Arguments against paying for plasma and other Substances of Human Origin (SoHO)

 Substances of Human Origin (SoHO) have a growing, often lifesaving role in modern medicine, from breast milk for premature babies, to kidneys for transplant, to blood and blood plasma, which the World Health Organization categorizes as an essential medicine for a wide variety of ailments and injuries.  However concern for protecting the donors of SoHO from exploitation has led to a considerable debate about whether donation must always be uncompensated, and motivated purely by altruism.
 

Two important cases are donation of kidneys and of blood plasma. Payment to donors of kidneys for transplant is banned almost everywhere, but a few countries (among which the U.S. is prominent) allow payment to plasma donors. Kidneys are in short supply, so patients with kidney failure very often die prematurely without receiving a transplant, but among high and middle income countries almost no one is today dying from a shortage of plasma and plasma products.  That isn’t because countries that don’t pay plasma donors generate sufficient supply for their domestic needs, it is because they can import plasma pharmaceuticals from countries that do pay donors, chiefly the U.S. which exports tens of billions of dollars of plasma products annually.
 

Here's an article arguing that payment for plasma and other SoHOs is always and everywhere wrong and should be stopped. (The  authors seem to agree with the WHO that countries should raise enough plasma domestically from unpaid donors, although no country has yet managed to do this.)  Furthermore, they suggest that companies that collect and process plasma must be nonprofits.

Prevention of Trafficking in Organs, Tissues, and Cells by Martin, Dominique E. PhD1; Capron, Alexander M. LLB2; Fadhil, Riadh A. S. MD3; Forsythe, John L. R. MD4; Padilla, Benita MD5; Pérez-Blanco, Alicia PhD6; Van Assche, Kristof PhD7; Bengochea, Milka MD8; Cervantes, Lilia MD9; Forsberg, Anna PhD10; Gracious, Noble MD11,12; Herson, Marisa R. PhD1; Kazancioğlu, Rümeyza MD13; Müller, Thomas PhD14; Noël, Luc MD15; Trias, Esteve MD16; López-Fraga, Marta PhD17 Transplantation, October 22, 2024. | DOI: 10.1097/TP.0000000000005212
 

“It is essential that all national laws “concerning the donation and human application” of human organs, tissues, and cells, as well as all derived therapies, conform to the principle of financial neutrality, prohibiting financial gain in the human body or its parts.9,70 Healthcare professionals, service providers, and organ, cell, and tissue procurement organizations, as well as other industry stakeholders involved in processing, manufacture, storage, and distribution of SoHOs and SoHO-based therapies, are all entitled to “reasonable remuneration” for their work and coverage of the costs associated with various sector activities.66,71 However, what may be considered a reasonable and proportionate remuneration in this context is ill defined. There have been reports of service providers and professionals generating disproportionate profits from such activities, creating potential financial conflicts of interest in service provision and potentially violating ethical norms and legal standards prohibiting trade in SoHOs.30
 

“Development of innovative therapies using human cells and tissues has increased, with the potential therapeutic value of these resources spurring commercial interests that, in some cases, has led to practices in which donated SoHOs are treated as commodities.30,72–75 Furthermore, some SoHOs may undergo substantial processing, resulting in these therapies being regulated outside the regulatory framework governing the transplantation of organs, tissues, and cells as such, and rather being considered as medicines, where commercial profits are expected and guide the production and distribution activities.74,75
 

“Mechanisms should be developed to ensure that strategies used in donor recruitment, which may involve actual or perceived financial incentives, are routinely disclosed and open to scrutiny.70 Transparency of practice is also required to enable scrutiny of the fees charged to cover costs of procuring, processing, storing, manufacturing, and distributing cells, tissues, and SoHO-based therapies and to assess the potential influence of financial interests on decision-making about the use of SoHOs in particular SoHO-based therapies, or distribution of SoHO-based therapies.74 These measures would furthermore help to facilitate equitable access to treatments for all patients.21
…
Box 1, first recommendation
“Recommendations for action to prevent trafficking in SoHOs
•    1. All countries should establish laws that prohibit payment for donation of SoHOs, trafficking in SoHOs, and trafficking in human beings to obtain SoHOs.
o    a. Legislation should prohibit activities that make the human body or its parts a source of financial gain exceeding the recovery of the costs of obtaining, processing, storing, and distributing those parts or the products made from them and of ensuring the sustainability, safety, and quality of donation and transplantation systems.”

