In order to cope with the retailing system of OTC Medicines to be newly established in accordance with the revised Pharmaceutical Affairs Law, the five trade associations in the OTC drug industry (*) filed a joint petition under the title, gA petition for ensuring smooth enforcement of the revised Pharmaceutical Affairs Lawh with the Director General of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare. The gist of the petition is as follows:
1. We would request that the retailing system be established which has consideration for the convenience of the populace.
(1)
We would request that a draft of classification (three classes) of OTC Medicines be proposed as promptly as practical. We would further request that an opportunity be given where opinions from all quarters be adequately listened to for discussing the advisability of the draft.
(2)
We would request that a draft of the entries to be indicated on the immediate containers be proposed as promptly as practical. We would further request that the labeling of the three classes be simple, for example, gMedicine Ah, gMedicine Bh, and gMedicine Ch and that neither specific logos nor colours be used for discerning those medicines. Incidentally, the labeling is intended for discerning those medicines, therefore, we would request that the proper labeling be required only on the outer containers, but not on the immediate containers.
(3)
We would request that the labeling requirements for the three classes of OTC Medicines be announced as promptly as practical so that manufacturing/distribution license holders, by way of spontaneously tackling the issue, may be allowed to ship their newly labeled products prior to the date of the enforcement.
(4)
We would request that a draft of a rule to review the classification of OTC Medicines be proposed as promptly as practical and that opinions from all quarters be adequately listened to.
(5)
Concerning the display of the OTC Medicines in the stores, we would request that separated displays be not strictly complied with and such devices as partition walls, screens, or different colours of shelves which can facilitate the consumers to discern the classes be permitted out of consideration for providing them with convenience in selection of the medicines.
2. We would request that the studies be conducted in such a fashion as will enable us to smoothly provide the consumers with information.
(1)
We would request that the provision of information at the point of sales of medicines be in principle conducted using the information contained in Package Inserts.
(2)
As for the means of providing information, we would request to enlighten the consumers on utilization of not only media in paper (Package Inserts, etc.) but also IT such as Websites released by the government and the industry.
(3)
From the viewpoint of media for providing information to the consumers, we would request that gStandards for Appropriate Advertisements of Pharmaceuticalsh be undergone a sweeping review so that provision of information to the consumers can be properly done.
3. We would request that an examination system be established for approving OTC medicines which have better efficacy and safety responding to the publicfs needs.
(1)
We would request that the examination system for OTC Medicines be strengthened by increasing officials in charge of examination and by other measures, and that the adherence to the specified time limit required for examinations be encouraged.
(2)
We would request that development of Rx-to-OTC switches, introduction into Japan of Western herbs commonly used as medicines overseas, and studies of new indications of OTC Medicines which reflect an epidemiological shift in disease patterns be materialized. We would further request that the conventional paradigm be not stuck to when such materialization is contemplated.
4. Other issue
(1)
(1) As for the medicines for which mail-order business is permitted, we would request that thelegal framework which specifies the scope of the relevant medicines and other matters be established based upon the revised Pharmaceutical Affairs Law.
(*) (In Alphabetical Order)
- Home Medicine Association of Japan
- Japan Direct-Selling Pharmaceutical Manufacturers Association
- Japan Household Distribution Drug Manufacturers Association
- Japan Kampo Medicine Manufacturers Association Japan Self-Medication Industry
2.JSMI participated in a meeting of Working Group on a new vision initiated by the Economic Affairs Division, Health Policy Bureau, Ministry of Health, Labour and Welfare
With the Five-Year Plan of Drug Industry Vision firstly mapped out in 2002 coming to an end during the current year, the Economic Affairs Division, Health Policy Bureau, Ministry of Health, Labour and Welfare explained to draw up a new vision (to be implemented from 2007) at the gConfabulation on promotion of measures for the drug industryh held in June. As a follow-up, on August 30, the first meeting of gWorking Group on New Vision of Pharmaceutical Industryh was held, with attendance of the related bodies including JSMI. The theme of the meeting was gR & D and Clinical Studiesh. The gist of the JSMI presentation is as follows:
The issues facing with Research and Development of OTC Medicines, and Measures
Japan Self-Medication Industry
1.The recent development of OTC Medicines
In our country, a sharp decline in the birthrate and a rapid increase in aging populations are urging an individual consumer to become self-dependent and self-helping. In other words, it becomes critical for the country to promote self-medication.
