Guidelines for transparency in relationships with medical institutions, etc.
Based on its Corporate Philosophy, Rohto Pharmaceutical has established the ROHTO Group Action Agenda for Compliance, which outlines specific actions that employees must observe from legal and ethical perspectives.
According to the "Guidelines for Transparency in the Activities of OTC Pharmaceutical Companies and Their Relationships with Medical Institutions, etc." issued by the Japan OTC Pharmaceutical Association, while contributing to the development of life sciences, including medicine and pharmacy, companies are required to maintain high ethical standards and increase transparency in their relationships with medical institutions, etc. (Note 1) and medical professionals (Note 2).
In compliance with the Clinical Research Act and in support of the intent of the guidelines set forth by the Japan OTC Drug Association, and with a correct understanding of them, we have formulated the "Guidelines for Transparency in the Relationship between ROHTO Pharmaceutical Co., Ltd., Ltd. and Medical Institutions, etc." and will disclose information about our corporate activities related to medical institutions, etc. as follows.
(Note 1) What is a "medical institution, etc."?
Hospitals, clinics, nursing homes for the elderly, pharmacies, retail stores, other medical facilities, and medical-related research institutions, including CROs.
(Note 2) "Medical personnel"
Doctors, dentists, pharmacists, registered salespeople, nurses, and other medical professionals who work at medical institutions, as well as researchers in the fields of medicine and pharmacy, as well as life sciences such as science and engineering.
1. Eligible Expenses
Expenses related to research and development of OTC drugs and providing information to medical institutions and medical professionals
2. Publication Method
Payments for the previous fiscal year (April 1st to March 31st) will be made public at an appropriate time after the end of the fiscal year through our website, etc.
3. Release start date
The data will be made available starting from the fiscal year 2021 (April 1, 2021 to March 31, 2022).
4. Subject to disclosure
We will disclose the payments that fall under A. to E. below.
A. Research and development expenses, etc.
Expenses for clinical trials conducted under public regulations such as the GCP Ministerial Ordinance, clinical trials for the development of OTC drugs, etc., post-marketing clinical trials, adverse drug reaction and infectious disease case reports conducted under public regulations such as the GPSP Ministerial Ordinance and the GVP Ministerial Ordinance, and post-marketing surveillance, etc.
- Joint research expenses: total amount per year
- Commissioned research expenses: total amount per year
- Clinical trial costs: total amount per year
- Post-marketing clinical trial costs: total annual amount
- Adverse reaction and infectious disease case report: total amount per year
- Post-marketing surveillance costs: total amount per year
B. Academic Research Grants
Scholarship donations and general donations made for the purpose of promoting academic research and providing research grants, as well as academic society donations and academic society co-hosting fees to support the costs of holding academic meetings, etc.
- Scholarship donations: Number of donations per year and total amount
- General donations: Number of donations per year and total amount
- Donations to academic societies: Number of donations per year and total amount
- Co-hosting fees for academic conferences: Number of events and total amount per year
C. Manuscript writing fee, etc.
Expenses for lectures, manuscript writing, and consulting services requested to provide scientific information on OTC drugs, etc.
- Lecturer fees: Number of cases per year and total amount
- Manuscript writing and supervision fees: Number of cases per year and total amount
- Consulting and other outsourcing fees: Number of cases and total amount per year
D. Information provision-related costs
Expenses for lectures, information sessions, etc. necessary to provide scientific information on OTC drugs, etc. to medical professionals (excluding expenses related to sales promotion activities)
- Lecture fees: Number of events per year and total amount
- Information session fees: Number of sessions per year and total amount
- Costs for providing medical and pharmaceutical literature etc. ... total amount per year
E. Other Expenses
Expenses as a social courtesy to medical professionals involved in the research and development of OTC drugs, etc.
- Entertainment expenses: total amount per year
Specific clinical research information disclosure
In accordance with the Clinical Research Act, we will disclose the information below.