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Price- & reimbursement

Price- and reimbursement

New Pharma Law came into effect January 1st  2021. As Iceland is a member of the EU‘s single market via the EEA agreement the law is fully in line with all relevant EU directives and regulations.

The  objective  of  the Act is to ensure a sufficient supply of necessary medicinal products, as efficiently distributed as possible on the basis of fair and equitable competition, and in  accordance  with  the  rules  which  apply  in  the  European  Economic  Area.

It is, furthermore, the objective of the Act and related regulations to ensure as far as possible the quality and  safety of medicinal products and services, increase public information on the use of medicinal products, counter their excessive use and keep costs to a minimum – given the special circumstances of the Icelandic Pharma Market.

The Icelandic Medicines Agency is the regulatory authority and is responsible for price- and reimbursement decisions. To meet the objective of „keep costs to a minimum”, as stated in the Pharma law, the IMA shall take into account price and reimbursement requirements in the Nordic countries.

When deciding allowed wholesale price for general medicines the IMA shall monitor and „take notice of“ the price of the same medicines in the Nordic countries.

General information

When reimbursements decisions are taken in general the following is evaluated:

  • Safety of the drug
  • Clear indication and place in therapy
  • Price in relation to efficacy and in comparisons to already reimbursed drugs
  • Budget impact – how many patients, for how long
  • Reimbursement in Denmark, Norway, Sweden and Finland
The law criteria for Specialty care high-cost medicines (hospital medicines) are:

  • Costly
  • Challenging to administer
  • Only to be used according to clinical guidelines
The IMA has to ask the Medicines Committee of the National Hospital for an opinion before approving new hospital medicines. When deciding allowed wholesale price for hospital medicines the IMA shall take notice of the lowest price in the Nordic countries. However, if there is a contract or an agreement between MAH and buyer, the IMA may publish the average price in the Nordic countries in the official price catalogue.
Further information is available here.

Application process – flowchart