own treatment, or persons from whom SoHO are collected as part of their own current or future medically assisted reproduction treatment or as part of such treatment in the context of within-relationship use, should not be considered as SoHO donors in the context of this Regulation. The protection of the health of such persons being treated in autologous or within-relationship context is the responsibility of the national healthcare systems and applying provisions targeted at the protection of SoHO donors, for example monitoring such persons on SoHO donor registries, would be disproportionate. However, when SoHO collected from such persons are processed or stored, their quality and safety should be ensured. In particular, contamination from the environment or cross-contamination with infectious pathogens from other SoHO should be prevented and there should be full traceability to avoid mix-ups. Therefore, persons from whom SoHO are collected in the autologous context or in the medically assisted reproduction context are not covered by the SoHO donor protection provisions of this Regulation, but are deemed duly protected under the SoHO recipient provisions.

(26) Solid organs are excluded from the definition of SoHO for the purposes of this Regulation and, thus, from the scope of this Regulation. Their donation and transplantation are significantly different, determined, inter alia, by the effect of ischemia in the organs, and are regulated in a dedicated legal framework, set out in Directive 2010/53/EU of the European Parliament and of the Council (9). Composite vascular allografts, such as hands or faces, should be considered as falling within the definition of organs, as indicated in that Directive. Nonetheless, when organs are removed from a SoHO donor for the purpose of separating tissues or cells for human application, for example heart valves from a heart or pancreatic islets from a pancreas, this Regulation should apply.

(27) While the donation and banking of human breast milk should be regulated to prevent disease transmission and ensure quality and safety, the feeding of one’s own child with one’s own breast milk should not fall within the scope of this Regulation. This includes also personal situations where such breast milk is handled or stored in a communal facility, such as a hospital, childcare facility or workplace, since it would be disproportionate to apply this Regulation to those settings. However, if such breast milk is processed by a specialised SoHO entity, in particular if it is pasteurised, this Regulation should apply.

(28) This Regulation should not interfere with national legislation in the health area having objectives other than quality and safety of SoHO, where such legislation is compatible with Union law, in particular legislation concerning the organisation of health-care systems or 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 SoHO or particular services that use SoHO. This Regulation should also not interfere with decisions of an ethical nature made by Member States. However, such decisions should adhere to the Charter. Such ethical decisions might concern the use, or limitation of the use, of specific types of SoHO, including reproductive SoHO and embryonic stem cells. When a Member State allows the use of such cells, this Regulation should apply with a view to ensuring quality and safety and to protecting human health. However, this Regulation does not require a specific use distribution or import of SoHO where such use, distribution or import is prohibited under national legislation concerning ethical aspects.

(29) A derogation from compliance with certain provisions of this Regulation should be envisaged for specific circumstances. In many Member States, military organisations are active in carrying out SoHO activities, in particular in the collection, testing, processing, storage and distribution of blood and blood components. Those organisations and their SoHO activities should be regulated by this framework to ensure levels of SoHO donor and SoHO recipient protection equivalent to those provided by civil services. However, making public the locations and activities of those organisations is likely to compromise national security or defence. Therefore, the reporting and oversight provisions of this Regulation should apply to those organisations, but the publication of associated information should not be obligatory. Derogations from compliance with this Regulation, in particular regarding the obligation to authorise SoHO preparations, should also be envisaged for specific SoHO recipients when justified by their clinical circumstances, or for specific groups of SoHO recipients in the context of health emergency situations or in man-made or natural disasters.

(30) When SoHO are used in the autologous context without any processing or storage, the application of this Regulation would not be proportionate to the limited quality and safety risks arising in such a context. In certain cases, such as hemodialysis at the bedside or at home, or red-cell salvage during surgery, closed-system medical devices are used in the autologous context. Where such a closed-system medical device has been CE marked for a specific purpose, and has therefore been demonstrated to achieve the intended result, and where the process carried out within that device does not meet the criteria for classification under another regulatory framework, this should be seen as analogous to non-removal from the surgical field and should not be considered as falling within the scope of this Regulation. However, this Regulation should apply to the processing of SoHO at the bedside or in the same surgical procedure by using medical devices for which quality, safety and effectiveness have not been demonstrated as part of the CE marking process for that specific purpose.

(31) When SoHO for autologous use are collected and processed before being applied again in the same person and without storage, risks associated with the processing of that SoHO should be mitigated. Therefore, there should be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the SoHO recipient. In such cases, the SoHO preparation authorisation should specify the required quality control tests and checks to be performed during the process, and therefore, no release step should be required before human application to the SoHO recipient. Similarly, in the case of intra-uterine insemination for within-relationship use, where SoHO are collected and processed from one of the partners before being applied to the other partner without storage, such SoHO should not be subject to a SoHO release step but the SoHO preparation authorisation should specify the required quality control tests and checks to be performed during collection, processing and human application. Where SoHO for autologous use, or SoHO for within-relationship use, are collected to be processed and also stored, risks of cross-contamination, loss of traceability or damage to the biological properties inherent to the substance, and necessary for effectiveness in the SoHO recipient, also appear. Therefore, the requirements for SoHO release and for SoHO establishment authorisation should apply in those circumstances.

