Standards of quality and safety for substances of human origin intended for human application

EPODIN POSITION AND PROPOSALS (see full version attached) EPODIN thanks the European Commission for all its work. In particular, EPODIN strongly supports the balanced approach of the European Commission. The complexity of the topic, and the multiplicity of stakeholders make the SOHO legislation something complex to work on.

The umbrella organization of registered German naturopaths (Dachverband Deutscher Heilpraktiker e.V./DDH and Drug Commission of German natural practitioners/AMK) welcomes the opportunity to provide feedback on the Commission’s Proposal for a Regulation on Substances of Human Origin (SoHO). The reasons and objectives of the proposal refer (source page 1 point 1) to Directives 2002/98/EC and 2004/23/EC.

With the aim to harmonize the development, clinical testing and sustained patient access of advanced therapy medicinal products (ATMPs), the Dutch platform for cancer-specific ATMP Research (DARE-NL) supports the proposal of the European Commission to increase the safety and quality of substances of human origin.

In July 2022, the European Commission adopted the proposal for a regulation on standards of quality and safety for substances of human origin (SoHo) intended for human application. Previously unregulated at EU level, this new proposal has extended its scope of SoHo to “human breast milk”.

The Vigilance Expert Subgroup (VES) of the National Competent Authorities expert group for Blood, Tissues and Cells has reviewed the proposed Regulation on Substances of Human Origin as published in July 2022, with a special focus on requirements related to vigilance. With reference to the VES recommendations which were submitted in 2021, many are incorporated in the proposed regulation which we welcome.

Sanquin Blead bank (the Netherlands) welcomes the proposed SoHO Regulation. We are pleased to see that all substances acquired or donated from the human body with the purpose of applying it to a human body will fall under the scope of the SoHO Regulation.

Filed in Dutch · English published by the European Commission

Trip (Transfusion and Transplantation Reactions in Patients) welcoming the proposed regulation for substances of human origin, which will produce about many causes in response to Shortcomings which emerged from the evaluation of the blood, tissues and cells legislation. In the attachment TRIP reports the Commission’s awareness to a number of areas of group.

Filed in Dutch · English published by the European Commission

FACHVERBAND DEUTSCHER HEILPRAKTIKER e.V. • Maarweg 10 • 53123 Bonn The reasons and objectives of the proposal refer (source page 1 point 1) to Directives 2002/98/EC and 2004/23/EC. These have contributed to the "safety of millions of patients treated with blood transfusions, transplants, or medically assisted reproduction." The new safety standards are intended to update the blood, tissue and cell regulations, which…

World Marrow Donor Association (WMDA), the association of not-for-profit donor registries and cord blood banks, welcomes the Commission’s proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application. WMDA maintains the database of over 40 million potential volunteer donors and cord blood products available from 55 countries.

The Association for the Advancement of Blood and Biotherapies (AABB) is an international, not-for-profit association representing institutions and individuals involved in transfusion medicine and biotherapies. AABB is committed to “improving lives by making transfusion medicine and biotherapies safe, available and effective worldwide.” AABB works toward this vision by developing and delivering standards…

International Plasma and Fractionation Association (IPFA) welcomes this European Commission proposal for a new regulation on SoHOs. We are pleased to see that many of our recommendations have been considered in this proposal. IPFA also recognises the intense preparative work accomplished by the Commission in integrating all SoHOs in this proposal.

The European Hematology Association (EHA) warmly welcomes the legislative proposal for an EU SoHO Regulation which represents a big step forward for protecting patient and donor safety, improving access to SoHOs and innovative SoHO-derived therapies, ensuring sustainability of supply, facilitating innovation, and for increasing efficiency and coherence of regulation and oversight.

Introduction We acknowledge the European Commission’s proposal on standards of quality and safety for Substances of Human Origin (SoHO) for human application and welcomes the opportunity to participate to this consultation.

The German Society for Transfusion Medicine and Immunohematology („Deutsche Gesellschaft für Transfusionmedizin und Immunhämatologie”, DGTI) welcomes the objectives of this proposal of a regulation for Substances of Human Origin (SoHOs).

Sevibe Cells welcomes the Commission proposal for an EU regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application (2022/0216). We agree that a up to date framework in needed for this kind of activities to place EU in the latest and highets standards in this field, a challenging field for the benefit of patients and donors.

The Norwegian Medicines Agency (NOMA) welcomes the possibility to comment on the Commission proposal on the regulation of the Standards of Quality and Safety for Substances of Human Origin (SoHO). NOMA acknowledges the need for revision of the SoHO legislation. However, as commented on previously, NOMA is concerned about the lack of clarity as well as the expansion of scope in the Commission proposal.

The International Patient Organisation for Primary Immunodeficiencies (IPOPI) welcomes the European Commission proposal for a Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application published in July 2022.

AIM, the International Association of Mutual Benefit Societies, the leading international association of not-for-profit healthcare insurers, representing not-for- profit organisations providing health coverage to around 200 million people in Europe, welcomes the European Commission’s proposal to revise the framework for standards of quality and safety for substances of human origin.

