Transparency Guideline for the Relation between Corporate Activities and Medical Institutions Revision of Disclosure Method of "A. Research and Development Expenses, etc.
Japan Pharmaceutical Manufacturers Association (JPMA) has revised the disclosure method of "A. Research and Development Costs, etc." in the "Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" in light of the request from the Japan Medical Association and the Japan Medical Association, recent cases of inappropriate clinical research, and our "Basic Idea on How Pharmaceutical Companies Should Support Clinical Research" in response to such cases. The revised guideline is based on the previous version of "A. Research and Development Expenses, etc.
Under the revised guidelines, the annual total amount of "A. Research and Development Expenses, etc." was previously disclosed by each member company, but starting with payments for new contracts in fiscal year 2016 for each member company, the annual number of cases and payment amounts for each individual payee for clinical funding, etc., and for non-clinical funding, etc., the annual total amount and payment amounts for each individual payee for each member company are now disclosed. For non-clinical funding, the annual total amount provided by each member company and the individual payee will be disclosed starting in fiscal year 2017.
A. Research and development expenses, etc.
Expenses, etc. related to research and development of ethical drugs and post-marketing drug development will be disclosed in the following manner.
| Item | Specific details | Details to be disclosed | |
|---|---|---|---|
| Collaborative research expenses | Expenses for basic research and clinical trials not subject to official regulations such as GCP, GVP, GPSP, etc. (*1) | Funds provided to medical institutions, etc. for research supported by medical institutions, etc. based on contracts (*2) | Annual total |
| Commissioned research expenses | Funds provided to medical institutions, etc. for research that companies contract with medical institutions, etc. (*3) | Annual total | |
| Clinical trial expenses (Development clinical trial expenses) |
Expenses for clinical trials, adverse drug reaction/infection case reports, post-marketing surveillance, etc. conducted under official regulations such as GCP, GVP, GPSP, etc. | Annual total | |
| Post-marketing clinical study expenses |
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| Adverse drug reaction/infection case Reporting expenses |
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| Post-marketing surveillance expenses | |||
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In principle, the name of the facility, etc. to which the fee is provided shall be the name of the contractual partner of the member company.
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Fees paid to SMOs are disclosed as funds provided to medical institutions, etc.
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Fees paid to CROs are not subject to disclosure in principle, but funds paid to medical institutions via CROs are disclosed as funds provided to medical institutions.
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However, case report fees will be disclosed under "A. Research and development expenses, etc." instead of "C. Manuscript writing fees, etc.," even if the fees are paid to individuals.
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For payments made under new contracts in fiscal year 2016 and thereafter, the following guidelines will be restated.
Item Specific details Details to be disclosed Joint research expenses
(See *1-3)Clinical Expenses for clinical research after Phase I Name of the facility, etc. to which the research is provided, number of contracts with payment in the current fiscal year, and amount
Non-clinical Expenses for non-clinical research after Phase I Total number of contracts per year, total amount per year, and list of names of facilities, etc. to which the funds are provided Commissioned research expenses
(See *1-3)Clinical Expenses for clinical research after Phase I Name of the facility, etc. to which the research is provided, number of contracts with payment in the current fiscal year, and amount
Non-clinical Expenses for non-clinical research after Phase I Total number of contracts per year, total amount per year, and list of names of facilities, etc. to which the funds are provided Clinical study expenses (clinical trial expenses) Name of the facility, etc. to which the research is provided, number of contracts with payment in the current fiscal year, and amount Post-marketing clinical study expenses Adverse drug reaction/infection case report expenses Post-marketing surveillance expenses Other expenses Funds provided to parties other than those subject to disclosure, etc. Annual total of each item -
Other Expenses" includes expenses associated with holding meetings (e.g., venue, food and beverage, travel expenses, etc.) and inspection expenses not paid to medical institutions, etc.