Background to the confidential managed entry agreements
Based on Article 111 (better known as the old Article 81) of the Royal Decree of 1 February 2018, pharmaceutical companies and the NIHDI can conclude MEAs, which most often relate to new and often expensive medicines. Under an MEA, the publicly-listed price and the reimbursement basis are complemented with confidential compensation mechanisms for the Belgian government. These confidential compensation mechanisms can be (1) financial-based, such as a flat discount or a price-volume discount based on the expenditure, or (2) health-outcome-based, such as performance-linked clawbacks or outcome guarantees. Health-outcome-based conditions are expected to become increasingly important.
Confidential nature subjected to more criticism
The importance to provide early access to medicines even when no final reimbursement decision can (yet) be taken, particularly because the (cost-)effectiveness is still unknown or the budget impact is uncertain, has led to a more widespread use of such MEAs. For example, in 2018, almost 30% of the 2018 budget for medicines was used for medicines under an MEA. This popularity has also come with criticism about these agreements’ confidential nature. In the new Act’s preparatory documents, it is stated that the MEAs’ confidentiality is problematic as it prevents the Chamber of Representatives from performing its control over the Belgian government and the effectiveness of the health budget. The new Act aims to improve the transparency related to these MEAs.
Before the new Act, confidentiality could only be waived for the competent authorities for disciplinary, administrative, criminal or civil proceedings or investigations, or in the event that the pharmaceutical company on its own initiative enters into a joint reimbursement procedure with one or more partner countries. Additionally, the members of the NIHDI’s General Council and of the Court of Audit could request access to the actual evolution of aggregated information and under strict limits. The concerned entities who are granted access must respect the MEA’s confidentiality.
Increased transparency by granting wider access to the Court of Audit for a management audit
The new Act provides that if the Chamber of Representatives entrusts the Court of Audit with a management audit (as set out in Article 5 of the Act of 29 October 1846 on the organisation of the Court of Audit), then the Court of Audit is granted access to the entire MEAs, including the confidential annexes, to be able to successfully complete the research assignment. The legally enshrined confidentiality is in such a case lifted only for sharing the information marked as confidential with the Court of Audit.
The Court of Audit remains bound by the confidentiality and, in exception to the general principle, the Chamber of Representatives (or its members) has no right of inspection or information as foreseen in Articles 33 and 34 of the Court of Audit’s rules of order.
Importantly, the new Act will apply only to MEAs concluded after the entry into force of the Act. This will happen ten days after the publication in the Belgian State Gazette, which has not yet occurred at the date of publication of this blog post.