Belgium - Liberalisation of distribution channel for medical devices
- 30/01/2019
- Articles
A Royal Decree of 18 December 2018 regarding the liberalisation of the distribution channel for medical devices (the “Royal Decree”) was published in the Belgian Official Journal on 28 January 2019. The Royal Decree abolishes a number of provisions for the purpose of allowing supermarkets and other stores to also sell, as from 7 February 2019, certain medical devices that until now could only be sold through pharmacies (these devices are listed in the Royal Decree of 18 March 1999 on medical devices, annex XIII, items 1.1 through 1.5). Belgium thus seeks conformity with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices pursuant to which “Member States shall not refuse, prohibit or restrict the making available on the market or putting into service within their territory of devices which comply with the requirements of this Regulation” (Article 24).
The Royal Decree applies to all medical devices that are available without prescription. In practice, it is expected to impact mainly the distribution of sterile medical devices, such as tubes and band aids, which until now could be sold only through pharmacies. By contrast, the sale of medical devices available on prescription remains limited to pharmacies.
The supermarkets and other stores that will sell medical devices under the Royal Decree will have to meet the same quality, security and traceability criteria as the pharmacies and will need to register in advance with the Federal Agency for Medicines and Health Products.
According to the Minister of Public Health, Maggie De Block, foreign examples show a marked price decrease of medical devices when these are also made available outside the pharmacy channel. The Minister hopes that the Royal Decree will have the same effect on pricing.
Here goes a link to the Dutch and French versions of the Royal Decree of 18 December 2018 :
Royal Decree of 18 December 2018
