1.Lecture Meeting on the pharmaceutical developments in the U.S. and Japan
In the afternoon of April 25, at the Tokai University Club, a lecture meeting was held to exchange information on the latest pharmaceutical developments in the U.S. and Japan.
Mr. David C. Spangler, Vice President, International Affairs, Consumer Healthcare Products Association (CHPA), U.S.A. was invited as a lecturer. Mr. Spangler talked about CHPA as self-introduction and explained about the activities undertaken by Consumer Health Education Center in the U.S., the Rx-to-OTC Switch Climate, and the Tax Parity Project. On the other hand, Kenji Sato, Chairman, Pharmaceutical & Regulatory Affairs Committee made a presentation on the progress of the recommendations/specific measures envisaged in the interim report by Expert Consultation for Streamlining Procedures to Approve and Examine OTC Medicines, "Role of Over-The-Counter Medicines in Self-Medication", issued on November 8, 2002, and Fumio Kita, Chairman, Working Group To Study Retailing System and Chairman, Drug Safety Committee, talked on the outlines of the revision of pharmaceutical retailing system and the predicted effect on the OTC industry.
The
action programme consists of five pillars centering on
revitalization of OTC medicines. They are (1) Enlargement
of the scope of OTC medicines through introduction of new
OTC medicines such as Rx-to-OTC medicines and herbal medicines,
(2) Acceleration of launching the pharmaceutical products
having much better efficacy, (3) Enlightenment of consumers
on self-medication and extending supports to school education
on self-medication, (4) Improvement in the provision of
information to consumers and professionals through utilizing
Information Technology (IT), and (5) Building closer relationships
with the competent authorities, academic societies concerned,
and industrial associations involved.
In the international arena, JSMI conducts brisk exchanges of views and opinions
with the WSMI member associations and extensive marketing research in order
to promote self-medication in the WSMI Asia Pacific Region.
Following suit of the Ordinary General Assembly, the 32nd General Assembly
of JSMI Information Service was held and the actioin programme and the
budget plan for the same fiscal period were approved. The Information
Services issued the 10th edition of the "OTC Encyclopedia".
As the name speaks itself, the series of this directory has been utilized
and the latest up-dated edition contains new items such as "A list showing
the comparison of quantities of the active ingredients used in nonprescription
and prescription medicines", "<Diseases and the nonprescription medicines
for which precautions are necessary> designed for guiding the sufferers
of chronic diseases for compliance" and other various pieces of information.
The latest edition contains 2,850 items, classified by therapeutic
categories, which are manufactured and distributed by the JSMI member companies.
2.Seminars for ensuring fair advertising practices of OTC medicines
In Tokyo and Osaka in June, the seminars designed for ensuring fair advertising practices of OTC medicines were held. The participants counting approximately 660 in total included not only those from the pharmaceutical industry but also the pharmaceutical regulators of prefectural governments, and those engaged in the jobs related to advertising at TV stations, newspapers, advertising agencies, advertising makers, and the like.
The agenda included, among others, special lectures by the experts entitled "My thoughts on the pharmaceutical advertisements" and "Consumers living in the age of the Internet | Consumers who utilize information in three dimensions". The lectures were followed by a report of the pharmaceutical regulator on the interesting topics relating the pharmaceutical advertisements recently run.
Then, Chair of the JSMI Working Group on Advertising, Advertising Committee elucidated some inappropriate examples of the pharmaceutical advertisements chosen out of those run over the period of last eight months. Also he reported on the revision of "Self-imposing agreement on the advertisements of OTC medicines" which is the industryfs voluntary arrangement to control the advertisements.
The major themes of "Self-imposing agreement on the advertisements of OTC medicines" revised in April are as follows:
(1)
"Medicines" and "Quasi-drugs" shall be clearly mentioned in the advertisements so that there shall be drawn a clear distinction between those items and dietary supplements.
(2)
From the viewpoint of providing consumers with information, it shall be permitted that feelings after use or after taking, and data such as properties of the medicines be described only on some specified media.
