(8) Medical Law

Organ Donation

 About donation


Organ donation

The demand for organs massively exceeds supply.

One solution, in relation to some organs, such as kidneys, is to encourage donation by living people. That is discussed briefly above. Altruistic donation of, for instance, bone marrow or even a kidney by live donors is lawful in many jurisdictions, often, and particularly in the case of a significant sacrifice such as a kidney, after an extensive investigation by a regulatory body to check that the would-be donor is making the offer freely, and understands fully what is involved. But this obviously won’t work for hearts, lungs, and so on. If they are to be used at all, they have to be retrieved from dead bodies.

There are two main legal worries about this. The first concerns consent: have the deceased or, where appropriate, the relatives, given the appropriate permission? And the second concerns death: is the deceased really, irretrievably dead?

The ability of people to decide what happens to their bodies after their deaths is, in most countries, largely governed by statute. Those statutes generally tend to assume that autonomy extends into the grave, and that we should each be able to decide whether we rot, burn, or are recycled. Several mechanisms are used to honour autonomy. Some jurisdictions say that if you haven’t indicated what you want done with your body, it is wrong to use any organs. One therefore has to ‘opt in’ to donation. Others assume that if you had any objection to donation, you’d have said so, and accordingly that silence indicates consent: (‘opt out’). Others require you to make a choice, for instance as a requirement of obtaining a driving licence (‘mandated choice’). There is a great deal of discussion among ethicists about the acceptability of these options, and among politicians and doctors about their efficacy in increasing donation rates, but they are legally not very interesting. More legally interesting are the questions that concern the definition of death

(on which turns the propriety of harvesting organs from ‘beating-heart donors’) and the suggestions that are sometimes made about taking organs from patients in permanent vegetative state (universally unlawful at the moment, on precisely the same grounds as it would be unlawful to remove organs from a healthy person who happens to be undergoing an anaesthetic for an appendectomy) and from anencephalic children (which turns in all countries, at the moment, on satisfaction of the standard criteria for determining death, but which one might coherently argue should be more readily done, since the prognosis is so obvious and so dire).

Guidelines from the World Health Organization embody the broad international consensus on the safeguards to be applied when it is proposed to remove organs from a beating-heart donor, including - for ghoulishly obvious reasons-a requirement that death is certified by someone other than the clinicians who want to effect the transplant.


Intellectual property rights


The idea that a biotechnology company should point to a piece of the genome and say ‘That’s mine: I alone have the right to make money from knowledge of the sequence’ raises all sorts of political, philosophical, and theological hackles.

As one might expect from the case of Moore (above), the Americans are more laissez-faire about this than the Europeans. Their deep-seated free-market tendencies, in this respect at least, get the better of their religious conservatism. The Supreme Court, endorsing a patent for a genetically engineered oil eating bacterium, observed that the legislature had intended the patent laws to include ‘anything under the sun that is made by man’, and that ‘made by man’, in this context, included the manipulation by man of naturally occurring nucleic acid: Diamond v Chakrabarty (1980).

The difference between the US and Europe was shown clearly by a mouse. Harvard University produced a mouse (the OncoMouse), which was a sort of biological time bomb. It had a human cancer gene stitched into its DNA, so that it inevitably developed cancer. Harvard patented the mouse without any problem in the US. But the Europeans were more cautious. The mouse eventually got its patent, but not without a struggle against the contentions that it was immoral to patent a living organism and unlawful to patent an animal variety (both objections that arose out of the European Patent Convention). For fewer patents for human gene sequences have been granted in Europe, than in the US. But for a time it seemed that Europe was easing up. DNA, it has been held in Europe, is not ‘life’, and accordingly the ‘playing God’-type objections fall away. It would be disastrous for research funding, it was said, were it otherwise. But the Europeans remain intrinsically conservative when it comes to the patentability of human material. That conservatism is now embodied in the 1998 EC Directive on the patentability of biotechnological inventions. It indicates clearly where the battle lines for future legal and ethical debate are drawn. Article 5(1) provides that ‘The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.’ And, by Article 6(1), ‘[I]nventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality … the following, in particular, shall be considered unpatentable: … processes for cloning human beings … [and] … uses of human embryos for industrial or commercial purposes.’ The general position of those battle lines is similar in most jurisdictions.


