09.07.2026

Fallacy 9: EU HTA can simply be managed alongside existing responsibilities

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Fallacy 9

EU HTA can simply be managed alongside existing responsibilities – no additional resources are needed.

Really?

 

💊 One of the most common assumptions we hear is that EU HTA can be absorbed into existing Market Access or HEOR activities.

The first experiences from companies already preparing for or working with JCA suggest a different reality. We see the same in our own work. Having supported three JCA procedures, we have found that EU HTA is significantly more resource-intensive than many organizations initially expect. Beyond dossier preparation, success depends on strong cross-functional collaboration, clear governance and sufficient expert capacity. This is particularly important during the post submission phase, where requests for clarification must often be addressed within very short timelines.

 

Experiences:

👥 More resources: At the "Sharing Experience" conference in Strasbourg on 19 June 2026, representatives from two companies currently undergoing the JCA process highlighted that implementing EU HTA requires substantially more resources than initially anticipated. EU HTA does not replace existing work, it adds new workstreams.

⌛ More workload: They noted that the workload extends well beyond dossier preparation and creates additional demands across multiple functions.

⚖️️ Existing responsibilities / EU HTA timelines: Maintaining existing responsibilities while meeting the new EU HTA timelines was described as a significant challenge. So, building capabilities early is an investment, not an overhead.

 

At the same time, our experience from both JCA projects and EU HTA readiness engagements has shown that there is no universal operating model. Some companies rely more heavily on external support, others build centralized capabilities, while some establish dedicated cross-functional EU HTA teams. The right model depends on the company's portfolio, pipeline, organizational maturity and long-term ambitions.

 

📌 Key takeaways:

💡 EU HTA is not a project that can simply be added to existing workloads.
💡 Sustainable success requires deliberate investment in people, processes and governance.
💡 The key question is not whether to build capabilities, but which capability model best fits your organization.