On January 12, the Health Technology Assessment (HTA) rules take effect, improving access to innovative technologies for EU patients.
The rules establish an EU framework encouraging state collaboration for informed decisions on pricing and reimbursement of health products, easing patient access to new and effective technologies.
These rules apply to companies seeking product approvals, introducing a new permanent EU HTA framework, including:
- a single EU file for joint clinical assessments to efficiently share resources and enhance scientific quality.
- faster procedures requiring joint assessments within 30 days post-approval.
- systematic consultation of patients and clinicians during assessment preparations.
As of January 12, rules apply to new cancer and advanced therapy medicinal products, expanding to orphan drugs in 2028 and all new products by 2030. High-risk medical devices are included starting 2026.
This replaces longstanding EU cooperation while respecting national health service management.
Background
HTA is a process to develop safe health policies by summarizing medical, social, economic, and ethical aspects of technology use.
The Commission proposed its HTA regulation in 2018, adopted in December 2021, with full application from January 2025 after a transition period establishing necessary structures.
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