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

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

The EU considers tightening bans on compensating donors of Substances of Human Origin (SoHO)

 Peter Jaworski considers an  EU proposal this month to harmonize across the EU bans on paying donors for Substances of Human Origin (SoHO).  Presently Germany, Austria and Chechia allow payment to plasma donors.

The E.U. Doesn't Want People To Sell Their Plasma, and It Doesn't Care How Many Patients That Hurts. The United States currently supplies about 70 percent of the plasma used to manufacture therapies for the entire world.  by PETER JAWORSKI 

"The European Union looks like it might take the foolish step of banning financial incentives for a variety of substances of human origin, including blood, blood plasma, sperm, and breast milk. The legislation on the safety and quality of Substances of Human Origin includes an approved amendment that says donors can only be compensated for "quantifiable losses" and that such donations are to be "financially neutral." This legislation is supposed to harmonize the rules across the 27 member countries, promote safety, with the ban on financial incentives intended to avoid commodification and the exploitation of the poor. 

...

"Already the E.U. is dependent on plasma collected in the United States for around 40 percent of the needs of its 300,000 rare disease patients. They're not as dependent as Canada because Germany, Austria, Hungary, and the Czech Republic allow a flat-fee donor compensation model and so are able to have surplus collections that contribute 56 percent of the E.U. total. The remaining 23 countries, each of which runs a plasma collection deficit, manage just 44 percent. 

"So what is likely to happen if the new rules make this flat-fee donor compensation model illegal? Will safety improve and commodification and exploitation be avoided? No, the E.U. will just become even more dependent on the United States."

The World Health Organization (WHO) at 75

 An editorial in Nature considers the complicated history of  the World Health Organization. 

The WHO at 75: what doesn’t kill you makes you stronger. The World Health Organization is emerging from the peak of the pandemic bruised. Its member states must get back to prioritizing universal health care.

"When thinking about the WHO’s 75 years, it’s worth remembering the time and circumstances of its creation. In the aftermath of the Second World War, the newly established United Nations and its specialized agencies, including the WHO, were designed to future-proof the world from another global conflict. Around 80 million people died during the two world wars, many from famine or disease.

"The WHO deserves more money for its core mission — and more respect

"The WHO’s founding constitution states unequivocally: “Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity. The enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.”

"And yet, the agency’s creators chose not to prioritize robust systems of universal health care that would meet these goals. This absent focus is one factor in why infectious diseases continue to impact populations in low- and middle-income countries. The eradication of smallpox in 1980 was a big win. But for other diseases, the agency and its donors have been unable to reach targets, including in the elimination of HIV and AIDS, malaria and tuberculosis.

"The WHO does, however, have a consistent record for establishing itself as the go-to organization for setting global standards for the efficacy, safety and quality of vaccines and medicines. As we have seen during the pandemic, the agency is central to alerting the world to new infectious diseases, helped in no small measure by the revolution in biomedicine and health data, especially genomics."

In general I think the WHO does important work reasonably well, but I have reservations about their policies concerning blood and transplants, which seem to me to reflect some now outdated repugnance to the complexities of “Substances of Human Origin (SoHO)." (Not that these issues don't remain complex.)

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

 The EU has proposed a strengthening of European prohibitions against compensating donors of "substances of human origin" (SoHOs).  Here's an op-ed in VoxEU considering how that might effect their supply.

Consequences of unpaid blood plasma donations, by Axel Ockenfels and  Alvin Roth / 4 Nov 2023

"The European Commission is considering new ways to regulate the ‘substances of human origin’ – including blood, plasma, and cells – used in medical procedures from transfusions and transplants to assisted reproduction. This column argues that such legislation jeopardises the interests of both donors and recipients. While sympathetic to the intentions behind the proposals – which aim to ensure that donations are voluntary and to protect financially disadvantaged donors – the authors believe such rules overlook the effects on donors, on the supply of such substances, and on the health of those who need them.

