Full article reprinted from "PharmAsia News" October 7, 2008
Find out why Japan's Pharmaceuticals and Medical Devices Agency's advisory council decided Oct. 1 to formally introduce conflict-of-interest prevention rules, including a cap on consultation and other fees that PMDA-registered outside experts receive from pharmaceutical manufacturers.
Full article reprinted from "PharmAsia News" October 7, 2008
Japan Sets Conflict Rules For Outside Drug Reviewers
Japan's Pharmaceuticals and Medical Devices Agency's advisory council decided Oct. 1 to formally introduce conflict-of-interest prevention rules, including a cap on consultation and other fees that PMDA-registered outside experts receive from pharmaceutical manufacturers.
The rules have been in force since May 2007 but on a provisional basis and without sanctions for violations, PMDA spokesman Shinichi Watanabe said. At the Oct. 1 meeting, the PMDA Management Advisory Council decided to enforce the rules formally in the coming months after distributing them to more than 900 PMDA-registered outside experts, he said.
The announcement comes after a fourth physician acknowledged in court that he received $166,000 from AstraZeneca after sitting on a panel that endorsed the company's Iressa (gefitinib), drawing into view ongoing conflict-of-interest problems in Japan.
The rules would cover clinical trial, product approval and examination-related consultation and advice on pharmaceuticals, medical devices and related products, according to PMDA documents distributed at the meeting.
Watanabe said that under the pre-May 2007 rules, PMDA refused to register as outside experts physicians and others that served on boards of pharmaceutical companies, held equity in such companies, or engaged in other acts comparable to insider trading rule violations - but the agency lacked rules tailored more specifically to the pharmaceutical industry.
While maintaining the former guidelines, Watanabe said the new rules require drug sponsors to include in marketing applications a list of "arms-length" parties, such as principal investigators, who must be excluded from agency examination work, both for drugs at issue and for comparable drugs submitted by rivals.
PMDA has set a company payment cap of ¥5 million ($48,000) per year, after which an expert would be excluded from examining a drug. For experts who receive between ¥500,000 and ¥5 million ($4,800-$48,000) a year from a company, PMDA may allow them to express opinions about a product, but would deny them voting rights, Watanabe said.
To help determine who has received more than ¥5 million, experts will report on whether they received payments exceeding that amount in any year during the past three years, including the reporting year.
PMDA will post on its website a list of experts who have participated in examination meetings, as well as documents on donations, contract sums and other payments submitted voluntarily by the experts. Watanabe said PMDA has no plans to include penalty provisions in the rules.
Japan's Ministry of Health, Labor and Welfare's Pharmaceuticals and Food Safety and Sanitation Commission enacted similar conflict of interest rules in May 2008.
In Japan, new drug applications are first submitted to PMDA for scientific examinations. Upon completion of PMDA examination work, results are submitted to MHLW, which then asks the Pharmaceuticals and Food Safety and Sanitation Commission for its recommendation before going to the minister of MHLW for final approval.
- Toshio Aritake
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Companies mentioned in this article:
AstraZeneca
