European Commission adopts Joint Clinical Assessment rules to accelerate access to medicines

The European Commission has adopted Joint Clinical Assessment (JCA) rules to streamline evaluations of new medicines, aiming for faster, equitable access to innovative therapies across EU Member States by January 2025.

On May 23, 2024, the European Commission adopted the first implementing act for JCA under the Regulation on Health Technology Assessment (HTA). This initiative aims to streamline the evaluation process for new medicinal products across EU Member States, facilitating faster and more equitable access to innovative therapies for patients throughout Europe. Through standardizing the clinical assessment process, the Commission seeks to ensure timely access to new and effective treatments for patients across the EU.

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Streamlined assessment process

The newly-adopted rules provide clear timelines and procedural steps for conducting JCAs at the EU level. These assessments, conducted soon after a medicine’s marketing authorization, will offer robust scientific evidence to national authorities, assisting them in making informed decisions about the integration of these medicines into their health systems. The goal is to harmonize the evaluation process across the EU, reducing duplication of efforts and speeding up decision-making.

Stella Kyriakides, Commissioner for Health and Food Safety, emphasized the importance of this development, stating,

“Innovation and technology are key drivers for a strong European Health Union and for bringing medicines to patients. We want these medical technologies to be reaching our patients as quickly and equally as possible.”

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Industry perspective

The Heads of HTA Agencies Group (HAG) welcomed the adoption of the first ((EU) 2024/1381), highlighting the significance of procedural rules and templates for conducting JCAs. They noted that this regulation must be supplemented by detailed methodological guidance and supporting documents from the HTA Coordination Group to ensure comprehensive implementation by January 2025.

By pooling expertise from across the EU, the JCA process aims to compare the effectiveness of new treatments against existing ones, supporting healthcare systems in delivering high-quality care with the latest technologies. A representative from Regulatory Pharma Net commented on LinkedIn,

“This act represents the EU’s commitment to enhancing the HTA process, ensuring that new treatments are assessed swiftly and thoroughly.”

From an industry perspective, the JCA framework presents both opportunities and challenges. Health technology developers now have an extended 100-day window to finalize JCA dossiers and the ability to appeal decisions on confidential information. However, they must prepare strategically, aligning internal processes and anticipating assessment scopes to navigate the JCA procedures effectively.

Regarding the changes to the draft act, a LinkedIn post from SKC Beratungsgesellschaft mbH stated, “The changes to the original draft version of the act from March 5th can largely be viewed as concessions to the industry, which had voiced its concerns and demanded changes to the draft IA during the public consultation process.” It added that it was important not to “forget the overall aim: JCA is not about pleasing the JCA Subgroup by addressing all PICOs, it is about building the optimal basis for successful price negotiations to reach and help as many patients as possible.”

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Future steps

This implementing act is the first in a series of six expected by the end of 2024, including rules for Joint Clinical Consultation, conflict of interest management, and information exchange with the European Medicines Agency (EMA). The JCA process will begin with assessments of oncology drugs and advanced therapy medicinal products starting January 2025, followed by orphan drugs in 2028, and eventually encompassing all healthcare interventions by 2030.

As the healthcare community anticipates the full implementation of the HTA framework, ongoing collaboration among Member States, health technology developers, and clinical experts will be crucial in maximizing the benefits of these reforms. The JCA framework is expected to improve outcomes and quality of life for patients by ensuring faster access to innovative therapies.