Access to Medical Treatments (Innovation) Bill

Christopher Chope Excerpts

Friday 16th October 2015 Commons Chamber

[Dr Sarah Wollaston (Totnes) (Con)]

As with any book, we should not judge a Bill by its cover. All Members want to improve access to innovative medical treatments, but I sincerely believe that the Bill is not the right way forward. My hon. Friend the Member for Daventry (Chris Heaton-Harris) referred to a number of organisations, implying that they are in favour of the Bill, but he knows that the overwhelming majority of research and charitable organisations are ranged against it. It is opposed by the Association of Medical Research Charities, whose membership reads like an “A to Z” of expertise, including bodies such as Cancer Research UK, the Wellcome Trust—the list is very long, so I will not detain the House by reading it out. The Academy of Medical Sciences opposes the Bill, as does the Academy of Medical Royal Colleges, including all those he quoted in his speech.

The General Medical Council, the British Medical Association and the Patients Association oppose the Bill, and I direct my hon. Friend to their article in The Guardian. Action against Medical Accidents, and even the Association of the British Pharmaceutical Industry, oppose the Bill because of its unintended consequences. Legal experts, including Sir Robert Francis, firmly oppose the Bill. All those organisations oppose the Bill because it is unnecessary, it is unworkable, it would unravel important patient protections and, most importantly, it would have unintended and dangerous consequences for research.

I pay tribute to all the Bill’s sponsors and absolutely understand that they are motivated by very good intentions. I would love to sit down and work with them on how we genuinely improve access to innovative treatments. I hope they understand that I oppose the Bill because I sincerely believe that it is the wrong way forward.

The Secretary of State already has the power, as the hon. Member for Lewisham East (Heidi Alexander) pointed out, to set up a register of innovative treatments, so we simply do not need that provision. We also do not need the heavy hand of legislation. We do need a register, but it needs to be set up by the research bodies themselves and to be adequately funded. We absolutely need transparency. There is a danger that we will misunderstand the science.

[Mr Christopher Chope (Christchurch) (Con)]

My hon. Friend refers to the power of the Secretary of State to set up a system. When does she expect that to happen, and what is causing the delay?

[Dr Wollaston]

My hon. Friend makes a good point. Principally, there are issues with funding and complexity. The Bill fails to recognise the science and the issues that a vast, sprawling database might cause. My hon. Friend the Member for Daventry referred to the desirability of the public being able to access a database and gave the example of male pattern baldness. There would be vast profits to be made by the quackery industry from male pattern baldness products. I envisage a vast, sprawling database of anecdotal treatments, and I am afraid it would act as free advertising for the quacks of this world. It is an invitation to quackery.

I started in medicine in the late ’80s and worked for a while in paediatrics. The prognosis for children with leukaemia was grim, but today most of the children diagnosed with the same conditions will survive and thrive, not because of access to a vast, sprawling database of unconnected, anecdotal treatments but because of the meticulous progress of medical research, whereby with thousands of people we compare existing treatments with innovative treatments and find out which are genuinely the best. Any single anecdotal treatment might be effective in one single patient, but that does not tell us whether, when applied to a population, it is better or not.

Another problem with the Bill is the danger that it would undermine medical research. In effect, it would give private clinics the opportunity to offer anecdotal treatments as a way of bypassing clinical trials. When individuals, and particularly parents, are desperate because they have a dreadful diagnosis, they are at their most vulnerable to the claims of individuals who say, for example, “Look at the database and see how it worked for Mr Smith.” They might be lured into thinking that was the best way forward. Someone in a very vulnerable place might be lured into not taking part in a clinical trial by the siren call of an anecdotal treatment recorded on a publicly accessible database. I am afraid that the Bill would undermine research, and that is why the vast majority of bodies are very unhappy about it.

My hon. Friend should reflect on all the concerns that have been expressed about the Bill, and think about how science moves us forward. We progress not by a series of anecdotal treatments but through a solid research community.

