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Insights from Pharma 2025: Ready or not? Preparing for the EU HTA wave
At the Pharma 2025 conference in Barcelona, global industry leaders, innovators, and changemakers gathered to explore the evolving landscape of pharmaceuticals and healthcare. Cencora conducted in-depth interviews with experts across the sector, uncovering valuable perspectives on the challenges and opportunities shaping the future. Key topics discussed included accelerating access to innovation, enhancing patient-centric care, and harnessing the power of data and digital transformation.
These conversations reflect the pulse of an industry in motion, committed to driving smarter, more sustainable healthcare solutions in an increasingly complex world. From regulatory evolution and market access to technological breakthroughs and cross-sector collaboration, each expert offered a unique perspective on how the pharmaceutical industry is adapting to meet future needs.
Here we share the key insights from the engaging dialogue between Herbert Altmann, Vice President of Market Access and Healthcare Consulting Europe at Cencora, and Casper Paardekooper, Partner at Vintura, part of Cencora, on the implications of the EU Health Technology Assessment (HTA) regulation.
Here we share the key insights from the engaging dialogue between Herbert Altmann, Vice President of Market Access and Healthcare Consulting Europe at Cencora, and Casper Paardekooper, Partner at Vintura, part of Cencora, on the implications of the EU Health Technology Assessment (HTA) regulation.
The current landscape and preparation challenges
As Altmann and Paardekooper delved into the topic, it became clear that the rollout of the EU HTA regulation is still a critical concern for many organizations, particularly smaller and mid-sized pharmaceutical companies. Paardekooper pointed out that, “there is still a limited understanding of how to prepare for this new regulation,” emphasizing the critical need for heightened awareness and readiness among industry stakeholders. As the deadline looms, companies must act swiftly to align their strategies with the new regulatory expectations.
Altmann echoed this sentiment, stressing the urgency of moving swiftly from readiness to strategy, and ultimately to implementation. Paardekooper also cautioned, “The risk for smaller companies is to jump into implementation mode too late,” highlighting the necessity for a structured approach to navigate the complexities of the new regulations.
Altmann echoed this sentiment, stressing the urgency of moving swiftly from readiness to strategy, and ultimately to implementation. Paardekooper also cautioned, “The risk for smaller companies is to jump into implementation mode too late,” highlighting the necessity for a structured approach to navigate the complexities of the new regulations.
Importance of cross-functional collaboration
A significant theme in the discussion was the need for enhanced cross-functional collaboration within pharmaceutical companies. Altmann emphasized that “creating awareness across the organization” is crucial for aligning medical, regulatory, commercial, and market access functions. This comprehensive collaboration is vital as the leadership team plays a pivotal role in preparing for the changes introduced by the EU HTA regulation.
He added that larger companies often struggle with silos and disjointed efforts, making it imperative to foster seamless collaboration between headquarters and local affiliates. “Optimizing evidence packages is crucial to convincing regulators and HTA bodies,” he noted, stressing the importance of a unified approach.
He added that larger companies often struggle with silos and disjointed efforts, making it imperative to foster seamless collaboration between headquarters and local affiliates. “Optimizing evidence packages is crucial to convincing regulators and HTA bodies,” he noted, stressing the importance of a unified approach.
Regional variations in readiness
The conversation also highlighted the disparities in preparedness among HTA bodies across Europe. Paardekooper expressed concern that, while many countries seem on track, significant capacity challenges could hinder effective implementation. Altmann echoed this concern, noting that some nations are publicly committed to the regulation yet lack the resources and skills needed for effective adaptation.
This inconsistency in readiness poses a challenge, especially for smaller companies that may not have the infrastructure to engage effectively with local HTA bodies. Paardekooper remarked, “Some countries are more open to dialogue, while others remain hesitant, which could impact the overall harmonization effort.”
This inconsistency in readiness poses a challenge, especially for smaller companies that may not have the infrastructure to engage effectively with local HTA bodies. Paardekooper remarked, “Some countries are more open to dialogue, while others remain hesitant, which could impact the overall harmonization effort.”
The role of Joint Scientific Consultation (JSC)
A key component of the EU HTA regulation is the Joint Scientific Consultation (JSC), designed to streamline the alignment of clinical trial designs with HTA expectations. Both speakers recognized this as a valuable opportunity for pharmaceutical companies to engage early with HTA bodies and the European Medicines Agency (EMA).
However, both experts acknowledged potential limitations, including the slow rollout of available JSC slots, which could lead to bottlenecks in the process. Paardekooper emphasized that while the JSC is a critical component, the uncertainty surrounding its non-binding nature may deter companies from fully leveraging this opportunity.
However, both experts acknowledged potential limitations, including the slow rollout of available JSC slots, which could lead to bottlenecks in the process. Paardekooper emphasized that while the JSC is a critical component, the uncertainty surrounding its non-binding nature may deter companies from fully leveraging this opportunity.
The path forward: Learning and adaptation
As the conversation drew to a close, Altmann underscored the importance of viewing the EU HTA as a learning system. He highlighted the necessity for continuous dialogue and sharing of experiences among stakeholders to optimize the new regulatory framework. The establishment of initiatives like the European Think Tank on Healthcare Innovation and Collaboration Solutions (ETTHICS) group, that Altmann is a member of, is pivotal in contributing to this learning curve, allowing stakeholders to share best practices and insights from various regions.
Both speakers concluded with a call for a unified approach, stating, “If we keep our focus on the common goal of bringing innovative medicines to patients, we can break down internal barriers and work towards a successful implementation of the EU HTA Regulation.”
The insights shared at Pharma 2025 underscore the collective commitment of industry leaders to navigating the complexities of the EU HTA regulation, ensuring that patient access to innovation therapies is both improved and equitable across Europe.
Both speakers concluded with a call for a unified approach, stating, “If we keep our focus on the common goal of bringing innovative medicines to patients, we can break down internal barriers and work towards a successful implementation of the EU HTA Regulation.”
The insights shared at Pharma 2025 underscore the collective commitment of industry leaders to navigating the complexities of the EU HTA regulation, ensuring that patient access to innovation therapies is both improved and equitable across Europe.
Watch the full conversation
To gain a deeper understanding of the evolving EU HTA regulation and its implications for the pharmaceutical industry, watch the full conversation between Herbert Altmann and Casper Paardekooper.
The contents of this piece contain marketing statements and do not include legal advice.
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