The Supreme Court’s Second Petit Bench ruled 4-0 on Jan. 11 that the health and welfare ministry’s ban on the sale of nonprescription drugs over the Internet is null and void. Two firms had filed the lawsuit. While maximum priority should be given to drug safety, a balance must be struck between safety and convenience for consumers. The government should work out a rational rule for the sale of nonprescription drugs over the Internet since demand for such sales will inevitably increase.
In June 2009, when the revised Pharmaceutical Affairs Law went into force under the Liberal Democratic Party-Komeito administration, the ministry issued an ordinance dividing nonprescription drugs into three categories in accordance with the intensity of their possible side effects.
Drugs of the first category must be sold by pharmacists while drugs of the second and third categories must be sold by pharmacists or registered drug sellers.
The ordinance, in principle, requires person-to-person sales in order to ensure sufficient explanations of possible side effects and the conditions under which a drug should not be used. At present, only nonprescription drugs in the third category, such as vitamins, are allowed to be sold online.
The Supreme Court ruling said that the ordinance restricts the freedom of business activities as guaranteed by the Constitution to some extent and goes beyond the limits of delegated authority provided by the revised law. It also said the revised law neither specifically require person-to-person selling at drug stores nor calls for the prohibition of their sale over the Internet.
The top court also pointed out that when the ordinance was issued, there was considerable demand for Internet sales and that some experts and even some officials within the government opposed the prohibition of such sales.
The ruling in effect confirms the Democratic Party of Japan government’s Cabinet decision, based on consumer requests, to relax the Internet sales prohibition.
Permitting drug sales over the Internet will be helpful to people living in remote areas such as islands or in mountain villages, elderly people, and people busy with child rearing and nursing care. As the graying of the nation’s population advances, the need for drug sales over the Internet certainly will increase.
Even in person-to-person sales, explanations by pharmacists are often perfunctory. While the sale of nonprescription drugs of the first category is supposed to be accompanied by written explanations, it is reported that this rule is not strictly followed.
Nonprescription drugs do carry the risk of side effects. According the health and welfare ministry, more than 1,200 cases of side effects from nonprescription drugs were reported from fiscal 2007 through fiscal 2011, including shock, liver dysfunction and even death. Therefore, it has become all the more necessary for the government to work out concrete rules for the sale of nonprescription drugs over the Internet that maximize both safety and consumer convenience. Pharmacists should be able to provide drug explanations by email or, if necessary, by telephone. For their part, consumers should always read and follow the instructions, which also list potential side-effects, provided with the drugs.