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Why falsified medicines reach patients: an analysis of political and economic factors in Romania
INTRODUCTION: To protect patients against falsified medicines, countries around the world implement stringent regulations. Despite efforts to protect supply chains in the European Union (EU), authorities continue to find falsified medicine. We studied how in Romania, one of the poorest EU countries,...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10175937/ https://www.ncbi.nlm.nih.gov/pubmed/36731920 http://dx.doi.org/10.1136/bmjgh-2022-009918 |
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author | Nistor, Adina-Loredana Pisani, Elizabeth Kok, Maarten Olivier |
author_facet | Nistor, Adina-Loredana Pisani, Elizabeth Kok, Maarten Olivier |
author_sort | Nistor, Adina-Loredana |
collection | PubMed |
description | INTRODUCTION: To protect patients against falsified medicines, countries around the world implement stringent regulations. Despite efforts to protect supply chains in the European Union (EU), authorities continue to find falsified medicine. We studied how in Romania, one of the poorest EU countries, political and economic factors influence the risk of patients being exposed to falsified medicines. METHODS: For this case study, we reviewed 131 documents and interviewed 22 purposively selected key informants. RESULTS: In Romania, several politically and economically motivated policies have led to persistent medicine shortages. Following the 2007 accession to the EU, fierce competition led to a decline in domestic medicine production. Soon after, the government introduced a tax on reimbursed medicines to support the national health budget. Prior to the 2015 elections, medicine prices were abruptly lowered to provide voters with the cheapest medicine in Europe. The low prices incentivised traders to buy medicines in Romania and sell them elsewhere in the EU. The high taxes and low prices led manufacturers to withdraw medicines from the market and impose product quotas to limit parallel trading. The accumulated effect of these market responses translated into persistent shortages of essential medicine, which have pushed patients and health professionals to unregulated markets with a high risk of exposure to falsified medicine. CONCLUSION: Strategies against falsified medicine with a narrow focus on safeguarding quality in the regulated supply are insufficient. To protect patients, governments must also ensure that patients have access to affordable medicines, as shortages provide an opportunity for those selling fake products. |
format | Online Article Text |
id | pubmed-10175937 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-101759372023-05-13 Why falsified medicines reach patients: an analysis of political and economic factors in Romania Nistor, Adina-Loredana Pisani, Elizabeth Kok, Maarten Olivier BMJ Glob Health Original Research INTRODUCTION: To protect patients against falsified medicines, countries around the world implement stringent regulations. Despite efforts to protect supply chains in the European Union (EU), authorities continue to find falsified medicine. We studied how in Romania, one of the poorest EU countries, political and economic factors influence the risk of patients being exposed to falsified medicines. METHODS: For this case study, we reviewed 131 documents and interviewed 22 purposively selected key informants. RESULTS: In Romania, several politically and economically motivated policies have led to persistent medicine shortages. Following the 2007 accession to the EU, fierce competition led to a decline in domestic medicine production. Soon after, the government introduced a tax on reimbursed medicines to support the national health budget. Prior to the 2015 elections, medicine prices were abruptly lowered to provide voters with the cheapest medicine in Europe. The low prices incentivised traders to buy medicines in Romania and sell them elsewhere in the EU. The high taxes and low prices led manufacturers to withdraw medicines from the market and impose product quotas to limit parallel trading. The accumulated effect of these market responses translated into persistent shortages of essential medicine, which have pushed patients and health professionals to unregulated markets with a high risk of exposure to falsified medicine. CONCLUSION: Strategies against falsified medicine with a narrow focus on safeguarding quality in the regulated supply are insufficient. To protect patients, governments must also ensure that patients have access to affordable medicines, as shortages provide an opportunity for those selling fake products. BMJ Publishing Group 2023-02-01 /pmc/articles/PMC10175937/ /pubmed/36731920 http://dx.doi.org/10.1136/bmjgh-2022-009918 Text en © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Nistor, Adina-Loredana Pisani, Elizabeth Kok, Maarten Olivier Why falsified medicines reach patients: an analysis of political and economic factors in Romania |
title | Why falsified medicines reach patients: an analysis of political and economic factors in Romania |
title_full | Why falsified medicines reach patients: an analysis of political and economic factors in Romania |
title_fullStr | Why falsified medicines reach patients: an analysis of political and economic factors in Romania |
title_full_unstemmed | Why falsified medicines reach patients: an analysis of political and economic factors in Romania |
title_short | Why falsified medicines reach patients: an analysis of political and economic factors in Romania |
title_sort | why falsified medicines reach patients: an analysis of political and economic factors in romania |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10175937/ https://www.ncbi.nlm.nih.gov/pubmed/36731920 http://dx.doi.org/10.1136/bmjgh-2022-009918 |
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