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Guest article by Catherine Hartmann, EPHA’s Scientific Advisor on Brussels Advocacy and former Executive Director of the European Blood Alliance (EBA)

Next week, EU decision-makers will make choices regarding Substances of Human Origin (SoHO) that will tie the European Union for at least the next decade – why should you care?

In a world and time when health and healthcare are mainly approached from a commercial perspective  – with recent examples of hyper profits made over prevention of COVID-19 thanks to vaccines – one field of care remains out of a profitable scheme, the procedure of donating blood and its main components, red blood cells, plasma and platelets, for the benefit of patients with a chronic disease (e.g. hemophilia) or an acute need (e.g. bleeding from giving birth; cancer treatment with platelets).

Plasma, the yellow liquid part of blood, is the largest single component of blood, making up roughly 55%. It contains many important substances, namely antibodies, clotting factors, and proteins such as albumin and fibrinogen. After collecting donated plasma, healthcare professionals freeze it to preserve its quality and function. They refer to this as fresh frozen plasma, or FFP. Plasma may be transfused to a patient or used for the production of plasma derived medical products (PDMPs).

In all EU but four countries (Czech Republic, Austria, Germany and Hungary ) plasma donors are not paid for their donation. The EU Member States generally abide by the rule of volunteer-non-remunerated donations (VNRD) and the absence of commodification of body parts.

Several EU national policymakers presently reviewing the SoHO new draft legislation (Directive and Regulation) are challenging this rule, arguing that shortages plasma and our reliance on US plasma could be addressed through payments to the “donor” to encourage more and more frequent “donations”.  In addition to the fact that several studies demonstrated that remuneration (through indirect financial benefits, costly “gifts” or cash) is not a long-term and sustainable incentive [1][2], it raises crucial ethical and pragmatic questions EPHA members are invited to reflect upon, in line with EPHA’s position on public heatlh equality, equity and access to care.

Ethics Matter

Blood collection has been a pioneer in ethics, and has established ethical standards commonly referred to as benevolence, voluntariness, anonymity and non-for profit (gratuity).

Donating one’s blood to treat another person is at the crossroad of sociology, philosophy, public health and ethics and not the ordinary purely pragmatic piece of legislation as the potential cure is a living body. Globalisation of the market, merchandising of the human body, and social inequalities must be taken into consideration when discussing blood transfusion since blood can be eventually considered as a gift that is special in that it is a source of manufactured goods (PDMPs).

Complying with the principles of non-maleficence and beneficence means that the donor should not be subject to unnecessary or unreasonable harm. However, remuneration and profit have been objectively shown to encourage high frequency donations with potentially harmful consequences for the donors.

A paid donation system commodifies the body and creates a society in which everything has merely a market value. Is this what we wish for the future of our SoHO donations, donors and patients?

Blood and plasma are unique as they serve as a treatment sourced from a living human body to another human being; drawing blood and blood components is a two-way process that has a donor and a recipient, and the safety of both of them is critically important from the prospective of the medical ethics. The source is not unlimited, there is no production chain nor guarantee of safe and continuous supply.

Payment of donors goes against protection of the donor’s dignity, and the prohibition of making the human body and its parts as such a source of financial gain, as expressed by Council of Europe [3] and the Nuffield Council on Bioethics in its report on “Human bodies: donation for medicine and research.

While blood can be commodified into a marketable system, doing so would result in a dangerous precedent that erodes the inherent level of respect that must be given to the human body (as an essential component of one’s entire life experiences).

Calling for more plasma donation through payment encourages the less wealthy part of the population to put their life in danger through over donations [4], while maybe helping blood recipients but it is not acceptable to rob Peter to pay Paul.

Paying people to donate their plasma creates the possibility of exploitation by others as it will mostly attract the less well-off who may need that money to sustain (see example for the US, where the system is widely implemented) and is de facto creating a divide and risks to the donors’ health.

Publicly, all companies based in the EU running private plasma collection centres will state that they abide to the principle of not making any financial gain out of plasma donation, but some private companies offer a one-hundred Euro “reward” after X number of donations, or e.g. if the donor brings a friend. Most of them will contest the term “remuneration” and argue that they are “compensating” for time loss, travel to donation centres and inconvenience. But the level of compensation is often much higher then the monetary value of the disrupt – which is difficult to calculate. The EU Commission and Parliament have attempted to frame this compensation in the draft text that some Member States legislators will contest.

Why remunerating donors is risky business?

The development of commercial plasma collection centres using paid donors erodes the voluntary donor base and might jeopardize the sustainability of the blood supply. In countries where unpaid and paid coexist, blood establishments have increasing difficulties in recruiting and retaining donors after they have been paid for a donation (aka the “crowding out” effect). There is a high probability that a donor once paid will not return to the unpaid system. This could destroy the European donation culture based on voluntary unpaid donations.

We have examples from the past in Belgium of private plasma centres closing down because they were not making enough business – their donor base was completely lost, those who used to provide their plasma in these centres did not go to the Belgium Red-Cross to donate their blood and/or plasma.

Blood and plasma are commonly used in healthcare, they are essential components of care, and even more so with the evolution of medicine and of international movement and settling which force blood establishments to find solutions to address what were rare occurrences of diseases in the past in the EU (dengue, zika, for instance) from a bigger variety of ethnic backgrounds.

Some EU Member States have competition between several providers of blood products for the supply of hospitals. The for-profit sector will cherry-pick who it wishes to sell its products to, leaving the obligation to supply hospitals with all mandatory life-saving products to ensure self-sufficiency at a basic fee. This risks creating a 2-tier health system where the costs of treating the patient with blood-derived products will be accessible for those who pay, not the others – another illustration of potential privatisation of the system.

In line with EPHA’s vision and values*, I shall encourage you all to pay good attention to the development of SoHO policies both at national and EU levels, as a true reflection on what we wish for the future of healthcare.

*Our vision is of a Europe with universal good health and wellbeing, where all have access to a sustainable and high quality health system: A Europe whose policies and practices contribute to health, both within and beyond its borders.

Our values:

• Equity
• Solidarity
• Sustainability
• Universality
• Diversity
• Good Governance