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New Cannibal Markets

 | 
Jean-Daniel Rainhorn
, 
Samira El Boudamoussi

Part 5. The Human-Product-Banking Industry

In the Name of Quality and Safety: Commercialization of Human Cells and Tissues

Jean-Paul Pirnay

Texte intégral

1When I read the invitation for the international research symposium called “Globalization and Commodification of the Human Body: A Cannibal Market?”, I hesitated to accept. Professor Jean-Daniel Rainhorn, one of the organizers of the symposium, reassured me: the subtitle referred to “therapeutic cannibalism” and not to “alimentary cannibalism.” But the inertia of my brain made me think of the movie Soylent Green (based on the 1966 novel Make Room! Make Room! by Harry Harrison), which I saw in my youth and had left a profound impression. It is the year 2022 and, as natural resources have been exhausted, people are fed synthetic Soylent products (green crackers said to be made of plankton). At the end of the movie, Detective Thorn (Charlton Heston) uncovers the disturbing truth about the real ingredients of Soylent Green: recycled human bodies. As it takes some time for my brain to shift momentum, I asked myself (out loud, in the office): “Would the activity of the Soylent Corporation—i.e., recycling human bodies into food—be legally permissible today?” A colleague immediately replied: “No, because cannibalism is illegal in the Western world.”

  • 1 www.rickgibson.net/perform.html
  • 2 news.sky.com/story/910630/dutch-tv-presenters-in-cannibal-stunt

2But is it, in fact? I screened the Internet and soon found out it wasn’t. England, for instance, does not have a specific law against cannibalism. In 1988 and in 1989, Rick Gibson legally ate the flesh of another person in public.1 When he tried to eat a slice of human testicle in Vancouver, the police confiscated the testicle. However, the charge was dropped and he finally ate the piece of human testicle on the steps of the Vancouver courthouse. In 2011, two presenters of a Dutch TV show ate each other’s flesh on air.2 A piece of their muscle tissue was surgically removed and was then fried and eaten in front of a studio audience. A lawyer had advised the program’s producers that cannibalism is not itself against the law. The presenters consented and claimed that there was no risk of ill health, as long as the human meat is properly cooked. Produce quality and safety shall prevail. The presenters were not prosecuted. So cannibalism is not illegal, providing consent and adherence to some quality and safety requirements, but—and this is important for any new business—is there a market for human meat? Well, pending global famine (this business has a high growth potential), the Soylent Corporation could focus on the very lucrative exclusive food market (anyway, it is recommended to start with a small business). Recently in Nigeria, police shut down a “cannibal restaurant” with roasted human flesh on the menu. The human flesh was sold as an expensive treat, but there were some consent and quality and safety issues.

3I’m not, however, a specialist in food safety, and food-industry-promoted cannibalism is not the topic of this paper. I was asked to elaborate on “therapeutic cannibalism” and more specifically on the issues associated with the increasing commercialization of human cells and tissues.

Human cells and tissues

4There are important differences between tissue and organ donation that the public are not aware of. Solid organs such as kidneys, livers, and hearts can be taken only from donors who are brain-dead and on life support or immediately after irreversible cardio-respiratory arrest. They need to be transported as quickly as possible from donor to recipient and are not, or only slightly, processed. Surgeons in transplant hospitals control their procurement and national or regional organizations coordinate their allocation. In contrast, human cells and tissues (HCTs) such as bone, skin, and heart valves may come from live organ donors, but more often they come from deceased donors in hospitals, morgues, or even funeral homes. These HCTs are often transformed and stored—they are preservable for years—in “tissue establishments” from which they can be globally distributed. Tissue brokers, processors, and distributors steer the allocation of the resulting HCT products. The HCTs of one donor can be used in 25 to 100 people.