(3)
In consideration of the advertisements of dietary supplements, the claimable scope of the indications of so-called vitamin preparations shall be enlarged.
3."Partial revision of the Pharmaceutical Affairs Law" was promulgated
The Bill to propose "Partial revision of the Pharmaceutical Affairs Law", passed by the House of Representative on June 9, which consists of two pillars of a comprehensive review of the OTC medicines retailing system and tightening up of the countermeasures for illegal drugs (the details were reported in the JSMI NEWSLETTER, May 2006) was promulgated on June 14 in the official gazette(YAKUSHOKUHATSU No.0614006).
Date for the full enforcement of the revised law shall be "set by Government Ordinance within three years from the date of promulgation". The designation of Classification of the risks for OTC medicines shall be implemented on April 1, 2007.
The rules concerning the tests to be conducted by the Prefectural Governors for qualifying Toroku-hanbai-sha shall be set forth within 2 years from the date of promulgation. The interim measures have been set so that the license for selling drugs currently doing business shall be able to conduct the ordinary business until "the date set by Government Ordinance within 3 years from the date of enforcement" even without being granted a Tempo-hanbai-gyo license. The interim measures have also been set so that the Yakushu Sho license for selling drugs currently doing business shall be recognized as Toroku-hanbai-sha.
Hereafter, cabinet orders and ministerial ordinances will be issued to determine the implementation of various matters.
4.The OTC medicines market trend of the year 2005
The overall market trend OTC medicines sales at pharmacies and drugstores in the fiscal year 2005 (April 2005 ~ March 2006) were Japanese YEN (JPY) 1,145.52 billion (approximately US$ 9.961 billion), showing a minus growth of 0.3% as compared with the previous fiscal year, having registered a market stagnation for four consecutive years.
The weather throughout the year 2005 which considerably affected the sales was characterized by rather high temperatures throughout the country and, particularly in summer, the western region experienced little rain and hot days. During the period from December to January, the temperatures were low in all parts of Japan, and the northern region and the Japan Sea side having suffered from record-breaking snowfalls. In April and May 2005, the more dispersal of cedar pollen contributed to a vigorous growth of the sales of rhinitis remedies, eye drops, anti-allergics and the like, but, in March 2006, the less pollen amount drastically reduced the sales of these products as compared with the previous same period.
The therapeutic categories which registered a plus growth in the year 2005 included dermatological drugs, intestinal regulators, analgesics and anti-inflammatory preparations, Vitamin B1 preparations, KAMPO-YAKU (Traditional Chinese Medicine(TCM)) and the like. On the other hand, those which registered a minus growth included DRINKs (tonics & nutrients), Vitamin C preparations, multi-symptom cold remedies, Vitamin E preparations, MINI-DRINKs (tonics & nutrients) and the like.
For the whole market, the units of sales slightly increased by 0.9 % indicating an opposite trend to that of the value of sales, which showed a decline. This leads to think of progressing recovery from the deflationary spiral.
The trend in the physical distribution Among those drugstores whose stocks are listed, top-ranking companies continued to increase their sales. The restructuring is advanced among the various business sectors not limited to only voluntary chains and groups of drugstores.
The trend in the pharmaceutical administration In March 2006, the Bill to propose "Partial revision of the Pharmaceutical Affairs Law" was submitted to the Diet. The revision of the OTC medicines retailing system has two different aspects of both reducing and tightening the regulation. It is predicted that the revision will significantly affect the marketing and distribution of the OTC medicines.
Family budget inquiry According to the family budget inquiry conducted by the Ministry of Internal Affairs and Communications, in the year 2005 (January ~ December), the expense for medicines (excluding the expense spent on the products for the maintenance of health) per household were JPY 22,010 (US$ 191.4), a minus spending of 0.1 % as compared with the previous year. The breakdown by the therapeutic categories is as follows. Cold remedies: JPY 2,265 (US$ 19.7), plus 1.3%; Gastrointestinal remedies: JPY 1,230 (US$ 10.7), plus 1.1%; Nutrients: JPY 6,197 (US$ 53.9), plus 0.8% as compared with the previous year respectively. The expenses for the products for the maintenance of health including health foods were JPY 17,283 (US$ 150.3), plus 14.9 %, a significant increase over the previous same period. * The expenses for medicines included the costs of prescription medicines dispensed at the pharmacies outside of the medical institutions where physician issued the prescriptions.
