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World Marrow Donor Association

WMDA

Our Vision A world where access to life-saving cellular therapies for all patients is assured and donors’ rights and safety are protected. Our Mission We work with our members to ensure reliable provision of life-saving cells while promoting care and safety for both patient and donor. Our Aims • Optimising ‘Search, Match & Connect’: A global ‘Search, Match & Connect’ environment that facilitates the most suitable cell source for patients. • Supporting global development: supporting members to develop and grow, so that more patients find the most suitable cell source. • Promoting donor care: ensuring the rights and safety of cell donors are promoted and protected;. • Ensuring quality: promoting quality and global collaboration through standardisation. * Driving member engagement: Safeguard and elevate the voice of our members

Lobbying Activity

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

8 Sept 2022

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. Additionally, WMDA operates a certification programme for organisations exchanging hematopoietic cells to ensure compliance with international legislation. Furthermore, WMDA facilitates serious adverse occurrence reporting to promote donor care on a global scale. The proposed legislation builds on current practice, while ensuring safety and quality of hematopoietic cell products, streamlining imports from third countries, promoting donor care through voluntary non-remunerated donation and vigilance reporting. WMDA welcomes that authorities are allowed to consider delegation of supervisory activities such as inspections performed by professional societies (JACIE and WMDA) (explanatory memorandum p. 11/art. 29(10)) and activity data collection (art. 33 and 44) and would like to understand the potential role in the described cross-entity registry (art.53 (3)). WMDA’s mission is focused on donor care and encourages that this legislation covers donations outside the clinical use (e.g., research & development and ATMP starting material) – principle 17 (p. 21). The proposed definition of donor recruitment (“any activity aimed at encouraging persons to become SoHO donors”), is broad and could be understood that each social post is seen as donor recruitment activity (p. 32 (13)). WMDA observes that an increasing number of countries allow to reveal the donor’s identity to the recipient after two years if there is expressed wishes of both parties. Article 53 limits this current practice to exceptional circumstances and does not define a timeframe. A broad range of organisations influence safety, quality and efficacy of SoHOs. Most of those organisations carry out a single SoHO activity, such as: donor centres, donor registries, collection centres, transplant centres, cord blood banks and many more. If each organisation has to register individually as SoHO establishment this will create administrative burden (art.18 (3)). WMDA welcomes the introduction of joint regulation approach, which will promote harmonisation across EU Member States and the leverage of expert bodies to respond to changes in science and practice to ensure safety, quality and efficacy of SoHOs while promoting innovation in the sector. As the technical requirements for SoHOs are further defined, we would like to encourage their alignment with countries outside of the EU wherever possible to promote global collaboration and reduce burden on industry and regulators. WMDA welcomes articles 41(4) and article 22(5) which allows the use of existing clinical registries (WMDA Serious Adverse Occurrence registry), thus avoiding duplication and reducing administrative burden for healthcare professionals and encouraging centralised reporting. The requirement to report within five working days (art. 47(3)) puts administrative burden and potential risk to incomplete reporting. WMDA would like to avoid reporting obligations for serious adverse occurrences that are known and welcomes clarification on the timeline and on the reporting obligations. To ensure accurate vigilance, WMDA encourages to exploit existing international consensus standards on robust traceability of SoHOs (e.g. Global Registration Identifier for Donors developed with support of ICCBBA). WMDA would like to avoid potential delays in importing hematopoietic cells to EU Member States and would like to understand if the previously legislated exemptions are covered under article 28(9). WMDA endorses the comments provided by EBMT, CoRe SoHO consortium, ICCBBA and NMDP. WMDA looks forward to contributing to the ongoing legislative process.
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Meeting with Anne Bucher (Director-General Health and Food Safety)

23 Oct 2019 · revision of EU legislation in certain areas in order to maintain the safety and quality of stem cells for transplantation