(32) Where SoHO are collected for the purpose of manufacturing products regulated by other Union legislation, the provisions laid down in this Regulation that aim to protect SoHO recipients should contribute also to the objectives of the legislative measures adopted in those other frameworks to ensure a high level of protection of recipients of those products manufactured from SoHO. Therefore, without prejudice to Directive 2001/83/EC and Regulations (EC) No 1394/2007, (EU) No 536/2014 and (EU) 2017/745, this Regulation should always apply to the registration, evaluation and testing of SoHO donors, as well as to SoHO collection and release. This Regulation should also apply to the storage, import and export of SoHO up to and including their distribution to a manufacturer regulated by other Union legislation. This means that close interaction between this regulatory framework and other related frameworks is essential to ensure coherence between relevant legal frameworks, without gaps or overlaps.

(33) SoHO can be combined with other regulated products, in particular with medical devices, before human application. Close interaction between this regulatory framework and the medical device framework is necessary to ensure a high level of human health protection for all cases where such SoHO combined with medical devices are intended for human application. Where the device element in a SoHO-medical device combination has the primary function, for example a hip prosthesis coated in demineralised bone to help promote integration in the patient, the final combination should be regulated as a medical device. Conversely, where the device element has an ancillary function, for example in the case of demineralised bone that is mixed with a synthetic gel to facilitate delivery to the patient as a bone graft, the final combination should be regulated as a SoHO. In both cases, each element of the combination should be fully in compliance with the relevant regulatory framework. Therefore, the demineralised bone in those examples should be subject to the SoHO preparation authorisation provisions of this Regulation, to ensure the property of inducing bone formation is preserved, and the medical device element should have a CE mark for the purpose for which it is being used. This applies regardless of whether the final product is regulated as a medical device or as a SoHO.

(34) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures. If they do so, Member States should make details of such measures publicly available for reasons of transparency. More stringent protective measures put in place by Member States should be compatible with Union law, and be proportionate to the risk to human health. Such measures should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless those measures or their application are objectively justified by a legitimate aim, and the means of achieving that aim are appropriate and necessary. They could include, for instance, the presence of, or the access to, qualified medical professionals where SoHO collection takes place.

(35) The verification of compliance with this Regulation through SoHO supervisory activities is of fundamental importance to ensure that, across the Union, the objectives of this Regulation are effectively achieved. SoHO competent authorities should monitor and verify, through the organisation of SoHO supervisory activities, that relevant Union requirements are effectively complied with and enforced.

(36) SoHO competent authorities should be designated by the Member States for all the areas that fall within the scope of this Regulation. Since Member States are best placed to identify the SoHO competent authority or authorities for each area, for example by geography, topic or substance, they should also be required to designate a single independent SoHO national authority that ensures appropriately coordinated communication with other Member States’ SoHO national authorities and with the Commission, and that carries out other tasks pursuant to this Regulation. The SoHO national authority should be considered the same as the designated SoHO competent authority in Member States where only one SoHO competent authority is designated. The designation of a single SoHO national authority should not prevent Member States from assigning certain tasks to other SoHO competent authorities of that Member State, in particular where there is a need to ensure an efficient or agile communication with the Commission or other Member States. Furthermore, the list of all SoHO national authorities should be made publicly available on the EU SoHO Platform provided for in this Regulation.

(37) For the performance of SoHO supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate SoHO 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, SoHO competent authorities should be free from political influence and from interference by industry or other actors that might affect their operational impartiality. Member States should designate SoHO competent authorities that act in the public interest, are appropriately resourced and equipped, and offer guarantees of impartiality, professionalism and transparency. When infringements relate to health risks, and the publication of information regarding those infringements can contribute to risk mitigation and the protection of SoHO donors, recipients, offspring from medically assisted reproduction or public health, SoHO competent authorities should, where necessary, be able to prioritise transparency of their enforcement activities over the protection of confidentiality of anyone that has infringed this Regulation.

(38) In carrying out their SoHO supervisory activities, SoHO competent authorities should ensure transparency. Nonetheless, professional and legal rights should be protected by ensuring confidentiality of the information provided in the course of inspections and other supervisory activities. However, when a serious risk to human health is detected that results in the SoHO competent authorities taking enforcement action, they should give priority to transparency over confidentiality. Circumstances such as the detection of an entity offering services to the public without the required registration, and without complying with standards for SoHO recipient protection, such as communicable disease testing, should be considered as posing a serious risk to human health, and such information should be made publicly available.

