Towards a more proactive, patient-focused medicines and health products authority

The medicines and health product sector is changing fast. For example, in the past few years, the number and complexity of new medicines and health products arriving on the market has increased. Several new European regulations and directives, including the new EU pharmaceutical strategy, require more adaptations for medicines agencies. Furthermore, the Covid-19 pandemic clearly demonstrated the potential risks associated with medicines and medical devices shortages.

To date, Luxembourg is the only EU member state without its own medicines agency. The new government has identified such an agency as a priority.

The ALMPS would have more autonomy and independence in the regulatory oversight of medicines and health products. Its mandate would cover – in addition to the products currently covered by the DPM – cell/tissues, blood and other health products whose status is yet to be defined. Its range of activities would be expanded to include health technology assessment-related activities.

A pressing concern, in Luxembourg as in many countries, is to ensure the proper use of medicines and address shortages. That entails, for example, setting up a medicines registry and other digital platforms related to medicines and health products. Therefore, the digitalisation of processes is a key priority. Digitalisation will be a backbone in the new Agency’s procedures, using all relevant tools available, including AI, for a future-proof set-up.

Another priority is to identify the right channels and organisations for engaging effectively with patients, taking into account the Luxembourg landscape.