Medical devices

Excessive pricing practices in the pharmaceutical sector – NCAs’ scrutiny continues

Nele De Backer

Last week, the Belgian and Italian consumer associations Test Aankoop/Test Achats and Altroconsumo filed complaints with their respective national competition authorities, alleging that the pharmaceutical group Biogen is abusing its dominant position by charging excessively high prices for the medicine Spinraza, which it has the exclusive right to market as an orphan drug until 2029. Read More

Report on Competition Policy 2018: The pharmaceutical sector remains a priority

Francesca Miotto

Last week, the European Commission (EC) published its Report on Competition Policy 2018, which provides a non-exhaustive summary of the activities undertaken by the EC in the field of competition law and policy in the year 2018.Whilst this report does not specifically refer to the pharmaceutical sector, the accompanying Commission Staff Working Document, which was Read More

Belgium amends procedure for notification of implants and certain invasive medical devices

Kaat Van Delm

On 1 June 2019, a new Royal Decree (dated 7 April 2019) altering the notification procedure for implants and certain invasive medical devices for long-term use entered into force. Previously, the Belgian Sickness and Invalidity Institute (RIZIV/INAMI) needed to be notified if implants and certain invasive medical devices were used long-term, while distributors of medical Read More

Belgium amends procedure for notification of implants and certain invasive medical devices

Kaat Van Delm

On 7 April 2019, a law altering the notification procedure for implants and certain invasive medical devices for long-term use was adopted. Previously, the Belgian Sickness and Invalidity Institute (INAMI) needed to be notified if implants and certain invasive medical devices were used long-term, while distributors of medical devices were required to register with the Read More

New Dutch Policy rule on the interpretation of “medical device”

Alex Crespo van de Kooij

The Dutch Health Minister has introduced a Decision setting out a policy rule on the interpretation of the definition of medical device (medisch hulpmiddel), as laid down in the Act on medical devices (Article 1, first paragraph, under a). The Decision was published on 4 April 2019 and entered into effect on the same date. Read More