The European Union’s long-awaited Health Technology Assessment (HTA) Regulation comes into effect on 12 January, ushering in a new era of healthcare innovation across the EU.
On Sunday, the EU takes a pivotal step forward with the implementation of the Regulation on Health Technology Assessment (HTA).
This groundbreaking framework aims to enhance the availability of innovative and effective health technologies, ensuring patients across the EU benefit from timely access to life-changing treatments.
Discussing the HTA, Olivér Várhelyi, Commissioner for Health and Animal Welfare, noted: “I welcome the start of application of the new EU rules on Health Technology Assessment.
“European patients need quicker access to innovative and lifesaving medicines and medical devices, and we are one step closer to making this a reality.
“We must now ensure that these rules are fully put into practice across the EU – to make better use of available resources, to ensure faster entry into the market for pharmaceuticals with lower costs, less red tape and faster administrative procedures to get them included into the reimbursement schemes.
“This is central for a strong European Health Union that delivers for citizens and strengthens the EU’s competitiveness.
Health Technology Assessment explained
Health Technology Assessment is an evidence-based, scientific process that evaluates the medical, social, economic, and ethical dimensions of health technologies. Its purpose is to guide policymakers in crafting informed and safe healthcare strategies.
The new regulation builds on a vision proposed by the European Commission in January 2018 and represents a significant achievement of the EU Pharmaceutical Strategy.
Following its adoption in December 2021, the regulation entered into force in January 2022 but allowed for a three-year transitional period to establish the necessary governance structures and prepare for seamless implementation.
Key features of the regulation
The HTA establishes a unified framework for assessing health technologies, including medicines and medical devices, by promoting collaboration among EU Member States.
This approach will streamline processes for developers, ensure higher scientific quality, and reduce redundancy in national assessments.
The regulation includes several transformative elements:
- Unified submission file: Developers will submit a single EU-level dossier for joint clinical assessments, minimising duplication and pooling resources for greater efficiency.
- Accelerated timelines: Joint Clinical Assessments will now be completed within 30 days of a product’s authorisation, speeding up market entry for critical treatments.
- Stakeholder engagement: Systematic consultations with patients, clinicians, and other stakeholders will ensure assessments reflect diverse perspectives.
Phased implementation timeline
The rollout of the new rules begins with marketing authorisation applications for new cancer treatments and advanced therapy medicinal products (ATMPs).
From 2026, high-risk medical devices will be incorporated into the framework. Orphan medicines are set to follow in 2028, with the regulation covering all new medicinal products by 2030.
This phased approach reflects the EU’s commitment to ensuring a smooth transition while addressing the varying complexities of health technologies.
Impact on patients and healthcare systems
The benefits of the HTA Regulation are far-reaching. Patients will gain faster access to cutting-edge treatments, particularly in areas like oncology and rare diseases.
National healthcare authorities will have a robust foundation for making informed decisions on pricing and reimbursement, improving healthcare equity across Member States.
The streamlined processes are also a boon for health technology developers. By reducing administrative burdens and fostering early collaboration, the framework encourages innovation and accelerates the path from research to patient care.
The regulation marks a departure from the EU’s previous project-based approach to health technology assessment. While the new framework fosters collaboration, it respects the autonomy of Member States in managing their healthcare systems according to national priorities.
Teresa Ribera, Executive Vice-President for Clean, Just and Competitive Transition, added: “Supporting Member States and providing better access to evidence-based healthcare and innovative technologies is key for patients.
“With these new rules, we are strengthening EU-wide cooperation in health and reinforcing the competitiveness of the EU’s health ecosystem.
“This will save Member States and health technology developers precious time, effort and resources and will help patients across the EU to have timely access to the most effective and efficient therapies and medicines.
A future-focused vision for healthcare
The HTA Regulation signals a new chapter in EU health policy, one that emphasises efficiency, inclusivity, and innovation.
Standardising assessments and promoting cooperation sets the stage for a more equitable and effective healthcare system that prioritises patient needs.
As the first applications of the regulation take effect this week, the EU reaffirms its commitment to ensuring that groundbreaking medical advancements reach the people who need them most – swiftly and efficiently.
