Is there really a need for the "Medical Innovation Bill"?

Is there really a need for the "Medical Innovation Bill"?

There is some opposition from both medical and legal professionals to Lord Saatchi's Medical Innovation Bill. The criticisms have four main themes:

1. The bill isn't needed - the law allows safe, responsible innovation
2. The bill will allow quackery - we should only be practising evidence-based medicine
3. The bill denies patients compensation for negligence
4. The bill will cause confusion

I will address each of these in turn. 

The bill isn't needed - the law allows safe, responsible innovation

It is true that under the current legal regime, innovation is permitted. Part of this confusion is related to a misunderstanding to what is meant by innovation in the bill. It does not refer to the conduct of medical research. It refers to the provision of untried treatments to individual patients in the hope of benefiting those individuals, a trial of n=1. 

It is true the law recognizes that medical innovation is essential. It would be negligent NOT to provide new treatments where proven superior to the old treatment (at which stage it could be argued this is the new customary care). No one has suggested that the law intentionally suppresses innovation. There is however an issue of whether the current legal standards have an unintentional effect of discriminating against innovative treatments. So what are the legal standards?

A doctor is not negligent if his treatment corresponds to that generally accepted, or accepted by a responsible body of medical opinion. Further, the basis for this practice can be subject to scrutiny by the courts (although this rarely if ever alters the standard of care). Research is an entirely different matter, because clearly the benefits and harms of the treatment are not known. This is the basis for the current regime of research governance. 

Innovation as defined above is somewhere between the two. Although adherence to standard practice protects a doctor from claims of negligence, the law certainly does not consider that deviation from standard practice is negligent BUT there is greater onus on the practitioner to justify his individual practice. Thus it is incorrect to say that the law does not permit innovation, but neither is it correct to say that there are no legal barriers to innovation. As Dame Butler-Sloss commented in Simm v Simm

"Is there a responsible body of medical opinion which would support the PPS treatment within the United Kingdom?” the answer in one sense is unclear. This is untried treatment and there is so far no validation of the experimental work done in Japan. The Bolam test ought not to be allowed to inhibit medical progress."

So it is clear that the Bolam test does potentially inhibit medical progress. As for whether the current law really is a barrier to innovation, I'm not sure if the empirical data are available to show this. Certainly when the first bio-engineered trachea was implanted, it was not in the UK. Numerous other innovations come out of countries with less investment in medical research but a more permissive medico-legal environment. The argument isn't that innovation isn't permitted by the law, but that the current regime inhibits innovation. Not by particular decisions, but by the uncertainty that responsible innovation will be supported. The opponents will argue that this points to a need for greater education. The supporters of the bill might argue that it is necessary to get out of the risk-averse culture in the UK by a new statute that provides assurances that innovation in certain strictly defined situations will not be considered negligent by comparison to an inappropriate legal standard. As Lord Wolff put it

"I do know about ... cases where doctors are sued for negligence because they have innovated in the treatment they offer, rather than following generally-accepted medical standards."

adding

"It is important to understand here that we are talking about a new law that will make a limited, but significant contribution in a small number of difficult cases. Maurice Saatchi, with the support of Health Secretary, Jeremy Hunt, and of the government, is seeking to introduce legislation that will only apply to: (1) patients who are not responding to conventional treatments; (2) patients who give their consent to such innovation; (3) new treatments that are still at a experimental stage; (4) new treatments that hold out a real prospect of being able to help, both the patient and others in similar circumstances who come after them."

from http://www.telegraph.co.uk/news/features/10785352/Saatchi-Bill-your-last-chance-to-help.html