Tradable goods

5Another major difference between organs and HCTs is that almost anywhere in the world the latter are considered to be tradable goods. Inside the global market, HCTs give rise to immense opportunities for profits. Theoretically, a single United States (US) donor could generate up to $230,000 in HCT products (solid organs not included), but usually HCTs for a value averaging “only” $80,000 are harvested (United States Congress 2001). As is the case for organs, HCTs are donated for free by donors or their families and, in most parts of the world, it is illegal to buy and sell HCTs. Then, how are profits made? Large tissue establishments set up seemingly altruistic offshoots to collect the HCTs that are later processed into lucrative products. Nobody charges for the tissue itself—this would be illegal—but it is legal to charge “reasonable fees” to compensate for the procurement and the handling of the HCTs. Unfortunately, the term “reasonable fee” has never been defined and this loophole is now used by brokers and tissue establishments to turn altruistic donations into large profits.

6HCTs are not only used in transplantation surgery. “Big Pharma” is also interested in HCTs. Using human instead of animal HCTs in the early stages of new medicinal product (drug in the US) testing will help to predict more accurately their safety and can speed up their development. Large firms have been set up to supply HCTs for research. HCTs for medicinal product testing are scarce, and as a result they are said to be worth more than diamonds, being valued at $500/gram (Barnes 2006).

IFAs—illegal and fraudulent activities

7Already in 1985, philosopher Malcolm Muggeridge warned the transplantation field that the “hacking-out of bits of peoples’ organs and putting them on the market is becoming an extraordinarily lucrative occupation—It’s going to be a very big trade” and that “where you have money being the decisive factor, there you will have trouble and disruption inevitably” (Marcus 1985). Since then, numerous scandals involving activities that today competent authorities call “illegal and fraudulent activities” (IFAs), have proved him right. Examples of IFAs are non-consented procurement, direct payment for human body parts, inadequate testing, inaccurate or false donor files, and absence of traceability. Whistle blowers exposed black-market sales of cadaveric body parts all over the world. For instance, executed Chinese prisoners were found to provide organs, but also tissues (e.g., skin), for transplantation (Smith 2001). The media had a field trip. Mediagenic and shocking cases such as the “New York body-snatching ring” (Waltz 2006) and the “Alder Hey organ retention scandal” (Redfern et al. 2001) drew public attention. Investigations, recalls (more than 60,000 HCT products were recalled in the US between 1994 and 2007) (Willson et al. 2012), lawsuits, out-of-court settlements, convictions, resignations, and the shutdown of tissue establishments followed. Corporate tissue establishments were often involved, but managed to keep out of the clutches of the court. The judge in the “New York body-snatching” case stated: “Just because the district attorney never prosecuted the executives from the bigger companies doesn’t necessarily mean they didn’t ‘participate in an enterprise.’” The “New York body snatcher,” Michael Mastromarino, was sentenced to 18–54 years in prison, and yet he concluded, “Nothing is going to change, there are too many people making too much money” (Willson et al. 2012).

8Public dissatisfaction prompted politicians to act. In the US, a Congress-Senate committee concluded that the federal government’s oversight of tissue banks was insufficient (United States Congress 2001). Although the incidents that had triggered policymakers were not representative of the entire tissue-banking community, and could have been prevented through adequate enforcement of the then-applicable laws and guidelines, more stringent HCT legislation was implemented in 2004 in the US and also in the European Union (EU). Efficient industry lobby, risk-averse competent authorities and policymakers, and US’s and EU’s urge to promote growth of (biotechnology) markets and jobs led to business-oriented HCT legislation (Pirnay et al. 2013). They introduced pharmaceutical industry quality and safety requirements such as Quality Management System, Good Manufacturing Practice (GMP), and Marketing Authorization, which in turn facilitated industry’s takeover of the HCT transplantation field. Ethical issues and public-health interests were evaded.

Ethical issues: out of scope, out of mind?

