National bioethics committees have been established in most European countries since the 1990s. This review considers the opinions expressed by national and international European bioethics committees, comprising all those issued by 27 European Union member countries, one international bioethics committee (embracing 5 European countries) and the relevant institutions at the European Union level (the European Group on Ethics in Science and New Technologies (EGE), the Bureau of European Policy Advisers (BEPA) of the European Commission) and at the European Council level (Committee of Ministers and Steering Committee on Bioethics).
To date the national ethics committees of 9 out of 27 EU member states have published documents concerning cord blood banking, to which the opinions expressed at European level and a Recommendation by the Committee of Ministers must be added. The Committees and the relevant opinions are listed in .
Opinions on cord blood banking issued by European National Bioethics Committees and other European Institutions.
As cord blood banking is a rather specific topic, 9 opinions are a significant number, especially when compared with the number of opinions dealing with other, more wide-ranging topics such as organ donation and transplantation, on which only 8 national bioethics committees have issued documents.
All the opinions regarding cord blood banking considered here take the most significant scientific and clinical data as a fundamental basis for any ethical evaluation.
National bioethics committees are unanimous in recognising that certain statements, position papers and declarations on cord blood banking issued by authoritative scientific societies and associations are essential points of reference in the debate.
Most of the opinions from European national bioethics committees on cord blood banking issued after 2004 repeat (or summarise) the principles listed by the EGE in its opinion n. 19 “Ethical aspects of umbilical cord blood banking”, published on March 16th
. This document does, therefore, deserve particular attention. According to the EGE “there are several fundamental ethical principles and values which can be considered relevant” for umbilical cord blood banking:
- - “The principle of respect for human dignity and integrity, which asserts the principle of noncommercialisation of the human body.
- - The principle of autonomy or the right to self-determination on the basis of full and correct information.
- - The principles of justice and solidarity, as regards to fair access to healthcare services.
- - The principle of beneficence, or the obligation to do good, especially in the area of health care.
- - The principle of non-maleficence, or the obligation not to harm, including the obligation to protect vulnerable groups and individuals, to respect privacy and confidentiality.
- - The principle of proportionality which implies a balance between means and objectives”31.
Nevertheless, “there are also some value conflicts. The values of freedom and free enterprise can conflict with the principles of solidarity and justice, according to which access to healthcare should be on an equitable basis and based on realistic needs, as well as with the principle of protection of vulnerable groups”. A wide-ranging document accompanying this opinion is also available32
. shows the final recommendations submitted with the EGE’s opinion n. 1931
July 1998 the EGE issued Opinion n. 11: “Ethical aspects of human tissue banking”33
which underscored the following values: body integrity, respect of privacy and confidentiality of data, promotion of solidarity, fairness of access to healthcare and informed consent of the donors. With specific regard to umbilical cord blood, Opinion n. 11 stipulates that “the information provided to the woman or to the couple must clearly explain these prospective new treatments, but stress that they are still very much at the experimental stage”. The Opinion also provides that “in principle, tissue bank activities should be reserved to public health institutions or non-profit-making organisations” but that “tissue banks set up by industry should be subject to the same licensing and monitoring requirements as non-commercial operators”. It also insists on the need for appropriate quality and safety rules and calls for a European legal framework.
The opinion published by the EGE in 2004 is consistent with the Recommendation Rec(2004)8 issued the same year by the Committee of Ministers of the European Council34
. The Council recommends that “if cord blood banks are established, they should be based on altruistic and voluntary cord blood donation and used for allogeneic transplantation and related research; the promotion of donation for autologous use and the establishment of cord blood banks for autologous use should not be supported by member states or their health services; accurate information should be provided to the population about the advantages and disadvantages of cord blood banks; where autologous cord blood banks are being established, the promotional material or information provided to families must be accurate, and fully informed consent to cord blood storage must be obtained”.
The Austrian Bioethics Commission35
refers to the general principles summarised by the European Group on Ethics in Science and New Technologies: the principle of respect for human dignity; the right to physical and mental integrity; the principle not to exploit the human body and its parts for financial gain; the principle of autonomy or the right to self-determination, specifically: voluntary consent on the basis of full and complete information (informed consent); the principle of beneficence, implying the use of medical procedures for the well-being of the patient; the obligation not to do harm; the principle of justice; the principle of proportionality, implying a balance between the means and the objectives.
The Austrian Bioethics Commission recommends that in the context of allogeneic transplants, greater support should be given to public and private non-commercial cord blood banks which contribute to public welfare.
The Commission recommends that in accordance with the principle of community welfare justice, potential donors should be informed of the possibility to donate cord blood for purposes of both allogeneic transplantation and research.
