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Dutch Minister of Health, Welfare and Sport increases penalty of commercial license holders regarding culpable shortages of medicines

  • United Kingdom
  • Netherlands
  • Health and life sciences

09-12-2016

Précis

The Dutch Minister of Health, Welfare and Sport (in Dutch: Minister van Volksgezondheid, Welzijn en Sport) (“Minister”) announced in a letter to Parliament dated 23 June 2016 that the penalty in respect of culpable shortages of medicines will be increased.

The Minister will do this in two steps:

1.The penalty will be increased from 45,000 euros to 150,000 euros, since this is currently the maximum penalty within the Dutch Medicines Act (in Dutch: Geneesmiddelenwet). Such penalties and violations have been laid down in the Policy Rules administrative penalty (in Dutch: Beleidsregels bestuurlijke boete Minister VWS 2016). The Minster is working on an amendment to the Policy Rules administrative penalty and expects to finish the aforementioned amendment this summer.

2.Afterwards, the maximum possible penalty under the Dutch Medicines Act will be increased to 820,000 euros through a change in the Dutch law, which is also the level of the Commodities Act (in Dutch: Warenwet).

What?

The Dutch Medicines Act contains a best efforts obligation in which a commercial licence holder is responsible for ensuring that medicines in accordance with the commercial licence need to be sufficiently available for wholesalers and pharmacists to fulfill the needs of patients. The legal basis for this obligation is found in article 49 paragraph 9 of the Dutch Medicine Act. Further, the Medicines Act contains a best efforts obligation for wholesalers under article 36 paragraph 2. Those articles are based on article 81 of the Directive 2004/27/EC of the European Parliament and the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use.

So what?

Following a recent shortage of medicines, the Minister increased penalties for culpable shortages of medicines. An investigation is still pending to decide whether or not a pharmaceutical company operating in the Netherlands was liable for not having certain medicines sufficiently available for patients, the shortage of which had a significant impact on some patients. The event also drew a lot of attention in the Dutch media. Consequently, the Minister wrote a letter to Parliament that possible shortages should be notified on time by commercial licence holders. Commercial licence holders and wholesalers now risk a penalty of 150,000 euros after the amendment of the Policy Rules and 450,000 euros after the Dutch Medicine Act is amended if they do not have medicines sufficiently available.

At the moment, two points of contact have been established for the notification of shortages. Foreseeable shortages should be notified to the Medicines Evaluation Board (in Dutch: College ter Beoordeling van Geneesmiddelen, “MEB”) and unforeseeable shortages to the Healthcare Inspectorate (in Dutch: Inspectie voor de Gezondheidszorg, “HI”). Before the end of this year, a single point of contact should be set up by the MEB and HI jointly which should allow for an efficient process which enables notification of anticipated shortages to be received as soon as possible.

For more information contact

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