{"id":2157,"date":"2024-05-16T20:30:02","date_gmt":"2024-05-16T18:30:02","guid":{"rendered":"https:\/\/www.rivistaeco.com\/?p=2157"},"modified":"2024-05-27T18:02:09","modified_gmt":"2024-05-27T16:02:09","slug":"the-failings-of-the-blood-market-in-europe","status":"publish","type":"post","link":"https:\/\/www.rivistaeco.com\/en\/2024\/05\/16\/the-failings-of-the-blood-market-in-europe\/","title":{"rendered":"The Failings of the Blood Market in Europe"},"content":{"rendered":"

Ethical considerations and practical necessities collide in the context of European regulation. The EU strongly advocates for the principle of non-remunerated blood donation. This leads to a paradox: in order to meet healthcare needs, it is forced to rely on other countries where donors are paid.<\/span><\/i><\/p>\n

In December 2023, the European Union institutions reached an agreement on new regulations concerning human-derived substances, including blood, tissues, cells, breast milk, and gut microbiota. The new regulation aims to raise the safety and quality standards for these essential substances in the healthcare sector, while also ensuring better protection for donors and recipients. The regulated activities include the registration and verification of donors, the collection and processing of substances, clinical application, and monitoring of outcomes. The new rules also aim to facilitate the exchange between states and access to substances, establishing a harmonized framework at the EU level and a more flexible approach for future updates. The legislative update, set in the context of rapid scientific and technological progress, aims to strengthen coordination and collaboration among member states.<\/span><\/p>\n

Why Plasma Donations Are Needed<\/b><\/h3>\n

One of the most problematic issues of the regulation concerns the economic compensation of donors of human-origin substances, a matter that has caused controversy and debate. One of the most heated debates revolves around plasma, the liquid component of blood, which is crucial for multiple physiological functions, including blood clotting and defence against infections. In addition to its use in transfusions during medical emergencies, plasma is used in the production of medications. Through “fractionation,” it is separated into components such as albumin, immunoglobulins, and clotting factors, which are then purified and transformed into treatments for chronic diseases such as immunodeficiency and hemophilia. The demand for plasma is considerable. According to the Plasma Protein Therapeutics Association, about 300,000 European patients rely on plasma-derived medicines every day to treat various critical conditions. For example, it is estimated that producing the required amounts of immunoglobulin for a single patient with hemophilia requires over 1,200 plasma donations per year and over 900 for each patient suffering from alpha-1-antitrypsin deficiency. Plasma donation typically requires between 50 and 90 minutes per session and is performed through the technique of plasmapheresis, whereby blood is extracted from the donor and processed through a machine that separates the plasma from other blood components, such as red blood cells and platelets, which are then reinfused into the donor. This method allows plasma to be safely and efficiently collected, maximizing the amount gathered in each session without compromising the donor’s health. Properly recognizing donors’ contributions through some form of compensation can thus be seen as a way to value their time and commitment. Despite the critical importance of plasma, the opportunity to compensate donors raises a series of ethical questions in the EU, which has traditionally promoted voluntary and unpaid donation, rooted in the principle of “non-commercialization” of the human body. This approach reflects the idea of social policy pioneer Richard Titmuss: in his 1970 work “The Gift Relationship,” the intrinsic value of the “gift” itself serves as a form of moral and social compensation, strengthening community bonds and a sense of solidarity.<\/span><\/p>\n

A Different Approach Between Europe and the United States<\/b><\/h3>\n

While Europe, with some exceptions, upholds the principle of voluntary and unpaid plasma donation, the United States has an explicit monetary compensation system, where donors can receive between $25 and $100 per session. Some centres offer bonuses for new donors or loyalty programmes that can further increase compensation. Monetary incentives are used to attract and maintain a sufficient number of regular donors, which is essential for meeting the constant and high demand for plasma-derived products. To ensure the safety and well-being of donors, plasma can be donated no more than twice a week, with a minimum interval of 48 hours between donations, to allow the body time to restore to normal levels.<\/span><\/p>\n

This approach has not only facilitated the creation of a thriving plasma industry but has also ensured self-sufficiency that allows the United States to export plasma and derived products to other countries, including European ones, which struggle to meet their internal needs. According to a study by economists Emily Gallagher and John Dooley, 3.1 million adults in the United States (just 0.04% of the global population) provide about 70% of the world’s supply. Plasma-derived medications treat millions of patients and account for about 2% of US exports. Globally, about 90% of the world’s supplies come from countries that allow remuneration for plasma donations. In an article written with Julio Elias, Nicola Lacetera, Axel Ockenfels, and Alvin Roth, published in BMJ Global Health and titled “Quality and Safety for Substances of Human Origins: Scientific Evidence and the New EU Regulations,” we show that, in Europe, only countries that allow economic compensation for donors have achieved plasma self-sufficiency: Austria, Germany, Latvia, Czech Republic, and Hungary. Other states, including Italy, are not self-sufficient. Overall, the European Union depends on the United States for almost 40% of its needs. This dependency not only raises health security issues but also puts the EU in a position of logistical and economic vulnerability. The new European regulation, however, states that compensation is allowed only to prevent donors from suffering “quantifiable losses” due to their donation.<\/span><\/p>\n

