A lot has been happening in terms of research policy at the moment, from the announcement of the European adaptive licensing pilot to the Government’s Early Access to Medicines scheme. The newest addition is the Medical Innovation Bill. But, what does this Bill mean? How is it different to the other initiatives and why are we not supporting it?
What’s the difference?
The idea of adaptive licensing is that medicines should be licensed for use in patients more quickly. The Early Access to Medicines scheme announced earlier this month is run by the Government and, in principle, hopes to speed up the process by making drugs available several years before they are licensed. The net result should be much the same – earlier access to promising new drugs – but the UK scheme is already operational and should start having an effect more quickly.
However, the new process will be highly regulated by the Medicine and Healthcare Regulatory Authority (MHRA). Only drugs that have been proven to be safe and beneficial through clinical trials would be eligible, with the drug company themselves needing to apply for a license. As mentioned in our previous blog post, it remains to be seen how successful this scheme will be in bringing benefit to patients.
Whilst we support the idea of more drugs being made available to more people, more quickly – a key message echoed in the above schemes – the Medical Innovation Bill is a rather different story.
The Medical Innovation Bill
The Medical Innovation Bill, instead of speeding up the drug licensing process, proposes to allow doctors to prescribe drugs or other treatments in cases where no expert opinion would support this action.
Its supporters argue that for ground-breaking, innovative treatments expert opinion doesn’t count for much, and requiring doctors to take it into account represents an unjustifiable restriction on innovation – this is something the Association does not support and we have made a recommendation to the Government that it should not proceed with the Bill.
Why? If the Bill was to be put in place this would mean non-MND experts would be able to prescribe drugs where there is no evidence of their safety or beneficial effect. This removes safeguards that are in place to protect patients; also the prescribing doctor would not need to worry about being sued for medical negligence. By removing the expert advice, and waving away safe guards, we feel that this Bill could put people with MND at significant risk.
The Medical Innovation Bill will not allow non-MND specialists to prescribe drugs for MND patients. The Bill does not give licence to doctors to transfer from their particular specialism to treat patients outside their practice area.
The Bill will not protect a negligent doctor. The Bill does not change common law in regard to medical negligence.
The Bill will increase patent safeguards by insisting that a doctor cannot innovate without the express and transparent agreement of a relevant body of medical opinion – prior to any new treatment or intervention taking place. This agreement and any discussion surrounding the decision must be fully minuted and appended to the patient consent form.
The patient must also consent to any innovation.
The Bill only applies to qualified and registered doctors.
Thanks for posting your comment. While our response stands as a statement of our position, and the forthcoming revised draft of the Bill may render some or all of these issues moot, we feel we should quickly explain why we still have some concerns.
Regarding negligence law, courts will consider statute first and common law second; the Bill may not replace the existing common law, but it will render much of it redundant. A doctor who follows the procedure outlined in the Bill and goes on to cause harm to a patient could potentially be found negligent under the law as it stands today, but would not be found negligent if the Bill were enacted.
Regarding a “relevant body of medical opinion”, the Bill allows a doctor to pick and choose what medical opinion is relevant for these purposes. The Bill states that the doctor is only obliged to consult, “colleagues whose opinions appear to the doctor to be appropriate to take into account.”
It would still be possible, even taking the other points you raise into account, for a person with MND to be badly advised and prescribed an inappropriate and harmful treatment under the terms of the Bill. Even if those precise circumstance may not arise often, as we acknowledge in our response, we cannot support legislation that would make them legally possible.
We must also draw attention to the wider point made in our response, that fear of litigation is not an impediment to research and innovation, and this reason alone is sufficient for us to advise the Government that it does not need to proceed with this Bill.
However, we await the amended draft of the Bill with interest and will consider it carefully on its merits when published.
John Kell – Policy Manager, MND Association