(39) The correct application and enforcement of the rules falling within the scope of this Regulation require an appropriate knowledge of those rules. It is therefore important that the staff performing SoHO supervisory activities have an appropriate professional background and are regularly trained, in accordance with their area of competence, on the obligations resulting from this Regulation.

(40) Where there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, SoHO competent authorities should consult the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, advanced therapy medicinal products, medical devices or organs, and the SoHO Coordination Board (SCB) established by this Regulation, with the aim of ensuring coherent procedures for the application of this Regulation and other relevant Union legislation. SoHO competent authorities should inform the SCB of the outcome of their consultations and submit a request to the SCB for its opinion on the regulatory status of the substance, product or activity. When SoHO or SoHO preparations are used to manufacture products regulated by other Union legislation, SoHO competent authorities should cooperate with the relevant authorities responsible for the products regulated by other Union legislation on their territory. That cooperation should aim to reach an agreed approach for any subsequent communications between the SoHO competent authorities and those relevant authorities responsible for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHO or the product manufactured from SoHO. It should 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, where SoHO competent authorities decide not to follow the SCB’s opinions, they should justify their decisions, and the Commission should, upon a duly substantiated request of a Member State, or should be able, on its own initiative, to decide on the regulatory status of a particular substance, product or activity under this Regulation.

(41) In order to comply with the principle that the human body and its parts as such are not to give rise to financial gain and thereby to support a donation system that SoHO donors and SoHO recipients can trust, Member States should be able to take appropriate measures which aim to ensure that SoHO entities are transparent in the calculation of fees in respect of their technical services and in the financial management of their services. In that respect, it should be possible to refer, inter alia, to the cost of testing, processing, storage, distribution, personnel and transportation, infrastructure and administration, and to the need to invest in state-of-the-art processes and equipment to ensure the long-term sustainability of the services offered.

(42) SoHO competent authorities should perform SoHO supervisory activities regularly, on the basis of a risk assessment and with appropriate frequency, on SoHO entities and activities governed by this Regulation. The frequency of SoHO supervisory activities, and the mode in which inspections are carried out, should be established by the SoHO competent authorities, having regard to the need to adjust the degree of control to the risk and to the level of compliance expected in different situations, including the possible violations of this Regulation perpetrated through fraudulent or other illegal practices and based on previous compliance history. Accordingly, the likelihood of non-compliance with any provisions of this Regulation should be taken into account when scheduling SoHO supervisory activities.

(43) A broad range of public and private entities influence the quality, safety and effectiveness of SoHO, even if they do not store those SoHO. Many entities carry out a single SoHO activity, such as collection or SoHO donor testing on behalf of one or more entities that store SoHO. The SoHO entity concept includes this broad range of entities, from SoHO donor registries to hospitals and clinics where SoHO are applied to SoHO recipients or SoHO processing devices are used at the SoHO recipient’s bedside. The registration of all such SoHO entities should ensure that SoHO competent authorities have a clear overview of the field and its scale and can take enforcement action when deemed necessary. A SoHO entity registration should refer to the legal entity, regardless of the number of physical sites associated with the entity. Activities performed in a personal context, such as breast feeding or donating breast milk to the child of a friend or relative, while respecting the principle of voluntary and unpaid donation, should not be considered as SoHO activities. However, if such activities were to be carried out repeatedly as a service for multiple persons, or for many families, they should be considered as SoHO activities and should fall under the scope of this Regulation.

(44) Since SoHO preparations can be subjected to a series of SoHO activities, performed in accordance with the processing method chosen, prior to their release and distribution, SoHO competent authorities should assess and authorise SoHO preparations to verify that a high level of quality, safety and effectiveness is achieved consistently as a result of that specific series of activities, performed in that specific manner. When SoHO are prepared with newly developed and validated collection, testing or processing methods, safety and effectiveness in SoHO recipients should be demonstrated by means of clinical-outcome data collection and review. The extent of such required clinical-outcome monitoring 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 SoHO recipients or offspring from medically assisted reproduction or there is a high degree of certainty that benefit outweighs risk, based on the evidence provided, the vigilance requirements provided for in this Regulation should be adequate to verify quality and safety and effectiveness. This should apply for well-established SoHO preparations that are introduced in a new SoHO entity but have been robustly demonstrated as being safe and effective by their use in other entities.

(45) With regard to SoHO preparations that pose a risk that is more than negligible, and the benefit is expected to outweigh that risk, the applicant should propose a plan for clinical-outcome monitoring that should fulfil different requirements appropriate to the risk in question. The most up-to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM), which is a Directorate of the Council of Europe, should be considered relevant in the design of clinical follow-up plans proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk and a positive benefit-risk assessment, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of SoHO recipients. For moderate risk and a positive benefit-risk assessment, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose a SoHO clinical study with monitoring of pre-defined clinical end-points. In the case of high risk and a positive benefit-risk assessment, and cases where the risk or the benefit are not evaluable due to a lack of scientific and clinical data or knowledge, SoHO clinical studies should include a comparison with a standard therapy, ideally in a study with SoHO recipients allocated to test and control groups in a randomised manner. The SoHO competent authority should approve the plans before they are implemented and should assess the outcome data as part of a SoHO preparation authorisation. In SoHO clinical studies, patients’ rights, safety, dignity and well-being should always be the priority and the SoHO clinical study should be designed in a way that leads to reliable and robust data and conclusions.

