Amongst the various bills currently working their way through Parliament is the Medical Innovation Bill introduced by Lord Saatchi.  On the face of it the bill looks appealing.  It is a bill that is designed, apparently, to allow medical practitioners to innovate in medical treatment without fear of being sued.  Lord Saatchi’s particular interest appears to have been cancer and speeding up innovative treatments in patients who have end stage terminal cancer.  All very commendable.

The reality is the bill is badly drafted, vague, contradictory, unnecessary and ultimately dangerous.  In practice it is not helpful either to medical practitioners or to patients. 

The first part of the bill indicates that it is “not negligent for a doctor to depart from existing range of acceptable medical treatment for a condition”.  This is indeed true and it has never been negligent.  Medical practitioners depart from the existing range of accepted medical treatment on a fairly regular basis.  They do it with the support of their colleagues, with the detailed review that other practitioners can bring, in a controlled environment and with the hospital management on board so that the funding implications can be considered.  This happens all the time.  It is not a problem. 

Currently doctors who wish to innovate, particularly in the NHS, work through proposals, discuss them at multi-disciplinary team meetings, discuss them with senior colleagues, come together in the form of an ethics type group to discuss how it will be done, how it will be monitored, what the risks and benefits are, and funding is secured so that everyone knows what is being done and how it is being organised.  Lord Saatchi feels that this is cumbersome.  The bill allows for the removal of that “bureaucracy”. What perhaps he feels is time consuming, I consider to be protection for all involved.

In the bill, firstly the doctor must obtain the view of “one or more appropriately qualified” doctors in relation to treatment.  The obvious question is what is an appropriately qualified doctor?  Is it the junior doctor that you socialise with at the weekend?  Is it the registrar that you trained with?  Is it the consultant to whom you refer cases?  This is not defined in the bill. 

Furthermore, only one other doctor has to be consulted of the proposer’s choice.  We are talking about treatments where people could suffer significant harm.  We are looking at new surgical techniques, new medicines, new regimes of chemotherapy or other forms of treatment.  Would it not be in the patient’s interest to have a group of doctors who are appropriately qualified, a collection of people who can have some input into what is being proposed rather than one doctor? Perhaps some clinicians who can provide an independent view?

Further the doctor proposing the treatment has to take “full account of the views obtained and do so in a way which any responsible doctor would be expected to take account of such views”.  What exactly does this mean?  It appears that a doctor proposing innovative treatment simply has to ask one other doctor (“appropriately qualified” but level of skill otherwise unknown) and to be seen to be taking into account their views.  He or she doesn’t have to agree with them.

So instead of a group of senior medical practitioners who are reviewing matters we can have one doctor, one friend and even if they disagree the innovative treatment can proceed. How is that safe?

There is no requirement here for a full paper trail for full documentation.  The process must be transparent but it need not be documented. Difficult to review if the information is not recorded.

Lastly there is a type of catch all – the bill provides that it is necessary for the doctor to consider any other matter in order to reach a clinical judgment and take any steps which are necessary to secure that the decision is made in a way that is accountable and transparent.  Again there is no reference to a paper trail documenting the steps to a full and considered judgement. 

Dealing with the issue of qualification of the doctor proposing the innovative treatment the bill says that a doctor is appropriately qualified “if they have the appropriate expertise and experience of dealing with patients in the condition in question”.  There is no minimum level here.  Does that mean for example a junior doctor who has been working in the field for some time? Does it include a registrar or equivalent?  What level of expertise do we feel is appropriate?  Lord Saatchi hasn’t answered that question. 

Although the bill includes the statement that nothing will permit a doctor to carry out treatment for the purposes of research or for any other purpose other than the patient’s best interests, this is rather hollow.  Lord Saatchi hasn’t provided any checks on a doctor who makes a decision to use innovative treatment perhaps through flawed judgement but with the best of intentions.  There is no real protection for the patient here. 

The vast majority of doctors using this proposed legislation, like the vast majority now, will be responsible and thorough seeking opinion and guidance. But what of the doctor “on a frolic of his/her own”? Where is the control?

As a lawyer I look at the bill and I wonder how a patient who consents to innovative treatment which hasn’t been properly reviewed takes legal action.  I look at the end process and I can see that the lack of proper audit,  review and control makes it difficult.  A lack of paper trail, a lack of proper evidence, a lack of thorough review is a problem.   It is also a problem for the doctor seeking to establish compliance with the limited requirements of the proposed legislation.

However looking at the start of the process this doesn’t answer a doctor’s needs either.  Doctors are already allowed to innovate; there are processes by which doctors can take forward innovative treatment whether NHS or private. What exactly does the Bill do to improve matters? It is hard to see what it is for.

From the patient’s point of view this is a concern.  A doctor who may have had a brainwave about a particular form of treatment which may hold the key to an improvement in the treatment of a condition can essentially progress as long as he or she has one other doctor who might support this or might not.  If he or she can demonstrate that they have taken that view into account (it doesn’t have to agree) the doctor can proceed.  What if the doctor completely wrong-headed?

Of course some innovative treatments fail now and always will. But currently some don’t even commence because medical opinion and expertise stop them before they do harm.

The motivation for Lord Saatchi’s bill came from the false premise that doctors are not allowed to innovate due to bureaucracy or fear of litigation.  That is simply not true. 

As a clinical negligence lawyer I read hundreds of sets of medical records every year.  Some of those patients have had innovative treatment and sometimes it is good and works and sometimes it does not.  What it is, is subject to review and control and within that, because there is a proper consenting process based on a detailed knowledge from a variety of experts, usually there isn’t a legal claim to take forward. 

We all want innovative treatment and we all want protection.  We don’t need a charter to allow the rogue doctors to do what they want and to feel that they are free to do so.  Innovation is a part of medicine.  So are control, review and reflection. This bill doesn’t address that at all adequately.

I would urge people to review the bill and to look at the comments about it from both sides.  This is a bill which in my view needs to be challenged and opposed.  It is not helpful to the medical profession, it is not helpful to the lawyers but most importantly it is not helpful to patients.