My response from Grant Shapps office re MHRA application28 Jun 2023 13:48
For anyone interested yawning
hope you’re well – thanks very much indeed for taking the time to contact Grant, I’m responding on his behalf. I’d first just like to extend my sincerest apologies for such a delay in getting back to you – this is down to an administrative error in transferring your enquiry over to our caseworking system and assigning it to the correct inbox.
Grant’s really grateful to you for getting in touch about the delays being experienced in the UK’s drug approvals process. To ensure treatments provided to patients are safe and effective, it’s an extremely rigorous one – and each new drug or treatment has to of course go through the steps you’ve mentioned that Sareum feel are currently easier to go through in Australia. The appraisal from the National Institute for Health and Care Excellence (NICE) and its other processes have been designed to offer the best possible treatments for the best possible prices, protecting patients and taxpayers over pharmaceutical companies – Grant fully supports their work, and it’s his view that an independent assessor is vital in ensuring only the best and safest treatments reach patients.
As I’m sure you know, in the UK treatments are approved on an evidence-based approach, rather than an anecdotal approach. Clinical trials must be ethically robust and impartially observed, in order to ensure that the results of the trial are independently verifiable. This is crucial to protect patient safety. Without rigorous clinical trials, medication cannot, and should not, be licensed or distributed. But, perhaps most importantly and relevant to your concerns, NICE has committed to reforming its decision-making process to give patients earlier access to innovative treatments. These changes will place greater emphasis on health and medical benefits, improve how real-world evidence is used and streamline the process for Highly Specialised Technologies. It goes without saying that Grant absolutely welcomes this decision.
I do hope all of this is ok, and my apologies once again for such a delay in getting back to you. As always, if there are ever any other issues you’d like to discuss, please don't hesitate to get in touch.
Kind regards,
Joe Smith
Parliamentary Assistant | Office of The Rt Hon Grant Shapps MP