Medical practitioners in the UK will be given considerable freedom to experiment on patients if the new Medical Innovation Bill becomes law. Ignoring human rights concerns, Health Secretary Jeremy Hunt reasons that it is the role of the government to do whatever is needed to remove barriers that prevent medical innovation. “We must create a climate where clinical pioneers have the freedom to make breakthroughs in treatment”, he argues. He has, however, fundamentally misunderstood the responsibilities of government to protect the lives, freedoms and safety of its citizens. While press coverage trumpets the advantages to British medical research of experimenting on the dying, we should not be seduced by the hype. The draft bill offers few if any concrete restraints on medical experimentation on patients whether terminally ill or otherwise. On the contrary, the proposed legislation invites widespread, unaccountable, degrading and inhuman treatment.
Existing Freedom to Experiment
There is already significant freedom to experiment on patients in English law. Section 30 of the Mental Capacity Act 2005 currently permits non-therapeutic research on non-consenting mentally incapacitated patients so long as certain conditions are satisfied. Permissive clinical trials regulations allow clinical trials on children. The European Parliament has voted recently to relax the 2001 directive conditions still further. It is also well known that the Bolam test protects rather than undermines the interests of medical practitioners. As if all this were not enough, we now have the Medical Innovation Bill 2014 which seeks to allow more experimental research on patients. Medical law in the UK already allows great latitude for medical research. As long as a doctor can justify experimental treatment to his peers and the patient knows that the treatment is novel, the research can proceed. Medical negligence lawyers often have to advise clients that a case is unlikely to be successful because the treatment used would have made no difference either way. Medical negligence law far from guarding patients protects the interests and convenience of members of the medical profession.
There are two versions of the Bill online. Neither outlines any clear and definite criteria for experimenting on a patient. The central aim of the bill is to offer experimental medical research legal protection: “It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition, in the circumstances set out in subsection (3), if the decision to do so is taken responsibly.”
Clause 1 paragraph 7 states that: "The factors that may be taken into account in determining whether a process satisfies the requirements of subsection (6) include, in particular—(a) whether the doctor has discussed the proposed treatment with the patient and given the patient the explanation that the doctor would in the circumstances be expected to give of the doctor’s reasons for carrying out the treatment,(b) whether the decision has been made within a multi-disciplinary team, and (c) whether the doctor has given notification in advance to the doctor’s responsible officer (if any)."
There are indeed no compulsory requirements outlined whatsoever. There are only factors that may be taken into account. Further the bill allows GMC guidance, an easily alterable construct far from legislative in character, to set out factors that may be used to determine whether experimentation is acceptable.
In short, medical experimentation on patients is mainstreamed while no clear conditions as to what would constitute degrading and inhuman treatment are anywhere outlined. Indeed, the very possibility of degrading and inhuman treatment is not considered, whether in the language of the bill or in any preamble, and safeguards nowhere outlined.
The Bolam Test is not restrictive
The idea behind the proposed legislation is that the Bolam Test currently stifles experimental research by making it accountable to the law of negligence. Celebrity medic and long-time defender of the scandalously lethal Liverpool Care Pathway, Max Pemberton, writes:
“[I]n cases where the evidence is shaky, wanting or not yet clear, the Bill would set out a code by which doctors could try alternatives. It would provide a legal framework by which doctors, in discussion with their patients, could try off-label drugs or a device, treatment or intervention that might have some clinical data supporting it, but has yet to be fully proven.”
The Bolam Test however is already highly permissive. The case and its successors demonstrate that medical negligence law is far from restrictive. In Bolam v Friern Hospital Management Committee , the patient was subject to ECT and suffered injuries as a result. He failed to win damages on the grounds that the doctor had “acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.”
Indeed, a series of cases following Bolam shows the unwillingness of the courts to set any precedent that would force a finding of medical negligence. Far from restricting medical practice the test acts as legal protection for medical practitioners. Rather than a constraint on medical professionals the test acts as a bulwark against compensation claims. In Barnett v Chelsea & Kensington Hospital, for example, it was held that although the hospital had been negligent in failing to examine one of three men who went to casualty with arsenic poisoning, there was no proof that the deceased's death was caused by that negligence. In Whitehouse v Jordan the Lords found that the doctor's standard of care in a childbirth brain injury case did not fall below that of a reasonable doctor in the circumstances and so the baby was awarded no compensation. In Sidaway v Bethlem Royal Hospital Governors, the claimant developed paraplegia after a spinal operation. Again her claim for damages was refused and the court held that consent did not necessitate any detailed explanation of remote side effects. In an important dissent, Lord Scarman said that the Bolam principle should not apply to the issue of informed consent and that a doctor should have a duty to tell the patient of the inherent and material risk of the treatment proposed. In Maynard v West Midlands Regional Health Authority the patient presented with symptoms of tuberculosis but the decision of the physician and the surgeon to perform tests that were unnecessary and caused damage to the laryngeal chords of the patient was said by their expert peers to be reasonable in all the circumstances. Again in Hotson v East Berkshire Area Health Authority, certain injuries to a 13 year-old boy’s hip were not diagnosed until some five days later. By the age of 20, there was permanent disability to the hip. It was held at final appeal that even correct diagnosis and treatment would not have prevented the disability from occurring and so the plaintiff had failed on the issue of causation. Accordingly it was irrelevant to consider the question of damages. Wilsher v Essex Area Health Authority a junior doctor negligently administered oxygen during the post-natal care of a premature child. The child went blind. Because the oxygen treatment, according to the medical evidence, was one of five possible factors that could have led to blindness, the Lords found that causation had not been proved and the claim was rejected. In Bolitho v City and Hackney Health Authoritythe bronchial air passages of a two year old became blocked leading to cardiac arrest. Intubation would have helped. The doctor negligently failed to attend to the boy but said that she would not have intubated even if she had. While one expert witness agreed he would not have intubated another five experts said that they would have done so. Once again the claim was dismissed and the appeal failed. The case is authority for the proposition that Bolam is still good law except when "a judge can be satisfied that the body of expert opinion cannot be logically supported at all". As far as disclosure is concerned, Hedley Byrne & Co. Ltd. v Heller & Partners Ltd created the rule of "reasonable reliance" by the claimant on the professional judgment of the defendant. This is far from restrictive.