We need greater access to clinical trials. The searchable database set up by the National Institute for Health Research is a welcome step forward, but it is rather clunky. Patients need to be able to see very clearly what trials are available and be able to take part in them. There is progress, people are surviving today with treatments based on clinical trials that may have taken place 10 years ago and many go on themselves to take part in clinical trials that will benefit future generations. It is absolutely vital that we continue to support this approach.

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[Philip Davies]

I merely read out, word for word, Cancer Research UK’s response to the consultation; I can do no more than quote its words. I will take my hon. Friend’s point in that regard.

[Mr Chope]

If there is such widespread opposition to this Bill, why was it that the Saatchi Bill made such good progress in the other place during the last Parliament, when I understand it had the benign support of the Government?

[Philip Davies]

My hon. Friend often asks me questions that I cannot answer. He has now asked another that I am not in a position to answer. I often think it is a mistake to give way to him; he is far too clever for my liking. Again, he has stumbled across something that I cannot answer. He raises a very good point, so perhaps we shall leave it hanging there for others to have a crack at later in the debate.

The Academy of Medical Royal Colleges said that it applauds the intentions of the promoters of the Medical Innovation Bill:

“The stated purpose of the Bill is to encourage responsible innovation in medical treatment, and accordingly to deter innovation which is not responsible. Those are aims which medical Royal Colleges would wholeheartedly support and welcome.”

That is an important point.

--- Later in debate ---

[Philip Davies]

My hon. Friend is very kind, although it would have been rather better if he had not had to be prompted to say that. Nevertheless, I will take those comments in the spirit in which I know my good friend intended.

[Mr Chope]

My hon. Friend has not responded to the intervention of my hon. Friend the Member for Beckenham (Bob Stewart). Surely the point is that if we want to discuss this in more detail in Parliament, the ideal opportunity for that is in Committee when it can have detailed scrutiny.

[Philip Davies]

My hon. Friend makes a good point. I have not heard anything so far today to suggest that the Bill should not at least go into Committee for further scrutiny, and perhaps even for some improvement, if I may be so bold as to suggest that may be possible. I do not think I have heard anything today that suggests the Bill should be stopped in principle on Second Reading. I hope that my hon. Friend the Member for Totnes will appreciate, however, that I am also trying to be balanced in setting out some of the concerns that have been expressed, perhaps so they can be considered if we do get into Committee, which would be a useful exercise.

Another concern raised by some of my constituents is that the database may compromise patients’ anonymity. Innovative medical treatments will be applied on a case-by-case basis with a specifically honed technique for one particular individual. The fear is that a degree of detail will be needed in the register, which would end up compromising a patient’s anonymity. That is a valid concern, and protections would need to be put in place to ensure all information is stored securely within the database to protect anonymity. However, that may be at the cost of using innovative treatments. There may well be a tension between those two factors.

While the information stored in the database should only be accessible by doctors, it will need to remain confidential aside from access for medical purposes and, ultimately, it should be the patient’s choice whether to use an innovative treatment that will be recorded for medical purposes. Furthermore, in an age when we want more doctors to spend more time with patients and not at their desks, we need to be careful to ensure that the register does not become overwhelming to the point where doctors are put off from using innovative techniques for the sake of the amount of paperwork and red tape that would accompany it. The Academy of Medical Royal Colleges said

“current experience in the NHS show that establishing an effective register for far more standard procedures is a complex task. Establishing and maintaining a register of innovations would be a costly and potentially burdensome and bureaucratic task.”

My hon. Friend the Member for Totnes made that point. That is another factor that needs to be considered when the database is created. Of course the database and the information gathered should be rigorously checked and regulated. However, that is not always easy when doctors are already busy.

Overall, I believe this clause, originating from an amendment to Lord Saatchi’s Bill, is one of the key clauses. For rare diseases such as some cancers there is a lack of published evidence on which to rely when determining treatments to try. It is also widely regarded that some methods used to treat some types of cancers have remained similar for many years, with only slight modifications to the techniques. With this in mind, a database that allows knowledge to be stored and accessed at a doctor’s level will be not only desirable but probably essential for allowing doctors to innovate responsibly. It will encourage a culture of knowledge sharing, which, importantly, will include both successes and failures. This is a vital part of the Bill, and indeed I do not see how the power to innovate can move forward without the inclusion of a database recording the results of these treatments. I therefore commend my hon. Friend the Member for Daventry on including this clause.

