14 décembre 2022

A Belgian Cross-Stakeholder Perspective

ATMPs represent an emerging and rapidly evolving market. Due to the small patient numbers and the complexities related to the delivery of ATMP treatments, centers capable of delivering such therapies may only be available in some countries. This implies that patients may have to cross borders to get treatment in a treatment center abroad. In Belgium, the national law was recently adapted, making it possible for ATMPs to be reimbursed, while the treatment cannot be provided in a Belgian treatment center.

It should be assessed what challenges Belgian patients encounter in accessing treatment abroad and what can be done to overcome these barriers. To initiate this discussion, a multi-stakeholder roundtable was organized in September 2022.

Project summary

  • Customers: PTC Therapeutics, Orchard Therapeutics, Ultragenyx.
  • Main goal: To define what cross-border issues currently exist for ATMPs, and explore what practical solutions can effectively address these issues within existing regulatory frameworks.
  • Main result: A roundtable discussion with a representation of all relevant stakeholders.
  • Date: January - December 2022.

About the customers

PTC Therapeutics, Orchard Therapeutics & Ultragenyx are companies specializing in developing treatments for rare diseases. As they expect to encounter specific challenges to enable access to treatment, they have asked Hict to set up a multi-stakeholder discussion to establish issues and identify potential solutions to cross-border healthcare in the context of highly specialized treatments for ultra-rare diseases.

2. Approach

2.1. Intake and scoping

During the intake phase, we defined the general project approach and the critical question to answer. Starting from a landscape analysis of the topic, the scope was determined in an iterative co-creation process with the three companies involved.

2.2. Preread

A detailed preread document was developed, detailing current (European and Belgian) legislation, its possible shortcomings in the context of ATMPs, and suggestions for possible solutions.

A broad range of stakeholders and experts were identified and invited to participate in the roundtable discussion. Invitees who responded positively received the preread accompanied by a short questionnaire: this captured participants’ initial insights and feedback on this topic. The participant’s answers to the questionnaire were used as guidance for individual preparatory discussions.


Figure 1. In the preread, the treatment pathways and financial streams were visualized for each existing legislative route. This is an example of the so-called S2 route.

2.3. Roundtable discussion

Based on the preread and the individual preparatory discussions, Hict prepared a slide deck for the roundtable discussions, consisting of a short recap of the meeting objective, scope, and preread, and two working sessions to discuss (1) issues and (2) solutions.

The roundtable discussion was held in Brussels, Belgium. The meeting, held under Chatham House Rules, was chaired by prof. Callens, an expert in health law, and co-moderated by Hict. Hict also took care of the practical organization of this face-to-face roundtable discussion.

Hict developed a report reflecting the discussion and summarizing key messages and principal conclusions. In addition, we made a one-pager summarizing the setup and main findings.


  • Kick-off meeting and ad-hoc interactions with the customers.
  • Preread detailing current (European and Belgian) legislation, its possible shortcomings in the context of ATMPs, and suggestions for possible solutions.
  • Preparatory 1-to-1 interviews with participants of the roundtable.
  • Organization and moderation of the roundtable.
  • Report on the roundtable discussion.
  • Summary of the report highlighting the key conclusions of the roundtable.

Cross-border healthcare for ATMPs

Read our report

Appendix - Background material

Read the overview of existing legislation

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