Opinion Overview of the current system in Japan regarding Beyond-The-Pill

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Ryuiku Masuda, Senior Researcher, Pharmaceutical and Industrial Policy Research Institute (PIIPRI)

Introduction

The key words "Beyond-The-Pill" or "Around-The-Pill" may not have a clear definition, but they have been called out in and outside the industry for several years. Whether domestic pharmaceutical companies should specialize in prescription drug manufacturing and sales, or whether they should expand their business into the manufacture and sale of over-the-counter (OTC) drugs, medical devices, and other diversified businesses is a matter for individual company management to decide, and the purpose of this report is not to discuss the pros and cons of such decisions. On the other hand, it would not be out of place for a person engaged in the pharmaceutical industry to ignore the Beyond-The-Pill. This paper provides a basis for an overview of non-pharmaceutical businesses in the field of health care from the perspective of a pharmaceutical company. Whether the grass is greener on the other side or not, we hope it will be a light for those of us who are engaged in this industry in the future.

1. Background

The Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals and Medical Devices (hereinafter referred to as "Pharmaceutical Affairs Law") forms the basis of pharmaceutical administration, covering pharmaceuticals and medical devices used for the diagnosis, treatment and prevention of diseases, and contributes to the improvement of health and hygiene in Japan. On the other hand, when medical care is viewed more broadly as health care services, including nursing care, health promotion or prevention, and health-related products and services1), there is a vast array of options for health care services at present. From the pharmaceutical industry's perspective, this vast ocean of products and services may be called "Beyond-The-Pill" or "Around-The-Pill. In particular, there are growing expectations for new products and services that provide healthcare-related benefits to patients and healthy individuals, including technological advances in the digital arena. In the U.S., the Digital Therapeutics Alliance (DTx) is already established and active2), and in Japan, an application for the treatment of nicotine addiction has been submitted for approval as a medical device3). 3) In Japan, too, an application for the treatment of nicotine dependence has been submitted for approval as a medical device. Pharmaceutical companies are also considering the entry of DTx into the market as a service associated with pharmaceuticals or as a business other than pharmaceuticals, which is reported as "Around-The-Pill" or "Beyond-The-Pill" 4).

In Japan, the Ministry of Economy, Trade and Industry (METI) and others are promoting the "next-generation healthcare industry" in the Health and Medical Care Strategy.

The Ministry of Economy, Trade and Industry (METI) has indicated the industry group of services outside of public insurance in the field of health care as shown in Figure 1, and has forecasted that the market size will reach approximately 33 trillion yen by 2025. This figure is sometimes referred to as an "egg chart," but if we were to understand it simply, the yellow area (the yolk of the egg) is the area under the jurisdiction of the Ministry of Health, Labor and Welfare, which has been responsible for the administration of health and welfare in Japan, and the white area (the white of the egg) is the area envisioned by METI and other ministries.

Figure 1

In the services in the white space, there are likely to be products and services, including those to be created in the future, that will greatly contribute to health care. This paper will classify the white space into two main categories: "goods to be taken orally" = pharmaceuticals and health foods, and other = medical devices and health care devices, and will provide an overview of the regulations for each category.

2. Pharmaceuticals and Health Foods

The main readers of this report will not be familiar with the regulatory classification of pharmaceuticals, but the Pharmaceutical and Food Safety Law establishes regulations for manufacturing and sales based on business licenses and manufacturing and sales approvals.

(1) Outline of the health food system

In Japan, there is a clear distinction between pharmaceuticals and food products7). Pharmaceuticals are intended for use in the diagnosis, treatment, or prevention of human diseases, while foods are all food and beverage products other than pharmaceuticals and quasi-drugs. In addition to the nutritional function to sustain life (nutritional function, primary function) and the taste and sensory function to enjoy eating (sensory function, secondary function), food also has the function to regulate the physiological functions of the body (body condition regulation function, tertiary function )8). The Food Labeling Law, which came into effect in 2015, establishes a comprehensive and centralized system for food labeling. Although "health food" is not defined by law, it is broadly classified into "health function food" and "so-called health food," as shown in Figure 2.

Figure 2 Conceptual Diagram of Pharmaceuticals and Health Food

Table 1 Food with Health Claims

Since the Food Labeling Law newly established a system for food with functional claims, as of 2019, health foods are classified as Food for Specified Health Use, Food with Functional Claims, and Food with Nutrient Function Claims.

The current food labeling system for health and nutritional issues was created to overcome the challenges that existed before the Food Labeling Law was enacted, namely the limited number of target ingredients for food with nutrient function claims, and the high hurdles for small and medium-sized companies to overcome for food for specified health uses, as clinical trials on the safety and efficacy of each food are mandatory and the approval process is time-consuming and costly. The Foods for Specified Health Uses system has been established through regulatory reform efforts to overcome these hurdles for small and medium-sized enterprises. In addition, specific mechanisms to ensure the safety of health foods include specific measures to ensure the safety of raw materials, manufacturing process control (GMP), and third-party certification for ensuring the safety of health foods.

3. Medical Devices and Health Care Devices

There is a wide variety of digital tools, including devices, instruments, or applications in the health field at this time.

Even if we limit ourselves to "medical devices" as defined by the Pharmaceutical Affairs Law, there are diagnostic devices (endoscopes, CT, MRI, etc.), therapeutic devices (catheters, pacemakers, etc., and others), with more than 4,000 common names and 300,000 items10). In addition to medical devices, there is a vast array of health care equipment (non-medical devices) products and services.

