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, 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.

Identifying market risk for substandard and falsified medicines: an analytic framework based on qualitative research in China, Indonesia, Turkey and Romania.

Introduction: Substandard and falsified medicines undermine health systems. We sought to unravel the political and economic factors which drive the production of these products, and to explain how they reach patients. Methods: We conducted in-depth case studies in China, Indonesia, Turkey and Romania. We reviewed academic papers and press reports (n = 840), developing semi-structured questionnaires. We interviewed regulators, policy-makers, pharmaceutical manufacturers, physicians, pharmacists, patients and academics (n=88). We coded data using NVivo software, and developed an analytic framework to assess national risks for substandard and falsified medicines. We tested the framework against cases reported to the World Health Organization, from countries at all income levels. Results: We found that increasing political commitment to provision of universal health coverage has led to public procurement policies aimed at lowering prices of medical products. In response, legitimate, profit-driven pharmaceutical companies protect their margins by cutting costs, or withdrawing from less profitable markets, while distributors engage in arbitrage. Meanwhile, health providers sometimes protect profits by 'upselling' patients to medicines not covered by insurers. Cost-cutting can undermine quality assurance, leading to substandard or degraded medicines. Other responses contribute to shortages, irrational demand and high prices. All of these provide market opportunities for producers of falsified products; they also push consumers outside of the regular supply chain, providing falsifiers with easy access to customers. The analytic framework capturing these interactions explained cases in most high and middle-income settings; additional factors operate in the poorest countries. Conclusions: Most efforts to secure medicine quality currently focus on product regulation. However, our research suggests market mechanisms are key drivers for poor quality medicines, including where political commitments to universal health coverage are under-resourced. We have developed a framework to guide country-specific, system-wide analysis. This can flag risks and pinpoint specific actions to protect medicine quality, and thus health.