However, the Commission does not recommend the storage of cord blood stem cells for autologous transplantation at present.
The Belgian Bioethics Advisory Committee36
recommends a “coherent legislative framework” and, in particular, “a clarification of the legal status of placenta, umbilical cord blood and the stem cells thereof, in the light of an optimal and responsible use of umbilical cord blood”.
As regards the issue of allogeneic use versus autologous use, the Committee takes note that “at the moment there are no persuasive scientific grounds on which to recommend the storage of umbilical cord blood for autologous use for low-risk families. Autologous use of stem cells from umbilical cord blood in non-haematopoietic indications is still very speculative. Therefore only the storage of umbilical cord blood with an allogeneic purpose for the population in general, and with an autologous use for risk families, can be considered as a service of general benefit”.
The Committee underlines that “for the transplantation of bone marrow the organ transplantation model is presented by analogy”, while “umbilical cord blood taken from children after birth falls more under the analogy with the model of blood donations for transfusion (of the blood or blood components)”.
As regards public versus commercial banks “although not all the members of the Committee are in favour of a ban on commercial private banks, all members nonetheless recommend that storage of umbilical cord blood should always meet internationally applicable quality standards”.
The Committee “recommends that a financing system be worked out for the allogeneic storage of umbilical cord blood, both at national level and at European level” and augurs “the development of a system for collection of umbilical cord blood that guarantees that every patient who could receive a transplantation can quickly find a compatible donor”.
The Committee underlines the importance of information and emphasises that “the government should offer people comprehensive and accurate information on collection of umbilical cord blood and the various possible intended uses thereof”. “Clear and transparent information is needed” also “regarding the cost for patients”. The Commission warns against ambiguous commercial advertising: “The advertising carried out by the commercial private firms maintains a two-fold uncertainty, between the different sorts of stem cells on the one hand, and between autologous and allogeneic use thereof, on the other”.
The Cyprus National Bioethics Committee37
, like the Austrian Committee, adopts the general principles stated by the European Group on Ethics in Science and New Technologies.
The Committee underlines that “the State needs to introduce legal and/or administrative procedures based on which each cord blood bank either public or private, profit-making or non-profit making, will be subject to receiving authorisation for its establishment and operation and will be subject to systematic monitoring by the respective authority. Moreover the cord blood bank will have the obligation to maintain a register”. The Committee takes into account that “storage of cord blood for autologous use (…) is of doubtful value, and thus the reliability of the advertising and promotion of this use is challenged”. Nevertheless, the Committee “does not intend to recommend the prohibition of the establishment and operation of private profit-making cord blood banks” and lists a series of requirements that commercial banks should meet.
According to the French National Ethics Advisory Committee for Life Sciences and Health38
“ethical difficulties arise because the concept of cord blood banks for exclusively autologous use carries a number of perils: (i) the gravest danger is for society in so far as setting up such banks is likely to contradict the principle of solidarity, without which no society can survive; (ii) such banks raise hopes of utopia and disguise a mercantile project using assistance to children as a screen; (iii) they jeopardise justice and equity. If any reasonable indications existed, then the offer should be systematic, organised, managed, and supervised by public authorities; cost and broadness of scale then enter the picture. The disproportionate, and for the time being useless, cost of generalised autologous storage is in total contradiction with the obligation to provide public health based on solidarity and awareness of priorities; (iv) management by the private sector may be seen as discrimination based on wealth. However, this would hardly be exceptional in the healthcare sector, and those who use these programmes cannot be blamed for their ingenuousness; and (v) the futility of autologous banks and their cost would be a provocation in the eyes of the very poor, in particular in the Southern hemisphere”.
The Committee’s “recommendation to decision-makers is that they should encourage a considerable extension of public cord blood banks for essentially allogeneic purposes, rather than subscribing to the creation of private banks for strictly autologous purposes, the potential therapeutic usefulness of which is, as yet, in no way corroborated”.
According to the Greek National Bioethics Commission39
one of the major problems is “how to ensure the widest possible utilisation” of cord blood stem cells. The Commission underlines that “as things stand today, this purpose is better served by heterologous transplantation which is ensured by networks of collections (for-profit or non-profit) and not by autologous transplantation. Since the potential use of the material exclusively by the donor or his/her family members is negligible (and, conversely, the probability of final destruction of cells very high) the choice of private use cannot be justified on ethical grounds. All the more so considering that this choice would discourage making cells available for common use and would drastically reduce the availability of grafts to those who need them”.