The sales trends of the major therapeutic categories
DRINKs and MINI-DRINKs
The sales were JPY 156.54 billion (US$ 1.361 billion), minus 3.6% as compared with the previous same period. The sales of DRINKs were JPY 74.57 billion (US$ 648 million), minus 5.2%, and those of MINI-DRINKs were JPY 81.98 billion (US$ 713 million), minus 2.1% as compared with the previous same period, indicating that both categories diminished.
Concerning DRINKs, as the results of the first and second measures for reducing regulation in the OTC medicines retailing, new quasi-drugs came to occupy 80% of the market share. Their sales in the pharmacies and drugstores decreased by almost 30% comparing to that before the first measure,representing a decline of an index from 100 for 1999 to 73 for 2005.
On the other hand, MINI-DRINKs which had gone into a slump for a long period recorded a decrease in the minus figures for the second straight year. In the year 2005, quasi-drug MINI-DRINKs recorded a positive growth of 9.4 % as compared with the previous year.
The sales of both DRINKs and MINI-DRINKs in the pharmacies and drugstores continued to be sluggish, but, even when the sales at the general retail outlets are added to those sales, the total 2005 statistics showed both DRINKs (minus 3.3 % as compared with the previous year) and MINI-DRINKs (minus 2.1 % ditto) remained at a low level, suggesting that the measures of reducing regulation aiming at expansion of retail outlets have not yet contributed to the growth of the market.
Nutrients and tonics other than DRINKs and MINI-DRINKs
The sales were JPY 213.33 billion (US$ 1.855 billion), recording a minus 1 % growth. The breakdown by therapeutic categories is as follows. Nutrients and tonics: JPY 59.98 billion (US$ 522 million) plus 1.5 %; Multi-vitamins: JPY 28.89 billion (US$ 251 million), minus 1.9 %; Vitamin E Preparations: JPY 11.89 billion (US$ 103 million), minus 13 %; Vitamin B1 preparations: JPY 44.5 billion (US$ 387 million), plus 3.7 %; Vitamin C preparations: JPY 13.06 billion (US$ 114 million), minus 17.7 %; Calcium preparations: JPY 4.16 billion (US$ 36 million), minus 8.6 %.
A close review of the trend for each therapeutic category identified two patterns, namely, one is "sluggish" group in which all the products performed poorly, and the other is "activated" group in which only certain products were in great demand. The products belonging to the latter pattern were those claiming alleviation of neuralgia and arthritis/joint pain and remedies for urinary disorders, whose sales kept rising since 2003. Other than those, the medicines to alleviate female menopausal disorders sold well in the year 2005. Conceivably, the products specifically and clearly claiming therapeutic efficacies were well accepted by the middle- aged and senior people.
Gastrointestinal remedies
The sales were JPY 65.57 billion (US$ 570 million), a slight increase of 1.8 % as compared with the previous year, showing a constant decline was stopped. In the year 2005, all of the major branded products either recorded a growth over the previous year or reduced a negative growth, with the sales having attained the satisfactory results.
While major branded products of H2 blockers for alleviating symptoms such as stomachache, heartburn and the like continued to record a stabilized growth, new products emphasizing stomachical efficacy were launched. Of intestinal regulators, new products specifically claiming regulation of stools were placed on the market. All in all, the products claiming improvement in bodily functions appeared to have been accepted by the consumers.
Cold remedies and medicines related to a common cold
The total sales of the medicines related to a common cold (Multi-symptoms cold remedies, Anti-tussives and expectorants, Rhinitis remedies, Oral cavity drugs, and Gargles) were JPY 198.62 billion (US$ 1.727 billion), registering a minus 1.3 % as compared with the previous year. While the last year saw favorable factors such as the rampancy of influenza and the record rise in the amount of pollen which contributed to a considerable increase in the sales, the year 2005 suffered a reaction downward in sales.
