MHRA lays out its thinking on AI and medicines regulation - pharmaphorum

The Medicines and Healthcare products Regulatory Agency has published a document, which pharmaphorum has generously framed as the regulator 'laying out its thinking.' Thinking is indeed what one does between now and 2030 — the horizon the MHRA has attached to its own name, MHRA Strategy 2030. In the plan, AI is anointed one of the 'defining medical technologies' of coming years, a claim that lands with roughly the force of a coastguard announcing that water is, on the whole, a bit wet. Personalised medicines get a mention too, presumably so nobody has to define either term.

The substantive pledge is 'faster and more predictable regulatory decisions.' Faster than what is not specified, though the benchmark is presumably the current arrangement, in which a novel therapy ages quietly in a filing cabinet. 'Predictable' is the more charming adjective, given that predictability is precisely what a regulated industry buys with its fees, and precisely what a regulator promising to speed up — using the very technology it is meant to police — cannot straightforwardly sell. The plan also proposes improving 'real-world evidence generation and regulation' with AI assistance, which is a charming way of saying the machines may help assemble the evidence base for the machines. The homework-grading vibe is hard to miss.

There is, admittedly, something to be said for a regulator publishing anything at all. As we noted recently, the creative industries have been drafting ethical charters in the vacuum of government policy, so a statutory body producing a document with 2030 on the cover counts as a pulse. It is not, however, a deadline. It is a hint with a logo attached. Somewhere between the pledge of speed and the promise of predictability sits the bit nobody puts in the PDF: what happens when a faster decision, assisted by the technology under review, turns out to be the wrong one.