Belgium

BeneluxA collaboration joint pricing negotiations fail

Eveline Van Keymeulen

The first joint pricing negotiations for a medicinal product in the context of the BeneluxA collaboration with respect to health technology assessment and pricing and reimbursement have failed. On 23 May 2017, the Belgian Minister of Health announced that the Belgian National Institute for Health and Disability Insurance (RIZIV), joined by the Dutch competent authorities, Read More

Belgian Sunshine Act enters into force

Eveline Van Keymeulen

On 23 June 2017, the Royal Decree implementing the December 2016 Belgian Sunshine Act was published in the Official Gazette. The Royal Decree marks this date as the official entry into force of the Sunshine Act, which requires a large category of life sciences companies to notify the Federal Agency for Medicines and Health Products Read More

Belgium: FAMHP issues guidance for clinical trial pilot project

Eveline Van Keymeulen

Following the April 2017 adoption of the new Belgian law on clinical trials with medicines for human use, which implements the new Clinical Trial Regulation (Regulation (EU) No 536/2014), and a first call for applicants for a pilot project in January 2017, the Federal Agency for Medicines and Health Products (FAMHP) has now adopted guidelines Read More

Proposal on Horizon Scanning for pharmaceuticals for the BeNeLuxA collaboration published

Veerle Pissierssens

On 20 April 2017, the Belgian Healthcare Knowledge Centre (KCE) published its proposal on horizon scanning (HS) for pharmaceuticals. The proposal forms part of the work of the “BeNeLuxA Collaboration”, a collaboration between the Belgian, Dutch, Luxembourg and Austrian governments on pharmaceutical policy, focusing on HS, health technology assessment, and pricing and reimbursement. The KCE Read More

Belgium’s absolute advertising prohibition for oral and dental care services incompatible with EU law

Charlot Van Der Jeucht

On 4 May 2017, the EU Court of Justice (CJEU) ruled that a general and absolute prohibition of any advertising for the provision of oral and dental care services is incompatible with EU law (Case C-339-15). The Court found that Directive 2000/31 on electronic commerce as well as the freedom to provide services laid down Read More