9The main ethical principles that are applicable to the HCT transplantation field are: the basic principle of “respect for human dignity” and the consequent principle that “human body material should not be considered as a commercial product or a commodity.” The emerging HCT legislations, however, disregard these principles. Throughout the elaboration process of the EU HCT legislation, various stakeholders presented a wide variety of philosophical, social, religious, and economic viewpoints on relevant ethical issues and in particular on the prohibition of commercialization and commodification of human body material, which lead to fierce ethical debates (particularly in the European Parliament). For some stakeholders, tissues originating from an altruistic (free) donation should only be handled by non-profit-making cell and tissue banks and laboratories, while others argued that the processing of tissues (e.g., into tissue-engineered products) involves costs that justify their commercialization, which in turn provides an incentive for industry to invest in tissue engineering. In the end, ethical issues were deemed legitimate, but out of the scope of Article 152(4)(a) of the Amsterdam Treaty: i.e., the quality and safety of organs and substances of human origin (Pirnay et al. 2013).

10The subsidiarity principle was used to pass down the ethical issues, caused by the liberal EU HCT legislation, to the member states. As prescribed by the EU, Belgium tried to address some ethical issues in its national transposition of the EU HCT directives. In Belgium, the manager of HCTs must be a medical doctor (MD) (should obey medical deontological codes), an ethical committee must approve the activities and goals of tissue establishments, and the price of HCT products (and of some processes) are fixed by ministerial decree. Unfortunately, these additional national measures have proven insufficient, as MDs can be opportunists too, ethical committees have approved unethical activities (e.g., of a private autologous cord-blood bank), and a private company successfully lobbied for a ten-fold reimbursement price (Pirnay et al. 2013).

11It seems impossible to deal with ethical issues on a local level, while being forced to be part of a liberal global market. Moreover, it is clear that ethical issues, such as paid or unpaid donation, the type and extent of donor consent and the eventual commercialization of HCTs, also impact quality and safety and should thus be dealt with at the EU level, or even better, at a global level. This moment of parliamentary “cultural ethical relativism” (each culture—i.e., EU member state—should use its own standards to judge all actions and institutions) is rather strange when it comes to the field of health-care, because one may assume that health is a universal ethical good. In the organ transplantation field, where industry plays a less pronounced role, similar ethical issues are dealt with on a global level (Steering Committee of the Istanbul Summit 2008). Concordantly, the HCT transplantation field would also greatly benefit from a global ethical framework that prohibits financial gains on the human body and its parts (Pirnay et al. 2010).

The globalization of human cells and tissues

12In 1983, Harvard Business School professor Theodore Levitt argued that companies should emphasize offering standardized products all over the world (Levitt 1983). Companies that concentrated on idiosyncratic consumer preferences would not be able to take in the forest because of the trees. As today’s successful global brands demonstrate, this notion clearly makes sense from a linear/mechanistic economical point of view. Globalization is typically accompanied by technological advances and the introduction of regulatory frameworks said to be necessary to increase quality and safety. For instance, small food producers are suffering under new product regulations. Established (some are around for centuries) and tasty local products are suddenly presumed of inferior quality and safety and are gradually replaced by uniform pale global brands with (a perception of) superior quality and safety. Bioengineering is rapidly transforming the crop-development industry, accelerating the concentration and centralization of agrochemical corporations pushing (genetically modified) monocultures and undermining the cultural diversity of local farmers (McMichael 2001). Over the last decades, small independent beer brewers are diminishing in significance as brewing multinationals have transformed one of the oldest industries in the world from a local market into a global one (Hurt 2010). The US artisan cheese world was shaken when the US Federal Drug Agency (FDA) shutdown several small (award-winning) cheese-making facilities due to bacteria findings in cheeses. And so on and so forth. Those defending the age-old methods of local craftsmen find the quality and safety rules to be over the top and argue that the products of large-scale food companies have caused many more illnesses than any product from small producers.

