EU HTA Regulation: German Pharma Access
The implementation of the EU Health Technology Assessment (HTA) Regulation in January 2025 introduces significant shifts in how pharmaceutical products gain market access in Germany. While the regulation aims to harmonise clinical assessments across Europe, it also presents complex challenges for German pharmaceutical companies, especially in multi-market access planning and regulatory compliance.
New Requirements Under EU-HTA Regulation
The HTAR mandates Joint Clinical Assessments (JCAs), initially targeting oncology drugs and advanced therapy medicinal products (ATMPs) with new active substances. These JCAs will later expand to include additional therapeutic areas. Companies must now prepare a comprehensive EU dossier, which includes:
- Detailed clinical trial data
- Health economic models
- Safety and efficacy evidence
However, despite this centralised process, national HTA processes—such as Germany’s Medicines Market Reorganisation Act (AMNOG) —remain active, requiring companies to prepare additional national dossiers. These parallel demands increase complexity and resource investment.
Timing and Process Challenges
A major issue is the timing misalignment between the EU-JCA and Germany’s AMNOG pricing and reimbursement process. The EU JCA report is published only weeks after a drug’s approval, which may delay German market entry. Companies must therefore coordinate internal processes to meet both EU and German regulatory timelines.
Ongoing Procedural Uncertainty
Even with published EU-HTA guidelines, several procedural questions persist. One key issue is the variability in the required PICOs (Population, Intervention, Comparators, Outcomes), which complicates clinical trial design. Additionally, the extent to which Germany and other member states will accept the EU-JCA findings remains unclear.
These uncertainties place significant strain on internal teams, especially within smaller pharmaceutical firms, which may lack the resources to prepare dual dossiers and adapt quickly to new compliance standards. The vfa (Association of Research-Based Pharmaceutical Companies) has called for extended preparation periods and greater industry involvement in defining assessment criteria.
Implications for Market Access in Germany
Although the AMNOG process has been updated to reflect the EU-HTA framework, national price negotiations remain grounded in domestic assessments. While the EU-JCA results must be “duly considered,” there is no clear rule on how heavily these results will influence final pricing and reimbursement decisions in Germany.
Special categories like orphan drugs and ATMPs face further complications. By 2028, orphan drugs will be subject to the HTAR, possibly clashing with Germany’s current regulations that presume added benefit for rare disease therapies. For ATMPs, where established evaluation methods are limited, delays and inconsistent assessments are likely.
Strategic Recommendations for Pharma Companies
To adapt to the new landscape, pharmaceutical companies should:
- Engage early with both EU and German authorities for alignment
- Develop adaptive health economic models applicable across jurisdictions
- Invest in training staff on the HTA framework, especially for niche therapeutic areas like rare diseases
- Advocate for clear, unified guidelines and reduce redundant documentation
Beyond 2025
While the EU-HTA Regulation promises long-term efficiency, it introduces short-term complexity, particularly for German market access. The dual-layered assessment—centralized EU review and national decision-making—creates uncertainty that may impact launch strategies, pricing, and time-to-market.
For German pharmaceutical companies, success will hinge on agility, cross-functional coordination, and strategic planning to navigate this evolving regulatory environment. The full impact of the HTAR will unfold over the coming years, with 2025 marking a pivotal point in how Europe—and especially Germany—evaluates innovative medicines.
By Nicole Quirin, Associate Director, Germany
