Published: 2017-12-09

A gloss in approval of judgement ii gsk 2765/16 issued by the Polish Supreme Aministrative Court on 6 october 2016

Filip Manikowski
Zeszyty Prawnicze
Section: Glosy
https://doi.org/10.21697/zp.2017.17.1.07

Abstract

Summary

The Supreme Administrative Court judgement which is glossed in this article concerns reimbursement due to a patient for medications not normally available in Poland on a reimbursed prescription but admitted in special cases as an individual (targeted) import on the grounds of a central permit. In this judgement the Court ruled that contrary to the literal interpretation of Art. 39 of the Reimbursement for Medications, Special-Purpose Foodstuffs, and Medical Products of 12 May 2011 (Ustawa z dnia 12 maja 2011 r. o refundacji leków, środków spożywczych specjalnego przeznaczenia żywieniowego oraz wyrobów medycznych; Dziennik Ustaw 2016, Item 1536), patients who have a central permit admitting a medication they are taking for individual (targeted) import can claim a reimbursement for their expenses incurred due to the import of the medication. I fully agree with this ruling, especially as it takes a pro-constitutional approach to the interpretation of the provisions on reimbursed medications.

Keywords:

reimbursement, pharmaceutical law, central marketing authorization, marketing authorization, orphan drugs, rare diseases.

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Citation rules

Manikowski, F. (2017). A gloss in approval of judgement ii gsk 2765/16 issued by the Polish Supreme Aministrative Court on 6 october 2016. Zeszyty Prawnicze, 17(1), 149–161. https://doi.org/10.21697/zp.2017.17.1.07

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