The Regional Administrative Court has accepted the application by Latima, manufacturer of the anti-cancer drug Rigvir, for waiving the Health Inspection Decree of 1st of December 2016, thus recognizing that Latima has not taken unfair commercial practices by placing information regarding Rigvir medication on sites virotherapy.eu and cancervirotherapy.eu. The judgment clearly indicates the flawed assessment of Health Inspectorate and the first instance court concerning medicinal product advertising and its impact on the consumer purchase decision making, underlining that a decision on the purchase and use of a medicinal product is exclusively taken by a doctor. Concurrently, the District Court has stated that in certain situations healthcare professionals may provide information about the "off-label" (non-approved) use of the product, as they do have acquired the decision-making expertise and have access to necessary information sources to evaluate the efficacy of particular “off-label” application.
Also, the District Court has specified that the European Medical Agency has defined the concept of "off-label" as situations where medical products are intentionally used for medical purposes in a form that does not conform to the approved product information. "This practice is not prohibited and is sufficiently widespread. The European Parliament has adopted a resolution signaling to the European Medical Agency to make proposals for developing off-label guidelines. Consequently, the European Union has recognized the widespread use of "off-label" practices also at the official level", says the text of the court decision.
Kristine Jučkoviča, Chief Operating Officer at Rigvir Group, welcomes the judgment of the Regional Court. She emphasizes that the company is not currently considering the possibility of recovering losses from the state due to the consequences of the biased assumptions and unlawful decision of the Health Inspectorate.
"We need to continue our work. We are aware that the state is our ally for both daily work and future objectives", Jučkovica stated.
Latima appealed against the judgment of the Administrative District Court of 29th December 2017. The decision of the Health Inspectorate was canceled by the date of its adoption on 1st December 2016. The court also ruled that the state should pay a state fee to the manufacturer of Rigvir.