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EU HTA Regulation: Draft Conflicts Of Interest Rules Fail To Consider Orphan Drugs

 
• By Francesca Bruce

Coupled with a recent top court ruling, the draft implementing act on CoIs under the Health Technology Assessment Regulation show a general trend towards stricter conflicts of interest rules.

COLD
Certain experts could be left out in the cold thanks to impending conflict of interest rules relating to joint clinical assessments • Source: Shutterstock

Proposed rules on managing conflicts of interest (CoIs) among stakeholders involved in forthcoming EU-level joint clinical assessments (JCAs) under the Health Technology Assessment (HTA) Regulation risk excluding rare disease and ultra rare disease experts from the JCA process, warned speakers at an industry webinar.

Furthermore, the draft rules, alongside a recent ruling from the European Court of justice indicate an increasingly rigid approach to...

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