Ministry of Health of the Slovak Republic
E t i c a t i on
Chairman: MUDr. P. Križan, CSc.; Secretary: Mgr. P.Valúch tel. (02)59 373 362, e-mail: peter.valuch@health.gov.sk Ministry of Health, Limbová 2, 837 52 Bratislava, Slovak Republic
Opinion of the Ethics Committee of the Ministry of Health.
Donation, storage and use
stem blood-forming cells from cord blood
In view of the topicality of the subject of donation, storage and use of stem blood cells from cord blood The Ethics Commission of the MZ SR (hereinafter EtK MZ SR) has repeatedly analysed this issue from an ethical, material and legal point of view and has prepared an opinion, which it submitted as a proposal for further solution to the Minister of Health of the Slovak Republic.
In its opinion EtK MZ SR also states:
1. Legislation governing the collection, processing, storage and release of blood stem cells from cord blood
Law 140/1998 Z.z. (as amended) ranks cord blood (strain) cells as a transfusion preparation in the category of medicinal product.
Law 576/2004 Z.z. (as amended) excludes cord blood cells from the definition of tissue, transplant and tissue bank.
Following the wording of Laws No 140/1998 Z.z. and No 576/2004 Z.z lacks explicit adjustment of good laboratory practice for stem cord blood-forming cells and also lacks a price range for such a prepared transfusion agent. However, the correction deficit also applies by analogy to bone marrow stem cells and peripheral blood stem cells.
Medical establishments which withdraw, process, store and release for the application of transfusion preparations (medicines) containing stem cells shall not be subject, in the sense of equality before the law, accreditation and control, whether separate or part of another medical facility, whether national or private.
Transfusion products, including preparations of stem haematopoietic cells from cord blood, are excluded from advertising as medicinal products. There is a lack of legal definition, sanctionable and ethical control of the interface between the promotion of treatment and the promotion of cell storage for possible treatment in the future, as is the lack of explicit regulation (advertising) activities aimed at recruiting donors.
The rights and obligations of maternity care workers who, with the informed consent of the parent, withdraw cord blood in accordance with good laboratory practice and transfer it for further treatment to an authorised health care establishment are not regulated. There is also a lack of adjustment or provision of remuneration for procurement and related activities.
EtK MZ SR states that the current legislation in Slovakia does not allow sufficient professional guidance, management and supervision by the state, with the consequence of neglecting the rules for biobanks. The current legislation does not comply with the binding Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 laying down standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Under this Directive blood stem cells from cord blood should not be considered as a blood product, should not be regulated as a medicinal product and treatment should be governed by the rules applicable to cell and tissue banks (biobanks).
EtK MZ SR recommends that MZ SR address this issue comprehensively from the point of view of legislation, health care provision and financing, which is currently lacking.
2. True public information
In the future, there was an urgent need to avoid misleading advertising by the misleading public, in particular the target group of future mothers, in relation to the marketing and storage of cord blood stem cells for possible autologous use.
EtK MZ SR recommends that MZ SR pay attention in this respect to the legal regulations and ethical aspects of marketing activities of commercial companies aimed at recruiting donors or customers and customers of the services of payment collection, storage and autologous use of stem blood-forming cells from cord blood.
3. Establishment of a non-commercial nationwide cord blood biobank
EtK MZ SR considers it necessary to create conditions for the establishment and proper functioning of a nationwide blood stem cell biobank from cord blood for allogeneic use based on non-profit principles and co-financed from public sources.
EtK MZ SR recommends supporting the initiative of the National transplant program, resolve its legislative and organisational basis without undue delay and explicitly address stem blood cells from cord blood.
The opinion of the MZ SR was released for publication at its 20th ordinary plenary session on 24 June 2008. The opinion is the basis for a technical discussion, which will be held in the first round in cooperation with the Health Section of the Slovak Republic with the participation of the main experts of the Slovak Republic.