On 18 September 2025, the Belgian Competition Authority (BCA) published a communication clarifying how pharmaceutical companies may exchange information when jointly applying for reimbursement for combination therapies before the National Institute for Health and Disability Insurance (NIHDI) under competition law.
Combination therapies involve the joint use of two or more distinct medicines, often developed by different companies, and are particularly relevant in treating complex diseases such as cancer. These therapies typically consist of a “backbone medicine”, already authorised and reimbursed as a monotherapy for a specific therapeutic use, and an “add-on medicine”, which is developed for another therapeutic use.
In Belgium, to obtain reimbursement for such therapies, pharmaceutical companies must follow a complex procedure stipulated by the NIHDI. Currently, only the add-on company can submit the reimbursement request. The backbone company gets involved only after the add-on medicine has been approved for reimbursement, triggering a separate procedure to adapt the reimbursement conditions for the backbone medicine. This fragmented process delays access to combination therapies and creates uncertainty for companies in terms of financial and strategic implications.
To address these shortcomings, facilitate patient access to innovative therapies and ensure compliance with competition rules, the BCA collaborated with the NIHDI and pharmaceutical industry associations (Pharma.be and Medaxes). The resulting communication from the BCA provides legal certainty for companies on the permissible scope of information exchanges necessary for joint reimbursement applications.
The BCA stresses that exchanges of information between companies must be strictly limited to what is objectively necessary for obtaining reimbursement. The guidance distinguishes between information that may be shared and information that must remain confidential:
- Permissible information includes administrative data (e.g. timelines), standard of care identification, epidemiological data (e.g. disease incidence), patient-level data (e.g. treatment duration), summaries of therapeutic value and budget impact analyses from the NIHDI’s perspective.
- Prohibited information includes commercially sensitive data such as company-specific costs, net prices, margins, marketing or investment strategies, market data and budget impact analyses from the perspective of the companies or the healthcare system.
The BCA underlines that sharing such commercially sensitive data could amount to an infringement of competition law. Each company must independently assess the necessity and proportionality of any information exchange. Participation in the reimbursement process does not automatically justify the sharing of sensitive data.
To mitigate risks, the BCA recommends precautionary measures:
- Appointing dedicated internal teams to manage the process and prevent the exchange of competitive information.
- Ensuring traceability and limiting access to essential personnel only.
- Implementing strict and robust confidentiality and compliance protocols.
This communication provides practical guidance for pharmaceutical companies operating in Belgium. By clarifying the boundaries for lawful cooperation, it aims to strike a balance between fostering access to innovative combination therapies for patients and safeguarding effective competition. The initiative also reflects the BCA’s growing role in providing sector-specific guidance where regulatory and competition issues overlap.