1.IT IS NOT POSSIBLE TO CALL A GIFT TO AN EVENT THAT IS FINANCIALLY REMUNERATED We hope that the new European regulation will solve the problems of structural dependence on paid human plasma for the manufacture of medicines used in Spain (and the European Union as a whole): between 50 % and 70 % of the plasma used comes from the purchase/sale of plasma from poor US (and Mexican) donors who should never be considered…

Filed in Spanish · English published by the European Commission

1 Will it be necessary for sponsors of IMT products to apply and secure approval from both the drug regulatory bodies and the SoHO authorities, i.e. will two pathways need to be followed? EBX has been developing its products primarily according to the pharmaceutical legislation as the company intends to apply for a Marketing Authorisation in one or more medical conditions.

Our cooperation of Professional Associations of German State-Registered CAM Practitioners (Gesamtkonferenz Deutscher Heilpraktikerverbände und Fachgesellschaften) welcomes the opportunity to provide feedback on the Commission’s Proposal for a Regulation on Substances of Human Origin (SoHO).

As a patient-focused, values-based, R&D-driven global biopharmaceutical company, Takeda welcomes the proposal for a new Regulation on Substances of Human Origin (SoHO) and the Commission's efforts to help ensure legislation can respond to new scientific and technical developments while meeting the needs of European patients and safeguarding donor health and safety.

Fertility Europe would like to present remarks to be considered. - We welcome proposed increased level harmonisation of practices in the field of MAR across European Member States by proposing a joint regulation to replace the current Directives. - We appreciate the proposed change in the definitions of ‘within couple use’ and ‘third party donation’ to replace the current terminology.

ESHRE welcomes the Commission’s publication of the Proposal for a Regulation on standards of quality and safety for substances of human origin (SoHOs) intended for human application. While we have already made a number of recommendations for the field of medically assisted reproduction (MAR) during its drafting phase, we would like to use this opportunity to express our position on the published proposal and present…

European Sperm Bank welcomes the commission’s proposal and acknowledges the increased focus on donor protection, regulatory oversight and the recommendation of implementation policy option 2. European Sperm Bank believes that a strengthen harmonization across countries as we believe this will benefit both the donors, the parents, and the donor children.

The Alliance for Regenerative Medicine (ARM) welcomes the European Commission’s efforts to update and harmonise the standards of quality and safety for substances of human origin (SoHO) and the choice of a Regulation as the legal instrument for this. The proposed Regulation is of great relevance to ATMP developers because SoHO are most often used as starting materials for ATMPs.

MedTech Europe welcomes the Proposal for a Regulation on substances of human origin adopted by the European Commission in July 2022. We agree that the sector needs updated legislation, and the proposed text reinforces the rules for safety and quality. We are looking forward patients to having smooth access to products, the availability of which is uninterrupted on the European market.

Cryos International Sperm & Egg Bank agrees on the identified shortcomings and inadequacies in the current European Tissues and Cells Directive and implementing Directives and welcomes update of the current legislation to allow for more flexible alignment to scientific and technological developments. Cryos appreciates that policy option 2 is chosen to solve the current challenges.

Our company develops microbiota-derived Live Biotherapeutic Products We have a couple of concerns: 1. Regarding the updating of Pharmaceutical legislations, will SoHO or the legislation prevail? Shall we need to fulfill both drug and SoHO preparations requirements? 2. Regarding single strains, will they be considered as SoHO, which is highly questionable Best,

The proposed Substances of Human Origin(SoHO) Regulation intends to harmonize measures for Member States and organizations involved in activities related to SoHOs for human application, facilitating cross-border exchange and continuity of supply in the EU. EFPIA supports these aims but is concerned about areas of the SoHO Regulation that appear incoherent with medicinal product regulation.

We would like to thank for the possibility to comment 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 (hereinafter “SoHO Regulation Proposal”).

ICCBBA (www.isbt128.org/about-iccbba) broadly welcomes the proposed framework for Blood, Tissues and Cells as an advance on the current directives. We wish to highlight the following: A prerequisite for safety through biovigilance is an ability to effectively trace a product from the donation event to its transfusion or transplantation into another person.

Introduction We acknowledge the European Commission’s proposal on standards of quality and safety for Substances of Human Origin (SoHO) for human application and welcomes the opportunity to participate to this consultation.

We welcome the Commission proposal for an EU regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application (2022/0216). Regarding the choice of the legal instruments, the implementation of a single Regulation that will directly apply in all member states and the possibility to use EDQM and ECDC guidelines for more efficient updating of the technical requirements…

Introduction We acknowledge the European Commission’s proposal on standards of quality and safety for Substances of Human Origin (SoHO) for human application and welcomes the opportunity to participate to this consultation.

Amsterdam 8 September 2022 Feedback Winclove Probiotics BV on proposed SoHO regulation COM(2022) 338 final To the European Commission, Winclove Probiotics BV in Amsterdam welcomes the opportunity granted to provide feedback to the proposed Regulation on standards of quality and safety for substances of human origin intended for human application (COM(2022) 338 final).

Application for Amendment Relating to the proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on quality and safety standards for substances of human origin for use in humans and the cancellation of Directives 2002/98/EC and 2004/23/EC The new safety standards are intended to ensure the safety and quality of substances of human origin (hereinafter "SoHO") and thus a high level of health…

We acknowledge the European Commission’s proposal on standards of quality and safety for Substances of Human Origin (SoHO) for human application and welcomes the opportunity to participate to this consultation. This will increase EU harmonization on protection of the rights and safety of SoHO donors and recipients and create a regulatory status and common rules for SoHOs currently not regulated neither as medicinal…

Grifols welcomes the adoption of the proposal for a Regulation on standards of quality and safety for substances of human origin (SoHO). The proposal is an important step to modernise the SoHO regulatory framework and has the potential to increase the supply of essential medicines for patients reliant on plasma therapies for rare, chronic and life-threatening conditions.

