Doctors innovate all the time, and the law already gives them strong protection when they do. Currently, a doctor needs to be able to get agreement from colleagues who understand the illness they are treating, so that the new treatment is carefully thought through and as safe as possible. The Medical Innovation Bill tries to remove this safeguard.

Sir Robert Francis QC, author of the author of the two Mid-Staffordshire NHS Foundation Trust enquiries and chair of the current review on NHS culture and whistleblowing, in his Damning report on the Bill says “The law of negligence does not prevent responsible innovation and never has.”

The current law has flexibility, and innovation is expressly permitted for doctors where it is reasonable. The law has allowed for cases such as the injection of PPS into the brains of two teenagers without any in-human trial (Simms) and has allowed doctors to provide innovative care where only a small body of agreement exists. The Bolitho case made clear that this must be responsible, logical opinion. Cases include those where only two other doctors would have agreed with the treatment proposed, or only 11 surgeons out of thousands. The Bolitho requirement adds protection from domineering opinion, while the law retains the flexibility to be very permissive to innovative treatment options.

The law at present ensures that innovation is allowed, while preventing negligent treatment. In this context, negligence is falling below a minimum standard of competence. It has nothing to do with ‘standard procedure’. The bill would transform the law of negligence to allow a defence for treatment that would formerly be regarded as negligent.

Further Reading

Medical Defence Union Response to Consultation
Damning report on the Saatchi Bill – Sir Robert Francis QC

The Medical Defence Union says that fear of litigation is not a barrier and so does the NHS Litigation Authority which has to pay out damages. Britain’s biggest cancer research charity,Cancer Research UK, puts it bluntly: “We have been unable to find evidence that fear of medical litigation is currently a barrier to innovation in cancer.” The Royal College of Physicians, the Royal College of Radiologists, the Academy of Medical Royal Colleges, the Academy of Medical Sciences, Medical Research Council and Wellcome Trust, the British Medical Association and the Motor Neurone Disease Association all say that there is no evidence that fear of litigation is preventing innovation. If there was a problem in understanding the current law, the way to solve it would be through training, not by passing a new law.

The British Medical Association says “We have no evidence to suggest that the threat of litigation is a barrier to the provision of innovative treatment of this kind and we strongly question the necessity and desirability of introducing statute to clarify or change the law in this area.” They continue, “The BMA strongly believes that the draft Bill should not become law and, for the reasons outlined in this response, does not believe that primary legislation which focuses on redefining clinical negligence is the best mechanism to promote or encourage responsible innovation.”

The Motor Neurone Disease Association says “Even if our fears were to prove unfounded, we must also observe that the Bill would not remedy the problem it is aimed at, for such a problem does not exist: uncertainty around the law or fear of litigation do not, as far as we can see, dissuade doctors from trying new treatments.”

Further Reading

What do doctors, lawyers and medical charities say?

The bill has been promoted as a way to “empower patients to demand that every possible route should be tried to prolong their life and improve its quality.” However, the power to choose or reject new treatments remains with the doctor. While the patient can suggest a treatment, the doctor can still reject it. The bill does not give patients the power to make the doctor consider any new treatment at all.

Sir Robert Francis QC identifies some of the barriers to treatment as “overzealous bureaucracy, scarcity of resources, ethical reservations and decision-making processes.” The bill does not solve any of these genuine problems, and an over-worked doctor hemmed in by overzealous bureaucracy or limited funding is no more likely to agree to innovate after the bill is passed than he or she was before.

The Motor Neurone Disease Association says “the Bill poses a risk to legitimate research.”

In directing patients who could be included in trials and trial networks toward alternative options it diminishes uptake of trials and reduces the evidence available. Results will have no meaning without strict, robust, standardised procedure and selective patient analysis which is inappropriate and unrealistic for individual patient care.  It may also draw funding away from research into safe, effective treatments, towards unpromising, ineffective ones, and removes the importance of focus on funding and access to trials in rare conditions, in children, and other cases where patient care and treatment options would be progressed by a widening of, not reduction in, research.

The Academy of Medical Royal Colleges  are “concerned that the Bill could inadvertently undermine the undertaking of or participation in proper clinical trials. If individual clinicians feel that the Bill offers them the opportunity of by-passing the need for clinical trials on a regular basis we believe that there will be adverse consequences. If innovation is to be of general benefit it has ultimately to be a collective and not an individual activity.”

