Legal regulation of the medicines reimbursement in Ukraine: implementation of international experience

Автор(и)

  • Nataliia Maika West Ukrainian National University
  • Yulia Trufanova West Ukrainian National University
  • Rostyslav Lukashov West Ukrainian National University

Ключові слова:

reimbursement, medicines, state regulation of pharmaceutical industry, availability of medicines, state guarantees

Анотація

The article is devoted to the problems of legal adjusting of relations concerning the reimbursement of the cost of medical services by the state for the benefit of subjects of the pharmaceutical industry: manufacturers, pharmacies, healthcare institutions, etc. The nature of reimbursement relations was investigated.

Current domestic legislation on reimbursement is fairly new and is the result of implementing the principles of regulatory policy in the field of health care adopted in the EU. It was also developed to implement the provisions of the Association Agreement between Ukraine and the EU. Therefore, it is logical to conclude that the domestic legislation has a number of disadvantages, in particular regarding the extremely narrow list of diseases for the treatment of which medicines can be reimbursed. In addition, the fact that only the NHSU may be party to reimbursement agreements significantly reduces the opportunities for practical implementation of state guarantees in the sphere of public health care. Instead, expanding the scope of subjective relationships at the expense of local governments will significantly increase the effectiveness of public policies on the availability of medicines.

The analysis of foreign experience has made it possible to establish the effectiveness of such principles of the reimbursement system as therapeutic expediency and value for money / treatment. These principles are the foundations of the reimbursement systems in Germany, France, the United Kingdom, the Baltic States, the Czech Republic, Slovakia, etc. The attention is also drawn to the experience of the United Kingdom in maintaining a register of medicinal products which may be subject to reimbursement mechanisms, the inclusion to which is based solely on information about the efficacy of such medicinal products as confirmed by clinical trials. All of this requires further study in order to introduce the legal support of the medicines reimbursement relations into the domestic practice.

Завантажити

Дані для завантаження поки недоступні.

Посилання

Pinchuk, D. V. (2019). Rehuliatorna polityka u sferi torhivli likarskymy zasobamy [Regulatory policy in the sphere of trade in medicinal products]. Extended abstract of candidate’s thesis. Kyiv [in Ukrainian].

Maidanyk, R. A. (2014). Dostup do likarskykh zasobiv v ukraini: pryntsyp spivrobitnytstva i yurydychna model farmatsevtychnoho rynku [Access to medicines in Ukraine: the principle of cooperation and the legal model of the pharmaceutical market]. Pravo i hromadianske suspilstvo – Law and civil society, 1, 165-176 [in Ukrainian].

Poltavtseva, A. S. (2014). Funktsionuvannia systemy reimbursatsii: yevropeiskyi dosvid dlia Ukrainy [Functioning of the reimbursement system: European experience for Ukraine]. Aktualni problemy derzhavy i prava – Actual problems of the state and law, 71, 226-232.

Konstytutusiia Ukrainy [Constitution of Ukraine ] (1996, July 28). Retrieved from https://zakon.rada.gov.ua/laws/show/254%D0%BA/96-%D0%B2%D1%80 [in Ukrainian].

Zakon Ukrainy «Osnovy zakonodavstva Ukrainy pro okhoronu zdorovia: pryiniatyi» 19.11.1992. [Law of Ukraine «Basics of Ukrainian legislation on health care» from November 19 1992] ( 1992, November 19). Retrieved from https://zakon.rada.gov.ua/laws/show/2801-12#n18 [in Ukrainian].

Zakon Ukrainy «Pro likarski zasoby pryiniatyi» 04.04.1996. [Law of Ukraine «About medicines» from April 04 1996] (1996, April 04, No. 123/96-VR.) Retrieved from https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80 [in Ukrainian].

Uhoda pro asotsiatsiiu mizh Ukrainoiu, z odniiei storony, ta Yevropeiskym Soiuzom, Yevropeiskym spivtovarystvom z atomnoi enerhii i yikhnimy derzhavamy-chlenamy, z inshoi storony [Association Agreement between Ukraine, on the one hand, and the European Union, the European Atomic Energy Community and other member states, on the other hand] (2014). Retrieved from https://zakon.rada.gov.ua/laws/show/984_011#n2574 [in Ukrainian].

Skaskiv, T. (2017). Vidpovidnist medychnoi reformy vymoham Uhody pro asotsiatsiiu Ukrainy z YeS: pohliad yurysta [Compliance of the medical reform with the requirements of the Association Agreement of Ukraine with the European Union: a lawyer's view]. Ukrainskyi medychnyi chasopys – Ukrainian medical journal. Retrieved from https://www.umj.com.ua/wp/wp-content/uploads/2017/10/UkraineEU-1.pdf?upload [in Ukrainian].

Voron, R. M. (2010). Reimbursatsiia yak zasib hospodarsko-pravovoho rehuliuvannia tsinoutvorennia farmatsevtychnoi produktsii [Reimbursement as a means of economic and legal rehuliovannya tsinutvorennia pharmaceutic products]. Pravo i suspilstvo – Law and society, 5, 105–109 [in Ukrainian].

Poltavtseva, A. S. (2014). Funktsionuvannia systemy reimbursatsii: yevropeiskyi dosvid dlia Ukrainy [Functioning of the reimbursement system: European experience for Ukraine]. Aktualni problemy derzhavy i prava – Actual problems of the state and law, 71, 226-232 [in Ukrainian].

Bielichenko. A. V. (2010). Derzhavne rehuliuvannia zabezpechennia naselennia likarskymy zasobamy [State regulation of providing the population with medicinal products]. Extended abstract of candidate’s thesis. Kharkiv [in Ukrainian].

Nemchenko, A. S. & Kurylenko, Yu. Ye. (2017). Analiz normatyvno-pravovykh aktiv shchodo derzhavnoho rehuliuvannia tsin na likarski zasoby dlia likuvannia sertsevo-sudynnykh zakhvoriuvan [Analysis of legal acts regarding the state regulation of prices for drugs for the treatment of cardiovascular diseases] Sotsialna farmatsiia v okhoroni zdorovia - Social pharmacy in health care, 3 (3). 12-20 [in Ukrainian].

Soldatenko, O. (2010). Reimbursatsiia yak odyn iz vydiv finansuvannia vydatkiv na okhoronu zdorovia [Reimbursement as one of the types of financing of health care expenses]. Viche – Viche. Retrieved from http://veche.kiev.ua/journal/1963/ [in Ukrainian].

Завантаження

Опубліковано

05.02.2023

Номер

Розділ

ЦИВІЛЬНЕ ПРАВО І ЦИВІЛЬНИЙ ПРОЦЕС. СІМЕЙНЕ ПРАВО. МІЖНАРОДНЕ ПРИВАТНЕ ПРАВО. ГОСПОДАРСЬКЕ ПРАВО. ГОСПОДАРСЬКО-ПРОЦЕСУ

Як цитувати

Схожі статті

Ви також можете розпочати розширений пошук схожих статей для цієї статті.