Counterfeit And Falsified Medicines In The Eu
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| Author | : Kohli, Vishv P. |
| Publisher | : Edward Elgar Publishing |
| Total Pages | : 192 |
| Release | : 2021-09-07 |
| Genre | : Law |
| ISBN | : 178897820X |
This timely book investigates the issue of counterfeit and falsified medicines (CFM) in the EU, identifying that this is a problem that lies at the intersection of three spheres of law – medicine, intellectual property (IP), and criminal law. The book highlights key issues such as infiltration of the legal supply chain and the involvement of organised crime, analysing relevant EU law and demonstrating the challenges of CFM.
| Author | : Institute of Medicine |
| Publisher | : National Academies Press |
| Total Pages | : 377 |
| Release | : 2013-06-20 |
| Genre | : Medical |
| ISBN | : 0309269393 |
The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.
| Author | : OECD |
| Publisher | : Org. for Economic Cooperation & Development |
| Total Pages | : 0 |
| Release | : 2020 |
| Genre | : |
| ISBN | : 9789264426986 |
This report, one in a series of studies by the OECD and the European Union Intellectual Property Office (EUIPO), enhances understanding of the issues and challenges facing governments, businesses and society posed by the trade in fake pharmaceutical products. Illicit markets for fake pharmaceuticals are attractive for counterfeiters, given the high profit margins, low risks of detection and prosecution, weak penalties, and the ease with which consumers can be deceived into believing that the counterfeit products are genuine. Counterfeit medicines not only cause economic damage for the sector, but are also a significant threat to public health, since fake medicines are often not properly formulated and may contain dangerous ingredients. Fake pharmaceuticals include antibiotics, lifestyle treatments, pain killers, anti-malarial drugs, diabetes treatments and central nervous system medicines.
| Author | : Mark Davison |
| Publisher | : John Wiley & Sons |
| Total Pages | : 432 |
| Release | : 2011-08-04 |
| Genre | : Medical |
| ISBN | : 1118023668 |
This book overviews and integrates the business and technical issues that pharmaceutical companies need to know in order to combat the major global problem of counterfeit medicines. In addition to discussion of the problems, the author Davison addresses analytical techniques scientists use to detect counterfeits and presents some possible solutions to the threat of counterfeit medical products. Coverage moves from basic overview of the problem, costs / risks to consumers (toxic products, mistrust of drug companies) and business (revenue loss, public trust), government oversight and regulation, authentication strategies (packaging, analytical techniques), product tracking and supply chain, and case studies from around the globe.
| Author | : Yaser Mohammed Al-Worafi |
| Publisher | : Academic Press |
| Total Pages | : 656 |
| Release | : 2020-06-03 |
| Genre | : Medical |
| ISBN | : 0128204125 |
Drug Safety in Developing Countries: Achievements and Challenges provides comprehensive information on drug safety issues in developing countries. Drug safety practice in developing countries varies substantially from country to country. This can lead to a rise in adverse reactions and a lack of reporting can exasperate the situation and lead to negative medical outcomes. This book documents the history and development of drug safety systems, pharmacovigilance centers and activities in developing countries, describing their current situation and achievements of drug safety practice. Further, using extensive case studies, the book addresses the challenges of drug safety in developing countries. - Provides a single resource for educators, professionals, researchers, policymakers, organizations and other readers with comprehensive information and a guide on drug safety related issues - Describes current achievements of drug safety practice in developing countries - Addresses the challenges of drug safety in developing countries - Provides recommendations, including practical ways to implement strategies and overcome challenges surrounding drug safety
| Author | : Rameshwar Verma |
| Publisher | : OrangeBooks Publication |
| Total Pages | : 196 |
| Release | : 2021-05-25 |
| Genre | : Business & Economics |
| ISBN | : |
The Book “Basic concepts of Track and Trace System for Pharmaceutical Industry” is collection of my experience and guide of my Team, the book gives the clear understanding of serialization processes, Global standards, Regulatory requirements and supply chain visibility using various technologies like RFID, Al, IoT and Blockchain etc. Complete understanding of regulatory requirements like DSCSA, EU FMD along with emerging markets. Concise explanations of terminologies. The book basic for beginner and expert the peoples. Who’s want to know all about the track and trace system.
| Author | : Roger Bate |
| Publisher | : AEI Press |
| Total Pages | : 489 |
| Release | : 2012-05-01 |
| Genre | : Business & Economics |
| ISBN | : 0844772348 |
Roger Bate has spend years on the trail of counterfeit medicines in Asia, Africa, and the Middle East, learning the anatomy of a nebulous, far-reaching black market that has resulted in countless deaths and injuries around the world. Phake: The Deadly World of Falsified and Substandard Medicines is the culmination of Bate's research and travels—both a fascinating first hand account of the counterfeit drug trade and an incisive policy analysis with important ramifications for decision makers in the U.S. Food and Drug Administration and the international World Health Organization.
