Introduction
The Stockholm Administrative Court of Appeal recently considered whether financial aspects can be assessed when determining whether there are special requirements for granting a named patient permission. The court dismissed arguments that high prices and limited availability of an authorised medicinal product constituted special requirements for a named patient permission for an unauthorised medicinal product. The assessment of the need for a named patient permission must be based on an assessment of available medicinal care. The court’s reasoning prevents the marketing authorisation system from being put out of balance by medical prescriptions and reduced prices of unauthorised products.
Named patient permission
On February 19 2014 the agency rejected a named patient permission application for a medicinal product that was not authorised in Sweden. The medicinal product was used to treat familial amyloidotic polyneuropathy syndrome (also called Corino Andrade’s disease), which is a degenerative neurological condition. The agency stated that an authorised medicinal product was already available on the Swedish market to treat the disease. However, based on a recommendation by the Association of Local Authorities and Regions, due to the product’s high price and the fact that it was not included in the reimbursement scheme, the approved product should be prescribed to a limited number of patients only where treatment was deemed indispensable for each patient.
The pharmacy and the individual patient appealed to the Uppsala Administrative Court, arguing that the product authorised in Sweden was effectively unavailable to the patient due to the association’s recommendation and the product’s high price. Thus, there was a special requirement for a named patient permission.
The Uppsala Administrative Court held that it was unclear whether the patient’s medicinal needs could be satisfied by the product that has been approved in Sweden and referred the case back to the agency on the grounds that the patient would not receive adequate treatment if a named patient permission were not granted. This decision was also appealed, this time by the agency; the Stockholm Administrative Court of Appeal rendered its judgment on October 13 2015.
Decision
The Stockholm Administrative Court of Appeal granted the agency’s appeal, declaring its initial decision correct on all accounts.
The question before the appeal court was whether there are special reasons to grant a named patient permission for an unauthorised medicinal product where an authorised medicinal product is available on the Swedish market that can satisfy the patient’s medicinal needs, but the patient cannot be expected to be able to pay for it.
In light of the ECJ judgment and Medicinal Products Directive, the appeal court held that the possibility to grant a named patient permission and thereby make an exception from the requirement for market authorisation for a medicinal product must be interpreted restrictively. An exception may be granted based only on medicinal grounds in the individual situation. Financial considerations should not form part of the assessment of whether a special requirement exists. Thus, the appeal court granted the agency’s appeal and found that the agency was correct in rejecting the application.
For further information on this topic please contact Jonas Löfgren, Anna Tarring or Annie Kabala at Advokatfirman Lindahl KB by telephone (+46 8 527 70 800) or email (jonas.lofgren@lindahl.se, anna.tarring@lindahl.se or annie.kabala@lindahl.se). The Advokatfirman Lindahl KB website can be accessed at www.lindahl.se.