1.New Japanese Retailing System of OTC Medicines Starts this June
Full implementation of amended Pharmaceutical Affairs Law, PAL, has been set about on 1st June, 2009. The amendment was mainly focusing on the retailing system of OTC medicines which had been settled in the first implementation of PAL in 1960, about 50 years ago.
Key features of the amendment are summarized as follows;
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Classification of OTC medicines into three categories based on their safety risks
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Qualification of persons for retailing OTC medicines as to pharmacists and “Toroku-Hanbaisha,” as registered retail persons
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Construction of well-informed retailing of OTC medicines
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Simplification of outlet for OTC medicines into three types of retailers
1. Background of the amendment of PAL in 2006
After the deliberation at the Minister’s advisory board of MHLW, the amendment of PAL which mainly provides new retailing system of OTC medicines was promulgated in June 2006. According to the notice at the time that the full implementation of the amendment should be put in force within 3 years, it was executed as of 1st June 2009.
2. Classification of OTC medicines
In the long history of OTC medicines in Japan, there was no given definition of OTC medicines in PAL. On this occasion, the definition of OTC medicines was first introduced in the amended PAL with classification into three (3) categories based on safety risks of each product as follows;
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Category 1 medicines: A product containing ingredients which should be used with special care as there exists risks for health disorder by its adverse event. And a product which is under surveillance of safety, such as Rx-to-OTC switching product, also belongs Category 1 medicines.
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Category 2 medicines: A product containing ingredients which have risks for health disorder by its adverse event. About fifty ingredients within Category 2 medicines were designated as the ingredients requiring care for use. Those products including such ingredients are labeled as Designated Category 2 medicines.
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Category 3 medicine: A product containing ingredients which are not listed in Category 1 or Category 2 medicines.
The Category of each product has to be indicated on its package as illustrated below.
Category 1 medicines:
Category 2 medicines: or
Category 3 medicines:
3. Qualification of person in retailing OTC medicines
After execution of the amended PAL, only pharmacists and “Toroku-Hanbaisha,” registered retail persons, can retail OTC medicines to consumers. “Toroku-Hanbaisha” is a newly introduced qualification in the present amendment which shall be given to persons who have passed the qualification examination.
Products of Category 1 must be retailed by pharmacists, and those of Category 2 and Category 3 must be retailed by pharmacists or “Toroku-Hanbaisha.”
4. Construction of well-informed retailing of OTC medicines
Well-informed retailing of OTC medicines is one of the key features of the amendment .
In retailing Category 1 medicines, pharmacists are obliged to ask consumers about their health condition to judge the feasibility of the product based on the specified information sheet comprising name of product, ingredients, usage, cautions and advices from pharmacists.
Regarding Category 2 medicines, pharmacists or “Toroku-Hanbaisha” are encouraged to provide the information of the product to customer at retailing.
Regarding Category 3 medicines, there is no obligation to provide information at retailing, however, pharmacists or registered retail persons must answer the question by customers.
As described above, Category 1 and Category 2 medicines are to be retailed with consultation by pharmacists or “Toroku-Hanbaisha”, and the principle of face to face retailing was highlighted in the amendment. Thus, in the case except for face-to-face retailing, it is limited to only Category 3 medicines, and this evoked heated controversy about “internet selling” of OTC medicines.
5. Simplification of outlet of OTC medicines
In Japan, there were five types of outlets for OTC medicines since the execution of original PAL. After the amendment, OTC medicines can be distributed through Pharmacy, “Tenpo-hanbaigyo”/registered retail shop, a newly introduced license and “Haichi-hanbaigyo,” a traditional distributor.
Pharmacy can retail all of the Categories of OTC medicines. “Tenpo-hanbaigyo” and “Haichi-hanbaigyo” can basically retail Category 2 and Category 3 OTC medicines, and they can handle Category 1 OTC medicines only by the existence of pharmacists.
Regarding “Haichi-hanbaigyo,” a stuff supervised by pharmacists or “Toroku-hanbaisha” deliver a set of OTC medicines to customers’ home once or twice a year, when the stuff collect the value for used items as well as filling the deposit set.
2. The 1st Meeting of APSMI-ExC and RAC in Kuala Lumpur
The first meeting of Executive Committee, ExC, and Regulatory Affairs Committee, RAC, for Asia Pacific Self-Medication Industry, APSMI, was held in Kuala Lumpur, Malaysia on 30th April 2009. In total 20 persons from 5 countries, in addition to Dr. David E. Webber, Director General of WSMI.
The meeting was opened with a welcome address by Mr. Chandra, head of PhAMA OTC committee, in which updated information of OTC market in Malaysia and South East Asia was shared.
Then the background, past progress, objectives and future challenges of APSMI were explained by Mr. Hatori of JSMI, Chair of APSMI Task Force, starting from an attractive pharase, “A journey of a thousand miles begins with a single step”, likening the way toward establishment of APSMI. Also he announced that instead of the Task Force, APSMI-ExC and -RAC just started those activities for building the fundamentals of future APSMI.
