Denis Horgan: HTA in Action – A Turning Point for European Healthcare?
Denis Horgan, Chair of ICGC ARGO Independent Advisory Committee at International Cancer Genome Consortium, shared a post on LinkedIn:
“HTA in Action: A Turning Point for European Healthcare?
Brussels, January 21st, 2025: The EU Regulation on Health Technology Assessment (HTA) came into force on 12 January 2025, marking a transformative era for European healthcare. Years of collaboration by EAPM with the European Parliament, Member States, and national HTA agencies have resulted in this framework, designed to streamline the assessment of health technologies and ensure faster, more equitable access to treatments. As Bertolt Brecht observed, ‘Because things are the way they are, things will not stay the way they are.’ This regulation promises to address inefficiencies and disparities in healthcare, but its success depends on effective implementation.
The HTA regulation establishes a single EU-level submission file for joint clinical assessments, eliminating duplication and reducing burdens on developers while accelerating patient access. Assessments must be completed within 30 days of marketing authorisation, ensuring timely delivery of treatments.
It also integrates input from patients and clinicians, aligning evaluations with real-world needs.
The regulation initially applies to cancer medicines and advanced therapy medicinal products (ATMPs), with orphan medicines included by 2028 and all new medicinal products by 2030. High-risk medical devices will follow from 2026. This replaces fragmented cooperation, providing a consistent, permanent framework for assessments across Europe.
The regulation’s success relies on addressing key challenges. Member States must collaborate to harmonize processes and ensure equitable access across diverse healthcare systems. Stakeholder engagement must empower patients and clinicians to shape decisions and build trust. Effective use of data, balanced with protection, is essential for evidence-based decision-making.
Local adaptation will also be vital.
This regulation is a significant step toward unifying European healthcare systems by aligning processes and pooling resources. Brecht’s words remind us that positive change requires shared commitment. The HTA framework offers the potential to set a new standard for collaboration in healthcare.
As implementation continues, the European Alliance for Personalised Medicine (EAPM) will support its success. EAPM will work with Member States to align processes, promote knowledge exchange, and address challenges such as data use and engagement. Collaboration with policymakers, clinicians, and patient advocates will ensure the framework delivers meaningful benefits for all, particularly patients.
The EU has taken a major step toward a more cohesive healthcare system. The success of the HTA regulation will depend on collective will, collaboration, and focus on patient outcomes.
Through unity and decisive action, this framework can drive meaningful change, ensuring that innovation reaches those who need it most and that no patient is left behind.”
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