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.

Focuses on industrial standardization of pharmaceuticals which makes modern medicines spread around the world as well as quality problems Discusses the IMPACT led by WHO which has misled the discussions on the nature of the problem worldwide Examines the divided markets corresponding to the wealth gap Proposes the poor quality pharmaceuticals are accordingly caused by the failures of government and markets

Autorentext

Satoru KIMURA is a counselor at the Pharmaceutical and Medical Device Regulatory Science Society of Japan, and has been engaged in publishing audio-visual materials about drug-induced social suffering. One of his works (co-author) is 'Drug-Induced Suffering in Japan (Japanese-English).' After graduating from the Biophysical Engineering, School of Engineering Science, Osaka University in 1972, he started his career in the food industry and then, was engaged in duties related to clinical studies and drug safety/pharmacovigilance in American and European affiliated pharmaceutical companies. In March 2017, he completed the Doctor's Program in the International Cooperation Studies, Graduate School of Human Sciences, Osaka University. His Ph.D. thesis investigated, 'Conflicts of Interest around the Quality of Medicines in the International Community.' Since May 2018, he has been a board member at the WHO Association of Japan.
Yasuhide NAKAMURA is a Professor of School of Nursing and Rehabilitation, Konan Women's University and Professor Emeritus of Osaka University.After graduating from The University of Tokyo, and working as a pediatrician at Tokyo Metropolitan Hospital, he started global health to encourage maternal and child health in Indonesia as a Japan International Cooperation Agency (JICA) expert (1986-88) and to promote the refugee health program in UNHCR Pakistan Office (1990-91). Dr. NAMAKURA was a Takemi Fellow (1996-97) in Harvard School of Public Health for international health and worked in the Graduate School of Human Sciences, Osaka University (2000-2017). He is widely interested in conducting research through an interdisciplinary approach in the spirit of the fieldworker; international Maternal and Child Health (MCH) Handbook Programs; humanitarian relief for refugees and victims by natural disasters, and health care systems in Japan.Dr. Nakamura is president of the Japan Association for International Health (JAIH), the representative of International Society of Volunteer Studies and president of the WHO Association of Japan. He got the 43th Medical Achievement Award (Iryo Kourou Sho) in 2015.

Inhalt
Preface.- Global aspect of imitated products and poor quality pharmaceuticals.- Problem awareness among the WHO and other major international organizations.- Precedent academic works and media reports.- Bias or misleading by the WHO?.- Standardization and its advantages in globalization.- Global events associated with modern medicines.- WHO medicines policy in public health.- IMPACT and conflicts of international society.- Case study I: Access to medicines in Indonesia.- Case study II: Supply side of medicines in India.- Case study III: Health-care service market in Japan.- An interpretation and lessons to learn.