Thank you for the possibility of an opinion! In principle, the European Commission’s intention to strengthen patient and consumer protection in connection with substances of human origin (SoHO) is very welcome and is strongly supported by us.

Filed in German · English published by the European Commission

DONOR HUMAN MILK AS SUBSTANCE OF HUMAN ORIGIN – JOINT STATEMENT of the German Human Milk Bank Initiative (FMBI), Bundesverband "Das frühgeborene Kind" e.V., the national parent organization for preterm infants in Germany, German Society for Pediatric and Adolescent Medicine (DGKJ), German Society for Social Pediatrics (DGSPJ), German Society of Gynaecology and Obstetrics – Working Group Obstetrics and Prenatal…

In the context of the French Bioethics Law, Article 35 describes the existence of authorised stool collection centres for medical purposes. The responsibility of these centres covers the selection of donors to the transmission of human samples, but biological quality remains the responsibility of the processor. Health responsibility, for its part, rests on both entities.

Filed in French · English published by the European Commission

The European Haemophilia Consortium (EHC) welcomes the European Commission’s proposal for a regulation on quality and safety standards for substances of human origin. The EHC represents European people with rare congenital bleeding disorders, including haemophilia and von Willebrand Disease. For some of these conditions, plasma-derived medicinal products (PDMP) remain the primary source of treatment.

The National Agency for the Safety of Medicines and Health Products (ANSM) welcomes the important work carried out by the European Commission in proposing an ambitious text in relation to existing European legislation, which is based on extensive consultation, taking into account the problems raised by the current directives and the innovation of products developed in this field, in particular by targeting all…

Filed in French · English published by the European Commission

EBMT welcomes the Commission proposal for an EU regulation on standards of quality and safety for substances of human origin intended for human application Leiden, 8 September 2022 The EBMT is a community of hospitals and healthcare professionals specialised in stem cell transplantation and cellular therapies.

Introduction Europe has gained a leading position in microbiome science and yet, to fulfil societal expectations, an international consensus will be essential on key aspects. For this reason, the Human Microbiome Action project (IHMCSA - grant number 964590) welcomes the proposal for a regulation on standards of quality and safety for Substances of Human Origin (SoHO) intended for human application which, by…

AVIS – (Associazione Volontari Italiani Sangue), the Italian association of volunteer blood donors, welcomes the Commission’s proposal on standards of quality and safety for substances of human origin intended for human application, which is certainly capable of increasing the quality and safety levels of donated blood and blood components in the Member States.

The Regulatory Institute is pleased to respond to the “Blood, tissues and cells for medical treatments & therapies – revised EU rules” proposal. The Regulatory Institute is a non-profit think tank which identifies, develops and promotes best regulatory practices. We aim to improve regulation globally so that regulations benefit us all.

General remarks : - The current proposal has been edited with mainly input from the Competent Authority (CA), with limited input from the field. - The need to collect information in an IT platform, separate from the own registration and QMS systems of the individual SoHO establishments, will give rise to duplication of work and possibly errors.

PPTA feedback on EU Commission proposal for a EU Regulation on standards of quality and safety for substances of human origin (SoHO) The EU Commission proposal for a SoHO Regulation is an opportunity to help ensure broad and reliable patient access to life-saving plasma-derived medicinal products (PDMPs) and the health and the safety of plasma donors.

Finnish Red Cross Blood Service (FRCBS) is the sole Blood Establishment in Finland and is responsible for the national blood supply chain in normal and exceptional circumstances. In addition, FRCBS operates the Finnish Stem Cell Registry and acts as a manufacturer of ATMP medicinal products.

Application for Amendment Relating to the proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on quality and safety standards for substances of human origin for use in humans and the cancellation of Directives 2002/98/EC and 2004/23/EC The new safety standards are intended to ensure the safety and quality of substances of human origin (hereinafter "SoHO") and thus a high level of health…

Dear EU Commission, first of all thank you for this proposal regarding the regulation on standards of quality and safety for Substances of Human Origin (SoHO) intended for human application which will increase EU harmonization on protection of the rights and safety of SoHO donors and recipients.

IPA Europe representing the probiotic food and food supplements in Europe acknowledges the European Commission’s proposal on Blood, Tissues and Cells and welcomes the opportunity to participate to this consultation. The Substances of Human Origin (SoHO) framework applies on the first activities in the chain (donation, collection, testing).

Polski Bank Komórek Macierzystych (PBKM) is the stem cell bank in Poland. It stores biological material from customers from dozens of European countries. It also have great experience in donating material for transplantation.

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…

EuropaBio welcomes the adoption of the proposal for a Regulation on SoHO revising the EU’s Blood, Tissues, and Cells (BTC) legislation. The EU needs a predictable, future-proof, and robust SoHO framework to ensure the uptake of transformative advanced therapies which hold great potential for both the health and wellbeing of patients and the sustainability of healthcare systems.

The European Blood Alliance, representing public/not-for-profit blood establishments, welcomes the European Commission’s proposal for a SoHO Regulation and is pleased with the general direction of the proposal and its level of ambition.

