UK Set to Make Drug Approvals ‘Faster and Nimbler’; Could MDMA Be Among the First Beneficiaries?
On Wednesday, the UK’s Chancellor Jeremy Hunt announced the Spring Budget, which sets forth the government’s economic priorities.
Among these announcements was a £10m (over two years) award to the Medicines and Healthcare products Regulatory Agency (MHRA), which is intended to “help it maximise use of its Brexit freedoms and accelerate access to treatments.”
In practice, this will be achieved via “partnerships with trusted international agencies, such as in the US, Europe and Japan, to provide simple, rapid approvals for medicines and technologies that have received their approval from 2024.” The aforementioned ‘Brexit freedoms’ include the fact that the MHRA is, effectively, no longer ‘slowed down’ by the European Medicines Agency (EMA). Taken together with these potential ‘mutual recognition’ partnerships with agencies like the FDA, these developments might make MHRA approvals process among the fastest.
While the UK government is seeking to couch these moves in the discourse of post-Brexit freedoms and innovation, the simple fact of the matter is that ‘little Britain’ is just that: a small market. Given that fact, pharmaceutical companies would likely favour larger markets, such as the US, EU and Japan, when deciding on the order of national marketing authorisation submissions; meaning the UK would be left behind in terms of access to innovative medicines if it insisted on national submissions alone. It’s also worth noting that MHRA was forced to cut around a fifth of its workforce following Brexit, which saw the agency lose millions of pounds in funding from the EU.
We covered this potential development last month (Bulletin 131) after our eagle-eyed Medical Advisor, Michael Haichin, caught wind of it. At that time, we asked: “might MAPS PBC’s MDMA-assisted therapy for PTSD be among the first products considered under this new reciprocal drug approval pathway?”
With the Chancellor’s formal announcement and funding of these attempts to make MHRA’s approval process “faster and nimbler” by 2024, it only seems more likely that MDMA-AT may be among the first drug products to be reviewed under this protocol.
But, it’s by no means a done deal: discussions with other regulators are at the ‘exploratory’ stage and MDMA-AT is not exactly a ‘normal’ drug product.