Blood transfusion for dogs and cats

 Somewhat as in human donation around the world, blood donors for veterinary transfusions of cats and dogs are both volunteers and professionals. (Of course all these donors are themselves dogs and cats.)

Here's the NYT on the story:

 The Pet ‘Superheroes’ Who Donate Their Blood.
Transfusions have become an important part of veterinary medicine, but cat and dog blood is not always easy to come by.  By Emily Anthes

 "All kinds of ailments — including injuries, infectious diseases, immune conditions and cancer — can leave a pet in desperate need of blood, and transfusion has become an increasingly routine part of veterinary care.

“It is just as important a part of veterinary medicine as it is for human medicine,” said Dr. Dana LeVine, a small-animal internist at Auburn University and the president of the Association of Veterinary Hematology and Transfusion Medicine.

...

"There is no canine Red Cross. Instead, there are hospitals with in-house blood donation colonies, veterinary clinics with a roster of ad hoc donors on call and a small number of commercial blood banks, with wait lists that can stretch for months. There is also a growing community of pet owners who are signing their animals up to provide blood for other pets in need 

...

"Commercial blood banks for animals began emerging in the 1980s. Some rely on “closed colonies,” a group of cats or dogs that live on site, providing blood for several years before they are put up for adoption.

"Closed colonies have been a critical source of animal blood and can be run humanely, experts said. “I know many places that have fabulous cat rooms for cat donors,” said Dr. LeVine, who adopted her previous cat, Salt, from a blood donation colony.

"But animal rights activists have also exposed mistreatment and abuse at some commercial blood banks with closed colonies, and demand far outstrips the volume of blood they can provide.

"These factors have helped fuel interest in an alternate model, which recruits local pets to become regular donors. At DoveLewis, roughly 90 dogs and 40 cats serve as regular donors, or what the hospital calls “superheroes.”

...

"Community blood banks don’t pay pet owners for blood, but they do offer other perks, which often include free veterinary exams, blood work and flea and tick preventatives. The animals are rewarded, too. At DoveLewis, donor dogs get a jar of chicken or beef baby food. “It’s just the perfect size jar of smelly meat,” said Kelsey Reinauer, the blood bank director. “And then they get to pick out a toy from our toy bucket.”

########

See also

California Animal Blood Banks Program

“Historically, California required commercial blood banks for animals to be closed-colony establishments. On January 1, 2022, Assembly Bill 1282, the California Pet Blood Bank Modernization Act, went into effect. This law aims to address the shortage of animal blood available for veterinary transfusion medicine in California and transition the state from closed-colony blood banks to community blood banks.”

Blood supply in West Africa

 Here are some thoughts on blood shortages in West Africa by Jappah and Tao. (Jappah has just returned from Sierra Leone...)

To meet demand, blood donation should not rely solely on volunteers
A misalignment between supply and demand especially hurts people in low-income nations. by Jlateh Vincent Jappah and Ruoying (Carol) Tao, Harvard Public Health, December 4, 2024

"The World Health Organization advocates for 100 percent voluntary, non-remunerated blood donation—a position that was more defensible in the 1970s, before widespread screening for bloodborne diseases like hepatitis. Today, two-thirds of the world face shortages of blood and blood products, leading to many preventable deaths, especially among women and children. More than 80 percent of the world’s population has access to only 20 percent of the global blood supply. These global inequities in blood and blood product supplies are unacceptable.

"Africa, in particular, faces a disproportionate demand for blood and blood products. The continent relies heavily on family-based donation, which is not sustainable. Policies about blood supply in Africa, meanwhile, are generally based on research generated outside the continent—and in that research field, the idea of addressing blood shortages in Africa by providing adequate incentives and compensation to blood donors is met with skepticism.

"We are conducting research with nonprofit organizations such as Lifeline Nehemiah Projects and with government agencies in West Africa, and shortly we will begin field experiments, to study whether non-cash incentives increase blood donation.

...

"The misalignment between blood supply and demand is especially acute in low-income countries, where the demand for blood is high due to disease burdens, traumatic injuries, and medical conditions that require transfusions. Blood shortages in these regions are also driven by factors such as a higher prevalence of sickle cell anemia and bloodborne pathogens. And yet problems such as poor nutrition limit people’s ability to donate blood voluntarily.

...

"Blood donation should not rely solely on charity but also on empowering individuals and communities to meet their own needs. In Sierra Leone, for instance, humanitarian organizations provide food and transportation to blood banks, to encourage blood donations. These incentives have significantly increased donation rates, though blood banks sometimes struggle with supply shortages, such as blood bags and needles."

Jlateh Vincent Jappah is a physician and a Ph.D. candidate in health policy at Stanford University. He is a fellow at the McCoy Family Center for Ethics in Society at Stanford.

Ruoying (Carol) Tao
Ruoying (Carol) Tao is a Ph.D. student in health care management and economics at The Wharton School at the University of Pennsylvania. She previously worked in health care management consulting.

##########

Earlier:

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

#####

*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."

#########

Related:

Wednesday, August 28, 2024

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

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

###########

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."