BIOPROTEC is a French tissue bank authorised to carry out activities in the preparation, preservation, distribution and disposal of vessels of human origin kept between + 2 °C and + 8 °C in order to meet the therapeutic needs for vascular surgery.

Filed in French · English published by the European Commission

EUCOPE welcomes the proposal for a Regulation on standards of quality and safety for substances of human origin intended for human application. We welcome the transition of the BTC Directives into one Regulation which will increase regulatory predictability and harmonization. We welcome the continued regulatory delineation between BTCs and pharmaceutical products to increase regulatory predictability.

The Blood Transfusion Association (BTA) welcomes the European Commission’s proposal for a Regulation on Substances of Human Origin (SoHO) and the opportunity to provide feedback. The BTA is satisfied with the positive progress made with the proposal. However, we are eager to see improvement in certain areas of the proposal.

In July 2022, the European Commission (EC) adopted the proposal for a Regulation on Standards of Quality and Safety for Substances of Human Origin (SoHO) Intended for Human Application. We note that SoHO has been extended to “human breast milk” (as described in the proposal), which was previously left unregulated at EU level.

As the umbrella organisation of 1 903 German hospitals in public, private and non-profit-making capacity, the German Hospital Company (DKG) has been playing a constructive role in health policy at EU level for many years.

Filed in German · English published by the European Commission

I report these comments on behalf of EATCB, European Association of Tissue and Cell Banks. In the file attached there is a more detailed table for your consideration. Below a brief summary. Art 2. The Regulation shall not be applied to the entities that carry out human application of SoHOs.

UEG Response to the EU Proposal for a Regulation on Blood, tissues and cells for medical treatments & therapies United European Gastroenterology (UEG) is a professional non-profit organization combining all the leading European medical specialists and national societies focusing on digestive health.

The European Network Of Tissue Establishments (eNOTE) gathers several European tissue banks, mainly involved in the field of bone grafting for orthopaedic et dental applications. Contrary to the heterogeneous situation that prevails today between Member States with Directive 2004/23, the new regulation 2022/0216 provides a favorable framework for the harmonization of practices, conditions of authorization and…

The Finnish Medicines Agency (Fimea) would like to thank the European Commission for the possibility to comment 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 (hereafter, the SoHO Regulation Proposal).

Art 2. The Regulation shall not be applied to the entities that carry out human application of SoHOs. Since each SoHO preparation is approved, a package insert should be available providing the relevant instructions for use so users will have access to necessary information to similar medical devices and pharmaceuticals.

Terumo Blood and Cell Technologies (TBCT) welcomes the opportunity to provide feedback on the Commission’s Proposal for a Regulation on Substances of Human Origin (SoHO). While the Proposal significantly improves the regulatory framework for SoHO products, additional steps outlined in this submission will strengthen the Regulation to ensure greater protection for patients and donors, and safeguard SoHO products…

Cerus welcomes the European Commission's proposal for a Regulation on standards of quality and safety for substances of human origin (SoHO), as it presents an opportunity to further foster innovation and address the above challenges.

BIOBank is the leading French bone tissue bank whose grafts are used in France and in several European Union countries for bone tissue regeneration in orthopedic surgery, spinal surgery, maxillofacial surgery and oral implantology. Several hundred surgeons perform more than 60,000 grafts per year.

The Cord Blood Association (CBA) is an international, non-profit organization that promotes both public & family cord blood banking, with the objective to accelerate the use of cord blood and perinatal tissues to benefit patients and advance medicine. The CBA appreciates the initiative of the European Institutions to harmonize the regulation of substances of human origin (SoHO).

FFDSB’s position on the European regulation resulting from the revision of European directives. The French Federation for Voluntary Blood Donation enshrines its comments and proposals, in the ethical spirit of respect for the health and dignity of the donor of donated elements from the human body, in accordance with the principles laid down in the Oviedo Convention.

Filed in French · English published by the European Commission

The PRI welcomes the proposal for a Regulation on standards of quality and safety for Substances of Human Origin (SoHO) intended for human application which will increase EU harmonization on protection of the rights and safety of SoHO donors and recipients.

Mentop Pharma e.K. produces autologous homeopathic medicinal products in accordance with Paragraph 13 of the AMG. We want a derogation from the EU SoHO Regulation for autologous homeopathic medicinal products. I propose the following amendment: It is therefore proposed to supplement Article 2(2) SoHO-VO(E) with the derogation set out in point (d) as follows: (2) In cases of autologous use of SoHO, where (...) (D)…

Filed in German · English published by the European Commission

In this memo (see attachment), Red Cross Belgium supplements the recommendations of the European Blood Association (EBA) with general and specific comments. The general comments concern: 1. Role of national blood societies and Red Cross Societies: A unified European market implies that priority is given to commercial players. 2.

Art 2. The Regulation shall not be applied to the entities that carry out human application of SoHOs. Since each SoHO preparation is approved, a package insert should be available providing the relevant instructions for use so users will have access to necessary information to similar medical devices and pharmaceuticals.

The new safety standards are intended to ensure the safety and quality of substances of human origin (hereinafter "SoHO") and thus a high level of health protection for the citizens of the EU. This intent is definitely most welcome! However, as a result of the language in the current proposal, it would no longer be possible to perform numerous common procedures of a proven method of therapy, namely autohemotherapy.

