The Tokyo High Court has issued a decision invalidating a health ministry order that bans sale of most nonprescription drugs over the Internet or other “distance selling” methods.
Encouraged by the ruling, Internet vendors are stepping up calls for the government to reinstate the previous rules that allowed distance selling methods for over-the-counter products.
The Ministry of Health, Labor and Welfare is now faced once again with the vexing issue of balancing deregulation with the need to prevent harm from potential side effects and other unforeseen consequences linked to the consumption of nonprescription drugs.
“We are grateful to the judicial branch for their sensible judgment,” said Genri Goto, president of Kenko.com Inc., an online drug and consumer goods vendor. His firm, together with industry peer Wellnet, had lodged the lawsuit against the state that resulted in the high court ruling.
“We really hope to put an end to this abnormal state of affairs as early as possible,” Goto said after the April 26 ruling.
Health ministry officials were dismayed by the appellate court ruling, which overturned a March 2010 Tokyo District Court decision that ruled the ministry’s ban on Internet sales was constitutional.
The issue stems from the revised Pharmaceutical Affairs Law that took effect in June 2009 under the Liberal Democratic Party-led government. In line with it, the health ministry issued an ordinance mandating strict regulations on previously allowed sales via the Internet and other nonphysical store sales.
The idea behind the ordinance against distance selling was that drugs should be sold in principle through in-person consultations with a pharmacist at a shop, so that consumers are able to get adequate information necessary to prevent harm from side effects.
Over-the-counter drugs have since been classified into three categories and Internet and other distance sellers are allowed to market only one of the categories — the third group with the lowest perceived side effects, including vitamins and mouthwash.
Category 1 items cover hair growth treatments and some strong gastrointestinal agents, while category 2 lists, among other items, common cold medicines, antifebriles, pain relievers, Chinese herbal remedies and pregnancy tests.
Those who live on remote islands, as well as those who take medicines regularly, are allowed to buy category 2 items over the Internet until next May.
The ordinance has impacted not just online vendors but also those businesses that take orders and provide consultations over the phone, as well as mail-order companies selling Chinese herbal medicines.
These businesses say their principal clients are the elderly, many of whom cannot visit shops because of their frail health.
Yukio Nemoto, director of the Nihon Kampo Renmei, an association of Chinese herbal medicine shops, said: “Consumers’ health has in fact been threatened” by the ordinance.
The high court ruling said the revised law, by its intention, “is thought to have envisaged a wide range of methods in providing information, such as through the Internet.” The court judged that the existing regulation limits people’s rights to access drugs.
Having been blamed in a number of health damage cases stemming from pharmaceutical products, the health ministry has been pushing measures to prevent the occurrence of similar incidents.
“The primary focus that must be considered for people should be safety,” said Jugo Hanai, the head of a national association for victims of defective drugs. Hanai contracted HIV through a tainted blood product.
If online sales are allowed, it would be difficult to ensure adequate information is provided to consumers, leading to health problems from misuse or allowing some people to buy large volumes of drugs for unintended uses, he said.
The ministry says it receives around 200 cases of health problems from side effects of over-the-counter drugs every year, including serious incidents such as liver dysfunction and death.
But the ministry has hardly been keeping track of the side-effect consequences of over-the-counter drugs sold via mail order. The high court chastised the ministry, saying, “It cannot be acknowledged sufficient research was conducted (before the law revision).”
Ahead of the high court ruling, the government took a step in the direction of deregulation last year. The Democratic Party of Japan-led government issued a Cabinet decision in July to review regulations, including the ban on Internet sales of pharmaceutical products.
“One way or the other, we have to take a second look at it,” a health ministry official said. However, a swift review of the law has yet to be seen.
Some officials believe a degree of deregulation is necessary, while others remain completely opposed to the lifting of the ban.
Vendors, for their part, appear to be doing their best to balance safety and convenience. Kenko.com‘s Goto cited the use of Internet-based phone services in providing consultations to consumers.
The Japan Association of Chain Drug Stores has drafted a vendor policy that calls for in-person consultation on the first purchase but allows for distance selling from the second purchase onward.