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The Dutch authorities will compensate companies for additional costs due to the Falsified Medicines Directive

The Netherlands

As a result of the Falsified Medicines Directive, companies are obliged to adapt the packaging of their medicines which leads to additional costs. These additional costs cannot always be compensated by a price increase, due to the Drug Price Act (Wet geneesmiddelenprijzen). As a pharmaceutical company, it might be challenging to maintain a reasonable profit margin in case of a low sales number and a low pharmacy price.

The Ministry of Health, Welfare and Sport in the Netherlands has therefore decided to compensate these additional costs when the following conditions are met:

  • The medicine concerned has an estimated sales volume of less than 250,000 packages in 2018, and
  • The difference between the maximum price per package and the pharmacy purchase price:
    • at an estimated volume of less than 100,000 packages in 2018: is smaller than €0.34 and €0.34 is 3% or more of the pharmacy purchase price;
    • at an estimated volume of 100,000 to 250,000 packages: is smaller than €0.12 and €0.12 is 3% or more of the pharmacy purchase price; and
  • the pharmacy purchase price is not higher than the maximum price per package.

In summary, this applies to products that are cheaper than €11.33/package (in case of a sales volume of <100,000) or cheaper than €4 (in case of a sales volume of 100,000-250,000).

Applications for compensation of these additional costs need to be submitted before 15 December 2018, 12h:

More information can be found here and in Staatscourant Nr. 60878.

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