The reasons and objectives of the proposal refer (source page 1 point 1) to Directives 2002/98/EC and 2004/23/EC. These have contributed to the "safety of millions of patients treated with blood transfusions, transplants, or medically assisted reproduction." The new safety standards are intended to update the blood, tissue and cell regulations, which are outdated after more than 20 years, to achieve a high level of…

Buongiorno, as an association of priority and life-saving patients using plasmaderate drugs, seems to us to focus on system, safety and availability priorities. On the issue of safety, we do not see any particular problems of satisfaction.

Filed in Italian · English published by the European Commission

The Regulation will make it very difficult for small tissue establishments and tissue establishments which are an integral part of regular activities, such as bone tissue establishments where femur heads are absorbed in the context of primary hip prostheses. Among other things, the requirement for machine-readable labels may be difficult to achieve.

Filed in Swedish · English published by the European Commission

Dear Sir / Madam, The proposed regulation also applies to homeopathic preparations of human origin. We send our statement as an interested party (European Committe for Homeopathy) We call for an exemption for homeopathic preparations, defined in Article 1 (5) of Directive 2001/83/EC.

Time for Lyme ASBL welcomes the opportunity to give feedback about blood transfusion safety. Lyme disease (including Borreliosis), which is transmitted to humans by infected ticks, is the most common and increasing zoonosis in Europe.

Comments from the Ethics Council on the Proposal for a Regulation of the European Parliament and of the Council on standards of quality and safety of substances of human origin intended for human use address the following: The Council notes that the proposed Regulation can have a positive impact on ensuring the safety of donors and recipients, as well as on ensuring access to and quality of blood tissues and cells…

Filed in Danish · English published by the European Commission

BPI welcomes the proposal for a Regulation on Substances of Human Origin (SoHO) presented by the European Commission on 14 July 2022 to replace the current EU legislation on blood, tissues and cells (BTC). The European Union needs a predictable, future-proof and resilient regulatory framework for SoHO.

From the sterility section of the Spanish Society of Ginecology and Obstetricia (SEGO), having analysed the draft European Regulation, we would like to submit the following suggestions for consideration: 1.- knowledge and medical experience indicate that ectopic pregnancy, like non-evolutionary pregnancy or molar degeneration, are risks inherent to pregnancy itself and, consequently, should not be regarded as…

Filed in Spanish · English published by the European Commission

CSL Vifor welcomes the European Commission’s proposal on Blood, Tissues and Cells. The existing Directives have done much to ensure the safety of blood and blood derived products. However, the consultations that the European Commission has carried out showed that the legislation has not done enough to manage the sustainability of red blood cells, blood derived product and plasma products.

General 1. MMCC/EMC has sent a questionnaire to his 18 participating nations. The intent was to create a database of blood products in use its member states, to show available blood products in the respective nations and the possible options of substitution. 2.

Good days, following a review of the European Commission’s proposal for a regulation, the training of the head of a SOHO centre should be reviewed, as it is stated that he must be a doctor. The training for this post should be extended to other training courses such as chemists, biologists, biochemistry, biotechnologists or persons accrediting training in that position, but should not leave it exclusively for…

Filed in Spanish · English published by the European Commission

The European Commission has identified donor human milk as a substance that is unregulated or regulated in divergent ways within the EU. The German Human Milk Bank Initiative welcomes and supports the European Commission’s intention to regulate the use of donor human milk in order to ensure that patients and donors are not exposed to avoidable risks but emphasises that availability of donor human milk must not be…

The Human Milk Foundation (HMF) welcomes the European Commission’s Inception Impact Assessment on the revision of legislation related to blood, tissues and cells. As the planned revision will include innovative therapies, including novel substances of human origin in current use but not regulated at EU level, we understand that the potential regulation of donor human milk from human milk banks will be considered.

As the recent report of the European Academies of Science Advisory Council (EASAC) and Federation of the European Academies of Medicines (FEAM) indicated (2nd June 2020), as well as the statement of the Committee for the Advanced Therapy European Medicines Agency of 28th April clearly warned, there is a growing problem of the offering of unregulated, unproven therapies named the stem cells therapies proposed as…

A revision of the BTC legislation to ensure a more holistic and consistent approach to the regulation of substances of human origin is welcomed and endorsed, to ensure mutual trust and acceptance between national authorities, regulatory certainty and equal levels of safety and quality for patients. Moreover, a harmonised and consistent approach to donor safety and traceability is urgently needed.

EuropaBio is committed to ensuring the EU’s uptake of transformative advanced therapies which hold great potential for both the health and wellbeing of patients and the sustainability of healthcare systems. Some ATMPs are subject to the provisions of both the BTC and the legislation for medicinal products.

Comments from the Norwegian Medicines Agency on the Inception Impact Assessment for the revision of the Union legislation on blood, tissues and cells The Norwegian Medicines Agency (NOMA) welcomes the possibility to comment on the Commission’s Inception Impact Assessment for the revision of the blood, cell and tissue (BTC) legislation. NOMA acknowledges the need for revision of the BTC legislation.

EURORDIS-Rare Diseases Europe acknowledges the need to revise existing legislation for Blood, Tissue and Cell derived products as they did not suffice to ensure EU self-sufficiency for these products, while their safety may still be a concern. Also, important disparities exist in the EU, between Member States where these products are available and used, and other MS where they are too difficult to obtain.

