Building a fit-for-purpose medicines agency in Luxembourg

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

  • Publication
  • March 27, 2024

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.

operation scissors

“We need to work more collaboratively, with patients, and with the public and private sectors, within the European market and beyond.”

Dr Anna ChiotiHead of DPM, Luxembourg

Michèle Paque, PwC Belgium’s healthcare and life sciences specialist, spoke with Dr Anna Chioti, Head of the Division of Pharmacy and Medicines (DPM) in the Health Directorate of the Luxembourg Ministry of Health and Social Security, about setting up a proactive and patient-focused national medicines agency in Luxembourg.

The aim is for the Luxembourg Agency for Medicines and Health Products (ALMPS – Agence Luxembourgeoise des Médicaments et Produits de Santé) to become Luxembourg’s national regulatory authority for medicines and health products. Anna outlined the developments and strategy driving this decision. 

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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.

Dr Anna Chioti

Dr Anna Chioti

Head of DPM, Luxembourg

Find out all about the latest plans for the new Luxembourg regulatory authority for medicines and health products.

Read our interview with Dr Anna Chioti

Contact us

Matthias Reyntjens

Matthias Reyntjens

Partner, Platforms & Industries Leader, Consulting Lead, PwC Belgium

Tel: +32 476 44 53 92

Jan Debaere

Jan Debaere

Partner, Health Industries Lead, PwC Belgium

Tel: +32 473 92 46 11

Michele Paque

Michele Paque

Senior Advisor Life Sciences & Healthcare, PwC Belgium

Tel: +32 477 60 50 51

Connect with PwC Belgium