The government have published their Medicines and Devices Bill, which covers the licensing and regulation of new medical treatments.
Dr Malcolm Finlay, Consultant Cardiologist, Barts Heart Centre, Queen Mary University of London (QMUL), said:
“This is a government action in two halves.
“Firstly, this bill aims to boost the access to cutting edge medicines available to patients. These can often be seen as experimental right now, but many of the innovative approaches that we’re now thinking about to treat severe and previously intractable disease don’t fit into current frameworks of regulation. Indeed, the government’s approach must be welcomed, giving opportunity to patients as well as a boost to the incredibly important biotech sector of the economy.
“There is a mixed message for medical devices though, with the government indicating that they will seek to increase the regulatory burden required. The big fear in the sector is that the new Medicines Device Regulation 2020 (which is coming into force right now) prevents much needed leads in innovation and technology access to patients in the UK. It’s not clear if a further severe hurdle would be introduced by this bill that would further throttle UK lead innovation for patients. We have a small but burgeoning startup medical devices industry here in the UK, and the government rightly see this as an area where the UK could lead the world. But the barriers preventing successful university spin-outs remain significant and unfortunately this prevents good ideas becoming world-beaters, and when things are adopted, it’s usually overseas first. The government needs to ensure that the right balance between protecting patient safety, bringing the best innovations to the NHS and supporting and nurturing this critical industry which has real global export potential is made. The bill should be carefully scrutinised and amended to ensure no unintended consequences that ultimately would be a retrograde step.
“By reducing the regulatory burden on small, innovative companies, high-value innovations arising from the great UK university and NHS network will be more likely to be directed to problems affecting the NHS population. This, plus cash investment from the central pot, will leverage private investment to boost the UK medtech and biotech industries and ensure that their outputs can be targeted to patients at home as well as across the world.
“The bill also contains significant ideas around how healthcare may be delivered to patients. Already many hospitals are moving to offering virtual clinics, and nurse prescribing, these are solid given policy weight and the backing of central government will move these from local innovations to centre stage in delivering efficient and effective health care to our NHS users!”
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Dr Malcolm Finlay: “Founder of Epicardiotd. Chief Medical Officer & Founder of Echopoint Medical Ltd. Founder & NED of Rhythm AI Ltd. Research support from Abbott UK Ltd. Lecture fees from Medtronic.”