Change of the Responsible Pharmacist: The Aspect of EU Concession Law, Especially after the Adoption of the Amendment ZLD-1D

The Slovenian Pharmacy Practice Act (Zakon o lekarniški dejavnosti – ZLD-1) does not provide a direct answer as to whether changing the responsible phar- macist in a company that holds a concession in this field (which, according to the current provisions of the ZLD-1, necessarily implies that the same person must simultaneously assume both the business management of the conces- sionaire company and a majority share in its capital) is admissible from the perspective of concession regulation under ZLD-1. In its decision U-I-166/17 of 5 November 2020, the Constitutional Court of the Republic of Slovenia specifically drew attention to the shortcomings of the ZLD-1 provisions on concessions in this regard. The article examines the issue within the broader context of EU concession law. The authors argue that changing the responsi- ble pharmacist may be permissible, provided that, taking into account specific circumstances of such an organisational change, it remains within the limits of

»structural changes during the performance of the concession«, as described in paragraph 77 of preamble of Directive 2014/23/EU.

Key words: pharmacy, Pharmacy Practice Act, concession, EU Law, directive, healthcare.