13A decade ago, the globalization tide caught up with the HCT transplantation field. As with most (if not all) markets, the emerging global HCT market is inherently confronted with financial considerations. Emerging HCT legislations focus on quality and safety, evade ethical issues, and exhibit loopholes that allow excessively free maneuvering of those that seek economic advantage. This is quite logical from an economical point of view. Moreover, in the EU it was one of the goals of the HCT regulation to “allow competitiveness in a key biotechnology area and growth of an emerging industry” (Pirnay et al. 2013). Unfortunately, service to public health is not seen as industry’s key priority.

14In the 1970s, most supporters of a market economy embraced Friedman’s view (1970) that the social responsibility of business is to increase its profits (for shareholders), not to relax the conditions of profit-maximization on behalf of the wider interests of society. But, is this acceptable when it comes to health-care? Or, to quote Bela Blasszauer (1997): “medicine is a moral enterprise whether it is practiced in the system of slavery or market economy.” Defenders of Friedman’s thesis claim that for executives to use company resources to advance social goals would be for them to usurp the political function (Norman 2000). Indeed, it is up to the political world to demand that health-care companies defy the laws of economics and fulfill social duties. Policymakers should not be allowed to hide behind cost-based (economic) options to protect the interests of private companies. They should assume their social responsibility (Pirnay et al. 2012).

LEPRAs—legal excessive profit-making activities

15Up until now, policymakers turned a blind eye to the commercialization and commodification of HCTs. In most parts of the world, the processing of donated HCTs into lucrative products is legal, provided that: 1) there is no proof of payment for the tissue itself, only for processing; 2) some kind of consent is obtained (no necessity to mention eventual non-therapeutic use or commercialization); 3) involved tissue establishments/brokers are registered/accredited; and last but not least 4) all relevant quality and safety requirements are fulfilled.

16This introduces a new class of problems to the HCT transplantation field: legal excessive profit-making activities (LEPRAs) (Pirnay et al. 2012). The proportion of LEPRAs is much greater compared to IFAs, and they can be equally deleterious for the HCT transplantation. The four most common LEPRAs are: exploitation of low-income countries to procure “raw materials,” excessive processing fees, irresponsible allocation, and commodification.

Exploitation of low-income countries to procure “raw materials”

17The supply of HCTs creates problems for companies as they face pressure to maximize their profits. For example, the product AlloDerm® (a skin substitute derived from human cadaveric skin), which earned the biotech firm LifeCell the sixteenth place on Fortune’s 100 Fastest-Growing Companies list in 2004, was confronted with a potential hitch: raw material (human-donor skin) supply constraints (Birger 2006).

18Today, LifeCell Corporation produces several human allograft tissue matrix products: AlloDerm®, Cymetra®, GraftJacket® and Repliform®. In 2013, the firm reported that the demand for their tissue-matrix products was significant and increasing in the United States, and they continued to expand their manufacturing capabilities to meet this demand. Although, since 2010, the inventory of AlloDerm has been maintained at a level sufficient to meet market demand, LifeCell acknowledges that it is still dependent on the availability of sufficient quantities of raw materials, including donated human cadaveric tissue, and that any shortfall in their ability to procure unprocessed tissue, or manufacture AlloDerm in sufficient quantities to meet market demand would negatively impact their growth (Centaur Guernsey L. P. 2012).

19Stock-exchange-listed companies need to maintain profit growth trends; stagnation is not an option. For this they need increasing amounts of raw materials, at the lowest possible cost. In this context, the unequal distribution of wealth and the lack of a global ethical framework (Pirnay et al. 2010) create exploitation opportunities that are considered by some as unethical.

20International brokers are known to supply human organs, cells, and tissues, obtained in low-income countries without self-sufficiency—basically located in Africa, Asia, Eastern Europe and South America—to the powerful human-tissue industry (Council of Europe 2009). As such, some large tissue establishments in rich Western European, North American and Asian countries obtain large amounts of raw materials for small procurement fees, which in turn make welcome additions to salaries in low-income countries. Corporate firms process these “raw materials” into lucrative products for users in high-income countries and emerging countries that have embraced global capitalism (US firms distribute more than 2 million HCT products per year). The local health-care systems in the “donor countries” mostly remain deprived of the transplantation of the exported types of tissues.

