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The Latest on Internet Pharmacies, Supplements, Designer Drugs, and Other High-Risk Merchants

LegitScript study: 0.1% of Japanese Internet pharmacies comply with regulations

LegitScript recently concluded a study regarding the prevalence and nature of rogue Internet pharmacy websites targeting Japan — the world’s second-largest prescription drug market measured by country. In our study, which is based on data from early 2013, we look to the following two questions:

  • What is the prevalence of rogue Internet pharmacy websites in Japanese language search results?
  • Of the search results that lead to rogue Internet pharamcy websites, which criminal networks are the most commonly represented?

—> Download the study (English version) and data. Or download the Japanese version.

Our report first recaps the state of Internet pharmacy laws in Japan. Unless offering a limited range of over-the-counter drugs, online sale of prescription drugs is currently illegal in Japan. (A recent Supreme Court decision appears likely to result in the legalization of most or all OTC sales online, but not prescription drugs.) Like other countries, pharmacies must be licensed; drugs must be approved; and a prescription must be issued by a licensed physician who has physically examined the patient.

As a general rule, prescription drug importation to the patient is also illegal. There is a very narrow exception that the Japanese Ministry of Health, Labor and Welfare (MHLW) has implemented; this can be found at mhlw.go.jp/kinkyu/diet/tuuchi/0828-4.html. As we explain in the report, rogue Internet pharmacy operators sometimes point to the existence of this “guidance” from the MHLW to tell domain name registrars, banks and the public that prescription drug importation into Japan is legal, and Internet pharmacies from abroad can thus operate unrestricted.

The problem is, that’s not what Japanese law says. And — as our study shows — the exception is so narrow that it is virtually impossible for an Internet pharmacy to comply with the exception: Our study found that only 0.1% of websites selling prescription drugs to Japanese residents — indeed, only one website out of 2,345 — complied with the MHLW’s guidance. The remainder blatantly ignored it.

The State of the Japanese Internet Drug Market

This graphic from the MHLW, which was translated by LegitScript into English, highlights in yellow prohibited activity:

mhlw

Untangling the graphic above, first note that Article 68 of Japan’s Pharmaceutical Law prohibits the advertisement of unapproved drugs. (For example, a 100 mg Viagra tablet, even if genuine, cannot be advertised, because only 50 mg and 25 mg dosages are approved in Japan.) What’s more, the seller of the drugs cannot advertise unapproved drugs to the general public — in Japanese, cannot kibo wo tsunoru  (translated literally, cannot “stoke the hopes [interest]” of potential customers). And, the merchant can only be a facilitator or “agent” and cannot be the one physically distributing the drugs themselves. Rather, they must be a “passive third party” who merely provides a mechanism for the customer to contact the pharmacy or other entity supplying prescription drugs (and not the reverse).

Unpacking the Data

In LegitScript’s 2013 study, we reviewed 2,345 search results for drug and pharmacy-related search terms such as “Lipitor mail order” and “Lexapro importation agency.” We were interested in looking at the percentage of those search results that exist for the purpose of dispensing prescription drugs either online or offline, and of those that were online, how many actually comply with the extremely narrow guidance issued by the MHLW.

Of the 2,345 search results, 1,553, or 66%, exist for the purpose of dispensing prescription drugs, either online or offline. (“Offline” dispensing refers to legally operating clinics physically located in Japan, for example.) The remainder were informational or fell into a neutral category — for example, informational medical pages, personal blogs or Internet user forums.

Of these 1,553 search results, rogue Internet pharmacies that fail to comply with Japanese laws and regulations — including failing to comply with the personal prescription drug importation agent exception — accounted for 1,454 search results. Another 55 were clinics operating (insofar as we know) lawfully that do not dispense prescription drugs online, but merely advertise their location and the services they offer to walk-in patients. Drug manufacturers accounted for another 34 search results, and websites selling over-the-counter drugs only — some of them are still unlawful as of this writing, but in the process of being liberalized as per a Japanese Supreme Court decision — accounted for eight websites.

Discouragingly, among all of these results, only one website representing two separate search results might be considered to adhere to the passive personal importation exception, because it did not show the unapproved drug names and prices on the top page; rather, customers had to type part of the drug name for any information at all to be displayed. In other words, only 0.1% of Japanese-language search results for websites that sell prescription drugs adhere to the very restrictive prescription drug importation guidance issued by the MHLW. The rest violate Japanese laws and regulations.

Main Rogue Internet Pharmacy Networks

We also took a look at the major rogue Internet pharmacy networks targeting Japan. We found that 44% of the rogue Internet pharmacy search results were attributable to three rogue Internet pharmacy networks:

  1. The BestKusuri (aka BestKenko) network. BestKusuri (now doing business as BestKenko) websites accounted for 419 out of the 2,345 search results. To put this in perspective, compare this number to the fact that all clinic websites and all pharmaceutical companies’ websites combined only reached 89 in number. In other words, BestKusuri’s websites alone outweigh the number of legitimate websites in total in Japanese prescription drug-related search results by nearly a factor of five. LegitScript has previously written about the BestKusuri/BestKenko network.
  2. Roy Union rogue Internet pharmacy network. Roy Union is a rogue Internet pharmacy network that appears to be operating out of China. The websites accounted for 183 of the websites in our search results. This is less than half of those that were related to BestKusuri/BestKenko, but still more than double the number of all the legitimate clinic and pharmaceutical company websites combined. We have also previously written about the Roy Union network.
  3. RxCash.biz. RxCash.biz is a multinational criminal enterprise headquartered in Israel that targets the US, European Union nations, Japan and other regions including the Middle East. RxCash.biz websites worldwide have consistently sold prescription drugs, including controlled substances, without a prescription. The drugs are unapproved and in some cases are reputed to be counterfeits. Examples of websites in this network include i-kusuri.jp and kenkostore.org.

It is important for the Japanese public to be aware that the websites that are selling prescription drugs to Japanese residents are not legitimate, licensed pharmacies in another country that happen to make a few (or a lot) of sales to Japanese residents, but are otherwise nothing more than a friendly neighborhood pharmacy or a trusted chain drug store selling drugs approved by the US FDA or another drug safety agency. Rather, these are multinational criminal networks operating outside of any regulatory safety controls, not unlike ronin samurai of ancient Japan who served no master and existed within no recognized social structure.

Click here to read this blog in Japanese.