Access to Medical Treatments (Innovation) Bill — House of Commons, 2015-10-16
Topic: Health
George William Freeman (Conservative, Centre-right): The hon. Lady raises an interesting point. I am just looking at clause 3(2): "For the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition, a doctor must in particular— (a) 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, (b)take full account of the views obtained…(and do so in a way in which any responsible doctor would be expected to take account of…), (c) obtain any consents required by law", including (d)(i) any opinions or requests expressed by or in relation to the patient, (ii) the risks and benefits" and to (e) take such other steps as are necessary to secure that the decision is made in a way that is accountable and transparent." Let me repeat that we would not even countenance supporting the Bill if its intention were in any way to change the basic test of clinical professionalism to which every clinician is subject. They remain subject to all the professional safeguards of the GMC and other regulatory bodies and clinical negligence law. The Bill merely seeks to put in place one particular mechanism on which doctors can rely to be clear that the innovation they propose is in accordance with the law. There is a danger of thinking of that if this Bill ever became law, it would be the last and final word on the area of medical innovation. It would absolutely not be; it is a small contribution to a vast canon of common law and practice that—importantly for the Government—does not change Counsel’s advice to us has been very clear that the negligence provisions provide no immunity to irresponsible doctors. Under both existing common law and this Bill’s provisions, doctors will need to show that they have acted responsibly. There will be no escape for a negligent doctor Members have asked whether the Bill will allow doctors to prescribe untested medicines. It is important to make it clear that the Bill does not change existing medicines legislation, which permits the use of unlicensed medicines —tested or untested—prescribed by physicians on their own responsibility, subject to all their own professional tests, regulatory conditions and the law. This will be based on what they believe, in their own professional clinical judgment, is right for their patients. If there is an unmet medical need, there is clearly more scope for clinicians to innovate Finally, I was asked whether the Bill will prevent patients from making a claim if they receive negligent treatment. No. I want to be clear that this Bill in no way changes patients’ rights to claim for negligent treatment. We are completely committed to ensuring that patients are safe and protected. On the occasions when, regrettably, things go wrong and treatment has been given negligently, it is absolutely right that patients are entitled to seek compensation. It is essential that any new legislation or any amendments to the Bill do not put patients at risk in any way. If a doctor carries out a procedure negligently, they would not be protected by this Bill, as is made clear in clause 4(3) In conclusion, let me highlight that although substantial concerns have been raised—my hon. Friend the Member for Totnes has expressed some of them this morning—it is true to say that there has been support for the Bill. The "Empower: Access to Medicine" campaign has said: "This new Bill provides a real opportunity to renew the focus on patients’ rights to try innovative medicines within a reasonable risk framework. Empower: Access to Medicine has long advocated appropriate access, for some patients, to certain medicines earlier in the clinical trials process. Chris Heaton-Harris’ new Bill provides a real opportunity to make that ambition a reality." It is particularly supportive of the accelerated access review that I am running. A number of colleagues have suggested that we look at the Bill in the context of those recommendations that will shortly arrive on my desk The Royal College of Physicians has said that it "generally welcomes the first part of the Bill to enable the secretary of state…to establish a database of medical treatments. However, the RCP strongly recommends that the medical and research communities should lead in developing the database." If the Bill becomes law, it is very important for that to happen. I understand that the RCP has particular concerns about the second half of the Bill Let me also highlight what was said in the extensive discussion of the Medical Innovation Bill, which was launched in the other place. The chief medical officer, Dame Sally Davies, said that she was "confident that, with the amendments made in Committee stage, the Bill is safe for patients and has the potential to encourage responsible innovation." She was referring to the provisions in the second half of the Bill. Sir Bruce Keogh, clinical director of NHS England said, in connection with the same provisions in the former Bill: "Encouraging innovation in medicine and protecting patients are both of vital importance. This is why I am pleased that amendments have been devised to address concerns about patient safety." Sir Michael Rawlins, president of the Royal Society of Medicine said that the Medical Innovation Bill would "allow responsible innovation in treatment...I believe that the use of the provisions in the draft Medical Innovation Bill will benefit patients, especially those with rarer diseases, and the furtherance of medical science." I appreciate that there are real issues of contention and debate, but I wanted to highlight the views of eminent people on both sides of the debate, of which the House should be cognisant I was particularly struck by the comments of the hon. Member for Lewisham East. At the end of the last Parliament, her predecessor as shadow Health Secretary said, interestingly, that he was "disappointed" that the Liberal Democrats had withdrawn their support for the Bill. He said that "there should at least have been some cross-party talks about this", and I was glad to hear the hon. Lady echo that view this morning. He went on to say: "The Bill was heavily amended and extra safeguards put in, and I worry a little bit that those who are opposed to it don’t realise that it is actually quite a different Bill now." He said that for parents whose children suffered from untreatable diseases and had no hope, the Bill was "about opening up hope", and added: "It is often parents who struggle to get their voice heard" In the other place, although some peers had concerns about the Bill, a number of others supported it. I have a list in front of me, which shows that the numbers were equal on both sides. It also shows that some pretty eminent peers supported the Bill: Lord Kakkar, Lord Patel, Lord Ribeiro, Lord Mackay, Lord Woolf, Baroness Gardner, Lord O’Donnell, Baroness Butler-Sloss and Lord Blencathra. Those are all eminent people in their fields. I am not suggesting for a minute that there is not a debate, but I think it is a genuine debate, which is, after all, what the House is here to provide The Government support the intention of the Bill to promote innovation, to reinforce existing medical negligence law, to promote the dissemination of information on innovations, to protect and reinforce the sovereignty and the freedom of clinicians to vary and innovate treatment in the interests of their patients, and to promote the use of identification and data on innovation as critical to 21st-century healthcare. We are—and I am— very concerned to ensure that the Bill promotes, rather than undermines, patients’ and doctors’ trust in the legal and regulatory framework for innovation, to ensure that it fits into the wider landscape and framework for innovation that I—along with various bodies—am putting in place, and to ensure that it reflects and supports the growing discussion about research medicine and innovation The House has many and varied ways of improving the lot of our citizens, and private Members' Bills are one important way. As you well know, Madam Deputy Speaker, we Ministers are normally sceptical about the virtues of private Members' Bills, and jealously guard our, and the Government’s, unique monopoly on legislative virtue and competence; but I believe that when a Bill—such as this Bill—seeks to do something that we support, even if the mechanics proposed may not yet be perfect, there is a strong argument for it to proceed to a Committee stage and be subjected to detailed scrutiny. I hope that the Bill is given such a hearing in Committee. The hon. Member for Lewisham East has signalled her willingness to work on a cross-party basis to try to get the Bill into a shape that will address the concerns that have been expressed, and I was delighted to hear my hon. Friend the Member for Totnes make a similar offer.