"Largely unnoticed by the general public, the European Commission and the European Parliament’s Health Committee have been drafting new rules to regulate the use of ‘substances of human origin’ (SoHO), such as blood, plasma, and cells (Iraola 2023, European Parliament 2023). These substances are used in life-saving medical procedures ranging from transfusions and transplants to assisted reproduction. Central to this legislative initiative is the proposal to ban financial incentives for donors and to limit compensation to covering the actual costs incurred during the donation process. The goal is to ensure that donations are voluntary and altruistic. The initiative aims to protect the financially disadvantaged from undue pressure and prevent potential misrepresentation of medical histories due to financial incentives. While the intention is noble, the proposal warrants critical analysis as it may overlook the detrimental effects on donors themselves, on the overall supply of SoHOs, and consequently on the health, wellbeing, and even the lives of those who need them. We illustrate this in the context of blood plasma donation.

"Over half a century ago, Richard Titmuss (1971) conjectured that financial incentives to donate blood could compromise the safety and overall supply. This made sense in the 1970s, when tests for pathogens in the blood supply were not yet developed. But Titmuss’ conjecture permeated policy guidelines worldwide, despite mounting evidence to the contrary. Although more evidence is needed, a review published by Science (Lacetera et al. 2013; see also Macis and Lacetera 2008, Bowles 2016), which looked at the evidence available more than 40 years after Titmuss’ conjecture, concluded that the statistically sound, field-based evidence from large, representative samples is largely inconsistent with his predictions.

"Getting the facts right is important because, at least where blood plasma is concerned, the volunteer system has failed to meet demand (Slonim et al. 2014). There is a severe and growing global shortage of blood plasma. While many countries are unwilling to pay donors at home, they are willing to pay for blood plasma obtained from donors abroad. The US, which allows payment to plasma donors, is responsible for 70% of the world’s plasma supply and is also a major supplier to the EU, which must import about 40% of its total plasma needs. Together with other countries that allow some form of payment for plasma donations – including EU member states Germany, Austria, Hungary, and the Czech Republic – they account for nearly 90% of the total supply (Jaworski 2020, 2023). Based on what we know from controlled studies and from experiences with previous policy changes, a ban on paid donation in the EU will reduce the amount of plasma supplied from EU members, prompting further attempts to circumvent the regulation by importing even more plasma from countries where payment is legal. At the same time, a ban will contribute to the global shortage of plasma, further driving up the price and making it increasingly unaffordable for low-income countries (Asamoah-Akuoko et al. 2023). In the 1970s, it may have been reasonable to worry that encouraging paid donation would lead to a flow of blood plasma from poor nations to rich ones. That is not what we are in fact seeing. Instead, plasma supplies from the US and Europe save lives around the world.

"In other areas, society generally recognises the need for fair compensation for services provided, especially when they involve discomfort or risk. After all, it is no fun having someone stick a needle in your arm to extract blood. This consensus cuts across a range of services and professions – including nursing, firefighting, and mining – occupations, most people would agree, that should be well rewarded for the risk involved and value to society. To rely solely on altruism in such areas would be exploitative and would eventually lead to a collapse in provision. Indeed, to protect individuals from exploitation, labour laws around the world have introduced minimum compensation requirements rather than caps on earnings. In addition, payment bans on donors, even if they’re intended to protect against undue inducements, raise concerns about price-fixing to the benefit of non-donors in the blood plasma market. In a related case, limits on payment to egg donors have been successfully challenged in US courts. 1

"In addition, policy decisions affecting vital supplies such as blood plasma should be based on a broad discourse that includes diverse perspectives and motivations. Ethical judgements often differ, both among experts and between professionals and the general public, so communication is essential (e.g. Roth and Wang 2020, Ambuehl and Ockenfels 2017). Payment for blood plasma donations is an example. We (the authors of this article) are from the US and Germany, countries that currently allow payment for blood plasma donations while most other countries prohibit payment. On the other hand, prostitution is legal in Germany but surrogacy is not, while the opposite is true in most of the US. And while Germany currently prohibits kidney exchange on ethical grounds, other countries – including the US, the UK, and the Netherlands – operate some of the largest kidney exchanges in the world and promote kidney exchange on ethical grounds.

"The general public does not always share the sentiments that health professionals find important (e.g. Lacetera et al. 2016). This tendency is probably not due to professionals being less cognitively biased. In all areas where the question has been studied, experts such as financial advisers, CEOs, elected politicians, economists, philosophers, and doctors are just as susceptible to cognitive bias as ordinary citizens (e.g. Ambuehl et al. 2021, 2023). Recognising the similarities and differences between professional and popular judgements, and how ethical judgements are affected by geography, time, and context, allows for a more constructive and effective search for the best policy options.

