Protecting blood donor health to meet the patient’s needs

Safeguarding donor health and wellbeing, along with safeguarding and improving patient care and promoting voluntary non-remunerated blood donation, are essential pillars to the missions of the European Blood Alliance¹.

According to Article 168 of the Treaty of Functioning of the Europe Union (TFEU), “a high level of human health protection shall be ensured in the definition and implementation of all European Union (EU) policies and activities”². The European Parliament and the European Council are to contribute to the achievement of the objectives referred to by, among other things, measures setting high standards of quality and safety of blood and blood derivatives.

The blood and blood products 2002/98/EU directive³, currently due for revision, has allowed considerable progress to be made on issues of donor and patient safety, as well as patient care⁴. This is true not only within the EU; these directives have set standards that are relevant internationally. However, these directives should evolve and be strengthened, notably with regard to donor vigilance^4,5.

The purpose of blood products (including plasma for fractionation into plasma-derived medicinal products) is to provide care as they meet patients’ needs. However, without blood and plasma donors, provision of such life-saving therapies is not possible. Blood donors should therefore be alongside patients at centre stage of the process to revise these directives in order to further secure a safe, resilient, and sustainable supply of blood products and plasma-derived medicinal products in the EU.

All blood and plasma donors have similar and overlapping safety concerns, and should therefore not be considered separately. One individual donor will indeed contribute to several blood products. Currently, over half the plasma for fractionation collected in Europe is provided as “recovered” plasma from whole blood donation (alongside red blood cells and, possibly, platelets)⁶. In addition, the same blood donor may give both whole blood donations and plasma and/or platelet apheresis-mediated donations.

Reliance on a large donor base, notably for plasma donation, is critical to ensure resilience in times of crisis. Furthermore, a large donor base allows for low frequency plasma donations that are compatible with reduced donor burden, voluntary non-remunerated donation, and increased donor health protection⁷. In addition, low frequency plasma donation is associated with increased protein content (including immunoglobulins) in the collected plasma⁸.

Protecting donor health is obviously essential. Non-maleficence is a fundamental ethical principle owed to blood and plasma donors. Furthermore, donor trust and confidence in the safety practices of the donation procedures is critical to ensure the continuous provision of blood and plasma, and, hence, to meet patients’ needs.

Therefore, donor vigilance requirements in the EU must be strengthened. An EU-wide donor vigilance programme should include data from all involved stakeholders, including public and private operators within the EU. This donor vigilance programme should not only address short-term, well-characterised, adverse reactions (such as the donor fainting⁹), but also the less known potential mid- to long-term effects that are currently not considered in most hemovigilance programmes: adverse effects of iron¹⁰, lymphocyte¹¹, or protein/immunoglobulin¹² depletion.

Such potential adverse events are difficult to capture in the absence of dedicated hemovigilance programs. Hence, the opportunities offered by what is often called “big data” needs to be implemented for the benefit of our donors. A EU-wide General Data Protection Regulation (GDPR)-compliant vigilance program able to link donor/donations information with general population health databases, as pioneered in Scandinavian countries^11,13, will be a major step forward regarding donor protection. In addition, such donor vigilance program should allow informing evidenced-based decision-making regarding donor health. Such approaches are a priority of the European Commission, as exemplified by the recent call for EU4health action grant to develop a pilot project for an EU infrastructure ecosystem for the secondary use of health data for research, policy-making and regulatory purposes¹⁴.

Lastly, EU Directives lack the flexibility and the capacity to evolve as warranted by progress in knowledge. Therefore, the revised Blood Directives should set the principles governing all donations of all blood components, while leaving the technical provisions to recognized expert bodies such as the European Center for Disease Control (ECDC)¹⁵ or the European Directory for the Quality of Medicines and Healthcare (EDQM)¹⁶ of the Council of Europe.

Overall, the revision of the EU Blood directives is an opportunity to increase blood donor protection and better meet patient’s needs in Europe. An opportunity not to be missed.