(46) For the sake of efficiency, it should be permitted, without changing the regulatory status of the SoHO concerned, to implement clinical-outcome monitoring plans using the established framework in the pharmaceutical sector for clinical trials, as set out in Regulation (EU) No 536/2014, when SoHO entities wish to do so. While applicants can choose to record the clinical data generated during the implementation of the clinical-outcome monitoring plans themselves, they should also be permitted to use existing clinical registries as a means of such recording when those registries have been verified by the SoHO competent authority, or are certified by an external institution, in terms of the reliability of their data quality management procedures. The existence of a registry of approved SoHO clinical studies at Union level is critical to facilitate patient participation in such SoHO clinical studies, to boost multi-centre studies and to foster collaboration to generate more robust results and conclusions, and to make the knowledge generated available to other researchers, healthcare professionals, participants themselves and the general public.

(47) In order to facilitate innovation and reduce administrative burden, SoHO competent authorities should share with each other information on newly authorised SoHO preparations together with 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 human application to SoHO recipients. Such sharing could allow SoHO competent authorities to accept previous authorisations granted to other SoHO entities, including in other Member States and thus significantly reduce the requirements to generate evidence. SoHO competent authorities should also share with each other information on approved SoHO clinical studies, via the EU SoHO Platform.

(48) SoHO competent authorities should periodically review the SoHO entities registered in their territory and ensure that those entities that carry out both processing and storage, or release, or import, or export of SoHO, are inspected and authorised as SoHO establishments before starting those activities. A SoHO establishment authorisation should refer to the legal entity, even when one SoHO establishment has many physical sites. SoHO competent authorities should consider the impact on quality, safety and effectiveness of the SoHO activities carried out by SoHO entities that do not fall within the definition of a SoHO establishment and decide whether particular SoHO entities should be subject to authorisation and inspection activities applicable to SoHO establishments due to the risk or scale associated with their activities. Similarly, SoHO entities that have a poor record in terms of compliance with reporting or other obligations might be suitable candidates for authorisation and inspection.

(49) With regard to standards concerning the protection of SoHO donors, SoHO recipients and offspring from medically assisted reproduction, this Regulation should provide rules for their implementation. As risks and technologies change, these rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines, based on available scientific evidence, for implementing the standards set out in this Regulation. For the purposes of this Regulation, reconstructive surgery should not be considered as an aesthetic use. 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 an appropriate means to demonstrate compliance with this Regulation and the standards thereof to ensure high level of quality, safety and effectiveness. SoHO national authorities are involved in the process of establishing those guidelines through their participation in the governance bodies of both the ECDC and the EDQM. Member States should be able to adopt other guidelines, as a reference for SoHO entities located in their territory. When adopting such other guidelines, Member States should verify and document that those guidelines achieve compliance with the standards set by this Regulation. In cases of detailed technical issues for which neither Union legislation nor the ECDC and the EDQM, nor other guidelines, have defined a technical guideline or rule, SoHO entities should apply a locally defined rule that is in line with relevant internationally recognised guidelines and available scientific evidence and is appropriate to mitigate any risk identified.

(50) 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/EC (10), 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 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 that context, the work of the EDQM on developing and updating technical guidelines on quality and safety of blood, tissues and cells, should be considered an important contribution to the field of SoHO in the Union.Those technical guidelines are developed on the basis of scientific knowledge, including an evaluation of up-to-date scientific evidence. They address issues of quality and safety beyond the risks of communicable disease transmission, such as SoHO donor eligibility criteria for the prevention of the transmission of cancer and other non-communicable diseases and the assurance of quality and safety during collection, processing, storage and distribution or export. It should therefore be possible to use those technical guidelines as one of the means to implement the standards provided for in this Regulation. Within the financial framework partnership agreement between the Union and the Council of Europe, the Commission supports the EDQM with multi-year contribution agreements in order to effectively contribute to the development and update of technical guidelines on quality and safety of SoHO. The Commission should be able to adopt binding rules to establish Union-wide standards for quality and safety where the necessity to guarantee a coherent approach at Union level is identified.

(51) The ECDC, established by Regulation (EC) No 851/2004 of the European Parliament and of the Council (11), 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 quality and safety of SoHO from a communicable disease threat perspective, should be considered an important contribution in the field of SoHO in the Union. In addition, the ECDC established an expert network for the Microbial Safety of SoHO, 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 SoHO. 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 SoHO donors and the investigation of serious adverse reactions and events involving suspected transmission of a communicable disease.

