Public Policy Planning & Consulting Co. (SEISAKU-KOUBOU) is a public policy consulting firm based in Tokyo, covering broad policy areas such as economic policy, fiscal policy, regulatory policy, administrative reform, international trade and investment, etc.
PPPC provides consulting and briefing services to the clients in the central/local governments, Diet, local assemblies and the private sector.

This blog is aimed at providing general information, latest updates and some of our analytical reports about Japan's public policy in English.
The contents include;
- updates on some important government councils, especially those in which our executive officers serve as the members,
- weekly reports on latest news in Nagata-cho, the political center in Japan, (partially).
- analytical reports and articles by our members and distinguished experts outside the firm,(partially).


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 Strategyif 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 Abes 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 experts
  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 Japans
  legislation this time puts no evidence that internet sales could
  be risky in this country.

 When imposing regulations, it is the regulators 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 productsgiven 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.

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)

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