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.

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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

 

Medical Treatments for Transgender Minors--Oral argument in Supreme Court

 Yesterday the Supreme Court heard oral arguments about the Tennessee ban on transgender treatment for minors.

Supreme Ct. Hears Case on Medical Treatments for Transgender Minors
"The Supreme Court heard oral argument in United States v. Skrmetti, a case on whether Tennessee’s ban on transgender medical treatments for minors violated the Equal Protection Clause of the 14th Amendment. Tennessee enacted its law in March of 2023, which stated that there was a “compelling interest” to protect minors from physical and emotional harm by banning health care providers from administering hormone/puberty blockers and surgery to minors for transgender purposes. Transgender minors and their families sued the state, and the Justice Department intervened on their behalf, arguing the law discriminated on the basis of sex. A district court then stopped the ban on hormone and puberty blockers, but the Sixth Circuit Court of Appeals reversed that decision. The Justice Department then appealed to the Supreme Court. Chase Strangio, who argued on behalf of trans minors and their parents, was the first openly transgender lawyer to argue before the Court. 

Opening statement (text compiled from uncorrected Closed Captioning):

"MR. CHIEF JUSTICE, AND MAY IT PLEASE THE COURT, THIS CASE IS ABOUT ACCESS TO MEDICATIONS THAT HAVE BEEN SAFELY PRESCRIBED FOR DECADES TO TREAT MANY CONDITIONS INCLUDING GENDER DYSPHORIA. BUT SB-1 SINGLES OUT AND BANS ONE PARTICULAR USE. IN TENNESSEE THESE MEDICATIONS CAN'T BE PRESCRIBED TO ALLOW A MINOR TO IDENTIFY WITH OR LIVE AS A GENDER INCONSISTENT WITH THE MINOR SEX. IT DOESN'T MATTER WHAT PARENTS DECIDE IS BEST FOR THEIR CHILDREN. IT DOESN'T MATTER WHAT PATIENTS WOULD CHOOSE FOR THEMSELVES, AND IT DOESN'T MATTER IF DOCTORS BELIEVE THIS TREATMENT IS ESSENTIAL FOR INDIVIDUAL PATIENTS. SB 1 CATEGORICALLY BANS TREATMENT WHEN AND ONLY WHEN IT'S INCONSISTENT WITH THE PATIENT'S BIRTH SEX. TENNESSEE SAYS THAT SWEEPING BAN IS JUSTIFIED TO PROTECT ADOLESCENT HEALTH, BUT THE STATE MAINLY ARGUES THAT IT HAD NO OBLIGATION TO JUSTIFY THE LAW AND THAT SB 1 SHOULD BE UPHELD SO LONG AS IT'S NOT WHOLLY IRRATIONAL. THAT'S WRONG. SB 1 REGULATES BY DRAWING SEX-BASED LINES AND DECLARES THAT THOSE LINES ARE DESIGNED TO ENCOURAGE MINORS TO APPRECIATE THEIR SEX. THE LAW RESTRICTS MEDICAL CARE ONLY WHEN PROVIDED TO INDUCE PHYSICAL EFFECTS INCONSISTENT WITH BIRTH SEX. SOMEONE ASSIGNED FEMALE AT BIRTH CAN'T RECEIVE MEDICATION TO LIVE AS A MALE, BUT SOMEONE ASSIGNED MALE CAN. IF YOU CHANGE THE INDIVIDUAL SEX, IT CHANGES THE RESULT. THAT'S A SEX CLASSIFICATION FULL STOP, AND A LAW LIKE THAT CAN'T STAND ON BARE RATIONALITY. HERE TENNESSEE MADE NO ATTEMPT TO TAILOR ITS LAW TO ITS STATED HEALTH CONCERNS. RATHER THAN IMPOSE MEASURED GUARDRAILS SB 1 BANS THE CARE OUTRIGHT NO MATTER HOW CRITICAL IT IS FOR AN INDIVIDUAL PATIENT. THAT IS A STARK DEPARTURE OF PEDIATRIC CARE IN ALL OTHER CONTEXT. SB 1 LEAVES THE SAME MEDICATIONS AND MANY OTHERS ENTIRELY UNRESTRICTED WHEN USED FOR ANY OTHER PURPOSE EVEN WHEN THOSE USES PREVENT SIMILAR RISKS. THE SIXTH CIRCUIT NEVER CONSIDERED WHETHER TENNESSEE COULD JUSTIFY THAT SEX-BASED LINE BECAUSE THE EQUAL PROTECTION CLAUSE REQUIRES MORE, THIS COURT SHOULD REMAND SO THAT SB 1 CAN BE UNDER THE CORRECT STANDARD. I WELCOME THE COURT'S QUESTIONS. 

########

HT: Kim Krawiec

 

Medpage Today summarized the hearings under this headline:

Supreme Court Appears Likely to Uphold Bans on Transgender Care for Minors
— Justices' decision is not expected for several months

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.”

##########

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.”

#########
 

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.

#####

*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."

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

The Ethical Limits of Markets by Kim Krawiec

 Here's a new summary by one of the leading scholars of "taboo trades."

Kimberly D. Krawiec, "The Ethical Limits of Markets: Market Inalienability," Forthcoming, The Research Handbook On The Philosophy of Contract Law (edited by Mindy Chen-Wishart and Prince Saprai)   3 Apr 2024

Abstract: Although ethical critiques of markets are longstanding, modern academic debates about the “moral limits of markets” (MLM) tend to be fairly limited in scope. These disputes center, not on the dangers of markets per se, but on the dangers of exchanging particular items and activities through the marketplace. Proponents of MLM theories thus do not want to eliminate markets entirely, but instead seek to identify the moral and ethical boundaries of the marketplace by considering which goods and services are inappropriate for market trading. This chapter summarizes and categorizes some of the more important arguments within this debate, with a focus on recent research, controversies, and applications. The goal is to provide an overview of these debates, highlighting some of the topics that have generated robust discussion, particularly when relatively recent empirical or theoretical work may shed new light on a topic. Specifically, I focus on crowding out, corruption, leaving a space for altruism, equality, and a trio of related debates regarding paternalism (coercion, unjust inducement, and exploitation).

Here's her opening paragraph:

"Markets have limits—even the staunchest libertarian agrees with that idea.1 But the consensus ends there. There is no agreement on what those limits should be or why, as demonstrated by the vast variation in legal regimes around the world. For example, markets in sex are legal in much of the world and illegal in most of the United States.2 Markets in gametes and surrogacy services are legal and thriving in most of the United States and illegal in much of the rest of the world.3 Most of the world prohibits payments to plasma donors and, as a result, are forced to meet their domestic plasma needs by importing plasma-derived products from the United States, which in turn meets demand by paying plasma donors.

Sex work contracts are enforceable in small claims court, in Canada

 In Nova Scotia (where selling sex is legal but buying it is not), a sex worker sued a delinquent client for her fee and won (despite his argument that contracts requiring a party to commit a crime were unenforceable).

Former sex worker's victory in small claims court sets precedent, lawyer says. Decision clarifies that contracts for sex work are enforceable. by Moira Donovan · CBC News 

"A former sex worker in Nova Scotia has successfully sued a client in small claims court for non-payment of services. She and her advocates hope the decision will change the legal landscape for sex work in Canada.

"The case relates to an incident in January 2022 when Brogan, whom CBC News is only identifying by her first name because she is a survivor of human trafficking, spent an evening with a client.

"Afterward, the client refused to pay the agreed-upon fee.

"Brogan then turned to small claims court to recover the money — in what advocates believe is the first time such a case has come before the courts in Canada — and won a judgment that she was entitled to the unpaid amount, plus interest and costs.

...

"Brogan met the client in question, ... through a website called LeoList that's used by sex workers and their clients. After some discussion about rates and services, Brogan travelled to Samuelson's apartment, where she spent the evening.

...

"There was offer, there was an acceptance of the offer, there was certainty of terms, so all the hallmarks of an enforceable contract were there," said Jessica Rose, Brogan's lawyer.

"But the central question in the case was whether contracts for sex work are enforceable — a question that relates to the legislation governing sex work in Canada. 

"The Protection of Communities and Exploited Persons Act, which passed in 2014, is supposed to protect people from the risks involved in sex work. It amended the Criminal Code to remove the criminal penalty for individuals who sell their own sexual services, and eliminated criminal charges for those who support sex workers, such as drivers or security personnel.

"But aspects of that work remained criminalized, including the purchase of services.

"In this case, the defendant argued that contracts for sexual services were not enforceable because you could not have a contract in which one party — in this case, the client — had to do something illegal.

...