(52) SoHO entities should keep a record of their activities, including the types and quantities of SoHO, as part of their working procedures and quality management systems, and report data relating to certain SoHO activities, at least the data sets included in the EU SoHO Platform. In cases where national or international registries collect activity data meeting the criteria defined on the EU SoHO Platform and such registries have been verified by SoHO competent authorities as having in place data quality management procedures that ensure accuracy and completeness of data, Member States should decide if SoHO entities should be able to delegate the submission of the activity data to such registries.

(53) When a serious genetic disorder that might result in a life-threatening, disabling or incapacitating condition is detected in the offspring from medically assisted reproduction with third-party donation, the transmission of that information enables the prevention of further use of donations affected by that genetic risk. It is therefore important that relevant information in such cases is effectively communicated between SoHO entities and acted upon appropriately.

(54) This Regulation respects the fundamental rights and observes the principles recognised by the Charter, in particular human dignity, the integrity of the person and the prohibition on making the human body and its parts as such 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 those 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 SoHO donors, SoHO recipients and offspring from medically assisted reproduction should always be taken into account, inter alia, by ensuring that consent for donation is freely given and SoHO donors or their representatives are informed with regard to the intended use of the donated material, that SoHO donor eligibility criteria are based on scientific evidence, that the use of SoHO in humans is not promoted for commercial purposes or with false or misleading information regarding effectiveness so that the SoHO donors and SoHO recipients can make well-informed and deliberate choices, and that activities are conducted in a transparent manner that prioritises the safety of SoHO donors, recipients and offspring from medically assisted reproduction. In addition, allocation and equitable access to SoHO should be in accordance with national law, on the basis of an objective evaluation of medical needs, such that the health of SoHO recipients and offspring from medically assisted reproduction is not compromised by SoHO allocation actions that do not respect their dignity. This Regulation should therefore apply accordingly.

(55) Given the special nature of SoHO, due to their human origin, and the increasing demands for such substances for human application, including for the manufacture of products regulated by other Union legislation, it is necessary to ensure a high level of health protection for living SoHO donors as well as for recipients and offspring from medically assisted reproduction. SoHO should be obtained from persons whose health status is such that no detrimental effects will ensue as a result of the donation. This Regulation should therefore include standards and technical rules to monitor and protect living SoHO donors. This is particularly important where the donation involves significant risk to the SoHO donor’s health, such as where there is a need for pre-treatment with medicinal products, for example in the case of donation of oocytes or of hematopoietic stem cells from peripheral blood, a medical intervention to collect the SoHO, for example in the case of donation of bone marrow, or the possibility for SoHO donors to donate frequently, for example in the case of donation of plasma. As different types of donation entail different risks for SoHO donors, with varying levels of significance, the monitoring of the SoHO donor’s health should be proportionate to those levels of risk.

(56) Due to the high sensitivity of the protection of SoHO donor anonymity and taking into account the rights of offspring from medically assisted reproduction following third-party donation, SoHO entities should, in the case of SoHO donation by a person that is unrelated to the intended SoHO recipient, refrain from revealing the SoHO’s donor identity to the SoHO recipient or the offspring from medically assisted reproduction, apart from circumstances where such information exchange is permitted in the Member State concerned.

(57) Article 3 of the Charter prohibits making the human body and its parts as such a source of financial gain. The use of financial incentives for SoHO donations can have an impact on the quality and safety of SoHO, posing risks to the health of both SoHO donors and recipients and therefore to the protection of human health. Without affecting the responsibilities of the Member States for the definition of their health policy, and for the organisation and delivery of health services and medical care, SoHO donation should be voluntary and unpaid, and be founded on the principles of altruism of the SoHO donor and solidarity between donor and recipient. Such solidarity should be built from the local and regional levels up to the national and Union levels, aiming for self-sufficiency of critical SoHO, and spreading the responsibility for donation evenly across the Union population to the extent possible. Voluntary and unpaid SoHO donation contributes to the respect for human dignity and to protecting the most vulnerable persons in society. It also contributes to high safety standards for SoHO and therefore to the protection of human health, increasing public trust in donation systems.