Rhinitis remedies were the only therapeutic category that recorded a tangible increase (the sales were JPY 33.96 billion or US$ 295 million) of 3.1 % over the previous year. The sales of multi-symptoms cold remedies that account for 55 % of this sector were JPY 109.41 billion (US$ 951 million), minus 1.9 %, indicating shrinkage for the three consecutive years. The sales of gargles (JPY 10.5 billion or US$ 91 million, minus 2.5 %), anti-tussives and expectorants (JPY 33.11 billion or US$ 288 million, minus 2.7%) and oral cavity drugs (JPY 11.65 billion or US$ 101 million, minus 3.2 %) registered negative growth respectively.
Anti-pyretics and analgesics
The sales were JPY 46.3 billion (US$ 403 million), minus 1 % as compared with the previous year. The number of the products tend to increase, which is packed in the packages in warm colours such as pink and red or the packages so designed as to attract attention of female consumers.
Eye drops
The sales were JPY 66.93 billion (US$ 582 million), a slight decrease of 0.8 % as compared with the previous year. On the other hand, the sales in the units showed a steady increase of 2.3 % as compared with the previous year.
The products claiming alleviation of discomforts caused by dry eyes and targeting at the users of contact lenses as well continued to show a steadily high growth.
On the other hand, due to the less amount of pollen in the spring of 2006 than usual and the repercussion generated from the increase in sales attributable to the rise in the amount of pollen in the previous year, the sales of antiallergics and eye washing solutions considerably decreased in their sales.
Topical analgesics and anti-inflammatory drugs
The sales were JPY 74.4 billion (US$ 647 million), plus 3.1 % over the previous year, indicating steady growth.
The percentage of the Rx-to-OTC Switch in this sector kept increasing year after year. (2003¥ 42.6 %; 2004¥44.5 %; 2005¥46.5 %)
Dermatological drugs
The sales were JPY 91.97 billion (US$ 800 million), plus 4.3 %, indicating the consecutive growth over the previous year for two years.
The breakdown is as follows. Topical products for dermatitis: JPY 40.08 billion (US$ 349 million; plus 3.7 %); Antiseptics: JPY 19.69 billion (US$ 171 million, plus 7.8 %); Topical drugs for common skin problems: JPY 18.6 billion (US$162 million, plus 6.6 %); and Topical drugs for pruritus: JPY 13.6 billion (US$ 118 million, minus 1.4 %)
The continuously steady growth of this sector was attributable to the weather such as the summer with the temperatures higher than usual and the winter much colder than usual which favorably affected this sector throughout the year.
Athletefs foot products
The sales were JPY 24.86 billion (US$ 216 million), minus 4.0 %, registering minus growth for the two consecutive years.
Market share by therapeutic categories
(Figures of 2004)
Multi-symptoms cold remedies
9.6 % (9.7 %)
DRINKs
7.2 % (7.3 %)
MINI-DRINKs
6.5 % (6.8 %)
Dermatological drugs
8.0 % (7.7 %)
Topical analgesics and anti-inflammatory drugs
6.5 % (6.3 %)
Nutrients and tonics
5.2 % (5.1 %)
Eye drops
5.8 % (5.9 %)
Gastrointestinal remedies
5.7 % (5.6 %)
Anti-pyretics and analgesics
4.0 % (4.1 %)
Vitamin B1 Preparations
3.9 % (3.7 %)
Anti-tussives and expectorants
2.9 % (3.0 %)
Others
34.7 % (34.8 %)
Courtesy: Kabushiki Kaisha INTAGE
For further information, please contact INTAGE at the following address:
Kabushiki Kaisha INTAGE INTAGE Akihabara Building
3-Banchi, Kanda Renpei Cho, Chiyoda-ku, Tokyo 101-8201
TEL: +81-3-5294-0111 FAX: +81-3-5294-0199
