薬のネット販売 やむを得ない最低限の規制

The Yomiuri Shimbun November 8, 2013
Minimum restrictions necessary for online sales of OTC drugs
薬のネット販売　やむを得ない最低限の規制（11月7日付・読売社説）

The government has made a decision that places importance on balancing the convenience of purchasing general over-the-counter drugs and ensuring their safety.
　市販薬購入の利便性と安全性のバランスを重視した判断である。

It has formulated a policy to lift the ban on Internet sales of OTC drugs within three years after they have been switched from prescription to OTC status. This will result in 99.8 percent of OTC drugs becoming available online.
　政府は、市販薬のインターネット販売に関し、医療用医薬品から切り替えた薬の場合、３年以内に解禁する方針を決めた。これにより、市販薬の９９・８％はネット販売が認められることになる。

The government will submit a bill to revise the Pharmaceutical Affairs Law during the extraordinary Diet session so the new rules can be put into practice next spring.
　今の臨時国会に薬事法改正案を提出し、来春の実施を目指す。

The Supreme Court ruled in January that the ministry ordinance banning Internet sales of OTC drugs, with some exceptions, was illegal. As online sales of OTC drugs have been left unregulated since the ruling, we are glad legal action will be taken at last.
　最高裁は１月、市販薬のネット販売について、一部を除いて禁じた厚生労働省令は違法、との判断を示した。その後、ネット販売は野放し状態だっただけに法的な措置がとられるのは評価したい。

There are 23 OTC drugs that were recently switched from prescription status and will be designated as drugs requiring the full three years for the ban on their sale to be lifted. Among them, the painkiller Loxonin S and some other drugs will complete the three-year period for confirming their safety by next spring.
Thus the ban on their online sale is likely to be lifted shortly after the enactment of the law. The Internet sale of five powerful drugs will be banned.
　「３年以内」の適用対象になる市販薬は２３品目ある。このうち、鎮痛薬のロキソニンＳなどは来春までに安全性の評価が終わり、法施行後ただちにネット販売が解禁される可能性が高い。劇薬指定の５品目の販売は禁止される。

The latest decision by the government was based on opinions compiled by a study panel of medical and pharmaceutical experts for the Health, Labor and Welfare Ministry.
　政府決定の根拠になったのは、医学・薬学の専門家による厚労省の検討会の見解だ。

Regarding prescription drugs that are to be changed to OTC status, the panel said, “Pharmacists must make individual decisions in light of the symptoms of a potential user” to avoid dangerous side effects.
　医師が処方する医療用医薬品からの転用薬について、新たな健康被害が起きかねないとして、「薬剤師が使用者の症状などを直接判断すべきだ」と指摘した。

Although the number of cases has been limited, even OTC drugs sometimes cause fatal side effects. Once-prescription drugs that are made available over the counter are particularly strong in both their direct effects and their side effects.
　市販薬でも、数は少ないものの副作用による死亡例はある。特に転用薬は効果も副作用も強い。

Confirmation period needed

To confirm there are no problems, it is inevitable for online sales of OTC drugs to be regulated for a certain period. During that period, they can be purchased only in person at a pharmacy. Whether pharmacists appropriately explain the possible side effects to users and properly confirm their symptoms during that period will come into question.
　ネット販売で問題がないか確認するため、一定期間、販売規制を続けるのはやむを得まい。
　その間は、薬局での対面販売でしか購入できない。薬剤師が、副作用の説明や症状の確認をきちんと行うかどうかも問われよう。

The ministry should make efforts to shorten the restriction period by promptly assessing the safety of such switched drugs.
　厚労省は、転用薬の安全性の評価を迅速に行い、規制期間の短縮に努力すべきだ。

The appropriateness of online sales of general OTC drugs has been a focal point of the government’s regulatory reform.
　市販薬のネット販売の是非は、政府の規制改革の焦点だった。

“The Internet is the safest sales channel for drugs,” said Hiroshi Mikitani, president of major online retailer Rakuten, Inc., expressing his opposition to the government’s latest decision. Mikitani said he would file a complaint with a court if the law is revised.
He also said he would resign as a private-sector member of the government’s Council on Industrial Competitiveness, which discussed this issue.
　ネット通販大手、楽天の三木谷浩史会長兼社長は「ネットこそ安全に薬を販売できる販路だ」と政府決定に反発し、法案が成立すれば提訴する構えだ。この問題を議論した政府の産業競争力会議の民間議員は辞任する意向という。

However, his stance, which appears to give priority to convenience and business advantage, is questionable.
　だが、利便性やビジネスを優先するかのような姿勢は疑問だ。

The problem is how to prevent damage from side effects. The ministry is asking businesses that sell general OTC drugs online to also have brick-and-mortar stores licensed as pharmacies or drugstores by the ministry. The ministry is further requiring measures to be taken to prevent bulk purchases of particular drugs.
　課題は、いかに副作用被害を防ぐかである。厚労省は、ネット販売を行う業者に対し、薬局・薬店として許可された店舗を持つよう求めている。大量購入を防ぐ手段をとることも必要とした。

Surveillance must also be reinforced on malicious business operators that run dubious sites for online drug sales or sell fake drugs.
　偽サイトや偽造薬など悪質業者の監視も強化したい。

It is also important for general users to purchase drugs online after sufficiently confirming on the Internet such information as the possible side effects of the drugs they plan to buy.
　利用者は、副作用などの情報をネットで十分に確認したうえ、購入することが大切である。

(From The Yomiuri Shimbun, Nov. 7, 2013)
（2013年11月7日01時36分  読売新聞）