New EU Rules for Health Technology Assessments: A Game-Changer in Healthcare

On January 12, 2025, the European Union implemented new regulations for health technology assessments (HTA), marking a significant advancement in healthcare access and decision-making. This regulation, known as Regulation (EU) 2021/2282, aims to streamline the process of evaluating new medicines and medical devices, potentially accelerating patient access to innovative treatments.

Key Features of the New Regulation:

1. Joint Clinical Assessments (JCA): The HTA Coordination Group will conduct assessments to determine the relative clinical effectiveness and safety of new health technologies compared to existing ones.

2. Parallel Joint Scientific Consultations (JSC): Collaboration between regulators and HTA bodies to provide scientific advice to technology developers, ensuring that evidence generation meets the needs of both parties.

3. Information Exchange: Improved sharing of data on upcoming applications and future health technologies for better planning and horizon scanning.

Implementation Timeline:

- January 2025: Initial application to new active substances for cancer treatment and advanced therapy medicinal products (ATMPs).

- January 2028: Expansion to include orphan medicinal products.

- 2030: Coverage of all centrally authorized medicinal products.

- 2026: Assessment of selected high-risk medical devices.

Role of the European Medicines Agency (EMA):

The EMA will play a crucial supporting role in implementing this regulation:

1. Providing relevant information from regulatory assessments to support JCAs.

2. Collaborating on parallel joint scientific consultations.

3. Exchanging information on upcoming applications and future health technologies.

Expected Impact:

For 2025, the HTA Coordination Group anticipates conducting:

- 17 JCAs for cancer medicines

- 8 JCAs for ATMPs

This new regulation builds upon existing cooperation between EMA and HTA bodies, aiming to enhance decision-making processes for regulators and HTA bodies while maintaining independent assessments within their respective remits.

ema.europa.eu/en/news/new-eu-rules-health-technology-assessments-become-effective

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