Japanese-American Biopharmaceutical Industry in the 21st Century Optimizing Ethical Drug Availability

Between These Two

Pharmaceutical Superpowers"

The Japanese-American biopharmaceutical industry represents an ongoing international effort between the two top pharmaceutical markets in the world. These two economic powers provide consumers with a majority share of all pharmaceuticals produced in the world. However, a number of pharmaceutical products that are currently available to U.S. residents are unavailable to Japanese consumers. From a humanitarian perspective, this discrepancy denies access to life-enhancing and life-saving drugs to the Japanese population. An economic perspective indicates that excluding pharmaceuticals from the Japanese market causes an increase in prices in other markets, since fewer pharmaceuticals can be sold on a worldwide basis.

The problem that will be addressed in this study is how the United States and Japan can work collaboratively to optimize the availability of ethical pharmaceuticals so that every American and Japanese citizen is permitted free access to life-enhancing and life-saving drugs.

List of Figures

Chapters

Introduction

Statement of the Problem

Importance of the Problem

Definition of Terms

Limitations and Delimitations

Review of the Literature

1990 to 1996

1997 to 2002

Methodology

Research Design

The Hypothesis

Special Tests

Statistical Procedures Used

Data Gathering

Population Descriptions

Results

Statement of the Results

Statistical Findings

Summary

Conclusions

68 Supporting Findings

Contradicting Findings

Recommendations

Additional re-search

Implications for revising the current body of knowledge

Change in related practices

Appendices

Table 1 represents the worldwide pharmaceutical market in 1990. This table demonstrates that the Japan is second to the United States in total dollar amount at $29.6 billion and medical cost per capita at $166.

List of Figures

Figure 1 represents the total global pharmaceutical expenditures for research and development initiatives by country. This demonstrates that Japan is only second to the United States in total Market. This figure demonstrates the importance of the routing and entry mechanisms involved in pharmaceutical delivery to Japanese residents. A breakdown of drug sales at the top of the figure reveals that a large majority of pharmaceutical sales in Japan are derived from a combination of prescription and over-the-counter drugs. (From DR Reports, P. 6)

Figure 2 represents the Japanese medical expenditures from 1975-1990. This demonstrates that and expenditures for elderly residents have steadily increased during this period, demonstrating the increasing importance of pharmaceuticals for the Japanese population.

Figure 3 represents the primary incidence of specific diseases in Japan. This demonstrates that in Osteoporosis and Cerebral Infarction are highly prevalent in the Japanese population; therefore, these illnesses require additional consumption of pharmaceuticals designed to treat such ailments.

Chapter 1

Introduction

Statement of the Problem number of ethical pharmaceutical products that are currently available to Americans are unavailable to Japanese consumers. From a humanitarian perspective, this occurrence denies access to life-enhancing and life-saving drugs to the Japanese population. An economic perspective indicates that excluding pharmaceuticals from the Japanese market causes an increase in prices in other markets, including the American market, since fewer pharmaceuticals can be sold on a worldwide basis.

The United States and Japan represent the two largest markets for pharmaceuticals in the world, respectively. Until recently, a large number of pharmaceuticals were unavailable for sale and distribution in Japan as a direct result of the following: 1) the rather strict regulatory drug approval process regulated by Koseisho, the Japanese equivalent of the U.S. Food and Drug Administration (FDA), 2) the desire for each economic power to limit the other's access to its own pharmaceutical market for economic and financial purposes, and 3) The strongly regulated and fragmented healthcare system in Japan has failed to stimulate growth to the same extent as the deregulated U.S. environment.

With the recent adoption (April 1990) of the International Conference on Harmonization (ICH), the United States, Japan, and the European Union (EU) have met on five separate occasions over the past decade to continue their ongoing efforts to harmonize the availability of ethical pharmaceuticals in these three areas, which collectively represent the world's three largest pharmaceutical markets. The problem that will be addressed is how the United States and Japan can work together to optimize the availability of ethical pharmaceuticals in both countries so that every American and Japanese citizen is permitted free access to life-enhancing and life-saving drugs.

