What changed between the draft committee report and the plenary report

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

10 unchanged paragraphs

on the proposal for a regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC

(COM(2022)0338 – C90226/2022 – 2022/0216(COD))

(Ordinary legislative procedure: first reading)

The European Parliament,

– having regard to the Commission proposal to Parliament and the Council (COM(2022)0338),

– having regard to Article 294(2) and Article 168(4), point (a), of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C90226/2022),

– having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

– having regard to the opinion of the European Economic and Social Committee of 27 October 2022,

– after consulting the Committee of the Regions,

– having regard to Rule 59 of its Rules of Procedure,

Changed:– having regard to the report of the Committee on the Environment, Public Health and Food Safety (A90000/2023),(A9-0250/2023),

1. Adopts its position at first reading hereinafter set out;

2. Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3. Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Change 1

Changed:Recital 3: (3) As regards Article 168(4), point (a), TFEU, standards for the safety and quality of organs and SoHOs, blood and blood derivatives should ensure a high level of human health protection. Therefore, this Regulation aims at setting high quality and safety standards by ensuring, amongst others, the protection of SoHO donors, taking into consideration their fundamental role in the provision of SoHOs and for recipients, as well as measures to monitor and support the sufficiency of the supply of SoHOs that are critical for the health of patients. UnderIn accordance with Article 3 of the Charter of Fundamental Rights of the European Union, thesethose safety standards should be based on the fundamental principle of not allowingthat the human body toor its parts cannot be a source of financial gain.

Change 2

Changed:Recital 4: (4) Directives 2002/98/EC16 and 2004/23/EC172002/98/EC16and of2004/23/EC17of the European Parliament and of the Council constitute the Union’s regulatory framework for blood and for tissues and cells, respectively. Although these Directives have harmonised to a certain degree the rules of Member States in the area of safety and quality of blood, tissues and cells, they include a significant number of options and possibilities for Member States to implement the rules they laid down. This results in divergences between national rules, which can create obstacles to cross-border sharing of these substances. A fundamental revision of those Directives is needed for a robust, transparent, up-to-date and sustainable regulatory framework for these substances, which achieves safety and quality for all parties involved, enhances legal certainty and supports continuous supply, whilst facilitating innovation for the benefit of public health and the cross-border sharing of these substances. 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.

Change 3

Changed:Recital 5: (5) Directives 2002/98/EC and 2004/23/EC are highly interconnected and contain very similar provisions for oversight and equivalent principles for safety and quality in the two sectors they regulate. In addition, many authorities and operators work across these sectors. As this Regulation aims to define high level principles that will be common to both the blood and of tissues and cells sectors, it would be appropriate that it replaces these Directives and merges the revised provisions into one legal act, taking into consideration the special characteristics of each oftype theof substances,substance, as recognised by the technical guidelines referred to in this Regulation.

Change 4

Removed:Recital 10: (10) When SoHOs are used in the autologous setting without any manipulation, processing or storage, the application of this Regulation would not be proportionate to the limited quality and safety risks arising in such a setting. When autologous SoHOs are collected and processed before being re-used in the same person, risks appear that should be mitigated. Thus, there needs to be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the recipient. When autologous SoHOs are collected to be processed and also stored, risks of cross-contamination or contamination from medical personnel, loss of traceability or damage to the biological properties inherent to the substance, and necessary for efficacy in the recipient, also appear. Thus, the requirements for SoHO establishment authorisation should apply.

Added:Recital 9: (9) All SoHOs that are intended to be applied to humans fall within the scope of this Regulation. Articles 53, 54, 55 and 56 of this Regulation should apply also to SoHO donations intended for research. SoHOs can be prepared and stored in a variety of ways becoming SoHO preparations, which can be applied to recipients. In these circumstances, this Regulation should apply to all activities from donor recruitment to human application and outcome monitoring. SoHOs or SoHO preparations can also be used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in particular on medical devices, regulated by Regulation (EU) 2017/745 of the European Parliament and of the Council19, on medicinal products, regulated by Directive 2001/83/EC of the European Parliament and of the Council20and by Regulation (EC) No 726/2004 of the European Parliament and of the Council21, including on advanced therapy medicinal products, regulated by Regulation (EC) No 1394/2007 of the European Parliament and of the Council22, or on food, regulated by Regulation (EC) No 1925/2006 of the European Parliament and of the Council23. The criteria that define when SoHOs or SOHO preparations become products regulated under other Union legislation are not defined in this Regulation but are defined in those other acts. In addition, this Regulation should apply without prejudice to Union legislation on genetically modified organisms.