Takeda is a global, patient-focused, values-based and R&D-driven biopharmaceutical company committed to better health and a brighter future. We welcome the initiative to review EU legislation on Blood, Tissues and Cells (BTC) to ensure it considers new scientific and technical developments and includes the necessary provisions to meet donor and patient needs, while ensuring their safety.

The Cord Blood Association (CBA) appreciates the opportunity to submit comments regarding the revision of the Blood Directive 2002/98/EC and the Tissues and Cells Directive 2004/23/EC that have helped maintain quality and safety for millions of patients undergoing blood transfusion, transplantation and medically assisted reproduction.

SEE FULL VERSION ATTACHED As the largest European storage service provider for cord blood stem cells and adipose tissue, Polski Bank Komórek Macierzystych (“PBKM”) Famicord provides more than 380.000 patients across Europe with the possibility to preserve blood and tissue samples. These samples might be used at some point to treat a variety of potentially life-threatening conditions.

MedTech Europe - the European trade association for the medical technology industry including diagnostics, medical devices and digital health - welcomes the opportunity to contribute to the initial consultation regarding the revision of the Union legislation on blood, tissues and cells.

The EHC is pleased to see that the revision of the legislation maintains its original objectives, i.e. to ensure safety and quality of blood components as well as to safeguard the health of patients and donors. This is paramount to the rare bleeding disorders community, which in the past has experienced first-hand devastating effects of the lack of provisions ensuring safety and quality of plasma-derived therapies…

EFS fully supports the comments provided by the French Ministry of Health. The additional comments presented aim to address in more detail specific issues we identified in our areas of expertise. EFS does not agree with the statement “the lack of […] national monitoring provisions for the supply of BTC makes it difficult to predict EU supply interruptions and to take action to mitigate the risks to patients” when it…

IPFA’s mission is to promote policies which ensure access to safe PDMPs to the patients. In this objective and since 2016, IPFA has alerted the European institutions of the unbalanced supply of plasma for PDMPs from third country, namely the US and called for Strategic independence in plasma for fractionation and PDMPs.

Border between substances of human origin' legal framework and substances of human origin-derived medicines' legal framework is not clear and this create confusion and inequality in the requirements expected from hospitals compared to other sponsors such as pharmaceutical industries. This is the major challenge to be addressed for the coming years.

The challenging points/blind areas of the blood directives presented by the Commission are relevant and we welcome the promotion of this issue through an open, transparent process such as an online feedback channel. In addition to the challenging points/blind areas for blood products, it is important that the general principles of Soho products from a commercial and economic point of view are laid down at EU level.

Filed in Finnish · English published by the European Commission

EURORDIS acknowledges the need to revise legislations for Blood, Tissue and Cell derived products. Current legislations and rules did not suffice to ensure EU self-sufficiency for these products, and their safety might still be a concern.

As the world’s leading professional society in human reproduction, the European Society of Human Reproduction and Embryology (ESHRE) welcomes the initiative of the EU decision-makers to revise the Union legislation on blood, tissues and cells (BTC).

The Thalassaemia International Federation represents a community of transfusion-dependent patients who rely on blood safety for their survival. We thus welcome the European Commission’s initiative to revise and update the Directive, especially with regard to the oversight of Member States in their respective practices to acquire adequate and safe blood supply.

1. The elaboration of a common text bringing together all legislation on substances of human origin (SoHO) is a priori a complex undertaking, unless the purpose of this company is to legislate only basic and inalienable general principles. Such a text could allow for some common support tools and be seen as the framework for further legislative development of each of the SoHO substances. 2.

Filed in Spanish · English published by the European Commission

Revision of the Union legislation on blood, tissues and cells – Feedback on the Inception Impact Assessment The Danish Sperm Bank Alliance consisting of Sellmer Diers Sperm Bank, European Sperm Bank and Cryos International Sperm Bank look forward to an evaluation of BTC legislation with focus on strengthening the security, quality and supply of tissues and cells.

EUCOPE, the voice of small to mid-sized innovative companies active in the field of pharmaceuticals, bio- and medical technologies at the European level, shares the Commission’s views that the Blood Directive 2002/98/EC and the Tissues and Cells Directive 2004/23/EC (the BTC legislation) does not provide adequate measures for self-sufficient supplies of blood, tissues and cells and that divergent approaches at…

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.

The Alliance for Regenerative Medicines (ARM) thanks the European Commission for providing insights on its plan for addressing gaps and shortcomings in the current Blood, Tissues and Cells (BTC) legislation and welcomes the European Commission (EC)'s objectives to ensure safety and quality for patients and to support innovation.

The European Eye Bank Association (EEBA) appreciates the opportunity to provide feedback and strongly supports all undertakings that seek to reduce the diversity of interpretation and implementation of BTC legislation in Member States, to assure the same levels of quality and safety throughout the EU, to protect patients from avoidable risks, and to break down barriers to cross-border exchanges.

Tampere University Regea Cell and Tissue Center supports the initiative for updating the legislation on blood, tissues and cells. Product classification: An EU level mechanism for product classification should be implemented for products having SOHOs as starting materials.

We propose the Policy Option 2 to be applied as it was stated in the Inception Impact Assessment: “EU-level safety and quality requirements defined by European Expert Bodies and strengthened national inspection, EU audits and classification advice Safety of donors, recipients and offspring will be strengthened through a system of co-regulation.