21The “Skin and Bone” project of the International Consortium of Investigative Journalists for instance revealed that Slovakia and Ukraine export cadaver parts to Germany, Germany exports finished products to South Korea and the US, South Korea exports to Mexico, and the US to more than 30 countries. Shipments came in under vague import codes such as “orthopedic implant material” and Ukrainian tissue was exported from Germany to the US as a product of Germany. Raw materials and finished products are moved around the world without much scrutiny (Willson et al. 2012). The implementation of a global coding system for medical products of human origin (MPHOs) (WHO 2015), a “Vigilance and Surveillance of Substances of Human Origin” (SOHO V&S 2015) program, and effective cross-border inspections are bound to enhance traceability, vigilance, and surveillance of international HCT movements. But, even then, most transactions are legal, providing the presence of mandatory paperwork regarding quality and safety requirements and the absence of paperwork referring to the direct purchase of HCTs.

22Why do some tissue establishments in rich countries prefer to procure HCTs in developing countries? Are regulatory requirements in developing countries less stringent, procurement costs lower, rights of donor families less founded, or corruption in health-care more widespread? In 2008, the Declaration of Istanbul on Organ Trafficking and Transplant Tourism urged EU member states “to take measures to protect the poorest and vulnerable groups for transplant tourism and the sale of tissues and organs, including attention to the wider problem of international trafficking in human tissues and organs” (Steering Committee of the Istanbul Summit 2008).

Excessive processing fees

23It is not illegal to charge reasonable fees for the procurement and processing of HCTs. As the term “reasonable fee” has not been defined, there is a grey zone and plenty room for misuse in terms of profit making. If everybody would charge reasonable fees then there should not be too much price variation. Instead, a wide variation in HCT product prices (hundreds to thousands of dollars per product) from company to company, city to city, and country to country is observed. Sports medicine tendon and bone allografts are popular (even in auto-graft indications) and fetch higher prices than tendon and bone products for general orthopedics. Average HCT product prices are almost five times higher in the US than in Belgium (Pirnay et al. 2010). The reason for this is that, in the US, rules of supply and demand are setting the price, just as in any other business, while in Belgium HCT product prices are fixed by the government. In 2007, US Senator Charles Schumer introduced the Safe Tissue Act, designed to “improve the oversight and regulation of tissue banks and the tissue donation process, and for other purposes” (Schumer 2007). The bill, if accepted, would determine the concept “reasonable processing fee.” So far, the bill has not become law.

Irresponsible allocation

24Where hospitals mostly focus on medically important trajectories for health-care, private tissue establishments take a business approach to ensure their profits, often taking a more lucrative approach with respect to the processing of donated HCTs. A striking example is the processing of human-donor skin, the gold standard in the management of severe burns (Hermans 2011), into products that can be used in plastic surgery or in vanity procedures such as penis-widening or lip enhancements, in people with normal penis and lip sizes. The “burn-wound market” is relatively small (fortunately, severely burnt patients are rare today) and prices of skin-derived products for burn treatment are relatively low. The use of human skin-derived filler substances in tissue augmentation is established in clinical practice (Klein 1998) and donor skin-derived products for cosmetic or vanity applications fetch much higher prices. LifeCell estimated the potential revenue from AlloDerm in reconstructive and cosmetic surgeries at $200 million, ten times what they hoped to make assisting burn victims (Heisel et al. 2000).