Removed:Recital 11: (11) When SoHOs are used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in order to ensure a high level of protection and contribute to legal clarity and certainty, this Regulation should apply to the extent that the activities to which they are subjected are not regulated by the other Union legislative framework. Without prejudice to other Union legislation, and in particular to Directive 2001/83/EC, Regulations (EC) No 726/2004, (EC) No 1925/2006, (EC) No 1394/2007 and (EU) 2017/745, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, issuing, import and export when those activities concern SoHOs up to the point of their transfer to operators regulated by other Union legislation. This means that close interaction between this regulatory framework and other related frameworks is essential to ensure interplay and coherence between relevant legal frameworks, without gaps or overlaps.

Added:Recital 10: (10) When SoHOs are used in the autologous setting without any manipulation, processing or storage, the application of this Regulation would not be proportionate to the limited quality and safety risks arising in such a setting. Furthermore, this Regulation should not apply where the handling of SoHOs toccurs during a surgical intervention within a sterile field or within a closed-system medical device. When autologous SoHOs are collected and processed before being re-used in the same person, risks appear that should be mitigated. Thus, there needs to be an assessment and authorisation of the processes applied to ensure that they are demonstrated to be safe and effective for the recipient. When autologous SoHOs are collected to be processed and also stored, risks of cross-contamination, contamination of medical personnel or environmental contamination, loss of traceability or damage to the biological properties inherent to the substance, and necessary for efficacy or functionality in the recipient, also appear. Thus, the requirements for SoHO establishment authorisation should apply.

Removed:Issuing is a step that takes place once a product has been released and after or in parallel to distribution. It allocates a blood product to a specific patient, thus making it easier to trace that product until it is used for transfusion.

Added:Recital 11: (11) When SoHOs are used to manufacture products regulated by other Union legislation, or as the starting and raw material thereof, in order to ensure a high level of protection and contribute to legal clarity and certainty, this Regulation should apply to the extent that the activities to which they are subjected are not regulated by the other Union legislative framework. Without prejudice to other Union legislation, and in particular to Directive 2001/83/EC, Regulations (EC) No 726/2004, (EC) No 1925/2006, (EC) No 1394/2007 and (EU) 2017/745 and Regulation (EU) No 536/2014 of the European Parliament and of the Council1a, this Regulation should at least apply to the recruitment and selection of donors, donation, collection and donor testing as well as to release, distribution, issuing, import and export when those activities concern SoHOs up to the point of their transfer to operators regulated by other Union legislation. This means that close interaction between this regulatory framework and other related frameworks is essential to ensure interplay and coherence between relevant legal frameworks, without gaps or overlaps. / 1a Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1).

Removed:Recital 15: (15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law and founded on the principle of voluntary and unpaid SoHO donation. Member States should notify the Commission and the EU SoHO Platform set up by this Regulation of any such measures. More stringent protective measures put in place by Member States should be evidence-based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and the means of achieving that aim are appropriate and necessary.

Added:Recital 13: (13) Given the special nature of SoHOs, resulting from their human origin, and the increasing demands for these substances for human application or for the manufacture of products regulated by other Union legislation, or as the starting and raw material thereof, it is necessary to ensure a high level of health protection for donors as well as for recipients. SoHOs should be obtained from individuals whose health status is such that no detrimental effects will ensue for them as a result of the donation. This Regulation should therefore include principles and technical rules to monitor and protect donors. This is particularly important where the donation involves significant risk to the donor’s health such as where there is a need for pre-treatment with medicinal products, for example in the case of oocytes, a medical intervention to collect the substance, for example in the case of bone marrow or peripheral blood stem cells, or a possibility for donors to donate frequently, for example in the case of plasma. As different types of donation entail different risks for donors, with varying levels of significance, the monitoring of donor health should be proportionate to those levels of risk.

Removed:Recital 18: (18) Programmes promoting the donation of SoHOs should be founded on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient. Voluntary and unpaid SoHO donation is also a factor which contributes to high safety standards for SoHOs and therefore to the protection of human health. It is also recognised, including by the Council of Europe Committee on Bioethics24, that while financial gain should be avoided, it may also be acceptable to ensure that donors are not financially disadvantaged by their donation. Thus, financially neutral compensation to remove any such risk is acceptable but should never constitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate more frequently than is allowed, posing risks to their own health and to that of prospective recipients. Such compensation should, therefore, be set by national authorities, at a level appropriate in their Member State to reach such objectives.