How frequently can whole blood safely be donated?

 Maybe only twice a year for people who don't take iron supplements, according to this recent comment (on a randomized trial in the Netherlands).

Protecting the blood donor: ferritin-based intervals to improve donor health, by Laura Infanti, Lancet (online first) Published:June 13, 2024DOI:https://doi.org/10.1016/S0140-6736(24)01212-1

"Strict eligibility criteria and the ageing of the general population are among the main factors limiting blood donor availability,1 and render the retention of experienced donors and the acquisition of new volunteers a demanding task. Also, a temporary inability to give blood (eg, due to recent travel or a medical condition) can be a reason for abandoning blood donation permanently.2 Blood establishments are constantly making efforts to counteract blood shortages and the overall declining trends in donations.

"In this context, low haemoglobin concentration, which is the most common reason for donation deferral, is a key risk factor for the loss of active volunteers. Due to the loss of 220–250 mg of iron with each whole-blood donation, iron deficiency with or without anaemia is the most important side-effect of blood donation.

...

"A strong predictor of iron deficiency is the interval between donations. For healthy individuals not taking iron supplementation, recovering iron stores after the drawing of 450–500 mL of blood requires at least 180 days.6 Several observational studies questioned the minimal donation interval allowed by regulation as being too short for preventing iron deprivation,7 and the randomised INTERVAL study showed that shorter donation intervals, although increasing blood procurement, resulted in more frequent haemoglobin deferrals.8 Indeed, ensuring a sufficient blood supply and protecting healthy volunteers at the same time is very difficult. Thus, despite available evidence, European and US regulations permit whole-blood donations up to once every 56 days for both sexes, although at a maximum of six donations per year for male donors and four donations per year for female donors in Europe.

Here's the study itself:

• Meulenbeld A, 
• Ramondt S. 
• Sweegers MG
• , et al.

Effectiveness of ferritin-guided donation intervals in whole-blood donors in the Netherlands (FIND'EM): a stepped-wedge cluster-randomised trial.

Lancet. 2024; (published online June 13.)

https://doi.org/10.1016/S0140-6736(24)01085-7

Why High Incentives Cause Repugnance, by Robert Stüber

 Here's a nice experiment in the EJ:

Robert Stüber,Why High Incentives Cause Repugnance: a Framed Field Experiment, The Economic Journal, 2024;, ueae018, https://doi-org.stanford.idm.oclc.org/10.1093/ej/ueae018 

"Abstract: Why are high monetary payments prohibited for certain goods, thereby causing shortages in their supply? I conduct (i) a framed field experiment with a general population sample and (ii) a survey experiment with this sample and with ethics committees. In the experiment, participants can prohibit others from being offered money to register as stem-cell donors. I document that, whereas the majority of participants do not respond to changes in the incentives (63%) or become more in favour of the offer with higher incentives (20%), a minority of 17% prohibit high incentives. I show that this minority wants to protect individuals who are persuaded by high incentives. I also show that a lottery scheme reduces their objections to high incentives. Finally, I document that the public is much more supportive of high incentives than are ethics committees."

"In the experiment, participants can prohibit a transaction that involves another person signing up as a potential stem-cell or bone-marrow donor for money.1 Participants initially make a decision for two distinct amounts of compensation: one low (€10) and one high (€500). The main outcome is participants’ willingness to pay for prohibiting or permitting the offer. I find that the majority of participants (63%) do not respond to changes in the incentives or become more in favour of the offer with higher payment (20%). A clear minority (17%) reveal a stronger preference for preventing the offer when the payment is €500 rather than €10. This finding is mirrored in a second outcome, in which separate participants make simple binary decisions to prohibit the offer or not.

"Why do some participants want to prevent high monetary incentives for signing up? I answer this question by randomly assigning participants to different treatments. In the main treatment, Reservation Price, participants again decide whether to permit an offer of €500 for becoming a stem-cell donor. However, they know that, even if they permit the offer, the offer will be made only if the individual potentially receiving the offer agrees to sign up as a donor for €10 in an independent decision made beforehand. If the individual is not willing to sign up for €10, no offer is made. Put differently, the treatment ensures that the €500 offer is made only to individuals with reservation prices of €10 or less. The offer therefore cannot attract individuals with high reservation prices. The treatment drastically reduces the resistance of individuals who prefer low incentives: the median person who was previously willing to pay €2.50 to prevent the €500 offer is now willing to pay €1.50 to permit it. "

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.

#######

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

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.

##########

“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.

#####

Earlier:

Monday, April 22, 2024

Plasma donation in the EU: compensated and uncompensated

Plasma donation in the EU: compensated and uncompensated

 Here's a commentary on the EU Parliament's current efforts to ban compensation to plasma donors in the EU, published today.

 Julio J Elias, Nicola Lacetera, Mario Macis, Axel Ockenfels, Alvin E Roth, "Quality and safety for substances of human origins: scientific evidence and the new EU regulations," BMJ Global Health, Volume 9, Issue 4 (21 April, 2024) https://doi.org/10.1136/bmjgh-2024-015122

"Summary box

The new European Union (EU) ‘Regulation on standards of quality and safety for substances of human origin (SoHOs) intended for human application’ is based on a long-standing diffidence towards offering compensation to donors of SoHOs.

