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Common representation of Substances of Human Origin’s (SoHO)

CoRe SoHO

The main goal of this consortium is to provide representative technical expertise to the European decision making organizations in the field of SoHO.

Lobbying Activity

Response to Revision of the Union legislation on blood, tissues and cells

7 Sept 2022

The Common Representation of Substances of Human Origin (CoRe SoHO), the consortium of professional scientific associations in the field of SoHO, welcomes the proposed Regulation that reaffirms its central principles: • VUD - non financial gain The principle of voluntary and unpaid donation has been upheld in the proposal, which also includes references to the provisions in the European Charter of Human Rights, such as integrity of the person and non-commercialisation of the human body. • Donor protection The proposal includes standards to strengthen the safety and wellbeing of SoHO donors, patients and children born from donated eggs, sperm or embryos as well as the requirement to collect data in these groups, such as Serious Adverse Occurrences. Nevertheless, there is a need for some clarifications. While we encourage reporting of SAOs in general, the regulation should be more specific on what should be reported to avoid unnecessary administrative burden. • Sufficiency and access The Commission’s choice to legislate through a Regulation, directly applicable in all Member States (MS), will improve harmonization across MS and facilitate exchange of SoHO between them, which is necessary for ensuring patient access and sufficiency of supply. CoRe SoHO was also pleased to see the recognition of the importance of building and supporting a strong public and non-profit sector for ensuring resilience and continuity in supply of SoHO. However, CoRe SoHO would also like the regulation to foresee the development of policies or strategies at the EU-level to encourage sufficiency of SoHO in the EU, and not only in times of crisis. • Promotion of clinical efficacy, quality and safety of treatments and the development of new treatments The more comprehensive approach to regulating SoHO should mean that it will be easier to develop innovative products and methodologies, as well as ensure patients' access to these. In addition, the new framework to include the expertise of EDQM and ECDC will also contribute to a more flexible and future-proof regulatory environment. Moreover, the established collaboration between these bodies and expert societies from the specific SoHO fields ensures that guidance is based on the latest scientific evidence. The regulation should also seek to develop common standards and guidelines, and thus EU added-value, for the consent and use of donated blood, tissues and cells that have been evaluated as being unsuitable for use on patients instead to be used for research, training and educational purposes. Finally, we support risk based data collection requirements to improve monitoring of the efficacy and safety of treatments, particularly in the case of innovative treatments. However, resources should be made available to all entities involved to offset the increased administrative burden. Overall, the CoRe SoHO consortium and its individual constituent professional scientific associations look forward to engaging with the European decision-making organisations in the finalisation of this legislation. We also look forward to collaborating with the European Commission, ECDC, EDQM and MS competent authorities in the implementation, assessment, progress monitoring/oversight of the resulting Regulation, through adequate representation in the SoHO Platform and in the coming process of developing the new proposed standards and quality for SoHOs. The CoRe SoHO consortium is composed of representatives from: • European Association of Tissue and Cell Banks (EATCB) • European Blood Alliance (EBA) • European Eye Bank Association (EEBA) • European Society for Blood and Marrow Transplantation (EBMT) Although not a full partner of CoRe SoHO, the European Society of Human Reproduction and Embryology (ESHRE) supports this statement. You can read a more detailed position, as well as more about the CoRe SoHO consortium and its members, in the attached file.
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Response to Revision of the Union legislation on blood, tissues and cells

14 Dec 2020

The Common Representation of SoHO Associations (CoRe SoHO) formed by the 4 professional associations EBMT, EEBA, EATCB, EBA from the fields of stem cells, eye banking, tissue and cell banking and blood respectively, welcomes the opportunity to give feedback on the Inception Impact Assessment. Overall, of the 3 proposals presented, there is a shared preference for Proposal 2 in so much as it is understood as a very high-level outline and if the reliance on external bodies to develop the technical requirements is made robust and clear. We also understand that a combination of options could also emerge. CoRe SoHO highlights the following aspects considered of common interest that are addressed by the assessment: 1. Classification and novelty o SoHO are likely to see growing applications as medicinal products as technology and research evolve and CoRE SoHO agrees that the field is constantly progressing. This requires a more agile framework to be able to respond to changes in science and practice. We see the need to develop a mechanism to distinguish between substances and regulatory frameworks, inclusive of all stakeholders and safeguarding research and development optimising patient access to therapies.. o The evaluation of the legislation on blood, tissues and cells highlighted classification of borderline products to be a source of inconsistency and uncertainty. Public feedback also reported “inconsistencies between the SoHO legal frameworks”. This impact assessment mentions this issue, refers to novelty and proposes a European mechanism to “advising [sic] Member States on [which] … framework… should be applied”. However, this understates the question and it is not clear what this mechanism will be and how it will help to ensure consistent implementation and interpretation of the legal framework across the EU. More details of what is proposed are very much needed before a more considered opinion could be offered. 2. Variation between member states in the implementation o We believe that this needs to be addressed through more common inspection policies and procedures and leveraging or complementing existing professional certification schemes e.g., JACIE and would support those measures proposed in the Assessment. 3. VUD o Candidates to be donors come forward out of altruistic motives and any move towards commercialisation of this key process risks coercion and exploitation of donors, increased risk to patients, harm to local clinical programs and international exchange, and the possibility of benefiting some patients while disadvantaging others. o The Impact Assessment appears to say that VUD will be left to the Member States in spite of the Evaluation highlighting this as unsatisfactorily addressed under the current framework. More details on what is proposed are necessary. 4. Harmonisation outcome data collection o The use of outcome data collected in a common platform on the principle of ‘collect-once, use-often’ to minimise duplication with data sharing rules to allow multiple stakeholders access o Consideration needs to be given as to how to bridge the gap between the tissue establishment (TE) and the site of clinical application which creates a data vacuum and undermines any attempts to link outcome to TE performance and compliance o Mechanisms to support data collection on supply and needs of SoHO to achieve maximum levels of sufficiency at EU level 5. Donor protection o The legal framework should firmly protect donor interests and health including follow-up 6. Commoditisation of SoHO o The four associations support any measures that avoid commoditisation of SoHO 7. Measures to ensure EU-level sufficiency of SoHO
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Meeting with Anne Bucher (Director-General Health and Food Safety)

1 Apr 2019 · topics of discussion: Donor/patient protection ( monitoring and prevent SARE, communicate risks, balance donor risk with patients benefits, use of SoHO as starting material for ATMP, etc); Legislation: impact of EU regulation for SoHO sector; Directives review and possible revision; SoHO classification; current challenges; and impact for donation and clinical application; Access to treatment and harmonization of practices