Access to Medical Treatments - stop the Bill now!
With the party conference season done and dusted for another year, MPs returned to Westminster for a busy week of parliamentary business.
Lurking in the schedule alongside the first evidence sessions in the Health Committee’s very welcome childhood obesity inquiry, and a lively round of questions to Jeremy Hunt, is a sinister piece of draft legislation which, if passed, will have detrimental effects on the wellbeing of children, says Royal College of Paediatrics and Child Health President Professor Neena Modi...
The Access to Medical Treatments (Innovation) Bill 2015-16 will be debated by MPs on Friday 16 October. This Bill is unnecessary but more importantly, poses a real danger to the safety of infants, children and young people in England and Wales.
The Bill, sponsored by Chris Heaton-Harris MP, is an altered version of Lord Saatchi’s Medical Innovation Bill from the previous Parliament, which attracted much opposition from the medical profession. The authors say its purpose is to enable practitioners to employ "innovative" treatments without fear of litigation and create a “register” of such practices.
Children will be placed at risk
What is “innovation” in medical care? It is introducing a new treatment, service, or healthcare intervention. Actually we already have a word for this; this is “research”. Medical research is the objective method through which a new treatment or healthcare practice is tested rigorously. In the UK medical research is - rightly - tightly regulated through a strong framework to safeguard patients. Research requires detailed peer review, approval by an independent Research Ethics Committee, a commitment to publish results, and for many forms of research, inclusion in a public register prior to commencement. The Bill places patients - in particular infants, children and young people - at grave risk by suggesting that it is acceptable for a doctor to employ a new treatment without independent scrutiny or any of these safeguards.
The Bill will encourage irresponsible experimentation. Families, already at heightened susceptibility to the promise of miracle cures because of the illnesses of their children or loved ones, will be prey to at worst quackery and at best to the possibly strongly held but inadequately justified convictions of medical practitioners who do not know how, or do not wish, to test treatments objectively.
The Bill is unnecessary
What’s more, the Bill’s stated purpose of enabling practitioners to employ innovative treatments without fear of litigation is completely unfounded. There is no evidence to suggest that fear of litigation is a deterrent to a clinician’s use of innovative treatments. Doctors are already able to try new treatments under existing law. Doctors are covered for professional negligence purposes through the Clinical Negligence Scheme for Trusts and for research purposes through indemnity schemes provided by research sponsors. Not to mention the fact that this Bill would not even supersede common law on negligence!
The second aim of the Bill, to create a voluntary register of innovative treatments, is similarly unnecessary. A doctor that has employed an untested treatment is unlikely to register a failure. In contrast, good research practice already promotes - and in the case of clinical trials, requires - registration in a public database regardless of the outcome.
The Bill will create confusion, red tape and set back genuine innovation
Let me be clear. The Royal College of Paediatrics and Child Health is a strong proponent of clinical research to bring innovation into the care of sick children. The UK has envied strengths in clinical research, developed through recognition that it is a prime means to advance patient care. This Bill will set back such progress. Legal and public confusion will be created over what constitutes "innovation" and what constitutes research. Efforts to improve public understanding of scientific method will suffer, and parent support for research that aims to improve the care of children will be placed at risk. If there are novel medical interventions which fall outside research and clinical frameworks, or a lack of databases in which they might be registered, then surely this is an argument to strengthen existing structures, not create a new one?
What you can do
We want to see the Bill withdrawn. If you share our concerns and would like to write to your MP about this disastrous Bill, please contact our Public Affairs team (email@example.com) for more information.