On Friday 5 December 2025, the Luxembourg Chamber of Commerce published its response to the amendments concerning the creation of the Luxembourg Agency for Medicines and Health Products.
The Chamber of Commerce said it had taken note of the amendments adopted by the Committee on Health and Social Security regarding Bill No. 8491, which aims to establish the Luxembourg Agency for Medicines and Health Products and, while it welcomed certain clarifications that have been introduced, it regretted that its main recommendations, expressed in its first opinion of 12 May 2025 and reiterated in its opinion of 26 November 2025, had not been taken into account.
The Chamber of Commerce said it welcomed the clarification of the respective missions of the Agency and the Health Directorate, the strengthening of the Agency’s scientific framework and governance, as well as the alignment of the Agency’s role in the authorisation of clinical trials with Regulation (EU) 536/2014, thereby facilitating the opening of international trials in Luxembourg.
However, it said it “nevertheless regrets that the majority of its observations have not been retained” and reiterated its opposition to the creation of a “health reserve”, which it stated should form the subject of a separate bill. The Chamber also highlighted that its request for clarifications concerning medicines used outside the scope of marketing authorisation (with respect to the financial coverage of such medicines), as well as its request for details on the Agency’s structural funding and the coverage of medicines for special needs had not been met.
