The Saatchi Bill applies to all doctors and to all their patients whatever their conditions. It applies to decisions to give treatment at the start of life and to withdraw treatment at the end of life. It applies to decisions to give alternative treatment and to cease mainstream, evidence-based treatment. And it applies to the treatment of children who are too young or too sick to make decisions for themselves.
The Bill is intended to encourage responsible medical innovation but seeks to achieve that end by changing the law in respect of treatment which departs from the existing range of accepted treatments. If such treatment, including treatment which no responsible body of doctors would support, harms a patient the bill removes the right of patients and their families to compensation. Treatment which is now regarded as negligent will no longer be negligent. Families of children who would have received compensation will no longer be entitled to compensation.
The one thing all parents wish for their children is good health. Parents of children who have a terminal illness or an incurable and disabling condition are put through hell and back. A number of them have been persuaded that the Saatchi Bill will make available treatments which are not made available now because their children's doctors are fearful of being sued. The campaign in support of the bill has reached out to such parents, encouraging the belief that the Bill offers them hope.
Before too much faith is placed in the Bill, the following points should be considered:
1. Parents cannot insist on a doctor providing a specific treatment for their child. The doctor will of course take the parents' wishes fully into account but must act in what he believes are the child's best interests. On rare occasions a dispute about the best interests of the child has to be determined in court. The General Medical Council issues detailed guidance to doctors about treating children, consent and assessing best interests. That guidance recommends much wider consultation about proposed innovative treatment than is set out in the Saatchi Bill. The bill will not change that guidance or give parents an unfettered right to choose treatment for their child.
2. If there is compelling evidence that a new treatment will be likely to benefit the child, then the assessment of the best interests will be relatively straightforward. Doctors do not need the Saatchi Bill to tell them to try something new if there is evidence it may help the child. It happens now. As I understand it, paediatrics is one of the main fields where off label prescriptions are deployed. Again the GMC has issued detailed guidance about prescribing unlicensed drugs.
3. What if there is little evidence that proposed treatment will work but there are good reasons to think it might help and will not cause harm? The GMC guidance says that when prescribing an unlicensed medicine a doctor must be satisfied that there is sufficient evidence or experience of using the medicine to demonstrate its safety or efficacy. Perhaps that is where the Saatchi Bill might make a difference? Well in the case of Simms and Simms, Lady Butler-Sloss found that it was in the best interests of two patients, lacking capacity, who had vCJD to be given very new treatment for which there was no evidence or experience to support its use. She said that the Bolam test of negligence would apply such that the doctor giving the treatment would not be regarded as negligent. Why? Because giving the treatment in the desperate circumstances and with no other viable options was reasonable and rational. So, even without any prior experience of the effectiveness of the treatment a doctor may give the treatment if it is rational and reasonable to do so. Again the Saatchi Bill is not needed to allow doctors to do this. As the GMC told the government in response to a consultation on the Saatchi Bill :
"Medicine is a risky business. There are many people alive today due to the
willingness of doctors to innovate, deal with uncertainty and take reasonable risks
which are understood by, shared with, and consented to by, the patient."
4. However if there is really no evidence or basis at all on which a rational and reasonable decision could be made to give treatment to a child, then how can it be said to be in the child's best interests to give the treatment? The Saatchi Bill requires that a doctor only act in what he or she believes is their patient's best interests. As can be seen the GMC, which regulates the medical profession, already has detailed guidance about that assessment. Trying something just for the sake of trying it will not be in a child's best interests and will expose the doctor to sanctions from their professional regulators irrespective of whether the doctor is sued in negligence. It might cause the child avoidable and serious harm but with no corresponding benefits. So the Bill will not allow doctors to give treatment to a child when there is no evidence and no basis on which to conclude that it will be in the child's best interests.
5. For any parent (are there any?) who wants a doctor to experiment on their child for research purposes, the Saatchi Bill is clear - treatment for the purpose of research is not permitted by the bill.
6. Who does the doctor think would sue him? Doctors are not sued by strangers but by their injured patients. A claim in negligence is a claim for compensation. It is not a disciplinary process. A doctor is not "found guilty" - they, or more often the NHS Trust they work for, are found liable to compensate for harm done by negligent acts or omissions. A claim for compensation is brought by the patient whom the treatment harmed, or their family if they have died. If a doctor says he is afraid that his patient will sue him for giving treatment, then he is clearly afraid that the treatment is unjustified and will cause harm. He is also saying that he does not trust the patient, or his or her parents, not to sue him if the treatment is unsuccessful.
7. Even if a doctor believes that innovative treatment is in the child's best interests, and lawful consent to the treatment is given, it does not follow that the child will be provided with the treatment. Someone has to pay for it. The NHS does not fund every available treatment, let alone every possible innovative treatment for which there is scant evidence of its effectiveness. It strikes me that the Saatchi Bill is really for those who can afford to pay privately for expensive treatment which is not within mainstream practice. It certainly does not unlock funding restrictions within the NHS.
So why oppose the Bill if it will not change anything? The answer is the law of unintended consequences. Suppose parents are refused treatment for their child because the doctor does not believe it is in the child's best interests. Parents have an instinctive drive to do everything they can to help their child. Advice that there is nothing more that can be done is not easy to hear let alone to accept. Some parents will accept it. Others will go to another doctor, and then another until they find a doctor who agrees to try something else. They may think they have nothing to lose. They may go to a doctor in private practice who offers something different than the NHS offers. They may try to raise money to pay for treatment. In some cases the parents might turn out to be right: the treatment they sought might benefit their child. Unfortunately and inevitably there will be some other cases where the first doctor was right and the second doctor was negligent in offering the treatment. The result that no-one wanted happens: the treatment causes the child serious and avoidable harm.
This is where the Saatchi Bill becomes the enemy of the patient and the patient's family. At present a doctor who negligently treats a child in a way which no responsible body of doctors would condone, may be sued in negligence and found liable to compensate that child for the harm caused. A child may need life long professional care, specialist equipment and accommodation because of injuries caused by medical negligence. Under the Saatchi Bill that child's entitlement to compensation will be removed if the doctor has met with the bill's tests about making the decision to treat.
Treatment which is reasonable and has a sound, rational justification will not be negligent. This bill protects doctors who are negligent, not those who take reasonable care. It replaces the current substantive requirement to give reasonable and rational treatment with a procedural requirement about how to make a decision to treat. Do parents really want that for their children?