Monetary incentives for plasma donations: an example from the US<\/b><\/p>\n

\"\"
Source: CSL Plasma.<\/figcaption><\/figure>\n

Do Europe’s Concerns Have Merit?<\/b><\/h3>\n

The main concern is that monetary incentives might lead people to hide personal risk factors, such as the potential presence of transmissible infections, thus compromising the safety of the supply. For example, the new regulation prohibits mentioning remuneration in advertising and promotional activities in1 donor recruitment campaigns: thus, materials like those shown in Figure 1 are prohibited in the EU. However, scientific evidence and experience over the last few decades demonstrate that the quality and safety of plasma are not compromised when donors are compensated. There are strict rules and practices followed during the collection, processing, and distribution process. They include extensive testing for transmissible diseases, thorough evaluation of donors, and standardized procedures for handling and storing plasma. To further reduce the risk of transmitting infectious agents, fractionation processes include specific treatments that eliminate or inactivate viruses and bacteria. Facilities that treat and process plasma must adhere to international quality standards and are subject to regular inspections. Safety and quality standards apply equally to plasma from compensated and uncompensated donors, ensuring that all derived products meet the same high safety and quality levels, regardless of their origin. Plasma from the United States is considered safe and is imported by numerous countries that do not pay their donors, such as Canada and Australia. This reveals a certain hypocrisy in the global supply system: while some countries strongly support the principle of unpaid donation, they still depend on the plasma of paid donors from other countries to meet their health needs. Certain types of activities, such as organ donation and surrogacy, when performed for compensation, can raise significant moral concerns, since paying for such activities may lead individuals in precarious economic conditions to make risky decisions purely out of financial necessity. Moreover, there is a fear that the commercialization of these services could commodify aspects of life and the human body, undermining the intrinsic value of the person and fostering exploitation and inequalities. As demonstrated by the case of plasma, we are faced with delicate compromises. On one hand, the practice of economically compensating plasma donors has proven its safety and reliability for decades, significantly contributing to the global availability of vital treatments. On the other hand, ethical concerns regarding compensation for donations of biological substances must be considered. In a 2020 study, Alvin Roth and Stephanie Wang observed that both markets and bans on markets require broad and shared social support to be effective. Analyzing citizens’ opinions in Germany, Spain, the Philippines, and the United States regarding morally controversial trades, they discovered discrepancies in several cases between popular opinions and regulation. For example, support for commercial surrogacy exceeds 60% in all four considered countries, including those where the law prohibits the practice. The gap between perception and evidence is crucial, as it can directly influence policy formulation.<\/span><\/p>\n

Pay Attention to What Citizens Think<\/b><\/h3>\n

Citizens’ preferences, however, are not fixed and immutable but can be modulated, as they depend on the empirical evidence available, even in the case of controversial practices. In a study published in the American Economic Review in 2019, which I conducted with Julio Elias and Nicola Lacetera, it was found that the proportion of Americans in favour of a regulated system of payments to organ donors increases based on the number of lives that are estimated to be saved. A majority of Americans would be in favour of compensating organ donors (a practice almost universally prohibited, including in the US), if the system were managed by a public agency that guarantees transparency and fairness. Unfortunately, there is little research on European citizens’ opinions regarding economic compensation for donors of human-origin substances. Together with Frederike Ambagtsheer and other colleagues, we have proposed a research programme in an article published in Transplant International. It could provide the necessary evidence to help European rulers develop ethically shared incentive programmes. This type of research is essential to ensure that policies not only respect ethical objectives but are also effective in practice and based on solid empirical foundations. In an article published in Science, with Nicola Lacetera and Robert Slonim, we presented strong empirical evidence indicating that economic compensations are not incompatible with the motivation to make altruistic donations. On the contrary, they can even prove to be complementary to altruism, further incentivizing people to donate. Europe is at a crossroads: it can continue to follow an idealized model that does not provide compensation, risking not meeting its own health needs. Or it can seek to achieve a balance between ethics and pragmatism that allows for greater self-sufficiency and long-term security. Individual member states are given some discretion in interpreting the new regulation, allowing for example “fixed allowances” or “non-financial forms of compensation.” They potentially have the freedom to define what constitutes a “quantifiable loss” and to decide whether to include forms of compensation within these parameters. Clearly defining policy objectives, collecting and effectively using evidence to inform and modulate public opinions, are essential elements for the future management of biological resources in Europe. It will also be important to monitor the effects of the new regulation on supply and security goals, to provide citizens with the elements necessary to evaluate the effectiveness of the policies implemented and ensure that choices are aligned with their needs and expectations.<\/span><\/p>\n

Mario Macis<\/strong> is <\/span>Professor of Economics at the Johns Hopkins University Carey Business School and at the Johns Hopkins Berman Institute of Bioethics, and research associate at the National Bureau of Economic Research (NBER), Economics of Health Program.<\/span><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

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