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EU HTA Regulation: Views Wanted On Draft Rules On Joint Scientific Consultations

 
• By Francesca Bruce

A newly published draft implementing act sets out the procedural rules for the joint scientific consultations that are foreseen by the EU’s Health Technology Assessment Regulation.

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Joint Scientific Consultations will help companies prepare for forthcoming EU-level joint clinical assessments • Source: Shutterstock

Health technology developers will for the next four weeks have a chance to influence the rules governing the joint scientific consultations (JSCs) that will help them prepare for EU-level joint clinical assessments, which go live from January.

HTA Regulation And Joint Scientific Consultations

The 2022 Health Technology Assessment Regulation aims to increase cooperation on HTA across Europe and lays the foundations for EU-level joint clinical assessments. These assessments will be similar to relative effectiveness assessments performed at member state level.

Joint scientific consultations (JSCs), which are also foreseen under the HTA Regulation, allow companies to seek scientific advice from the Member State Coordination Group on HTA during early clinical development.

Industry has expressed concern that the number of JSC slots is inadequate, and that there is a lack of opportunity for companies participate in the JCA scoping process. (Also see "Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines" - Pink Sheet, 19 April, 2024.) 

On 1 October, the European Commission published for consultation its draft implementing act on procedural rules for the JSCs....

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