As in several other European countries, Belgium has a system in place to allow the temporary use of certain innovative medicines on the Belgian market when no reimbursement decision has been taken due to the therapeutic effectiveness of the medicine not yet being proven. This system of “managed entry agreements” is institutionalised through the so-called Article 81 agreements between the government and pharmaceutical companies. Such agreements usually impose conditions on pharmaceutical companies to demonstrate the medicine’s effectiveness, often in exchange for certain confidential price reductions.
The Court of Auditors highlighted in an analysis of September 2019 that the reimbursement of medicines related to these Article 81 agreements represented 29.07% of the total reimbursement cost of medicines in 2018, compared to only 18.55% in 2016. As both the number of such agreements as well as their financial impact are increasing, criticism has been voiced that the Article 81 system is being used too frequently. The strict confidentiality obligations enshrined in the current legal framework however prevented Parliament from reviewing the efficiency of such agreements and their impact on the Belgian healthcare budget.
As a result, in November 2019, a Bill was introduced in Parliament to obtain more access to these confidential agreements. The new Bill will grant the Court of Auditors, when assigned to conduct a specific inquiry by the Chamber of Representatives, wider access to information relating to this type of agreement (that is, beyond what is provided by the legal provisions today). The proposed Bill received the green light from the Council of State and an amended version was unanimously adopted by the subcommittee of the Chamber of Representatives on 10 March 2020. The Bill has yet to be adopted in plenary session.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, April 2020 Issue (Thomson Reuters).