Medical Innovation Bill and Tort Law

Medical Innovation Bill and Tort Law

Lord Saatchi is trying to steer a bill to facilitate responsible medical innovation through Parliament. His personal mission is motivated by the death of his wife from ovarian cancer, a disease which as well as being difficult to diagnose is difficult to treat. There are many rare and less common cancers which collectively amount to a majority of cancer deaths: 

Current data shows that 46% of cancers diagnosed are rare and less common cancers, yet they account for 54% of cancer deaths

from http://www.cancer52.org.uk/about-cancer52/

The draft of the Medical Innovation Bill states:

1        Responsible innovation

   

   (1)   The purpose of this Act is to encourage responsible innovation in medical treatment and to deter reckless departure from standard practice.

   (2)   It is not negligent for a doctor to depart from the pre-existing range of accepted treatments for a condition (standard practice) if the decision to innovate is taken responsibly.

   (3)   A responsible decision to innovate will, in particular, be based on consideration of—

 (a)    the reasons why the available research or other evidence is insufficient or unclear including, in particular, whether it is referable to the nature of the condition (as in, for example, a cancer that affects relatively few patients),

 (b)   the relative risks that are, or can reasonably be expected to be, associated with the treatment the doctor proposes to apply and other treatments,

 (c)    the relative likely success rates of the treatment the doctor proposes to apply and other treatments, in the doctor’s reasonable judgment,

 (d)   the relative likely consequences of applying, or failing to apply, the treatment the doctor proposes to apply, and other treatments;

 (e)    opinions or requests expressed by or in relation to the patient, and

 (f)    any other matter that appears to the doctor to be reasonably necessary to be considered in order to reach a clinical judgment.

(  (4)   A responsible decision to innovate must be made in accordance with a process which is accountable, transparent and allows full consideration of all relevant matters; the process may include, in particular—

 (a)    decision-making within a multi-disciplinary team;

 (b)   notification in advance to the doctor’s responsible officer (within the meaning of Part 5A of the Medical Act 1983);

 (c)    explanation to the patient of the doctor’s reasons for proposing to depart from standard practice, including discussion of any contrary opinions expressed by the doctor’s colleagues.

   (5)   Nothing in this section permits a doctor—

 (a)    to provide treatment without consent that is otherwise required by law, or

 (b)   to administer treatment for the purposes of research or for any purpose other than the best interests of the patient.

The aim of the bill is to ensure that doctors have the confidence to responsibly innovate. It is not blanket immunity for the quacks to exploit. It is attempting to make the legal situation sufficiently clear that innovation is not deterred. 

Innovation is distinct from medical research. The motivation for innovation is to benefit the individual patient. An example of innovation would be compassionate use of an unproven drug. By contrast, the main motivation of medical research is to gain knowledge about the efficacy and safety of a treatment for future patients. This will usually entail providing some patients with the treatment, and others with regular treatment and/or a placebo.

It is always necessary to explain to patients the nature of the treatment they are receiving, and in the case on innovative treatment the patient must understand that the treatment is untried, and may have unexpected side-effects. The law is well aware of the need for medical innovation, yet certain legal doctrines militate against innovative treatments. 

There are various solutions that have been suggested. One is the principle of offsetting risks, so that where a treatment creates new risks but also reduces known risks, this should be taken into account in clinical negligence cases (this is discussed in 'Misalignments in Tort Law' by Ariel Porat, Yale Law Journal (2011) 121:82). 
Another is the application of strict liability to injuries as a result of innovative treatments. This is unattractive to me, as the patient receiving innovative treatment knows the risks and intends to benefit from the innovative treatment. This suggestion is based on the assumption that doctors are most concerned about reputational damage, and so strict liability removes the aspect of blame. This ignores the issue of publicity and prospect of disciplinary hearings.
 A third option I propose is the establishment of a statutory scheme similar to the vaccine damage scheme which offers some payment for injuries caused by innovative treatments, but not tortious damages. The clinician would be required to register his innovation on a national register which enable data to be collected on innovations, and to use a statutory consent form which emphasizes the unknown adverse effects of innovative treatments.