Added:Recital 15: (15) This Regulation does not prevent Member States from maintaining or introducing more stringent protective measures that are compatible with Union law and founded on the principle of voluntary and unpaid donation. Member States should notify the Commission as soon as possible after their introduction so that the other Member States can be informed accordingly, via the EU SoHO Platform, of any such measures. More stringent protective measures put in place by Member States should be evidence-based and proportionate to the risk to human health, for example based on overall safety concerns and corresponding risks in a Member State or specific local risks. They should not discriminate against persons on grounds of sex, racial or ethnic origin, religion or belief, disability, age or sexual orientation, unless that measure or its application is objectively justified by a legitimate aim, and based on scientific evidence and the means of achieving that aim are appropriate and necessary. In order to prevent any discrimination, it is appropriate to require that Member States report to the Commission any such measures that could constitute discrimination, in particular as several Member States have implemented restrictions against men who have sex with men in blood donation procedures. Member States should therefore replace donor eligibility criteria based on sexual orientation or gender identity with individual risk-based screening criteria for all donors, regardless of their gender …

Removed:Recital 22 a (new): (22a) For the performance of supervisory activities, competent authorities should ensure the impartiality and independence of the inspectors and provide them with induction training.

Added:Recital 16: (16) This Regulation should not interfere with national legislation in the health area with objectives other than quality and safety of SoHOs, where such legislation is compatible with Union law, in particular legislation concerning ethical aspects. Such aspects arise due to the human origin of the substances, which touches upon various sensitive and ethical concerns for Member States and citizens, such as access to particular services that use SoHOs. This Regulation should also not interfere with decisions of an ethical nature made by Member States and, in particular, no provision of this Regulation should be construed as imposing an obligation on Member States to use types of SoHOs that are legally prohibited in that Member State. However, decisions should adhere to the Charter of Fundamental Rights of the European Union. Such ethical decisions might concern the use, or limitation of the use, of specific types of SoHOs or specific uses of SoHOs, including reproductive cells and embryonic stem cells. When a Member State allows the use of such cells, this Regulation should apply in full with a view to ensuring safety and quality and to protecting human health.

Removed:Recital 24: (24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult with the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, innovative therapies, medical devices, organs or food, with the aim of ensuring coherent procedures for the application of this Regulation. Competent authorities should inform the SoHO Coordination Board of the outcome of their consultations and submit a request to it for its opinion on the regulatory status of the substance. When SoHOs or SoHO preparations are used to manufacture products regulated under other Union legislation, or as the starting and raw material thereof, competent authorities should cooperate with the relevant authorities on their territory. This cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for SoHO and for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHOs or the product manufactured from SoHOs. Member States should respect the Coordination Board’s opinion on the regulatory status of substances. In order to ensure consistent decisions across all Member States with regard to borderline cases, the Commission should be empowered to, on its own initiative or at the duly substantiated request of a Member State, decide on the regulatory status of a particular substance, product or …

Added:Recital 17: (17) This Regulation is not meant to cover research using SoHOs when that research does not involve application to the human body, for example in vitro research or research in animals, except provisions regarding donor protection. However, human substances used in research involving studies where they are applied to the human body should comply with the rules laid down in this Regulation.

Removed:Recital 24 a (new): (24a) Health care personnel should be informed about, and trained in, patient blood management, as recommended by the World Health Organization1a. Raising awareness among prescribers could avoid the application of SoHOs where therapeutic alternatives are available. This practice can also contribute to the sufficiency of supply by ensuring optimum use of SoHOs. / 1a World Health Organization Resolution WHA 63.12, ‘Availability, safety and quality of blood products’, 21.5.2010.