In June this year when the revised Pharmaceutical Affairs Law specifying establishment of the new pharmaceutical retailing system was enacted, during the interpellation, the government pledged publicly to promote self-medication. The new pharmaceutical retailing system which ensures both safety and convenience of OTC Medicines is slated to be in effect in 2009. It can be concluded that an environment conducive to launching a great variety of OTC Medicines which can adequately meet the diversified needs of the consumers has been created.
2.The current situation of OTC Medicines
In 2002, Expert Consultation for Streamlining Procedures to Approve and Examine OTC Medicine, Ministry of Health, Labour and Welfare issued [Interim Report on Role of Over-The-Counter gOTCh Medicines in Self-Medication], wherein Recommendations were made for the purpose of encouraging the introduction of a great variety of OTC Medicines which can meet the consumersf needs. Of the Specific Measures outlined in the Recommendations, the following items have not been satisfactorily progressed as yet:
(1)
Consumers are not made to fully understand what OTC Medicines really are and what role the medicines can play:
(2)
Adequate supplies of the OTC Medicines that meet the consumersf needs have not been made:
(3)
A variety of health foods such as Food for Specified Health Use have been available in the market and some of them misunderstood by the consumers for substitutes for the medicines have been in wide use.
3.Proposals of Measures
In order to cope with the soaring medical service fees incurred by a decline in the birthrate, a graying society, and an epidemiological shift in disease patterns, each and every consumer is required to improve the skills to manage onefs own health and to practice to maintain onefs own health by oneself. Under such circumstances, making efficient use of OTC Medicines as resources of self care and medical care needs to be promoted. For this purpose, it is essential for those concerned to develop high quality OTC Medicines with a role and a function good enough to meet the new needs of the consumers. For achieving this, we would like to strongly propose that an environment be created where the following measures can be implemented:
(1)
Promotion of Rx-to-OTC switches
* To regularly select and publicize, by official agencies, the candidates for Rx-to-OTC switches
* To formulate a clear guideline on application procedures for Rx-to-OTC switches
* To implement a new evaluation method (AUT: Actual Use Trial, a test conducted at a pharmacy to observe actual usage patterns) to replace clinical tests currently done in OTC Medicines
* To make the most of data on results of clinical trials as information on the products
(2)
Review of approval procedures for Western herbs
3.JSMI offered Lectures on Self-Medication
On October 15, under the joint auspices of newspaper publishing companies, lectures on self-medication under the stimulating title, gLetfs try to become women with great personal attractions, both in mind and body ! ~ Self-care for women in pre-menopauseh were offered. There were more than 300 attendees and two key note addresses were given; one entitled gPre-menopause depicted in the novelsh given by a physician practicing at a clinic majored in diseases of female adults and the other entitled gWhat kind of pains you suffer from? Explain your pains ably so that you can practice self-medication which best fits your syndromes.h given by a pharmacist as a proprietor of a pharmacy.
After the lectures, a lively panel discussion under the tile gInformation and Self-medicationh was held by the panelists including, among others, Yoshihiro Miwa, JSMI Vice-chairman (President, Kowa Co., Ltd.) .
JSMI with its Public Affairs Committee acting as a prime mover has been implementing various initiatives to widen the understanding on gSelf-medicationh among the people. The major initiatives planned for implementation during the current business year are shown as follows:
(1)
Lectures on themes relating to health will be offered twice under the auspices of newspaper publishing companies.
