Access to Medical Treatments (Innovation) Bill

Edward Leigh Excerpts

Friday 16th October 2015 Commons Chamber

[Chris Heaton-Harris]

I shall come to that point in a moment.

When this idea was introduced during the passage of Lord Saatchi’s Bill, it was not a novel one. Several of the royal medical colleges, among others, had already called for such a database. The Academy of Royal Medical Colleges has recently stated that it believes that there should be

“an explicit requirement for the results of an innovation to be properly recorded with the outcomes made available to clinical colleagues for scrutiny and learning…The Academy believes that this is an essential requirement.

The Association of Medical Research Charities has said of data collection:

“This is a key aspect of innovation since new interventions require an evidence base to demonstrate safety and efficacy and to ensure effective uptake in practice.”

[Sir Edward Leigh (Gainsborough) (Con)]

I am not opposed to my hon. Friend’s Bill, which he is presenting in a very effective way, but I want to ask him a question about scrutiny. Might not a bureaucratic procedure that required medical practitioners to put innovations on to a database prevent some of those innovations from being carried out in the first place because people would fear being called to account? Might that not hold people back?

[Chris Heaton-Harris]

I will continue, if my hon. Friend will allow me, because in the depths of my speech I shall come to that point and go into detail about how this will work. I am simply proposing to confer on the Secretary of State the power to establish this process, and I hope to be able to give my hon. Friend a detailed answer to his question in due course.

The Royal College of Surgeons has stated:

“The value of innovation is severely diminished if we cannot learn from it. Registration of the results of an innovative treatment, whether positive or negative, ensures that clinicians can consider the data to learn from mistakes or spread instances of good practice.”

--- Later in debate ---

[Chris Heaton-Harris]

I am not particularly worried about what is going on up top, but what I would envisage is that if I wanted to get an extra bit of thatch put on I could go to my doctor, have a conversation with him and he would be able to look on the database and say, “There is nothing there. This is all pie in the sky, hokum pokum stuff and not worth going for.” The database gives people a way of checking on the success or failure of the various treatments on offer, and if innovations such as this miracle cure for baldness are not there at all, there must be questions to be asked.

Perhaps some of the treatments on offer do work, but I doubt that the quacks out there would want their supposed innovations placed under the spotlight of transparency in both practice and outcome that the database would offer. There is another much more compelling reason for having a database that records the outcomes of medical innovation, be they successes or failures. It is impossible to learn, to move forward or to spread best practice if innovation is conducted in a silo and if no one else in the health community knows what is going on.

[Sir Edward Leigh]

My hon. Friend and I are fellow Conservatives and we have battled over the years to stop more and more bureaucratic burdens being put on professionals. Our ethos is that we should trust professionals and if they have a good treatment, they will want to test it in their own time and put it on the database. What worries me is that if we have this great bureaucratic mechanism with piles and piles of untested information poured into it, although it might discourage good doctors it will not necessarily discourage quack practitioners. Does he see my point? How does he meet this Conservative objection to the Bill?

[Chris Heaton-Harris]

There are many elements to this genuine concern. My hon. Friend was the Chairman of the Public Accounts Committee and I served on that Committee for five years. We have seen plenty of IT action in the health service space that has not worked at all, but we have moved forward into a new era of big data and can now manipulate it sensibly and shrewdly. All that would be required from the medical practitioner would be a coding on the patient’s notes that would go into the system electronically. All the work would be done behind the scenes to make that visible to the rest of the registered medical practitioner community. Hopefully, it will mean a very small amount of work in exchange for a huge amount of best practice being spread across the NHS.

I have been reading a truly great book by the author Matthew Syed, which is called “Black Box Thinking”. Essentially, it makes the case for the database, for the recording of success and failure and for trying to encourage the reporting of failure so that lessons can be learned. To paraphrase, he basically says that it is rare for someone to come across “a eureka moment” without a huge amount of previous work. In fact, although most invention comes from innovation, most of it comes from innovation in tiny steps that occasionally build up to a large leap.

In a recent radio interview, the author said that healthcare needs a

“scientific mind-set that allows people to learn from their mistakes”

and to be “brutally honest about failure”. He said:

“For senior doctors, who have spent years in training and have reached the top of their profession, being open about mistakes can be almost traumatic. Society, as a whole, has a deeply contradictory attitude to failure.”

He went on:

“Preventable medical error is one of the biggest killers in the UK—when doctors make mistakes they are worried about litigation so they are not open about mistakes and they are made again and again.”

If preventable medical error was a disease, we would devote a whole medical specialty to dealing with it. Among the many causes of that disease would be fear and a culture of blame rather than learning that lead many doctors to conclude that the best option is not to be open about mistakes, which are then repeated again and again. As Matthew Syed says

“at a collective level…success can only happen when we admit our mistakes, learn from them, and create a climate where it is, in a certain sense, ‘safe’ to fail.”

So the database would do several important things. It should increase transparency in innovation, creating an even clearer trail of evidence which not only improves patient safety but encourages further innovation. It would, hopefully, encourage a culture of information sharing, spreading good ideas and also learning from less successful ones. Additionally, I want registered medical practitioners to know and feel confident that they can use the database to innovate and to discover the innovations of others, and this is partly behind clause 3.

I want to provide clarity and give confidence to doctors about how they can demonstrate that they have acted responsibly when innovating, while using the database or not. The second part of my Bill, therefore, does one thing: essentially, it brings forward what the medical community knows as the Bolam test. Currently, the Bolam test is applied only when proceedings have gone to court. However, bringing it forward to an earlier stage would allow a responsible doctor to take a series of steps to prove that they are being exactly that—responsible when providing treatment. This does not change common law. A doctor can continue to rely on the existing Bolam test before the court.

The Bill supplements the existing law; it does not replace it. The Bill will not stop a doctor being sued for clinical negligence. It simply allows a registered medical practitioner to demonstrate what their actions were and with whom they consulted. It gives a doctor that extra bit of confidence that they can prove that what they are doing is responsible and therefore not negligent. The Department of Health did a consultation on Lord Saatchi’s Medical Innovation Bill that revealed that some doctors do find the threat of litigation to be a block to innovation, although this view is not universally or widely held.

However, given that that engagement has identified that some respondents feel constrained from innovating, there is a case for addressing this through legislation. This Bill is aimed at reassuring those doctors, even if that is just an underlying fear, and to encourage the culture change I described earlier.

As Dr John Hickey told me:

“As a registered medical practitioner, a former NHS Trust Chairman and with 30 years’ experience in the field of legal medicine with the Medical Protection Society (the last five years as Chief Executive), I believe I am adequately qualified to comment on your Bill.

Over the last 30 years I have seen how doctors have increasingly practised defensive medicine both because of the fear of litigation and disciplinary action by their regulators; this defensiveness is not in patients’ best interests.

I believe that your Bill, if approved by Parliament, would assist in meeting the concerns of clinicians treating such patients . . . I believe there are adequate safeguards in your Bill, particularly with respect to consent, to prevent the potential ‘quackery’ about which some of the critics of your Bill and Lord Saatchi’s previous Bill have expressed concern.”

I hope that my Bill is given the chance to fulfil the expectations of Dr Hickey, and many others who have contacted me to express their support for it.

I know that this Bill comes in the context of perhaps a new era in treatment, where patient choice is at the heart of decision making. Following on from the Montgomery v Lanarkshire ruling by the Supreme Court earlier in the year, I think it is fair to expect that all registered medical practitioners are now consulting their patients in a full and responsible manner and involving their patients in decisions about their ongoing treatment. So following these appropriate consultations a doctor might choose to innovate in the treatment of their patient and should feel confident to do so.

This Bill is not about research or about testing on patients. It is about harnessing the trust in the common law and the already well respected, tried and tested Bolam test. The Bill just provides clear steps to evidence Bolam, but before treatment takes place. It has always struck me as bizarre that although our national health service is constantly innovating, it rarely captures the innovative practice itself, let alone the results of that innovation. Out there right now in GP practices and in hospitals registered medical practitioners are innovating to help their patients. It is beyond belief that we fail to capture these innovations and allow others to understand and learn from them and then develop them to help others. That is the intention behind my Bill and I commend it to the House.