Added:Recital 18: (18) As a matter of principle, programmes promoting the donation of SoHOs should be founded on the principle of voluntary and unpaid donation, altruism of the donor and solidarity between donor and recipient. Such solidarity should be built from the local and regional levels up to the national and Union levels, ensuring autonomy, spreading the responsibility of donation evenly across the Union population and ensuring that recipients receive appropriate treatments. Voluntary and unpaid SoHO donation is also a factor which contributes to high safety standards for SoHOs and therefore to the protection of human health, and increases public trust in donation systems. It is also recognised, including by the Council of Europe Committee on Bioethics24, that while financial gain should be avoided, it may also be acceptable to ensure that donors are not financially disadvantaged by their donation. Thus, financially neutral compensation to remove any such risk is acceptable but should never produce a financial gain for the donor or constitute an incentive that would cause a donor to be dishonest when giving their medical or behavioural history or to donate in any way that could pose risks, in particular donating more frequently than is allowed, to their own health and to that of prospective recipients. Compensation and reimbursement should under no circumstances serve an incentive to recruit donors, should not expose vulnerable persons in society to exploitation and should not lead to c…

Removed:Patient blood management has at least two advantages: it makes it possible to offer patients therapeutic alternatives that are less invasive than transfusions and ensures better management of the available blood supply.

Added:Recital 19: (19) In order to maintain public trust in SoHO donation and use programmes, information that is given to prospective donors, recipients or physicians regarding the likely use and benefits of particular SoHOs or SoHO preparations when applied to recipients should accurately reflect reliable scientific evidence and under no circumstances attribute or imply levels of safety or efficacy that are not supported by scientific methods. This should ensure that donors, or their families, are not coerced to donate by exaggerated descriptions of benefits and prospective recipients are not given false hopes when making decisions on their options for treatment. The verification of compliance with this Regulation through supervisory activities is of fundamental importance to ensure that, across the Union, the objectives of the Regulation are effectively achieved. The responsibility to enforce this Regulation lies with the Member States, whose competent authorities should monitor and verify, through the organisation of supervisory activities, that relevant Union requirements are effectively complied with and enforced.

Removed:Recital 35: (35) The EDQM is a structural part of the Council of Europe working under the European Pharmacopoeia Partial Agreement. The text of the Convention on the elaboration of a European Pharmacopoeia (ETS No. 050), accepted by Council Decision 94/358/EC26, is considered to be the text of the European Pharmacopoeia Partial Agreement. Member States of the Council of Europe that have signed and ratified the European Pharmacopoeia Convention are the member States of the European Pharmacopoeia Partial Agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement, including among others: the European Pharmacopoeia Commission, the European Committee on Organ Transplantation (CD-P-TO), the European Committee on Blood Transfusion (CD-P-TS) and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The European Pharmacopoeia Convention has been signed and ratified by the European Union and all its Member States, all of whom are represented in their intergovernmental bodies. In this context, the work of the EDQM on developing and updating guidelines on safety and quality of blood, tissues and cells, should be considered an important contribution to the field of SoHOs in the Union and should be reflected in this Regulation. The guidelines address issues of quality and safety beyond the risks of communicable disease transmission, such as donor eligibility criteria for the prevention of the transmission of…

Added:Recital 20: (20) Competent authorities should be designated by the Member States for all the areas that fall within the scope of this Regulation. While Member States are best placed to identify the competent authority or authorities for each area, for example by geography, topic or substance, they should also be required to designate a single independent national authority that ensures appropriately coordinated communication with other Member States’ competent authorities and with the Commission. The SoHO National Authority should be considered the same as the designated competent authority in Member States where only one competent authority is designated. The list of all SoHO national competent authorities should be made publicly available.

Removed:Recital 36: (36) The ECDC, established by Regulation (EC) No 851/2004 of the European Parliament and of the Council27 is a Union agency with the mission of strengthening Europe’s defences against communicable diseases. The work of the ECDC on developing and updating guidelines on safety and quality of SoHOs from a communicable disease threat perspective, should be considered an important contribution in the field of SoHOs in the Union and should be reflected in this Regulation. In addition, the ECDC established an expert network for the Microbial Safety of SoHOs, which ensures the implementation of the requirements on the ECDC’s relations with the Union Member States and EEA Member States stated in Regulation (EC) No 851/2004, regarding strategic and operational collaboration on technical and scientific issues, surveillance, responses to health threats, scientific opinions, scientific and technical assistance, collection of data, identification of emerging health threats, and public information campaigns related to the safety of SoHOs. This SoHO expert network should provide information or advice in relation to relevant outbreaks of communicable diseases, including those exacerbated by climate change, in particular regarding the eligibility and testing of donors and the investigation of serious adverse occurrences involving suspected transmission of a communicable disease.

