Transparency Guideline*

*Takeda Pharmaceutical Company “Transparency Guideline for the Relation between Corporate Activities and Medical Institutions" (Japan Edition)

1. Timing and method of disclosure

Takeda is disclosing information on payments made each fiscal year²⁾ to medical institutions, starting from payments made during fiscal year 2012.

>The information on payments made for corporate activities and to medical institutions (in Japanese)

2. Scope of the information to be disclosed

Scope of the information to be disclosed with regard to payment to medical institutions is as follows:

A. Research and development expenses

Expenses to be paid to medical institutions with regard to research and development to be conducted jointly with, or entrusted to, medical institutions (including expenses for clinical trials for new drugs, post-marketing clinical studies, adverse drug reaction/infection case reporting, post-marketing surveillance activities conducted under regulations such as GCP ordinance³⁾, GPSP ordinance⁴⁾ and GVP ordinance⁵⁾ .

• 1.Joint research expenses (annual total amount)
• 2.Consignment research expenses (annual total amount)
• 3.Clinical trial expenses (annual total amount)
• 4.Post-marketing clinical study expenses (annual total amount)
• 5.Adverse drug reaction / infection case reporting expenses (annual total amount)
• 6.Post-marketing surveillance expenses (annual total amount)

 

B. Academic research support expenses

Academic research support expenses including donations

• 1.Scholarship donations⁶⁾ (annual total number and amount of donations per medical institution⁷⁾ )
• 2.General donations⁸⁾ (annual total number and amount of donations per medical institution⁷⁾ )
• 3.Academic conference donations⁹⁾ (total amount of donations per academic conference)
• 4.Co-sponsored academic conference hosting expenses¹⁰⁾ (total amount of expenses per academic conference)

 

C. Manuscript writing fees, etc.

Fees paid to medical institutions for lectures, manuscript writing, consulting services, etc.
 

1.   Lecture fees (annual total amount and medical institution’s name)

2.   Manuscript writing fees and editorial supervising fees¹¹⁾ 
      (annual total amount and medical institution’s name)

3.   Consulting service fees¹²⁾ (annual total amount and medical institution’s name) 
      (Note: disclosure of annual total number and amount per medical institution⁷⁾ will start from fiscal year              2014.)

 

D. Expenses for information provision

Expenses of lectures and briefing sessions, etc. for providing medical institutions with information on medical science and pharmaceutical science.

• 1.Lecture expenses (annual number of meetings and total amount)
• 2.Briefing session expenses (annual number of sessions and total amount)
• 3.Offering expenses related to Medical / pharmaceutical literature, etc. (annual total amount)

 

E. Other expenses

Expenses for hospitality, etc. as social courtesy
Expenses for hospitality, etc. (annual total amount)

• 1.“Medical institutions” means the following in Japan:
  • (1)hospitals, clinics, long-term care health facilities, pharmacies and other institutions providing medical care and medical research organizations;
  • (2)academic societies, research groups, foundations and other medical organizations; and
  • (3)physicians, dentists, pharmacists, nurses and other healthcare professionals.
  “Medical research organizations” includes CROs (Contract Research Organizations), universities, hospitals, national/public research institutions (including research institutions of incorporated administrative agencies).
• 2.“Fiscal year” means one year period from April 1 of each year to March 31 of the following year.
• 3.“GCP ordinance” (Good Clinical Practice) means the Ordinance on Standards for Conducting Clinical Trials on Pharmaceuticals (Ordinance of the Ministry of Health, Labour and Welfare No. 28 as of March 27, 1997).
• 4.“GPSP ordinance” (Good Post-marketing Study Practice) means the Ordinance on Standards for Conducting Post-Marketing Surveillance and Studies on Drugs (Ordinance of the Ministry of Health, Labour and Welfare No. 171 as of December 20, 2004).
• 5.“GVP ordinance” (Good Vigilance Practice) means the Ordinance on Standards for Post-Marketing Safety Management of Drugs, Quasi-drugs, Cosmetics and Medical Devices (Ordinance of the Ministry of Health, Labour and Welfare No. 135 as of September 22, 2004)
• 6.“Scholarship donations” means donations for the purpose of academic promotion or research promotion.
• 7.“Per medical institution” means (i) per individual healthcare professionals in cases where expenses are paid to individual healthcare professionals and (ii) per organization in cases where expenses are paid to medical institutes, medical research organizations or other organizations, as the case may be.
• 8.“General donations” means donations to be provided for the purpose of supporting operation of medical institutions, such as anniversary events.
• 9.“Academic conference donations” means donations to be provided for the purpose of supporting conferences hosted by academic societies.
• 10.“Co-sponsored academic conference hosting expenses” means expenses paid by Takeda with regard to academic conferences hosted jointly by academic societies and Takeda, such as expenses for meeting venues (excluding lecture fees).
• 11.“Manuscript writing fees and editorial supervising fees” means fees for manuscript writing or editorial supervising of promotion materials (including those paid through advertising agencies or event planning companies).
• 12.“Consulting service fees” means fees for consulting or advisory services with regard to research, development and marketing.