Unità di Bioetica, Presidenza, Istituto Superiore di Sanità, Rome, Italy
Numerous documents (declarations, codes, recommendations, guidelines) issued by eminent institutions recommend that the donation of blood should be voluntary and unremunerated. This does not preclude the possibility: 1) that donors receive some form of reimbursement; 2) that subsequent procedures, which inevitably incur costs, may involve considerable financial activity; 3) that legislation in some nations may allow trade in certain types of human biological material; 4) that voluntarily donated human blood be used to derive products that are subsequently marketed. The present article highlights some of the contradictions generated by these considerations and affirms that they do not undermine the primary duty to uphold the voluntary nature of donation.
Key words: bioethics, blood, informed consent, legislation, plasma-derived, medicinal products
THE BAN ON COMMERCIALISATION OF THE HUMAN BODY OR ITS PARTS
The principle that the human body should be neither commercialised nor a source of gain is enshrined in numerous respected documents.
The World Health Organisation's Guiding Principles on human cell, tissue and organ transplantation (Resolution WHA 63.22) states that "Cells, tissues and organs should only be donated freely, without any monetary payment or other reward of monetary value. Purchasing, or offering to purchase, cells, tissues or organs for transplantation, or their sale by living persons or by the next of kin for deceased persons, should be banned" .
For Council of Europe member countries the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine  published by the Council in 1997, is a key document and an essential reference for bioethics and biolaw. Under the heading "Prohibition of financial gain", Article 21 of the Convention states: "The human body and its parts shall not, as such, give rise to financial gain". Article 22 ("Disposal of a removed part of the human body") rules that "When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures". The Explanatory Report  annexed to the Convention clarifies that the words "body parts" include "organs and tissues proper, including blood" but not products such as "hair and nails, which are discarded tissues, and the sale of which is not an affront to human dignity". Blood is thus explicitly included in Articles 21 and 22 of the Convention .
Within the European Union this concept is echoed in European Directive 2004/23/EC, which uses the term "donor" to designate "every human source, whether living or deceased, of human cells or tissues" .
Other documents that adopt the principle that the human body and its parts (including blood ) should not be a source of gain have been issued by the United Nations Educational, Scientific and Cultural Organisation (UNESCO), notably the Universal Declaration on the Human Genome and Human Rights , the International Declaration on Human Genetic Data  and the Universal Declaration on Bioethics and Human Rights .
Table 1 lists some of the key documents that affirm this principle of non-commercialisation of the human body or its parts. Many of those listed also address such topics as: different procedures for donating blood or other human biological material; the requisites for informed consent; the rights involved.
The Table is not exhaustive, but indicates some examples of the different types of document that, albeit in different contexts, affirm this principle that the human body or its parts should not be a source of gain.
Of the various considerations generated by these documents, two are of interest here and are addressed below (in the following two paragraphs): 1) Regulations allowing various forms of buying and selling of human biological material are in force in several countries that are also signatories to documents affirming the non-commercialisation of the human body. 2) Forms of reimbursement to donors of biological material, particularly blood, are recognised as legitimate - and even in some cases encouraged - in several documents published by national institutions and by some legislative frameworks.
ON THE TRADE IN HUMAN BIOLOGICAL MATERIAL ENVISAGED IN NATIONAL LAWS
The statute books of several nations that have signed documents such as the Convention on Human Rights and Biomedicine  mentioned above allow various forms of trade in buman body parts .
In Belgium, for instance, the "Arrêté ministeriel fix-ant le prix du matériel corporel humain" of 14 October 2009 contains a detailed list of the cost (in euros) of different parts of the human body .
In Germany biological material taken from the human body can be subject to ownership and there are no laws or guidelines that prohibit trade in it. As a result, sales of human biological material stored in hospital biobanks are legally held, even without the consent of the persons from whom the material was taken .
Although Spanish law bans trade in the human body or its parts, the "commercial donation" of gametes for purposes of medically assisted procreation or for research is allowed in Spain, and precise rates are specified .
In an international context, the case of umbilical cord blood donated at birth for philanthropic purposes and stored in public biobanks that are part of international networks is of interest. Cord blood "is a high value commodity frequently trading at £15,000 to £20,000 per unit. In a growing number of cases patients receive costly multiple transplants to increase the likelihood of therapeutic success (...). This represents a substantial income for those banks selling CB given that the cost of storage is, on average, considerably lower (usually less than 10% of the export price). Based on units traded through the World Marrow Donor Association (WMDA), the international CB market was worth in excess of £20 m during 2008 and is rising sharply" .
It is thus evident that human biological material is treated in many countries as property and that property rights may be granted.
