Hospital-exemption cell therapies at scale, backed by a shared registry
European law already lets hospitals make advanced therapies for their own patients. Pair that with a shared outcomes registry so academic CAR-Ts and similar treatments can prove themselves without a commercial licence.
The EU hospital exemption (and analogous national point-of-care manufacturing provisions in the UK, Spain, Japan and elsewhere) permits non-routine manufacture of advanced therapy medicinal products for individual patients under national oversight. It is used unevenly and generates little comparable evidence. The proposal is a harmonised framework: common quality standards, a mandatory prospective registry with standard outcome and toxicity capture, and a defined pathway by which registry evidence supports wider use or a conditional marketing authorisation. This lets academic products reach patients years earlier and creates a real-world evidence base for regulators.
- The valley of death between lab and product · Most academic discoveries die before anyone tests them in people because nobody funds the middle step.
- Manufacturing cost and time for living and radioactive medicines · Cell therapies take weeks to make for one patient and cost hundreds of thousands of dollars. Isotopes run short.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.