(58) It is recognised, including by the Council of Europe Committee on Bioethics in its ‘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’ from March 2018, that while financial gain should be avoided, compensation should be able to be acceptable to prevent SoHO donors being financially disadvantaged by their donation. Therefore, compensation to remove any such risk is deemed appropriate as long as it endeavours to guarantee financial neutrality and does not result in a financial gain for the SoHO donor or constitute an incentive that would cause a SoHO donor to not disclose relevant aspects of their medical or behavioural history or to donate in any way that could pose risks to their own health and to that of prospective recipients, in particular by donating more frequently than is allowed. It should be possible for compensation to consist of the reimbursement of expenses incurred in connection with SoHO donation or of making good of any losses, preferably based on quantifiable criteria, associated with the donation of SoHO. Whatever the form of compensation, including through financial and non-financial means, compensation schemes should not result in competition between SoHO entities for SoHO donors, including cross-border competition and in particular between SoHO entities collecting SoHO for different purposes, such as the manufacture of medicinal products versus human application as a SoHO preparation. The setting of an upper limit for compensation at national level and the application of compensation that is financially neutral for the SoHO donor have the effect of removing any incentive for SoHO donors to donate to one SoHO entity rather than another, significantly mitigating the risk that compensation differences might result in competition between SoHO entities, in particular between public and private sectors. It should be possible for Member States to delegate the setting of such conditions to independent bodies, in accordance with national law. Prospective SoHO donors should be able to receive information regarding the possibility of having their expenses reimbursed or of receiving compensation for other losses, through information tools, such as website ‘Question and Answer’ pages, information email addresses, telephone lines or other such neutral channels of factual information dissemination. However, because of the risk of undermining the voluntary and unpaid character of SoHO donation, references to compensation schemes should not be included in advertising, promotion and publicity activities that form part of SoHO donor recruitment campaigns, for example using advertising billboards or posters, on television, newspaper, magazine or social media advertisements or similar.

(59) SoHO entities should not offer financial incentives or inducements to potential SoHO donors or to those giving consent on their behalf as such an action would be contrary to the principle of voluntary and unpaid donation. Refreshments and small gifts, such as pens or badges, should not be considered as inducements and the practice of offering them to SoHO donors is acceptable as a recognition of their efforts. On the other hand, rewards or benefits, such as payment of funeral expenses, or payment of health insurance unrelated to the SoHO collection, should be considered as inducements, and as such contrary to the principle of voluntary and unpaid donation and should not be permitted.

(60) This Regulation is not meant to cover research using SoHO when that research does not involve human application, for example in vitro research or research in animals. However, SoHO used in research involving studies where they are applied to the human body should comply with this Regulation. In order to avoid undermining the effectiveness of this Regulation, and in particular in view of the need to ensure a consistently high level of protection for SoHO donors, and sufficient availability of SoHO for recipients, the donation of SoHO that will be exclusively for use in research without any human application should also comply with the standards concerning voluntary and unpaid donation set out in this Regulation.

(61) In order to maintain public trust in SoHO donation and the use of SoHO, information that is given to prospective SoHO donors, SoHO recipients or physicians regarding the likely use and benefits of particular SoHO when applied to SoHO recipients should accurately reflect reliable scientific evidence and under no circumstance attribute or imply levels of safety or effectiveness that are not scientifically supported. This should ensure that SoHO donors or their families, are not coerced to donate by exaggerated descriptions of benefits and prospective SoHO recipients are not given false hopes when making decisions on their options for treatment.

(62) When persons with an intimate physical relationship use their own sperm and oocytes for treatment by medically assisted reproduction, testing for genetic conditions fall outside the scope of this Regulation as such testing is associated with particular ethical concerns that fall outside the scope of this Regulation.

(63) Where evidence demonstrates that specific procedures reduce or eliminate the risk of transmission of specific communicable or non-communicable disease agents, the quality and safety standards for the verification of SoHO donor eligibility by means of SoHO donor health evaluations, including testing, and the related guidelines for their implementation, should take this evidence into account.

(64) It is necessary and beneficial to all parties to promote information and awareness campaigns at national and Union level on the importance of SoHO donation. The aim of those campaigns should be to ensure the broadest possible SoHO donor base, with a view to a more resilient supply of critical SoHO, and help European citizens to decide whether to become SoHO donors during their lifetime and record or let their families or legal representatives know their wishes regarding donation of SoHO after death. As there is a need to ensure the availability of SoHO for medical treatments, Member States and the Union should support the establishment of public donation facilities and promote the voluntary and unpaid donation of SoHO, including plasma, of high quality and safety, thereby also increasing self-sufficiency in the Union. For that purpose, Member States should consider taking measures to ensure availability and accessibility of SoHO within the Union. Member States are also urged to take steps to encourage a strong involvement of all relevant sectors, both public and non-profit, in the provision of SoHO services, in particular for critical SoHO and the related research and development, and to take steps to promote affordability of the collected SoHO within the Union.

(65) The COVID-19 pandemic can be considered as having been one of the biggest health crises that has affected Europe. It had an adverse impact on the resilience of the SoHO donor base in some countries whose collection systems rely on a small number of persons donating SoHO 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 developing medical treatments. In the case of SoHO, the pandemic drastically reduced the number of SoHO donors and imports from third countries, putting the Union in a situation of shortages of some SoHO and patients at serious risk due to a lack of adequate treatments. In that context, the initiatives for a strong European Health Union should work in favour of European self-sufficiency, in particular as regards the supply of critical SoHO and the ability to minimise the risk of shortages. 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 Council (12) lays down the guidelines to be followed for that purpose. To increase European self-sufficiency in terms of SoHO, Member States should be urged to increase their collection capacity and donor base for critical SoHO, in particular plasma, by developing non-profit and public plasmapheresis programmes.