The Commission recommends: “The adoption of an explicit provision of law entrusting a public authority with the licensing and supervising of the operation of companies that collect and store umbilical cord blood. In view of relevance with transplants this authority could be the National Organization of Transplantation”. The Commission also recommends the “adoption of standards of quality and safety for biological material”; “the development of appropriate public information tools (…) by the Ministry for Health (…) and of consent forms and information documents for prospective users of already operating companies”. Moreover “once a public licensing system for these banks is put in place, the content of these documents should be reviewed as a prerequisite for the license. Companies should also register forthwith with the Data Protection Authority, to protect the confidentiality of the sensitive data of blood donors”.
December 2010 the Irish Council for Bioethics
ceased to operate “as a result of a Government decision to discontinue funding the operation of the Council”40
. The Council has not published opinions specifically devoted to cord blood biobanks. Nevertheless, the problem of cord blood banking is mentioned in the more general document “Stem cell research: hope or hype? Exploration of the ethical questions”41
. The Council does not adopt a definite position regarding cord blood banking, but notes that “there is currently a debate about whether storing a child’s umbilical cord blood is a worthwhile investment for future healthcare or an expensive procedure, which might never prove beneficial. Concerns have been raised regarding the promises made about the potential for cord blood transplants to treat a number of diseases for which there is, at present, no medical evidence. Therefore, opponents argue that the State should not be paying for storage when there are no proven benefits. Opponents also argue that the chances of umbilical cord blood stem cells ever being needed by all of the families who store it are very small. Therefore, they raise concerns regarding the commercial storage of umbilical cord blood.
They state that allowing parents who can afford to pay for storage to do so would force those who cannot afford to store their babies’ cord blood to feel unduly guilty. Proponents argue that given the nature of recent scientific advances there is a reasonable likelihood that umbilical cord blood stem cells will become of significant medical value in the coming years. Some argue that the State should put resources into establishing a national umbilical cord blood bank, similar to the national blood bank, where everyone can donate their babies’ cord blood and where cells are shared with patients based on medical need. Others argue that parents who wish to pay commercial companies to store umbilical cord blood should not be prevented from doing so. They state that umbilical cord blood storage is akin to other forms of medical insurance, which might never be needed, and that parents who can afford to do so should be free to make an autonomous decision i.e. a decision free from external influences”.
The Italian National Bioethics Committee42
- - the use of cord blood stem cells can be extended to persons other than those from whom they were taken provided their use does not contravene the ban on obtaining profit from the human body or its parts;
- - when private banks are authorised to collect and store cord blood stem cells these must be subject to a system of authorisations that allows the effective exercise of the forms of public controls envisaged in the EC Directive;
- - any indemnity offered to donors must be in the form of a reimbursement of the expenses incurred for the donation.
The National Bioethics Committee also hopes that suitable measures will be taken to inform the non-specialist public concerning the realistic therapeutic applications of cord blood-derived stem cells supported by advances in scientific knowledge, and that the public will have access to biobanks, including through a rational geographic distribution of these facilities.
Finally, the National Bioethics Committee expresses the hope that the new legal regulations concerning the storage and use of cord blood stem cells will be in line with the principles and rules governing transfusions and the production of blood products in Italy, to enable the unequivocally voluntary and free donation of umbilical cord blood following informed consent and verification of the donor’s physical fitness and in compliance with the principle of non-commercialisation of the human body”.
The Swedish National Council on Medical Ethics43
“proposes that a public biobank for umbilical cord blood be established and recommends that the law on biobanks be reviewed and clarified on specific points. Biobanks outside of the health care sector should also be regulated. The National Board of Health should develop specific information material targeted to parents about the storage of umbilical cord blood”.
In the United Kingdom, the Nuffield Council on Bioethics44
published the report “Human bodies: donation for medicine and research”. The authors state: “By contrast with blood donation by adults, the idea of obtaining cord blood from the umbilical cord, in order to obtain stem cells from a baby at birth, has been much more controversial, particularly where the cord blood is subsequently stored only for private use. We note the growing evidence as to the potential value of publicly-accessible sources of stem cells, and the procedures recommended by the Royal College of Obstetricians and Gynaecologists to protect the welfare of mothers and babies where donation of cord blood is considered. We conclude that the collection of cord blood in these circumstances for public use is an example of a justified public intervention, and endorse the work of the NHS Cord Blood Bank, Anthony Nolan Trust and others in facilitating the collection of cord blood for this use. We note the recent report from the UK Stem Cell Strategic Forum calling for a significant increase in the UK’s ‘inventory’ of cord blood and recommending that a UK Stem Cell Advisory Forum should be established in order to manage a UK cord blood inventory, along with a UK stem cell registry and a database of patient outcomes following transplantation”. The Nuffield Council “endorses these recommendations”.