Further reading

Gambling With Lives

Attempting to find a cure for a disease this way is much like attempting to solve a financial crisis by suggesting people buy lottery tickets. Buying a ticket does not guarantee a win, most people can’t win, and creating more lotteries doesn’t magically create more money to be won. Worse, because of the way the bill is worded to exclude research use, it is like buying a lottery ticket and then refusing to check the numbers.

The evidence base for any new treatment would not be increased by any data captured under the bill, because of differences between treatment and data gathering methods between different doctors.  To suggest that it would help find cures is to confuse innovative treatment at the bedside, that is already provided for patients, with research.

As the pioneering cancer surgeon Prof Michael Baum points out, “The odds of some maverick coming up with an effective drug treatment for cancer using the ‘suck it and see’ principle are vanishingly small but the chances of toxic side effects are close to 100%.”

The Academy of Medical Sciences, Medical Research Council and Wellcome Trust says “We feel that innovation and research are intimately linked since innovation requires an evidence base if it is to be put into practice, which is unachievable using data obtained from a single patient (or a small number of patients).”

In order to be protected by the Bill, a doctor must consult with a colleague. There is nothing to stop the doctor ignoring any objections of that colleague and carrying on with the treatment regardless. Ultimately, the decision to treat, and the decision on whether it is a good idea to treat, rest entirely with the doctor. Having decided to treat, the doctor is protected from having his or her decision questioned.

The Bill’s writers have deliberately avoided ensuring that a doctor must have agreement from anybody, so they can act in a way that no colleague would support and still be protected by the Bill.

The Academy of Medical Royal Colleges say that “It seems to give licence to be selective in the opinions which the doctor seeks and ignore views which do not accord with the doctors own opinion. If this is what is actually intended we do believe it is completely inappropriate.”

The British Medical Association say that it “risks removing important protections for patients and could encourage reckless practice, with attendant risks for patient safety”

The Motor Neurone Disease Association says that the bill does not “appear to offer any safeguard against the inappropriate or exploitative use of unproven treatments.”

Sir Robert Francis QC says “There is an alarming lack of accountability or scrutiny or other safeguard built into the Bill. It explicitly frees the doctor to offer treatment which has no support from responsible medical opinion.”

Further reading

The Bill that eats itself by José Miola, Professor of Medical Law at the University of Leicester

The bill can applied to any illness. It is not clearly defined as applying to only terminal cases.

Sir Robert Francis QC says “The Bill is not successfully limited in its effect to the sort of treatment Lord Saatchi has in mind and it abolishes the well established and understood principles of negligence in the clinical field across a very wide range of cases.”

Dr. Margaret McCartney says “To pretend that this gives patients any protection from naked quackery would be misguided”

Further Reading

The New Legal Advice by José Miola, Professor of Medical Law at the University of Leicester

The Saatchi Bill would not preserve the Bolam Test by Nigel Poole QC

Damning report on the Saatchi Bill – Sir Robert Francis QC

No Protection Against Quackery

The bill explicitly protects a doctor who makes a decision that none of his or her colleagues would support, or who makes a decision with no logical or reasonable basis that may be very harmful for a patient. It then seeks to remove the ability for a court to decide whether that decision is negligent.  It allows ineffective treatment to be given that could harm a patient. It is, in short, a “Get Out of Jail Free” card for bad treatment decisions.

As Sir Robert Francis QC says, “a doctor would be protected by forming an opinion that treatment was in the best interests of the patient however irresponsible or unreasonable that opinion might be.”

The bill undermines the regulation of medical professionals, making it hard and inconclusive for a professional body to take action against a doctor who has acted in accordance with the law, but in the process has breached professional regulations and guidance, resulting in patients being harmed.

Sir Robert Francis QC says that “for all its good intentions, it is actually dangerous for patients because it proposes “safeguards” which are illusory and which may give free rein to mavericks peddling dangerous remedies to vulnerable and desperate people.”

José Miola, Professor of Medical Law at the University of Leicester, says that “so long as the Bill is complied with then it is not open to a judge to assess the content of the decision to innovate, only to check whether the Bill’s processes are complied with.”