We need to look at what we consider to be a responsible innovative treatment. Clause 2(2) states that a treatment is regarded as

“‘innovative’ if it involves a departure from the existing range of accepted medical treatments”

for a condition. We can therefore assume a wide scope to cover the cases that should be recorded in the new database.

However, concerns have been raised regarding the distinction between innovation and research. While clause 5(2) specifically states that this Bill does not apply to medical research, some medical organisations have raised concerns as to how this would work in reality. The Academy of Medical Royal Colleges states:

“We do not understand the distinction between ‘individual patient innovation’ and ‘research’. The distinction seems false and potentially dangerous. As a college president stated ‘Innovation without research isn’t innovation, it’s more often just advertising’.”

Although the Bill uses the two in harmony, it is important to raise these points and for them to be considered in Committee.

One of the main differences that separates the two is that this legislation allows doctors more freedom to modify and specifically cater treatments towards the individual they are treating. That is very important and worthwhile. Although they will not be finding a brand new cure for cancer, it allows doctors to cater treatment plans more specifically to the patient’s needs and wishes. Many patients will benefit from that, and often would prefer it.

We have discussed the Bolam test. By working from the current common law Bolam test, the Bill identifies the steps a doctor can take to show that they have acted responsibly before innovating. The common law Bolam test is defined as the test

“used to determine the standard of care owed by professionals to those whom they serve, e.g. the standards of care provided to patients by doctors.”

Established from the case Bolam v. Friern hospital management committee in 1957, it shows that if a doctor acts in accordance with a responsible body of medical opinion, he or she will not be negligent. Subsequently this standard of care test was amended—the Bolitho amendment—to include the requirement that the doctor should have behaved in a way that “withstands logical analysis” regardless of the body of medical opinion.

This determination of whether a professional’s actions or omissions withstand logical analysis is the responsibility of the court. The Bill, through clause 3, aims to reflect as closely as possible the steps under the current common law which a responsible doctor could be expected to satisfy when innovating. However, clause 3 has caused specific concern for many of my constituents and I would like to raise some of their concerns today.

Most groups and individuals from the medical profession seem to be satisfied with the current Bolam test as a standard for regarding medical innovation, with the Royal College of Surgeons regarding it as “adequate”, so there are concerns that, instead of clarifying the legal position, clause 3 will confuse the current mechanism for judging responsible innovation.

Subsection (2)(a) requires a doctor to

“obtain the views of one or more appropriately qualified doctors in relation to the proposed medical treatment, with a view to ascertaining whether the treatment would have the support of a responsible body of medical opinion”.

This implies that the innovating doctor need only rely on an interpretation of a responsible body, and need not gain the support from a responsible body itself. In practice this might not be a problem, however, as the Bill specifically states that those supporting views must be obtained from “appropriately qualified doctors”—that is, those with appropriate expertise and experience in dealing with patients with the condition in question. It may therefore be taken that the doctor is qualified in the relevant field, which would provide reassurance. It is this clause that many of my constituents are concerned about, however.

This brings me to another point that was raised by my hon. Friend the Member for Totnes. Some of my constituents fear that the database could be used as a tool by quacks, crooks and charlatans, giving them the flexibility to use devious experimental treatments. Indeed, that concern has been echoed by the Royal College of Surgeons, which claims, in reference to clause 3(2)(a):

“This sub-clause could also provide post-hoc justification for an unethical treatment from a doctor asserting s/he sought the view of one other doctor.”

We must be sure, therefore, that appropriate safeguards are in place to protect patients from such doctors. I do not think that many of them exist, but I do not know. My hon. Friend the Member for Totnes and I might have some disagreement about that. The important point is that there needs to be a safeguard, because it is inevitable that some such doctors will exist.