Scientific and regulatory approaches to confirm quality and improve patient perceptions of generic drug products in Japan

Hiroko Shibata,Ken-Ichi Izutsu,Hiroyuki Yoshida,Chikako Yomota,Yukihiro Goda,Haruhiro Okuda

doi:10.1186/s41120-016-0008-z

Hiroko Shibata, Ken-Ichi Izutsu + Show 4 more

Open Access

https://doi.org/10.1186/s41120-016-0008-z

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Journal: AAPS Open	Publication Date: Oct 7, 2016
Citations: 9	License type: CC BY 4.0

Affiliation: National Institute of Health Sciences

Abstract

The rapidly growing medical expense going with aging population in Japan requires the use of generic products derived from off-patent active pharmaceutical ingredients (APIs) formulations to reduce the financial burden for the national health insurance system, while at the same time avoiding undermining the quality of medical care. This article provides an overview of the regulatory approaches available to confirm the quality of generic products and gain their greater acceptance by patients. Among several approaches taken by the Ministry of Health, Labor, and Welfare (MHLW), designing systems to supply higher quality products, and providing scientific information to patients and healthcare professionals are key elements to promote the voluntary choice of the generic product. The revision of bioequivalence guidelines and the enhancement of good manufacturing practice (GMP) requirements facilitate the rational development and manufacturing control of generic formulations. A program termed Quality Reevaluation of Ethical Drugs was carried out from 1997 to 2012 using dissolution tests to avoid any significant bioINequivalence between originators and generic oral formulations. The evaluation of product quality and the assessment of the literature information by the Expert Committee on Quality of Generic Drug Products have provided a unique science-based and patient-focused approach for the distribution of reliable generic products. Some current and future issues regarding complex generic drugs are also discussed.

Highlights

The rapidly aging population, which is growing at the fastest speed among countries belonging to the Organization for Economic Cooperation and Development (OECD), makes the increasing gross medical care expenditure a major social issue in Japan (OECD 2015)
General background A generic drug is defined as a drug that is interchangeable with the original reference drug, contains the same amount of the same active pharmaceutical ingredient (API), and has the same administration routes, indication, therapeutic effects, and dosage regimen as the original drug
Both the National Health Insurance and the Employees’ Health Insurance systems set relatively high official drug prices for generic ethical pharmaceuticals (60–70 % until 2013, currently 50–60 % of the corresponding brand product), and low copayment ratio, which reduces difference in each patient’s payment and their choice of generic products. (c) The general patient’s preference for branded products and the absence of formulation substitution rights for pharmacists resulted in a barrier that prevents usage of generic drug products

Summary

Introduction

The rapidly aging population, which is growing at the fastest speed among countries belonging to the Organization for Economic Cooperation and Development (OECD), makes the increasing gross medical care expenditure a major social issue in Japan (OECD 2015). The Ministry of Health, Labor, and Welfare (MHLW) is promoting the use of generic drugs, introduced after the patent has expired and the original drug reexamination period (usually 8 years) has passed, instead of off-patented brand products, in order to reduce the financial burden for patients and the health insurance system (MHLW 2012b). Regulations supporting development and continuous supply of Shibata et al AAPS Open (2016) 2:6 drugs. A decade ago, the use of generic drugs in Japan was much more limited (18.7 % of volume in 2007) than those in US and EU countries (over 50 %)

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