A Multifaceted Study on the optimization of the "Period of Market Exclusivity for New Drugs" in Japan

2021 Fiscal Year Final Research Report

• Project/Area Number: 18K09968
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Review Section: Basic Section 58010:Medical management and medical sociology-related
• Research Institution: The University of Tokyo
• Principal Investigator: Masuda Sachiko 東京大学, 先端科学技術研究センター, 准教授 (70508150)
• Project Period (FY): 2018-04-01 – 2022-03-31
• Keywords: 新薬市場独占期間 / 特許制度 / ジェネリック / バイオシミラー

Outline of Final Research Achievements

The market exclusivity period of a new drug should be optimized for the entire pharmaceutical industry, since it is necessary to recoup the huge investment in new drug development, while it also makes the timing of the launch of relatively inexpensive generics and biosimilars. This study analyzes the institutional factors that affect the market exclusivity period, with a particular focus on biopharmaceuticals such as antibody drugs, and, in light of recent developments, identifies issues in the current system that will likely affect the market exclusivity period for new drugs in the future.

Free Research Field

医療社会学

Academic Significance and Societal Importance of the Research Achievements

本研究の成果は、我が国の医薬品産業において、新薬開発のインセンティブを失わずに、ジェネリック・バイオシミラー市場を拡大していくための適正な新薬市場独占期間の設定に資するものである。新薬市場独占期間に関する制度的要因は多岐にわたるため、それらを複合的、包括的に分析し、将来的に各ステークホルダーに与える影響を予測することは社会的意義がある。