Transparency guidelines for the relationship between company activities and medical institutions, etc. (ethical medicines)
Ominedo Pharmaceutical Industry Co., Ltd. (hereinafter called “the Company”) established the “Transparency guidelines for the relationship between company activities and medical institutions, etc.” as follows in order to ensure the transparency of relationships with medical institutions, etc. 1) in all stages from research and development of medical medicines to the manufacture and sales of products and to obtain a broad understanding that the Company activities are conducted upon securing high ethical standards.
1. Method and timing of disclosure
The Company will disclose via the Company website the funding that is to be disclosed for the target annual year (October to September) after the settlement is finalized.
2. Target for disclosure
A. Research and development expenses, etc.
Research and development expenses, etc. include those for clinical studies performed under public regulations such as the GCP Ordinance 2), clinical trials to develop medical medicines, and post-marketing clinical studies. They also include expenses for adverse reaction/infection reports, post-marketing surveillance, etc. performed under public regulations such as the GPSP Ordinance 3), the GVP Ordinance 4), etc.
・Joint research expenses Total annual amount
・Outsourcing research expenses Total annual amount
・Clinical study expenses Total annual amount
・Post-marketing clinical study expenses Total annual amount
・Adverse reaction/infection report expenses Total annual amount
・Post-marketing surveillance expenses Total annual amount
B. Grants for academic research
Scholarship donations and general donations provided for academic research and research grants, as well as donations to academic societies and co-sponsored expenses as support for meetings held by academic societies, etc.
・Scholarship donation5) XX University, XX class: XX cases, XX yen
・General donation6) XX University (XX Foundation): XX cases, XX yen
・Donation to academic society7) The XX Academic meeting (XX regional meeting/XX research meeting): XX yen
・Co-sponsored expenses8) The XX Academic meeting, XX seminar: XX yen
C. Manuscript writing expenses, etc.
Expenses for requests of lecture meetings and manuscript writing to provide information, etc. on medical and pharmaceutical fields as well as those for consulting services.
・Expense for lecture Professor XX (Director), Department of XX, XX University (XX Hospital): XX cases, XX yen
・Manuscript writing/supervising expenses9) Professor XX (Director), Department of XX, XX University (XX Hospital): XX cases, XX yen
・Expense for consulting contracts10) Professor XX (Hospital Director), Department of XX, XX University (XX Hospital): XX cases, XX yen
D. Information provision-related expenses
Expenses of lectures and explanatory meetings necessary for providing medical and pharmaceutical information to healthcare professionals.
・Annual number of cases and annual total amount of lecture expenses
・Annual number of cases and annual total amount of explanatory meeting expenses
・Annual total amount of medical and pharmaceutical literature, etc. supply expenses
E. Other expenses
Expenses for hospitality, etc. as courtesy
・Annual total amount of expenses for hospitality, etc.
1) Medical institutions, etc. indicates the following (1) to (4) in Japan.
(1) Medical institutions…Hospitals, clinics, nursing homes for the elderly, pharmacies, other medical facilities and organizations.
(2) Research institutions…Research departments affiliated with medical institutions, medical and pharmaceutical departments in universities, and other life science research departments.
(3) Medical organizations…Medical organizations …Medical associations, pharmaceutical associations, medical societies, pharmaceutical societies, other medical and pharmaceutical organizations.
(4) Healthcare professionals…Medical professionals (doctors, dentists, pharmacists, public health nurses, nurses, persons involved in other medical and nursing jobs), medical staff (directors and workers in medical institutions other than medical professionals, and other people in medical institutions involved in the selection and purchase of ethical medicines), life science researchers in science and technology fields other than those in medical and pharmaceutical fields.
2) GCP Ordinance…Good Clinical Practice (GCP) Ordinance indicates the “Ordinance on the standards for the implementation of clinical trials” of the Ministry of Health, Labor and Welfare.
3) GPSP Ordinance…Good Post-marketing Study Practice (GPSP) Ordinance indicates the “Ordinance on the Standards for the Implementation of Post-Marketing Surveillance and Study” of the Ministry of Health, Labor and Welfare.
4) GVP Ordinance…Good Vigilance Practice (GVP) Ordinance indicates the “Ordinance on Standards for Post-Marketing Safety Management for Medicines, Quasi-Medicines, Cosmetics, and Medical Devices” of the Ministry of Health, Labor and Welfare.
5) Scholarship donation…A donation provided to research institutions such as universities for to support academic research and research grants.
6) General donation…A donation provided to support the anniversary business and other business operations of medical institutions, etc.
7) Donation to academic society…A donation provided to support meetings held by an academic society, etc. and supports of other activities.
8) Co-sponsored expenses…Expenses including venue costs borne by the Company for meetings jointly held with an academic society, etc.
9) Manuscript writing/supervising expenses…Expenses for manuscript writing and supervising of materials for the provision of medical and pharmaceutical information.
10) Expense for consulting services…An expense incurred when instruction, advice, etc. is received based on a contract with a medical institution, etc.