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They also suggest that there is widespread human trafficking in SoHO, although they acknowledge that there isn’t a lot of data to support this:

“since 2010, there have been few empirical studies of organ trafficking, with more recent studies often consisting of qualitative interviews or surveys with individuals who participated in organ trafficking or were victims of human trafficking for organ removal several years earlier.7,32,52 Legal case analyses have focused primarily on seminal cases that detail activities that occurred in the early 2000s.33,38 Much of what is known about current trafficking activities is gleaned from sporadic media reports, which make clear the global prevalence of organ trafficking.”

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Earlier:

Wednesday, August 28, 2024  WHO Says Countries Should Be Self-Sufficient In (Unremunerated) Organs And Blood, by Krawiec and Roth

Monday, April 22, 2024 Plasma donation in the EU: compensated and uncompensated

Saturday, November 4, 2023  The EU proposes strengthening bans on compensating donors of Substances of Human Origin (SoHOs)--op-ed in VoxEU by Ockenfels and Roth

Kim Krawiec interview about WHO demands for national self sufficiency in blood donation and kidney exchange

 The University of Virginia takes note of the recent Krawiec & Roth paper I blogged about in August.

Here is their interview with Kim about the paper:

WHO Stifles International Blood and Organ Donations, Argue Professors. Professor Kimberly Krawiec, Nobel Prize Winner Alvin E. Roth of Stanford Argue World Health Organization Policies Need Revision

Here are the first two Q&As

"What motivated you to critique the WHO principles of self-sufficiency and nonremuneration in organs and blood? ​

"The severe shortage of both blood products and transplantable organs, especially kidneys, was our motivation and has motivated much of our other work, both together and separately. In the United States alone, the organ transplant waiting list is approximately 100,000 people, and if current trends continue, it will only grow in the coming years.

"Shortages of blood products present a similar challenge. Although wealthy countries are typically able to satisfy domestic whole blood needs, the vast majority of low- and middle-income countries (LMIC) are not. As a result, in many LMIC, shortages of blood for transfusion contribute to maternal death, death from traffic accidents and complications from childhood anemia. Moreover, even wealthy countries experience seasonal shortages of whole blood or deficiencies in some blood components, such as platelets, which are harder to collect and have a shorter shelf life.

The shortage of plasma-derived medicinal products (PDMPs) is particularly severe and entirely preventable. PDMPs are life-saving treatments for multiple acute and chronic conditions for which there are no alternative treatments. Yet these life-saving therapies are unavailable to much of the world’s population. The United States, one of the few countries to pay plasma donors, supplies 70% of the world’s plasma needs, with Germany, Austria, Hungary, Czechia and Latvia (which also permit some form of payment for plasma donors) supplying another 20% of the world total. In other words, a handful of countries supply plasma to the rest of the world, including other wealthy countries. Meanwhile, LMIC who can neither collect and process their own nor afford to purchase blood products on the open market (or are prevented from doing so under the terms of the foreign aid that supports their health system) simply do without, to the detriment of their citizens.

"How do current WHO policies on organ and blood donation contribute to this problem?

"WHO policy mandates both national (or sometimes only regional) self-sufficiency and an absence of remuneration for both blood products and transplantable organs — what we refer to in the paper as “the twin principles.” These twin principles are unhelpful separately and unworkable together. Their effect on blood products is particularly stark — no country that fails to compensate donors is self-sufficient in plasma collection and few LMIC collect sufficient supplies of whole blood.