(1) Medical devices

Like pharmaceuticals, medical devices are regulated by the Pharmaceutical Affairs Law, which requires business licenses and approvals for their manufacture and sale (Figure 3). Medical devices are classified according to the degree of risk, as shown in Table 2. Medical devices differ from pharmaceuticals in that a system has been established under the Pharmaceutical Affairs Law for the certification of designated highly controlled medical devices by a registered certification body11). In addition, when the Pharmaceutical Affairs Law was revised to the Pharmaceutical Affairs Law, programs (software) were newly made subject to approval for manufacture and sale, etc. as medical devices. In the treatment of medical device programs, not all programs related to medical care are treated as medical devices, but only programs for the purpose of diagnosis and treatment, as indicated in the notice12).

Figure 3 Outline of Classification of Devices in Health Care Related Fields

Table 2 Classification and regulations related to medical devices

(2) Health care devices (non-medical devices)

Programs other than medical devices, i.e., those not regulated by the Pharmaceutical Affairs Law, are positioned as health care devices (non-medical devices). However, some consider that there is a gray zone13), and some products and software marketed as "healthcare devices" are ambiguously classified as medical devices, such as similar products marketed under the "medical device" category14).

Furthermore, for ICT-based healthcare devices, the Ministry of Economy, Trade and Industry (METI) has been studying the direction of industry promotion and optimal system design since 2012. After this study, the General Health Software Promotion Council (hereinafter referred to as "GHS") was established in the industry in 2014 to establish health software development guidelines. After establishing industry voluntary guidelines and creating an environment in which users can use good health software, the GHS has established a declaration of conformity mark (GHS Mark) 15) to communicate this information to users in an easy-to-understand manner.

(3) Health care services

The government is encouraging the formulation of voluntary certification systems, guidelines, etc. by and across industries for the quality evaluation system of healthcare services. Specifically, the Ministry of Economy, Trade, and Industry (METI) has proposed guidelines and certification systems to be developed by industry associations in the "Guidelines for Healthcare Services, etc. (hereafter "the Guidelines") 16) formulated in April 2019. The Guidelines define "healthcare services" as "the production or sale of goods or services that contribute to the maintenance and promotion of good health and the extension of healthy life expectancy through the prevention of nursing care. (However, this excludes goods and services that require permits and approvals, etc. under individual laws. This is defined as "the production or sale of products or services that contribute to the extension of healthy life expectancy through care and prevention. The Guidelines state that voluntary industry guidelines should be developed based on the perspectives of transparency, objectivity, and continuity. In addition to these perspectives, the Guidelines also state that the purpose and objectives of the guidelines, specific and detailed requirements for healthcare services, terms and conditions including verification methods regarding safety and effectiveness, and the nature of advertising displays The report states that it is necessary to position

Transparency, objectivity and continuity

4. Summary

People must be able to receive appropriate medical care when they truly need it. Society must create an environment and system that allows "humans" to benefit from it. However, the most desirable thing for a "human" is to never need to receive medical care in his/her lifetime. Perhaps we should devote more resources and effort to eliminating the need for medical care than to creating an environment in which those who need it can receive appropriate medical care. We should promote health care to avoid the need for medical care, to strengthen the ability to fight diseases that have taken hold, and to create health so that people can remain active and free to make choices for as long as possible.

The above is a statement contained in a section of "Ideal Medical Care" in the "Grand Design of Japanese Medical Care 2030" (Japan Medical Association, Research Institute for General Policy).

Although the value of medicine and pharmaceuticals as important tools for medical care will not be completely lost, as mentioned here, it is expected to realize not only the treatment of diseases that have developed, but also interventions to prevent diseases from developing and preemptive medicine (intervention before the onset of disease). As a part of this, it is expected that significant technological advances, especially in the digital field, will be applied to completely new products and services related to health. The new mechanisms are being put in place to implement these new products and services in society. It is not easy to disseminate these new mechanisms to the public. For example, even in the food labeling system overviewed in this paper, the government, industry, and various companies have been trying to disseminate the system in various ways, but a survey showed that the percentage of respondents who accurately understood the meaning of each category was only about 35% for Tokuho and 10% for others17). The pharmaceutical industry has a wealth of experience in educating the public about "pharmaceuticals. It goes without saying that continued efforts are needed to gain public understanding of products and industries, even when it comes to health. In addition to the effort required to develop completely new products and services, it is also important to create a new environment in which the public can choose products and services with peace of mind. In this context, it is no less significant for pharmaceutical companies and their industry associations, with their vast experience in proving efficacy and safety and their extensive track record of contributing to the treatment of patients around the world, to play a proactive role in creating rules for healthcare services. For example, the pharmaceutical industry's vast experience and know-how in such areas as the Evidence Based approach and certification process, safety assurance and contingency planning, supply responsibility, and business operations based on close collaboration with the medical field can be put to good use.

Is it not a foolish and unfounded fear that the core competence of our industry could one day become significantly obsolete ahead of the creation of new products and services in health care? Through drug discovery, we hope that pharmaceuticals will continue to be the essential object of treatment and health promotion, and that our industry will remain an entity that continues to contribute to humanity. In this context, we need to pay close attention to the benefits that non-pharmaceutical products and services bring to the field of healthcare, as well as to the trends in the policy system for such products and services. When we think about patients and consumers in the vast ocean of healthcare services, we believe that the pharmaceutical industry, with its focus on drugs and its vision of "Beyond-The-Pill," can make a contribution that can only be fulfilled by the pharmaceutical industry.

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