Ministry of Health of the Slovak Republic
Ethics Committee
Resolution 32/39
Current Opinion of the Ethics Committee of the Ministry of Health of the Slovak Republic.
(29.11.2011)
Donation, storage and use of stem haematopoietic cells from cord blood
Given the topical nature of donation, storage and use of stem cells cord blood haematopoietic cells Ethical Commission of MZ SR (EtK MZ SR) repeatedly analysed this issue from an ethical, factual and legal point of view and produced an opinion which it submitted as a proposal for a further solution Minister of Health of the Slovak Republic.
The EtK MZ SR has already dealt with this issue in detail in the past. the participation of invited experts in the Eurocord, National the transfusion service, the principal expert of MZ SR for the field of haematology, as well as another specialist in the field. It then adopted an opinion on the subject. (order), which was published on 16 October 2008 on the website of MZ SR
In its current opinion EtK MZ SR also states:
1. Regulation of collection, processing, storage and release for application stem blood-forming cells from cord blood
The new version of Act No. 362/2011 Coll. on medicinal products and medical devices and on amendments to certain laws, in force from 1 December 2011, in parallel to previous legal status ranks cord blood cells as transfusion product to human product category. Compared to previous legislation Precisely specifies 4 types of authorisations in relation to transfusion medicinal products, which is distinguished by the scope of the activity. Against this background, it defines the a centre that may make a choice under statutory conditions; and testing of blood donors, blood collection and blood collection and blood storage; and transfusional medicinal products. For the preparation of blood transfusions from cord blood is To be authorised in the range of the preparation of transfusion medicinal products from cords blood-bloods, which, in addition to the operation of the collection centre, also allow processing cord blood and preparation of transfusional medicinal products from cord blood.
It also specifies, once again, the obligation for the professional representative responsible for collection of cord blood ensures that each cord blood collection is performed and released only to cord blood processor holding authorisations for the preparation of transfusional medicinal products from cord blood.
The new version of Act No. 362/2011 Coll. strengthens the current Status quo.
There is therefore still a situation in which, under Law No 576/2004, Z. z. (as amended) later regulations) are (strain) cord blood cells excluded from the definition tissue, transplant and tissue bank, also given that real the relevant European directives - Directive 2004/23/EC of the European Parliament
(EP) and Council of 31 March 2004 laying down quality and safety standards donated, taken, tested, processed, preserved, stored, and the distribution of human tissues and cells; and Commission Directive 2006/17/EC of 8. 28 February 2006implementing Directive 2004/23/EC of the European Parliament and of the Council as regards concerning certain technical requirements for the donation, procurement and testing of human tissues cells.
The directives in question could be transposed into Slovak legislation without authorising provision in the relevant law through Approximation Regulation of the Government of the Slovak Republic but under such conditions as to avoid the current double-trackness of the solution to the issue at issue - i.e. in terms of transfusion product on one side and human tissue and cells on the other.
2. True public information
In relation to marketing of take-off and storage of stem umbilical cord blood cells for possible autologous use may be to conclude that there was no desirable objectiveisation compared to the past, in particular the target group of future mothers.
Information on the need for collection and storage of stem umbilical cord blood cells for autologous use and not for Longer-term allogeneic therapy, i.e. for the treatment of a consistent non-relative Patient About 10 autologous transplants out of 1 will be performed annually worldwide A million privately stored, cord bloods. Neither the European Commission has not changed its negative opinion on autologous sampling and use so far cord blood.
Informing the public about the use of cord blood stem cells for the autologous use must be based on data from the sources –Evidence Based Medicine published opinions of professional companies (e.g. Haematological and the SLS transfusiological company).
The therapeutic benefit of allogenic (non-narrow) cord transplantation blood is convincingly proven, so experts strongly recommend storage cord blood for allogeneic haematopoietic stem cell transplantation. Storage for autologous (private) need may be considered if such storage is Part of a programme whose primary objective is to use cord units blood for allogeneic haematopoietic stem cell transplantation. *
However, it should be noted that there is currently no regulation based on legislation. Advertising issues fall under the Ministry of Economy SR.
3. Informed Consent for procurement, Processing, storage, use of stem cord blood haematopoietic cells
The informed consent is to be obtained directly by the employee or person in the same employment relationship with cord blood bank (Slovak Register) placental haematopoietic cells o.z. Intermediately, in return for payment, medical officer. The healthcare professional is, within the meaning of the legislation in force, responsible only for the administrative health care (i.e. for carrying out cord blood collection) and not for other services provided by cord blood banks.
In addition, this informed consent must be obtained during pregnancy and not in border, stress situations (i.e. during childbirth, etc.).
Another procedure is based on serious suspicion of conflict of interest as well as on the ethics of enforcement the health profession.
4. Establishment of a non-commercial nationwide cord blood biobank
EtK MZ SR considered it necessary to create conditions for establishment and proper the functioning of a nationwide blood stem cell biobank from corded blood cells blood for allogeneic use based on non-profit principles; and co-financed by public funds.
In this regard, it must be noted that there has been no progress in the dealing with the issue compared to the time when the opinion of the EtK MZ SR approved.
* Opinion of the SLS Committee on Haematological and Transfusiology 30.06.2008
Chairman: MUDr. P. Križan, CSc.; Secretary: Mgr. P.Valúch tel. (02)59 373 362, e-mail: peter.valuch@health.gov.skMinistry of Health SR, Limbová 2, 837 52 Bratislava, Slovenská Republic