Belgium

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, beneluxa.org, 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

Ethical health platform Mdeon designated as organisation to handle disclosure under Belgian Sunshine Act

Eveline Van Keymeulen

On 22 August 2017, the second Royal Decree implementing the December 2016 Belgian Sunshine Act was published in the Official Gazette. The decree designates the ethical health platform Mdeon as the organisation that will handle the practical aspects of disclosure under the Sunshine Act on behalf of the Federal Agency for Medicines and Health Products Read More

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