This morning I attended the Empower Access to Medicines campaign meeting to discuss speeding up access to medicines for patients most in need.
I was particularly pleased to hear that government thinking was “at an advanced stage” with “active discussion across Whitehall” about the introduction of a new “promising innovation medicine” designation as part of their proposed scheme.
Earl Howe explained that the UK government recognises the success of “breakthrough therapy” designation in the United States over the past 18 months and hopes that the new UK designation would provide a similar boost for innovative therapies developed in the UK. We’ve seen the importance of “breakthrough therapy” designation at the FDA on investor sentiment and the speed of drug approval in the USA, so it would great for companies in our sector to see this real policy innovation from the UK government.
I think that such a “promising innovation medicine” designation would enable companies to signal in a straightforward way to potential patients and investors that they were adopting the speediest and most efficient regulatory process and had mapped-out and would utilise the most appropriate route to work with NHS centres of excellence and Academic Health Science Networks to ensure timely adoption and usage of a new therapy.
In addition to its potential to significantly accelerate designated treatments to those patients who need them, the designation is likely to have a positive effect on the companies developing the products and on the investment community’s perception of those companies.
I believe the “promising innovation medicine” designation could prove more valuable than the FDA’s “breakthrough therapy” designation because it is likely to be linked with a process that delivers reimbursement via an Early Access to Medicines scheme. Medicines receiving the “promising innovation medicine” designation will be on the fast track for the most efficient regulatory engagement with the MHRA using all the existing flexibilities available and then given VIP access into the NHS system through the appropriate centres of excellence.
The combination of the “promising innovation medicine” designation and an Early Access to Medicines scheme should enable NHS patients in the UK to be amongst the first in the world to benefit from new therapies and ensure the UK is a world leading location to start, build and develop the biotech companies that deliver such breakthroughs.
I have reason to be optimistic.