(66) In the development of national SoHO emergency plans, Member States should cooperate with relevant stakeholders and should take into account the opinions of the Health Security Committee established by Article 4 of Regulation (EU) 2022/2371 and the Health Crisis Board referred to in Article 5 of Council Regulation (EU) 2022/2372 (13), where applicable. Member States should also benefit from the supportive role of the appropriate Commission services, such as the Health Emergency Response Authority, the risk assessments and recommendations of the ECDC and the guidelines of the EDQM in the establishment and operation of national SoHO emergency plans. National SoHO emergency plans might include, among preparedness and response measures, stockpiling of certain SoHO where possible and appropriate.

(67) In order to ensure self-sufficiency and sustainability of supply of critical SoHO, Member States should establish national SoHO emergency plans setting out measures for cases where the supply situation for critical SoHO presents or is likely to present a serious risk to human health. Such plans should incorporate measures that impact the demand for critical SoHO, SoHO donor recruitment and retainment strategies and arrangements for cooperation between SoHO competent authorities, experts and relevant stakeholders. National SoHO emergency plans contribute to European self-sufficiency in terms of supply of critical SoHO. Providing training and better information for prescribers would reduce the risk of unnecessary human application of SoHO. Furthermore, it is important that Member States improve patients’ safety by minimising the risks associated with human application of SoHO, and improve patient outcomes, while at the same time ensuring sufficiency of SoHO supplies and reducing financial pressure on healthcare systems of Member States. Some Member States do so, inter alia, via the Patient Blood Management (PBM) approach as endorsed by the World Health Organization.

(68) In cases where the availability of critical SoHO or products manufactured from critical SoHO depends on potential commercial interests, such as those related to the production and distribution of plasma-derived products, there is a risk of not having the interests of patients and research at the forefront, and thus to jeopardise the quality and safety of SoHO, SoHO donors and recipients. There could even be situations in which some products with low profitability are no longer produced, thereby hampering their accessibility for patients. Therefore, by considering all reasonable efforts for an appropriate and continuous supply of critical SoHO, Member States contribute to limiting the risk of shortages of products manufactured from critical SoHO.

(69) The exchange of SoHO 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 SoHO that need to be matched between the SoHO donor and the SoHO recipient, such exchanges are essential to allow SoHO recipients to receive the treatment they need in the optimal timeframe. This is for instance the case of hematopoietic stem cell transplants, for which the level of compatibility between the SoHO donor and the SoHO recipient has to be high, which requires coordination at a global level, so that each SoHO recipient has as many options as possible to identify a compatible SoHO donor.

(70) In order to promote a coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission and the Member States should participate in its activities and co-chair it. The SCB should contribute to 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 appointed by the Member States based on their role and expertise in their SoHO competent authorities, and should also involve experts that are not working for SoHO competent authorities, for specific tasks where access to necessary in-depth technical expertise in the field of SoHO 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 and donor and patient representative groups at Union level in the field of SoHO.

(71) 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 SoHO. The SCB should receive relevant information on national decisions made on cases where questions were raised on the regulatory status of SoHO. The SCB should keep a SoHO compendium of the opinions issued by the SCB or the SoHO competent authorities and of decisions made at Member State level, so that SoHO competent authorities considering the regulatory status of a particular substance, product or activity are able to inform their decision-making process by referring to that SoHO 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. The Commission should support the SCB in its cooperation with similar advisory bodies responsible for issuing an opinion on the regulatory status of products under other relevant Union legislation, in particular by organising meetings, at least annually. Such meetings should contribute to promote understanding and to ensure efficiency and scientific consistency with other relevant Union legislation and coherence with the different regulatory status mechanisms established under other Union legislation. Those measures should promote a coherent cross-sectoral approach and facilitate SoHO innovation.

(72) The Commission should have the necessary experience and knowledge to be able to perform controls as to the Member States’ effective application of the relevant requirements set out in this Regulation. The controls could be organised in different ways, such as audits, visits or surveys, and in collaboration with the Member States so as to limit the administrative burden. They should also serve to investigate and collect information on enforcement practices or problems, emergencies and new developments in Member States. They should be performed by personnel who are independent, free from any conflict of interests and in particular who are not in a situation which, directly or indirectly, could affect their ability to carry out their professional duties in an impartial manner.

(73) In order to limit administrative burden on SoHO competent authorities and the Commission, the latter should establish an online platform (the ‘EU SoHO Platform’) to facilitate timely submission of data and reports. The EU SoHO Platform should contribute to improving transparency of reporting and SoHO supervisory activities and to the exchange of information between relevant parties, including decisions on the regulatory status of substances, products or activities. The EU SoHO Platform should also serve as a reliable source of information for the general public regarding the work of the SCB, SoHO national authorities, expert bodies, including the EDQM and the ECDC, and SoHO entities. The SoHO Platform should be further used for the sharing of best practices documented and published by the SCB on SoHO supervisory activities.

