Re-blogged with permission from Ten Reasons to Oppose the Saatchi Bill by Nigel Poole QC
Without waiting for the results of the government’s consultation on his earlier draft, Lord Saatchi has introduced a new version of the Medical Innovation Bill into the House of Lords. It is due to have a second reading on 27 June 2014.
A copy of the new draft Bill can be found here.
1. It is based on the false premise that the existing law of clinical negligence is a barrier to medical innovation
Lord Saatchi’s publicly stated belief is that “The law defines medical negligence as deviation from standard procedure. But as innovation is deviation, non-deviation is non-innovation. This is why there is no cure for cancer.” Of course, the law does not define medical negligence as deviation from standard procedure, but as acting in a way which no responsible body of relevant medical professionals would condone. As it happens almost every medical, research or patient body which responded publicly to the government’s consultation said it had no evidence that litigation or the fear of litigation is an obstacle to innovation. That ought to put paid to the bill. It is designed to help the medical profession address a problem which the medical profession does not believe is a problem.
2. It will not stimulate innovation
Progress in treating cancer or other conditions is unlikely to be advanced by a lone doctor whose treatment no other responsible body of medical opinion supports. Even if an individual doctor has a brilliant, innovative idea for treatment, why would he not want to have that tested and discussed by other doctors, and their agreement that it is a reasonable treatment to attempt, before using it on a patient? This bill does not require him/her to do so. The bill does nothing to address research, funding or the regulation of new treatments.
3. It will replace the Bolam test of whether treatment decisions are negligent
The Bolam test has stood the test of time (over 50 years). It is flexible and simple to understand. Under the bill doctors will still be able to claim that their treatment is not negligent if supported by a responsible body of opinion, but the bill provides them with a defence if the treatment is not supported by a responsible body of opinion. Thus the current level of protection for patients which the common law provides, which some believe is too weak as it is, will be significantly weakened.
4. It will prevent patients from seeking redress for harm caused by negligent treatment
Patients harmed by a doctor’s treatment, or their families if the patient dies as a result of the treatment, would no longer be able to claim redress from the doctor giving the harmful treatment even if the treatment would not be supported by any other doctor. This is true also of decisions not to treat, even if beneficial treatments are available but are not given. Surely there are better ways of promoting innovation than by depriving injured patients of a right of redress?
5. It does not require a doctor’s decisions to be rational or to be authorised or sanctioned by any other doctor
It merely requires a doctor to go through certain procedural requirements when making a treatment decision, but does not require a decision to treat to be rational or reasonable or for it to be agreed or sanctioned by any other doctor or authorised person. The individual doctor is free to disregard the opinions of others.
6. It applies to all treatment, not just innovative treatment
“Innovative treatment” is not defined and so the bill applies to any treatment which departs from existing range of accepted treatment, whether innovative or otherwise. Treatment is defined as including decisions not to treat, and to include management of a patient. Thus the bill has a very wide ambit. Although it is called the Medical Innovation Bill it is not at all focused on innovation.
7. It is likely to lead to increased litigation
The bill will not reduce the number of patients harmed by doctors who act outwith the range of accepted treatments. Some argue it will risk increasing that number. It will not reduce the numbers of patients seeking redress for the harm they suffer. Those patients will seek to establish that the requirements under the bill have not been met. Thus the need for litigation will continue and, under the bill, new issues for litigation will arise. The lack of precise definition under the bill and that lack of any previous case law relevant to its interpretation means that it will be fertile ground for legal argument. I am not opposing this bill on the grounds that it will lead to less litigation. I am warning that it could well lead to more litigation.
8. It will increase the “red tape” for doctors
Doctors who have to make treatment decisions will have to seek to comply with the decision making requirements under the bill in order to “cover their backs”. At present all they are expected to do is to make a rational decision with which a responsible body of doctors would support. Under the bill there will be various requirements for consultation and notification.
9. It will put the most vulnerable patients at risk
This bill will encourage maverick doctors by protecting them against negligence actions. This is not an exaggeration – after all the bill’s purpose is to give doctors freedom to try treatments which are not accepted by other doctors. For every one brilliant idea, there might be a hundred disastrous ones which do no good and cause harm. The patients most vulnerable to exploitation from mavericks are those who believe that mainstream medicine will not work or has failed to work. This bill will expose them to greater risk of harm.
10. It risks undermining the current regime for regulation for doctors
How can a doctor be found to be unfit for practice for giving harmful treatment if he/she has acted in accordance with the requirements of an Act of Parliament in relation to the treatment he/she has given? Why should a new medicine be prohibited if it would not be negligent to use it? I believe that this bill will have significant consequences for professional regulation and the regulation of new medicines and devices.