25Many doctors have used Alloderm as a material to widen the penis. On the Internet, they state that the tissue itself is processed from a deceased human being, but stress that it is disease free according to reports issued from tissue banks that supply it, abiding by FDA rules and AATB (American Association of Tissue Banks) general rules. Quality and safety are important indeed. Nevertheless, the use of human allograft products in augmentation phalloplasty is not without risk (Bruno et al. 2007; Park et al. 2011). In 2009, a leading US tissue establishment introduced BellaDerm®, the first dermal tissue graft (derived from donated human skin) offered specifically for facial and body contouring procedures. Did donor families consent to transform the skin from their loved ones into penis-and lip-fillers?

26Even more problematic is the possibility that some less lucrative, but life-saving HCTs will no longer be available. US burn centers were reported struggling to obtain skin because local skin banks committed all their donated skin to firms that market products for plastic and cosmetic surgery (Heisel et al. 2000). The director of a tissue bank that sent all its skin to LifeCell Corporation stated: “I’d like to say that the price didn’t enter into it, but it was a factor.” There are also indications that donor skin will be replaced by less performing, but from an industry point of view more interesting, biosynthetic dressings for the temporary covering of burns.

27It also goes without saying that the skin of executed Chinese prisoners was processed into beauty products (Cobain and Luck 2005). Fully in line with expectations, a UK consultant plastic surgeon and government adviser stated: “I can see the utility of it, as they have access and no ethical objection,” he said. “The main concern would be infective risk.” Quality and safety are important indeed. But, no need to worry, quality and safety of human organs and tissues for transplantation are also important matters of concern to the Chinese authorities. According to a Chinese official, “the use of a bullet to the back of the head is ideal for transplants because the bullet does not contaminate the organs with poisonous chemicals as lethal chemicals do and does not directly affect the circulatory system as a bullet through the heart does,” and “If they want the corneas they shoot in the chest,” “If they want the internal organs, they shoot in the head” (Sun 1994). When lethal injection was introduced, chemicals were chosen that were suitable to organ harvesting.

Commodification

28Donor families expect HCTs to be treated with respect and recognized as resulting from a donation from their loved ones. However, industry increasingly processes HCTs into products with little or no resemblance to human tissue. These include cubes, screws, chips, paste, glue and powder, which are then sealed in appealing packaging and advertised in glossy catalogues or on flashy Internet sites (including online allograft-tissue order forms).

29There is a major discrepancy between donor family expectations and the activities of some tissue processing firms. In their slogans—“The Gift of Life,” “The Gift of Hope,” “You can give hope and life to 25 people,” “Tissue donors save lives,” “Changing lives through tissue donation,” “You have the power to change 100 lives”—large procurement establishments respond to the expectations of the former, while providing HCTs to the latter. A penis enlargement is bound to change someone’s life (note that most penis enlargements are performed in men with normal penis sizes [Mondaini et al. 2002]), but I doubt that this is what donor families were hoping for. Our civilization, for centuries, has accepted and demanded respect for the dead (Marcus 1985). Turning human bodies (in secret, i.e., without donor-informed consent acknowledging potential non-therapeutic and/or commercial uses) into lucrative commodities in a global market is not very respectful and if publicly known it would reduce the public’s trust in the entire transplantation field.

30Moreover, when donated HCTs give rise to financial gain, do donors (or their family) have the right to share in any of these financial benefits? The issues with regard to ownership, property rights and commercialization of donated HCTs for research are discussed in depth by Bernice S. Elger in this book. Research has revealed that contributors of biospecimens to genomic biobanks saw in their samples (the DNA and the information it encodes) something of unique value in the “business” of medical research, i.e., the traditional definition of a “trade secret” (Conley et al. 2012). Others would be allowed to exploit their trade secrets under restrictive conditions. Much like conventional trade-secret licensors, contributors also demanded—among other things—compensation, restrictions on access and use, the opportunity to share in the benefits of future research, and a limited term to the license (Conley et al. 2012). It is likely that HCT donors who give consent to turning their HCTs into (lucrative) therapeutic or cosmetic products have similar demands.