"The self-sufficiency mandate presents a real hurdle to progress in transplantation, especially for smaller countries and LMIC. This is especially the case because some of the most exciting and promising developments for increasing the availability of transplants have been in kidney exchange, a mechanism that leverages in-kind exchange, rather than financial compensation, to encourage and facilitate donation among those with willing but incompatible partners. But kidney exchange works best when a large pool of patient-donor pairs can engage with one another. So, requiring that transplantation be contained within national boundaries unnecessarily limits access to transplants that could be achieved only by cross-border exchange."

IV fluid shortages in the U.S.--perhaps we should allow international imports?

There's a hurricane-induced shortage of intravenous (IV) fluid.  Maybe we should import some? (But...international borders...)

An obstacle is that FDA approval of the factories is usually needed, but can be (and in the past has been) suspended, to allow imports from places that do their own high quality inspection (like Australia and Ireland in 2017--I guess it's good that the labels are in English) .  

More generally, after the Covid pandemic we learned of the fragility of supply chains that have concentrated overseas sources (like surgical masks from Wuhan).  The reaction has been to onshore more production. But concentrated domestic production also makes for fragile supply chains, and being able to diversify to overseas producers could strengthen them.

Statnews has the story:

White House should declare national emergency over IV fluid shortages caused by Helene, says hospital group. Hurricane Helene shuttered a Baxter plant that manufactures 60% of IV solutions for the U.S.  By Brittany Trang 

"Amid Hurricane Helene shuttering a major IV solution manufacturing plant and Hurricane Milton now barreling toward other IV manufacturing facilities in central Florida, the American Hospital Association on Monday asked the Biden administration to declare a shortage of IV solutions and invoke national emergency powers to ease the crisis. 

'In late September, Hurricane Helene shut down a Baxter plant in Marion, N. C., which manufactures approximately 60% of the IV solutions for the U.S. Both Baxter and “all other suppliers” of IV solutions have restricted how much their customers can order and have stopped taking new customers, AHA president Rick Pollack wrote in the organization’s letter to Biden. As a result, hospitals have declared internal shortages and restricted IV use. 

...

"In addition, the letter asked for the government to declare a national emergency and public health emergency so that Medicare and Medicaid rules around IV infusions can become more flexible, and to invoke the Defense Production Act to expand the production of IV solutions and bags. The AHA also suggested the government put the Federal Trade Commission and Department of Justice on alert for price gouging during the shortage.

Another step the FDA could take is to allow the importation of IV bags from other countries,* as it did when Hurricane Maria shut down Baxter’s Puerto Rico-based IV saline plants in 2017. That shortage mostly affected small IV bags. According to Vizient, a health care performance improvement company, the North Carolina Baxter plant is largely a producer of large IV bags, including saline, dextrose, and Ringer’s lactate solutions.

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*In 2017: "To address a shortage of intravenous solution bags exacerbated by Hurricane Maria, the Food and Drug Administration has granted permission for a health supply company to import certain products to the United States from Australia and Ireland."

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Related:

Wednesday, August 28, 2024

WHO Says Countries Should Be Self-Sufficient In (Unremunerated) Organs And Blood, by Krawiec and Roth

Compensating plasma donors, or buying plasma from the U.S.? Europe clutches its pearls (The Economist)

 The Economist summarizes the plasma situation well.

The plasma trade is becoming ever-more hypocritical. Reliance on America grows, as other countries clutch their pearls

"Last year American blood-product exports accounted for 1.8% of the country’s total goods exports, up from just 0.5% a decade ago—and were worth $37bn. That makes blood the country’s ninth-largest goods export, ahead of coal and gold. All told, America now supplies 70% or so of the plasma used to make medicine.

...

"America’s booming blood trade is not an unmitigated success story, however, since it reflects problems elsewhere. The trade is mostly driven by two factors. The first is greater demand for plasma products: doctors have found ever more uses for the medicines, especially intravenous immunoglobulin. According to Marketing Research Bureau, a data firm, the market for immunoglobulin has grown by 5-7% a year for the past quarter of a century.

