EU Joint Clinical Assessment for Drugs and Medical Devices on the Horizon

The EU has begun its transition to pan-European joint clinical assessment. The move will replace the current system of national HTA bodies, addressing redundancy and inconsistent standards. However, the harmonization efforts will not eliminate each country’s authority in health services organization, reimbursement resource allocation, and drug pricing.

According to Werner Kulp, PhD, and colleagues, “While such harmonization might lead to a reduction of redundant HTA activities at the manufacturer level as well as benefit countries which are not equipped with in-depth HTA expertise and/or infrastructure, this is a new and evolving process that is likely to impact the way manufacturers approach the market access hurdles in Europe. Therefore, manufacturers should remain close to the updates to ensure informed strategic planning for their pipeline assets.”

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(Source: Xcenda, February 17^th, 2022)