Legislation to encourage medical innovation

1. Introduction

1.1    This consultation paper has its origins in the written Ministerial statement made to the House of Commons by the Secretary of State for Health on 22 November 2013 (see opposite) and has support from the sponsors of the Private Members’ Bills mentioned there.

1.2   Medical innovation (that is, departure from established treatments) has helped increase life expectancy over the last century. Boys and girls born in 1912 were expected to live for 53 and 56 years respectively. By 2012, life expectancy at birth was 79 years for boys and nearly 83 years for girls.1  To continue this progress, it is important to ensure doctors continue to look for effective innovations and to carry out research.

1.3    As explained in chapter 2 of this consultation paper, case law on clinical negligence currently gives doctors a good basis for innovating where there is support for their decision from a responsible body of medical opinion. However, where a doctor is not confident that there would be such support if the matter came to court, the doctor may feel that there is pressure not to innovate. This consultation therefore asks:

•   should legislation clarify what a doctor may responsibly do in that situation?

•    and if so, what should the details of the legislation be? Chapter 3 sets out the Government’s proposals.

1.4    We welcome comments on the proposals from all interested parties – including, in particular, doctors, patients and the public, and the legal profession. Comments should reach the Department of Health by 25 April 2014. There is information about how to submit comments in Annex E at the end of this document.

1.5    The Government aims to respond to the consultation as soon as possible and, subject to the results of the consultation, to seek an opportunity for legislation to be brought forward thereafter.

1.6    The Government remains committed to supporting and encouraging responsible innovation by means other than that considered in this consultation paper, including through NHS England’s work on Innovation, Health and Wealth.

The current legal position

2.1    A potential barrier to departing from established procedures and carrying out an innovative treatment is the possibility of a clinical negligence claim. Some argue that our increasingly litigious culture (see Figures A and B) puts pressure on doctors to practise defensive medicine.

2.2 Currently, there is no Act of Parliament that indicates the meaning of responsible medical innovation or that sets out a test of clinical negligence. Instead, the existing law governing negligence is to be found in case law (decisions by the courts).

2.3 The main case law is in the case of Bolam v Friern Hospital Management Committee, which was later refined in Bolitho v City and Hackney Health Authority.5 These cases establish that to avoid a successful claim in negligence a doctor should be able to

demonstrate support for a decision from a responsible body of medical opinion (Bolam) and that the opinion is capable of withstanding logical analysis by the courts (Bolitho).

2.4 Subsequently, in the case of Simms v Simms,6 which concerned innovative treatment for variant Creutzfeldt-Jakob disease, Lady Butler-Sloss was satisfied that support from a small but well-informed body of experts was sufficient to meet the Bolam test. She also said:

“The Bolam test ought not to be allowed to inhibit medical progress. And it is clear that if one waited for the Bolam test to be complied with to its fullest extent, no innovative work such as the use of penicillin or performing heart transplant surgery would ever be attempted.”

The implications for treatment decisions

2.5 The current legal position gives doctors a clear basis for innovating where they have support from a responsible body of medical opinion (in other words, where they can satisfy the Bolam test).

2.6 But, notwithstanding the remarks of Lady Butler-Sloss, questions have been raised about how the law will be applied in cases where there may not be a responsible body of medical opinion that supports a decision to carry out an innovative treatment. Some have argued that there are at least two different ways in which the current law might be interpreted in such cases:

• on one reading, the current test for a responsible decision requires a doctor to demonstrate that there is a body of medical opinion to support that decision. A court will make sure that this opinion is logical (Bolitho). A doctor who could not present any such support is more likely to be found negligent;

• on another reading, if the courts are faced with a case where there is no body of medical opinion to support the decision taken by the doctor, then it is possible they might look to medical best practice to determine if the doctor has acted responsibly and thus not negligently.

2.7 In whichever way the current law is viewed, it is easier for a doctor to feel confident of support from a responsible body of medical opinion when the treatment decision is based on a well-trodden path. The more commonplace the treatment, the less anxious a doctor will be about a possible negligence claim. The further away a doctor moves from common procedures, the more uncertainty there will be about how to show that the decision is responsible and not negligent. It is this lack of clarity that might deter doctors from offering innovative treatment, and which the draft Bill aims to address.

2.8 A doctor who is not confident of being able to satisfy the Bolam test may feel obliged to follow standard treatments, even where those standard treatments have poor outcomes. The vignette in Box A illustrates this.

2.9 We are keen to hear views, especially from doctors, on whether medical innovation is being unduly constrained by the possibility of litigation. We also want to hear from patients whose experience suggests that the possibility of litigation has been a factor in their doctor’s attitude to possible innovation.

3. The proposed legislation

3.1 The draft Bill that the Government proposes is at Annex A to this consultation paper, with explanatory notes at Annex B.

What the Bill aims to do

3.2 If the draft Bill is put in place, its aim would be to encourage responsible innovation in medical treatment in certain circumstances. It would do this by providing that, in those circumstances, it is not negligent for a doctor to depart from the standard medical treatment for a condition if the decision to do so is taken responsibly. The draft Bill aims to provide clarity about what requirements should be met in those circumstances if the doctor is to be able to demonstrate that a decision to depart from standard practice has been taken responsibly, and therefore not negligently. The Bill also aims to protect patients by deterring doctors in those circumstances from carrying out an innovative treatment unless they meet the requirements set out in the Bill.

3.3 The Bill does not change the position on consent to treatment. Nor does it permit a doctor to carry out treatment for research purposes or for any purpose other than the patient’s best interests.