HEALTH TECHNOLOGY ASSESSMENT | EU Implements New Rules to Offer Quicker Access to Advanced Medicines

The new rules establish an EU-wide framework for assessing health technologies by promoting collaboration and coordination among EU Member States. The goal is to help national authorities make more timely and informed decisions regarding the pricing and reimbursement of health technologies. This is expected to lead to faster and broader access to new and more effective innovative products for patients.

Starting January 12, these rules apply to marketing authorization applications. The scope will expand to include orphan medicines in January 2028, and by 2030, it will cover all new medicinal products.

Discussing the HTA, Olivér Várhelyi, Commissioner for Health and Animal Welfare, noted: “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’’.

The Thalassaemia International Federation (TIF) is a full member of the HTA Stakeholder Network appointed by the European Commission to support the Member State Coordination Group. The first meeting of the Network took place on 14 June 2023 in Brussels with TIF’s participation.

Key Features of the Regulation

The HTA establishes a cohesive framework for evaluating health technologies, such as advanced medicines and medical devices, by fostering collaboration among EU Member States. This approach aims to streamline processes for developers, improve scientific quality, and reduce redundancy in national assessments.

The regulation introduces several key changes:

• Unified Submission File: Developers will now submit a single EU-level dossier for joint clinical assessments. This change minimizes duplication and pools resources for greater efficiency.
• Accelerated Timelines: Joint Clinical Assessments will be completed within 30 days of a product’s authorization, expediting market entry for crucial treatments.
• Stakeholder Engagement: Regular consultations with patients, clinicians, and other stakeholders will ensure that assessments incorporate diverse perspectives.

Impact on Patients and Healthcare Systems

The HTA Regulation offers significant benefits. Patients will enjoy quicker access to advanced treatments, especially in fields like rare diseases and oncology.

National healthcare authorities will be better equipped to make informed decisions about pricing and reimbursement, promoting healthcare equity across Member States.

The streamlined processes also benefit health technology developers by cutting down on administrative hurdles and encouraging early collaboration. This framework not only fosters innovation but also speeds up the transition from research to patient care. As such, the framework encourages innovation and accelerates the path from research to patient care.