IML's opinion on draft law 8491 ALMPS

The new bill 8491 aims to establish the Agence Luxembourgeoise des Médicaments et Produits de Santé (ALMPS) as the national authority responsible for the regulation, monitoring and control of medicines and health products in Luxembourg. This initiative will structure a governance structure dedicated to the management of medicines throughout their life cycle, from initial development to marketing and post-marketing surveillance. ALMPS will be responsible for the application of European and international regulations, notably in the field of health technology assessment (EU-HTA). It will also be involved in crucial aspects such as the regulation of off-label medicines, the management of special needs, and compassionate use. Its structuring as a privately-managed public establishment is designed to guarantee greater administrative flexibility and responsiveness to developments in the pharmaceutical sector.

IML welcomes this initiative, which could encourage a more fluid organization of the Luxembourg drug market, and hopes that ALMPS will help to facilitate access to therapeutic innovations, while maintaining appropriate and coherent regulation. IML considers the creation of the ALMPS to be a major step forward for the regulation of healthcare products in Luxembourg, helping to clarify and structure the organization of the market while improving its fluidity.

IML would like to make a few clarifications and looks forward to further clarifications on the draft law. As a directly involved player, IML offers its analysis with a view to opening a dialogue to establish the most efficient agency possible.

The full opinion can be consulted in the PDF below.