Belgium: Digital platform for medical files to be launched

Tine Carmeliet

In early January 2018, the Belgian Minister of Health published an announcement on the creation of a digital platform called the “Personal Health Viewer”. The goal of this digitalisation initiative is to engage patients in the management of their own health. In particular, the platform will enable patients to access their own medical file online and Read More

Belgium: New proposal to cease reimbursement of costly medicinal products after patent expiry

Tine Carmeliet

In December 2017, the Commission of Social Affairs of the Belgian Chamber of Representatives approved the Minister of Health’s proposal to cease the reimbursement of certain medicinal products which after patent expiry remain much more expensive than less costly alternatives. The proposal, which has not been published, must be formally approved by the Chamber of Read More

Belgian Royal Decree on clinical trials adopted

Eveline Van Keymeulen

Recently, the Belgian Government adopted a new Royal Decree regarding clinical trials (Royal Decree), which implements the law of 7 May 2017 on clinical trials with medicines for human use (Clinical Trial Law) (see our update, Belgium adopts law to prepare for Clinical Trial Regulation implementation). Both the Royal Decree and the Clinical Trial Law Read More

Belgium: Stricter checks on price-setting of medicinal products

Veerle Pissierssens

An amendment to the Royal Decree of 10 April 2014 regarding the procedure for setting a price for medicinal products now allows the price administration of the Belgian Ministry of Economic Affairs (Ministry) to request accounting or bookkeeping information and documentation from pharmaceutical companies in relation to medicinal product price-setting dossiers submitted.  A pharmaceutical company that Read More

BeNeLuxA collaboration moves forward with launch of e-platform and two additional pilot projects

Tine Carmeliet

On 6 September 2017, the website of the BeNeLuxA collaboration,, was officially launched (see Belgian and Dutch government press releases).  The BeNeLuxA collaboration is an initiative between Belgium, the Netherlands, Luxembourg and Austria on pharmaceutical policy that aims to ensure sustainable and affordable access to innovative medicines (in particular, orphan drugs) by levelling the Read More