So powerful is this “Get Out Of Jail Free” card that doctors may well feel compelled to use it for all treatments that depart from standard practice in any way. This would greatly increase the amount of administrative work required to treat patients, for no benefit.

Further Reading

The New Legal Advice by José Miola, Professor of Medical Law at the University of Leicester

Sir Robert Francis QC says the bill “exposes vulnerable patients to unjustified risks and deprives them of remedies when mistreated by those who have no acceptable justification for what they have done.”

The bill would allow treatment that would today be considered negligent. If a body of medical opinion, no matter how small, would support the treatment, based on some form of logic, in all likelihood it would not be found to be negligent today. The bill redefines what negligence means, so that patients given bad, unjustified treatments would be unable to  get compensation.

Further Reading

Response to Consultation – Sir Robert Francis QC

Sir Robert Francis QC says “there is likely to be protracted and complex litigation about the meaning of this Bill”.

The bill does nothing to reduce the cost of litigation and will be “a field day” for lawyers. More doctors are likely to be involved in a litigation process as a result of the complexities of the legal position following the bill, which is likely to result in them being more reluctant to innovate, the opposite of the intention of the bill. Many more legal avenues could be pursued by lawyers over the meaning of terms in the bill.

The bill does nothing to address the rising costs of litigation arising from negligence in normal practice. Supporters of the bill offer no evidence that there is any significant amount of litigation currently taking place over the use of innovative treatment.

Further Reading

Damning report on the Saatchi Bill – Sir Robert Francis QC

Patients and those making decisions on their behalf will almost always want to try anything at all. This bill expressly permits harm and exploitation of this vulnerability and does nothing to promote shared decision making or patient empowerment. It may lead to protracted, distressing suffering for those approaching the end of their life, followed by a block on any legal action being taken for decisions that would today be considered negligent. In the words of Dr Arthur Bloomfield, “There are some patients whom we cannot help…there are none whom we cannot harm.”

Sir Robert Francis QC says “It increases the risk to vulnerable patients of mavericks with irrational or unjustifiable grounds for proposing a treatment and those with commercial interests in promoting dubious treatments.”

The Motor Neurone Disease Association says “There is a clear danger that the Bill could lead to the exploitation of vulnerable people.”

The Royal College of Radiologists says that “Relaxation of these governance mechanisms, which this Bill proposes, risks exposing vulnerable and desperate patients to false hope, futile and potentially harmful (and expensive) treatments.”

The bill doesn’t solve the problem of funding for any treatments proposed, nor does it help patients make informed, independent decisions about what treatment they would like to pursue. The patient may be offered a treatment with no logical basis, without any means to check what their best option would be, thus reducing respect for the dignity and autonomy of a patient in the decision-making process.

While Lord Saatchi’s campaign team claim “overwhelming support”, in fact the results of the official Department of Health Consultation have not yet been published, and the promoters of the bill have not seen all the consultation responses. What the Saatchi campaign claim as an overwhelming “consultation response” is actually composed chiefly of people who signed a petition in support of the bill, and a much smaller number of people who filled in a web form on the Saatchi campaign website. Neither group had an opportunity to read the bill, and people viewing the petition had no alternative option to say if they opposed it. It is likely that many of the petition and web form answers are from the same people.

Conversely, respondents to the official Department of Health consultation included large medical, legal and patient groups, which were almost all unsupportive of the bill, either opposing it entirely or requiring major modifications before they could support it. These modifications have either been ineffectively made, or have not been made at all, while the campaign for the bill has air-brushed both the opposition and the official consultation almost completely out of all discussion.

The British Medical Association say, “The BMA strongly believes that the draft Bill should not become law”. The Motor Neurone Disease Association say, “The Bill has no place on the statute book.” and go on to say “The bill would be bad law.” The Patients Association say “As things stand the Patients Association would oppose this Bill.” The Medical Defence Union say “No. The draft Bill should not become law.” Action Against Medical Accidents say “Parliament must not sleepwalk into this dangerous and unnecessary bill.” The list goes on.

Further Reading

What do doctors, lawyers and medical charities say?

The expert responses to the Saatchi Bill must not be ignored

An Inexhaustively Incomplete (But Completely Exhausting) List of Saatchi Bill Comments

Selling the Sizzle