Rising healthcare costs, the rapid development of medical technologies, and the need for more efficient resource use have led to the adoption of Health Technology Assessment (HTA) as a key tool for informed decision-making in healthcare. However, varying approaches among EU Member States, combined with the growing number of innovations and financial pressures, have highlighted the need for a standardized and coordinated assessment model.

In response to this challenge, the EU Regulation on Health Technology Assessment (EU HTAR), adopted in 2021, established a common framework for the evaluation of new technologies across the EU. This Regulation represents a major step forward in ensuring more transparent, timely, and evidence-based decisions that directly impact access to innovation and patient safety.

The new European HTA framework includes joint clinical assessments, scientific consultations, the systematic identification of new technologies, and voluntary cooperation among Member States. This approach is expected to support faster and more efficient integration of innovative solutions into healthcare systems, ultimately improving treatment outcomes and contributing to the sustainability of healthcare services.

This position paper presents concrete recommendations for the effective implementation of the HTA framework within the Croatian healthcare system, aiming to strengthen institutional capacity, accelerate decision-making processes, and improve access to high-quality care. It emphasizes the need for more transparent and predictable procedures, constructive dialogue with marketing authorization holders and manufacturers of medicinal producst, and recognition of the true value of innovative therapies and medical products.

AmCham's position paper is available here.