Terminology

Transparency guidelines

In 2011, the Japan Pharmaceuticals Manufacturers Association (JPMA), an industry group of major pharmaceutical companies, formulated guidelines in response to a movement in Europe and the U.S. to disclose information about the payments they make to doctors. Member pharmaceutical companies follow the guidelines and disclose information on payments made to individual doctors, medical institutions, and research organizations.

Category A: Research and development funding, etc.

Funding for research and development, including clinical research, clinical trials, and post-marketing clinical trials

Category B: Academic research funding, etc.

Payments made mainly to universities and research institutions to support academic research; they also includes fees for co-sponsoring conferences and other events.

Category C: Manuscript fees, etc.

Remuneration paid mainly to individual doctors, including fees for speaking events, manuscripts, and consulting services.

Key opinion leader (KOL)

Doctors who have influence in the medical industry; they are often professors at university hospitals, directors of large hospitals, or authorities in certain fields. Pharmaceutical companies work with KOLs to promote their products, with KOLs helping spread the latest pharmaceutical information to other doctors. They are sometimes called influencers.

Treatment guidelines

Guidelines that summarize the latest information on the rationale and procedures for medical care, including prevention, diagnosis, treatment, and prognosis of diseases. The guidelines also clearly state recommended medications, and doctors often decide on a treatment plan and prescribe medication based on these guidelines. The guidelines are created by committees comprised of academic societies and others in each medical field.

Pharmaceuticals and Medical Devices Agency (PMDA)

An organization under the Ministry of Health, Labor and Welfare (MHLW), the PMDA is in charge of reviewing pharmaceuticals and medical devices, establishing safety measures, and preparing package inserts in accordance with the Pharmaceutical and Medical Device Act. The PMDA is responsible for approving new drugs for use in Japan.

Drug Pricing Organization (DPO)

After a new drug is officially approved, the DPO, comprised of doctors and researchers, determines its price based on a draft submitted by the MHLW. Organization members are selected by the MHLW.