Belgium - Royal Decree Reins In Prescriptions for GLP-1 Analogues to Protect Diabetes Patients and Other Patients in Need
- 22/11/2023
- News
The Belgian Official Journal of 14 November 2023 contains a Royal Decree of 9 November 2023 (the RD - attached) that limits the scope of authorised prescriptions for GLP-1 analogues to the following categories of patients:
- Patients suffering from type 2 diabetes mellitus;
- Patients suffering from a form of serious obesity (with a body mass index in excess of 35 kg/m² or in excess of 30kg/m² if in combination with a weight-related comorbidity);
- Patients relying on this type of medication as part of a clinical trial.
In Belgium GLP-1 analogues are indicated for the treatment of type 2 diabetes under varying conditions but, following successful trials, are increasingly prescribed off-label to treat excess weight as well. Like in other countries around the world, GLP-1 analogues, including medication based on semaglutide, are now in short supply. With the exception of one, the medicines which the RD covers (Bydureon®; Ozempic®; Rybelsus®; Trulicity®; and Victoza®) also feature in the shortages catalogue of the European Medicines Agency (EMA). This is a list of medicines for which EMA has assessed the shortage situation and provided recommendations to both healthcare professionals and patients.
The RD seeks to mitigate the adverse consequences of the shortage of GLP-1 analogues for the above categories of patients who are thought to be most in need. It follows similar measures in the United Kingdom and is regarded as an alternative to export bans which are in place or under consideration in several European countries.
In advice dispensed on 7 November 2023 (see, attachment) the Council of State expressed satisfaction with the statutory basis for the RD (Article 3, §2, section 1 and Article 7, §1 of the Law of 25 March 1964 regarding medicines for human use and Article 30, section 1 of the Law of 22 April 2019 regarding maintaining quality practice in healthcare). It also agreed that the prescribing measures are a justified restriction of trade of the medicines between EU Member States.