"adjudicator Darrel Pink concluded that because sex work is legal and the business arrangements supporting sex work are legal, it follows that the benefits of commercial law apply, including access to a civil claim — the same as any other service provider.

...

"Failure of the court to provide a remedy for a wrong or a breach of duty owed by a client would contribute to the very exploitation the legislation was designed to prevent," he wrote."

HT: Kim Krawiec

Markets in human milk, placenta, and feces

I've blogged earlier about markets for breast milk, but here is an article that considers them also in connection with placenta and feces: 

The Law of Self-Eating—Milk, Placenta, and Feces Consumption by Mathilde Cohen, Law, Technology and Humans, 3(1), pp.109-122.

"Milk, Placenta, and Feces 

"Since antiquity at least, there have been markets in human milk. Until the twentieth century, they relied primarily on wet nurses hired (or forced) to nurse infants directly on the breast.14Ancient Egyptian, Greek, and Roman pharmacopeias called for human milk as a therapeutic substance to treat burns as well as ailments affecting the ears, eyes, and genitals.15Traditional Chinese medicine  employed  human  milk  in  a  variety  of  preparations  to  cure  diseases,  such  as  debilitation,  arthritis,  rheumatism, voicelessness, amenorrhea, eye infections, and poisoning.16

"Today, markets in human milk continue to thrive.17Such markets assume two main forms: 1) informal markets through which people give or sell their milk peer-to-peer via their social circles or online; and 2) formal markets whereby profit or non-profit organizations, such as milk banks and commercial human milk companies, collect, process, and distribute milk to hospitals and a few outpatients for a fee. Human milk is sought after by three main categories of consumers: infants, adults, and researchers.

...

"Placenta

"Human placentas are used for spiritual, nutritional, medical, pharmaceutical, and cosmetic purposes. Placentophagy, or the act of eating one’s placenta after childbirth, has been practiced in the Global North since the beginningof the home-and natural-birth movement in the 1970s.22It is not an unprecedented phenomenon. Indeed, historian Jacques Gélis reported that:

    "Placentophagy, the custom of eating the newly expelled placenta,     has existed at various times amongst people of very different         cultures. From the sixteenth century onwards, European travellers to     the new world were much struck by this custom, which they         unfailingly reported.23

"According to Gélis, placentophagy was also practiced in Europe; however, “doctors and churchmen  were  more  and  more repelled, from the end of the seventeenth century onwards, by this custom . . . so ‘repugnant to humanity."  In the past decade, placentophagy has reemerged as a mainstream practice in the U.S., where it has been described as “anew  American  birth ritual.25

"Few randomized controlled trials have corroborated the benefits of placentophagy. However, placenta eaters are motivated by the hope of obtaining nourishment, hastening post-birth recovery, warding off postpartum depression, facilitating lactation, as well as spiritual motives, such as connecting with the baby and the environment. Placentas can be eaten raw or cooked."

...

"Minimally processed placental membranes have significant commercial and medical potential to treat, among other indications, eye diseases and acute and chronic wounds. The for-profit American company MiMedx also “grinds up amniotic tissue from placenta into an injectable product to treat tendinitis, strains, and other ailments.”29Much  like  human  milk,placentas  are increasingly seen as reservoirs of stem cells and thus are attractive to the field of regenerative and tissue engineering, and, more recently, as potential sources for treating coronavirus patients."

...

"Feces

"Excrement is typically regarded as disgusting; however, the medical use of human and animal feces has a long record. Heinrichvon Staden notes that:

"Most prominent among the ingredients in the Hippocratic pharmacological ‘dirt’ arsenal is the excrement of various animals. ..  .  the  belief  in  the  therapeutic  usefulness  of  excrement  was  shared  by  ancient  Mesopotamian,  Egyptian,  Greek,  Chinese, Talmudic, and Indian healers. . . . There is, therefore, abundant evidence that . . . ‘excrement therapy’—was a cross-cultural phenomenon extant already in the ancient world.32

"In Chinese medicine, human feces were used 1,700 years ago as a “suspension by mouth for patients who had food poisoning or severe diarrhea.”33

"Fast forward to the twentieth century, the community of microorganisms that dwell in the human gut has been shown to play a crucial role in human health. Fecal microbiota transplantation (“FMT”) was first identified in the modern scientific literature in 195834and has rapidly grown in popularity since the early 2010s. FMT consists in the delivery of processed stool from a healthy donor into the intestinal tract of a sick person via an enema, colonoscopy, naso-duodenal tube, capsules, or other means. As microbiologist Mark Smith and his colleagues noted, “the goal is to displace pathogenic microbes from the intestine by re-establishing a healthy microbial community.”35FMT  has  proven  strikingly  effective  in  treating Clostridium  difficile, a potentially lethal infection that most commonly affects older adults in hospitals or in long-term care facilities, typically after the  use  of  antibiotics."