(74) As the EU SoHO Platform requires the processing of personal data, including health data, it will be designed respecting the principles of data protection. Any processing of personal data should be limited to achieving the objectives and the fulfilment of obligations of this Regulation. Access to the EU SoHO Platform by SoHO entities, SoHO competent authorities, Member States or the Commission, should be limited to the extent necessary to perform SoHO related activities laid down in this Regulation.

(75) 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, including health data, laid down in Regulations (EU) 2016/679 (14) and (EU) 2018/1725 (15) of the European Parliament and of the Council.

(76) SoHO, by definition, relate to persons, and there are circumstances where the processing of personal data could be necessary to achieve the objectives and requirements of this Regulation, especially provisions relating to vigilance and communication between SoHO 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 quality, safety and effectiveness of new SoHO preparations should also be shared, with appropriate protective measures, to allow aggregation at Union level for more robust evidence gathering of SoHO preparations. For all data processing, such processing should be limited to what is necessary and appropriate with a view to ensuring compliance with this Regulation in order to protect human health. Data collected on SoHO donors, SoHO recipients and offspring from medically assisted reproduction should therefore be limited to the minimum necessary and pseudonymised. SoHO donors, SoHO recipients and offspring from medically assisted reproduction should be informed of the processing of their personal data, including health 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.

(77) In order to enable better access to health data in the interests of public health, Member States should entrust SoHO competent authorities as data controllers within the meaning of Regulation (EU) 2016/679 with powers to take decisions on the access to such data.

(78) In order to supplement this Regulation where necessary with additional standards concerning the protection of SoHO donors, SoHO recipients and offspring from medically assisted reproduction to take into account the technical and scientific developments in the field of SoHO, and with additional rules on the authorisation of importing SoHO establishments, on obligations and procedures for importing SoHO establishments, and on data protection, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (16). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(79) In order to ensure uniform conditions for the implementation of this Regulation regarding the application for an importing SoHO establishment authorisation, the activity data collection and reporting by SoHO entities, the minimum data to ensure traceability, the European coding system, and the general functionalities of the EU SoHO Platform, implementing powers should be conferred on the Commission. In order to ensure uniform conditions for the implementation of this Regulation, including the determination of the regulatory status of a substance, product or activity, the data set for SoHO entities to register into the EU SoHO Platform, the authorisation of SoHO preparations, common elements for the quality management system of SoHO entities and for the inspections of SoHO establishments, the consultation and coordination related to vigilance, the implementation of the standards concerning the protection of SoHO donors, in particular with regard to the frequency of donations when such frequency implies a risk, SoHO recipients and offspring from medically assisted reproduction, the management and tasks of the SCB, and the transitional provisions concerning SoHO preparations, implementing powers should also be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (17). In addition to the implementing acts that relate directly to the protection of human health, and therefore fall within the scope of Article 5(4), second subparagraph, point (a), of Regulation (EU) No 182/2011, this Regulation provides for implementing acts that relate to consultation and communication tools, supervisory functions, traceability and import rules and monitoring, for example of activity volumes. Those implementing acts will have significant impact on the Member States’ public services in the field of health and on the way their health authorities work and cooperate in practice. it should therefore be provided that the Commission cannot adopt a draft implementing act where the committee established by this Regulation to assist the Commission, delivers no opinion, in accordance with Article 5(4), second subparagraph, point (b), of Regulation (EU) No 182/2011.

(80) Since the objective of this Regulation, namely to ensure quality and safety of SoHO and a high level of protection of SoHO donors by establishing high standards of quality and safety for SoHO, based on a common set of requirements that are implemented in a consistent manner across the Union, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale or effects, be better achieved at Union level, 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. This Regulation should also serve to increase coordination between Member States.

(81) Transitional provisions should be laid down in order to ensure a smooth transition from the former regimes for tissues and cells and for blood and blood components to this new Regulation, in particular in order to adapt practices to the new requirements and the changes in the rules on SoHO entities, SoHO establishments and SoHO preparations, as well as to avoid that donated SoHO are discarded unnecessarily. A transitional regime for establishments already designated, authorised, accredited or licensed before the general date of application of this Regulation should be introduced to ensure legal certainty and clarity. In particular, there should be clarity for the establishments concerned as regards their registration and authorisation status as well as their tasks and responsibilities under this Regulation, whilst allowing SoHO competent authorities additional time to transfer the relevant information to the systems introduced by this Regulation. To allow for a smooth transition, it is also appropriate that those preparation processes already authorised and lawfully used under the former regimes are still valid, and that SoHO already collected and stored before that date are able to be used for a certain period of time.

(82) The European Data Protection Supervisor was consulted in accordance with Article 42(1) of Regulation (EU) 2018/1725 and delivered an opinion on 7 September 2022 (18),