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.
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.
The European Court of Justice (ECJ) interpreted the term ‘special requirements’ under the Medicinal Products Directive in Case C-185/10, in which it held that an exception should be granted only if no equivalent authorised medicinal product is available and if it is motivated based on individual medicinal grounds. Financial considerations cannot in themselves lead to recognition of the existence of special requirements which can justify an exception to the requirement for authorisation.
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.
The decision confirms that it is not possible to assess financial considerations when determining whether there are special requirements for granting a named patient permission. The appeal court’s reasoning is in line with ECJ case law and establishes that only the individual patient’s need for a certain medicinal product should form basis of the assessment.
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 (email@example.com, firstname.lastname@example.org or email@example.com). The Advokatfirman Lindahl KB website can be accessed at www.lindahl.se.