The doctrine of double effect

31The European Group on Ethics in Science and New Technologies (EGE) acknowledged that the issue of commercialization of HCTs might be controversial, but concluded: “It is difficult to exclude tissue banking activities by commercial organizations, such as large private laboratories. This is particularly true where human tissues are used as a basis for ‘engineered’ products requiring the use of sophisticated medical techniques” (EGE 1998).

32The key question is: Can the processing of human body material lead to a product that is no longer subject to ethical principles? One could consider HCTs to be “dual products,” consisting of human body material and an added value in the form of a technological process. Both parts clearly have a different moral status, which leads to an ethical dilemma; the human body material is not a tradable good, while the added technological process (know-how) clearly is. The problem is that one cannot be sold without the other. A possible way out of this dilemma would be to use the “doctrine of double effect” (Cavanaugh 2006): if an action has foreseen harmful effects practically inseparable from the good effect (for example, killing non-combatants when bombing a military target), it is justifiable if the following are true:

  • The nature of the act is itself good, or at least morally neutral.
  • The agent intends the good effect and not the bad either as a means to the good or as an end itself.
  • The good effect outweighs the bad effect in circumstances sufficiently grave to justify causing the bad effect and the agent exercises due diligence to minimize the harm.

33Translated to the HCT-transplantation field, this could imply that the commercialization of human body material (foreseen harmful effect) could be justified when tissue establishments act in good faith and produce HCTs for use in meaningful (e.g., life-saving) therapies (good effect in grave circumstances). The good faith of cell-and-tissue establishments could be reflected in a HCT cost price that only relates to the added technological process and this in a reasonable manner. This rationale could be the basis of a clear and global ethical position overcoming the above-mentioned commercialization issues.

In the name of quality and safety

34In the late 1990s, at the peak of the biotechnology hype, industry incited policymakers to create a regulatory environment that would facilitate the emergence of a strong biotechnology market. The mediatized safety and ethical scandals involving HCTs presented policymakers with an ideal opportunity to issue new HCT legislation. Officially, industry representatives and policymakers emphasized that new legislation was urgently needed to improve the quality and safety of HCT products. However, most incidents involving unsafe HCTs were not the result of too-loose quality and safety requirements in the then prevailing legislations. They were due to the greed of opportunists that downright ignored the existing guidelines and common sense and engaged in profit-maximizing activities that ultimately endangered patients and trampled ethics. It is also important to stress that these incidents were not representative of the entire tissue-banking community. We need to keep in mind that quality and safety is no fairy dust and GMP no magic formula. In some cases, substantial increases in quality and safety requirements will not substantially increase quality and safety, but will indisputably result in a massive increase in costs, which in turn will negatively impact social health-care systems (Pirnay et al. 2013).

35A false perception of quality and safety is creeping in. For example, in 2011 the French authorities issued a guideline urging 30,000 French women to have their breast implants removed (Chrisafis 2011). A French company was found to have made breast implants from cheaper industrial-grade silicone normally used for electronics, mattresses, and the agriculture industry (which is of course illegal). And yet, they were granted a certificate of conformity with European standards and hundreds of thousands of them were sold on three continents. The problem here of course was not the legislation itself, but the fact that competent authorities had not uncovered the fraud in a timely manner. The (predictable) reaction of policymakers, however, was to call for more stringent legislation. The HCT-transplantation field that was shocked by IFAs is now suffering from LEPRAs, and increasingly stringent quality and safety requirements are no solution, on the contrary.