Added:Recital 21: (21) For the performance of supervisory activities aimed at verifying the correct application of SoHO legislation, Member States should designate competent authorities that act independently and impartially. It is therefore important that their function of oversight is separate and independent from the performance of SoHO activities. In particular, competent authorities should be free from undue political influence and from interference by industry or other actors that might affect their operational impartiality.

Removed:Recital 36 a (new): (36a) The Health Emergency Preparedness and Response Authority (HERA), established by Commission Decision 2021/C 3931a, is a Commission service whose missions include strengthening health security coordination within the Union during preparedness and crisis response times, and ensuring the availability and equitable distribution of medical countermeasures during crises. This service should be given an observer role that allows it to access information that may fall within its remit in order to prepare, prevent and respond to the emergence of any diseases that might be transmitted by SoHOs. To this end, HERA will work with the competent national authorities, other Commission services and the ECDC. / 1a Commission Decision of 16 September 2021 establishing the Health Emergency Preparedness and Response Authority (OJ C 393 I, 29.9.2021, p. 3).

Added:Recital 24: (24) When there is doubt about the regulatory status of a particular substance, product or activity under this Regulation, competent authorities should consult the relevant authorities responsible for other relevant regulatory frameworks, namely medicinal products, advanced therapies, medical devices, organs or food, and the SoHO Coordination Board (SCB), with the aim of ensuring coherent procedures for the application of this Regulation and other relevant Union legislation. Competent authorities should inform the SCB of the outcome of their consultations and submit a request to it for its opinion on the regulatory status of the substance. When SoHOs or SoHO preparations are used to manufacture products regulated under other Union legislation, or as the starting and raw material thereof, competent authorities should cooperate with the relevant authorities on their territory. This cooperation should aim to reach an agreed approach for any subsequent communications between the authorities responsible for SoHO and for the other relevant sectors, as needed, regarding authorisation and monitoring of the SoHOs or the product manufactured from SoHOs. Member States should respect the SCB’s opinion on the regulatory status of substances. However, in order to ensure consistent decisions across all Member States with regard to borderline cases, the Commission should be empowered to, on its own initiative or at the duly substantiated request of a Member State or the SCB, decide on the re…

Removed:Recital 37: (37) It is necessary to promote information and awareness campaigns at national and Union level on the importance of SoHOs. The aim of these campaigns should be to help European citizens to decide whether to become donors during their lifetime and let their families or legal representatives know their wishes regarding donation after death. As there is a need to ensure the availability of SoHOs for medical treatments, Member States and the Union should promote the donation of SoHOs of high quality and safety, including plasma used as the starting material for manufacturing of plasma-derived medicinal products. These measures support European self-sufficiency, based on the broadest possible donor base, with a view to ensuring a more resilient supply system. Member States and the Union should also take steps to encourage a strong public and non-profit sector involvement in the provision of SoHO services, in particular for critical SoHOs and the related research and development.

Added:Recital 26: (26) Commission experts should have the necessary experience and knowledge to be able to perform controls, including audits, in Member States to verify the effective application of the relevant requirements of competent authorities and of the supervisory activity systems. Commission controls should also serve to investigate and collect information on enforcement practices or problems, emergencies and new developments in Member States. Official controls should be performed by personnel who are independent, free from any conflict of interest 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.

Removed:Overly frequent plasma donations affect the protein content of the plasma collected and could thus affect the quality of the donation. The more a system relies on a large number of donors, the less likely it is to be affected by external factors (such as the emergence of a pandemic) as the proportion of donors unable to visit a donor centre is, by definition, lower.

Added:Recital 27: (27) Since SoHO preparations are subjected to a series of SoHO activities prior to their release, distribution and issuing, competent authorities should assess and authorise SoHO preparations to verify that a high level of safety, quality and efficacy is achieved consistently by the application of that specific series of activities, performed in that specific manner. When SoHOs are prepared with newly developed and validated collection, testing or processing methods, consideration should be given to the demonstration of safety and efficacy in recipients by means of requirements for clinical outcome data collection and review. The extent of such required clinical outcome data should correlate with the level of risk associated with the activities performed for that SoHO preparation and use. Where a new or modified SoHO preparation poses negligible risks for recipients (or offspring in the case of medically assisted reproduction), the vigilance reporting requirements provided for in this Regulation should be adequate to demonstrate safety and quality. This should apply for well-established SoHO preparations that are introduced in a new SoHO entity but have been robustly demonstrated as safe and effective by their use in other entities.