We point to recent, growing empirical evidence indicating that carefully designed compensation can increase the supply of SoHOs without negatively affecting quality and safety. We also elaborate arguments that address some of the moral concerns that motivate the aversion to payments.

As member states proceed to adopt the new EU regulation, our article may provide insights on how to achieve both self-sufficiency and safety"

...

"At least where plasma for fractionation is concerned, the unpaid-donor system has failed to meet demand. Table 1 indicates that in Europe, countries allowing monetary compensation for donors are the only ones achieving self-sufficiency in plasma collection for the production of immunoglobulin. The plasma sector in countries that compensate plasma donors, notably the USA, serves as supplier to many countries experiencing chronic shortages. The USA alone collects about 70% of the world’s plasma supply.10 A combination of a favourable regulatory environment, an extensive collection network and advanced technological infrastructure contributed to establishing the US position.11

Table 1

Plasma self-reliance and models of plasma collection15–19

Country	Reliance on domestic supply (% of total national need)	Monetary payments allowed	Current payment amount	Other incentives
Austria (2020)	100	Yes	€30–40	–
Czech Republic (2020)	100	Yes	€30–35	–
Germany (2020)	100	Yes	€25	–
Hungary (2020)	100	Yes	€30	–
Latvia (2018)	100	Yes	€17	–
Italy (2018)	76	No	–	Paid leave of absence from work
Slovenia (2017)	54	No	–	Paid leave of absence from work
Belgium (2019)	50	No	–	Paid leave of absence from work
France (2020)	50	No	–	–
Netherlands (2020)	45	No	–	–
Slovakia (2018)	41	No	–	–
Denmark (2018)	34	No	–	–
Spain (2020)	34	No	–	–
Portugal (2018)	22	No	–	Exemption from National Health Service user fees

• The table shows, for each country, the percentage of plasma needed for immunoglobulin (Ig) production that is collected domestically. The year in parenthesis is the one to which the data on self-reliance refer. The table then reports whether monetary payments are allowed, the current range of payments per donation and any other incentives in use in each country. In countries that allow payments, plasma collectors offer, in addition to monetary compensation for each donation, additional monetary or in-kind rewards, for example, when a donor reaches a certain number of donations (eg, 5, 10,…), or to first-time donors. The figures reported above do not include these additional rewards.

Plasma in Canada: payments and protests

 The local newspaper in Niagara on the Lake, a town in Ontario, Canada, covers the proposed opening next year of plasma collection centers that will pay for plasma.

Pay-for-plasma centre draws criticism from Health Coalition. The centre, which will pay residents to donate their blood plasma, is scheduled to open on Hespeler Road by early 2025, by Matt Betts

"The chair of the Waterloo Region Health Coalition is raising concerns about a pay-for-plasma centre slated to open on Hespeler Road in Cambridge by early 2025.

"Just as it sounds, residents can be compensated for donating their blood plasma.

"It's all part of an agreement between Spanish global healthcare company, Grifols, and the Canadian Blood Services.

"In September 2022, Canadian Blood Services announced our action plan in response to a global shortage of medications called immunoglobulins and plasma needed to make them," CBS said in an email to CambridgeToday.

"With funding from governments, Canadian Blood Services is opening 11 plasma donor centres in Canada and collecting more plasma ourselves. Our agreement with Grifols, a global healthcare company and leader in producing plasma medicines, is another part of that plan."

...

"paying for donations is banned in Ontario, Quebec and British Columbia. 

"However, CBS said its been in close discussions with the government and has an exemption.

...

"The agreement also complies with Ontario’s Voluntary Blood Donations Act, which has always contained an exemption for Canadian Blood Services, with implicit consideration of our agents, given our role as the national blood operator and supplier of blood products in Canada. Through our agreement, Grifols will operate under the Act as an agent of Canadian Blood Services."

"Per the agreement, Grifols must use plasma they collect in Canada to make immunoglobulins exclusively for patients in Canada, which reduces reliance on the global market, CBS said.

"But the whole operation doesn't sit right with Waterloo Region Health Coalition chair, Jim Stewart.

"It's a repugnant example of profit driven healthcare," Stewart said, questioning who's profiting in the end.

"What's next, paying people for their organs or embryos? This is just another example of Premier Doug Ford’s drive to privatize our healthcare system."

...

""These pay-for-donations centres really impact the homeless, people with low incomes and those with high levels of unemployment. This is going to dismantle the voluntary donor base and the sustainability of blood supply could be in jeopardy."

...

"While not confirmed by Grifols, Canadian Blood Resources and giveplasma.ca states qualified donors can earn up to $70 per donation and can donate twice in a seven day period."

#####

HT: Frank McCormick

Earlier:

Sunday, September 18, 2022

Canadian Blood Services to start paying Canadian plasma donors