At first glance who would not be supportive of a Bill with such a title? As you would expect we are indeed very much pro-innovation and would certainly value a Bill that truly supports medical innovation – it’s just as currently constituted this is not such a Bill.
In its current form, we believe the Bill is both unnecessary and potentially harmful for patients, in part because it lacks clarity, and yet this Bill has honourable intentions. Most of us, when faced with the loss of a loved one, in tragic circumstances, would want to leave no stone unturned in trying to improve the “system” for future generations. We acknowledge and are grateful for the efforts Chris Heaton-Harris MP has made to engage with stakeholders and to hear our concerns.
However, we remain concerned that the Bill may inadvertently act to discourage patients and their clinicians from participating in robust research studies, where novel or experimental treatments – especially unlicensed drugs – are prescribed in settings where there are proper arrangements for clinical monitoring and ongoing data collection. Even a doctor ‘acting responsibly’ might choose to prescribe an innovative treatment to a patient rather than enter them into a clinical trial, particularly as this would guarantee them access to the treatment, whereas in a trial they might be assigned to the control arm.
From discussion with experts in the community we do not think the Bill is necessary. In the context of the Bill, any reassurance about perceived fears of litigation needed to change doctors' practice would be better achieved via changes to GMC guidance.
Furthermore, the Bill potentially adds complexity and confusion to the law surrounding medical negligence rather than the intended purpose of reducing perceived fear of litigation. This is particularly so since the judgement in Montgomery v Lanarkshire Health Board  UKSC 11 which moves the informed consent test away from the ‘reasonable body of opinion’ test to a far more subjective patient-focused test. Arguably the test in the proposed legislation to ‘obtain the view of one or more appropriately qualified doctors’ does seek to change the law of negligence despite the stated intention not to do so.
Database of innovative medical treatments
The proposal to capture innovative medical treatments in a database acknowledges concerns raised in the previous incarnation of the Bill (Saatchi’s Medical Innovation Bill). However, we do not believe that legislation would be needed to establish such a database.
Furthermore, as framed, it is unclear what it would add above publishing case reports in the literature and the non-mandatory nature of entries to this database means that there remains a significant risk that information of both beneficial and harmful effects of treatment would not be captured. We have reservations about the utility and safety of a database that is not mandatory. Existing databases which are mandatory, such as the Systemic Anti-Cancer Therapy Database (SACT), are still incomplete. We anticipate that there is little chance of this non-mandatory database being populated to any meaningful level. So we question the rationale for not making it mandatory?
Other research funders, including the Medical Research Council, share our concerns.
We are not convinced that legislation is the best way to address these issues, given this lack of evidence regarding the perceived problems. There are significant other barriers to medical innovation that the Bill does not address – including funding, regulatory complexity, and clinical training and development. We believe efforts are better focused on understanding and tackling these wider barriers. Hopefully, the Accelerated Access Review launched by the George Freeman, the Minister for Life Science, is an opportunity to address some of these elements.
If there is to be new legislation at least make it good legislation which delivers for patients and makes a positive difference by addressing specific barriers to innovation. AMRC and its members have actively engaged with likeminded organisations in the Accelerated Access Review and hope that the interim findings – soon to be published- will tackle head on the existing barriers to innovation.