(2)
1) 210,000 copies of booklet titled gSelf-medication Handbookh will be published.
(3)
Public Relations will be focused on the academic societies such as shown below:
* Academic Society of Self-medication
*
Japan Health Science Institute
*
Conferences of Federation of Asian Pharmacist Association
(4)
Activities for enlightenment on self-medication will be conducted through the JSMI Home page.
4.The OTC medicines market trend in the first half of the year 2006
OTC medicines sales in the first half of the year 2006 (April ~ September 2006) were 99% as compared with the same period of the previous year. With the term gMetabolic Syndromeh being much talked about, new products relating to the term and the items appealing to the consumers from the unprecedentedly novel standpoints met with favorable sales.
As for the therapeutic category relating to a common cold, the unseasonable weather during the first quarter was responsible for an increase in the incidence of a common cold characterized by the symptoms developed in the throat. Thus Multi-symptoms cold remedies registered a two-digit growth in April, May, and June consecutively. During the same period, Anti-tussives & expectorants, and Oral cavity drugs also recorded favorable sales. Also during September, the month of a change of season, many people under the weather with a cold contributed to a growth of the sales of the therapeutic category relating to a common cold. All in all, the first half of the year saw sales, as compared with the same period of the previous year, of 108%, 105% and 102% in Multi-symptoms cold remedies, Anti-tussives & expectorants, and Oral cavity drugs respectively.
Rhinitis remedies, which had shown a considerable increase in the sales in the spring of 2005 due to the record rise in the amount of pollen, showed a considerably large minus growth in April and May this year. The sharp decline resulted in 72% as compared with the previous period. The sales of Eye drops, also influenced by pollenosis (hay fever), were 96% as compared with the previous year. Both an increase in the number of users of contact lenses and steady sales of Eye drops used as supplement for tears were attributable to the less minus growth of Eye drops as compared with that of Rhinitis remedies.
The sales of Topical drugs for pruritus, one of the seasonal goods, recorded 103% due to the fierce heat in August. On the other hand, the sales of Athletefs foot products, also one of the seasonal goods for summer, with the exception of a couple of items in high demand, were sluggish, resulting in 95%, a large minus growth as compared with the previous year.
Several therapeutic categories other than those mentioned above which registered steady sales in the first half of the year are shown below:
As for Intestinal regulators, the market showed two-digit growth to be 112%, as compared with the previous year, by the launch of a certain product for which novel and unique promotion from unprecedented standpoints was conducted.
As for the KAMPO-YAKU, Traditional Chinese Medicines (TCM), the hot term gMetabolic Syndromeh triggered an extraordinarily rapid growth to 122% of the herbal medicines based on BOFUTSUSHOSAN formulation. Also the KAMPO-YAKU based on KAKKONTO formulation increased the sales as a common cold became prevalent, resulting in an overall increase in the sales of the KAMPO-YAKU.
Some items targeting women of middle or advanced age contributed to attainment of 109% of the category of Drugs for female use. As for the drugs targeting middle-aged and senior people, the items appealing for relief of joint pain continued to record a rather steady growth.
Contrasting strikingly with the therapeutic categories which all showed a favorable growth, those which did not perform well included Tonics & Nutrients such as DRINKs (93%), MINI-DRINKs (98%), Vitamin C Preparations (80%), and Vitamin E Preparations (90%). The declining trend observed among some of these products has been rather persistent. The emergence of dietary supplements and the similar products appears to have been irresistibly suppressing the rejuvenation of Tonics & Nutrients to the former sales levels.
Over the past several years, in the OTC drugs market, those products appealing for actual use by the general public and those supported with sales promotional activities laying special emphasis on the consumersf perspective have been gaining an immense popularity. This trend remained unchanged in the first half of 2006. In other words, the first half of 2006 was typified as the period where the products which skillfully conveyed their specific features to the consumers proved to have become the winners in the market.
The market performance of the major therapeutic categories as compared with the previous year is shown in the following table:
