Belgium - Public Health Insurer Reminds Hospitals of Obligations under Tendering Rules for Biological Medicines
- 06/03/2024
- News
The National Institute for Health and Disability Insurance (RIZIV / INAMI – NIHDI) took a new step to publicise recent rules designed to increase competition for biological medicines and boost the uptake of biosimilar products in hospitals. A few weeks ago, NIHDI had already clarified these rules in a series of questions and answers to help stakeholders comply with the requirements in relation to public tenders for biological medicines organised by hospitals (see, Van Bael & Bellis Life Sciences News and Insights of 13 February 2024).
On 4 March 2024, NIHDI sent a circular letter to hospitals advising them of the reimbursement and availability on the market of Ximluci® (active substance: ranibizumab), a biosimilar medicine used to treat adults with specific sight problems caused by damage to the central region of the eye’s retina which is known as the macula (see, attachments). The reference biological medicine of Ximluci® is Lucentis®.
The circular letter reminds hospitals of their obligations pursuant to the Royal Decree of 13 September 2023 “establishing specific rules on public procurement of biological medicines” (the RD) (see, Van Bael & Bellis Life Sciences News and Insights of 25 September 2023). First and foremost, hospitals planning to purchase ranibizumab for an amount in excess of EUR 221,000 will be required to organise a public tender procedure in accordance with applicable European rules by the end of a nine-month period on 1 December 2024 (Ximluci® became available on the market as a reimbursable medicine on 1 March 2024). Specific Belgian public procurement rules may apply under that threshold.
The circular letter goes on to describe the other rules imposed by the RD with regard to issues such as contract duration; contract termination; selection criteria; award criteria; technical specifications; and exceptions to the nine-month rule (see, Van Bael & Bellis Life Sciences News and Insights of 25 September 2023).
