Netherlands

Dutch guidance on inducements by medical devices companies published

Iradj Nazaryar

On 31 August 2017, the Dutch Ministry of Health published Policy Rules providing guidance on the ban on inducements, which was introduced by the amendment of the Dutch Medical Devices Act of 17 May 2017.  The amendment establishes a prohibition on inducements, whether in cash or in kind, offered by medical device suppliers to professionals 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

Dutch Data Protection Authority publishes guide on cloud storage of patient data

Iradj Nazaryar

The Dutch Data Protection Authority (DPA) recently published a guide intended for healthcare providers about the cloud storage of patient data. The guide provides a practical interpretation of the DPA’s Guidelines on personal data protection (2013) which indicate how healthcare providers can fulfil data protection obligations. The key points within the guide refer to: Patient 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

Dutch Medicines Evaluation Board publishes assessment criteria for combination packages

Iradj Nazaryar

The Dutch Medicines Evaluation Board (MEB) recently published the “Assessment criteria for combination packages” policy document (MEB 47).  The MEB 47 sets out the conditions that the MEB applies for assessing and authorising combination packages, i.e. packages with more than one medicinal product that are marketed under a single trade name and marketing authorisation. The Read More