1) Clinical Trials ActIn response to the so-called Diovan scandal, in order to restore trust and ensure transparency in Japanese clinical research, the Review Committee on the System for Clinical
Research concluded that legal regulations are necessary for the provision of funds for clinical research from pharmaceutical companies to HCPs/HCOs. Accordingly, the Clinical Trials Act has been
effective since April 1, 2018.The purpose of the Clinical Trials Act is to “promote the conduct of clinical trials through ensuring the confidence in clinical trials of citizens including clinical trial
subjects in order to contribute to the improvement of public health and hygiene" (Article 1). And the Act obliges pharmaceutical companies to conclude contracts to provide funding for clinical
research (Article 32) and to publish the funding (Article 33).2) Subject and method of publicationPharmaceutical companies shall publicize research funds, donations, manuscripts, or lecture fees, etc. The recipients subject to the publication include the person responsible
for the clinical research, the institution to which the person responsible belongs, and the organization who controls and manages the research funds.Obligation for publication started from the business year beginning on or after October 1, 2019, and the publication shall be made within 1 year after the end of each business
year. The duration of the publication is 5 years from the disclosure.
Disclosure based on Voluntary Standard
1) JPMA’s Transparency GuidelineThe World Medical Association (“WMA”) states in the WMA Statement concerning the Relationship between Physicians and Commercial Enterprises that although “industry support
enables the furtherance of medical research, scientific conferences and continuing medical education that can be of benefit to patients and the entire health care system”, “conflicts of interest
between commercial enterprises and physicians occur that can affect the care of patients and the reputation of the medical profession" so therefore, “rather than forbidding any relationships
between physicians and industry, it is preferable to establish guidelines for such relationships. These guidelines must incorporate the key principles of disclosure, avoidance of obvious
conflicts of interest and the physician’s clinical autonomy to act in the best interests of patients”.In addition, the Final Recommendation issued on April 28, 2010 by the Review Committee for Pharmaceutical Administration for the Verification and Prevention of Recurrence of
Hepatitis Drug Injuries required appropriate management of conflict of interest and measures to enhance transparency that had been conducted overseas be taken.Considering these backgrounds, JPMA issued the "Transparency Guideline for Relation between Corporate Activities and Medical Institutions" (the “Transparency Guideline”) in 2011. The
Transparency Guideline was last revised in September 2018 in response to the enactment of the Clinical Trials Act.The purpose of the Transparency Guideline is to gain a wide understanding of the pharmaceutical industry’s contribution to life sciences, such as medicine and pharmacy, and for
corporate activities to be conducted with high ethical standards, by making the relation between member companies’ activities and HCPs/HCOs transparent. Each member company is expected to prepare
its own in-house policy for transparency as a code of practice, referring to the Transparency Guideline.2) Recipients subject to publication and method of publicationThe recipients subject to the publication are as follows.
(i) Medical Institutions;(ii) Research Institutions;(iii) Healthcare-related organizations;(iv) Foundations;(v) Healthcare professionals;(vi) Researchers in medicine, pharmacy, or life sciences of science or engineering, etc.
In addition, the following items are subject to publication.(1) Research and development expensesPublication shall be made in accordance with the following procedures, together with the annual total amount of expenses incurred in R&D and post-marketing drug surveys for
prescription drugs.
Item
Details
Contents of Publication
Specified clinical trials expenses
Funds provided to medical institutions in specified clinical trials conducted under the Clinical Trials Act
Name, etc. of the relevant institution, etc.Number of cases, XX yen
Expenses on research expenses based on Ethical Guidelines
Funds provided to medical institutions in research conducted under the Ethical Guidelines for Medical and Health Research Involving Human Subjects.
Name of the relevant institution, etc.Number of cases, XX yen
Research expenses other than clinical trials
Funds provided to medical institutions in research other than Phase I or later clinical research (basic research, pharmaceutics research, etc.)
Name of the relevant institution, etc.
Clinical trial expenses
Expenses for clinical trials, post-marketing clinical studies, case reports of adverse reactions/infectious diseases, post-marketing surveys, etc. conducted under
the regulations under the Pharmaceutical Affairs and Medical Devices Act, such as the GCP/GVP/GPSP Ordinance, etc.Expenses on clinical trials include funds provided for physician-initiated clinical trials.
Name of the relevant institution, etc.Number of cases, XX yen
Post-marketing clinical study expenses
Adverse drug reactions/infection case reporting expenses
Post-marketing surveillance expenses
Other expenses
Funds arisen outside the subject of the publication
Annual total amount
2) Academic research support expensesFunds provided for promotion of academic research will be publicized in the following manner, together with the total annual amount for each item.
Item
Details
Contents of Publication
Scholarship donation
Donations in university medical faculties, research institutes, and donations through open recruitment of research institutes
XX Department of XX University: Numberof donations, XX yen
General donation
Donations allowances that do not fall under the category of "scholarship donation" or "donation for academic society, etc.”, free provision of prescription drugs,
donation of goods, donation to foundations, etc.
XX University (XX Foundation): Numberof donations, XX yen
Donation to academic society, etc.
Donations to the cost of meetings by academic societies and activities by academic societies other than meetings
XXth XX Academic Society Meeting (XXRegional Meeting, XX Study GroupMeeting): XX yen
Expenses of co-sponsored conferences, etc.
Expenses paid to the co-sponsoring entities at luncheon seminars, evening seminars, co-sponsored lecture meetings, etc.
XXth XX Academic Society Meeting, XXSeminar: XX yen
(3) Manuscript/writing fees, etc.For provision of scientific information on in-house drugs, medicine, and pharmacy, as well as for fee as consideration for lectures and writing or supervision of the manuscript
that are related to research and development, or commissioning services including consulting contracts, etc. will be publicized in the following manner, together with the total annual amount for
each item.
Item
Details
Contents of Publication
Lecture fees
Chairman, panelists, lecturers, etc.
Professor (Director) XX, XX Department of XX University (XX Hospital): Number of services, XX yen
Manuscript writing fee/supervisionfees
Hospital ___.
Professor (Director) XX, XX Department of XX University (XX Hospital): Number of services, XX yen
Consulting and commissioning fees
Consideration for a fee for services who does not fall under the category of lecture, manuscript writing or supervision.
Professor (Director) XX, XX Department of XX University (XX Hospital): Number of services, XX yen
4) Information provision related expensesExpenses of lecture meetings and explanation meetings, for providing information, etc. related to in-house products, medicine and pharmacy to medical professionals will be
publicized in the following manner.
Item
Details
Contents of Publication
Expenses for meetingsincluding lectures, etc.
Travel, accommodation, venue, and reception fee
Annual number of meetings and total amount
Explanation meeting expenses
Expenses on snacks and boxed lunch at explanation meeting, etc.
Annual number of meetings and total amount
Medical/pharmaceuticalliterature, etc. supply expenses
Medical and pharmaceutical books, goods of small and appropriate value, necessary and useful goods, etc.
Annual total amount
5) Other expensesExpenses for hospitality, etc. as social courtesy will be publicized in the following manner.
Item
Details
Contents of Publication
Expenses for hospitality, etc.
Expenses for congratulations and condolences, provision of meals, etc.
Annual total amount
Sanctions Agaist violation
Under the Clinical Trials Act, MHLW may recommend pharmaceutical companies publicize the relevant information, the Minister may publicize the name of the company when and the
company does not comply with the recommendation.In addition, MHLW may, to the extent necessary, request that a person who conducts specified clinical trials submit the necessary report or books, documents or other items, or
have the Ministry's official enter the workplace of such person to inspect books, documents or other items or to question persons concerned (Article 35 of the Clinical Trials Act). If a
pharmaceutical company refuses to submit a report or makes a false report, a fine of not more than ¥300,000 will be imposed (Article 42 of the Clinical Trials Act).
