The key facts about regulatory reform in Luxembourg. Prepared in association with Emmanuelle Ragot, an independent firm anchored in Luxembourg, this is an extract from The Pharma Legal Handbook: Luxembourg, available to purchase here for GBP 99.
*Many laws (11) have been published in Luxembourg in 2020, but 100% of them are in relation to the management of COVID 19.
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.