Over- and under-development of medicines: A study on “local drugs” and “drug lag” in Japan

• Published in: Japanese Journal of Health Economics and Policy Vol. 36; no. 2; p. 2024.10
• Main Author: Shiroiwa, Takeru
• Format: Journal Article
• Language: Japanese
• Published: Japan Health Economics Association / Institute for Health Economics and Policy 24.03.2025; 医療経済学会/医療経済研究機構
• Subjects: country drugs; drug lag; drug loss; drug price; European Medicines Agency (EMA); local drugs; Pharmaceuticals and Medical Devices Agency (PMDA); regulatory science; the US Food and Drug Administration (FDA); カントリードラッグ; ドラッグ・ラグ; ドラッグ・ロス; ローカルドラッグ; 医薬品医療機器総合機構 （PMDA）; 医薬品規制; 欧州医薬品庁（EMA）; 米国医薬食品局（FDA）; 薬価
• ISSN: 1340-895X; 2759-4017
• DOI: 10.24742/jjhep.2024.10

Objective: “Local drugs” (or “country drugs”) are medicines which are approved and distributed only inJapan. “Drug lag” and “drug loss” indicates medicines approved in other countries (the US or Europe) whichreceive delayed or no approval in Japan, respectively. Specifically, the former problem indicates the “overdevelopment”of medicines, while the latter indicates “under-development.” Notably, drug lag remains acontroversial issue in Japan from 2000s. This study quantitively clarifies the current situations of theseproblems in Japan. 　Methods: For local drugs, I used the list of medicines approved by Japan’s Pharmaceuticals and MedicalDevices Agency (PMDA) from 2017 to 2023. These data were combined with the approval status of the US Foodand Drug Administration (FDA) and European Medicines Agency (EMA). Next, the new medical entities (NMEs)approved by the FDA from 2017 to 2023 were examined to quantify the problems of drug lag and drug loss inJapan. Besides Japan, the launch days of the following countries were obtained from the Multinational IntegratedData Analysis System (MIDAS) database by IQVIA: Europe (Germany), the UK, Switzerland, Canada, Australia,New Zealand, Korea, Taiwan, and Singapore. These days were compared with the approval days by the FDA. 　Results: For new medicines without new ingredients, the percentage of local drugs in Japan is approximately40%. This number reaches 60% if the manufacturers are limited to Japanese companies. The main developers oflocal drugs are relatively small-size Japanese companies. Next, 20% of the new medicines with new ingredientswere not approved either by the FDA or EMA. This number rises to 40% of medicines which were manufacturedby Japanese companies. Meanwhile, the percentage was even higher for regenerative medical products.Further, 70% (80% for Japanese companies) of the medicines approved first in Japan were not approved bythe FDA or EMA. Conversely, regarding the drug lag and drug loss, the proportion of the launched medicinesin Japan to the FDA-approved medicines was inferior to Europe (Germany) and the UK. However, it was thecomparable with Canada and Switzerland, and higher than that in both the Oceanian (Australia and NewZealand) and Asian countries (Korea, Taiwan, and Singapore). The results remain unchanged during the subgroupanalysis for anti-cancer drugs, orphan drugs, and drugs developed by new companies. Finally, the timeto launch in Japan from the FDA approval day is similar to that in Canada and Switzerland. It is much fasterthan the three Asian countries. This is especially true for the launch speed of anti-cancer drugs, where it is thehighest except that in Germany and the UK. However, the launch speed of orphan drugs tends to be lower. 　Discussion: Clearly, the problem and percentage of local drugs are not negligible. In terms of drug lag anddrug loss, most medicines are available in Japan except that in Germany and the UK. As Germany is one of thebest countries among European countries in terms of the access to new medicines, the Japanese situation maybe better than several European countries. Considering these results, further investigation is needed regardinghow much investments should be made to improve access to medicines. Finally, the policy’s cost-effectivenessabout drug lag or drug loss should be discussed.