...

"Despite these differences, milk, placenta, and feces share two sets of core similarities that justify their grouping in this analysis. First, milk, placenta, and feces are tissues that can be severed from the body without harm or risk of harm. Notably, milk and feces  are  replenishable  bodily  substances,  while  the  placenta  is  a  transient  organ  expelled  from  the  body  during  childbirth. Thus, far from constituting “corpse medicine”42(i.e., medicine that uses human materials obtained from dead bodies), the use of such substances can be characterized as living food or medicine. There are also no adverse health effects associated with the act of donation. Quite the opposite, good health requires that people eject the milk, placenta, and feces they produce from their bodies.  

...

"Second, these three products have similar channels of circulation, including via private, domestic consumption, peer-to-peer markets, medical and research institutions, and global markets in foods, drugs, and cosmetics. This wide scope for circulation is possible due to the potential for DIY treatments alongside higher tech uses involving special processing and expertise. Milk, placenta, and feces are collected, processed, and distributed by banks similar to other tissue banks; however, aspiring consumers can  also  obtain  milk,  placenta,  and  feces  and  use  them  on  their  own.  Unlike  blood  transfusion  or  organ  transplantation,  no professional expertise or complicated equipment is necessary to achieve basic forms of consumption. Milk, placenta, and fecescan be obtained directly from their producersafter some screening (or not) and consumed as is or minimally processed at home. Conversely, bio-banks systematically screen donors, subjecting them and their samples to a battery of tests, before processing their  products  in  various  ways;  for  example,  by freezing,  thawing,  pooling,  enriching,  freeze-drying  (in  the  case  of  milk), irradiating (in the  case of placenta), encapsulating (in the  case of stool). This is a fast-evolving field.

...

"No uniform perspective  has emerged on the  legal  classification of the  various body materials consumed by humans. In this respect, milk, placenta, and feces provide a case in point, as they do not fit neatly within the standard legal classifications for comparable products, such as foods, drugs, tissues, cosmetic ingredients, or waste products. Different countries have adopted contrasting legal regimes—or no regimes at all—to regulate these substances.

...

"In  the  so-called  post-colonial  era,  the  law  of  self-consumption  illustrates  the broader phenomenon of a “jurisprudence of disgust,” to use an expression that Alison Young developed to describe the legal censorship of provocative or “obscene” artwork.71A  significant  dimension  of  contemporary  law  making  can  be  characterized  as  a  response  to  what  is  considered disgusting around or among us, which reflects an endeavor to confine and tame what repulses us. This is particularly obvious in the context of what legal scholar Kim Krawiec calls “taboo trades” (and economist Alvin Roth dubs “repugnant markets”); that is, the exchanges and transactions of products that are considered culturally immoral and uncaring, such as those involving organs, babies, sex, drugs, and corruption."

Are embryos property?

 A Virginia judge has managed to make a repugnant legal argument about a repugnant transaction, since the relevant precedent he identifies has to do with the ownership of slaves.

Virginia judge rules human embryos are ‘chattel’ based on centuries-old slave laws  by Matthew Barakat, Associated Press

"Frozen human embryos can legally be considered property, or “chattel,” a Virginia judge has ruled, basing his decision in part on a 19th century law governing the treatment of slaves.

"The preliminary opinion by Fairfax County Circuit Court Judge Richard Gardiner – delivered in a long-running dispute between a divorced husband and wife – is being criticized by some for wrongly and unnecessarily delving into a time in Virginia history when it was legally permissible to own human beings.

“It’s repulsive and it’s morally repugnant,” said Susan Crockin, a lawyer and scholar at Georgetown University’s Kennedy Institute of Ethics and an expert in reproductive technology law.

...

"In a separate part of his opinion, Gardiner also said he erred when he initially concluded that human embryos cannot be sold.

“As there is no prohibition on the sale of human embryos, they may be valued and sold, and thus may be considered ‘goods or chattels,’” he wrote."

HT: Kim Krawiec