Medical negligence lawyers have a financial interest in the outcome, it is true, but Mark Slater, medical negligence lawyer at Price Slater Gawn, is surely far from misguided or biased when he says:
"Lord Saatchi’s bill may have an unintended and far more dangerous consequence. The law as it stands would permit any doctor to innovate so long as they can justify the treatment to their peers (that is to say other doctors not lawyers) and the patient is aware that the treatment is new. It appears that Lord Saatchi wants a situation where doctors don’t have to tell patients that the treatment is new and untested. That would render being a cancer patient as close to being a laboratory rat as a human being could get. It would also open up the possibility that unless the bill is worded so tightly as to not change the law at all, innovation could become a Defence (sic) to something far worse than simple negligent treatment." (Italics are mine.)
One significant defect of Slater’s analysis is that it fails to take account of the very real human rights incompatibilities introduced by the draft bill.
Human Rights Incompatibilities
The terminally ill are among the most susceptible and desperate of people. It cannot be assumed that medical researchers, driven as they may be by medical curiosity or ordinary ambition, are always honourable in pursuing research. History suggests they are not. Utilitarian thinking, at the same time, sees the human being at the end of life as a useful source of data, tissue and body parts. Routine experimentation on the terminally ill on the grounds that they make the best subjects, in their capacity as non-productive and almost dead anyway, invites serious exploitation. It also encourages corrosive attitudes to the dying. Article 3 of the European Convention on Human Rights affirms that: “No one shall be subjected to torture or to inhuman or degrading treatment or punishment.” The lessons of the 20th century remind us of the dangers to the defenceless of medical advance won by instrumentalist or end-justifies-the-means strategies.
Progressivism and Medical Experimentation on the Dying
There is then already considerable medical freedom from legal proceedings evident in English law. What is sought here is further freedom to experiment on patients with still less legal accountability. The fact that research takes place in a “multi-disciplinary team” is no guarantee that the experimentation is not degrading or inhuman.
How Maurice Saatchi, who is introducing this bill, has been coaxed into believing that medical law in the UK is restrictive one can only guess. Current medical law allows a great deal of medical freedom to do research on agreement with one’s professional peers. Perhaps what explains Saatchi’s cause is this. An unfortunate feature of modern life in Britain is that the wealthy remain far removed from the sorrow of political powerlessness. Their friends are the 'innovator' celebrities most likely to confirm their prejudices about the public interest. Their friends see innovation as progress and remain blind to human vice operating in combination with bad law. But the political alternative is no better. The Left appears to despise its own natural constituency, the weak and powerless, invariably promoting an ideology of ‘progress’ or, worse still, for its failure to address the issues the day, ‘revolution’. When their numbers and clout are most needed, their proponents are spectacularly absent from discussions that affect the weakest and most vulnerable. Debates about medical homicide, opt-out organ harvesting and experimentation on the vulnerable are conducted by marginal groups like the disabled and religious. All these developments are then paraded as socially advantageous initiatives favoured by the broad-minded. Both sides, liberal progressives to a man, omit to consider the needs of those who cannot speak for themselves while promoting an increasingly unaccountable catalogue of political, financial and research interests.
Routine medical experimentation on patients, particularly the dying, naturally undermines patient safety, endangers the desperate, and makes forensic determinations of medical wrongdoing almost impossible. There is no reference in the bill to the question of degrading and inhuman treatment. Indeed there appears to be a catastrophic failure to address this fundamental feature of Europe’s recent history in the press coverage that surrounds the bill. Perhaps it is thought that by avoiding the language of inhuman treatment, the dangers will vanish. Perhaps the bill was dreamed up by those who see medical research as an unmitigated good and regard medical professionals as above human vice. Mainstreaming medical innovation on the dying, while refusing to address the very real danger of degrading and inhuman treatment leaving it to multi-disciplinary teams governed by easily alterable GMC guidance, suggests the bill introduces new human rights incompatibilities over and above those produced by existing mental incapacity and clinical trials regulations.