Joint scientific assessments are similar to relative effectiveness assessments conducted by EU member state health technology bodies but they are to be conducted on a European level for consideration in decision making by member state pricing and reimbursement authorities.

Advanced therapies and oncology medicines will be the first products to undergo a joint clinical assessment from 12 January 2025, followed by orphan products from 13 January 2028 and all other products from 13 January 2030.

The HTA Regulation also introduces joint scientific consultations, which allow companies to seek scientific advice from the Member State Coordination Group during early clinical development. However, the number of slots will be limited and priority will be given to certain products, as outlined in the regulation.

Lack Of Industry Involvement In EU HTA Scoping Process Exacerbates ‘Unworkable’ Timelines

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