Grand-Duchy of Luxembourg - Creation of National Medicines Agency
The Council of Government of the Grand-Duchy of Luxembourg approved on 20 December 2019 a draft bill that provides for the creation of a national medicines agency which will be known as "Agence luxembourgeoise des médicaments et des produits de santé" (« ALMPS ») (see attached press release). As its name suggests, ALMPS will be responsible for a range of products, including pharmaceuticals, medical devices, cosmetics, food supplements and other health products. As a result, Luxembourg will cease to be one of the few European countries without a medicines agency that is separate from the executive branch of government.
According to the press release, once operational, ALMPS will be in a better position to cope with a range of public health issues, including health risk management, medicine shortages and universal access to medicines.
Additionally and significantly, ALMPS will also be given an economic remit in that it will facilitate and preserve investment in the life sciences sector (the press release expressly mentions the biotechnology industry). ALMPS is supposed to achieve that goal by creating legal certainty in the form of a regulatory framework which will be “precise” and “administered efficiently” and will govern activities such as production, commercialisation and clinical trials.