❗Fallacy #12 ❓

It doesn’t matter who the assessors are in your JSC. The process and methodology are the same.

Really?

 

The JSC is designed as a European scientific consultation, with a common framework and methodology. So, in theory, it should not matter which Member State agencies are involved as assessors and co-assessors. But based on our experience, the assessor constellation can influence the focus and dynamics of the discussion.

 

🧩 Example:

When German assessors are involved, we have observed a strong focus on how closely the planned study population aligns with the intended label, including whether the evidence generated will be directly applicable to the target population.

When French assessors are involved, the discussion may place greater emphasis on the pre-specified analyses of the pivotal trial, including questions around multiplicity and the statistical interpretation of the evidence.

This does not mean that one Member State “owns” a particular methodological position. Rather, assessors bring their institutional experience, methodological perspectives and national HTA context to the scientific discussion.

 

🎓 For Health Technology Developers, this has an important strategic implication:

🔹 Know who is sitting at the table. Understanding the assessor constellation can help anticipate which aspects of the evidence strategy may receive particular attention. We therefore recommend asking in advance which Member State agencies will be involved as assessor and co-assessor.

🔹 Prepare for the discussion, not just the questions. A JSC is more than a written Q&A. The scientific discussion can reveal where assessors see potential weaknesses, uncertainties or methodological challenges.

🔹 Use the JSC strategically. The consultation can help identify issues that may become critical for the subsequent JCA and inform evidence-generation decisions while there is still time to act.

🔹 Capture the learnings. A structured strategic debrief after the JSC can translate the discussion into concrete implications for the future JCA strategy, evidence narrative and country-specific Market Access planning.

 

📌 Key takeaway:

💡 The JSC framework is European, but the people applying and interpreting that framework matter.

💡 The assessor constellation can influence which methodological and evidentiary aspects receive particular attention during the consultation.

💡 Therefore, understanding the likely perspectives around the table should be part of the JSC preparation and strategy, not an afterthought.

 

At Ecker + Ecker, we support our clients throughout the JSC journey, from strategy development and preparation through participation in the JSC and strategic debrief, including the translation of JSC learnings into implications for the future JCA strategy. 🤝