Poor Quality Pharmaceuticals in Global Public Health

1. Front Matter

   Pages i-xxiii

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2. Introduction: What “Goods” Are Pharmaceuticals?

   • Satoru Kimura, Yasuhide Nakamura

   Pages 1-24

3. Pharmaceuticals in Globalization

   1. Front Matter

      Pages 25-25

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   2. Global Circulation of Imitated Products, Poor Quality Pharmaceuticals, Fake Products, and Health Problems

      • Satoru Kimura, Yasuhide Nakamura

      Pages 27-61

   3. The World Health Organization

      • Satoru Kimura, Yasuhide Nakamura

      Pages 63-68

   4. Quality and Standardization for Globalization

      • Satoru Kimura, Yasuhide Nakamura

      Pages 69-89

   5. Global Rising Tides Associated with Pharmaceuticals

      • Satoru Kimura, Yasuhide Nakamura

      Pages 91-100

   6. A Dead End of IMPACT

      • Satoru Kimura, Yasuhide Nakamura

      Pages 101-116

4. Market and Access in Local Aspects

   1. Front Matter

      Pages 117-117

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   2. A Case Study in Indonesia: Self-medication and Limited Access

      • Satoru Kimura, Yasuhide Nakamura

      Pages 119-147

   3. A Case Study in India: Market as a Safety Net

      • Satoru Kimura, Yasuhide Nakamura

      Pages 149-167

   4. An Example of Healthcare Service Market in Japan

      • Satoru Kimura, Yasuhide Nakamura

      Pages 169-184

   5. Aiming for Global Safety Net—An Interpretation and Lessons

      • Satoru Kimura, Yasuhide Nakamura

      Pages 185-212

   6. Epilog

      • Satoru Kimura, Yasuhide Nakamura

      Pages 213-216

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.

• Quality of pharmaceuticals
• WHO
• IMPACT
• counterfeit drugs
• drug quality
• Intellectual property rights
• corporate social responsibility

• Department of Reference Standards, Pharmaceutical and Device Regulatory Science Society of Japan, Osaka, Japan

  Satoru Kimura

• School of Nursing and Rehabilitation, Konan Women's University, Kobe, Japan

  Yasuhide Nakamura

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.

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