Medical Technology in Japan

The Politics of Regulation

Christa Altenstetter

• Publisher: Routledge
• Year: 2017
• ISBN:
  9781351506199
• Edition: 1
• Topic: Medicine
• Subtopic: Medical Technology & Supplies

Japan is suffering from a "device gap." Compared to its American and European counterparts, Japan lags in adopting innovative medical devices and making new treatments and procedures available to its patients. Many blame its government and bureaucracy for Japan's delayed access to modern medicine and new medical devices. Christa Altenstetter examines the contextual social, historical, and political conditions of Japan's medical field to make sense of the state of the country's medical profession and its regulatory framework. She explores the development of regulatory frameworks and considers possibilities for eventual reform and modernization. More specifically, Altenstetter looks into how physicians and device companies connect to the government and bureaucracy, the relationships connecting Japanese patients to their medical system and governmental bureaucracy, and how the relationships between policymakers and the medical profession are changing. The issues addressed here are becoming increasingly relevant as numerous countries in Asia, Latin America, and Central and Eastern Europe are only now beginning to regulate medical technology, following the lead of the US and the European Union. Those interested in global medicine and Asian studies will find this book both informative and compelling.

1

Introduction

Japan suffers from a severe medical device lag, including in vitro diagnostic products (IVDs). This lag is conventionally understood as the absence of treatment and procedures that are available to patients in Europe and the United States on average three to five years earlier than in Japan. The lag can alternatively be described as treatment obtained only after considerable delays. To remedy this deficit, the Japanese government has engaged in building regulatory capacity, reorganizing existing regulatory structures, and bettering its medical-clinical infrastructures through a variety of initiatives, programs, and actions since 2005. Reform is ongoing.

This study seeks to explain the driving forces that have shaped medical technology regulations (both on paper and in practice), how and why these forces differ from other nations, and how and why they have changed in recent years. To do so, it integrates a theoretical approach with historical assumptions about how institutions evolve: how they change, resist change, or adjust and transform to meet new circumstances and developments (Thelen, 2003: 208–240; Hall, 2003: 373–404; Pierson and Skocpol, 2002: 693–721). Thelen also speaks to “mechanisms of institutional reproduction” (2003: 210–211) and “institutional layering.” The research found several traces of institutional reproduction and layering on several administrative levels: both at the macro and micro levels of the Japanese political-administrative system. Depending on the regulatory issue under consideration, some tools have substantial implications for the practice of medicine, the delivery of health services, and the use of medical devices in diagnosis and treatment, including clinical research. Several distinct but interlinked narratives will be offered explaining why Japanese patients have not benefited from the revolutionary advances of medical technologies of the last two decades, and why they are still disadvantaged compared to their American and European cousins. To provide the political and institutional context of medical technology regulation, the study draws on an extensive reading of scholarship in three disciplines (government and politics—including health policy analysis—law, and medicine). These sources provide valuable institutional and organizational foundations for this study of regulatory policy on medical devices in Japan.

Power and lobbying merit close attention. Yet reducing explanations to politics alone is simplistic. Knowing the content of regulatory policy and taking into account an array of highly complicated substantive details are necessary before any meaningful assessments of Japanese regulatory practices can be offered. Most relevant substantive details for achieving the twin objectives of medical technology regulation—reviewing and approving medical devices for trade while also securing patient safety concerns and releasing them for treatment in a timely fashion—are buried under layers upon layers of rules, technical details, and legal codes.

From the theoretical perspective of historical institutionalism, medical device regulatory policy is embedded in culture, law, and institutions both at the macro and the micro levels of the political system. This perspective also has implications for the advisory council and scientific committees and how they are anticipated to provide domain knowledge and expertise and hence contribute to the final decisions on regulatory policy of medical technologies. To set the stage for the recent regulatory developments and activities in the device sector in Japan in recent years, I show how the medical device-specific regulatory institutions have evolved in Japan; how they have changed since 2005 when PAL, the most important legislative project for drugs and medical devices, was adopted; and how and why these institutions and routines are different from those in the United States and the European Union.

The literature on comparative health-care reform (Marmor et al., 2005, 2009; Marmor and Wendt, 2011; Tuohy, 1999; “Legacies and latitude in European health policy,” 2005) and drug regulation is substantial, yet little research has provided comparative analyses of medical devices. The argument is often made that medical device regulation “is too technical” (Interview #8) and, by implication, of little interest to the social science community. This commentary is not convincing. How do we know what the conflicts among various parties are all about and why they arise, unless we disentangle the layers of technical norms and legal procedures and identify the various professional, political, and bureaucratic “mechanisms of institutional reproduction” (Thelen, 2003: 210–211) and channels of communication? On the other hand, law has largely disappeared from the mainstream curriculum of political science and public policy, despite Theodore J. Lowi’s (1972; 1973) early invitation to public policy scholars to not only ask what is policy as policy (government intentions), but also what is policy as law (procedures). Given the technological complexity of the subject matter and the high product differentiation, ignoring “technical details” is not an option.¹ Neither can the various political and institutional factors that impact regulatory policymaking in Japan be ignored.