Executive Summary We agree with the plan as set out for revision of the BTC Directives, and support Policy Option 2 as that most likely to fulfil the objectives. The voluntary unpaid donation principle should be positively encouraged and remain in the revision. Problem definition The issue, ‘patients are not fully protected .....not kept up to date with ...

The Plasma Protein Therapeutics Association (PPTA) is steadfast in its mission to promote the availability of, and access to, safe and effective plasma-derived medicinal products (PDMPs). 300,000 European patients rely on essential PDMPs to treat a variety of rare, chronic, and potentially life-threatening conditions.

Feedback from the Danish Patient Safety Authority on the Inception Impact Assessment on the revision of the Blood, Tissues and Cells (BTC) directives. The Danish Patient Safety Authority welcomes this first step from the European Commission in the revision of the BTC directives.

Comments from the Committtee for Advanced Therapies (CAT) on the Inception Impact Assessment for the revision of the legislation on blood, tissues and cells are supported. The scope of the exercise is unclear, i.e. ATMPs are legally defined; therefore, ATMPs should not be considered as ‘innovative BTC’ or product at the borderline of the medicines and tissue and cell legislations.

The legislation on blood and all blood components should stay within the public health framework irrespective of the end use of the project. Blood is not a commodity. We were surprised to read in the roadmap that blood establishments and competent authorities did not know or anticipate the supply and demand in blood an blood products during the Covid-19 crisis. We do not find evidence of this.

The Portuguese National Council for ART (CNPMA) follow closely the developments towards the revision of the EU legislation on blood, tissues and cells, expecting to attain a more suitable and comprehensive legislation that enhance quality and safety standards for couples, offsprings and third party donors, promoting an effective cooperation and trust. In particular, the CNPMA would like to highlight the following: .

The Blood Transfusion Association (BTA) welcomes the European Commission’s Inception Impact Assessment (IIA) on the revision of the blood, tissues and cells (BTC) legislation and the opportunity to provide feedback. The BTA is an international non-profit trade association dedicated to supporting the correct use and safe supply of blood for transfusion to ensure patient safety.

A revision of the BTC legislation is to be welcomed. In particular, a consistent approach to the unique identification of all products derived from a human donor is essential to ensure rapid and effective recall and follow-up.

Bristol Myers Squibb (BMS) welcomes the opportunity to provide input in this public consultation for the revision of the Blood, Tissues & Cells Legislation. In this contribution we will focus on the Blood directive specifically. For our response to the Tissues & Cells Legislation, we refer to the contributions of EFPIA, ARM and EUCOPE.

EBA agrees with the gaps and issues identified in the 1st part of the IIA and highlights the following: Reliance on 3rd countries on plasma for PDMPs is in part due to off-label non-evidence-based use.The EU needs to support more research on efficacy of the plasma-based products for a number of diseases while Member States (MS) need to increase their plasma collection from the not-for-profit sector EBA strongly…

IPOPI represents patients with primary immunodeficiencies (PIDs), chronic and rare conditions in which the immune system does not work appropriately or at all. Around 60% of PID patients need immunoglobulin replacement therapies (Igs) throughout their lives to keep the levels of antibodies within a “normal” threshold to fight infections. No alternative treatments are available for these patients.

Sanquin Bloedvoorziening is in favour of Option 2. Option 2 provides the most flexible framework for switching to innovation and developments within the BTC area, while it calls for a similar level of quality between countries for the benefit of cooperation in calamity and quota activities. EU supervision of national supervisory system ensures a good level of Aligning at European level.

Filed in Dutch · English published by the European Commission

Terumo BCT welcomes the European Commission’s Inception Impact Assessment (IIA) on the revision of the blood, tissues and cells (BTC) legislation. Terumo BCT is a global leader in blood component, therapeutic apheresis and cellular technologies. As rightly pointed out in the IIA, the BCT legislation lags behind innovation.

Grifols welcomes the opportunity to provide input to the Inception Impact Assessment for the revision of the BTC legislation. This legislation has helped standardize quality and safety requirements for blood, tissues and cells but it has not adapted to an evolving reality for blood establishments and patients who rely on blood products.

The Italian blood collection system is entirely based on the principle of the voluntary, anonymous, regular and unpaid donation (VUD) and on the cooperation between Italian health authorities, scientific societies, donor and patient associations.

We understand that comments on this document should be limited to how the Impact Assessment’s roadmap is designed, while specific comments and suggestions on the Policy options shall be provided in the forthcoming new Stakeholder consultation.

France is not in favour of option 1 as it would not reinforce cross-country harmonisation of quality & safety standards nor protection of donors nor benefit patients relying on BTC therapies. FR supports option 2, which allows the consultation & implication of representatives from BTC establishments & experts from all over EU.

• In addition to number 3 of the identified gaps and shortcomings in the evaluation: robust donor protection measures are mentioned in the IPA. These measures are not sufficiently highlighted and elaborated on in the mentioned objectives and policy options. Donor protection measures are an important aspect of maintaining supply.

Joint statement from hospital-based stool banks and faecal microbiota transplantation services in: Belgium: Ghent Stool Bank, University Hospital Ghent (Danny De Looze) Denmark: Centre for faecal microbiota transplantation, Aarhus University Hospital (Christian Lodberg Hvas); the stool bank at Odense University Hospital (Jens Kjeldsen) Germany: Cologne Stool Bank, University Hospital Cologne (Maria Vehreschild)…

The Committee included in its 2021 programme the revision of the directives on blood (DE 2002-98/EC) and tissues and cells (DE 2004/23/EC). These two directives provide an incentive for the Member States to collect blood and tissues and cells from voluntary and unpaid donors. this incentive leaves open the prospect of compensation or remuneration for the donor despite the definition of a voluntary and unpaid donor.

