LLMs now bring science directly to consumers. Editorial and peer review standards were built for researcher-to-researcher communication. They need to reflect a world where the public is more exposed — and the stakes for errors are higher.
The FDA is moving toward real-time clinical trials. Europe’s share of global clinical investment has collapsed from 22% to 12% over a decade. The bottleneck isn’t approval — it’s access. And Europe designed this outcome.
The HAS open letter functions less like a defence and more like an involuntary confession. HTA is not pure science — it is a purchasing decision informed by scientific inputs.
With US reimbursement now pegged to OECD reference prices, the US is inside the reference pricing web for the first time. Market access decisions can no longer be made in isolation.
Regulators see acceleration. Market access sees what’s waiting at the other end. Jan Geissler at DIA Europe: “We don’t have an innovation problem. We have an access problem.”