Essential medicines for universal health coverage

Abstract

In the Lancet Commission on Essential Medicines Policies by Veronika Wirtz and colleagues (Jan 28, p 403),1Wirtz VJ Hogerzeil HV Gray AL et al.Essential medicines for universal health coverage.Lancet. 2017; 389: 403-476Summary Full Text Full Text PDF PubMed Scopus (306) Google Scholar substandard, spurious, falsely labelled, falsified, and counterfeit medicines are discussed. The extent of the problem is mainly pervasive in low-income and middle-income countries,2Almuzaini T Choonara I Sammons H Substandard and counterfeit medicines: a systematic review of the literature.BMJ Open. 2013; 3: e002923Crossref PubMed Scopus (157) Google Scholar, 3Hamilton WL Doyle C Haliwell-Ewen M Lambert G Public health interventions to protect against falsified medicines: a systematic review of international, national and local policies.Health Policy Plan. 2016; 31: 1448-1466Crossref PubMed Scopus (56) Google Scholar but we hope to share a recent unprecedented event involving a counterfeit drug in Japan, a country that was thought to have sophisticated medicine quality and safety. Although several costly direct-acting antivirals (DAAs) for hepatitis C virus have caused troublesome budget implications for the country, the approved agents have been universally covered by the national health insurance, with low financial burden for patients. Currently, a single ledipasvir and sofosbuvir combination tablet costs about JPY 55 000 (US$480), and the drug has been prescribed for about 76 000 patients since September, 2015. In January, 2017, a patient informed a drug store in Japan that the tablets he bought had different colours from the previous ones, and the official investigation showed that counterfeit drugs were contained in the formally manufactured bottles.4Ministry of HealthLabour and WelfareOn counterfeits of the hepatitis C drug Harvoni.http://www.mhlw.go.jp/stf/houdou/0000148807.htmlDate: Jan 17, 2017Google Scholar, 5Jiji PressFake hepatitis C drugs found in Nara drugstore chain.Japan Times (Tokyo). Jan 18, 2017; (accessed Feb 10, 2017).http://www.japantimes.co.jpnews/2017/01/18/national/science-health/hepatitis-c-drug-fakes-found-nara-drugstore-chain/#.WJrA4BTPFWEGoogle Scholar They were sold by an unofficial route outside the major wholesalers that the pharmaceutical company contracts. DAAs can be purportedly sold for ten times the Japanese prices in China, where the drugs are not approved yet, and an international black market is suspected to exist. The recent trend of extravagant drug prices in high-income countries might increasingly create the motivation to make falsified and counterfeit medicines. The relevant stakeholders should recognise the problem as a worldwide issue, and pursue more rigorous international cooperation and coordination. We declare no competing interests. KT reports personal fees from Janssen Pharmaceutical KK, Takeda Pharmaceutical Company Limited, Celgene KK, and Pfizer. Essential medicines for universal health coverageAccess to medicines has long been a potent flashpoint in global health, from antiretrovirals to drugs that cure hepatitis C. Indeed, as a new Lancet Commission report, Essential Medicines for Universal Health Coverage,1 asserts, essential medicines should be at the centre of our vision for global health, affecting, as they do, the lives and dignity of people worldwide. Led by Veronika Wirtz, Hans Hogerzeil, and Andy Gray, the Commission identifies lessons learned from 30 years of implementing essential medicines policies. Full-Text PDF Essential medicines for universal health coverage – Authors' replyThe letter from Tetsuya Tanimoto and colleagues raises important questions that deserve a response. First, the WHO Member State Mechanism recommended in November, 2016, that the term counterfeit no longer be used to refer to quality-compromised medical products.1 The unwieldy term substandard, spurious, falsely labelled, falsified, counterfeit medical products, has been simplified to substandard and falsified medical products. In the case presented by Tanimoto and colleagues, the product appears to have been falsified. Full-Text PDF