Guidelines on Transparency of Relationals with Medical Institutions
In accordance with its Corporate Philosophy and the ROHTO CSR Charter, ROHTO Pharmaceutical has established the "ROHTO CSR Action Guidelines" for specific actions to be observed by employees from legal and ethical perspectives.
According to the Guidelines for Transparency in the Relationship between the Activities of OTC Pharmaceutical Companies and Medical Institutions, etc., presented by the Japanese OTC Pharmaceutical Association, while contributing to the development of life sciences, including medicine and pharmaceuticals, there is a need to increase the transparency of the relationship between high ethical standards and medical institutions (Note 1) and medical professionals (Note 2).
We agree to comply with the Clinical Research Law and with the guidelines stipulated by the Japanese OTC Drug Association. We have also formulated the "Guidelines for Transparency of Relations between ROHTO Pharmaceutical Co., Ltd. and Medical Institutions" based on a proper understanding. We will disclose information on corporate activities related to medical institutions, etc. as follows.
(Note 1) "Medical institutions, etc."
Hospitals, clinics, nursing facilities for the elderly, pharmacies, retailers of pharmacies, other medical services, and medical-related research institutes, including CRO.
(Note 2) "Medical Representatives"
Physicians, dentists, pharmacists, registered sellers, nurses, other medical professionals and medical and pharmaceutical researchers in science and engineering, etc.
1. Expenses covered
Expenses related to R&D and provision of OTC drugs, etc. to medical institutions and medical professionals.
2. Method of disclosure
Through our website, etc., we will disclose the amount of payments for the previous fiscal year (from April 1 to March 31) at the appropriate time after the closing of the account.
3. Start of disclosure
Disclosure will begin from fiscal 2021 (April 1, 2021 to March 31, 2022).
The period of publication shall be one year.
4. Open target
We will disclose the following payments corresponding to A. through E..
A. Research and development expenses, etc.
Expenses for clinical trials, clinical trials for the development of OTC drugs, etc., and post-marketing clinical trials conducted under official regulations such as GCP ordinance, reports on side effects and infectious diseases, post-marketing surveillance, etc. conducted under official regulations such as GPSP ordinance and GVP ordinance
- Total amount of joint research expenditure... per year
- Total amount of commissioned research expenses... per year
- Expenses for clinical trials... Annual total
- Total Post-Marketing Clinical Trials Expenses... Annual
- Total annual amount of side effects/infectious disease case report
- Post-marketing surveillance expenses: Annual total
B. Subsidy for academic research
Scholarship donations, general donations, and academic associations held for the purpose of promoting academic research and supporting research, as well as academic society donations and joint sponsorship fees.
- Number and total amount of scholarship donations per year
- General donations: Number and total amount of donations per year
- Annual number and total amount of academic society donations
- Academic Society Mutual Aid Expenses: Annual Number and Total Amount
C. Writing fees, etc.
Expenses for lectures, drafts, and requests for consulting services to provide scientific data on OTC drugs, etc.
- Number and total amount of lecturer fees per year
- Fees for writing and supervision of manuscripts: number and total amount per year
- Consulting and other outsourcing expenses: Number and total amount of cases per year
D. Expenses related to information provision
Expenses for lectures, briefings, etc. required for providing scientific data on OTC drugs, etc. to healthcare professionals (excluding expenses similar to sales promotion activities)
- Lecture fees: Number and total amount per year
- Briefing fees: Annual number and total amount
- Total annual expenditure on medical and pharmaceutical literature
E. Other expenses
Expenses as social courtesy for healthcare professionals related to R&D of OTC drugs, etc.
- Annual total amount of reception expenses, etc.
Public Information for Fiscal 2021
Disclosure of specified clinical research information
The following information will be disclosed based on the Clinical Research Law.
Public Information for Fiscal 2021