Belgium - Public Health Insurer Clarifies Tendering Rules for Biological Medicines

• 13/02/2024
• News

The National Institute for Health and Disability Insurance (RIZIV / INAMI – NIHDI) recently published a series of questions and answers to help stakeholders in complying with the rules that apply to public tenders by hospitals for biological medicines (see, attached FAQ in Dutch and French versions). These rules are provided for by Article 71bis of the Consolidated Law of 14 July 1994 regarding the mandatory insurance for medical care and benefits and the implementing Royal Decree of 13 September 2023 “establishing specific rules on public procurement of biological medicines”.
 
Both sets of measures were designed to increase the competition for biological medicines and boost the uptake of biosimilars in the hospital channel. However, as these rules only entered into force on 2 October 2023, many stakeholders, including hospitals and medicine suppliers, are still grappling with practical questions which the FAQ try to address.

For example, the FAQ indicate that: 

• it is safe to switch from the biological reference medicine to a biosimilar equivalent or vice versa and to switch from a biosimilar medicine to another biosimilar medicine of the same reference medicine; according to the FAQ, all these medicines are interchangeable; in the same vein, the FAQ stresses that there is no quality difference between the biological reference medicine and the biosimilar; 
• there may be grounds for a hospital to postpone organising a public tender procedure within the requisite nine months following the moment on which the first biosimilar medicine of a biological reference medicine becomes reimbursable and available, if the original molecule and its biosimilar version face shortages; in that case, the hospital will have to advise NIHDI and state reasons for the delay; 
• valid award criteria would be the ease of use of the various packaging types and the different therapeutic indications of medicines with the same active substance and an identical mode of administration; 
• patent disputes should be ignored, pending a “final judgment” (“definitieve uitspraak”/“jugement définitif”) – this is because, according to the FAQ, the biosimilar specialty will remain registered and reimbursable as long as no such final judgment has been delivered; this approach seems rather simplistic and will in specific cases cause suppliers of patent infringing medicines and the procuring hospitals to become liable for patent infringement if they choose to ignore a court judgment; 
• the documented evidence regarding the appropriate dosage for specific uses of the reference medicine will also apply to the dosage of the biosimilar equivalents; in other words, the dosage issue cannot give rise to a valid award criterion.