The Medical Innovation Bill
How is the Saatchi Bill progressing?
The parliamentary timetable is on course, but there is still a lot of division after a line by line examination of the Bill in the committee stage in the House of Lords. The present Bill (28th October 2014) is available on line. It is short and may give the false impression of simplicity. Because it has government backing it is likely to become law notwithstanding it being seen by many as unnecessary and, worse, potentially harmful to patients.
What are the key features of the Bill that are attracting attention?
The premise of the Bill is that doctors are fearful of trying untested treatments in life threatening conditions because of the threat of litigation. But there is no evidence this is so. Were it to be otherwise the Medical Defence Union would not be against it.
Its proposers hope that when doctors are considering innovative treatment, by following the “safeguards” in the Bill, they will be able to protect themselves in advance of starting treatment from a later action in negligence in the event that the treatment proves to be inefficacious or positively harmful.
The key is in clause 1(2) “It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly” (emphasis added).
The key questions are (i) will the Bill provide sufficient protection to patients and (ii) will it add anything to the protection doctors already have under the common law.
What are the concerns raised by charities around the extent of immunity offered to doctors who use experimental techniques?
There is justifiable concern. Medical research has a well regulated and recognized and internationally approved system of clinical trials designed to establish safety and efficacy of novel treatments. Charities which support such research are troubled that anecdotal evidence and the protection offered by the Bill will encourage irresponsible experimentation which will cause more harm than good (see the 100 doctor letter to The Times 13th November 2014).
How are those working in the clinical negligence/PI sector reacting to the Bill?
With widespread consternation. Not because clinical negligence work is going to dry up, on the contrary, it is because the Bill is seen as so flawed there will more litigation in this area. What Lord Saatchi is seeking to achieve, which I cannot see the law allowing, is to protect a doctor trying out unconventional therapies that no responsible body of medical opinion would support.
The present Bill restates the common law protection to a doctor whose treatment decision is supported by a responsible body of medical professional opinion.
However, the problem arises when there is no responsible body of medical professional opinion which would condone what a doctor did.Then the common law offers no further protection. Nor should it in my view. But in this situation does the Bill really offer any protection? How likely is it that a court could find that the doctor acted responsibly under the Actwhen no responsible body of professional opinion will stand by what s/he did?
What should lawyers consider as this Bill continues to be debated?
Innovative treatment is defined by default and applies to all medical treatment which lies outside “the existing range of accepted medical treatments for a condition”.
The central issue is whether there is really a need for such a Bill or whether the common law is sufficiently developed and flexible to deal with challenges in this area. In my opinion, the answer is unequivocal. The Bill offers nothing to patients but increased risk of harm to the vulnerable and no added protection to doctors which does not already exist.
The inference is that where a doctor acts outside the “existing range” s/he is in breach of the duty of care. That is not the case. Provided a doctor acts in accordance with a responsible body of medical professional opinion (as determined by the court applying the principles of logical analysis) s/he is not negligent.
To obtain the protection the Bill seeks to offer from a charge of negligence, a doctor inter alia has to take into consideration a number of matters, including the views of one or more appropriately qualified doctors, but whether or not s/he has acted responsibly by departing from the existing range of acceptable medical treatments for the condition will still be one of law.
Since the Bill does not exclusively define what is a “responsible decision” but only sets the minimal criteria for it, it is left open to the court to find that notwithstanding compliance with the criteria, no “responsible decision” was in fact made. Then the very purpose of the Bill fails. The last ditch statutory protection from a claim for causing harm by an act or an omission would fall away. Ultimately, the courts and not the medical profession will have to determine whether or not a doctor has acted responsibly – and that is necessarily a post hoc exercise. There could be no guaranteed advance protection.
There is even the prospect of a doctor being sued in common law negligence for failure to innovate. An amendment proposing to declare any failure to innovate could not be negligent has been dropped. Although unlikely, I can still see an argument being developed that although there may be no responsible body of medical professional opinion who would condone innovative treatment, a doctor might be under a duty to consider if not try a novel treatment. After all, if the decision were taken responsibly, s/he could not be found negligent by law.
Were the Bill to become law, perhaps the major benefit to patients would occur by doctors being persuaded to do more research into the present “range of accepted medical treatments” when considering treatment options, to discuss those options with the patients, to arrive at a professionally led consensus and, above all, to ensure that the treatment chosen is administered to the standards which responsible professional opinion requires. After all, any purported protection the Bill offers, would only come into play in respect of treatment outside the accepted range.