Confidentiality: where the body tells a story


A celebrity stays in a hotel. The chambermaid scrapes the flakes of dandruff off the pillow and sells them to a national newspaper, which proposes to analyse the DNA with a view to saying whether or not the celebrity is the father of a much discussed lovechild. Can the celebrity say that the dandruff is his property and should be returned to him? Is it property at all? If it is, has the celebrity abandoned it, so that anyone who picks it up acquires title in it?

The example isn’t so far from the real world of medical law. In the storerooms of many hospitals across the world there are tissues, legitimately removed in the course of operations and autopsies, which have been retained without the explicit consent of their erstwhile ‘owners’. They too can disclose valuable information-valuable to medical researchers, but potentially valuable too to insurance companies, who might be able to tell from scanning the genome whether the person from whom the tissue was claimed is a good insurance risk.

The dandruff and the hospital storeroom cases are very similar. The storeroom sample is bigger, which hardly seems like a sound reason for treating it in a different way from the dandruff. And yet, largely because of the sample size, lawyers across the world are much more ready to worry about whether the storeroom sample amounts to property and should be treated as property than they are about the dandruff.

We’ve seen already some of the problems about viewing body parts, whether of the living or the dead, as property. We’ve seen that the law is pragmatically happy to dub something property if that helps to give the right answer. But in both these cases, there’s really no need to begin to use property language to protect the interests that need protecting. What’s important is not the tissue itself, but the information that it bears. The best analysis is in the law of confidentiality or privacy, not of property. Lawyers and legislators in many jurisdictions are slowly realizing this. In the UK Human Tissue Act 2004, for instance, the unauthorized analysis of DNA is specifically recognized as a mischief in its own right. That’s surely the way forward—tailoring the remedy to the harm, rather than squeezing the problem into artificial and archaic boxes (such as the ‘property’ box), so complicating and distorting the law.


The future of medical law


Medical law, as a distinct speciality, is young. But young, in the law, doesn’t necessarily mean fit. And the medical law needs to be fit to keep up with the dramatically fast-moving professions it seeks to regulate. How is that fitness best achieved? Should we rip up the rag-tag, piecemeal, ad hoc collection of principles, rules, and speculations that comprise medical law, complaining that they’re irredeemably contaminated with Victorian notions of contract, duty, and trust, and draft a brand new, up-to-theminute code, informed by neuroscientific understandings of human volition and purged of metaphysics?

I suggest that we muddle on: that we evolve rather than revolt. The subject matter of medical law has always been and will always be the same: humans. The law that we’ve got was devised for humans by clever, reflective humans. The new problems that we’ll get will be variations of old problems. You can’t safely purge metaphysics from the law because you can’t purge the metaphysics from humans. But the speed of evolution needs to increase. Lawyers need to become more medically and philosophically literate. Good law presupposes a good understanding both of the medical facts and of the philosophical repercussions. That’s a big brief. The proliferation of medical law and ethics texts and courses suggests that it can be mastered. In texts above we looked at the complex relationship between law and ethics. But in the end the nature of the relationship doesn’t matter so much, as long as it’s close and amicable. The conversation between the two is ever more vital. Medicine is becoming increasingly technical, evidence-based, and protocol-driven. Despite a desperate rearguard action by the advocates of medical humanities, it’s increasingly embarrassing to talk about the Art of medicine. Talk about the death of the Art becomes a self-fulfilling prophecy. The medicine of the future will be run by technically brilliant nerds. They’ll look at their screens, or their shoes, but never at the patient, let alone at Sophocles. They haven’t got the time, even if they had the inclination or the ability, to wonder about whether a particularly sexy new intervention is

Dehumanizing. And if they concluded that it was, they might think that that was not a contraindication at all.

