European Regulators Publish Recommendations to Tackle Shortages of GLP-1 Receptor Agonists

• 01/07/2024
• News

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published recommendations to tackle shortages of GLP-1 receptor agonists (or GLP-1 analogues) which are indicated for the treatment of diabetes, for weight management, or for both (see, attached press release of 26 June 2024). They act in the same way as GLP-1, a natural hormone in the body, by increasing the amount of insulin which the pancreas releases in response to food. They thus help to control blood glucose levels and also regulate appetite.
 
EMA and HMA built on the work of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), the EU specialised body which deals with medicine supply problems (see, attached press release of 12 June 2024).
 
The recommendations target several stakeholders, including marketing authorisation holders, Member States, healthcare professionals, and members of the public, a group that also encompasses the patients, and cover a range of areas such as: 

• Off label prescriptions - The recommendations discourage physicians from prescribing diabetes products for conditions involving weight management. In addition, the recommendations indicate that none of the products, including those indicated for weight management issues, should be used for what is referred to as “cosmetic weight loss”, a phrase defined as the “use for weight loss in people without obesity or people with overweight who do not have weight-related health problems”.
• Promotion and awareness - Marketing authorisation holders should obtain approval from regulatory authorities for promotional activities on GLP-1 receptor agonists, where applicable. Additionally, promotional actions should be accompanied by awareness campaigns that cover weight management and discuss current shortages and their adverse impact on clinical practice.
• Supply – The recommendations urge marketing authorisation holders to increase their manufacturing capacities and craft short-term mitigation measures.
• Patient advice – Patients are warned that GLP-1 receptor agonists are prescription medicines whose use should be overseen by a physician. Weight management is first and foremost a function of diet and exercise. The medicines should be sourced with a pharmacist and online purchases should only be made from a trusted source. The recommendations ask users to beware for potentially dangerous counterfeit products.   

These measures have to be complemented by appropriate binding rules for which, by and large, Member States are responsible. One such rule is a prohibition on physicians to prescribe GLP-1 receptor agonists for off-label indications or purposes. In Belgium, the Royal Decree of 14 November 2023 limited the authorised prescription of GLP-1 receptor agonists to specific patient categories (see, Van Bael & Bellis Life Sciences News & Insights of 22 November 2023). The temporal application of that Royal Decree has just been extended until 28 February 2025 by the Royal Decree of 9 June 2024.