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New EU Health Technology Assessment Rules Promise Faster Patient Access to Innovation

A new European Union framework for Health Technology Assessment (HTA) took effect on Sunday, promising to accelerate access to innovative medicines and medical devices for patients across the EU. The regulation, part of the EU Pharmaceutical Strategy, is seen as a significant milestone in fostering collaboration among member states and ensuring faster, more efficient healthcare delivery.

Streamlined Assessments for Faster Access
The new rules introduce a unified EU-level approach for assessing health technologies, including medicines and high-risk medical devices. By requiring a single submission file for joint clinical assessments, the regulation aims to eliminate duplication, strengthen the scientific quality of evaluations, and streamline the approval process.

Key features of the regulation include:

  • Single EU-level Submission: A unified approach to reduce redundancy and optimize resources.
  • Faster Timelines: Joint Clinical Assessments to be completed within 30 days after product authorization.
  • Stakeholder Involvement: Direct consultations with patients, clinicians, and other stakeholders during the evaluation process.

The framework initially applies to cancer medicines and advanced therapy medicinal products (ATMPs). By 2026, selected high-risk medical devices will also be included, with orphan medicines to follow in 2028. By 2030, the regulation will cover all new medicinal products.

Benefits for Patients and Industry
The regulation replaces the EU’s previous project-based HTA cooperation, marking a permanent shift to coordinated assessments.

"Supporting member states and providing better access to evidence-based healthcare and innovative technologies is key for patients," said Teresa Ribera, Executive Vice-President for Clean, Just, and Competitive Transition, in a statement. "With these new rules, we are strengthening EU-wide cooperation in health and reinforcing the competitiveness of the EU’s health ecosystem."

The framework's stated benefits are meant to extend to the pharmaceutical industry, because it reduces administrative burdens and accelerating market entry for new products. Health technology developers can expect faster approvals and a more consistent process across ,ember states, according to the commission.

A Milestone for the European Health Union
Olivér Várhelyi, Commissioner for Health and Animal Welfare, emphasized the regulation's role in building a stronger European Health Union:

"European patients need quicker access to innovative and lifesaving medicines and medical devices, and we are one step closer to making this a reality," he said in a statement. "These rules will ensure faster market entry, lower costs, and less red tape for pharmaceuticals, benefiting citizens and bolstering the EU’s competitiveness."

Background and Next Steps
The European Commission adopted the HTA Regulation in 2018, with member states preparing for its implementation over the past three years. The regulation builds on the scientific process of HTA, which evaluates the medical, social, economic, and ethical aspects of health technologies to inform evidence-based policies.

As the framework takes shape, the EU anticipates smoother processes for pricing and reimbursement decisions, enabling faster patient access to cutting-edge therapies. member states and stakeholders will now focus on ensuring the regulation is fully implemented and operational across the bloc, the commission says.

About the Author

John K. Waters is the editor in chief of a number of Converge360.com sites, with a focus on high-end development, AI and future tech. He's been writing about cutting-edge technologies and culture of Silicon Valley for more than two decades, and he's written more than a dozen books. He also co-scripted the documentary film Silicon Valley: A 100 Year Renaissance, which aired on PBS.  He can be reached at [email protected].

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