It’s therefore very important that medical law isn’t over-deferential to medicine, as it has tended to be. Bolam should be nudged towards extinction, or at least put on the back foot, not because medicine is increasingly the business of accurately following a definitive guideline (which is the threat to Bolam at the moment), but because the law, not the doctors, should set the law’s standards. Law has the opportunity and the duty to be appropriately holistic. Medicine has the duty, but has just about lost the opportunity.

It needs confident medical lawyers to do law’s job properly. Some of Bolam’s more extravagant abuses arose simply because the advocates and the judges didn’t have the first idea what the doctors were talking about, and so decided that they ought to give the defendant the benefit of the doubt. There would have been no doubt in the minds of better-educated judges. So we should have specialist judges.

They will be faster, more medically fluent, and (at least because they’re not thumbing, intimidated, through a medical dictionary during the lunchtime adjournment) will have more chance of becoming properly steeped in the wider literature-the literature that will allow them to take the wide, deep, and long view that medicine has denied itself.

There are dangers with having a professional medical judiciary. It might attract the brothers of the medical nerds. It might mean that medical law is denied the cross-fertilization from other legal disciplines that has proved so fecund in the past. It doesn’t matter so much if a commercial court judge is simply a bewigged brain on a stick: he’s just got to deal with money. Medical judges have to deal with bodies, minds, and souls, and with whatever strange glue sticks them together. An interest in the mechanics of bodies might denote a lack of interest in the mechanics of souls. That would be sad. But, by and large, expert medical judges are a risk worth taking. We’ve already got, in many jurisdictions, a cadre of expert medical lawyers. They are made of good stuff. They need to be. There are some intellectually epic challenges ahead. What’s the status of the human embryo? Is it equivalent for all purposes (and if not, why?) to the adult? Is it ever permissible to kill X to save Y? If not, what should you do with the patient in PVS whose continued existence is consuming the funds that would buy life-saving treatment for many? Suppose the money spent on a cosmetic breast enlargement operation in London would save the lives of 10,000 children in the Congo. Should a judge in a London court conclude that it’s rational to enlarge the London breasts? Is life legally an all-or-nothing thing? Does a patient who hovers in the no-man’s-land between unconsciousness and death have precisely the same rights as a fully alert and healthy child? Does a woman have a right to inseminate herself with the semen left in a condom her boyfriend and she have just used? If so, what are the consequences for the boyfriend? Is it lawful to remove surgically the healthy legs of a patient because she decides she wants them mounted as an exhibit in her bathroom? A deaf couple, wanting to have a child with whom they can share the intimacy of the deaf world, create embryos by way of IVF, screen the embryos for a ‘deaf’ gene, and implant a ‘deaf’ embryo into the mother’s uterus. The child, when she’s born, sues the clinicians involved for her deafness. ‘But you wouldn’t have existed if you hadn’t been deaf,’ they retort. A drug is available which, if taken in pregnancy, gives the child a lifelong immunity to all types of cancer.


The parents refuse to take it. The child develops cancer and sues the parents. A doctor engages in a project to produce bionic soldiers who can run faster, jump higher, and see in the dark. Should he be stopped? What’s the difference in principle between this sort of enhancement and the provision of a hip prosthesis to an elderly, arthritic woman? A doctor prescribes cognitive enhancement drugs to a university student about to sit her exams. They will allow her to revise for much longer. Should that be allowed? What if they’re very expensive drugs, so that their prescription will mean that rich students do better in their exams? Is there anything wrong with genetic cognitive enhancement which increases the IQ of the subject by 50 points? If there is, does that mean that it’s wrong to buy your child private education which will have the effect of multiplying the number of neuronal connections in his brain so that he has a cognitive advantage? And so on. That’s an exhilarating in-tray.




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