Access to Medical Treatments (Innovation) Bill — House of Commons, 2015-10-16
Topic: Health
Philip Andrew Davies (Conservative, Centre-right): 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.