There are of course no boundaries or
‘rules’ (at least to a certain extent) when
it comes to innovation. But what about
when it involves living, breathing human
beings?
Here in the UK, there has been much talk
of changing the law of clinical negligence
in the context of treating cancer patients.
Since the passing of his wife, Lord Saatchi
has campaigned to change the law and
has introduced the Medical Innovation
Bill to Parliament. Essentially the Bill
provides that, with a patient’s consent,
doctors can treat a patient dying of
cancer or other diseases with new and
innovative treatments, provided that they
have ‘acted responsibly’ and consulted
their peers before doing so. Doctors will
also be encouraged to record successful
treatments on a national database.
The current legal test for clinical
negligence emerged from the case of
Bolam v Friern Hospital Management
Committee. Where a question of wrong
doing arises, a doctor will not be found
to be negligent if he has acted in
accordance with a practice accepted
as proper by a responsible body of
medical practitioners in the same
field (the ‘Bolam test’). In other words,
the test for negligence is providing a
standard of care that is considered
unacceptable by the profession which
causes harm to the patient. It does not
apply where something has just gone
wrong or a mistake has been made. (This
is a common misconception amongst
members of the public). The test was later
refined in the case of Bolitho v City and
Hackney Health Authority in that the Court
could make a finding of negligence if it
deemed a body of medical opinion called
upon to support the doctor to be ‘not
capable of withstanding logical analysis’.
The Bill essentially allows doctors to experiment
on patients without any form of redress should
something go seriously wrong.
wrong’. This, Saatchi argues, is what is
hindering innovation of medical treatment.
Supporters of the Bill claim that there will
be more clarity and certainty for patients
and doctors at the point that they are
being treated. George Freeman, Health
Minister, supports the Bill, stating that
there is growing pressure from patients
and medical charities for faster access to
innovation.
There has however been much
speculation and criticism from lawyers
and other medical organisations. The
Association of Personal Injury Lawyers
(“APIL”) has warned that the argument
that doctors are too scared to innovate
is a myth and the fear of litigation is
unfounded as there is no evidence to
suggest that doctors have been sued as a
result of attempting innovative treatment.
More worryingly, the Bill fails to make
provision for the danger of irresponsible
experimentation. What is ‘responsible
innovation’ without clear safeguards?
The Bill essentially allows doctors to
experiment on patients without any form
of redress should something go seriously
wrong.
The Bolam test has been applied by the
Courts for over 60 years, generating an
abundance of case law setting out various
circumstances in which negligence was
found. Under current law, innovation
is permitted as long as a responsible
body of medical opinion would support
it. By the same logic, trialling potentially
innovative treatment which does not work
is completely different to being negligent
in the care of a patient and causing
damage.
Unsurprisingly, the Bill is not supported
by any leading medical organisation or
representative. Indeed the British Medical
Association (BMA) stated in their response
to the Bill that a lack of allocation of time
for medics to undertake the necessary
studies in relation to cancer treatment, for
example, is the real barrier to innovation.
The BMA also agrees that there is no
evidence that the threat of litigation
hinders the development of innovative
treatments. It would appear that the real
problem with medical innovation in the
UK is a lack of funds for research and the
lack of availability of effective drugs (e.g a
new drug to treat breast cancer).
There is however concern within the
medical profession that the fear of being
sued has led to the practice of defensive
medicine, in which patients undergo
treatment that is not necessarily in their
best interests but protects the doctor from
potential litigation ‘should something go
Moreover, APIL has pointed out that there
are contradictory clauses in the Bill which
will cause confusion amongst doctors
and further undermine the safety of
patients. For example, doctors would not
know whether the treatment they apply
is covered by the Bill or the Bolam test.
From a legal point of view, uncertain or
contradictory clauses will almost certainly
generate further litigation relating to the
interpretation of the new law (so called
‘satellite litigation’).
As regards a doctor obtaining the views
of his or her peers, there is concern
that the Bill only requires a doctor to
obtain the views of other doctors and
to take account of those views, but it
does not actually require the approval of
those doctors (the presumed definition
of ‘approval’ in this context is another
matter). Agreement and ‘obtaining views’
are two different things. If the other
doctors do not agree with the innovative
treatment, the doctor who wants to use it
can still go ahead with the treatment and
still be protected by the Bill.
The Bill does not of course only apply
to patients who are terminally ill but
also to those who have a long term
illness affecting their quality of life. It is
argued that it would allow the doctor
to essentially play God and escape the
consequences should the innovative
treatment not result in a positive outcome.
Given that the current law requires that
responsibilities are exercised properly,
it is unclear how far doctors will be able
to develop new treatments in practice.
One would imagine that this is a field
reserved for committed researchers
dedicated to the study and trialling of new
treatment. Is the Hospital environment
really the appropriate domain in which to
apply untested treatment? And are we
essentially turning vulnerable patients
into human guinea pigs because they’ve
‘nothing to lose’?
By Magda Zimnicki
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