What is it?
The subject of much debate and widely publicised as The Saatchi Bill, the purpose of the Medical Innovation Bill (The Bill) is to ‘encourage responsible innovation in medical treatment’ and was introduced by Lord Saatchi after his wife died from ovarian cancer.
Do we need the Bill?
Many who support the Bill share the view that medical innovation and advances are stifled by the threat of litigation, resulting in defensive medicine with doctors reverting to standard treatments. The Bill aims to encourage innovation in relation to new and alternative treatments by offering sensible doctors protection from litigation.
In rare diseases and cancers there are often very few clinical trials available, due to the fact that there are an insufficient number of patients to make it profitable for pharmaceutical companies to develop new treatments. Patients are often left with surgical options only. Under the Bill a doctor can be given the confidence to offer an innovative treatment to a patient who would otherwise be ineligible to participate in a clinical trial.
It is not disputed that incurable diseases need better, faster and more effective treatments. However, opponents of the Bill consider that it purports to address a problem of law which does not exist and that the requirements are bureaucratic and ineffective. One opponent of the Bill is Sir Robert Francis QC who considers that it does not address the fact that healthcare organisations may be reluctant to authorise “treatment for financial reasons, or through organisational inertia, or through ethical reservations” and that the Bill introduces an ‘increased risk of provoking litigation over the meaning of the legislation’.
What is the position now?
Currently, if a doctor tries something new and it doesn’t work and/or harms the patient and that patient seeks compensation, the Bolam test is applied after the treatment has been implemented, by independent medical experts during the litigation process, determined by the court if the claim proceeds to trial. The litigation process is time consuming, lengthy and stressful for doctors (not to mention costly for the NHS).
What does the Bill do?
The Bill effectively brings the Bolam test forward, with the doctor proposing the treatment to seek the opinion of one or more doctors in the same field, prior to the treatment being commenced.
If the doctor obtains a consensus of opinion from other doctors and then obtains consent from the patient (a requirement of the Bill), they can proceed with the treatment and will be protected from a claim for negligence. If the doctor cannot demonstrate a consensus of opinion then they cannot rely on protection from the Bill. However, unanimity is not required.
Some doctors may feel confident enough to innovate without following the procedure under the Bill, and in this case, they would still be assessed against the Bolam test after the event, if litigation is pursued.
How will it work in practice?
A doctor will not be negligent if they depart from the existing range of accepted medical treatments, if the decision to do so is taken responsibly. For the purposes of taking a responsible decision the doctor must:-
- obtain the views of one or more appropriately qualified doctors (a doctor with appropriate expertise and experience in dealing with the condition in question);
- take full account of those views;
- obtain consent;
- consider opinions or requests expressed by or in relation to the patient;
- consider risk and benefits;
- consider any other matters necessary to reach a clinical judgment;
- register treatments with a scheme for capturing results of innovative treatment; and
- ensure the decision is made in a transparent and accountable way.
Further the doctor must document in the patient’s notes:
- all views obtained from the other doctor(s);
- the decision to depart from the existing range of accepted treatments; and
- the proposed treatment.
Will it come into force?
It is by no means certain whether the Bill will ever be implemented or whether it will remain in its current form. On 28 February 2015 the Liberal Democrats refused to debate the Bill in the House of Commons on 6 March 2015. Therefore, for now, the Bill is not being progressed at this stage. It remains to be seen what will happen after the general election.