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.