Wednesday 23 April 2014

"responsible" Innovation and responsible reporting

The Department of Health consultation on what has been referred to as the "Saatchi Bill" is about to close. 

The Medical Innovation Bill (to give it its proper title) has been considered on a number of other blogs (particularly here) but I have decided to set out (briefly) my views on the bill. 


The background to the bill and its intended purpose is set out here, where you can also respond to the consultation.


There are for me three main concerns: (the primary concern) whether the bill is necessary, the campaign which surrounds it, and the protection it provides.


Necessity
The Bill is necessary, it is claimed, because the current law on Medical Negligence prevents innovation, as "currently the law dictates that patients are only offered standard treatments."

As has been noted by other commentators, that is simply not a correct statement of the law. As all practitioners know, to be negligent, a doctor has to take a course of action which "no reasonable body of medical men, skilled in that particular art, would support. The House of Lords even went to far as to put it the other way (also in Bolam)


Putting it the other way round, a man is not negligent, if he is acting in accordance with such a practice, merely because there is a body of opinion who would take a contrary view


There is in principle no negligence in using a new or innovative treatment, provided that support can be found for it among some reasonable body of professionals. 


Let us consider an example. A patient is terminally ill with an unusual and/or complex cancer. There is no known effective treatment for the condition, and without treatment the patient will die. The doctor proposes a logical, reasonable procedure which may or may not be successful, and for which there is perhaps limited evidence. There are a number of outcomes:


i) The treatment is effective and the patient's condition improves: no claim lies in negligence (there is no loss)


ii)The treatment has no effect and the patient dies: No claim lies in negligence (there is no loss; there was no better alternative treatment)


ii)The treatment has no effect and the Claimant suffers some negative effects/harm:


  • A claim being brought in such circumstances is, in reality, unlikely. 
  • If the side effects were known and communicated to the patient, who properly consented, there is no claim in negligence (the treatment was not negligent)
  • If the side effects would not have been known or anticipated by a responsible                 body of professionals (i.e. because of limited evidence about the procedure), there is no claim in negligence. 


Much of the publicity around this bill has focused on the issue of new pharmaceuticals (particularly for cancer). The same applies to new drugs, but there is the more complex issue of licensing. That, however, is an issue for regulation, not for the law on clinical negligence.

Even the Medical Defence Union (always staunch in its defence of doctors) says that there is 'no evidence' to suggest that innovation is being stifled, and that "medical innovation should not leave them open to an increased threat of litigation". 


It is noteworthy that the campaign has not yet been able to point to a single example of a doctor being successfully sued for what would, under the bill, be 'responsible innovation'. 


The material on the issue on the "Saatchi Bill' website, and in articles, refers to the total damages paid out by the NHS, and to a "culture of defensive medicine". 


This, in my view, is the real issue. There is nothing in the current law on negligence which prevents the innovation which the bill's proponents (quite rightly) wish to see. What is preventing that innovation (if anything) is fear of litigation. The answer to that fear is re-education, not a wholesale change to the law on medical negligence. 


The Protections in the Bill

The wording of the Bill itself is (according to Lord Saatchi in the Google Hangout on 22 April 2014) going to be subject to some amendment following the consultation. I will therefore post again on this issue once the Bill has been redrafted. 

I will say briefly that, in its current form, the bill effectively removes all protection from medical negligence. 


The decision has to be based on: "the doctor’s opinion that there are plausible reasons why the proposed treatment might be effective".

The decision must consider the risks, likely success rates, and opinions of colleagues. 


There is no objective consideration of whether the treatment is reasonable or appropriate. Provided the Doctor complies with the steps and shows that he has considered the relevant factors, the treatment is not negligent. 



The Campaign

It is perhaps not surprising that a bill supported by one of the founders of Saatchi and Saatchi should come with a very effective social media campaign.  

However, I have concerns about the way in which it has been conducted (not, I should say, by the said Saatchi and Saatchi). Specifically:

  • The way in which the current law is being expressed (which is simply incorrect);
  • The articles in the Telegraph (which fail to raise any of the important questions about the bill) by Dominic Nutt who fails to disclose that he is the Director of Communications for the Saatchi Cancer Initiative (the Saatchi Bill campaign). 
This campaign for greater innovation in the treatment of rare conditions is quite commendable. However it is based on a fundamental error: The change required is in education and policy, not in the law of negligence. 

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