Written by Johann Sanseau, Associate Consultant
In 2024, the Haute Autorité de Santé (HAS) celebrated 20 years of innovation and rigor, with their 2024 activity report demonstrating the continuous evolvement of HAS as a cornerstone of France’s health ecosystem. The 2024 report sheds light on critical reforms, new methodologies, and regulatory transitions that directly impact the pharmaceutical and biotech sectors. Here’s what matters most for industry stakeholders.
Accelerating Access to Innovation
HAS made significant progress in facilitating early access to innovative health technologies through optimized evaluation pathways and alignment with EU regulations.
- Early Access: Over 120,000 patients benefited since 2021, though stricter standards in 2024 led to a reduced approval rate, emphasizing the need to identify clear patient unmet need and robust proof of innovation in order to gain approval
- RIHN (référentiel des actes innovants hors nomenclature) 2.0: A revamped evaluation process for cutting-edge diagnostic techniques, including molecular biology and sequencing, now under HAS leadership
Evolving Economic Evaluation and Reimbursement Standards
HAS is committed to enhancing the economic evaluation of health technologies to improve spending efficiency and outcome-driven decisions.
- New dedicated department for economic assessments from 2025
- Emphasis on real-world evidence, patient-reported outcomes (PROs), and cost-effectiveness
Digital Tools and AI: Standards in Progress
HAS launched a digital platform for device reimbursement requests and updated its mobile health application guidelines, raising the bar for medical content and user information.
- Focus on telemonitoring devices and therapeutic digital medical devices (DMNs).
- AI is now used to enhance literature review processes and patient feedback analysis.
Strategic Project 2025-20230
A new strategic plan has been developed to anticipate future changes and reaffirm the HAS’s values of scientific rigor, independence and transparency. The key priorities for this plan are:
- Promoting an integrated approach to the patient journey
- Defending quality within a strained health system
- Preparing for the future
Final Thoughts
HAS is a central player in Europe’s health innovation landscape. For pharma and biotech leaders, proactively engaging with HAS and aligning with its evolving strategic and methodological priorities will be key to navigating the 2025-2030 healthcare ecosystem.
Source: https://www.has-sante.fr/rapport-d-activite/2024/data/HAS-Rapport-d-Activite-2024.pdf