"The second reason is restrictions on plasma collection in other countries, owing to a combination of misplaced worries about safety and concerns about the morality of rewarding people for their bodily fluids. It is, for instance, illegal to pay for plasma donation in Britain, although the National Health Service does offer gifts and acknowledgments when donors reach certain milestones. In June the European Parliament approved new regulations that allow compensation to be offered for donations, but ban it from being mentioned in advertising and cap payments to an amount proportionate to the value of time spent donating. 

...

"Such qualms do not stop countries from importing American blood. Britain and Canada are almost entirely dependent on the country’s plasma; Europe brings in lots, too. China, a great rival of America in other areas of trade, is also more than happy to take advantage of America’s supply. Some 43% of Chinese imports of blood products now come from its geopolitical rival, up from just 14% a decade ago, according to figures from the UN. Chinese policymakers ban imports of plasma—a legacy of an attempt to prevent the spread of HIV in the 1980s—with the exception of a single protein, known as albumin. That alone is driving the trade.

"Some countries are even more flagrant in their double standards. France lobbied against the European Union’s recent regulatory changes, arguing that they risked making the human body a commodity, as is “already a reality in the United States”. At the same time, the French government is the sole shareholder in a company that owns six plasma centres in America, which pay donors, with the fluid collected available for use in France."

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Here are all my posts about plasma.

WHO Says Countries Should Be Self-Sufficient In (Unremunerated) Organs And Blood, by Krawiec and Roth

 Requiring national self sufficiency in blood and plasma supplies is particularly hard on low and middle income countries, as is limiting the possibility of participating in active kidney exchange programs.

WHO Says Countries Should Be Self-Sufficient In (Unremunerated) Organs And Blood by Kimberly D. Krawiec and Alvin E. Roth : August 24, 2024,   Available at SSRN: https://ssrn.com/abstract=4935827

Abstract: This chapter critiques the twin World Health Organization (WHO) principles of self-sufficiency and nonremuneration in organs and blood, urging a more sensible approach to the scarce resources of blood products and transplantable organs. WHO and other experts have failed to acknowledge the tension between self-sufficiency and nonremuneration in blood products--no country that fails to pay plasma donors is self-sufficient. Furthermore, international cooperation and cross-border transplantation provide numerous benefits, especially in smaller countries and those without well-developed domestic exchange programs. The combination of these twin principles denies to health care many of the benefits that trade has brought to so many other human endeavors and the effects are particularly damaging to low and middle income countries. Substances of human origin are special, but not so special that we prohibit plasma or organ donation. We should be open to exploring and experimenting with ways to bring to health care some of the benefits that trade has brought to so many other human endeavors, such as the production and distribution of food and lifesaving vaccines and other medicines.

Here's the concluding paragraph:

"We close by noting that the combination of the nonremuneration principle and the self-sufficiency principle deny to health care many of the benefits that trade has brought to so many other human endeavors. Substances of human origin are special, but not so special that we prohibit plasma or organ donation. So we should be open to exploring and experimenting with ways to bring to health care some of the benefits that trade has brought to so many other human endeavors, such as the production and distribution of food and lifesaving vaccines and other medicines."

Blood donation by family members in India: LGBT donors still banned

 In India, where the shortage of blood supplies is addressed by having family members donate, the ban on donation by LGBT people is a serious constraint.

The BBC has the story:

LGBT Indians demand end to 'discriminatory' ban on blood donation  by Umang Poddar

"In 2018, India's top court legalised gay sex in a landmark ruling - but the country still doesn't allow transgender people and gay and bisexual men to donate blood.

"People from the LGBT community say the decades-old ban is "discriminatory" and have gone to court to challenge it.

...

"Activists argue that apart from it being discriminatory, the ban is also irrational because of the high demand for blood transfusions in the country.

"A study published by the Public Library of Science in 2022 estimated that India faced an annual deficit of around one million units of blood."

