Policy Research Institute page Publication of two research reports by the Policy Research Institute

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In Research Paper No. 73, "Reconsidering the Value of Pharmaceuticals," published in May 2019, the three stages of the pharmaceutical "value chain" are considered: "creating value (drug discovery)," "cultivating value (drug development)," and "delivering/utilizing value (active drug delivery). The "active pharmaceutical ingredient" is defined as the value of a pharmaceutical product that is created, delivered, and used appropriately to properly demonstrate its efficacy and effectiveness ( Fig. 1 ).

Figure 1 Chain of value of pharmaceuticals (three phases)

For this "active drug delivery," it is necessary for the provider (pharmaceutical company) to properly deliver effective and useful "products (pharmaceuticals)" and "information (necessary)" to the patients concerned, and for the users (patients) to follow the appropriate usage of the products. As the importance of "personalized medicine" or "appropriate medicine" increases due to advances in medical treatment technologies and drug therapies using new modalities (treatment technologies), we, the pharmaceutical companies, must further promote activities for the correct "active use" of drugs. In this context, we believe that it is necessary for pharmaceutical companies to further promote activities for correct "active drug use" ( Fig. 2 ).

Fig. 2 What is the future role of pharmaceuticals in light of environmental changes?

In light of this, Research Paper No. 75, "Reconsidering the Value of Pharmaceuticals from the Patient's Perspective: Toward a Virtuous Circle of Drug Discovery, Drug Development, and Active Pharmaceutical Ingredients," is intended to provide an overview of the correct "active pharmaceutical ingredients" and the challenges and solutions for their realization, as much as possible, from the perspective of patients and the public. The book is written from the viewpoint of patients and the public as much as possible. The book consists of four chapters.

Chapter 1 Why "Value of Pharmaceuticals" from "Patient Perspective

In "Three Phases of the Value of Pharmaceuticals," the author explains why he has focused on "active drugs" among the three phases of "drug discovery," "drug development," and "active drugs. The reason is that as biopharmaceuticals and other drug therapies advance, more and more of them are becoming difficult to use, and that patients, especially those requiring long-term treatment and those living longer, inevitably want to "live with the disease" and receive treatment without compromising their quality of life (QOL) as much as possible during the treatment. The natural desire on the part of patients to receive treatment without compromising their quality of life (QOL) as much as possible during treatment is also a reason for the growing importance of "active drugs". In addition, "active drug delivery" requires collaboration between physicians and patients, as well as between pharmaceutical companies and patients (basically through physicians and pharmacists). The Japan Pharmaceutical Manufacturers Association and the Japan Council for the Proper Use of Drugs describe "active drugs" as "drugs that must be used correctly.

Chapter 2: Three Values of Pharmaceuticals and Patient and Public Perspectives

The basic concept of "active medicines" is defined as "quality of products" x "quality of distribution" x "quality of information" (Figure 3), and the "medical value," "social value," and "health infrastructure value," as outlined in Research Paper No. 73, are explained once again from the perspective of patients and the public. In particular, the "medical value" and "patient and public perspective" are described based on the concept of "Patient and Public Involvement (PPI)," which has been gradually gaining attention in Japan in recent years, and how patients and the public should be involved in drug discovery and development. This chapter describes how patients and citizens should be involved in drug discovery and development based on the concept of "patient and public involvement" (PPI).

Fig. 3 "Active pharmaceuticals" = "Pharmaceutical (product) quality" x "Distribution quality" x "Information quality

Chapter 3 For Better "Active Pharmaceutical Use": Challenges and Solutions

This chapter positions "active drug development" as requiring the three elements of "drug" x "information" x "literacy," and describes what is required of information providers (pharmaceutical companies) and information users (patients), as well as the role of public (third-party) organizations in providing information.

Chapter 4: For Patients and Healthcare Providers to Fight Disease with the Same Orientation

With the keywords "risk communication" and "Basic Act on Patients' Rights," the paper discusses how the parties concerned should cooperate with each other in the common struggle against the common enemy of disease.

We hope that this research paper will help to bring pharmaceutical companies and patients, who have not necessarily had much direct contact with each other in the past, closer together and promote cooperation.

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The "Study Group on Utilization of Big Data in Medical and Health Fields," launched in July 2015, has completed its fifth year of activities in fiscal 2019. During this time, interest in and understanding of a data-driven society has grown, and movements toward the realization of a data-driven society, such as "Society 5.0" initiatives and digital transformation, have become more active in Japan as well. Therefore, in FY 2019, we focused on the "data element," which is the source of value creation.

In a data-driven society, it is important to form a "data ecosystem" in which data utilization develops autonomously and continuously. And to realize this, it is a prerequisite to generate data that can actually be used and to increase the accessibility of data. From this perspective, we have conducted a survey and research, focusing particularly on the elements of data "quality" and "accessibility" ( Figure 4 ).

Fig. 4 Components of the data ecosystem in the medical healthcare field

The main actor in the "data ecosystem" of medical healthcare is "digitized patient and consumer data. Starting with medical information such as electronic medical records and image data, a wide variety of information including genome information, personal health records (PHR) such as medical checkups, health screening data, and lifestyle/behavioral data will be covered. In order for these data to be generated as usable data, it will be necessary to ensure the quality of the data according to the purpose of use, enhance the possibility of linkage and interoperability, improve the accessibility of the data, and establish an environment in which the value and results generated from the data are promptly fed back.

However, since information related to health and medical care contains a particularly large amount of highly sensitive information, it will be necessary to strike a balance between the promotion of utilization and the protection of personal information. It is necessary to create an environment in which individuals can access and appropriately control their own data, and to establish a framework for expanding the use of data in research and projects that are of public interest.

From the viewpoint of promoting secondary use of data, it is important to design databases and registries based on the assumption of secondary use. In addition to these measures, it is also important to deepen the understanding of the public by building a system that allows data providers to provide data safely and securely, promoting research in cooperation with the public, and promoting social implementation of a system that makes it easy to realize the results and benefits of such research.

From this perspective, this report summarizes the following three perspectives as important measures (Figure 5). It is hoped that these initiatives will further advance the realization of data-driven healthcare. For more detailed information, please refer to the full report.

Figure 5 Key Measures