My hon. Friend makes an important point. The NICE clinical guidance to NHS England, after carrying out a health technology appraisal, is binding. NHS England has a duty to implement it across the system. There is an issue about how quickly different parts of the NHS implement guidance and how quickly innovative drugs are rolled out. Another Bill going through the House will be looking at what can be done to support the use of off-label drugs. My position on that is that the most profound barrier to the adoption of off-label drugs is in fact information for clinicians on the clinical benefits of an off-label indagation. It is the clinical evidence that provides the basis on which they are perfectly free at the moment to use alternative drugs.
Let me address the other points raised by my hon. Friend the Member for Totnes, the Chairman of the Select Committee. She expressed concern that the Bill would undermine research and clinical trials. That is an important point. I stress that the Bill, as drafted, does not cover clinical trials, which are regulated by the MHRA and the HRA from a scientific, safety and ethical viewpoint. Rightly, the Bill does not stray into that regulatory environment. I confirm that we would be concerned if it did. It does not relate to formal clinical research, only to clinicians’ duties to their care of individual patients. If the database is got right, we think it could contribute to the sum of healthcare knowledge by collecting information on innovations and their success or not.
My hon. Friend said that she fears the Bill would do more harm than good. I merely point out that the chief medical officer for England supported the final version of the Medical Innovation Bill, which ran out of time in the House of Lords at the end of the previous Parliament. The national clinical director for NHS England confirmed that he had no concerns about patients’ safety with regard to that Bill. Hon. Members may debate whether the Bill is needed, but it is really important to understand that we are clear that the Bill in no way damages patient safety. The test of responsibility under the Bill is intended to reflect absolutely the requirement of the Bolam test, which has been the gold standard for decades. I highlight that a doctor has to obtain any consents required by law when taking a decision to part from the existing range of medical treatments. The Bill expressly provides that a doctor must have regard in particular to the requirements of patient safety. Under both existing common law and the Bill, the doctor would need to show that they had acted responsibly. There is absolutely no escape for a negligent doctor under the Bill. The Bill seeks to give doctors access to the database as a source of learning—doctors, not patients. We hope that if the database has got right it could help to drive both innovation and information through the system.
My hon. Friend set out some concerns about safeguards for patients. I reiterate that the Government are clear that the negligence provisions in the Bill do not provide any immunity to irresponsible doctors. It would be irresponsible for anyone to suggest that they do. I want to make that point very clearly from the Dispatch Box and to reassure her that in our view the Bill does not remove any of the current safeguards in place to protect patients’ safety. Our view is that the Bill does not apply a weaker test to a doctor’s decision to innovate than the existing law on clinical negligence.
My hon. Friend raised points about the rigour of the database, which I will come on to in a moment. A number of other concerns have been raised. I want to run quickly through, in two batches, the concerns about the database and about negligence and legal protections. Colleagues have asked whether there is really a need for legislation for a database. I confirm that the Bill gives power to the Secretary of State to confer functions on the Health and Social Care Information Centre in relation to the establishment of a database. Legislation enables provision to be made for the disclosure of information from the databases, ensuring that the HSCIC has the necessary powers to disclose information and that appropriate safeguards are in place. Were the Bill to become law, we would obviously consult on regulations setting out the detail of how the database would be constructed.