HT: Vincent Jappah

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Earlier:

Tuesday, November 28, 2023

"Professional blood donors" in India (where paying blood donors is illegal)

Incentives for blood donation in China

 College students have serious (and competitive) incentives to donate blood in China.  This is from Ariana Tang's blog

blood donation bonus points for scholarship credits

"Incentives and Care for Blood Donating Students and Faculty at Shanghai University of Finance and Economics

"Students and faculty who participate in voluntary blood donation will receive a blood donation care package. This package includes a blood donation care card loaded with a nutrition subsidy of 220 RMB (previously, a 20 RMB meal subsidy was added to the care card). This card can be used at various campus restaurants and supermarkets.

"Additionally, the package contains a snack worth 40 RMB. Students who participate in voluntary blood donation will also receive an extra 0.5 points towards their scholarship.

"[translated excerpts from the official call-to-donation announcement, original file (in Chinese) archived here]

"scholarship system mechanics

"Key points: (1) scholarships are awarded by ranking of a score, and blood donation bonus is often a tie-breaker (2) scholarships are very important, and competitive.

"The major scholarship that students compete for—the ‘People’s Scholarship’ issued by the National Bureau of Education—quota is allocated to each class according to a designated ratio. For example, I compete among the pilot class with a total of 18 students for the following quota:

First-place: 18*2% = 0.36 -> 1 person.

Second-place 18*6% = 1.08 -> 1 person.

Third-place: 18*12% = 2.16 -> 2 person.

Students are ranked by their ‘comprehensive evaluation score’ which is mainly a weighted sum of their grades, physical exercises, adding a ‘bonus points’ which includes the aforementioned blood donation incentive:

...

"Notably, students can earn up to 0.5 points for each voluntary blood donation, with the potential to accumulate 1 point for two donations within a year.

...

competitions

The bonus from blood donations can decisively influence scholarship outcomes"

...

"the donation rush

"Scholarship is not only about money. The mental value that it carries, and more importantly, winning the ‘People’s Scholarship’ is a necessary for applying for further honors. Because of this huge incentive, students rush to get their blood donated.

"Given the scarcity of blood donation opportunities—only five to six campus visits yearly by the Shanghai blood center, each time offering around 150-200 quotas—students often queue from as early as 6 a.m. to secure a donation form. Latecomers, even those arriving slightly past 7 a.m., risk missing out due to the limited number of forms available.

"I’ve been there. Only got a form the second time."

Britain's Infected Blood Inquiry Report: Prime Minister's apology, and the benefits and perils of hindsight

 After the publication  yesterday of Britain's Infected Blood Inquiry Report, the UK's Prime Minister apologized to the nation. Here's the BBC story:

PM apologises after infected blood scandal cover-up  By Nick Triggle and Jim Reed, BBC News

"Prime Minister Rishi Sunak says he is truly sorry for the failures over the infected blood scandal, calling it a decades-long moral failure.

"He was responding to the public inquiry's report into the scandal, which has seen 30,000 people infected from contaminated blood treatments.

"It found authorities covered up the scandal and exposed victims to unacceptable risks.

"Mr Sunak described it as a "day of shame for the British state".

...

""Today's report shows a decades-long moral failure at the heart of our national life. I want to make a wholehearted and unequivocal apology."

"He said the attitude of denial was hard to comprehend and was to "our eternal shame".

...

Labour leader Sir Keir Starmer apologised too, describing it as one of the "gravest injustices" the country had seen and saying victims had "suffered unspeakably".

***********

I've now had the opportunity to read some of the (2000 page) report, and it leaves me in two minds.  On the one hand, as summarized in various news stories about the report, it deals with a long history during which British clinicians could have responded faster to growing evidence about hepatitis and HIV in the blood supply, and the various British governing coalitions could certainly have acknowledged earlier and more fully that people had been infected.

On the other hand, some of the harms to people who were infected by blood-borne pathogens are clearer in hindsight than they were at the times that they began to occur.

