The Access to Medical Treatments (Innovation) Act, aimed at improving patient access to innovative treatments, became law in March 2016.
The legislation originated as a Private Members’ Bill presented to the House of Commons in June 2015 by Chris Heaton-Harris MP. It included elements of a Private Members’ Bill from the previous parliament sponsored by Lord Saatchi, which was passed by the House of Lords in January 2015 but was never debated in the Commons.
The Medical Research Council (MRC) has taken an interest in the legislation as it has potential implications for medical research and patients, and will continue to work with the relevant government departments and agencies throughout any implementation phase.
MRC strongly supports innovation and the need to speed up access to new treatments developed as a result of medical research, and therefore supports the underlying aim of the Access to Medical Treatments (Innovation) Act. However, we had concerns that the Bill as initially introduced to Parliament might have had unintended consequences.
A major focus of the Bill as originally drafted was to set out a process doctors could follow to “responsibly” depart from standard medical practice, without it constituting negligence. MRC and others had concerns that this might have exposed patients to unwarranted risk. We also identified risks that the Bill might have discouraged patients and their clinicians from participating in clinical trials by encouraging the provision of novel treatments on an ad hoc basis, thus slowing the process of gathering the evidence required to make them widely available on the NHS. All new treatments require robust evidence on their safety and effectiveness before they can be widely introduced and this is best obtained via rigorously designed clinical trials, an area in which the UK excels. MRC worked with a number of other medical research funders, academies and professional bodies to raise awareness around these concerns and suggest ways in which they might be addressed.
During the House of Commons Report Stage of the Bill in January 2016, Mr Heaton-Harris and others introduced a number of amendments designed to address concerns raised by external stakeholders and Members during previous debates. All provisions relating to clinical negligence were removed, a major change that MRC welcomed.
The Bill was refocused around its second aspect, a mechanism for the Secretary of State for Health to create a database to collect and share information on innovative medical treatments. Further changes made it explicit that the proposed database should capture the use of off-label and unlicensed medicines, and – in a provision tabled by Life Sciences Minister George Freeman – include treatments carried out for the purpose of medical research such as clinical trials.
MRC ongoing concerns
MRC and others had supported the creation of a database alongside the clinical negligence provisions set out in the original Bill. This would have been necessary to record the results of any ad hoc use of innovative treatments for the benefit of subsequent patients, including both beneficial and harmful effects and failures to respond. As the final legislation did not create a new mechanism for “responsible innovation”, the purpose of such a database is no longer clear.
MRC believes further discussion is needed to consider whether a new database is necessary, taking account of possible overlap with other existing and planned databases and sources of information. Details of the database’s operation were not specified in the legislation, and would be the subject of subsequent regulation. Before any action is taken to create the database, it would be very important to have full consultation regarding its design and content, methods of capturing information, dealing with privacy concerns, and to ensure appropriate access for researchers. In particular, parameters for the design and operation of the database would need to be carefully considered to ensure there are no unintended biases introduced that might lead to over-reporting of the benefits of particular innovative treatments or under-reporting of associated risks.
MRC will continue to closely follow the legislation throughout any implementation phase.
For further information see the text of the Bill.