EU HTA Regulation FAQ: Key Clarifications for Developers on Transparency, Confidentiality & Timelines

The European Commission has published a Frequently Asked Questions (FAQ) document concerning the Regulation (EU) 2021/2282 on HTA (EU HTAR), which provides clarifications in response to stakeholder questions regarding the interpretation and application of the Regulation.

Key takeaways:

What will (and will not) be published

• JCA reports, summaries, full dossiers, and stakeholder inputs (i.e., experts, patients, developer responses), (if discontinued) justification for discontinuation and missing requested data, will be publicly available

• JSC outcome documents will not be published, alongside individual patient and investigator data

• However, the JCA assessors and co-assessors will have access to JSC outcomes

• If a product underwent JSC, the developer must incorporate the JSC advice in its JCA submission (e.g., listing the JSC’s recommendations and noting any deviations)

Confidentiality

• Developers can request redaction of commercially confidential information (CCI)

• Definition of confidential information is not explicitly defined; assessed case-by-case

• Generally includes information that “seriously undermines the commercial interests of the manufacturer”

• Developers must clearly justify confidentiality and identify specific data to redact

• Commission assesses requests, considering Member State input

• Final decision rests with the Commission

• Developers are informed of accepted/rejected redactions and their right to appeal

Timelines for engagement

• Prior to the completion of the draft JCA report, redaction requests must be submitted within 30 days of the EMA opinion

• Draft JCA reports are shared twice: for factual corrections and CCI claims; developers have 7 days to respond at each stage

Potential implications for developers

• Assess JSC participation, considering that publication risk is no longer a constraint, although JSC recommendations and company deviations will still be reviewed by the JCA and subject to scrutiny

• Plan early for a redaction strategy to accommodate tight timelines

• Ensure robust justification for any confidentiality claims, given the narrow scope of eligible information

References

1. European Commission (2026) Regulation (EU) 2021/2282 on health technology assessment (the HTA Regulation): Frequently Asked Questions (FAQ) about the Publication of the Joint Clinical Assessment Report

Article by Marietta Paraskevaides