The cases of hemophila patients (many of them children, many of them at Treloar's, a school for disabled children including many with severe hemophilia) are particularly jarring.  Many of those children are no longer living, having been infected with HIV in the  1980's, before it was positively identified as the cause of AIDS (but after there was evidence that something in the blood carried the infection). The clotting factors (extracted from plasma pooled from many donors) that were being explored to treat hemophilia patients, are  (today standard treatments for hemophilia, but in the period covered by the report they were subjects of research, and were, tragically, infected with HIV, and hepatitis C before it's virus had been identified.

Here's a passage (from Vol. 1, p23) of the report that crystallizes why I think it's easier to assess blame in hindsight than it was at the time: (NANBH stands for non-A non-B Hepatitis, as Hep C was still something of a mystery.)

"By 1978 there were a number of reports showing that NANBH was linked to persistent liver damage. Amongst them was a paper published in September 1978 in The Lancet, authored by Dr Eric Preston and colleagues in Sheffield. In his oral evidence to the Inquiry, Dr Mark Winter said that this paper “blew out of the water instantly the idea that this [NANB hepatitis] was nothing to worry about because their study showed, as did other studies, that most of these patients had very significant chronic liver disease”. He thought doctors had been unwilling to think that NANBH might be a problem, because factor concentrate had brought “such spectacular benefits”: it was this reluctance to face the facts described in scientific journals that had prevented earlier acceptance of the seriousness of the problem."

The report also dwells on the difficulties that the UK faced in becoming self-sufficient in non-commercial plasma and clotting factor from domestic sources.  But self sufficiency is a world-wide problem today in states that depend on unpaid domestic donors. So it's not clear how culpable the British blood services should be considered on that account.

And it's a complicated question, because some of the U.S. commercial suppliers started heat treating their plasma to effectively destroy many pathogens, before this became common in the U.K.

The report states (Vol 1, p49)

"Some clinicians were reluctant to embrace commercial heat-treated products. There was as yet little direct evidence of how reliable the claims about commercial heat-treated products were in practice. Although there was no evidence of side-effects after a year of use in the US, heat-treated commercial products were not licensed for use in the UK until early in 1985. It is not difficult to see why clinicians may have preferred to wait for domestic product rather than change their treatment practices. Further, commercial products were believed to be more likely to carry hepatitis than domestic ones. Understandable though this reluctance may have been, it did not excuse continued use of unheated products beyond a short period into 1985."

So, British physicians were caught between desire for domestic plasma (from unpaid donors, which they believed was safer), and reluctance to use U.S. commercial plasma as it became the safer alternative.  And British plasma processors waited until 1985 to start producing their own heat treated plasma products. The results were tragic, but (unlike some of the later delays and evasions that the report spells out) I don't see that there is in every instance a clear case of blame.

The chair of the Infected Blood Inquiry is Sir Brian Langstaff , "a former judge of the High Court of England and Wales."  Judges have experience at hearing evidence, and may have some professional inclination to explain events in terms of guilt.  Not that there isn't plenty to apologize for.

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Here are all my posts on blood plasma.

Britain's Infected Blood Inquiry Report published today

 The UK commissioned a report on infections in its blood supply in the 1970's and 80's, and on the government's belated responses during and afterwards, as some 3,000 people died from HIV and other infections.  It's a long and complicated report, which came out today, and is available at

Infected Blood Inquiry Report

I've started to read it, and hope have more to say in a few days.  (It condemns many past decisions about maintaining the blood supply, providing medical care, and then failing to acknowledge past harms, which the current report is particularly aimed at addressing.)

In the meantime, here are some news reports.

