Allowing foreign medicines violates Medicines Act
The Netherlands is seeing an acute shortage of medicines. Research by Dutch newspaper ‘NRC’ shows that almost one in seven Dutch patients now relies on medicines from abroad. PhD candidate Koosje van Lessen Kloeke spoke about the issue in ‘Mr’. magazine: ‘Dutch legislation on medicines is flawed’.
NRC's research shows that over 1.6 million Dutch patients are affected by the shortage of medicines. Many of these patients are now going abroad to access them as a result. In 2018, it was decided that in case of a major shortage of medicines, the Healthcare and Youth Inspectorate (IGJ) can grant permission to Dutch manufacturers, wholesalers and pharmacy owners to import medicines with the same active ingredient without a marketing authorisation from a mutual recognition agreement (MRA) country (Australia, Canada, Israel, Japan, New Zealand, Switzerland and the United States).
A recent ruling by the Administrative Law Division of the Council of State shows that this violates the Medicines Act. They argue that the IGJ may only grant permission to pharmacists if it is based on a prior request from a doctor. Van Lessen Kloeke: ‘In this ruling, the Administrative Law Division touches a sore spot: Dutch medicines legislation is flawed on certain points. Instead of making consistent legislation, it’s like a patch-up job that’s no longer working.’
According to the PhD candidate, the current policy is not a sustainable solution to the underlying causes of the shortage of medicines. According to her, this has everything to do with the Dutch government's pricing and reimbursement policy: ‘They don’t want medicines in the Netherlands to cost more than what you paid for an ice-cream at a campsite in the 1980s. This puts enormous pressure on the sustainable availability of critical drugs.' Van Lessen Kloeke argues that this has a paradoxical effect: ‘The hard truth is that imports from abroad to the Netherlands in the event of shortages actually leads to rising costs, because these temporary solutions are often more expensive.’
More information?
Read the full interview (in Dutch) in Mr.
Photo: Anshu A on Unsplash