Dependence on Pharmaceutical-Related Laws and Regulatory Approvals
First written in FY2016. 3 of 8 entries say "Restated". Latest entry: FY2024.
Toho Holdings moved to the "Worse" side of this theme in 2021, 2 years before the typical company in this theme (2023).
The whole theme swung hardest in 2021: 2 of 14 companies on the "Worse" side.
2 other companies' latest entry also says "Materialised".
- FY2024MaterialisedAnnual report
「In March 2022, 東邦薬品株式会社, a consolidated subsidiary of the company, received a cease-and-desist order and a surcharge payment order for violating the Antimonopoly Act in connection with bids for prescription pharmaceuticals ordered by the Japan Community Health care Organization. In March 2023, 九州東邦株式会社, another consolidated subsidiary, received the same orders for violating the Antimonopoly Act in connection with bids for prescription pharmaceuticals procured by hospitals in the Kyushu area, ordered by the National Hospital Organization Headquarters.」
Regarding the risk associated with dependence on pharmaceutical laws, regulations and regulatory approvals, the company disclosed throughout the fiscal year that 東邦薬品株式会社 and 九州東邦株式会社 had each received a cease-and-desist order and a surcharge payment order. - FY2022MaterialisedAnnual report
「At Pharma Mirai Co., Ltd., a consolidated subsidiary of the company, reports were submitted to the regional bureaus of health and welfare concerning stores that had improperly handled prescriptions and engaged in other activities, based on an internal investigation conducted in 2018. Four stores received administrative sanctions in fiscal 2021. Depending on the results of future investigations by the respective regional bureaus of health and welfare, 2 stores may receive administrative sanctions, including revocation of their designation as health insurance pharmacies.」
In addition to the existing risk associated with dependence on regulatory approvals, 4 dispensing pharmacies actually received administrative sanctions, and the possibility of sanctions against a further 2 stores was disclosed. - FY2022-Q2RestatedAnnual report
「However, 東邦薬品株式会社, a consolidated subsidiary of the company, was sentenced by the Tokyo District Court on 30 June 2021 to pay a fine of ¥250 million for violating the Antimonopoly Act in connection with bids for prescription pharmaceuticals ordered by the Japan Community Health care Organization (JCHO). The company estimated potential future losses, including fines, surcharges and penalties, and recognised a provision for losses related to the Antimonopoly Act in the previous consolidated fiscal year.」
The company reaffirmed the fine imposed on 東邦薬品株式会社 for violating the Antimonopoly Act, together with the estimation and provision for future losses. - FY2022-Q1MaterialisedAnnual report
「However, 東邦薬品株式会社, a consolidated subsidiary of the company, was sentenced by the Tokyo District Court on 30 June 2021 to pay a fine of ¥250 million for violating the Antimonopoly Act in connection with bids for prescription pharmaceuticals ordered by the Japan Community Health care Organization (JCHO).」
The risk relating to dependence on and compliance with pharmaceutical laws and regulations materialised as a fine imposed on 東邦薬品株式会社 for violating the Antimonopoly Act. - FY2020MitigatedAnnual report
「To ensure thorough compliance with these regulations, the company reorganised the Group’s pharmaceutical affairs functions effective 1 May 2020, strengthening governance. In addition to the Pharmaceutical Affairs Department of 東邦薬品株式会社, a pharmaceutical wholesale subsidiary, which was renamed the Pharmaceutical Affairs Information Department, the company established a new Pharmaceutical Affairs Management Department to oversee the Group’s pharmaceutical affairs functions.」
To address dependence on pharmaceutical laws, regulations and regulatory approvals, the company strengthened its oversight structure by establishing the Pharmaceutical Affairs Management Department and renaming the existing department the Pharmaceutical Affairs Information Department. - FY2019RestatedAnnual report
「The Group’s performance may be affected by the status of approvals and licences from regulatory authorities.」
The company continues to identify its dependence on permits, registrations, designations and licences under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other applicable laws as a risk. - FY2017RestatedAnnual report
「The Group’s operating results may be affected by the status of approvals and licences from regulatory authorities.」
The company continues to identify its dependence on permits, registrations, designations and licences under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other applicable laws as a risk. - FY2016First statedAnnual report
「The Group’s operating results may be affected by the status of approvals and licences from regulatory authorities.」
The business operates under permits, registrations, designations and licences granted pursuant to the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices and other applicable laws and regulations.