From the BBC:

NHS and government covered up infected blood scandal By Nick Triggle and Jim Reed, BBC News

From the NYT:

Report Finds ‘Catalog of Failures’ in U.K. Contaminated Blood Scandal - A six-year inquiry found that the deaths of about 3,000 people and the infection of tens of thousands of others could have mostly been avoided.  By Aurelien Breeden  May 20, 2024

The Design of Markets. Una Nobel Lecture (Two talks in Padua, on Tuesday and Wednesday)

 Following my talk in Rome today, I'll be speaking in Padua tomorrow and Wednesday, first giving a seminar on controversial markets, and then a public lecture on market design.

The Design of Markets. Una Nobel Lecture di Alvin Eliot Roth

"On Wednesday 8 May the University of Padua hosts the  Nobel Lecture

...

"The meeting opens with greetings from the vice-rector Antonio Parbonetti  and the director of the Galilean School of Higher Studies,  Gianguido Dall'Agata . The guest is introduced by Antonio Nicolò , coordinator of the Social Sciences Class of the Galilean School.

...

"The Nobel Lecture, which is held in English , is  open to the public . To participate, reservations are required 

You can also follow the meeting via  live streaming on YouTube .

---

The Padua Nobel Lecture by Alvin Eliot Roth is preceded, on Tuesday 7 May at 3pm, by a seminar aimed exclusively at professors, researchers, fellows of the Department of Economic Sciences of the University of Padua - dSEA .
The Economics Seminar  is entitled " Controversial markets and repugnant transactions " and is held at the department headquarters in via del Santo 33 in Padua.

Text of the new EU regulations on Substances of Human Origin

 Kim Krawiec points me to this newly published document, with the 'final' regulations intended to prevent compensation of donors of Substances of Human Origin (SoHO), such as blood plasma.  How this will effect the five EU member states that compensate plasma donors remains to be seen, as these regulations are now scheduled to go into effect only in 2027.

REGULATION (EU) 2024/… OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL … on standards of quality and safety for substances of human origin intended for human application 

After a quick read, I think these are the sections of the new regulations that are most relevant to their elements of market design, and compensation to donors.

(4)… safety standards are to be based on the fundamental principle that the human body or its parts as such are not to be a source of financial gain.

…

(26) Solid organs are excluded from the definition of SoHO for the purposes of this Regulation and, thus, from the scope of this Regulation. Their donation and transplantation are significantly different, determined, inter alia, by the effect of ischemia in the organs, and are regulated in a dedicated legal framework, set out in Directive 2010/53/EU of the European Parliament and of the Council

…

(57) Article 3 of the Charter prohibits making the human body and its parts as such a source of financial gain. The use of financial incentives for SoHO donations can have an impact on the quality and safety of SoHO, posing risks to the health of both SoHO donors and recipients and therefore to the protection of human health. Without affecting the responsibilities of the Member States for the definition of their health policy, and for the organisation and delivery of health services and medical care, SoHO donation should be voluntary and unpaid, and be founded on the principles of altruism of the SoHO donor and solidarity between donor and recipient. Such solidarity should be built from the local and regional levels up to the national and Union levels, aiming for self-sufficiency of critical SoHO, and spreading the responsibility for donation evenly across the Union population to the extent possible. Voluntary and unpaid SoHO donation contributes to the respect for human dignity and to protecting the most vulnerable persons in society. It also contributes to high safety standards for SoHO and therefore to the protection of human health, increasing public trust in donation systems. AM\P9_AMA(2023)0250(244-244)_EN.docx 49/306 PE748.903v01-00 EN United in diversity EN 

(58) It is recognised, including by the Council of Europe Committee on Bioethics in its ‘Guide for the implementation of the principle of prohibition of financial gain with respect to the human body and its parts from living or deceased donors’ from March 2018, that while financial gain should be avoided, compensation should be able to be acceptable to prevent SoHO donors being financially disadvantaged by their donation. Therefore, compensation to remove any such risk is deemed appropriate as long as it endeavours to guarantee financial neutrality and does not result in a financial gain for the SoHO donor or constitute an incentive that would cause a SoHO donor to not disclose relevant aspects of their medical or behavioural history or to donate in any way that could pose risks to their own health and to that of prospective recipients, in particular by donating more frequently than is allowed. It should be possible for compensation to consist of the reimbursement of expenses incurred in connection with SoHO donation or of making good of any losses, preferably based on quantifiable criteria, associated with the donation of SoHO.

