JCA governance framework

Project background

The European HTA Regulation is changing how health technology developers prepare for market access across Europe. With the Joint Clinical Assessment (JCA) dossier running in parallel with the EMA regulatory process, and with JCA outputs expected to inform subsequent national HTA submissions, cross-collaboration is now more important than ever.

Instead, JCA readiness requires coordinated input across clinical development, regulatory affairs, medical affairs, health economics, market access and country teams. For many organisations, this represents a significant shift in how departments communicate, make decisions and collaborate under time pressure.

In this context, a global pharmaceutical company turned to Asc Academics for guidance on how to adapt its internal governance structure for JCA preparation. The objective was to create a practical framework that would fit the organisation’s existing ways of working, while enabling clearer responsibilities, stronger cross-functional alignment and more efficient preparation for future JCA dossier development.

Challenges faced

There were two main challenges in developing the JCA governance framework. First, the formal JCA process had to be translated into a practical internal model that reflected the client’s organisational structure, decision-making culture and expectations. Although the EU HTA framework defines procedural steps and timelines for the JCA, these do not provide a one-size-fits-all blueprint for internal governance. This was particularly important because the company did not yet have a product in scope for JCA, meaning the proposed framework could not yet be stress-tested against a live submission.

Second, departments had little awareness on the JCA and were therefore not fully aligned around the level of cross-functional collaboration required for JCA readiness. Communication lines, roles and decision-making pathways had to be clarified to enable coordinated preparation across functions, regions and levels of seniority.

Our solution

We designed and supported the implementation of a tailored JCA governance framework through a two-step approach.

First, we mapped the governance structure of other departments within the organization, communication flows and cross-functional ways of working. This helped obtain different perspectives on the organizational structure as well as identify which departments needed to be involved in JCA preparation, how they could contribute to the dossier process and where clearer coordination was required.

Second, we developed a regional governance framework that translated the formal JCA process into a practical internal operating model. The framework was aligned with JCA dossier requirements and included role-specific responsibilities, cross-functional touchpoints, timelines, and guidance tailored to the client’s organisational structure.

Our impact

The project gave the client a clear governance structure for future JCA dossier preparation, including defined communication lines, roles, responsibilities, timelines and decision points. By translating the formal JCA process into a practical internal operating model, the framework supported the client prepare more efficiently and build organisational readiness for future JCA submissions by supporting stronger cross-functional alignment.