Removed:Recital 37 a (new): (37a) The COVID-19 pandemic has had adverse effects on the resilience of the donor base in some countries, whose collection systems rely on a small number of donors donating more frequently than elsewhere. These adverse effects are particularly evident in plasma collections and imports. Member States are urged to develop plasmapheresis programmes in order to increase their collection capacity. This will make the donor base more resilient by expanding it as far as possible and, as a result, it will ensure the continuity of supply, including in times of crisis.

Added:Recital 28: (28) Applicants requesting authorisation for a SoHO preparation should use the Euro GTP II methodologies or equivalent tools to assess the risk level of their SoHO preparation. Applicants should share the results of the risk assessments with competent authorities when requesting authorisation. With regard to SoHO preparations that pose a certain level of risk (low, moderate or high), the applicant should propose a plan for clinical outcome monitoring that should fulfil different requirements appropriate to the risk indicated. The most up-to-date guidance of the European Directorate for the Quality of Medicines & HealthCare (EDQM, a Directorate of the Council of Europe) should be considered relevant in the design of clinical follow-up studies proportionate in extent and complexity to the identified level of risk of the SoHO preparation. In the case of low risk, in addition to the mandatory continuous vigilance reporting, the applicant should organise proactive clinical follow-up for a defined number of patients. For moderate and high risk, in addition to the mandatory vigilance reporting and the clinical follow-up, the applicant should propose clinical investigation studies with monitoring of pre-defined clinical end-points. In case of high risk, these should include a comparison with standard treatments, ideally in a study with subjects allocated to test and control groups in a randomised manner, pursuant to Regulation (EU) No 536/2014. Where the standard treatment or control…

Removed:Recital 37 b (new): (37b) The loss of European sovereignty in the area of public health was thrown into sharp relief during the COVID-19 crisis. In this context, the initiatives for a strong Europe of Health should work in favour of European self-sufficiency, in particular as regards the supply of SoHOs and the ability to minimise the risk of shortages, especially of SoHOs for therapeutic use. Following the publication of the strategy for the promotion of European SoHO supply self-sufficiency, Member States should adopt national priority action programmes for donor recruitment.

Added:Recital 28 a (new): (28a) SoHO entities should request approval for SoHO clinical studies from the competent authorities, both in the context of the authorisation process of a new SoHO treatment or when comparing previously authorised treatments. In SoHO clinical studies, patients’ rights, safety, dignity and well-being should always be the priority and the clinical study should be designed in a way that leads to reliable and robust data and conclusions.

Removed:Recital 38: (38) In order to promote a coordinated application of this Regulation, a SoHO Coordination Board (SCB) should be set up. The Commission should participate in its activities and chair it. The SCB should contribute to a coordinating the application of this Regulation throughout the Union, including by helping Member States to conduct SoHO supervisory activities. The SCB should be composed of persons designated by the Member States based on their role and expertise in their competent authorities, and should also involve experts that are not working for competent authorities, for specific tasks where access to necessary in-depth technical expertise in the field of SoHOs is required. In the latter case, appropriate consideration should be given to the possibility of involving European expert bodies such as the ECDC and the EDQM and existing professional, scientific and donor and patient representative groups at Union level in the field of SoHOs. Other Union institutions, services and bodies should be involved as observers, in particular the European Health Emergency Preparedness and Response Authority (HERA), the EMA and the European Parliament.

Added:Recital 29: (29) In the interests of efficiency, it should be permitted to conduct clinical studies using the established framework in the pharmaceutical sector for clinical trials, as set out in Regulation (EU) No 536/2014 of the European Parliament and of the Council25, when operators wish to do so. The commitment to publish the clinical results obtained should be a requirement for SoHO clinical studies. Whilst applicants can choose to record the clinical data generated during the clinical studies themselves, they should also be permitted to use existing clinical data registries as a means of such recording when those registries have been verified by the competent authority, or are certified by an external institution, in terms of the reliability of their data management procedures. The existence of a registry of SoHO clinical studies at Union level is critical to facilitate patient participation in clinical studies, to boost multi-centre studies and to foster collaboration to generate more robust results and conclusions, and to make such generated knowledge available to other researchers, healthcare professionals, participants themselves and the general public.

