Luxembourg to Set Up Agency for Medicines, Health Products

The Luxembourg Cabinet today approved the bill establishing a National Agency for Medicines and Health Products, in the form of a public establishment.

This future agency, placed under the authority of the Minister of Health, will allow the pooling of expertise in the field of medication, medical devices and other health products (cosmetic products, food supplements, etc.) within the same entity, in the interest of public health. Indeed, it will make it possible to manage the potential risks that certain medication, medical devices or health products may generate on public health and will thus guarantee a high level of health security for all health products throughout their cycle life.

As pointed out by the Deputy Prime Minister and Minister of Health, Étienne Schneider: "The creation of a National Medicines Agency is all the more necessary as the challenges we face are major, especially in this concerning surveillance of the quality and safety of medicines on the market, in order to prevent harmful, substandard or counterfeit medicines from reaching the public".

In addition, in recent years, there has been an increase in the amount of medication in partial or total shortage. The National Agency for Medicines and Health Products will make it possible to fulfil the obligations of the industry to notify shortages but also to legitimately participate in the coordination initiatives of the network of European agencies and the European Medicines Agency (EMA) aimed at facilitating prevention, identification, management and communication regarding shortages. It also aims to promote rapid, supervised and broad access to all health products for the population.

At the same time, the agency aims to help to diversify the country's economy by enhancing the investments already made in the biotechnology sector. It will play a decisive role in attracting actors to set up in Luxembourg, because it will provide them with the guarantees required to be able to work within the context of a precise regulatory framework applied effectively for the authorisation and control of their production and commercialisation activities, as well as planning their clinical trials. The agency will thus respond to the double challenge of public health and economic positioning.

Luxembourg is currently one of the only European countries not to have a National Agency for Medicines and Health Products. Indeed, the competence concerning medication, health products and medical devices or even certain aspects of the products derived from blood, falls within the missions of the Directorate of Health, just like the supervision of the issuance of medicinal cannabis.