Access to Medical Treatments (Innovation) Bill — House of Commons, 2015-10-16
Topic: Health
Heidi Alexander (Labour, Centre-left): I congratulate the hon. Member for Daventry (Chris Heaton-Harris) on securing a place in the private Members’ Bills ballot and thank him for meeting me this week Sometimes in this place, we need to be careful what we wish for. The process of steering a private Member’s Bill through Parliament is not only time consuming, but can become very complicated. I suspect that, after the contribution of the hon. Member for Totnes (Dr Wollaston), the hon. Gentleman may be feeling that. I should probably be honest and warn him that my contribution may add to his headache The very fact that we are discussing the Bill means that we are having a vital debate about the critical issue of how we can improve patients’ access to innovative and effective treatments. In putting his case for the Bill’s Second Reading, the hon. Gentleman has demonstrated that he has the right intentions, but that is probably the best thing I can say Many people in this House will have been in the position of seeing someone they love dying too soon. In such situations, people want hope. I understand that. They want hope that there is a treatment or drug that offers a chance of survival or of extending life that little bit longer If I thought that this legislation would provide genuine, well-founded hope in a safe and sound manner, I would support it, but I am not convinced that it does. In truth, I am worried that it does the opposite. I am worried that unsafe treatments could be used on dying patients. I am worried that the Bill would muddy the waters for doctors who wish to innovate about the legal route to do so, that it would reduce participation in clinical trials and that it would reduce legal redress for patients with a genuine negligence claim In the few weeks that I have been in this job, I have approached the Bill with an open mind. I have met a range of experts, patient groups, royal colleges and charities. It is fair to say that they are overwhelmingly opposed to the Bill. I will put some of their concerns to the promoter of the Bill and to the Minister, who I understand is actively supporting it The first concern that has been put to me is that the Bill attempts to remedy a problem that does not exist. I will briefly quote a few of the experts in this area. The Academy of Medical Royal Colleges has said that "the Bill rests on the false assumption that it is fear of litigation that is holding back innovation by doctors. There is simply no evidence that this is the case" The British Medical Association has said: "We are not aware of any evidence to suggest that the threat of litigation inhibits innovation or that confusion exists amongst doctors over the circumstances under which they can deviate from standard practice." The Royal College of Surgeons has said that "there is no evidence that doctors are deterred from innovating due to the threat of legal action." The Motor Neurone Disease Association has said that "the Bill would not remedy the problem it is aimed at, for such a problem does not exist" Sir Robert Francis QC, who has done so much in recent years to make sure that the NHS is focused, rightly, on patient safety, has said: "The law of negligence does not prevent responsible innovation and never has." I could quote many more people, but I have probably made my point. Why do the hon. Gentleman and the Minister think that all those experts are wrong and they are right? What evidence do they have that litigation, or the fear of litigation, is preventing new treatments or hampering doctors from innovating? Even if that were an issue, does the Bill provide a robust and safe mechanism to tackle it? I am not sure that it does, but I am willing to work with the hon. Gentleman and the Minister, and anyone else who is interested, to consider how we can work on a cross-party basis to address any potential barriers to innovation Before setting out why I do not believe that the Bill is the right approach, I will first deal with clause 2, which provides the Secretary of State with power to establish a non-statutory database of innovative medical treatments. As the hon. Gentleman said, the clause was included as a result of concerns that were rightly raised in the other place by Lord Hunt when the previous incarnation of this Bill was debated. Lord Hunt’s amendment to that Bill would have required the Secretary of State to establish a database, but such a requirement does not exist in this Bill. As currently drafted, the Bill gives the Secretary of State "power" to establish a database, but places no obligation on them to do so I also question whether clause 2 is needed at all. According to the House of Commons Library, section 254 of the Health and Social Care Act 2012 gives the Secretary of State power to direct the Health and Social Care Information Centre to establish a system for the collection or analysis of information. Will the Minister confirm whether the Secretary of State already has the power to establish a non-statutory database of innovative treatments without legislation The Bill gives no detail about how such a database might work, but is that not crucial? A database will be effective only if it is compulsory, regulated and quality controlled. For a database to work requires participants to be just as likely to register failure as success. Will there be a requirement to remove an innovation that is not effective from the database? Will the database be quality assessed or peer reviewed? Will it be used for marketing to patients? The Bill makes no reference to those crucial points I am concerned about the impact of the Bill on research, and particularly on participation in clinical trials. As the Minister will know, we are a world leader in clinical research, and we must be careful not to do anything that would put that status at risk. Last December the Minister said that he hoped that the forerunner to this Bill would develop into a form that "the vast majority of medical opinion and respectable bodies in the medical field feel able to support".—[Official Report, 9 December 2014; Vol. 589, c. 853.] I am not sure we have got to that point Let me list some of the medical research charities opposed to the Bill: Alzheimer’s Research UK, the British Heart Foundation, Cancer Research UK, the Motor Neurone Disease Association, Parkinson’s UK, the Wellcome Trust. Is the Minister comfortable supporting a Bill that those experts say could have "significant unintended consequences for medical research"?