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Submission of a written request concerning unapproved cosmetic drugs

2012-09-11

On September 11th 2012, Medwatcher Japan submitted a written request to the Minister of Health, Labor and Welfare, the Japan Association of Aesthetic Medicine, Inc, the Japan Society of Aesthetic Plastic Surgery, and the Japanese Association of Cosmetic Surgeons, concerning unapproved cosmetic drugs.


In Japan, if doctors give (prescribe) their patients unapproved drugs (if healthcare professionals import and prescribe the drug under their own responsibility), then three strict conditions stipulated by the government must be met: that there is an urgent need for treatment, that there is no alternative treatment available, and that those who import the drug such as doctors will act under their own responsibility to diagnose and treat their own patient. The Ministry of Health Labor and Welfare explains that such conditions were established to prevent any unapproved drugs from entering the country illegally and therefore aim to prevent any harm to the public's health.
 
Not many cases in which unapproved drugs are used for cosmetic purposes require an urgent need for treatment. However, according to a statement by the Ministry of Health, Labor and Welfare in March 2012, 14,669 drugs out of 43,291 imported by healthcare professionals were for cosmetic purposes. That's 33.9%, or one third, of the total figure. Based on this, it is possible that the three conditions mentioned above, stipulated by the government, are not being properly adhered to, at least when it comes to unapproved cosmetic drugs.
 
If this situation continues, many patients will end up using (or being prescribed) unapproved drugs. It will therefore become difficult to prevent such drugs from illegally entering Japan, and to achieve the aim outlined previously, of preventing any harm to the public's health.

Thalidomide, one of the unapproved drugs, was imported into Japan by healthcare professionals in large quantities and used widely as a cancer treatment. Medwatcher Japan repeatedly made clear the dangers resulting from such a widespread and law-evading use of the drug, by submitting an emergency written request concerning Thalidomide.

In the written request concerning unapproved cosmetic drugs, Medwatcher Japan has asked the Ministry of Health, Labor and Welfare to thoroughly put into practice the conditions for the import of unapproved cosmetic drugs by healthcare professionals (the 3 conditions mentioned above), to establish a system of identifying patients due to use the drug and gather examples of symptoms and adverse reactions.
 
Medwatcher Japan has also requested that organizations of doctors who specialize in plastic surgery and actually give (prescribe) unapproved cosmetic drugs to their patients conduct fact-finding surveys on the use of such drugs, disclose the results and instruct each healthcare facility (doctors) to explain to patients considerately and meticulously the risks involved in using unapproved drugs.