Removed:Recital 41: (41) In order to limit administrative burden on competent authorities and the Commission, the latter should establish an online platform (the ‘EU SoHO Platform’) to facilitate timely submission of data and reports, to make it possible to share the elements used to determine the regulatory status of a substance and to improve the transparency of national reporting and supervisory activities. The competent national authorities should be encouraged to use the EU SoHO platform instead of maintaining national registers, in particular to limit the administrative burden.

Added:Recital 30: (30) In order to facilitate innovation and reduce administrative burden, competent authorities should share with each other information on the authorisation of new SoHO preparations and the evidence used for such authorisations, through the EU SoHO Platform, including for the validation of certified medical devices used for SoHO collection, processing, storage or application to patients. Such sharing could allow authorities to accept previous authorisations granted to other entities, including in other Member States and to thus significantly reduce the requirements to generate evidence. Competent authorities should also share with each other information on SoHO clinical studies, via the EU SoHO Platform.

Removed:Recital 47: (47) The exchange of SoHOs between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages. For certain SoHOs that need to be matched between the donor and the recipient, such exchanges are essential to allow patients to receive the treatment they need.

Added:Recital 32: (32) Competent authorities should periodically review the SoHO entities registered in their territory and ensure that those entities that carry out both processing and storage of SoHOs 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. Competent authorities should consider the impact on safety, quality and efficacy of the SoHO activities carried out at SoHO entities that do not meet the definition of a SoHO establishment and decide whether particular entities should be subject to establishment authorisations 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 as SoHO establishments.

Removed:Recital 47 a (new): (47a) The objective of this Regulation, namely to ensure quality and safety of SoHOs and a high level of protection of donors, needs to be achieved at Union level, by establishing high standards of quality and safety for SoHOs, based on a common set of requirements that are implemented in a consistent manner across the Union. Thus, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.

Added:Recital 33: (33) With regards to standards concerning donor, recipient and offspring protection, this Regulation should provide for a hierarchy of rules for their implementation. As risks and technologies change, this hierarchy of rules should facilitate an efficient and responsive uptake of the most up-to-date guidelines based on scientific evidence for implementing the standards set out in this Regulation. As part of that hierarchy, in the absence of Union legislation describing particular procedures to be applied and followed to meet the standards set out in this Regulation, following the guidelines of the European Centre for Disease Prevention and Control (ECDC) and the EDQM should be considered as a means to demonstrate compliance with the standards laid down in this Regulation. Member States should be able to decide that SoHO entities should be permitted to follow other recognised guidelines, provided that such guidelines are based on the most up-to-date scientific evidence and achieve the same level of quality, safety and efficacy. Member States should be involved in both the drafting of and voting on those guidelines and should follow a transparent process of consultation with other relevant Union authorities and stakeholders. SoHO entities should be permitted to follow other guidelines, provided that it has been demonstrated that those other guidelines are based on the most up-to-date scientific evidence and achieve the same level of quality, safety and efficacy. In cases of det…

Removed:This provision should apply throughout the text and not only to SoHO exchanges. For the sake of clarity, it is therefore recommended that recital 47 be divided into two separate recitals.

Added:Recital 35: (35) The EDQM is a structural part of the Council of Europe working under the European Pharmacopoeia Partial Agreement. The text of the Convention on the elaboration of a European Pharmacopoeia (ETS No. 050), accepted by Council Decision 94/358/EC26, is considered to be the text of the European Pharmacopoeia Partial Agreement. Member States of the Council of Europe that have signed and ratified the European Pharmacopoeia Convention are also member States of the European Pharmacopoeia Partial Agreement and are therefore the members of the intergovernmental bodies functioning within the framework of this partial agreement, including among others: the European Pharmacopoeia Commission, the European Committee on Organ Transplantation (CD-P-TO), the European Committee on Blood Transfusion (CD-P-TS) and the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). The European Pharmacopoeia Convention has been signed and ratified by the European Union and all its Member States, all of whom are represented in their intergovernmental bodies. In this context, the work of the EDQM on developing and updating guidelines on safety and quality of blood, tissues and cells, should be considered an important contribution to the field of SoHOs in the Union and should be reflected in this Regulation, without prejudice to the Union’s legal autonomy. The guidelines address issues of quality and safety beyond the risks of communicable disease transmission, such as donor eligibility …