Filed in French · English published by the European Commission

Continuous innovation in Assisted Reproduction Techniques (ART) means that clinical practice and current legislation do not go hand in hand on many occasions. In addition, the appearance of threats to the safety of patients with the extension of the use of gametes outside the regulatory framework (home inseminations, offer of donors directly on the network) justifies the need to adapt the different European…

Option 2 ! Option 1 is turning back time ; is opposite to the EU spirit (exchange/interaction/compatibility) ; is opposite to standardisation (introduction of subjectivity, arbitrary decisions) Option 3 is not compatible with the pace of scientific evolution in the field ; legislation will be either non-specific and/or outdated and thus will sooner or later conflict with expert opinion / international guidelines…

EBMT agrees with the problems to be addressed as set out in Part A and highlights the following: 1. EBMT supports all efforts to minimise variability in how the framework is implemented at national level. Haematopoietic stem cells (HSC) cross national borders and these unique life-saving substances are vulnerable to regulatory delays or obstacles. 2.

Comments from the Fédération Française pour l’Don de Sang Bénévole (FFDSB) The simplification and easing of European provisions on blood, tissues and cells must not mean deregulation and a free interpretation of ethics which will inevitably lead to the exploitation of the economically weakest people and to the endangering of their health. The documentary ‘’ the price of blood is a perfect illustration of this’.

Filed in French · English published by the European Commission

Feces Microbiota Transplantation is an established treatment for patients with Clostridioides difficile infection, and a promising approach for several other disorders. It is now mentioned in guidelines for treatment of C. difficile infection, and far beyond its pioneer phase. Stool banks have been founded to facilitate safe and cost effective FMT, and to enable quality assurance.

The AEBT strongly supports the approach proposed in IIA document, since correctly identifies and addresses the shortcomings of the current EU regulation applicable to Tissues and Cells. - The document is not clear how and by who the new BTC products will be classified - The option 1 presented in the IIA does not seem to be suitable to bring mutual recognition among Member States.

The AEBT strongly supports the approach proposed in IIA document, since correctly identifies and addresses the shortcomings of the current EU regulation applicable to Tissues and Cells. - The document is not clear how and by who the new BTC products will be classified - The option 1 presented in the IIA does not seem to be suitable to bring mutual recognition among Member States.

As a global biopharmaceutical leader in plasma protein therapeutics, CSL Behring supports patient centred policies that allow sustainable and safe access to Plasma Derived Medicinal Products (PDMPs). These therapies are essential for 300,000 European patients to treat a variety of rare, chronic and potentially life-threatening conditions.

The BTB endorses the proposed approach and agrees with the views planned for the future impact assessment. - Different interpretations of the current EUTCD requirements led to a high variability of “authorisations” issued in the different Member States (MS).

Revision of the Blood, Tissues & Cells (BTC) Legislation offers an important opportunity to ensure regulatory standards safeguarding patient safety and public health keep pace with technical and scientific advances, legal certainty and risk-based flexibility to facilitate innovation, and sustainability of supplies across EU for both therapeutic need and producing products derived from BTC.

Roadmap BTC 1. Patients are not fully protected from avoidable risks: We propose to include the COVID-19 test and any other test on viruses and adventitious agents, source of a potential risk, in the panel of assays to be performed on the donor. Serology should be updated with the known biological/infectious risk (e.g. COVID-19) of the donor. 2.

The EATCB enthusiastically welcomes this impact assessment as the first step in updating the legal framework covering the fields of tissues, cells, and blood. The EACTB supports the aims of the initiative in assuring the same levels of quality and safety for all EU citizens, recognizing the potential risks arising from differences between EU Member States as many tissues and cells (T&C) are exchanged within the EU…

Feedback from the Dutch Health and Youth Inspectorate (Blood and Tissue Division): The Inspectorate is in favour of combining the elements of the described policy options as also proposed in the document (last paragraph of section B). This will facilitate the examination and assessment of specific solutions through wider differentiation for specific problems.

Filed in Dutch · English published by the European Commission

• A Common Directive on Blood/Tissue/Cells with basic and robust common principles (protection of donors/recipients/children born from assisted human reproduction techniques, non-marketing of donated or derived products of human origin (SoHO), promotion of quality and safety, strengthening of control and inspection systems, etc.) is welcome although it may be desirable to articulate specific Directives containing…

Filed in Spanish · English published by the European Commission

In 2019, the EC published a report, "Evaluation of the Union legislation on blood, tissues and cells"; it encourages removing the permanent ban on MSM donors, which many MS created in response to the current EU legislation, 2002/98/EC, and was challenged at ECJ regarding France (C-528/13, Geoffrey Léger v. Ministre des Affaires sociales, de la Santé et des Droits des Femmes et Établissement français du sang).

Response by the European Foundation for the Care of Newborn Infants (EFCNI) The European Foundation for the Care of Newborn Infants (EFCNI) welcomes the European Commission’s Inception Impact Assessment (IIA) on the revision of the blood, tissues and cells (BTC) legislation and its planned revision for the fourth Quarter of 2021.