Friday, February 8, 2013

Can Japanese drugstores sell drugs online?

In Japan, the sale of drugs through the Internet by the drugstores was lawful for a long time. However, in 2009, the amended Enforcement Regulations of the Pharmaceutical Affairs Law banned most of the drug transactions conducted online.

The amendment was in accordance with the amendment of the Pharmaceutical Affairs Law which categorized the drugs into three categories, 1st, 2nd and 3rd, based on the possibility of their side effects. The 1st category drug is the most dangerous one, which needs the highest level of care. The 2nd category drug is less dangerous but care still needs to be taken. The 3rd category drug has the least amount of expected side effects (is it safe to say this?). Although the law itself did not stipulate anything on the sale of drugs through the Internet, the amended Enforcement Regulations advised that only 3rd category drugs may be sold through the Internet.

At that time, the drugs categorized in the 1st and 2nd categories made up 67% of all the sales of drugs. The Enforcement Regulations mean that virtually more than two thirds of all the drug transactions is prohibited. Two companies selling drugs filed a lawsuit. and Wellnet v. Japanese Government.

On January 11th, 2013, the Supreme Court rendered a judgment, affirming the high court's judgment, that the amended Enforcement Regulations of the Pharmaceutical Affairs Law is null and void. The court found that the law did not give the Minister of Health, Labour and Welfare the authority to amend the Enforcement Regulations to totally ban the online sales of 2nd and 3rd category drugs thus, because the Minister exceeded its authority, the Enforcement Regulations became invalid.

One good thing to note is that in Japan, it is really rare that the court agrees with the plaintiff and renders laws and regulations void. Although the Japanese Supreme court has the Marbury v. Madison like authority to nullify the laws and regulations against the Constitution, such authority is rarely exercised. It is said that there are less than ten occasions that the court nullified a law in its entire history since 1947 (when the Supreme Court of Japan was established). Even including the cases where regulations and ordinances are found invalid, it is safe to say that the January 11 Judgment is a very rare case.
As a result of the court's opinion, all the sales of drugs online by drugstores is now lawful. However, the government is trying to make new laws and regulations to restrict the sale of drugs through the Internet. Although I can understand the necessity to regulate them to some extent in order to prevent tragedy because of the adverse effect of some drugs, the regulation might make the plaintiffs fight against the government to win the freedom of the Internet, depending on the contents of the regulations. It is not clear how long the online drugstores can enjoy "the freedom of the Internet."

DISCLAIMER: "IT Law issues in Japan" only provides general information about Japanese information technology law and does not, under any circumstances, constitute legal advice. You should first obtain the advice of professional legal counsel who is qualified in Japan before acting or refraining from acting based on this blog.

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