With removing restrictions on Internet sales of nonprescription drugs a centerpiece of Prime Minister Shinzo Abe’s deregulation drive, officials are now working on the final details in a bill to revise the Pharmaceutical Affairs Law.
The Health, Labor and Welfare Ministry is opposed to permitting online sales of drugs that have yet to complete their safety assessment periods after becoming available on the market. Businesses, however, are pushing for full deregulation and apparently seek to include even prescription drugs.
“We request that you nip any regulation in the bud at an early stage,” said Hiroshi Mikitani, president of online shopping mall operator Rakuten Inc., in a petition for deregulation presented on Oct. 24 to Abe and relevant ministries.
Mikitani represents the Japan Association of New Economy, a business lobby consisting largely of information technology firms. He also serves as a private-sector member of the government’s Industrial Competitiveness Council.
At a meeting of the council Tuesday, he presented documents to make the case that “drug sales over the Net that also anticipate including prescription drugs will contribute to a cut in health care costs that are expected to increase in the years ahead.”
He called for wholesale deregulation, criticizing the health ministry for wanting to keep some regulations intact for over-the-counter products.
Given the importance the Abe administration places on online drug sales in its deregulation plan to rev up the economy, “the prime minister could lose face if the health ministry’s conservative plan is approved,” said a lawmaker of the ruling Liberal Democratic Party.
At the heart of the discussion over the law’s amendment are 23 products that have recently been put on the market. They include blockbuster drugs such as Loxonin S, a treatment for fever and pain, and the pollen allergy drug Allegra FX.
These drugs have yet to complete the required safety assessment period, which lasts four years in principle. The period is for collecting information on potential side effects.
The health ministry wants these drugs to be sold only through face-to-face consultation with pharmacists until their safety assessments are completed. The ministry also wants to bar five powerful drugs from online sales.
These 28 medicines comprise just 0.2 percent of the more than 11,000 nonprescription products currently sold. But an IT industry official said nonprescription drugs “represent only a transit point. The goal is deregulating Net sales of drugs for medical professionals.”
While the market for over-the-counter drugs is estimated at ¥600 billion, professional medications — numbering around 15,000 varieties — are worth ¥8.6 trillion. Many require prescriptions under the Pharmaceutical Affairs Law.
Several thousand are not so designated, but the health ministry has issued a notice that they must be provided with prescriptions.
Given regulations in the domestic market, some businesses are setting up abroad to sell professional drugs over the Internet.
Major e-commerce firm Kenko.com Inc. created a subsidiary in Singapore in 2009, selling products such as pregnancy tests and fertility monitors to consumers in about 30 countries.
“These are mainly for Japanese living abroad,” a company official said. “We also sell them to Japan and it is a private import that doesn’t violate the law or regulations.”
Japan allows private individuals to import medicines as long as their doses are limited to up to two months of use.
“The problem is unreasonable regulations by the state,” the official said.
The health ministry is concerned that if private imports become common, it may create “an improper understanding” among the public that it is safe to buy professional drugs over the Internet.
“In order not to cause a new health hazard, the online sales of the 28 items should be regulated,” a senior ministry official said. “That would become the bulwark against voices calling for the lifting on the online sales ban for professional medicines.”