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10 Plasma KCE Reports 120 THE REFLECTION ON ETHICAL DIMENSION OF STEPS: 1. Main specificities of blood and plasma donation The main traits of blood and plasma donation have been identified by Richard Titmuss and officially set out in the following article “Why give to strangers?“ Lancet 16 January 1971 6 and his book titled “The gift relationship: from human blood to social policy” (last edition 1997) 7 . The most specific traits of this “Gift relationship” is its potentially onesided and not rewarding dimension of this donation: • Physically uncomfortable • Anonymous and not rewarding (individually) • Potentially one-sided dimension (donor can be excluded from a future donation) • Absence of donation does not involve any sanction • The use of donated blood depends on a large number of people • For the donor, donation is no great or definitive loss whereas for the recipient, it can be a matter of life and death For all the reasons mentioned above blood and plasma donation can be considered as a very specific kind of gift, not to be compared with other kind of donations or “gift relationships”. Moreover blood and plasma donation as such entail specific symbolic dimensions (Myth of Blood). Further details: see Appendix 2. Main learnings It is important to underline that hindering factors for donation must be considered in close connection with the individuals’ past attitude towards donation (ie ever donors or non donors). The collection regimes may have an impact on donors’ motivation and donators’ profiles. In practice, it often involves a split between two donors profile. Therefore, it is of key importance to bear in mind that such subjects as financial compensation cannot be considered separately from other subjects. in countries were compensation is applied, plasma donors are generally younger, more educated, and less involved in professional life than whole blood donors. Conversely, in countries where no financial compensation is provided any clear distinction, in terms of donors’ profile, has been identified so far. MAXIMIZATION OF THE USE OF THE DONATED BLOOD AS AN ETHICAL IMPERATIVE Consensual prerequisites can be easily set out as follows, basically for purely practical reasons: - Plasma is a scarce resource (plasma as raw material is not industry-produced) - Plasma fractionation remains a complex and costly process. Therefore it involves very specific imperatives for stakeholders, more precisely: • Facilitating plasma collection (bringing down actual or potential barriers to donation) • Handling plasma and plasma-derived products cautiously • Distributing burdens and benefits fairly to all participants of the collection and supply chain • Needs of the population are not always easy to meet (self-sufficiency issue). ETHICS OF THE PLASMA ORGANIZATION Ethical dimension can work both ways: as clearly explained by Healy 8 , “Collection regimes do not simply increase or decrease the donation rate along a sliding scale. They shape the kind of activity that blood donation is. How you organize a blood supply system not only affects how much you collect and who you get it from, it shapes the character of donation”.
KCE Reports 120 Plasma 11 Therefore, it is of key importance to consider blood or plasma collection system not only from a technical point of view, but also from an ethical point of view, since each option – whatever it is- is apt to have a major impact on the ethical dimension on donation and thus on donors’ behaviour and indirectly on donors’ motivation as such. Given this background, four options can theoretically be considered: • A purely market-driven system: not affordable so far given the institutional European context described above. Besides it would require the fitting investments. • A solidarity-driven system: requires a strong social bond and can be easily implemented in smaller communities. In fact only strongly bound communities whose members identify themselves with the same core values can perform such a system and rely on it.. • A purely-voluntary system: “gift-fetishism”. However such a system does not seem to be reliable, as a matter of principle. Using incentives but retaining the “gift-like” features of the donation: the latter option money as such is not an incentive, but this does not exclude financial compensation. The latter option which is used in Austria or Germany for plasma donation raises specific problems as they can be seen as “borderline systems” from a purely ethical point of view. Clear-cut distinction between of incentive Vs remuneration is not always easy to make. The principle of voluntary unpaid donation Over the last decades, all the key institutions involved in blood and plasma donation have reasserted that profit as such must not be a motive for donation. Step by step, the principle of unpaid donation has been ethical standard for the countries of the European Union. This principle is officially mentioned by foremost international institutions, and thus accepted by Member States of these institutions: • International Red Cross and Red Crescent Societies / Core resolutions and guidelines on voluntary non remunerated blood donation: “Financial profit must never be a motive for the donors or those responsible for collecting the donation. Voluntary, non remunerated donors should always be encouraged” • Council of Europe / Art 2 of the European Conference N. R (95) 14: “Donation is considered as voluntary and non remunerated” (even if small tokens, refreshments, and reimbursement of travel costs are compatible with voluntary non remunerated donation). • World Health Organization: “Safe blood donors are the cornerstone of safe and adequate supply of blood and blood products. The safest blood donors are voluntary non remunerated blood donors from low-risk populations”. • Charter of Fundamental Rights of the European Union (Art 3): The right to the integrity of the person involves “The prohibition on making the human body and its parts as such a source of financial gain”. • Eventually, EU Directive 2002/98 Art 20 (opposable to all EU Member States) officially states that “Voluntary and unpaid blood donation are a factor which can contribute to high safety standards for blood and blood components and therefore to the protection of human health”. What emerges from all these statements is that blood and blood components are a subject of great ethical importance for the international and EU level. From an ethical point of view, the principle of voluntary unpaid donation is now accepted as the cornerstone of the donation policy in all EU countries. This is a key difference with other countries –especially the United States- where blood and plasma donation can be remunerated (even if it is not always remunerated).
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73. Financiering van het zorgprogra
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