Cancer Drugs: Licensing and Approval

Baroness Thornton Excerpts

Monday 8th November 2021 Lords Chamber

[Lord Kamall (Con)]

I thank the noble Baroness. It is important that NICE, MHRA and others hear some of the concerns, and the fact that we are being held to account today shows how important this is. Unfortunately, some existing legislation restricts MHRA’s ability to share information with partners, including NICE, which would help them to plan their processes more efficiently. NICE, MHRA, NHS England and NHS Improvement are talking about the concerns raised by noble Lords and generally about delays in the process. They are talking about how they can improve access, including through initiatives such as the Innovative Licensing and Access Pathway launched in January 2021, and sharing as much information as they can upfront. Both MHRA and NICE are aware of the concerns and made that clear when I met them recently after their board-to-board meeting.

[Baroness Thornton (Lab)]

My Lords, I will follow up on questions that noble Lords have already asked. The ongoing NICE methods and processes review missed the opportunity to propose a new process to mirror accelerated regulatory processes. There are concerns that capacity constraints will limit NICE’s ability to publish decisions as close to marketing authorisation as possible, including for oncology drugs, through the new Project Orbis route, as has been the case with the secondary breast cancer drug, Trodelvy. Have the Government assessed whether the system is fit for purpose in achieving the objective which the noble Lord has articulated: to deliver quick patient access to new, clinically effective treatments? What concrete steps have been taken so far to address any concerns?

[Lord Kamall (Con)]

Both NICE and MHRA are aware of the concerns, particularly regarding the delay between approval and licensing. That is why they are having conversations with NHS England and NHS Improvement to make sure, as far as possible, that they can discuss co-operation to ensure the speedy approval of drugs.