Importance of the Problem

For millions of Japanese residents that do not possess access to life-altering pharmaceuticals, the significance of such a problem can be a matter of life or death. By excluding the Japanese market...

As a result, fewer new drugs can be developed with existing capital.
As an aside, since the majority of the author's maternal relatives reside in Japan, the desire to gain access to the latest pharmaceutical treatments that are available in the United States is a personal matter. However, it is of critical importance that no American or Japanese citizen should be denied access to the most advanced pharmaceuticals as a result of stringent regulatory policies or economic factors. It is absurd that two of the world's wealthiest and most technologically advanced nations would intentionally limit access to a wide variety of extremely useful pharmaceuticals from each other. The author will identify the reasons for this failure to disclose access to important healing mechanisms and will provide suggestions and ideas for how the U.S.A. And Japan can widen mutual access to each other's pharmaceutical markets.

Definition of Terms

International Conference on Harmonization (ICH): A global effort conducted to create a uniform regulatory approval process for ethical drugs in the United States, Japan, and Europe.

Food and Drug Administration (FDA): The federal regulatory agency within the United States that regulates all foods and legal pharmaceuticals that can be sold. Their mission is to promote and protect public health by legalizing safe and effective products for sale in U.S. markets. The organization is also responsible for monitoring products to ensure continued safety while they are sold on the market. The FDA is a blend of science and law aimed at protecting the consumer.

The Ministry of Health, Labor and Welfare (MHLW, or Koseirodosho): The Japanese equivalent of the U.S. Food and Drug Administration. The Japanese pharmaceutical regulatory system differs significantly from the American system, and the primary law regulating the marketing of pharmaceuticals in Japan is the Pharmaceutical Affairs Law of 1960. Under this regulation, applications for drug marketing approval must proceed through various local and federal government bodies. Applications must begin at the Prefectural Government of the sponsoring pharmaceutical company, the equivalent to U.S. state government. The application is then filed with Koseirdosho, whose Pharmaceutical Affairs Bureau enforces drug regulations regulating drug usage, approval and efficacy. Koseirodosho has established a drug expert committee linked to the Chuikyo, or Pharmaceutical Affairs Council, consisting of academic, research, and medical authorities. The applicant then possesses the opportunity to respond to Chuikyo's decision. Concurrently, the National Institute of Hygienic Sciences and the National Institute of Health Sciences verify the specifications and analytical methods used in the application. The applicant is then given an explanation of the results of the Council's deliberation. A hearing my be held regarding additional documents in answers to directions issued by the Council. Finally, the Minister is requested to approve the drug for marketing. The average time of review and evaluation from the application stage at the Prefectural Government to MHLW approval is typically 18 months for prescription drugs, 10 months for non-prescription drugs, and 6 months for in vitro diagnostics.

Pharmaceutical Research and Manufacturers of America (PhRMA): This organization represents the leading research-based pharmaceutical and biotechnology organizations in the United States, and is devoted to developing medicines that allow patients to live longer, healthier, and more productive lives. The industry invested more than $30 billion in 2001 to discover and develop new pharmaceuticals. PhRMA organizations are leading the way in the efforts to search for new cures for a variety of diseases.

Japan Pharmaceutical Manufacturer's Association (JPMA): The Japanese equivalent of PhRMA. The JPMA is a voluntary organization of research-based pharmaceutical manufacturers that provide contributions to Japanese society by developing new pharmaceuticals. Member companies maintain appropriate communications with the objective to promote balanced public understanding of industry issues and developing solutions to these issues in order to support the thorough development of the industry. As of October 2001, the JPMA consisted of 82 members (including 20 foreign affiliates) and 16 committees. The JPMA consistently works in close cooperation with the International Federation of Pharmaceutical Manufacturers Association (IFPMA).

International Conference on Harmonisation (ICH): The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan, and the United States and experts from the pharmaceutical industries of each of these three regions to discuss the scientific and technical components of product registration. The purpose of this group is to make recommendations regarding the best ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or prevent the need to duplicate testing required during the research phase of new product development. The objective of such harmonization is a more economical use of human, animal and material resources and the elimination of any unnecessary delays in the global development and availability of new pharmaceuticals while maintaining safeguards…