International mechanism to confront medical products falsification as a means to improve the quality of Ukrainian pharmacy
DOI:
https://doi.org/10.24959/uekj.19.24Keywords:
falsified medical products, substandard medical products, unregistered/unlicensed medical products, medicine, medical product, IMPACT, the MEDICRIME conventionAbstract
Aim. To develop recommendations for improving the countering of medical products falsification in Ukraine using the international mechanism to confront, which should lead to increasing the pharmacy.
Results. The international mechanism for countering the falsification of medical products, as shown by the analysis of the WHO documents, the MEDIСRIME Convention and others applies to medicines (both for human and veterinary use), as well as medical devices. The use of “falsified” concept in the Ukrainian legislation in relation to medicines and other products includes, in terms of content, substandard, unregistered/unlicensed and falsified products themselves. This concept does not correspond to the international legal definition of such products. The study concluded that the institutional component of the mechanism to counter the falsification of medical products is a system of international organizations, consisting of organizations working in the field of public health, crime control and assistance in carrying out other measures to counter falsification of drugs. Ukraine, as a member of these organizations, can and should use its capabilities in this area. Organizational support, as a necessary component of the mechanism under consideration, consists in the direct activities of these international organizations in such key areas as preventing the falsification of medical products, detecting falsified medical products and responding to such facts.
Conclusions. The existing international mechanism for countering the falsification of medical products is a system of informational, institutional and organizational support of states for the prevention, detection and appropriate response. To increase the efficiency of using this mechanism in Ukraine, it is necessary to unify the definition of the concept of falsified medical products with the concepts of substandard, unregistered/unlicensed and falsified medical products, which are accepted by WHO.
References
Counterfeit Medicines WHO Fact Sheet No.275 revised February. (2006). Available at: http://whqlibdoc.who.int/fact_sheet/2006/FS_275.pdf
WHO Fact Sheet 31 January 2018 Substandard and falsified medical products. (2018). Available at: https://www.who.int/news-room/fact-sheets/detail/substandard-and-falsified-medical-products
Jack, A. (2012). Faking it. British Medical Journal. Available at: http://www.bmj.com/content/345/bmj.e7836
Lebed, S. O. (2018). Istorychni aspekty ta suchasnyi stan falsyfikatsii likarskykh zasobiv v Ukraini. Rivne: Volyn. Oberehy, 238.
Kovalenko, I. A. (2018). Falsyfikatsiia ta obih falsyfikovanykh likarskykh zasobiv: kryminalno-pravove doslidzhennia. Odesa: Vydavnychyi dim «Helvetyka», 210.
Mytrofanov, I. I., Prytula, A. M., Streltsov, Ye. L. (2015). Zlochyny proty zdorov’ia naselennia, shcho porushuiut pravo na yakisne zabezpechennia likarskymy zasobamy: monohrafiia. Odesa: Feniks, 284.
Hutorova, N. (n.d.). Vidpovidalnist za falsyfikatsiiu likarskykh zasobiv: chy stvorena v Ukraini nalezhna pravova baza? Available at: https://www.apteka.ua/article/485029?fbclid=IwAR3oVCZfquoE3zPyj3rgwPIxA7e0ACkzvUp1zM65_8IlTX6D-5JdsKulsHo
Hutorova, N. (n.d.). Falsyfikatsiia likarskykh zasobiv – yak v Ukraini suvorist kryminalno-pravovoi normy poiednuietsia z faktychnoiu bezkarnistiu falsyfikatoriv? Available at: https://www.apteka.ua/article/486071?fbclid=IwAR1hkn0ljj_GHvp4xdep7DOKyV1ihpm7f_yv7HcJ7jhxvPDiMDcDt7LzVTs
Zhytnyi, O. (2012). Naukovyi visnyk Dnipropetrovskoho derzhavnoho un-tu vnutr. sprav, 3(62), 395–403.
Demchenko, I., Soloviov, O. (2014). Poperedzhennia poshyrennia falsyfikovanykh likarskykh zasobiv na mizhnarodnomu ta natsionalnomu rivni. Kyiv: Novyi druk, 196.
Mackey, T. K., Liang, B. A., York, P., & Kubic, T. (2015). Counterfeit Drug Penetration into Global Legitimate Medicine Supply Chains: A Global Assessment. The American Journal of Tropical Medicine and Hygiene, 92(6_Suppl), 59–67. https://doi.org/10.4269/ajtmh.14-0389
Hamilton, W. L., Doyle, C., Halliwell-Ewen, M., & Lambert, G. (2016). Public health interventions to protect against falsified medicines: a systematic review of international, national and local policies. Health Policy and Planning, 31(10), 1448–1466. https://doi.org/10.1093/heapol/czw062
WHO Global Surveillance and Monitoring System for substandard and falsified medical products. (2017) Geneva: World Health Organization; Licence: CC BY-NC-SA 3.0 IGO. Available at: https://www.who.int/medicines/regulation/ssffc/publications/GSMSreport_EN.pdf?ua=1
Konventsiia Rady Yevropy pro pidroblennia medychnoi produktsii ta podibni zlochyny, shcho zahrozhuiut okhoroni zdorovia vid 28.10.2011. (2011). Available at: https://zakon.rada.gov.ua/laws/show/994_a91
Funestrand, H., Liu, R., Lundin, S., & Troein, M. (2019). Substandard and falsified medical products are a global public health threat. A pilot survey of awareness among physicians in Sweden. Journal of Public Health, 41(1), e95–e102. https://doi.org/10.1093/pubmed/fdy092
Attaran, A., Barry, D., Basheer, S., Bate, R., Benton, D., Chauvin, J., … McKee, M. (2012). How to achieve international action on falsified and substandard medicines. BMJ, 345(nov13 22), e7381–e7381. Available at: https://www.bmj.com/content/345/bmj.e7381. https://doi.org/10.1136/bmj.e7381
Zakon Ukrainy “Pro likarski zasoby” vid 4 kvitnia 1996 r., №123/96-VR. (1996). https://zakon.rada.gov.ua/laws/show/123/96-%D0%B2%D1%80
Zakon Ukrainy «Pro zastosuvannia reiestratoriv rozrakhunkovykh operatsii u sferi torhivli, hromadskoho kharchuvannia ta posluh» vid 6 lypnia 1995 r. N 265/95-VR. (1995). Available at: https://zakon.rada.gov.ua/laws/show/265/95-%D0%B2%D1%80WHO
WHO. Definitions of Substandard and Falsified (SF) Medical Products. (2018). Working Definition Document Approved by the Seventieth World Health Assembly. Available at: https://www.who.int/medicines/regulation/ssffc/definitions/en/
Zakon Ukrainy «Pro zakhyst prav spozhyvachiv» vid 12 travnia 1991 r. № 1023-XII. (1991). Available at:
Downloads
Published
Issue
Section
License
Copyright (c) 2019 National University of Pharmacy
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgement of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).