Most laypeople, regardless of whether they live in the United States, Japan, or Europe, are unaware of the range of medical devices, their multiple uses, and their benefits to patients and physicians in diagnosis and treatment, including the implantation of devices into the human body. This is why the first task requires identifying the descriptive characteristics of medical devices, the regulatory framework of medical devices, and the industrial sub-sector of medical devices, as well as clarifying technical issues. Drugs and medical devices share one property: they interact with the human body; but all common properties end there.

A hospital management expert and long-time observer of health-care delivery in Japan (Interview #43) explained five distinct properties of medical devices that drugs do not have. These properties merit close attention because they clarify why medical devices are not drugs. First, a medical device can be implanted in the body and is not supposed to leave the body, such as an artificial knee, hip, or breast implant. Second, a medical device can be in the body but is ultimately removable based on the doctor’s judgment, such as a screw. Third, a medical device can be in the body only temporarily (about five or ten minutes), such as a suture used during a procedure. Fourth, a medical device can touch the body and transmit energy, such as a thermal bandage. Finally, a medical device can either touch the body or collect information, such as a stethoscope.

From the above, it is obvious why physicians and surgeons play such an important role in patient outcomes apart from patients themselves, and why medical devices should not be treated as if they were drugs. Table 1.1 illustrates the broad spectrum of medical devices where individual devices make contributions distinct from drugs to health and patient outcomes and whose function and risk levels vary enormously. Yet despite these differences, all medical devices and approximately 370 in vitro diagnostic products (IVDs) on the Japanese market are regulated under the drug regime.² The submission of medical technology regulation under the drug regulatory framework in Japan has been the target of severe and enduring complaints by domestic and foreign device makers alike.

Table 1.1. Examples of medical devices.

• Anesthetic machines and monitors

• Apnea monitors

• Artificial eyes

• Blood transfusion and filtration devices

• Breast implants

• Cardiac monitors

• Cardiopulmonary bypass devices

• Clinical thermometers

• Condoms

• Contact lenses and prescribable spectacles

• CT scanners

• Defibrillators

• Dental equipment and dentures

• Dental material and restoratives

• Diagnostic kits and tests

• Dialyzers

• Electrosurgery devices

• Endoscopes

• Enteral and parenteral feeding systems

• Equipment for disabled people

• Examination gloves

• Fetal monitors

• Hearing aids and inserts

• Heart valves

• Hospital beds

• Hydrocephalus shunts

• Incontinence pads and controllers

• Intrauterine devices

• Intravascular catheters and cannulae

• Lithotripters

• Medical lasers

• Medical textiles, dressings, hosiery, and surgical supports

• Laboratory equipment

• Operating tables

• Orthopedic implants

• Ostomy and incontinence appliances

• Pacemakers

• Physiotherapy equipment

• Prescribing footwear

• Pressure sore relief devices

• Radiotherapy machines

• Resuscitators

• Special support seating

• Sphygmomanometers

• Stents

• Suction devices

• Surgical instruments and gloves

• Sutures, clips, and staples

• Syringes and needles

• Ultrasound imagers

• Urinary catheters, vaginal speculae, and drainage bags

• Ventilators

• Walking aids

• Wheelchairs

Source: Health Industry Task Force (2004). Adapted from Fabio Pammolli et al., Medical Devices: Competitiveness and Impact on Public Health Expenditure. Competiveness, Markets and Regulation (CERM), Rome. Study prepared for the Directorate Enterprise of the European Commission. July 2005: 11.

From the above, it is clear that medical devices are definitely not pills, nor are they derivatives of drugs. Neither are the two industries structurally identical cases (Altenstetter and Permanand, 2007). Four structural differences between the two sectors need to be differentiated, as they are the source of distinct political dynamics in each sector: first, the dominance of globally operating multinational drug companies in contrast to a majority of small- and medium-sized device-making companies, in addition to a few globally operating device makers. Second, patenting drugs and patenting medical devices are functionally not identical. Patenting medical devices in their entirety is not possible; only the basic principles of a medical device are patentable and can be used in different applications. Third, the long-term research and development process of drugs and devices greatly differ: drug testing primarily occurs in a controlled environment ex ante and limited observations ex post. While this is not the case for medical devices, with limited ex ante clinical trials, the only way to establish safety, performance, and efficacy are ex post clinical trials. Fourth, the medical device innovation process is incremental by nature. For example, pacemakers or orthopedic implants are improved in small steps from one generation to the next. A note to readers: While those two terms, efficacy and efficiency, may at first appear to be synonymous and interchangeable; in fact, they are distinct constructs. Efficacy refers to health outcomes achieved under ideal laboratory conditions, while effectiveness recognizes that outcomes are achieved under routine clinical con...

Table of contents

• Cover
• Half Title
• Title Page
• Copyright Page
• Table of Contents
• List of Tables
• Acknowledgments
• Abbreviations
• 1 Introduction
• 2 Knowledge, Analyses, and Experiences
• 3 Medical Technology Regulation
• 4 The Pharmaceutical Affairs Law (PAL)
• 5 Responses to Global Pressures
• 6 Organizational Reform and Government Responsibilities
• 7 Advisory Committees, Science, and Reimbursement
• 8 Initiatives, Operations, and Processes
• 9 Realities of Clinical Medicine
• Summary and Concluding Comments
• Bibliography
• Index