On 11 September 2025, the Belgian Competition Authority (BCA) published guidelines for pharmaceutical firms that seek to exchange information for purposes of applying for the reimbursement of a combination therapy (CT) of pharmaceuticals whose marketing authorisations are in different hands (see, attached English versions of press release, guidelines (the Guidelines) and information sheet).
 
A CT is a treatment relying on two or more medicines and/or medical devices in one combined treatment schedule to treat a single disease. CTs that consist of two pharmaceuticals are able to target multiple pathways of a disease simultaneously and may exhibit greater clinical efficacy than a single treatment when its component treatments have complementary, additive, or synergistic pharmacodynamic effects. Their importance has grown significantly in a range of therapeutic areas, including oncology.
 
The BCA has now outlined the principles that should facilitate limited forms of cooperation between firms that own marketing authorisations for medicines that form part of a CT. The Guidelines only cover the exchange of information and list data sets that can be exchanged among pharmaceutical firms (§ 31) and sets of information that should not be shared (§ 32).  According to the Guidelines, the first category of data includes matters such as: 

• epidemiological data (incidence of disease; presumable number of patients);
• patient-level data;
• therapeutic value of the CT resulting from the data generated by clinical data;
• budgetary impact of possible reimbursement arrangement if based on publicly available ex-factory price.

By contrast, the second category of information that remains off-limits for an exchange includes: 

• data concerning the net price, as well as the gross and net margins of the components of the CT;
• cost structure of the participating firms;
• information regarding the attribution of the therapeutic value to the various components of the CT;
• budgetary impact on medicine budget and overall healthcare budget. 

The Guidelines also recommend the creation of a dedicated “clean” team that is responsible for implementing and monitoring the reimbursement procedure and maintaining the confidentiality of business secrets (§§ 34 and following).
 
The BCA should be commended for its efforts, but the scope of the Guidelines is limited to the exchange of information and does not address other issues such as pricing arrangements between actual or potential competitors, a matter tackled by the UK Competition and Markets Authority in its advice regarding combination practices which it published in November 2023 (see, Van Bael & Bellis Life Sciences News and Insights of 21 November 2023). Additionally, the Guidelines seem premised on the relationship between actual or potential competitors. The scope for cooperation between firms that do not compete and have no perspective of competing in the relevant therapeutic areas should be larger.
 
Lastly, the BCA did well to specify that, from a competition law perspective, firms retain their autonomy and have the ability to withdraw from a pending procedure involving inter-firm cooperation at any time (§ 37).