This raises questions on, among other things, the "ownership" of the human body and its parts, an issue that is not generally addressed explicitly in national legislation. Without entering into the merits of this problem, which is not germane to the present article, it is worth recalling that: "This leads to the possibility of exploitation by others, which in turn remains unsanctioned because the initial refusal to grant property rights to the source means that no civil remedies are available and no criminal sanctions in relation to the dishonest appropriation are possible" . Hoppe suggests "a third way in terms of property classes. That of bioequity or property in biomaterial" . The omission of any notion of "ownership" of the human body or its parts from legislative frameworks is prompted by the laudable desire to avoid forms of commercialisation.
Paradoxically, this failure to provide a legal definition of ownership could encourage rather than contain ethically unacceptable forms of trade.
ON COMPENSATION FOR THE DONATION OF HUMAN BIOLOGICAL MATERIAL
In common with other institutions, the WHO recommends that: "National law should ensure that any gifts or rewards are not, in fact, disguised forms of payment for donated cells, tissues or organs. Incentives in the form of "rewards" with monetary value that can be transferred to third parties are not different from monetary payments" .
According to Directive 2002/98/EC "Modern blood-transfusion practice has been founded on the principles of voluntary donor services, anonymity of both donor and recipient, benevolence of the donor, and absence of profit on the part of the establishments involved in blood transfusion services" ("Whereas" n. 20); "Member States shall take the necessary measures to encourage voluntary and unpaid blood donations with a view to ensuring that blood and blood components are in so far as possible provided from such donations" (Article 20) .
Article 18 of the Directive 2004/23/EC  reads as follows: "As a matter of principle, tissue and cell application programmes should be founded on the philosophy of voluntary and unpaid donation, anonymity of both donor and recipient, altruism of the donor, and solidarity between donor and recipient. Member States are urged to take steps to encourage a strong public and non-profit sector involvement in the provision of tissue and cell application services and the related research and development".
Article 12 of the same Directive requires that the Member States "shall endeavour to ensure voluntary and unpaid donations of tissues and cells" . However, it provides for "compensation which is strictly limited to making good the expenses and inconveniences related to the donation" . The inclusion of "inconveniences related to the donation" could give rise to problems, as it could be interpreted as aimed at recruiting volunteers whenever these are judged to be in short supply. This practice could thus be construed as a financial stimulus of a kind that constitutes a disguised form of payment.
The notion of "unpaid donation" does not, however, rule out the possibility of "reimbursements" to cover expenses and missed earnings associated with donations (travel expenses, absence from work, etc.). Such procedures, which may verge on actual payments, are effectively envisaged in several countries.
The debate concerning these issues is a lively one: in the UK, for instance, where trade in human biological material is prohibited , the Nuffield Council on Bioethics published a report on Human bodies: donation for medicine and research  that proposed a "ladder" of procedures to facilitate donation. The first four rungs of this ladder are ethically uncontroversial and easily permissible, while the last two are ethically more complex and should be considered only when existing levels of altruism are not sufficient to cover a public health need; even then, they should not cause harm to donors or impinge on other important interests.
The six rungs proposed by the Nuffield Council are :
- Rung 1: The dissemination of information concerning the need for donations of bodily material for the treatment of other people or for medical research;
- Rung 2: Measures to recognise the value of and gratitude for altruistic donations; these could vary according to both the form of each donation and the circumstances of the donor;
- Rung 3: Measures to remove possible barriers and dis-incentives to donation encountered by those disposed to donate;
- Rung 4: Additional measures to prompt or encourage persons already disposed in principle to donate for altruistic reasons;
- Rung 5: Interventions that offer benefits in kind to encourage persons not ordinarily disposed to donate to contemplate doing so;
- Rung 6: Financial incentives that improve the financial position of the donor as a direct result of donating.
The report by the Nuffield Council  sparked a lively debate .
In discussing these issues it is useful to note that the documents listed in Table 1 concur in recommending that the donation of blood, cells and tissues should be voluntary and unremunerated. Vigilance is thus necessary to ensure that legitimate and proper reimbursements to donors (for travel, genuinely incurred expenses, loss of earnings) should not effectively conceal more or less explicit forms of payment. This is not an easy task because the boundary between reimbursements and payments is frequently blurred. The relevant regulations need therefore to be as explicit as possible: "National law should ensure that any gifts or rewards are not, in fact, disguised forms of payment for donated cells, tissues or organs. Incentives in the form of 'rewards' with monetary value that can be transferred to third parties are not different from monetary payments" .
