Belgian Competition Authority issues guidance on information exchange between pharmaceutical companies for combination therapies

Background 

Combination therapies involve the use of two or more distinct medicines, often developed by different pharmaceutical companies. They typically pair a foundational or “backbone” medicine, already authorised and reimbursed as a monotherapy for a specific therapeutic indication, with an “add-on” product, developed either for use as a stand-alone therapy or in combination with the backbone product. Combination therapies are becoming increasingly important in the treatment of severe or rare diseases, including certain cancers, as they can offer improved clinical results and lower the risk of treatment resistance over time, compared to monotherapies.

The pharmaceutical sector and regulatory authorities have identified shortcomings in the current Belgian reimbursement procedure for combination therapies, which are seen as significant obstacles to the availability of such treatments in Belgium. Under the existing framework, the developer of the add-on medicine must first submit a reimbursement request for its own product to the NIHDI—excluding the backbone company.

Only once the add-on medicine has been approved for reimbursement is a separate procedure initiated to adapt the reimbursement conditions for the backbone medicine, enabling reimbursement within the broader context of a combination therapy. This sequential, two-step process creates commercial and procedural uncertainty, particularly for the backbone company, as the financial implications of any adjustment to the reimbursement conditions—potentially affecting their revenue, profitability, and long-term strategy—are unpredictable. 

To address these challenges and facilitate the market entry of novel combination therapies, the NIHDI is considering a specific reimbursement procedure that would involve all pharmaceutical companies in the combination therapy. In anticipation, the BCA has been asked to clarify the competition law framework governing information exchanges between these companies, specifically in the context of a reimbursement application. Notably, the communication expressly excludes from its scope any “[a]greements or cooperation between companies concerning research and development of new pharmaceutical treatments or products”.

Applicable legal framework 

General

Relying extensively on the Horizontal Cooperation Guidelines of the European Commission (which contain a dedicated chapter on information exchanges between competitors),  the BCA’s communication confirms, inter alia, that the exchange of information between actual or potential competitors, even when undertaken for regulatory purposes or in the context of regulatory initiatives, may fall within the scope of Article 101(1) TFEU and Article IV.1(1) of the Belgian Code of Economic Law (i.e., the prohibition of restrictive agreements or concerted practices). In addition, the BCA reiterates that such exchanges may be prohibited, even if they do not directly affect the end-user prices or if the information exchanged is incorrect or misleading.

Permissible information exchanges

The communication then sets out in detail which types of information may, in principle, be exchanged between pharmaceutical companies, in the context of an application to the NIHDI for reimbursement of a combination therapy.¹  Importantly, the BCA emphasises that any information exchange must be strictly limited to what is objectively necessary for the procedure and to obtain reimbursement.

Permissible information exchanges concern, inter alia:

• The purpose of the application and timelines of the reimbursement procedure
• The comparator(s) or standard(s) of care used to demonstrate the efficacy of the combination therapy
• Epidemiological data, such as the number of patients affected and the disease incidence
• Patient-level usage data, including dosage intensity and duration of treatment
• A summary of the therapeutic value of the combination therapy, based on data from clinical studies, and its product characteristics
• An analysis of the budgetary impact of the proposal, based on volume and incidence data as well as the publicly available ex-factory price set by the Ministry of Economic Affairs, for each component of the combination therapy, including an assessment of the expenditure per year, for the first three years (the so-called “level 1 budget impact”)

Prohibited information exchanges

Conversely, the BCA makes clear that commercially sensitive information must not be shared between pharmaceutical companies, as such an exchange will “neither [be] strictly necessary nor proportionate to the objective of a request for reimbursement of a combination therapy.” 

This includes, inter alia:

• Net price information or any data that would allow the net price of medicines or pharmaceutical components to be calculated, including data on the gross or net margins for combination therapy components
• Information on cost structures of the companies participating in the combination therapy
• Marketing strategies, investment plans, and future business plans
• Specific market data, such as information about suppliers or customers
• Information on the distribution of therapeutic value among the different components of the combination therapy
• An analysis of the budgetary impact of the proposal on the medicine budget (the so-called “level 2 budget impact”) and on the healthcare budget (the so-called “level 3 impact”), including financial details and cost projections, as well as information on changes in the volume or turnover of one of the components of the combination therapy that influence the negotiations with the NIHDI regarding the net pricing of those components

Practical recommendations for compliance—precautionary measures

To mitigate the risk of unlawful information exchanges, the BCA also recommends that companies:

• Appoint a dedicated internal team to manage and oversee the reimbursement procedure. This team should ensure strict adherence to confidentiality protocols and put in place measures to monitor and trace all inter-company communications.
• Implement mechanisms to ensure that access to the information exchanged is traceable and, in any event, granted only to individuals essential to the reimbursement procedure, on a need-to-know basis and with appropriate data security and storage safeguards to keep the information confidential and prevent unauthorised disclosure or use.
• Ensure that any information exchanged is securely stored and, if the reimbursement procedure fails, destroyed in line with internal confidentiality protocols and legal requirements. Robust traceability should be maintained for both archiving and destruction of data, and internal processes should be reviewed to prevent that the information is—intentionally or inadvertently—used in other projects or files.
• Establish clear internal compliance protocols to support these safeguards.

Next steps

The BCA’s communication has been in force since its publication on September 10, 2025. Companies involved in the development and commercialisation of combination therapies may rely on its principles to assess, under their own responsibility, whether any information exchange is necessary, proportionate and compliant with competition law in their specific case. 

For more details or tailored advice, please contact your A&O Shearman contact. 

Footnotes:

1. With regard to reimbursement procedures for combination therapies, the exchange of non-price data has been characterised by several national competition authorities, including the UK Competition and Markets Authority, as generally less problematic. See, e.g., “Prioritisation statement on combination therapies”, available at https://www.gov.uk/government/publications/combination-therapies-prioritisation-statement (accessed on October 7, 2025).