On 16 April 2020 Parliament adopted a new act to increase the transparency of managed entry agreements (MEAs) concluded between pharmaceutical companies and the National Institute for Health and Disability Insurance (NIHDI). MEAs stipulate confidential compensation mechanisms for the government regarding the publicly listed price and reimbursement basis of the medicines concerned. The act provides that if Parliament's Chamber of Representatives orders a management audit, the Court of Audit is granted full access to the MEAs, including their confidential sections.
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 reimbursement basis are complemented with confidential compensation mechanisms for the government. These confidential compensation mechanisms can be:
- financially based (eg, as a flat discount or a price-volume discount based on the expenditure); or
- health outcome based (eg, 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. The new act's preparatory documents state that the MEAs' confidentiality is problematic as it prevents the Chamber of Representatives from performing its control over the government and the effectiveness of the health budget. The new act aims to improve the transparency relating to these MEAs.
Before the new act, confidentiality could be waived for the competent authorities for only 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. Further, 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 that are granted access must respect the MEA's confidentiality.
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), 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 to only MEAs concluded after the act's entry into force. This will happen 10 days after the publication in the State Gazette, which at the time of writing has not occurred.
