Czyżewscy Law Firm lawyers win court dispute with the Minister of Health regarding medicinal product reimbursement

Advocate Tomasz Jan Siemiński was representing a patient in dispute with the Minister of Health regarding reimbursement of medicinal products imported from abroad for patient’s individual needs (direct import procedure). The case concerned a patient suffering from a rare and serious illness.

According to the attending physicians, only administration of a specific medicine could give a chance to improve patient’s health. The medicine has been given the EU marketing authorization but it was not available on the market in Poland. Because of that the patient requested the Minister of Health to issue a permit allowing for direct import of the medicine. Due to a high price of the drug, the patient applied for its reimbursement as well. The Minister of Health allowed the medicine to be imported, however the request for reimbursement was denied.

The Minister of Health argued that in this particular case the reimbursement was not permissible on formal grounds due to the fact that the article 39.1 of the Act of 12 May 2011 on the Reimbursement of Medicines, Foodstuffs Intended for Particular Nutritional Uses and Medical Devices (Act on the Reimbursement) allows only for reimbursement of medicinal products which were not authorized for marketing on the territory of Poland.

The dispute found its conclusion before the Supreme Administrative Court (SAC) which ruled in favour of the legal argumentation presented by the Czyżewscy Law Firm in two separate judgments. The SAC therefore acknowledged that article 39.1 of the Act on the Reimbursement – even before its amendment – allowed for reimbursement of medicinal products authorized for marketing via the direct import procedure not available in Poland, despite the fact that the medicines were given an EU-wide marketing authorization. The SAC ruled that in such circumstances the Minister of Health could not deny the request for reimbursement of the medicine.



back