| Author | : Richard A. Crocombe |
| Publisher | : John Wiley & Sons |
| Total Pages | : 608 |
| Release | : 2021-04-28 |
| Genre | : Science |
| ISBN | : 1119636434 |
The most comprehensive resource available on the many applications of portable spectrometers, including material not found in any other published work Portable Spectroscopy and Spectrometry: Volume Two is an authoritative and up-to-date compendium of the diverse applications for portable spectrometers across numerous disciplines. Whereas Volume One focuses on the specific technologies of the portable spectrometers themselves, Volume Two explores the use of portable instruments in wide range of fields, including pharmaceutical development, clinical research, food analysis, forensic science, geology, astrobiology, cultural heritage and archaeology. Volume Two features contributions by a multidisciplinary team of experts with hands-on experience using portable instruments in their respective areas of expertise. Organized both by instrumentation type and by scientific or technical discipline, 21 detailed chapters cover various applications of portable ion mobility spectrometry (IMS), infrared and near-infrared (NIR) spectroscopy, Raman and x-ray fluorescence (XRF) spectroscopy, smartphone spectroscopy, and many others. Filling a significant gap in literature on the subject, the second volume of Portable Spectroscopy and Spectrometry: Features a significant amount of content published for the first time, or not available in existing literature Brings together work by authors with assorted backgrounds and fields of study Discusses the central role of applications in portable instrument development Covers the algorithms, calibrations, and libraries that are of critical importance to successful applications of portable instruments Includes chapters on portable spectroscopy applications in areas such as the military, agriculture and feed, hazardous materials (HazMat), art conservation, and environmental science Portable Spectroscopy and Spectrometry: Volume Two is an indispensable resource for developers of portable instruments in universities, research institutes, instrument companies, civilian and government purchasers, trainers, operators of portable instruments, and educators and students in portable spectroscopy courses.
| Author | : Aníbal de J. Sosa |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 553 |
| Release | : 2009-10-08 |
| Genre | : Science |
| ISBN | : 0387893709 |
Avoiding infection has always been expensive. Some human populations escaped tropical infections by migrating into cold climates but then had to procure fuel, warm clothing, durable housing, and crops from a short growing season. Waterborne infections were averted by owning your own well or supporting a community reservoir. Everyone got vaccines in rich countries, while people in others got them later if at all. Antimicrobial agents seemed at first to be an exception. They did not need to be delivered through a cold chain and to everyone, as vaccines did. They had to be given only to infected patients and often then as relatively cheap injectables or pills off a shelf for only a few days to get astonishing cures. Antimicrobials not only were better than most other innovations but also reached more of the world’s people sooner. The problem appeared later. After each new antimicrobial became widely used, genes expressing resistance to it began to emerge and spread through bacterial populations. Patients infected with bacteria expressing such resistance genes then failed treatment and remained infected or died. Growing resistance to antimicrobial agents began to take away more and more of the cures that the agents had brought.
| Author | : Satoru Kimura |
| Publisher | : Springer Nature |
| Total Pages | : 233 |
| Release | : 2020-01-16 |
| Genre | : Medical |
| ISBN | : 9811520895 |
This book aims to clarify the global aspects of poor quality pharmaceuticals, generic products in particular, becoming complicated through the process of IMPACT (International Medical Products Anti-Counterfeiting Taskforce) organized by the initiative of the World Health Organization (WHO) in 2006. The findings from this book provide a long-term perspective to policymakers. This book discusses from the following points: industrial standardization, healthcare market accessibility, motivation on supply side, WHO medicines policy and intellectual property rights. Standardization regulates the quality and enabled the generic medicines spreading to developing/emerging countries through technology transfer. However, quality is a part of cost and reflected to price. When a healthcare service market is divided according to wealth gap, compliance to standardization for quality on supply side is divided accordingly. Thus, poor quality pharmaceuticals are prevalent worldwide. Generic pharmaceuticals are essential resources in public health. The WHO has been involved in the dispute around the intellectual property rights under its intention to promote the new drug development for neglected diseases. Global pandemic of AIDs is a critical factor to accelerate the confusion. This created feelings of distrust among developing/emerging countries against developed countries if the WHO was in favour of developed countries. In addition to that, an easy and optimistic start of IMPACT stirred up conflicts of interests in the international community. The problem of poor quality pharmaceuticals became more complicated through the conflicts on intellectual property rights; patented drugs to generic drugs. A key for quality generic products is the formation of a single healthcare service market where good motivation on supply side together with fair competitiveness with patented pharmaceuticals and equitable access to services (both for the rich and the poor) are ensured. Political commitment to investment and regulatory infrastructure for the market is crucial.
