The Oslo District Court concluded last Friday that the Norwegian Medicines Agency’s recent inclusion of Neupogen / filgrastim on the substitution list is invalid. The Norwegian Pharmacy Act, therefore, does not authorize substitution of these biological medicines.
An appeal of the decision must be submitted within four weeks. The Norwegian Medicines Agency writes on its website that the government would review the content of the ruling and decide whether or not to appeal.
The court’s conclusion is as follows:
1. The State’s, by the Ministry of Health and Care, decision of 16 June 2010 to include Neupogen / filgrastim on the pharmacies substitution list is invalid.
2. The State, by the Ministry of Health and Care, shall pay Amgen Europe B.V.’s og Amgen AB Norge NUF’s costs for the case of 1 722 182 NOK, which includes VAT and case costs for the Oslo Enforcement Court case 10-102446TVI-OBYF/2.
3. The State, by the Ministry of Health and Care, shall pay the Industry Association’s costs for the case of 225 375 NOK which includes VAT.
Read the full court ruling HERE.
Published: June 4, 2011