Whatever the form of compensation, including through financial and nonfinancial means, compensation schemes should not result in competition between SoHO entities for SoHO donors, including cross-border competition and in particular between SoHO entities collecting SoHO for different purposes, such as the manufacture of medicinal products versus human application as a SoHO preparation. The setting of an upper limit for compensation at national level and the application of compensation that is financially neutral for the SoHO donor have the effect of removing any incentive for SoHO donors to donate to one SoHO entity rather than another, significantly mitigating the risk that compensation differences might result in competition between SoHO entities, in particular between public and private sectors. It should be possible for Member States to delegate the setting of such conditions to independent bodies, in accordance with national law. Prospective SoHO donors should be able to receive information regarding the possibility of having their expenses reimbursed or of receiving compensation for other losses, through information tools, such as website 'Question and Answer' pages, information email addresses, telephone lines or other such neutral channels of factual information dissemination. However, because of the risk of undermining the voluntary and unpaid character of SoHO donation, references to compensation schemes should not be included in advertising, promotion and publicity activities that form part of SoHO donor recruitment campaigns, for example using advertising billboards or posters, on television, newspaper, magazine or social media advertisements or similar.

(59) SoHO entities should not offer financial incentives or inducements to potential SoHO donors or to those giving consent on their behalf as such an action would be contrary to the principle of voluntary and unpaid donation. Refreshments and small gifts, such as pens or badges, should not be considered as inducements and the practice of offering them to SoHO donors is acceptable as a recognition of their efforts. On the other hand, rewards or benefits, such as payment of funeral expenses, or payment of health insurance unrelated to the SoHO collection, should be considered as inducements, and as such contrary to the principle of voluntary and unpaid donation and should not be permitted.

(60) This Regulation is not meant to cover research using SoHO when that research does not involve human application, for example in vitro research or research in animals. However, SoHO used in research involving studies where they are applied to the human body should comply with this Regulation. In order to avoid undermining the effectiveness of this Regulation, and in particular in view of the need to ensure a consistently high level of protection for SoHO donors, and sufficient availability of SoHO for recipients, the donation of SoHO that will be exclusively for use in research without any human application should also comply with the standards concerning voluntary and unpaid donation set out in this Regulation.

…

(68) In cases where the availability of critical SoHO or products manufactured from critical SoHO depends on potential commercial interests, such as those related to the production and distribution of plasma-derived products, there is a risk of not having the interests of patients and research at the forefront, and thus to jeopardise the quality and safety of SoHO, SoHO donors and recipients. There could even be situations in which some products with low profitability are no longer produced, thereby hampering their accessibility for patients. Therefore, by considering all reasonable efforts for an appropriate and continuous supply of critical SoHO, Member States contribute to limiting the risk of shortages of products manufactured from critical SoHO.

(69) The exchange of SoHO between Member States is necessary for ensuring optimal patient access and sufficiency of supply, particularly in the case of local crises or shortages. For certain SoHO that need to be matched between the SoHO donor and the SoHO recipient, such exchanges are essential to allow SoHO recipients to receive the treatment they need in the optimal timeframe. This is for instance the case of hematopoietic stem cell transplants, for which the level of compatibility between the SoHO donor and the SoHO recipient has to be high, which requires coordination at a global level, so that each SoHO recipient has as many options as possible to identify a compatible SoHO donor.

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“Next steps (from the European Commission): 

The Council will now formally adopt the new European Health Data Space regulation which is expected to be published in the Official Journal in autumn. It will then become applicable in different stages according to use case and data type.

The Council will also formally adopt the new revised legislation to increase the safety and quality of substances of human origin, which will become applicable in 2027.

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Earlier:

Monday, April 22, 2024

Plasma donation in the EU: compensated and uncompensated