Reimbursement of medicines not available in Poland – judgement of the Supreme Administrative Court

On the 21st of February, the Supreme Administrative Court addressed the possibility of reimbursement for a medicinal product that is authorized but not available in Poland. In practice, this issue applies to medicines covered by a central marketing authorization (valid within the whole EU), but not available in Poland. SAC investigated whether in such a case the medicinal product could be reimbursed under Art. 39 sec. 1 of the Polish Reimbursement Law.

According to the SAC’s judgement, public administration authorities and courts should follow a pro-constitutional approach to interpretation of the law and should not limit to the literal wording of the regulation. Such approach led the SAC to the conclusion that a product which is necessary to save a patient's life or health can be reimbursed under Art. 39 sec. 1 of the Polish Reimbursement Law, even if it was authorized in Poland, but is not available on the market. Thus, the SAC confirmed the possibility of reimbursement of mentioned drugs.

The SAC’s judgements are final. Detailed justification is available under the following link:
http://orzeczenia.nsa.gov.pl/doc/9074118821
http://orzeczenia.nsa.gov.pl/doc/5DD6B7AF5A