Introduction
Enough has been said about whether the bill is required (it
is to me wholly clear that it is not). However for now let us imagine that the
bill is in fact necessary.I want to provide some comment on the effect the bill would
have on the law.
I avoided doing so previously because it had been indicated
that the bill would be amended. The updated version of the bill has now been
published (and is available at the back of the briefing note here.)
The aim of the bill is now very helpfully set out in the Briefing Note:
The Bill for Session 2014-15 is set out in
Annex A: it is the shortest of all the versions
of the Bill so far, and it reduces the Bill
to its essential message – innovate by
following a responsible process with the
support of a responsible body of medical
opinion, and you can be confident that the
law will support you; innovate in a
reckless manner without the support of your
colleagues, and the law will not protect
you.
(The eagle-eyed reader will notice that this passage has a
hidden message: “follow… a responsible
process with the support of a responsible body of medical opinion… and the law
will support you.” That is, to all intents and purposes, an explanation of
the Bolam test. All that has been added is the phrase ‘innovate by…’ This is
why many lawyers agree that the bill is unnecessary; the Bolam test already
supports innovative treatment, provided that it is supported by a responsible
body of opinion.)
The Aim of the Bill
I digress. To return to the ‘aim’ of the bill. It is
(according to the briefing note) that the law will support innovation which is
‘responsible’ and which is carried out ‘with the support of a responsible body
of medical opinion’, but not to protect innovation which is reckless and ‘not
supported by colleagues’. That is an
entirely appropriate limitation on the type of treatment which the law should
support (and is the present law).
The real question is whether the bill in fact does this.
The answer is short: it does not.
The Content of the
Bill
Section 1(2) says that it is not negligent to depart from
the existing range of accepted treatments if the decision is taken in
accordance with a process which is accountable, transparent, and allows full
consideration of all relevant matters.
Section 1(3) says what that process must include:
(a) consultation with appropriately qualified colleagues, including any
relevant multi-disciplinary team;
(b) notification in advance to the doctor’s responsible officer;
(c) consideration of any opinions or requests expressed by or on behalf
of the patient;
(d) obtaining any consents required by law; and
(e) consideration of all matters that appear to the doctor to be
reasonably necessary to be considered in order to reach a clinical
judgment, including assessment and comparison of the actual or
probable risks and consequences of different treatments.
Section 1(4) provides:
Nothing in this section
(a) Permits a doctor to administer any treatment
for the purposes of research or for any purpose other than the best interest of
the patient, or
(b) Abolishes any rule of the common law in
accordance with which a decision to innovate is not negligent if supported by a
responsible body of medical opinion.
The Effect of the
Bill: What is Negligent?
Section 1(2) provides that treatment caught by Section 1(3)
will not be negligent. That is of course applicable to any treatment because there is no
definition of innovation. It provides an circumstances in which
treatment will not be negligent (i.e. additional to the Bolam test.) It
therefore diminishes and weakens the Bolam test.
This may appear contradictory to the later section 4(b)
which states that it retains the Bolam test. But what Section 4(b) in fact does is retain
the Bolam test in respect of what is not negligent.
It is already the case that treatment is not negligent
if supported by a responsible body of medical opinion (the Bolam test). By
virtue of Section 1(2) treatment which might not fall within the Bolam test
(and would therefore be negligent) could still avoid being negligent if it
falls within Section 1(3).
The Effect of the Bill:
Section 4(a)
Section 4(a) rightly prevents research taking place, though in
my view if a treatment is entirely unsupported by evidence and is properly to
be considered ‘innovative’ then it is likely also to be what one might consider
research.
It also prevents treatment for any purpose other than the
patent’s best interests. This seems to provide some protection to patients, but
in fact is likely to be interpreted as a subjective test (in line with the
remainder of the bill).
The ‘purpose’ of a doctor’s treatment will almost always be
the best interest of the patient: a doctor who has as his purpose the best
interests of the patient can still provide negligent treatment.
Doctors who make mistakes act with the purpose of the
patient’s best interests.
Those who believe in unverified alternative therapies
believe that they are acting with the patients best interests.
For this section to provide any adequate protection the ‘best
interests’ of the patient would have to be assessed on an objective basis, by
expert evidence. That would effectively be a return to the Bolam test.
The Effect of the
Bill: Section 1(3)
All of those matters listed must be included in the process
in order for it to be ‘caught’ by section 1(2).
But where, in that section, is the “support of a responsible
body of medical opinion” required? It is not. The closest that section comes to
requiring this is Section 1(3)(a), requiring ‘consultation with’ colleagues,
including the MDT.
Does consultation require the gaining of support? No.
The Legal advice on the bill (from Parliamentary Counsel who
drafted it, and available here),
says that the ‘duty to consult sets a high threshold’, referencing a number of
cases. Those cases are all public law cases on the duty of public bodies to
consult. They are not authority on the meaning of the word in statute, and
certainly not in the context of this Act.
A standard interpretation of consultation is a process of
listening. In this context, listening to colleagues. Courts are unlikely to
interpret that to include the gaining of explicit support. The argument will be
that if parliament had intended to require the gaining of support it would have
included that in the Act, rather than explicitly requiring only consultation.
So does the Bill provide that the law will not protect
innovation which is ‘not supported by colleagues’? For the same reasons, no.
Conclusions
The reality is that, under the Bill, a doctor could comply
with all of the procedural requirements in Section 1(2) and 1(3), consult with
colleagues, ignore their views and press ahead, and s/he would not be
negligent.
So the bill provides very limited protection to patients.
The protections are inadequate because to provide appropriate safeguards would
be to return to the Bolam test (as hidden in the ‘aims’ of the bill set out in
the briefing note). That is itself an indication of why the bill is not
required.
The Bolam test is the right test to provide the balance
between protecting patients and promoting innovation. If there is a perception
that doctors cannot innovate then more education is required.
