Belgium - Royal Decree Introduces Tendering Rules to Increase Competition for Biological Medicines
- 25/09/2023
- News
On 22 September 2023, the Belgian Official Journal (Belgisch Staatsblad / Moniteur belge) published a Royal Decree of 13 September 2023 “establishing specific rules on public procurement of biological medicines” with a view to increasing competition for biological medicines (Koninklijk Besluit van 13 september 2023 tot vaststelling van bijzondere regels inzake overheidsopdrachten voor biologische geneesmiddelen / Arrêté royal du 13 septembre 2023 fixant des règles particulières concernant les marchés publics pour les médicaments biologiques – the RD).
The RD implements Article 71bis of the Consolidated Law of 14 July 1994 regarding the mandatory insurance for medical care and benefits which the federal Parliament adopted in May 2022 to increase the efficiency of the public procurement rules which hospitals must apply for the purchase of medicines.
Noting that, despite earlier policy initiatives, the uptake of biosimilars remains low in Belgium and is only gradually increasing, the RD seeks to reduce entry barriers for biosimilars in three ways.
First, the RD establishes a requirement for hospitals to organise a public tender within nine months following the date of reimbursement and availability of a first biosimilar medicine (which is supposed to be the moment when competition for an existing biological medicine arises). Any attempt by a hospital to derogate from this requirement should be supported by reasons and should be notified to the National Institute for Health and Disability Insurance (RIZIV / INAMI – NIHDI). If NIHDI considers the hospital’s justification to be insufficient, it will transfer the file to the Belgian Competition Authority (BMA / ABC – BCA) for possible further investigation. The BCA will also receive annually a list of all notifications which NIHDI received in the previous year.
Hospitals are required to include in all contracts for biological medicines that are concluded from 2 October 2023 (i.e., the date of entry into force of the RD) a clause stipulating that the contract terminates if a new contract must be awarded pursuant to the RD. The RD’s preamble notes that, for ongoing contracts which do not contain a termination clause, the absence of a termination clause can be a ground for requesting a derogation from the nine-month period and is an element that will be considered by NIHDI in evaluating the derogation (in addition to other elements such as, for instance, the possible financial consequences of termination).
Second, the RD limits the duration of supply contracts resulting from public tenders to two years, subject to two possible extensions of one year as long as no additional biosimilars are reimbursed in, respectively, the first two years and the third year after the first biosimilar is reimbursed and available. The duration of supply contracts cannot exceed 4 years. NIHDI will inform hospitals by circular letter whether additional biosimilars are reimbursed.
Third, the RD bans the use of specific selection criteria, award criteria and/or technical specifications that are considered to limit competition for biological medicines. The banned tendering criteria are the following:
- criteria requiring that the medicine has already been on the market for a certain period of time (e.g., minimum turnover requirements);
- criteria relating to additional services that are unrelated to the subject of the public contract (e.g., requests to sponsor R&D or training sessions);
- criteria related to the efficacy, safety or quality profile of the biological medicines (the idea being that these criteria have already been assessed by the European Medicines Agency);
- criteria requiring that clinical switching data or financial support for clinical switching studies be provided;
- the granting of price discounts if several lots are awarded to the same tenderer, if this mechanism also applies to at least one lot for which there is no competition because of the protection of specific intellectual property rights;
- including different administration routes in the same lot (especially if only one tenderer can supply products for all administration routes); and
- creating contractual links with other medicines.
A copy of the RD is attached.
