New law will backfire

The Medical Innovation Bill is an unnecessary risk, warns Dr Marika Davies. Here she argues that the proposed law will greatly increase patient expectations and risk damaging the doctor-patient relationship. And pressure will be put on doctors to go against what they consider to be in their patient’s best interests

Doctor with female patient

It is natural that those who have very sick relatives or friends, suffering with what is thought to be an incurable disease, would welcome innovative treatments that may save the life of a loved-one.

The Medical Protection Society welcomes the debate the Medical Innovation Bill has ignited, but we believe that because innovation is so important, further research is needed to determine whether there are barriers to innovation and, if so, how they may be overcome.

In a modern medical system, we must ensure responsible medical innovation can happen. If there are barriers, they should be removed. But we are not convinced that this proposed bill is the way to do it.

The Medical Innovation Bill aims to encourage responsible innovation in medical treatment and to deter innovation that is not responsible.

The bill has public support and its stated purpose seems sensible, if not commendable.

It is supposed to encapsulate what is already best practice. So why have we and many others, including Cancer Research UK, raised concerns?

This bill would mean that if a doctor wishes to depart from the existing range of accepted medical treatments for a condition, then they must obtain and take into account the views of at least one doctor with the appropriate expertise and experience, relevant to the condition.

Treatment cannot be carried out for the purpose of research and must be in the best interests of the patient. The bill applies to both the NHS and private healthcare.

As the bill progresses through Parliament, amendments have been proposed that we believe could introduce safeguards and limit any risks created.

For instance, Lord Saatchi has made a commitment to consider exclusions from the bill which we welcome as an important step towards greater clarity.

The bill is not necessary

We are not aware of any evidence that doctors are prevented from innovating because of a fear of litigation.

Current law allows doctors to undertake responsible medical innovation. A doctor who tries an unproven experimental treatment may do so provided they are satisfied that it would be supported by a responsible body of medical practitioners (the Bolam test) and would withstand logical analysis (Bolitho).

This does not mean a treatment needs to have been used already by others, simply that there is a level of professional support for it that has a logical basis.

If a need for more clarity is warranted over the current law, this should be addressed with education and not further law-making, which will only complicate matters further and risk increasing litigation – see the case study on the opposite page.

The bill adds unnecessary bureaucracy to current good medical practice. At present, if doctors wish to depart from NICE guidance, they may do so on the basis of their professional judgement, in line with the Bolam-Bolitho tests.

GMC guidance, Consent: patients and doctors making decisions together (2008), recognises and allows for innovation. The bill may require future innovative decisions to be referred to colleagues as a matter of course, with more hurdles to treatment than there are at present.

Doc and patient boxDoctors may be falsely reassured by Lord Saatchi’s claims that if they follow the process outlined in the bill, they will be supported and protected by the courts.

This is incorrect in law: it will always be open to patients to challenge doctors through the courts and it is simply not possible for the bill to give doctors reassurance ahead of any court decision.

If there are barriers to medical innovation, it is likely that a number of complex and interrelated causes, not just fear of clinical litigation, are the cause.

These should be investigated and addressed in a sensible and proportionate way, not by simply introducing new laws.

The bill has risks

Independent practitioners will face particular challenges if the bill becomes law. In light of the high media profile, the expectations of patients may be higher, and the process of departing from standard guidance potentially more burdensome.

The bill may, in fact, increase litigation over the meaning and scope of the bill, decisions not to try innovative treatments or failure to warn of risks.

There is also a risk that patients will misunderstand and overestimate what this bill would do. Lord Saatchi claims the bill will ‘empower patients to demand that every possible route should be tried’.

But this will give patients false hope and may put pressure on doctors to provide inappropriate treatments that go against their medical judgement.

Sadly, the reality of most cases where the bill could apply is that there is seldom time to try all possible treatments, neither is there likely to be funding for these. The use of one innovative treatment may also preclude the use of another.

The bill gives the impression that all innovative treatments are readily available, and that all doctors have an understanding of every possible treatment with an obligation to provide them once the legislation is passed.

This is not the case, and it will be for the doctor to explain otherwise and risk damaging the doctor-patient relationship. Potent­ially, the bill could lead to fewer patients taking part in clinical trials, thus holding back responsible innovation and limiting risks.

Dr Marika DaviesIssues of funding and the possibility of a complaint to the GMC remain and so the bill may not achieve its intended aims of increasing innovation.

The proposed legislation is open to interpretation and the risk of abuse, which will put patients who are desperate to try anything at risk of harm from unsuccessful, ineffective and possibly harmful treatments.

Dr Marika Davies (right) is a medico-legal adviser at the Medical Protection Society