It should also not be forgotten that donations necessarily involve third parties (mainly healthcare professionals) as well as appropriate and frequently costly procedures and equipment, for all of which a fair price should be paid. It has to be acknowledged that there is a "need to cover legitimate costs of procurement and of ensuring the safety, quality and efficacy of human cell and tissue products and organs for transplantation...." . The storage and processing stages are not cost-free and the relevant expenses are borne by the facilities that use the donated (and variously modified) blood, cells and tissues.
In some cases the processing of voluntarily donated cells, tissues and blood renders the end-products very different from the original biological material, and various of these products may be marketed . This is ethically acceptable only in so far as the donor was fully informed and freely gave consent. It is usual in these cases for at least part of the end-product to be assigned to a public health scheme in recognition of the altruistic gesture of donation. At all events care must always be taken to ensure that donations are totally voluntary and that the entire procedure is carried out in compliance with current legislation.
It is the task of legislators and national authorities not only to define the most appropriate regulations to ensure that any reward offered to donors cannot be construed as some kind of economic incentive, but also to spread the culture of donation so that the public can fully appreciate how a life may depend on a simple gesture of altruism.
Conflict of interest statement
There are no potential conflicts of interest or any financial or personal relationships with other people or organizations that could inappropriately bias conduct and findings of this study.
1. World Health Organization. Guiding Principles on Human Cell, Tissue and Organ Transplantation. Resolution WHA63.22. 21 May 2010. (Guiding principle n. 5). Available from: www.who.int/entity/transplantation/Guiding_PrinciplesTransplantation_WHA63.22en.pdf.
2. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo, 4 April 1997. Available from: http://conventions.coe.int/Treaty/en/Treaties/html/164.htm.
3. Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Explanatory Report. 1997. Available from: http://conventions.coe.int/Treaty/EN/Reports/Html/164.htm.
4. European Parliament, Council of the European Union. Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. Official Journal of the European Union L102, 7 April 2004.
5. 5. O'Mahony B, Turner A. The Dublin Consensus Statement 2011 on vital issues relating to the collection and provision of blood components and plasma-derived medicinal products. Vox Sang 2012;102(2):140-3. DOI: 10.1111/j.1423-0410.2011.01528.x
6. United Nations Educational, Scientific and Cultural Organization (UNESCO). Universal Declaration on the Human Genome and Human Rights. 11 November 1997. Available from: http://portal.unesco.org/en/ev.php-url_d=13177&url_do=do_topic&url_section=201.html.
7. United Nations Educational, Scientific and Cultural Organization (UNESCO). International Declaration on Human Genetic Data. 16 October 2003. Available from: www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/human-genetic-data/.
8. United Nations Educational, Scientific and Cultural Or-ganization (UNESCO). Universal Declaration on Bioethics and Human Rights. 19 October 2005. Available from: www.unesco.org/new/en/social-and-human-sciences/themes/bioethics/bioethics-and-human-rights/
9. Lenk C, Beier K. Is the commercialisation of human tissue and body material forbidden in the countries of the European Union? J Med Ethics 2012;38(6):342-6. DOI: 10.1136/jme.2010.038760.
10. Agence Fédérale des Médicaments et des Produits de Santé. Arrêté ministériel fixant le prix du matériel corporel humain. 14 Octobre 2009. Moniteur Belge 2009;2009018418:69443.
11. Velasco JG. Egg donation in Spain. The Spanish point of view. Focus on Reproduction (Newsletter of the European Society of Human Reproduction and Embryology) 2007;5:26-30.
12. Brown N, Mackin L, McLeod D. Immunitary bioeconomy. The economisation of life in the international cord blood market. Soc Sci Med 2011;72(7):1115-22. DOI: 10.1016/j.socscimed.2011.01.024
13. Hoppe N. Bioequity: property and the human body. Farnham: Ashgate; 2009. p. 137.
14. European Parliament, Council of the European Union. Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC. Official Journal of the European Union L33, 8 February 2003.
15. Human Tissue Act 2004. Section 32(11). Available from: www.legislation.gov.uk/ukpga/2004/30/contents.
16. Nuffield Council on Bioethics. Human bodies: donation for medicine and research. 2011. Available from: www.nuffield-bioethics.org/sites/default/files/Donation_full_report.pdf.
17. Strong CW, Shafer T. Donation of bodily material for medicine and research. BMJ 2011;343: DOI: 10.1136/bmj.d6839.
18. Manning FJ, Sparacino L (Eds.). Forum on Blood Safety and Blood Availability, Institute of Medicine. Blood donors and the supply of blood and blood products. Washington DC: National Academies Press; 1996.
Address for correspondence:
Unità di Bioetica, Presidenza, Istituto Superiore di Sanità
Via Giano della Bella 34
00162 Rome, Italy
Received on 16 August 2012.
Accepted on 23 October 2013.