"In our view, the dangers of undersupply of critical medical substances, of inequitable compensation (particularly for financially disadvantaged donors), and of circumvention of regulation by sourcing these substances from other countries (where the EU has no influence on the rules for monitoring compensation to protect donors from harm) are at least as significant as those arising from overpayment. Carefully designed transactional mechanisms may also help to respect ethical boundaries while ensuring adequate supply. Advances in medical and communication technologies, such as viral detection tests, can effectively monitor blood quality and ensure the safety and integrity of the entire donation process – including the deferral of high-risk donors and those for whom donating is a risk to their health – without prohibiting payment to donors. Even if it is ultimately decided that payments should be banned, there are innovations in the rules governing blood donation that have been proposed, implemented, and tested that would improve the balance between blood supply and demand within the constraints of volunteerism; non-price signals, for instance, can work within current social and ethical constraints.

"As the EU deliberates on this legislation, it is imperative to adopt a balanced, empirically sound, and research-backed approach that considers multiple effects and promotes policies to safeguard the interests of both donors and recipients.

References

Asamoah-Akuoko, L et al. (2023), “The status of blood supply in sub-Saharan Africa: barriers and health impact”, The Lancet 402(10398): 274–76.

Ambuehl, S and A Ockenfels (2017), “The ethics of incentivizing the uninformed: A vignette study”, American Economic Review Papers & Proceedings 107(5), 91–95.

Ambuehl, S, A Ockenfels and A E Roth (2020), “Payment in challenge studies from an economics perspective”, Journal of Medical Ethics 46(12): 831–32.

Ambuehl, S, S Blesse, P Doerrenberg, C Feldhaus and A Ockenfels (2023), “Politicians’ social welfare criteria: An experiment with German legislators”, University of Cologne, working paper.

Ambuehl, S, D Bernheim and A Ockenfels (2021), “What motivates paternalism? An experimental study”, American Economic Review 111(3): 787–830.

Bowles S (2016), “Moral sentiments and material interests: When economic incentives crowd in social preferences”, VoxEU.org, 26 May.

European Parliament (2023), “Donations and treatments: new safety rules for substances of human origin”, press release, 12 September.

Iraola, M (2023), “EU Parliament approves text on donation of substances of human origin”, Euractiv, 12 September.

Jaworski, P (2020), “Bloody well pay them. The case for Voluntary Remunerated Plasma Collections”, Niskanen Center.

Jaworski, P (2023), “The E.U. Doesn’t Want People To Sell Their Plasma, and It Doesn’t Care How Many Patients That Hurts”, Reason, 20 September.

Lacetera, N, M Macis and R Slonim (2013), “Economic rewards to motivate blood donation”, Science 340(6135): 927–28.

Lacetera, N, M Macis and J Elias (2016), “Understanding moral repugnance: The case of the US market for kidney transplantation”, VoxEU.org, 15 October.

Macis M and N Lacetera (2008), “Incentives for altruism? The case of blood donations”, VoxEU.org, 4 November.

Roth, A E (2007), “Repugnance as a constraint on markets”, Journal of Economic Perspectives 21(3): 37–58.

Roth A E and S W Wang (2020), “Popular repugnance contrasts with legal bans on controversial markets”, Proc Natl Acad Sci USA 117(33): 19792–8.

Slonim R, C Wang and E Garbarino (2014), “The Market for Blood”, Journal of Economic Perspectives 28(2): 177–96.

Titmuss, R M (1971), The Gift Relationship, London: Allen and Unwin.

Footnotes: 1. Kamakahi v. American Society for Reproductive Medicine, US District Court Northern District of California, Case 3:11-cv-01781-JCS, 2016.

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

 India allows only unpaid blood donation, from altruistic donors or from "replacement donors" who are friends or relations of particular patients in need of blood (who must procure it before receiving it). There is a severe blood shortage, some of which is filled by black market "professional" blood donors, who are paid to pretend to be unpaid replacement donors.

Here's a story from the Indian news service Quint:

Out for Blood: Why Are Many Indians Forced To Seek 'Professional Blood Donors'? Although it is illegal, why is there a thriving market for paid blood donors in India?  by ANOUSHKA RAJESH and MAAZ HASAN

"Donating blood in exchange for money was banned in India in 1996. However, paying 'professional blood donors' to meet this requirement is still fairly common.

