On Friday, 27 June 2014, the Medical Innovation Bill, sponsored by Lord Saatchi, received its second reading in the House of Lords and took a further step towards achieving Royal Assent and becoming an Act of Parliament.  Following this second reading in the House of Lords, the widely debated Bill will now face further discussion in the committee stage and the Government has already stated that additional amends will be required for the Bill to more closely conform to the existing legal framework for assessing clinical negligence.
  
Current test for clinical negligence

The current test for the standard of care for professionals in relation to clinical negligence was established in the case of Bolam v Friern Hospital Management Committeeand is widely known as the Bolam test.  Bolam held that a doctor would not be considered negligent if the doctor can demonstrate that he had acted in accordance with a practice accepted as proper by responsible members of that particular profession even if others would not have taken the same view.  This test was later refined in Bolitho v City and Hackney Health Authority such that a doctor may still be held negligent when acting in accordance with a practice accepted by a responsible body of medical opinion if that opinion is not able to withstand logical analysis as decided by the court.

The Medical Innovation Bill

The purpose of the Medical Innovation Bill is “to encourage responsible innovation in medical treatment (and accordingly to deter reckless irresponsible innovation)”.  The Bill seeks to achieve this by providing that it will not be negligent “for a doctor to decide to depart from the existing range of accepted treatments for a condition if the decision is taken in accordance with a process that is accountable, transparent and allows full consideration of all relevant matters”.

This process, as set out in the current draft of the Bill, must include the following:

  • Consultation with colleagues, this includes any relevant multi-disciplinary team;
  • Notification by the doctor to their responsible officer;
  • Consideration of opinions or requests of the patient;
  • Obtaining those consents required by law; and
  • Consideration of matters reasonably necessary to reach a clinical judgment, this includes an assessment of risks and consequences.

Nothing currently contained in the Bill would allow a doctor to administer treatment for a purpose other than that which is in the best interests of the patient.

Lord Saatchi stated that the Bill seeks to achieve its aim of safe and responsible innovation by increasing certainty for doctors in order to overcome the prohibitive effect the possibility of litigation presents and move “the Bolam ‘responsible persons’ test from after the event to before the event”.  Lord Saatchi argued that this will result less uncertainty regarding what constitutes lawful medical innovation and thereby combat the potential barrier to innovative treatment posed by clinical negligence claims.

Current test for clinical negligence

The current test for the standard of care for professionals in relation to clinical negligence is known as the Bolam test and was established in Bolam v Friern Hospital Management Committee Bolam held that a doctor would not be considered negligent if the doctor can demonstrate that they acted in accordance with a practice accepted as proper by responsible members of that particular profession even if others would not have taken the same view.  This test was later refined in Bolitho v City and Hackney Health Authority such that a doctor may still be held negligent when acting in accordance with a practice accepted by a responsible body of medical opinion if that opinion is not able to withstand logical analysis as decided by the court.

Ongoing Debate

There is some debate as to whether the Medical Innovation Bill is necessary given the current legal framework.  Lord Colwyn expressed his uncertainty stating that “any need for additional support for doctors should be achieved through professional guidance, not rigid statute”.

In earlier comments on the draft Bill, Sir Robert Francis QC stated that the Bill was “based on the fundamental misapprehension that the law of negligence inhibits genuine and responsible innovative treatment” and that “the law of negligence does not prevent responsible innovation and never has”.  Lord Turnberg also questioned whether the fear of litigation currently acts as a barrier to innovation by putting off doctors.

In support of the draft Bill, former Lord Chief Justice Lord Woolf stated that it was “nonsense to suggest that the culture of litigation that now exists does not have a dampening effect on doctors” and that it “is something that hangs over them”.

Next Steps

The Bill will face continued debate in committee and, while giving broad support for the Bill, health minister Earl Howe has already identified additional amendments which will be required.  Earl Howe stated that the role given to multi-disciplinary teams was “a solution that Sir Bruce Keogh, national medical director for NHS England, and I do not consider appropriate” as they may struggle to focus on the evidence for innovative treatment and their quality can vary.

In place of the multi-disciplinary teams, Earl Howe proposed “that oversight should come from other doctors with experience and expertise in dealing with the condition in question, in line with the existing Bolam test for clinical negligence”. 

The Bill and issues raised may also be relevant for manufacturers of healthcare products which are used off-label by health professionals.