Counterargument on the Pharmaceutical Act Revision

 Prime Minister Abe, upon deciding the growth strategy in June, stated

loudly in his speech that “Regulatory reform is in fact at the very

heart of the Growth Strategy…if it is necessary for growth, I am

determined to take on any ‘bedrock’ without flinching.” (Speech on

the Third Round of Policies under the Growth Strategy on June 5).

However, because it lacked any concrete reform plans, the growth

strategy announced in June 14 (Japan Restoration Strategy) brought

about criticisms both domestically and internationally.

 In this context, still, one of the few specific plan entailed in the

growth strategy was a “lifting ban on the internet sales of general

drugs.” To borrow Abe’s own words,

“In the modern day, with online transactions now so firmly

established, it is logical to take an approach that in any event

enhances consumer safety and consumer convenience, whether purchases

are made face-to-face or online.

 We will lift the ban on the sales of all non-prescription drugs under

carefully crafted rules while ensuring the safety of consumers.” (the

same speech on June 5)

 Recently, however, the Abe Cabinet changed its course by withdrawing
the part of “all.” Instead, the Cabinet decided the policy direction
toward banning internet sales of totally 28 items of (1) general drugs
(available at drug stores) recently switched from the category of
prescription drugs by authorized doctors (*so-called after-switch items)

and (2)  powerful drugs.
 The government on November 12 stipulated this policy into articles

and submitted the “bill on amendments to Pharmaceutical Affairs Act

and Pharmacist Act.”

 But a group of private sector members released the following motion

opposing the bill.

----------------------------

Urgent Motion on the Revision of Pharmaceutical Act:

we request early reconsiderations on internet sales of drugs

 Although discussions have been going on over the revision of the

pharmaceutical act in the current Diet session regarding internet

sales of drugs, there are problematic points in said legislation.

1.While it is in line with prohibiting internet sales of 28 items of

  after-switch drugs and powerful drugs, there can be found no

  reasonable background for that. Looking at the report of expert’s

  investigation and verification meeting on after-switch items on

  October 8 which is believed to have justified the regulation, there

  is not even an explicit phrase such as that “internet sales should

  be restricted.”

  Further, there is no clear evidence that “while safety can be

  secured in face-to-face sales, internet sales are risky (therefore

  should be prohibited) even though pharmacists are involved as much

  as in drug stores.”

2.More problematic point is that the legislation entailed a provision

  banning internet sales of prescription drugs (having market size of

  ten times larger than that of general drugs) behind the back of

  disputed 28 items.

  With regard to prescription drugs, the provision to prohibit their

  internet sales was written-in without notice of the public or even

  without a process of discussion by experts’ panel. While some

  critics say the internet sales of prescription drugs should

  naturally be prohibited, the form of sales should not matter as long

  as they are based on the prescription by doctors. Internet sales of

  not only general drugs but some prescription drugs are permitted in

  the U.S., U.K. and in Germany under certain rules, but Japan’s

  legislation this time puts no evidence that “internet sales could

  be risky in this country.”

 When imposing regulations, it is the regulator’s task to release

reasonable evidences to impose such regulatory measures, including

making an international comparison and consideration.

 The process of policymaking this time lacks such procedures, and the

bill must be accused of having errors in its process.

Such a bill should not be passed into legislation.

 Even if it is the case that internet sales of the 28 items of

powerful drugs and prescription drugs should be prohibited this time,

the bill must at least promise that “the prohibition should be

reviewed promptly (within 1 year) after examination of the

reasonability of evidence and comparison with the other countries.”

 To note, the bill submitted by the Cabinet provides in its

supplementary clause (Article 12) that “the government shall consider

ways of sales of pharmaceutical products…given the effect of

implementation of this revised legislation after 5 years from

enactment.” This provision, in turn, might mean that the government

will not review the policy for the next five years. In short, the

legislation is not just satisfying.

Proposers:
Keiji ARITOMI, Advisor, Yamato Holdings Co. Ltd.
Munetomo ANDO, Associate Professor, Nihon University
Junji ANNEN, Professor, Chuo University Law School
Nobuo IKEDA, CEO, Agora Inc.
Hiroyuki KISHI, Professor, Keio Gijuku University
Takao KUSAKARI, Advisor, Nippon Yusen Kabushiki Kaisha
Shigeaki KOGA, former official of Ministry of Economy, Trade and Industry
Jiro KOKURYO, Professor, Keio Gijuku University
Toshiko SAWADA, Executive Director, EC Network
Masumi SHIRAISHI, Professor, Kansai University
Wataru SUZUKI, Professor, Gakushuin University
Yoichi TAKAHASHI, Professor, Kaetsu University
Atsushi TSUNEKI, Professor, Osaka University
Masayuki NAKAGAWA, Professor, Nihon University
Kazuhiko NISHIZAWA, Senior Chief Researcher, Japan Research Institute, Limited
Hiroyuki HASHIMOTO, Professor, Keio Gijuku University Law School
Eiji HARA, President, Public Policy Planning and Consulting, Co.
Hideo FUKUI, Professor, National Graduate Institute for Policy Studies
Michio MATSUI, President and CEO, Matsui Securities, Co. Ltd.
Naohiro YASHIRO, Visiting Professor, International Christian University
Fukuju YAMAZAKI, Professor, Nihon University
Shuhei YOSHIDA, Lawyer


(kana order)