Brussels, 2 April 2024 – EuropaBio contributed to the public consultation on the Health Technology Assessment Joint Clinical Assessment (HTA JCA) Implementing Act. As the representative association for bioindustries, EuropaBio recognises the pivotal role of the HTA Regulation in establishing a transparent and inclusive framework for HTA practices across the continent for the uptake of health biotech innovation. highlighting the need for measures that reduce redundancy and enhance predictability for all stakeholders involved.

EuropaBio underscores the risk from duplication of work, delays, and potential wasted resources inherent to the draft rules as proposed. EuropaBio also raises concerns over the lack of involvement of developers earlier in the process, which could hinder biotech innovator abilities to deliver on the aims of the Regulation. EuropaBio is concerned that the draft rules will not deliver on the HTA objectives of accelerating patient access to innovative medicines due to a lack of predictability and workability within the draft rules. EuropaBio appeals for a continued dialogue to improve the draft rules further.

Dr. Claire Skentelbery, Director General of EuropaBio added “The HTA regulation is key to ensuring uptake of biotech innovation for delivery of breakthrough therapies to patients. It is essential to give health technology innovators the predictability and time required to successfully complete the JCA.”

EuropaBio remains committed to ensuring the HTA Regulation can meet its objectives, and firmly believes that the proposed recommendations will significantly enhance the JCA process.