André Pereira
Do you have something about the cord blood bank mentioned on the DGSANCO 2007 answers (annex I of the draft report)?
YES, NEW LEGISLATION IMPLEMENTING EU DIRECTIVES:
1. Law 22/2007, of 29 June - implements DIRECTIVE 2004/23/EC
o Lei n.º 22/2007, de 29 de Junho Transpõe parcialmente para a ordem jurídica nacional a Directiva n.º 2004/23/CE, do Parlamento Europeu e do Conselho, de 31 de Março, alterando a Lei n.º 12/93, de 22 de Abril, relativa à colheita e transplante de órgãos e tecidos de origem humana
2. Law 12/2009, 26 March - implements Directive 2004/23/EC; 2006/17/EC and 2006/86/EC
o Lei N.º 12/2009, 26 de Março :Estabelece o regime jurídico da qualidade e segurança relativa à dádiva, colheita, análise, processamento, preservação, armazenamento, distribuição e aplicação de tecidos e células de origem humana, transpondo para a ordem jurídica interna as Directivas n.os 2004/23/CE, do Parlamento Europeu e do Conselho, de 31 de Março, 2006/17/CE, da Comissão, de 8 de Fevereiro, e 2006/86/CE, da Comissão, de 24 de Outubro
Questions
1- The status of cord blood: a medicine, stem cell, other or no legal status.
According to Art. 2, 2, e) Decree-Law 176/2006 (Statute of Medicament), hematoipoietic stem cells that are used in cell therapy, in which production an industrial process has been used is considered as a medicine.
2- Legal aspects of cord-blood banks: Is there a legal status for cord blood banks? (references of the legislation if any) Are they public or private, (profit or non profit organisation?) Do they need a legal authorization? or can they be created without legal frame ? Autologous or allogenic? or both?
Cord-blood banks are regulated by Law 12/2009, 26 March and other legislation concerning laboratories and medical services in general.[1]
There is one public bank and several private banks (profit organizations).
The public bank is allogenic, but the private ones are autologous.
This activity must obey the rules of the Law 12/2009.· Those banks that were already operating as the Act came into force (March 2009) had a period of 12 months to adapt to its requirements.
· The new centers – to be created after the enactment of the Law 12/2009 – do need authorization of the ASST (Autoridade de Serviços de Sangue e Transplantação) Authority for Blood and Transplantation Services.
3- Ethical aspects : do your national ethics committee (or another institution) give opinion on that? Especially on private autologous commercial cordblood banks.
There is no new Opinion of the National Ethics Committee for Life Sciences concerning this issue after Opinion on the draft bill on the legal regime of quality and safety relating to the donation, procurement, testing, processing, preservation, storage, distribution and application of tissues and cells of human origin (2008)[2]
4- practical aspects: how many cord blood bank do you have in your country , (references and status (public or private, allogenic or autologous?)
There is, at least, 1 public and 5 private banks = 6 banks
There is one public bank (created by Ordinance 14879/2009, 2 July: LUSOCORD[3]http://www.chnorte.min-saude.pt/lusocord.php
· It is a public, free of costs and allogenic (it may serve for everyone) cord blood bank, founded in 2009.
· It can be used all over the world.
· In January 2010, few month after the beginning of the service, there were already more than 1400 donations.
There are several private cord blood banks operating in Portugal, involved in a business activity, with aggressive advertisement, often misleading( speaking of a “biological life insurance”; “unimaginable possibilities”; “a spare imunitary system”; “a once in a life-time chance!”), offering unfounded hopes and playing with emotions of future parents. Regulation of advertisement of this service should be improved and more restrictive.[4]
I could find 5 laboratories:
Crioestaminal: http://www.crioestaminal.pt/pt/
Criovida: http://www.criovida.pt/adesao.aspx
Cytothera: http://www.cytothera.pt/pt/Home.aspx
Bebevida:http://www.bebevida.pt/subcanais_n2.asp?id_subcanal_n1=195&id_canal=114&subcanal_n2=270&gclid=CKTt1M22rKUCFYUw3wodvihVZQ
Bioteca: http://www.bioteca.pt/
· They are private, they cost (a reasonable amount of) money (from €1000 to €1500) and autologous
More information:
[1] A presente lei estabelece o regime jurídico da qualidade e segurança relativa à dádiva, colheita (…) preservação, armazenamento (…) e aplicação de tecidos e células de origem humana (…) (…) O disposto na presente lei é aplicável (…) tecidos e células de origem humana destinados à utilização em seres humanos, incluindo células estaminais hematopoiéticas (…) do sangue do cordão umbilical (…)” In Diário da República - Lei n.º 12/2009 de 26 de Março de 2009
[2] http://www.cnecv.gov.pt/NR/rdonlyres/446A21C0-8DF2-4D95-9700-BB39032C8BB8/0/55CNECV2008_EN.pdf
[3] Despacho n.º 14879/2009, de 2 de Julho: Criação do Banco Público de Células do Cordão Umbilical, nas instalações do Centro de Histocompatibilidade do Norte) –
[4] Art. 22/ 8 of Law 12/2009, 26 March, considers misleading advertisement the information that induces in mistake about the real utility of the cord blood banks, when not supported by sceitific evidence, according to national regulatory authorities.
