Belgian Competition Authority clarifies rules on exchange of information between pharmas for combination therapy

The Belgian Competition Authority (BCA)  published on 11 September its  guidance document regarding the exchange of information between pharmaceutical companies in the context of the reimbursement application procedure for combination therapies.

Medicinal products for human use may only be brought to market after successfully completing specific procedures to obtain market authorisation before the Belgian regulator or the European Medicines Agency. Afterwards, a reimbursement request may be submitted before the Centre for Reimbursement of Medicine (CRM), a branch of the National Institute for Health and Disability Insurance (NIHDI).

What are the current issues?

Combination therapy involves the combined use of two or more distinct, patented and potentially unpatented medicines. The therapy typically consists of at least one "backbone medicine", whose use and reimbursement is already approved by the CRM for patients as monotherapy, and at least one "add-on medicine", a medicine added to the backbone medicine to facilitate combination therapy.

These add-on medicines are often developed by a different company than the one developing the backbone medicine. Under the current reimbursement framework, applications for reimbursement of a combination therapy are to be submitted by the add‑on company. The backbone company is not a formal applicant, even though the assessment may have implications for the its product’s reimbursement conditions.

This approach presents various issues for both NIHDI and the companies involved. For NIHDI, effective evaluation of the clinical and economic value of a combination therapy often requires timely input from both companies, especially since the combination therapy is assessed regarding its therapeutic efficacy as a single product by the CRM. For the companies, the process can create uncertainty regarding the potential financial impact of any revisions to the backbone medicine’s reimbursement conditions, with possible effects on revenues, profitability, and long‑term planning. 

NIHDI is preparing to launch a new procedure intended to facilitate the development and bringing to market of innovative combination therapies and to enable both companies to participate in the assessment. As this may involve exchanges of commercially sensitive information between the companies involved, safeguards are needed to ensure compliance with competition law. In this context, the BCA has been asked to render an advice on the conditions under which such exchanges may lawfully occur.

Exchange of 'commercially sensitive information' rules 

The core principle of competition law is that each undertaking must determine its market conduct independently. While companies may lawfully adapt to competitors’ behaviour and market conditions, they must not engage in direct or indirect contacts that influence a competitor's conduct or reveal their own intended strategy, where the object or effect is to create conditions that deviate from the normal conditions of competition.

Where information is shared between existing or potential competitors, it must be verified that it does not qualify as an anticompetitive agreement. Exchanges of commercially sensitive information should always be strictly limited to what objectively necessary, and precautionary measures should be implemented whenever commercially sensitive information is involved. Even in the context of legislative provisions or when public authorities encourage exchange of information, the competition law principles remain applicable. 

What can or cannot be shared?

In general, only information that is objectively necessary to obtain a reimbursement for a combination therapy can be exchanged. In this case the BCA identifies on the one hand the following information that can in principle be exchanged:

• The purpose of the application.
• Administrative data concerning the timelines for the procedure.
• The identification of the comparator(s) and standard of care used to demonstrate the therapeutic efficacy of the combination therapy.
• Epidemiological data (number of patients concerned, incidence of the disease).
• Patient-level data (assumed duration of treatment, dose intensity in the clinical trial).
• Summary of therapeutic value (based on data from clinical studies).
• An analysis of the budgetary impact of the proposal 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 Belgian government agency the Federal Public Service 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 following categories of information are identified as commercially sensitive. As exchange thereof is neither strictly necessary nor proportionate for a combination therapy reimbursement request this information should not be shared. 

• 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 components of the combination therapy.
• 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 (for example,  data concerning suppliers or customers).
• Information on 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 NIHDI about the net price of the components of the combination therapy.

While these two lists provide non-exhaustive examples of what can and cannot be shared, any assessment of the exchange of information must be made on a case-by-case basis to decide whether there is any potential restriction on competition. In this analysis, the following factors shall be taken into account: 

• The nature of the information exchanged (e.g. whether it is non-public or not readily accessible to all competitors and the granularity of the information exchanged).
• The ability to reduce uncertainty about the commercial strategy of the companies concerned.
• The ability to maintain or strengthen the competitive position of the companies concerned on the market(s) concerned. 

BCA recommendations

The BCA recommends pharmaceutical companies to establish barriers and adopt precautionary measures to prevent information about key competition parameters from being exchanged with competitors. The following measures are advised:

• The appointment of an internal team responsible for implementing and monitoring the procedure. This team will ensure strict compliance with confidentiality policies by implementing procedures to control and trace communications between pharmaceutical companies;
• Traceability of access to information, which must be limited to those persons who are essential to the process, with appropriate security and data storage systems to prevent unauthorised disclosure or use;
• Clear internal compliance protocols must be put in place to strengthen legal certainty and minimise the risk of competition law infringements.

Osborne Clarke comment

When cooperating with a competitor on a combination therapy reimbursement application, companies may wish to consult the BCA guidelines and stay aware of the wider regulatory considerations that frame market access in Belgium and the EU.

It is generally advisable to maintain flexibility in the reimbursement process, with the option to proceed, adjust, or withdraw participation as needed. Alongside this, establishing careful information governance – such as secure document storage, restricted access, traceability, and defined management of shared materials – may help reduce risk and foster transparency.

Pharma and biotech companies could also benefit from documenting the nature, scope and purpose of shared information, which may serve to evidence good faith and regulatory alignment in a market access context; for example, during interactions with health technology assessment authorities such as NIHDI.

Careful distinction of what information is exchanged remains key. Commercially sensitive data such as internal cost structures or pricing information is typically kept out of scope for information-sharing, while only data necessary for the reimbursement procedure is shared and used for its intended purpose.

These measures not only assist with competition law compliance but also with the robust regulatory frameworks governing pharmaceutical approval, pricing, and reimbursement in Belgium and the EU. The guidelines have been published at a particularly pivotal time for the sector, as the draft EU pharma package signals forthcoming legislative and regulatory reforms that are set to reshape market access, competition, and collaboration frameworks across Europe.

Ultimately, success in combination therapy market access may hinge on a pharmaceutical company’s ability to combine pragmatic, responsible collaboration with ongoing compliance – across competition, regulatory, and reimbursement requirements – while maintaining a careful record of decision-making and information exchange.