When the Department of Health published their consultation document in January 2014 the introduction to the consultation reminded all those who might respond to it, and many have, that medical innovation has been vital to the dramatic rise in life expectancy over the last century. Accordingly the Government were exhorted to do whatever was needed to remove barriers that prevent innovation that can save and improve lives, with the Minister expressing an intention to create “a climate where clinical pioneers have the freedom to make breakthroughs in treatment”.
Since the consultation ended in July 2014, the draft Bill has started its progress through Parliament. While the Parliamentary debates have been measured and reasonable, identifying amendments that can be made to the draft Bill and highlighting issues that need more careful thought, you could be forgiven for thinking that this potential legislation is unnecessary or dangerous, especially if you read some of the more hysterical reports that have circulated in some quarters.
The Bill sponsors identified the threat of litigation as one (but not the only) barrier to innovation, explaining that legislation to clarify when medical innovation is responsible will reduce the risks of clinical negligence claims, which in the UK and in the NHS in particular remain a considerable drain on public funds. Their argument is that with this threat diminished, doctors will be confident to innovate appropriately and responsibly, taking and recording steps that could lead to major breakthroughs, the example offered being a cure for cancer.
Having been in report stage before the House of Lords in December 2014, when a number of amendments were aired, it has now been sent back to the House of Commons for further consideration. If it becomes law it could become an invaluable tool in the field of medicine and treatment, improving the clarity of the law and modernising society’s approach to innovation in healthcare. It will also inevitably become an obstacle to some claims for compensation as it will offer a defence to an allegation that clinical practices that have departed from accepted medical treatments were negligent, in reliance on what by then will be an Act of Parliament.
For those who have not yet seen this development looming, what we are talking about is a Bill that if it becomes law, aims to encourage reasonable innovation in medical treatment, offering a defence to practices that comprise “responsible innovation” but that nevertheless result in harm to the patient. The discussions in and outside Parliament so far have focussed largely on clarifying the extent to which the Bill might improve and supplement the existing common law, while not putting patients at risk, allowing good and responsible innovation in healthcare without placing undue bureaucratic burdens on the NHS and exposing doctors to risks of additional liabilities.
What the Bill does not attempt to do is change the common law or replace any existing common law defences: rather it supplements them by providing additional, statutory, protection. It does not apply to medical research and presently, by amendment, it also excludes cosmetic treatment, where many unregulated practices still exist and where there was a reluctance (in the House of Lords at least) to include such treatments, especially at a time where other consultations, have identified the need for greater regulation in that area.
What is (and what is not) responsible innovation?
What is not innovation is an ad hoc decision by a doctor to go “off piste”. At present the Bill essentially defines innovation as a situation where a doctor decides to depart from the existing range of accepted medical treatments for a medical condition. Nothing in the Bill would change the current situation where doctors must decide on the most clinically appropriate treatment for their patients, whether or not they are “innovating” under the Bill. The Bill does not say that a doctor must innovate, or that a patient can expect innovation or demand that a doctor should innovate. What it aims to do is provide a mechanism by which a doctor can take a deliberate decision to administer a treatment, following a degree of appropriate consultation, in the knowledge that if the patient suffers harm as a consequence, the doctor will not be held to have acted negligently in departing from an existing range of accepted treatments.
The fact that there will be a degree of consultation expected, inevitably excludes emergency situations. The amended Bill may make clear that such situations are in fact excluded.
To rely on what will be a legal defence, a doctor deciding to innovate must be able to demonstrate that their decision to innovate was responsible. That they decide to innovate at all will be due to the fact that the treatment they are about to administer does not carry a seal of approval that it is an accepted practice (ie, accepted as such by a responsible body of medical opinion). The factors that are envisaged would be taken into account in coming to a view that innovation was reasonable would be the degree of risk and likely success of performing (or not performing) the innovative treatment under consideration, plus the opinions or requests expressed by the patient and opinions expressed by those clinical colleagues who the doctor administering treatment deemed it appropriate to consult.
In terms of process, the Bill offers guidance that a responsible decision will be one that follows a process that is accountable, transparent, and allows full consideration by the doctor of all relevant matters. Importantly, nothing in the Bill seeks either to interfere with the existing law around patient consent to treatment, or allow treatment for purposes other than being in the patient’s best interests.
One point that remains under debate is the extent to which the process of innovation will be recorded. The amended bill requires a doctor to record in the patient notes the views obtained from other doctors on the proposed treatment, the decision to depart from the range of existing medical treatments, and the proposed treatment. There is also debate about collecting the results of medical innovation. There is widespread agreement that the results of any innovative treatment (positive and negative) need to be captured. People disagree on whether submission of results to a register should be compulsory or voluntary.
The Right Honourable Jeremy Hunt MP, referred to the proposed legislation as a “noble cause” and so it is. If you would like to follow the consultation process and see how it ended or review the progress of the Bill then the following link will take you to the right pages: