My Lords, I declare that I am vice chair of the NICE review committee. Amendment 66, moved by the noble Lord, Lord Hunt of Kings Heath, aims to ensure early access for NHS patients to medicines and medical devices. This must also involve ensuring that results of safety and efficacy from devices in real-time use—as well as in trials—are registered, published and then considered again in real time, a process that I hope will be helped and promoted by the patient safety commissioner role.
Noble Lords will remember that in Committee I tabled, along with the noble Lord, Lord Hunt of Kings Heath, an amendment to ensure provision for the development of a new rapid provisional two-year licensing procedure. The intention behind that amendment was to ensure that patients could more quickly access potentially life-saving medicines and medical devices.
I sincerely thank the Minister and his team for meeting with me on this, and for the other meetings they facilitated. I am reassured that the approval processes from the MHRA over device development are due to be revised completely over the coming year, with improved and streamlined processes, and I hope that today the Minister can confirm this, even with a timeframe, so that we can move forward quickly.
We have a unique opportunity to develop devices and roll them out to the NHS, but it is important that approval processes do not slow down or block patient access to improvements in treatment and management over a wide range of conditions, particularly rare disorders. Evidence from real-time use is crucial, and development and improvement can become a virtuous circle when that is rapidly fed back—so we become the intellectual innovation hothouse for our future prosperity, while also benefiting our patients. The UK can then be seen as a favourable place to develop, approve and supply medicines and medical devices.
Speeding up and widening approval processes, including two-year provisional licensing that I have been advocating with the Royal College of Physicians, would ensure that developing a new device from beginning to end—taking an idea from conception to supply—all in the UK is seen as an attractive prospect. Otherwise, we continue to risk new devices beginning their innovation journey in the UK, then being taken abroad part-way through the development process and marketed back to the UK. Keeping the entire process in the UK, with different models of fast-track approvals and provisional approvals, will allow better oversight of the safety and efficacy of devices during early access, with ongoing monitoring in real-time use. That would then facilitate moving into appropriately costed long-term approval processes.
We can innovate in the UK and stop intellectual capacity being outsourced. We can protect the safety of patients while getting them access to the latest treatments. It is patients who will suffer if we do not get this right, which is why the proposals in this amendment are so important.
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