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EU HTA Regulation: Assessors Risk Exclusion for Secrecy Breaches

 
• By Neena Brizmohun

The second of six implementing acts for the Health Technology Assessment Regulation has now been adopted. It deals with how the European Medicines Agency is to cooperate with the European Commission and HTA experts in Europe.

Concept Of Spending Money On Medicines
Health technology assessments help determine the value of medicines and medical devices (Shutterstock)

Health technology assessment (HTA) experts involved in the EU-level joint clinical assessments and scientific consultations that are to be conducted under the HTA Regulation may be excluded from joint work for up to two years if they intentionally or negligently breach professional secrecy obligations.

Key Takeaways
  • The second of six implementing acts for the EU Health Technology Regulation has now been adopted.
  • The new act sets out the...

This is a new provision in a newly-adopted implementing act that sets out the rules on how the EU’s Member State Coordination Group on HTA...

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