Renewed considerations on ethical values for blood and plasma donations and donors

In this issue of Blood Transfusion, Carlo Petrini, Head of the Bioethics Unit of the National Institute of Health in Italy, reviews the ethical implications for blood and plasma donors involved in supplying plasma for the production of plasma-derived medicinal products¹. There has been constant debate on this topic for a long time now, particularly regarding voluntary non-remunerated donations (VNRD) as opposed to paid donations. However, whereas issues regarding patients’ safety, donors’ safety and the impact on blood and plasma supply to meet patients’ needs have been extensively discussed^2–4, the ethical values underpinning this debate have hardly been considered in the recent past. In this respect, the article by Carlo Petrini, much inspired by the Nuffield Council on Bioethics report on “Human bodies: donation for medicine and research”⁵, brings a renewed vision of these ethical values which it is important to share with the “blood community” and all other concerned stakeholders. With two other recent reviews on this topic^6,7, the article by Carlo Petrini first brings insight into the ethical values involved and then provides helpful clarification of the related terminology. Finally, he offers the possibility of carrying out an ethical evaluation, using the tool described by the Nuffield Council report⁵.

First, it is essential to develop awareness of the ethical principles concerning donors and on motivating further promotion of VNRD, as has recently been done for blood products^1,5,6 and haematopoietic stem cells⁷. These principles are as follows: dignity, non-maleficence, beneficence, autonomy and justice.

The principle of dignity is closely related to the “prohibition on making the human body and its parts as such a source of financial gain”, clearly stated in the European Convention on Human Rights and Biomedicine of 1997 (“Oviedo Convention”)⁸ and the Charter of Fundamental Rights of the European Union⁹. In this respect, remuneration for blood donation would violate the principle of human dignity. Complying with the principles of non-maleficence and beneficence means that the donor should not be subject to unnecessary or unreasonable harm. Remuneration and profit have been objectively shown to encourage high frequency donations with potentially harmful consequences for the donors¹⁰. Donor safety is all the more important as the act of donation is a medical procedure for which the donor will not derive any direct benefit. This constitutive absence of beneficence for donors is a major difference from the ethics governing patients undergoing medical procedures and who are expecting therapeutic benefit from them. Respecting donor’s autonomy involves avoiding any coercion/pressure. As it may be more attractive to those from lower socio-economic groups who have a greater need to use this option to gain income, remuneration for blood could be viewed as coercion against donors, compromising their autonomous decision-making. The principle of justice requires that the burden of donation does not fall disproportionately on a particular group or class, especially when the benefit is accrued to a different group or class. When remuneration is used as an inducement to provide blood or blood components, the “burden of donation” is being shifted to underprivileged populations.

Once these ethical principles have been made clear and generally accepted, it is important to reflect on the terminology proposed by the Nuffield Council⁵ in respect of transactions made in connection with human bodily material, including blood and plasma. A recompense is a payment to a person in recognition of losses they have incurred, material or otherwise. This may take the form of either reimbursement of direct financial expenses incurred in donating bodily material (such as train fares), or compensation for non-financial losses (such as inconvenience, discomfort and time). A reward is a material advantage gained by a person as a result of donating bodily material, which goes beyond “recompensing” the person for the losses they incurred in donating. If reward is calculated as a wage or equivalent it becomes remuneration. A purchase is a payment in direct exchange for a “thing” (a commodity).

The review of the ethical principles and the proposed terminology about transactions of human bodily materials led the Nuffield Council to envisage shifting the attention away from the paid/unpaid donation dilemma towards making a distinction between altruistic and non-altruistic interventions. With the aim of seeking areas of shared consensus on what can be done by institutions and organisations to “facilitate” donation of human bodily material (such as blood and plasma), the Nuffield Council suggested an “Intervention Ladder” as a useful tool for analysing the ethical acceptability of different forms of encouragement for donating bodily material in various circumstances⁵. It is of prime importance to compare each of the six “rungs” of this “Intervention Ladder” with the definition of VNRD of the Council of Europe¹¹. Rungs 1–4 (encompassing, for example, information campaigns, letters of thanks, small tokens, refreshments and reimbursements of direct travel costs incurred in donating) have been classified as altruist-focused. They are fully compatible with the definition of VNRD of the Council of Europe. Rungs 5–6 (encompassing payment either in the form of cash or in kind which could be considered a substitute for money) have been classified as non-altruist-focused. They clearly do not comply with the Council of Europe’s definition of VNRD.

Developing awareness of the ethical principles concerning blood and plasma donations and donors, as well as the related terminology and the Nuffield Council “Intervention Ladder” should help in the assessment of current practices and in the better determination of what should be ethically acceptable when encouraging donations to meet patients’ needs for blood components and plasma-derived medicinal products. As an example, these tools should help reflection on the problematic status of time off work that might be far in excess of the time reasonably needed for donation and travel, which can still be given for a donation. This could lead, far from any polemics, to consider moving to ethically more acceptable modes of recognition- encouragement-compensation, as has happened in France, Romania and French-speaking Belgium in the past few years. Similarly, monetary incentives given to students frequently donating plasma could be reviewed and considered as financial motivation¹² and, as such, ethically questionable, and, it is to be hoped, lead to a move towards ethically more acceptable modes of recognition-encouragement-compensation. In any case, altruism (and VNRD), widely understood as entailing a selfless gift to others without expectation of remuneration, should continue to play a central role in ethical thinking in this field¹³, keeping in mind the wellbeing of the donor, and the potential for harm and exploitation that exists within donation practices.

Renewed awareness of these views should also help review and improve of the tools currently used to assess and monitor implementation of VNRD¹⁴ and its consequences for patients’ and donors’ safety. In addition, renewed consideration of these views could also help better implementation of the existing legal instruments regarding ethical principles for donors and patients and, consequently, VNRD^8,9,15. Further, this renewed vision of ethical values for blood and plasma donations and donors should help in supporting important communal values about the kind of society in which we wish to live: a society in which a growing proportion of the blood and plasma supply, sufficient to meet the needs of patients, comes from VNRD, as the most ethically acceptable way of obtaining blood and plasma for patients.

Ultimately, in a long-term perspective, this renewed vision of ethical values for blood and plasma donations and donors should help each of the involved stakeholders -mainly donors, blood establishments, plasma collectors, manufacturers of blood components and plasma-derived medicinal products, prescribers, health care providers, health authorities, policy- and decision-makers, and of course patients-understand and accept that VNRD should be considered as the best way to ensure both a safe and sustainable blood and plasma supply for patients and a safe and sustainable donor population.