Deutsche Gesellschaft für Transfusionsmedizin und Immunhämatologie e. V.
DGTI
Die Deutsche Gesellschaft für Transfusionsmedizin und Immunhämatologie e.
ID: 807363327717-37
Lobbying Activity
Response to Revision of the Union legislation on blood, tissues and cells
8 Sept 2022
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). Nevertheless, questions arise as to how these objectives can be achieved by the proposal of the SoHO Regulation:
It is planned that technical guidelines and monographs published by expert bodies, namely EDQM and ECDC become a key element of the future legislation. The rules for expert bodies publishing these technical standards should become part of the proposed SoHO Regulation. The proposal remains silent regarding the procedures for selection of members, mode of operation for review and update of technical standards, the requirements for expertise and transparency.
The technical standards will be issued by different bodies/organisations (ECDC, EDQM) based on an allocation into risks caused by communicable diseases and risks other than the transmission of communicable diseases. Regulations from different bodies might impose additional challenges for implementation. The dichotomous division into risks due to communicable vs. non-communicable diseases can generate ambiguities. The compilation of standards (on the same SoHOs!) in different bodies could lead to the fact that these standards are not consistent and are not fully complementary and regulation gaps might remain.
It is recognised that there are regulation gaps for SoHOs that are not or not sufficiently covered by current regulations (e.g. for breast milk, gut microbiota). It is questioned whether the necessary extension of regulations to further SoHOs justifies to change existing and proven regulations based on Directives 2002/98/EC and 2004/23/EC. From the national perspective, we disagree with the analysis of the current situation presented in the proposal (sect.1-5). There is no need for amendment for blood, blood preparations, tissues and cells. The regulation gap for some SoHOs could be filled by establishing a new regulation for this group of SoHOs - while retaining proven regulations for blood, cells and tissue
Member States cannot be prevented from maintaining or introducing more stringent protective measures. The Commission shall be empowered to adopt "delegated acts" to supplement this Regulation by defining specific criteria. In the total view of these points, a complex set of rules will determine the future legislation. While the draft Regulation provides some of the rules in quite some detail, it remains silent on other important aspects. At this stage, it is not possible to make an overall assessment of whether the ambitious objectives will be achieved.
We welcome the quality standards described in this Regulation. Among others, the regulation defines the qualification of the Responsible Person for release of SoHOs (Art. 38) and the Physician (Art.51). Education in current state of the art regarding collection, processing, testing and clinical use of SoHOs should consequently be part of the curriculum in medical training. Member States shall be encouraged to establish transfusion medicine as a mandatory subject of education in Medical School and to implement programmes for continuous medical education for all medical staff in transfusion medicine.
Aspects of transition from current regulation including national law and binding national guidelines to the new regulation need to be assessed.
The new regulation means additional burdens for SoHO establishments. Appropriate compensation in national health systems must be considered in its implementation.
For more details and additional feedback we refer to the attached statement of the DGTI.
DGTI is available for further consultation on the development of the proposal.
DGTI is the scientific professional society in the German-speaking countries, in which all aspects concerning the treatment with blood, cells and tissues are covered (Transparency Reg. No. 807363327717-37).
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