The key facts about regulatory reform in Luxembourg. Prepared in association with Wildgen, a leading global law firm, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
Yes, the ongoing draft law n°7383 which has been filed to the Chamber of Deputies on 25 October 2018 by the Minister of Health contains several proposals for reform that includes, without being exhaustive:
- allowing holders of a wholesale distribution authorization for medicinal products to supply directly certain medicinal products to the public, in particular for patients kept under oxygen at home (oxygen cylinder deliveries), or patients wishing to make dialysis at home (sachets of liquid dialysis) ;
- allowing state services to have access to medicinal products in the public health interest;
- allowing doctors and dentists to have access to and be supplied with an emergency kit to meet the needs of their patients to whom they give care; as well as
- introducing a set of exceptional cases to the principle of a prior marketing authorization for medicinal products (such as for compassionate use or health emergency situations).
Furthermore, the European directives on medical devices on which Luxembourg legislation is currently based will be amended by two new European Regulations, directly applicable in the European Union:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC; and
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
2. When are they likely to come into force?
It is not possible to foresee the date of entry into force of the draft law n° 7383, as it is in an early stage of discussion.
The above mentioned Regulations on medical devices will be fully applicable in May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.
Directory of Local Institutions
– Benelux Office for Intellectual Property (“Office Benelux de la Propriété Intellectuelle”)
Boîte Postale 90404
2509 LK La Haye
– Curative Care and Healthcare Quality Department (“Division de la Médecine curative et de la Qualité en santé”)
– European Medicines Agency (“Agence Européenne des Médicaments”)
Domenico Scarlattilaan 6
1083 HS Amsterdam
– European Patent Office (“Office Européen des Brevets”)
(formerly Erhardtstrasse 27)
– General Inspectorate of the Social Security (“Inspection Générale de la Sécurité Sociale”)
26 Rue Sainte-Zithe,
– Ministry of Health (“Ministère de la Santé”)
– Luxembourg Office of Intellectual Property (“OPI”)
19-21, boulevard Royal
– Medical College (“Collège Médical”)
rue Albert 1er
– National Health Fund (“Caisse Nationale De Santé”)
125 route d’Esch
– National Research Ethics Committee (“Comité National d’Ethique de Recherche”)
1a-b rue Thomas Edison
– Pharmacy and Medication Department (“Division de la Pharmacie et des Médicaments”)