As a start of ExC and RAC activities, the members of each committee were confirmed, who assume a responsibility to report the discussion and conclusion in the respective committees to their countries/associations. In the subsequent session for ExC, which mainly aims for an establishment of organization body as APSMI, the vision, mission, and frame working of future APSMI were discussed. On the other hand, in the session for RAC, based on unanimous recognition that the regulatory affairs shall be one of the key issues in the future APSMI, the members discussed how to make comparison and analysis of regulatory affairs of member countries. Through those sessions, the role, purpose/goal, action plan, rough schedule and so on were proposed. Agreed roles of the both committees are as follows.
Executive Committee (ExC): Drafting APSMI’s framework and building consensus among all associations and some active local/multinational companies in the region toward teh establishment in 2010
Regulatory Affairs Committee (RAC): Building up Database on regulatory information in the APR and conducting Analysis to sort out the problems/issues in each country for setting up the specific challenges to achieve “optimized regional OTC regulation” as the committee’s mid-term goal
Further discussion will be made in the future meeting and tele-conference.
3.The 9th JAPAN drugstore show
"The 9th JAPAN Drugstore Show" was held in Makuhari Messe (Chiba prefecture) for 3 days from March 13th to 15th 2009, hosted by JACDS (Japan Association of Chain Drug Stores).
With the theme of "Start self-medication life today. Drugstores bring vigor to the town and family safety", 317 companies such as pharmaceutical companies, cosmetics companies, and food manufacturers took part in the exhibition.
The hall was separated in 13 zones such as "Health care", "Beauty care", "Supplement", and "Foods & drinks", where each company held their exhibitions. In this Show, "South Korea zone" was set up for the first time, where 25 South Korea companies exhibited.
In total, 126,417 people visited the show (65,737 consumers). There were149people who participated from eight foreign countries as well, such as South Korea and China.
At the booths of the companies taking part in the exhibition, product introductions as well as attractions were exhibited, and a number of sample goods were distributed. At the theme booth of the host, exhibition of product display in drugstores after the revision Pharmaceutical Affairs Law were held.
Also, interactive information exhibition regarding anti-aging, metabolic syndrome, make-up and skincare, as well as various seminars and events concerning self-medication were held.
4.JSMI’s Action Plan in FY 2009
The new retail system for OTC medicines is enforced this year, which is expected to make a huge step to forward the Self-Medication in Japan.
In the international activity in JSMI, we advance the preparatory works in earnest toward establishment of APSMI, in which JSMI plays a central and leading role.
AS OTC medicines industry, we should make the new retail system valuable for the consumers to lead to the development of OTC market.
This year, JSMI would pursue important activities for further developing OTC market based on the clear vision and evidence to make more contribution to satisfactory healthcare system for consumers.
JSMI also intends to provide JSMI members with the prompt information in order to correspond to any drastic change under the current environment.
Our targeted action plans is as follows.
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Drawing the vision for further development of OTC market and aiming at practisizing it.
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Appealing for the social contribution of OTC medicines based on the evidence by enhancing recognition of new retail system and OTC medicines.
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Supporting the development of OTC medicines for new field, such as life style-related diseases.
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Advancing the preparatory works toward the establishment of APSMI in 2010.
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Strengthening the exchange activities with the related associations.
5.The 3rd Forum for revitalizing consumer understanding of OTC medicines
The 3rd Forum for revitalizing consumer understanding of OTC medicines was held in TFT Hall 500 (Tokyo Fashion Town Building) on April 11. The theme was “What are OTC medicines? / How will they be affected by the revision of the Pharmaceutical Affairs Law? – Proper use of OTC medicines for Self-Medication. In total 350 people including 50 media representatives attended the 3rd Forum.
The presentations and lectures about renewed retailing system were conducted as follows.
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Summary of consumer lifestyle survey, joint survey with Intage: by Mr. Tokita, Intage, Co. Ltd.
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The latest information of renewed retailing system: by Mr. Nishizawa, Managing Director, JSMI
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Activities toward implementation of the renewed retailing system in the Public Affairs Committee of JSMI: by Mr. Ohe, Chair of Public Affairs Committee, JSMI
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The Revised Pharmaceutical Affairs Law effective June 1: by Mr. Sekino, Pharmaceutical Affairs Director, Pharmaceutical and Food Safety Bureau, MHLW
Then, the panel discussed the proper use of OTC medicines after implementation of the renewed retail system. The members of the panel consisted of Mr. Sekino, MHLW, Ms. Mikami, a pharmacist, Ms. Masuko, a former member of Japan national volleyball team as a representative of the consumers, and Mr. Ohtsuki, Vice Chair of JSMI.
In order to show and explain the newly classified OTC medicines, the counter, the shelf, and the packages of OTC medicines were exhibited at the Forum.
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