Life Science Compliance Update

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November 18, 2014

Japan Pharmaceutical Companies Release Their Own "Sunshine" Data

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The Japanese pharmaceutical industry has been tracking and reporting transfers of value to healthcare professionals and academic centers based in Japan. In this article, we walk through the provisions of the Japanese transparency guideline before looking at the payment data and corresponding news stories surrounding the recent release of that data.

JPMA Transparency Code

The Japanese Pharmaceutical Manufacturers (JPMA) approved the “Transparency Guideline for the Relation between Corporate Activities and Medical Institutions,” in 2011. The voluntary code states that JPMA member companies and member companies’ affiliates based in Japan will track their payments to medical institutions and healthcare professionals whose primary place of practice is in Japan. The code requires tracking of five categories of payments:

  • (1) R&D expenses: joint research, research commissioning, clinical study, post-marketing study, post-marketing surveillance, and expenses incurred for adverse drug reaction/infection case reporting, reported on annual total amount
  • (2) Academic research support expenses: scholarships to medical schools, donations to academic societies for supporting conferences, and expenses of co-sponsored conference with academic societies, reported at the university and society level
  • (3) Honoraria: lecture fees, manuscript writing, supervising fee, consulting/ commission fee, reported at the individual physician and university level
  • (4) Medical Seminars and Education: lecture meetings, explanation meetings, medical/pharmaceutical literature supply, reported on annual total amount.
  • (5) Hospitality and “social courtesy” expenses, reported on annual total amount

Japanese manufacturers do not have to track meal payments, a category that dominates the total transactions in the U.S., but corresponds to very low payment amounts.  

Japanese Payment Data

The Japan News, an English-language source published by Japan’s largest newspaper, Yomiuri Shimbun, wrote that the top ten pharmaceutical manufacturers paid doctors and hospitals ¥190 billion last year (about $1.63 billion).  

The authors posit that the transparency initiative (which is voluntary under the JPMA Code) was spurred by the high profile research scandal in Japan over hypertension drug trials sponsored by Novartis. "Amid a scandal involving the alteration of clinical data on Diovan, a medicine to treat high blood pressure, senior members of the Japanese Society of Hypertension were criticized for promoting the efficacy of the medicine at lecture meetings and other venues," states the authors. Forbes has provided comprehensive ongoing coverage of this issue. 

Voluntary information disclosure by the pharmaceutical industry began in Japan last year, but there have been a "remarkable number of 'user unfriendly' cases," states the article. For example, the article states that "people cannot print out the disclosed documents or even see the documents unless they visit the company." This analysis isn't entirely clear, however. The companies are voluntarily disclosing their payments; it seems appropriate for them to post this information on their company website. 

Payment Breakdown

The article provides the following chart, which shows the breakdown of payments into the five categories outlined above. For reference, ¥1 billion is equivalent to about $8.5 million. 

Japan Payment chart

What's notable in this data is that while research takes up a large portion of the spend, the 2013 research payments are a marked decrease from 2012. Meanwhile, medical speakers' fees, the focus of the article, grew. "Rewards," the article calls such payment, "to individuals for appearing as lecturers were disclosed for the first time this year, with 65 pharmaceutical makers releasing the information as of the end of October."

Of these JPMA member companies, the top 10 held a total of 70,000 lecture meetings, the article states. "There were 14 doctors who gave lectures 50 times or more a year, and 11 doctors whose total payment exceeded ¥10 million [~$86,000]. One doctor earned more than ¥28 million [~$240,000] by delivering 155 lectures."

"The lecture meetings are ostensibly meant to provide information about different medicines and ailments to doctors working in hospitals and clinics," notes the article. "For the pharmaceutical makers, the meetings have served as precious opportunities to directly promote their products to the doctors who prescribe medicines."  

Per the article, a doctor running a clinic in Kyoto said: “The same person praised the medicines of company A when they lectured at company A’s meeting, and recommended those of company B at company B’s meeting. Sometimes I wonder which information is correct.”

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The scrutiny into clinical trial data and lectures in the Japanese pharmaceutical industry parallels the focus in the United States as well. For example, a recent article in Newsweek accuses pharma companies of "hiding the ball" with their trial data. Another article entitled "Drug Companies Didn't Want You To See These Allegations," focuses on Teva Pharmaceuticals' speaker programs. The article criticizes Teva for spending money on speaker programs and sending "medical education newsletters" to physicians. The article takes issue with the fact that prescribers  "who received the newsletter showed a leap in prescriber comfort level in putting patients on opioids, according to the lawsuit." Essentially, the "gotcha" moment is simply describing the learning process: a pharmaceutical company provided information to physicians about their new medication, and physicians changed their behavior according to these educational materials. 

We will continue to provide updates on transparency laws, both in the United States and, increasingly, abroad. 

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