magistrsko delo
Urška Stevanovič Petek (Author), Suzana Kraljić (Mentor)

Abstract

Magistrsko delo celostno obravnava problematiko dostopnosti zdravil za zdravljenje hipotiroze v Sloveniji in jo umešča v okvir temeljne človekove pravice do zdravja. Ugotavlja, da motnje v delovanju ščitnice, zlasti hipotiroza, v svetu naraščajo, medtem ko je v Sloveniji dostopnost zdravil za to bolezen omejena – na voljo sta le dve zdravili, kar nas postavlja na rep evropske lestvice. Ključen izziv predstavljajo stranski učinki obstoječih zdravil, ki veliko bolnikov silijo v iskanje alternativ. Delo poudari pravico do zdravja kot mednarodno priznano temeljno človekovo pravico, ki vključuje tudi dostopnost do zdravil. Pri tem analizira slovensko pravno ureditev in ključne mednarodnopravne vire, ki vplivajo na razlago te pravice. V iskanju rešitev se magistrsko delo osredinja na regulacijo zdravil, s poudarkom na različnih postopkih pridobivanja dovoljenj za promet z zdravili: centraliziran postopek na ravni EU, postopek z medsebojnim priznavanjem, decentraliziran postopek in zlasti nacionalni postopek v Sloveniji. Poleg sistemske regulative obravnava delo tudi vidik uresničevanja pravic iz obveznega zdravstvenega zavarovanja. V praksi se številni bolniki zaradi neustreznega odziva na razpoložljiva zdravila odločajo za zdravila, dostopna v drugih državah članicah, na beli recept. Čeprav ta zdravila niso vključena v pravice iz obveznega zdravstvenega zavarovanja, zakon v izjemnih primerih omogoča možnost povračila stroškov, če so izpolnjeni določeni pogoji. Delo predstavi tudi dve relevantni sodbi Višjega delovnega in socialnega sodišča, ki osvetljujeta prakso povračila stroškov zdravil v takih primerih. Magistrsko delo tako poudarja potrebo po širši dostopnosti zdravil za hipotirozo in v povezavi s tem analizira mogoče pravne rešitve.

Keywords

medicinsko pravo;človekove pravice;regulativa zdravil;ščitnica;hipotiroza;pravica do zdravja;dovoljenje za promet z zdravilom;pravice iz obveznega zdravstvenega zavarovanja;izjemno povračilo stroškov za zdravila;

Data

Language: Slovenian
Year of publishing:
Typology: 2.09 - Master's Thesis
Organization: UM PF - Faculty of Law
Publisher: [U. Stevanovič Petek]
UDC: 346.5:614.35(043.3)
COBISS: 247567619 Link will open in a new window
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Downloads: 1
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Other data

Secondary language: English
Secondary title: Legal aspects of access to medications for hypothyroidism in Slovenia in light of the right to health
Secondary abstract: The Master’s thesis provides a comprehensive examination of the issue of access to medication for the treatment of hypothyroidism in Slovenia and situates it within the framework of the fundamental human right to health. It finds that thyroid disorders, particularly hypothyroidism, are on the rise globally, while access to medication for this condition in Slovenia is limited—only two medications are available, placing the country at the bottom of the European scale. A key challenge lies in the side effects of the existing medications, which force many patients to seek alternatives. The thesis emphasizes the right to health as a fundamental human right recognized under international law, which also includes access to essential medicines. The analysis covers the Slovenian legal framework and key international legal sources that influence the interpretation of this right. In seeking solutions, the thesis focuses on drug regulation, with particular attention to the various authorization procedures for placing medicines on the market: the centralized EU procedure, mutual recognition procedure, decentralized procedure, and especially the national procedure in Slovenia. Beyond systemic regulation, the thesis also addresses the realization of rights under compulsory health insurance. In practice, many patients, due to inadequate responses to the available medications, resort to drugs accessible in other EU member states, using a private (“white”) prescription. Although such medications are not covered under compulsory health insurance, the law allows for the possibility of reimbursement in exceptional cases, provided certain conditions are met. The thesis also presents two relevant rulings of the Higher Labour and Social Court, which shed light on the practice of cost reimbursement for such medications. Overall, the thesis highlights the need for broader access to hypothyroidism medication and, in this context, analyzes potential legal solutions.
Secondary keywords: medical law;human rights;regulation of medicines;thyroid;hypothyroidism;right to health;marketing authorization for a medicinal products;rights from compulsory health insurance;exceptional reimbursement for medications.;Univerzitetna in visokošolska dela;
Type (COBISS): Master's thesis/paper
Thesis comment: Univ. v Mariboru, Pravna fak.
Pages: 1 spletni vir (1 datoteka PDF (IX, 64 str.))
ID: 26413770