...

"To see how easy it would be to 'arrange' a paid blood donor, FIT went to one of the busiest government hospitals in Delhi.

...

"All leads – from vendors to patient families and bootleg pharmacists – point us to Ashok (name changed). He sits, surrounded by 4-5 men, and is guarded when we make inquiries.

"He begins with the following line of questioning: 'Where is our patient admitted?  What surgery do they need?  Why couldn't we just get friends and relatives to donate?

"Posing as a patient's friend, the FIT reporter gives him preplanned answers. In the emergency ward.  He had an accident and needs surgery on his leg.  I donated blood a month ago. He has no family here, and everyone else we reached out to has refused.

"Only when he's satisfied with the answers, he says he would be able to 'arrange boys' by the next day, and that it would cost between Rs 3,500 to Rs 4,000.

...

"According to the Ministry of Health and Family Welfare, India's annual requirement for blood is around 1.5 crore units per year, while in reality, only around 1 crore units are available.

"This gap in supply and demand of blood poses a major public health crisis in the country. For example, around 70 percent of postpartum hemorrhage (PPH)-related deaths in India are due to lack of immediate availability of blood.

...

"The paid donors are generally young boys, between the ages of 20 and 25, from very poor backgrounds," says Dr Dubey. ""This will no doubt be detrimental to their health," he adds. Moreover, if caught, they face the risk of jail time.

"The protocol is to ask every donor a set of questions before we take their blood. "If they seem suspicious, we ask them questions like, 'how are you related to the patient?', 'what is the patient's name?', and 'what surgery are they having?', to sus them out. If we get enough proof, we either defer them, or hand them over to the cops," Dr Priyansha Gupta, PG resident, Public Health, who has worked in Delhi's AIIMS blood bank in the past.

"What, then, happens to the families who desperately need blood when their donors are deferred?

"Dr Dubey says they are referred to the social workers attached to the hospital to get them help.

...

"But you have to understand, blood is a scarce commodity, and there's only so much we have."

##########

Here's a story from the Hindustan Times (in 2022), which begins with some relevant background (before debunking myths that lead to a shortage of voluntary donors):

Common myths on blood shortage in India  "The article is authored by Dr Parth Sharma, researcher, Ranita De, researcher in Lancet Citizen's Commission on Reimagining India’s Health System and Dr Vaikunth Ramesh."

"The shortage of blood products has been a major public health problem in India. It is estimated that nearly 12,000 people lose their lives every single day due to the lack of blood products. Supporting a population of 1.4 billion, the present blood transfusion service is fragmented with a little over 3,700 blood centres of which about 70% are located in eight states only. As of 2020, 63 districts in India do not have a blood centre. Space crunch and a burgeoning population have led to the establishment of health care facilities without blood centres on their premises, which in turn depend on nearby blood or storage centres for access to safe blood.

"Unfortunately, India has one of the largest shortages of blood supplies globally, while several diseases requiring blood transfusions are on the rise.

"A recent study by Joy Mammen, et. al. estimated the shortage to be around 2.5 donations per 1,000 eligible donors which equals a shortage of 1 million units. Blood products are required not only for surgeries but also for patients suffering from various medical conditions causing severe anaemia. At present, the source of donated blood is a combination of voluntary donors and replacement donors. Although professional donors are forbidden by law, they still continue to persist in our system under the guise of replacement donors. Voluntary non-remunerated donors, who donate based on altruism and a sense of doing greater good for the community, unfortunately, account for only 80% of the donors in India.

#######

HT: I was directed to the above links from the Indian posting

India Policy Watch #2: Regulating SoHO  by Pranay Kotasthane, which was in part about the recent move in the EU to further restrict payment for Substances of Human Origin (SoHO), as discussed in

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

Airbnb Replies (with some data) to the Report of the NY State Attorney General

Here's a 2014 report by the NY State Attorney General's office, Airbnb in the city

Short-Term Rentals Experienced Explosive Growth. Private short-term bookings in New York City on Airbnb increased sharply during the Review Period, registering more than a tenfold increase. The associated revenue also spiked, nearly doubling each year. This year, revenue to Airbnb and its hosts from private short-term rentals in New York City is expected to exceed $282 million.

