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Japan: Court Decision Liberalizes Online OTC Drug Sales

(Mar. 13, 2013) The Supreme Court of Japan affirmed on January 11, 2013, that provisions of the Pharmaceutical Affairs Law Enforcement Ordinance that banned certain online drug sales were illegal. (S. Ct., H24(Gyo hi) 279, Jan. 11, 2013.)

The Pharmaceutical Affairs Law classifies over-the-counter (OTC) drugs in three categories, depending on the severity of side effects. Category One drugs may cause the most severe side effects among OTC drugs. (Pharmaceutical Affairs Law, Act No. 145 of 1960, last amended by Act No. 69 of 2006, art. 36-3.) Pharmacies must sell Category One drugs through pharmacists. Category Two and Category Three drugs can be sold through registered OTC drug sellers. (Id. 36-5.)

Under the Law, pharmacies that sell Category One drugs must have their pharmacists provide to the buyer drug information that is specified by the Ministry of Health, Labour and Welfare (MHLW) ordinance. (Id. 36-6, ¶ 1.) When Category Two drugs are sold, a pharmacist or a registered OTC drug seller must try to provide the drug-related information to the buyer, but is not obligated to make sure the attempt is successful. (Id. 36-6, ¶ 2.) If a buyer declines to receive the information, the pharmacy does not have to provide the information. (Id. 36-6, ¶ 4.) Pharmacies do not have to provide information relating to Category Three drugs at the time of sales unless buyers ask questions.

Category One drugs include hair-growth medications like minoxidil, such as Rogaine, and H-2 blocker stomach medicines, such as Pepcid. Category Two drugs include fever reducers, such as Tylenol and vitamin A. Category Three drugs include vitamin B and C and common eye drops. (Risuku bunrui o shirou [Know the Risks], Daiichi Yakuhin Kogyo Co., Ltd. (last visited Mar. 11, 2013).)

The Pharmaceutical Affairs Law provides that a MHLW ordinance may set detailed regulations on methods of providing drug information. The relevant MHLW ordinance states that Category One and Category Two drugs must be sold at pharmacies to make sure that drug information is provided by a pharmacist or a registered OTC drug seller personally, if necessary. (Pharmaceutical Affairs Law Enforcement Ordinance, Ministry of Health and Welfare Ordinance No. 1 of 1961, last amended by MHLW Ordinance 85 of 2012, arts. 159-14 – 159-17.) When this regulation became effective in 2009, Internet sales of Category One and Category Two drugs became illegal.

A pharmacy that sells drugs online sued the MHLW, stating that the Ministry had added excessive restrictions on sales of Category One and Category Two drugs, more than those allowed by the Pharmaceutical Affairs Law. It also stated it was possible to provide the necessary drug information online. The Tokyo District Court had determined that the regulation was within the discretion of the government. The Tokyo High Court then reversed the judgment. ( Won the Case at Court, OnlineShopping of Drugs to Restart [in Japanese), TSUSHIN HANBAI (Jan. 15, 2013).) The Supreme Court affirmed the judgment of the High Court. The Supreme Court stated that it constitutes excessive regulation to entirely ban sales of Category One and Category Two drugs online, and that the regulation went beyond the scope of the Pharmaceutical Affairs Law. (S. Ct., H24(Gyo hi)279, supra.)

The plaintiff pharmacies immediately restarted online Category One and Category Two OTC drug sales. Other pharmacies followed suit. (Kusuri netto tsuhan 100sha kosu [More than 100 Remote Shopping Companies Sell Drugs], NIHON KEIZAI SHINBUN (Feb. 9, 2013).) Currently, there is no regulation of online OTC drug sales. The government has started discussing what kinds of regulations of online drug sales are appropriate, including rules on methods of providing drug information to customers. (Deregulation Conference, Third Meeting summary (Feb. 25, 2013).)