Belgium - Bill Facilitating Biosimilar Market Entry in Hospital Channel
Member of Parliament Nawal Farih submitted in June 2021 a private member’s bill which seeks to facilitate market entry by biosimilar medicines (Bill 2157K001 – Wetsvoorstel tot wijziging van de Wet betreffende de verplichte verzekering voor geneeskundige verzorging en uitkeringen gecoördineerd op 14 juli 1994, met het oog op een financieel toegankelijker geneesmiddelenbeleid binnen de ziekenhuizen/Proposition de loi modifiant la loi relative à l’assurance obligatoire soins de santé et indemnités coordonnée le 14 juillet 1994, afin que les hôpitaux mènent une politique des médicaments qui les rende financièrement plus abordables - the Bill, see attachment). The Bill became publicly available just a few weeks ago.
Ms. Farih expects a larger uptake of biosimilars in hospitals to make biological medicines more accessible for patients and, more plausibly, to create additional savings on the health budget. The Bill is predicated on the finding that the biosimilar uptake in Belgian hospitals is still low and that this is attributable to a deficient application of the public procurement rules which most hospitals in Belgium are supposed to abide by.
On that basis, the Bill proposes to:
- Oblige hospitals to have the biological reference product and the biosimilar product form part of the same subdivision (perceel/lot) in any given request for proposals.
- Oblige hospitals to issue a call for tenders within 90 calendar days following the entry into force of reimbursement conditions for a new biosimilar. This obligation will come into play even if the hospital at issue has a pending contractual obligation to procure the reference biological product or another competing biosimilar medicine.
- Oblige hospitals to start a new procurement regime within 60 calendar days following the receipt of offers in response to a request for proposals.
- Limit the duration of any new supply agreement to 24 months, with the possible option, subject to conditions, to extend the agreement for a further 12 months.
- Guarantee the equal treatment of the reference biological products and the biosimilars. A model request for proposals may be established by Royal Decree.
- Create rules that will exempt hospitals from the application of the new procurement rules for biological products as soon as the biosimilars obtain a specific share of the market for a given active substance.
The Bill was prompted by a study published by the Christian sick-fund, one of Belgium’s major healthcare payors. While the Bill is a private member’s initiative, it may still gain traction, either autonomously or as part of a wider governmental initiative to promote biosimilars, which is one of the policy objectives of the current federal government.