On January 8, 2004 the business press in Japan reported that the little known Division of Clinical Trial Design & Management to the Translational Research Center of Kyoto University Hospital has conducted a study on anti-cancer drugs in Japan. For this study the Division has utilized a very modest methodology by comparing the list of drugs classified as “anti-cancers” in the 2003 edition of the "Current Medical Diagnosis and Treatment” - an easy-to-read manual believed to be commonly used by the US physicians, to the medicinal products approved in Japan for treatment of cancer. In short, the conclusion pointed that 30% of anti-cancers and 40% of the products for complementary oncology therapy were not yet approved in Japan by the end of 2003.
Although reported in a highly sensational style – the title in the local English-language “The Daily Yomiuri” was “Japan bars 30% of drugs used in U.S. for cancer”, it remains unclear whether the Division actually ever published the results of the study (emails and calls to it were not returned).
Whether the publicizing the findings triggered the current flow of approvals of anticancers in Japan is debatable, however it came amid a growing tension between all players in the oncology healthcare in Japan. By early 2004 it was widely acknowledged that a number of patients have been using unapproved, but imported drugs or domestically approved but applied off-label products. In one of the most demonstrative cases, as many as 500,000 tablets of Thalidomide were imported legally in Japan by individual patients for treatment of multiple myeloma. None of the accompanying costs for the purchase, shipping and custom clearance were borne by insurers and no entity has been responsible for post-marketing surveillance. All players involved – patients, providers (practicing physicians), payers, pharmas and the regulators, were unhappy but an exit from the impasse came in late 2004 by reaching the Basic Agreement of December 15, 2004 between the Minister of Health, Labor and Welfare and the Minister of State in charge concerning so-called “Mixed payment for medical examination and treatment” – or a concurrent provision of insured and noninsured services and therapies.
As a first measure the MHLW established a working group called Committee for the Examination of the Use of Unapproved Medicinal Products (aka as Investigational Committee for Usage of Unapproved Drugs, both titles are provisional translations) which already has had five regular meetings. Full details of the system for development of unapproved drugs in Japan are included in the report of the 21st New Drug Evaluation Division Information Meeting (available online at http://www.jouhoukoukai.com/Merchant2/merchant.mvc?Screen=PROD&Product_Code=JM_I_017&Category_Code=JMI), but in brief, the authorities are asking the pharma makers to initiate clinical trials of new products or for new indications, by providing support and reducing the red tape. At the latest meeting held on July 22, 2005 the Committee adopted a recommendation for clinical development of four new products.
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Technorati Tags: MHLW; Japanese regulatory affairs