36Back to Soylent Green. The “donor,” Sol Roth (Edward G. Robinson), surely looks healthy: he rides a cycle home trainer, eats apples and drinks a moderate amount of red wine. Upon arrival at the Soylent Corporation donor center, he fills in some paperwork (donor history questionnaire—“informed” consent?) and we can assume that during the euthanasia process he was injected with chemicals that are compatible with human consumption. A hint: according to the FDA, low amounts of pentobarbital in dog food (from processed euthanized cattle or horses) are unlikely to cause health problems. Next, Sol Roth’s body is transported under controlled conditions from the donor center to the processing plant. We see no proof of payment for the body, and we can assume that traceability was assured. The processing of the body into Soylent Green products seems to be performed in accordance with high quality and safety requirements. We assume that the Soylent Corporation obtained a Custom Meat Program license (to slaughter or process uninspected meat food animals). The 2012 “Pink Slime” or “Soylent Pink” scandal demonstrated that food product labels are not legally required to mention all animal (or human) components (Flock 2012). Not sure about the green color additive though.

The way ahead

37Cynics believe that the commercialization of all aspects of society, including health-care, is inevitable and resistance futile. Optimists, however, believe that one day policymakers will decide to give priority to the overall public interest and halt the erosion of public health-care systems. With regard to the HCT-transplantation field, a balance should then be sought between the solidarity principle of public tissue establishments and the interests of the biotech and pharmaceutical industry. The availability of medically important HCT products for all patients who can benefit from them, and this at a price that can be borne by social security systems, should be central in the development and authorization of HCT products and in the elaboration of relevant legislation. Not only IFAs, but also LEPRAs, should be banned. To achieve this, a combination of oversight actions is warranted (Table 1):

  • Ease off on quality and safety requirements (they are often overzealous and prioritize industry over the public sector).
  • Effectively enforce balanced HCT legislation (including cross-border inspections).
  • Define the term “reasonable processing fee” and fix HCT-product prices.
  • Enforce a global coding system for HCTs.
  • Enforce exportation rules with an emphasis on self-sufficiency.
  • Enforce a global ethical framework, possibly based on the “doctrine of double effect” and overcoming commercialization issues.

Table 1. Probable impact of different oversight actions on illegal and fraudulent activities (IFAs) and legal excessive profit-making activities (LEPRAs).

Oversight action

Probable impact on IFAs

Probable impact on LEPRAs

HCT legislation that focuses on pharmaceutical industry quality and safety requirements.

No impact on IFAs. Opportunistic offenders downright ignore any quality and safety requirement.

Promotes LEPRAs. Facilitates industry’s take-over of the HCT field.

Effective enforcement of balanced HCT legislation (including cross-border inspections).

Will reduce IFAs.

No direct impact. LEPRAs are legal. Balanced legislation ensures a level playing field, including public actors, and may indirectly reduce LEPRAs.

Definition of the term “reasonable processing fee” and fix HCT product prices.

Will reduce IFAs.
Will remove the incentive.

Will reduce LEPRAs.
Will remove the incentive.

Implementation of a global coding system for HCTs.

Will reduce IFAs.

Will have no impact.
LEPRAs are legal.

Global and binding ethical framework, possibly based on the “doctrine of double effect” and overcoming commercialization issues.

No impact on IFAs.
Opportunistic offenders will also ignore ethical rules.

Will reduce LEPRAs, when enforced in combination with a global coding system.

Acknowledgments

38I would like to thank my colleagues Carl Ceulemans, Daniel De Vos, Jean-Pierre Draye, Geert Laire, Pierre Neirinckx, Thomas Rose, Alain Vanderkelen, and Gilbert Verbeken for the support and the inspiring discussions.

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Notes

1 www.rickgibson.net/perform.html

2 news.sky.com/story/910630/dutch-tv-presenters-in-cannibal-stunt

Auteur

Was born in 1967 in Antwerp (Belgium). He graduated a biotechnology engineer at University College Ghent and received a PhD in medical sciences from the Université libre de Bruxelles. In 1993 he completed his military service in the military blood bank, but could not break clear of his military orbit. He is currently head of the Laboratory for Molecular and Cellular Technology, which harbors the human tissue banks and the GMP bio-manufacturing facility of the military hospital in Brussels.

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