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Combination therapies in Belgium: how to collaborate without breaching competition law

As the landscape of modern medicine evolves, combination therapies—those that use two or more distinct medicines, often from different companies—are becoming increasingly vital, especially in treating complex diseases like cancer. These therapies promise improved clinical outcomes through synergistic mechanisms of action. However, the reimbursement process for such therapies presents significant regulatory and legal challenges, particularly in the area of information sharing between pharmaceutical companies. Recognising this issue, the Belgian Competition Authority (the “BCA”) has issued on 10 September 2025 a communication clarifying how companies can cooperate without breaching competition law.

Combination therapies typically involve a “backbone medicine” – already approved and reimbursed in other indications – and an “add-on medicine”, developed – often by a different company – either as an independent monotherapy or specifically to work in combination with the backbone treatment. In Belgium currently only the add-on company can apply for reimbursement to the National Institute for Health and Disability Insurance (“NIHDI”), while the backbone company remains outside the initial process. This division creates practical and legal uncertainties for all involved. The lack of the backbone company’s direct involvement in early regulatory discussions limits predictability for the pharmaceutical companies, while the NIHDI cannot fully evaluate the therapeutic efficacy of the combination therapy without both parties’ involvement. As a result, the NIHDI is considering adopting a specific reimbursement application procedure for combination therapies (the “Procedure”), and in that context, the BCA was asked to clarify under what conditions pharmaceutical companies can exchange information during reimbursement negotiations without violating competition law. Therefore, the BCA has published a communication with guidance on this matter (the “Communication”).

At the heart of this issue is Article 101 of the Treaty on the Functioning of the European Union (“TFEU”) and its Belgian counterpart, Article IV.1 of the Belgian Code of Economic Law (“CEL”). Both prohibit anti-competitive agreements and practices, including improper sharing of commercially-sensitive information.

In its Communication, the BCA has reminded pharmaceutical companies that even when they are encouraged by legislation or public authorities to share information, this does not preclude applying Articles 101 TFEU and IV.1 CEL. However, not all information sharing is off-limits, though it must be limited to what is objectively necessary to obtain a reimbursement for a combination therapy. Luckily for the pharmaceutical companies, the BCA’s Communication goes also beyond that general principle, by giving specific examples of information that, in principle, may or may not be shared between pharmaceutical companies involved in the marketing of a combination therapy in a procedure before the NIHDI.

According to the BCA, pharmaceutical companies may share the following types of data when seeking combination therapy reimbursement:

• The application’s purpose;
• Administrative data concerning the timelines for the Procedure;
• The identification of the comparator(s)/standard of care used to demonstrate the combination therapy’s therapeutic efficacy;
• Epidemiological data (the number of patients concerned, the disease incidence);
• Patient-level data (assumed duration of treatment, dose intensity in the clinical trial);
• Summary of therapeutic value (based on data from the clinical studies);
• An analysis of the proposal’s budgetary impact from the perspective of the NIHDI and the patient, based on the data provided (volume, incidence) and the ex-factory price (if publicly available) set by the FPS Economy for each component of the combination therapy (level 1 budget impact). This analysis includes an assessment of the expenditure related to the pharmaceutical specialty per year for the first three years.

On the other hand, the BCA has warned that sharing the following commercially-sensitive information is in principle strictly prohibited. This includes (with the BCA’s clear warning that this list is not exhaustive):

• Information relating to the cost structure specific to the pharmaceutical companies participating in the combination therapy;
• Data concerning the net price, as well as the gross and net margins of the combination therapy’s components;
• Information concerning the marketing strategies, investment strategies and future plans of the companies participating in the combination therapy (expansion plans, market entry/exit, planned acquisitions, etc.);
• Specific market data (e.g. data concerning suppliers or customers);
• Information about the distribution of therapeutic value among the different products comprising the combination;
• Analysis of the budgetary impact on the medicine budget (level 2 budget impact) and on the healthcare budget (level 3 budget impact): financial details and cost projections, information on changes in volumes/turnover of one of the components of the combination therapy that have an impact on the negotiation with the NIHDI about the net price of the combination therapy’s components.

To comply with competition law while engaging in parallel reimbursement procedures, companies should adopt robust internal protocols:

• Appoint a dedicated internal compliance team to manage and monitor communications;
• Limit access to shared data to only essential personnel and maintain records of all exchanges. The BCA has explicitly warned about the unintentional – though equally unlawful – use of the shared information in other projects or files;
• Ensure the traceability and security of information storage and, if necessary when the Procedure would be stopped, data destruction.

Moreover, each company should retain full autonomy to opt in or out of the Procedure at any stage, for example if the proposed reimbursement conditions—such as a reduction in the backbone medicine’s reimbursement value—are deemed unacceptable by the backbone company.

The BCA’s Communication marks an important step toward reconciling innovation in drug development with strict competition safeguards. As combination therapies continue to play a pivotal role in personalised medicine, regulatory clarity and legal certainty are crucial for their successful integration into national healthcare systems. By clarifying the boundaries for information exchange, the BCA is enabling pharmaceutical companies to collaborate responsibly, ensure regulatory compliance, and ultimately, bring better treatments to patients faster. However, each company should ensure never to forget its individual responsibility of assessing the necessity and proportionality of any sensitive information exchange, and building internal awareness of the legal boundaries.

The full text of the BCA’s communication can be found here.

Authors: Carmen Verdonck, Beatrijs Gielen