20.500.12556/DKUM-97754 A regulatory and pricing divergence in pharmaceutical markets EU, Slovenia, U.S. A regulatory and pricing divergence in pharmaceutical markets: EU, Slovenia, U.S. This paper examines the chosen aspects, circumstances and frameworks in the field of pharmaceuticals. The Authors first investigate the role of the U.S., Slovenian and the EU bodies that regulate, monitor and supervise the functioning of the pharmaceutical industries. Both, the EU’s agency EMA and the U.S.’s administration FDA, try to achieve the same purpose – to establish and maintain public health and safety. With their qualifications and power, they greatly contribute to the quality of medicinal products on both markets. However, there is one big difference between them. That is the power over making the medicines available and the setting of prices. While the EMA and for example JAZMP, the Slovenian competent authority, have the control over this financial aspect, FDA does not. The paper further on examines, what are the checks and boundaries for the setting of prices and in this regard, what is regulated within the legislative framework of Slovenia, the EU and the U.S. The fact that health is a fundamental right in EU Member States, but not in the U.S., alone explains the striking divergence in the cost of drugs in the EU as compared to the U.S. Članek obravnava izbrane vidike, okoliščine in pravne ureditve na področju farmacevtskih izdelkov. Avtorja najprej preučita vlogo organov ZDA, Slovenije in EU, ki regulirajo, spremljajo in nadzirajo delovanje farmacevtske industrije. Tako agencija Unije EMA kot tudi ameriška agencija FDA si prizadevata za isti cilj – vzpostavitev in ohranitev javnega zdravja in varnosti. S svojimi kompetencami in pristojnostmi pomembno prispevata h kakovosti zdravil na obeh trgih. Med njima pa obstaja ena velika razlika. To je pristojnost za zagotavljanje dostopnosti zdravil in določanje cen. Medtem ko imajo EMA in na primer JAZMP, slovenski pristojni organ, nadzor tudi nad finančnim vidikom, FDA te pristojnosti nima. V nadaljevanju članek preučuje, kakšni so mehanizmi nadzora in omejitve za določanje cen in kako je slednje urejeno v pravnem sistemu Slovenije, EU in ZDA. Že samo dejstvo, da je zdravje temeljna pravica v državah članicah EU, v ZDA pa ne, pojasnjuje izrazito razliko v cenah zdravil v EU v primerjavi z ZDA. pharmaceuticals pharmaceutical law setting of drug prices medicinal products prices comparison of the US EU and Slovenian legal framework true false false Angleški jezik Slovenski jezik Neznano 2026-04-10 03:16:44 2026-05-28 11:50:09 2026-05-29 03:17:38 0000-00-00 00:00:00 2026 0 0 str. 1-41 no. 1 Vol. 19 2026 0000-00-00 Zaloznikova NiDoloceno NiDoloceno 0000-00-00 0000-00-00 2026-01-01 339.13:61 274544387 10.18690/mls.19.1.1-42.2026 2463-7955 https://journals.um.si/index.php/medicine/en/article/view/5975 1 f0ee136d-347a-11f1-92c6-00155d0001a1 https://dk.um.si/Dokument.php?lang=slv&id=205165 1_heller_(2).pdf 1_heller_(2).pdf 1 DB6D3C2C75DB13DF5BE6EC97CE28F652 5ae9b1ce5ff7f3efb0ea8f6e2c257fe2546d186113a4404489bd9785dafc8b10 99561455-5a7a-11f1-a150-00155d580e34 https://dk.um.si/Dokument.php?lang=slv&id=206506 Pravna fakulteta Medicine, law & society 0 0 0