Most Short-Term Rentals Booked in New York Violated the Law. State and local laws in New York—including the Multiple Dwelling Law and the New York City Administrative Code— prohibit certain short-term rentals. During the Review Period, 72 percent of units used as private shortterm rentals on Airbnb appeared to violate these laws.

Commercial Users Accounted for a Disproportionate Share of Private ShortTerm Rentals by Volume and Revenue. Ninety-four percent of Airbnb hosts offered at most two unique units during the Review Period. But the remaining six percent of hosts dominated the platform during that period, offering up to hundreds of unique units, accepting 36 percent of private short-term bookings, and receiving $168 million, 37 percent of all host revenue. This report refers to these hosts as “Commercial Users.”

Top Commercial Users Employed Rental Platforms to Run Multimillion-Dollar Short-Term Rental Businesses. Well over 100 Commercial Users each controlled 10 or more unique Airbnb units during the Review Period. Together, these hosts accepted 47,103 private shortterm reservations and earned $59.4 million in revenue. The highest-earning operation administered 272 unique Airbnb listings, booked 3,024 reservations, and received $6.8 million in revenue during the Review Period. Each of the top 12 New York City operations on Airbnb during that period earned revenue exceeding $1 million.

Private Short-Term Rentals Displaced Long-Term Housing in Thousands of Apartments. In 2013, more than 4,600 units were booked as short-term rentals through Airbnb for three months of the year or more. Of these, nearly 2,000 units were booked as short-term rentals for a cumulative total of half the year or more—rendering them largely unavailable for use by long-term residents. Notably, the share of revenue to Airbnb and its hosts from units booked as private shortterm rentals for more than half the year increased steadily, accounting for 38 percent of each figure by 2013.

Numerous Short-Term Rental Units Appeared to Serve as Illegal Hostels. New York law does not permit commercial enterprises to operate hostels, where multiple, unrelated guests share tight quarters. In 2013, approximately 200 units in New York City were booked as private shortterm rentals for more than 365 nights during the year. This indicates that multiple transients shared the same listing on the same night, as they would in an illegal hostel. The 10 most-rented units for private short-term rentals were each booked for an average of about 1,900 nights in 2013, with the top listing accepting 13 reservations on an average night.

Gentrified or Rapidly Gentrifying Neighborhoods Primarily in Manhattan Accounted for the Vast Majority of Revenue from Private Short-Term Rentals in New York City. Bookings in just three Community Districts in Manhattan—the Lower East Side/Chinatown, Chelsea/Hell’s Kitchen, and Greenwich Village/SoHo—accounted for approximately $187 million in revenue to hosts, or more than 40 percent of private stay revenue to hosts during the Review Period. By contrast, all the reservations in three boroughs (Queens, Staten Island, and the Bronx) brought hosts revenue of $12 million—less than three percent of the New York City total
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Here's a recent NY Times story on the data Airbnb has recently made available:
Airbnb Says Data Dump Shows Misuse of Service Is Rare

"With its release of a trove of data this week, the short-term rental company Airbnb sought to underscore how the majority of its hosts in New York City are playing by the rules. The point is a critical one for the company, valued by investors at about $24 billion, as it tries to pacify skeptical lawmakers and regulators.

Of particular concern to officials are the Airbnb hosts who lease multiple apartments, renting them out year-round and distorting their market value in a climate of scarce affordable housing.

The anonymized information released by Airbnb on rentals between November 2014 and November 2015 showed that 55 hosts in Manhattan, the borough with the most listings, have five or more full units listed on the platform, a tiny fraction of the more than 18,700 units listed in the borough.

...

Airbnb said it removed more than 2,000 listings last year after an affidavit was filed by the New York State attorney general, Eric T. Schneiderman, saying that two-thirds of the apartments listed in the city were illegal sublets.

A spokesman for Mr. Schneiderman’s office said that after a review of anonymized data Airbnb provided in 2014, it sought the identities of 124 hosts, all of whom had a minimum of 10 listings on the site and were earning an average of $500,000 a year. In June, the attorney general’s office referred the cases, including about two dozen hosts who had indicated a willingness to settle, to four city agencies with enforcement powers.

Wiley Norvell, a spokesman for Mayor Bill de Blasio, said that after receiving the attorney general’s referral, “city agencies began assembling cases to hold violators accountable.”

“We expect to announce those results soon,” he said.