In 2014 Lord Saatchi introduced his Medical Innovation Bill (the 2014 Bill) into the House of Lords. It was designed to encourage responsible medical innovation, and provided that it was not negligent for a doctor to depart from the usual treatments for a condition if the decision to do so was made responsibly. It went on to give further detail about when a decision would be made “responsibly”.
In the course of discussions in the House of Lords, a provision was added relating to collecting information about medical innovations. There was general consensus that a database should be set up to capture the results of medical innovation – it was felt there was little point in allowing responsible innovation if new developments did not benefit the profession (and therefore the public) as a whole. There was some debate as to whether or not providing information to the register would be compulsory.
The 2014 Bill ran into opposition in Parliament and beyond, with the result that it did not progress beyond the first reading in the House of Commons. We have previously written on the Bill’s contents, see the articles here and here.
From the wreckage of Lord Saatchi’s original bill comes the Access to Medical Treatments Bill 2015 (the 2015 Bill), a private member’s bill (albeit with government support) sponsored by Chris Heaton-Harris in the Commons, and Lord Saatchi in the Lords. It picked out what were felt to be the strongest parts of the 2014 Bill in order to advance them. One was the creation of a database of information to capture knowledge about best practice. This measure had wide parliamentary support.
In its passage through the Commons the 2015 Bill has undergone a number of changes. In particular, provisions (similar to those in the 2014 Bill) defining what constitutes responsible innovation, and reconciling those provisions with the existing common law, have been expunged. What we are left with, therefore, is the proposal to set up a database.
The 2015 Bill, in its current form, is intended to promote access to innovative medical treatments by:
- Providing for the establishment of a database of innovative medical treatments, and for access to information contained in the database.
- Encouraging responsible innovation by doctors in relation to the carrying out of medical treatment.
It does so by empowering the Secretary of State to make regulations on the point, with the data to be collated by the Health & Social Care Information Centre (the HSCIC). While the 2015 Bill is, in many respects, generic it is clear that it is designed to cover off-label drug use as well as, say, surgical techniques.
Given how far the 2015 Bill has reached – and the fact that it has been advanced relatively early in the lifetime of this Parliament – it seems likely to become law in due course. Despite that progress it is fair to say that the 2015 Bill, like its predecessor, has divided opinion. Mr Heaton-Harris has said of it:
“The database will give doctors a source of information on medical innovations, providing an evidence base and sharing platform for innovation. It will also increase transparency in innovative treatment decisions by recording the treatment and its outcomes.”
Medical providers are not so sure. The 2015 Bill has been opposed by, among others, the BMA, Royal College of Surgeons, the Medical Protection Society and the Medical Defence Union.
They have raised a number of points. The BMA is worried that there are no plans for the information and innovative treatments to be quality assessed or peer reviewed. They consider that the inclusion of events on a database may give the impression that they are approved or have been given some form of endorsement for use again. This may lead to the inappropriate use of a treatment and represent a risk to patient safety.
The BMA has also expressed concerns around patient anonymity. In particular, there is little information on proposed access arrangements to the database and there are concerns that without robust security, patient details could be accessed by companies who may target patients for commercial reasons.
Stepping back, many have stated that the current law already allows doctors to successfully defend a negligence claim involving innovative treatment provided they can show their actions were supported by a reasonable body of medical opinion and are logical. The BMA is not aware of any evidence that there is confusion or a lack of clarity in the current law or that the threat of litigation prevents doctors from innovating. Other bodies raised the same point.
The Bill also fails to take in to account the new law of consent in Montgomery v Lanarkshire Health Board, which highlights the need to ensure that the patient is fully aware of all the potential risks of undergoing a procedure or course of treatment, and emphasises the need to consider what the patient would have considered material when making the decision to undergo treatment (or not). How this precedent will work with the 2015 Bill could cause confusion.
The Association of Medical Research Charities has voiced concerns that the Bill may inadvertently discourage patients and their clinicians from participating in robust research studies. Their briefing states “even a doctor ‘acting responsibly’ might choose to prescribe an innovative treatment to a patient rather than enter them into a clinical trial, particularly as this would guarantee them access to the treatment, whereas in a trial they might be assigned to the control arm”.
As stated above, it seems likely that the 2015 Bill will reach the statute book in due course. The robust parliamentary debate has no doubt been useful in refining the text, as well as being a good demonstration of the scrutinising role that members of both chambers undertake. It is hard, however, to avoid the feeling that, even if the 2015 Bill becomes law, the debate is by no means over. The 2015 Bill merely empowers the Secretary of State to make regulations to set up a database, and to consult with the HSCIC before doing so. There is no guarantee that the database will ever be set up. Given the amount of interest in the 2015 Bill, it is likely that pressure will be brought to bear on the Secretary of State from both directions. Both the bill’s sponsors, and its sceptics, have shown sufficient interest to pursue the matter. The 2014 Bill was round one; the 2015 Bill was round two; any draft regulations will be round three.