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JSMI NEWSLETTER Number 58, Feb.20, 2004

CONTENTS
Activities & Initiatives undertaken by JSMI
New Year Greetings for 2004 from Chairman, Sachiaki Ibe
Collaboration for the WSMI 6th Asia Pacific Regional Conference- Beijing, People's Republic of China
Pharmaceutical Administration & Legislation
OTC Retailing Deregulation- Shifting into Quasi-drugs Regarded as Solution
Report Compiled on"Access to OTC at Midnight and in the Early Morning"


New Year Greetings for 2004 from Chairman,
Sachiaki Ibe

Trusting that our dear colleagues both at home and abroad as well as all the parties and persons concerned greeted the first morning of the new year in good health and condition, I have, as is quite customary with us, the pleasure of extending my New Year g reetings, by way of firstly retrospecting on the last year and secondly sharing with all of you the plans JSMI harbours for implementation this year.

Chairman Sachiaki Ibe

1: Activities undertaken nationally for promotion of responsible self-medication

On September 29, JSMI Website (in the Japanese language, for the time being) was completely renewed by adding anew "Medicines Retrieval Function". This Retrieval Function, instrumented in collaboration with Nonpre scription Medicines Database Center, enables consumers to retrieve approximately 3,500 items of nonprescription medicines from products' names, therapeutic categories, manufacturers' names, and symptoms. Further, it allows consumers to read a package insert of each drug item.

Addition of more data and public relations to raise consumers' awareness towards this renewed cyberspace gateway to nonprescription medicines which need to be properly used for responsible self-medication are the two areas planned for immediate imple-mentation.

The momentum, encouragingly generated at the WSMI 14th General Assembly and 5th Asia Pacific Regional Conference hosted by JSMI in November 2002, for striking root of responsible self-medication deep into the consciousness of consumers has never faltered over the period since these international events.

On the contrary, JSMI made every effort to increase the number of Health Forum, in addition to the Asahi Shimbun Health Forum held twice a year, spring and autumn, by newly co-hosting with the Yomiuri Shimbun dailies the First Yomiuri Self-Medication Symposium in autumn, focusing on "Obesity". All the participants had their "Degree of Obesity" (A Body Mass Index or BMI which is a formula in which a person's body weight in kilograms is divided by the square of his or her height in meters) measured to alert themselves to the potential danger of overweight or obesity.

The Symposium designed to allow the participants to gain their knowledge by "actual experience" was well accepted as compared to the conventional lecture-type symposia where participants tend to passively listen to lectures or talks which flow very much like one-way traffic.

This year's plan calls for co-hosting four events with both the Asahi Shimbun and Yomiuri Shimbun dailies.

2: Activities to be undertaken internationally for promotion of responsible self-medication

Our colleagues in the People's Republic of China, Chinese Self-Medication Industry (CSMI), at the very juncture when their name was changed from China Nonprescription Medicines Association (CNMA) to CSMI, volunteered ~ needless to mention, was warmly and unanimously endorsed by the WSMI Member Associations ~ to host the WSMI 6th Asia Pacific Regional Conference in Beijing from October 26 through 29 this year.

Although China is not separated from Japan by a narrow streak of water, much of what is today considered traditional in Japanese culture, arts and crafts was inherited from China, defying the geographical tyranny of distance. The corollary to this is that Chinese and Japanese cultures have a great deal in common.

Now, CSMI's First Announcement with a highly challenging title, "From the Past to the Future: Public Health, Regulatory and Industrial Opportunities on Responsible Self-Medication" has introduced Diaoyutai State Guesthouse in Beijing ~ which is unquestionably a most prestigious garden-villa complex flavoured with the timehonoured wisdom and, at the same time, equipped with advanced ideas and facilities ~ as the conference venue.

To reciprocate the then CNMA's great support extended to the WSMI international events in 2002, we are committed to developing the contribution that JSMI can make to CSMI. I would hereby encourage the JSMI member manufacturers to send their delegates as many as possible to China which is firmly positioned as the world's fastest-growing major economy and has become an increasingly important source of demand for exports from Asia and the rest of the world.

3 : Suggestions and recommendations to "Interim Report" from the industry

In November 2002, "Expert Consultation for Streamlining Procedures to Approve and Examine OTC Medicines" (an advisory task force for the Ministry of Health, Labour and Welfare) publicized "Interim Report on Role of Over- The -Counter (OTC) Medicines to be needed, trusted and used with confidence" (commonly termed "Interim Report").

Of the major thirteen steps for improvement proposed in the "Interim Report", the OTC drug industry delightfully observed its suggestions and recommendations were reflected into the revision to reduce the number of class of nonprescription medicines from six to four at filing an application for registration. This revision should be considered as a great improvement as it considerably alleviates the burden of an applicant when preparing an application dossier.

The industry is fully committed to continuing to make further suggestions and recommendations both to expedite Rx-to-OTC switches and to enlarge the scope of nonprescription medicines so that they can manage prophylaxis of lifestyle related diseases.

4:Nonprescription Medicines Retailing Deregulation

Recent movements of OTC medicines retailing deregulation (part of which were featured in JSMI Newsletters Nos. 56 and 57) were: "Working Group" of "Task Force on the selection of medicines presenting no major safety issues" (Chaired by Hiroshi Saito, Professor Emeritus, Tokyo University) selected approximately 350 items of nonprescription medicines in the 15 categories such as, among others, Digestives, Intestinal regulators, etc. as OTC medicines that "present no safety concerns".

It is very likely that those items will be sold outside of pharmacies, drugstores and other conventionally authorized retail outlets, providing more convenience in terms of visibility, accessibility and availability of medicines to the consumers.

Under the legal framework of the Pharmaceutical Affairs Law, it is mandatory that all the medicines are sold "face-to-face", in other words, retailers are obliged to have licensed pharmacists physically present.

H o w e v e r, rapidly increasing emergence of "e-commerce" (sales of medicines via the Internet) and sales of medicines via "Videophone" (a totally unprecedented retailing practice where a discount retailer sells drugs at midnight and in the early morning while using videophones linking its outlets to pharmacists) has begun presenting a serious issue for the industry as well as the competent authorities to tackle as promptly as practical.

Such phenomena, depending on how they develop, could inevitably affect the way the drug information is provided at time of purchase and sale of OTC drugs.

However drastically the social and economical environment may change, the necessity to educate and enlighten consumers on the importance of "To manage your own health by yourself" or Responsible Self-Medication shall remain unchanged.

JSMI is fully committed to ensuring the continued growth of the OTC drug industry through promoting responsible self-medication. Taking up this occasion, on behalf of the management and staffs at JSMI, I would like to make a fresh determination that we work closely with all of you in 2004.


Collaboration for the WSMI 6th Asia Pacific Regional Conference- Beijing, People's Republic of China

On January 9 when the JSMI 137th Board of Directors Meeting was held in Tokyo, JSMI extended its very warm welcome to Mr. Albert Yeung, Senior Advisor to China Self-Medication Industry (CSMI).

As was partly covered in the JSMI Chairman's New Year Greetings, CSMI will be hosting the WSMI 6th Asia Pacific Regional Conference in Beijing from October 26 through 29 this year.

Considering the Board of Directors Meeting as a golden opportunity for Mr. Yeung to make his personal appearance to encourage the JSMI member companies to attend the Conference, JSMI gladly managed to find a slot for him to make a brief presentation immediately after the Board Meeting adjourned.

There is a worldwide trend for people to take greater charge of their own health. The Wo r l d Health Organization (WHO) clearly stated this was a most desirable trend in the Alma-Ata Declaration in 1978 which endorsed the goal of health for all by the year 2000, with primary health care being the key to attaining it.

Professor Zhang He-Yong, President, CSMI remarked in his greetings in the CSMI First Announcement as follows:

"People everywhere are becoming more aware of the importance of health, and the opportunity they have for self-care. Many factors - social, economic and political - are encouraging people to take more responsibility for their own healthcare, and in this self-medication has an important place. Government interest and regulatory development in self-medication are therefore high on the agenda in many countries.

"China is no exception to the global trend, and has made rapid strides in medicines classification and regulation in recent years.

"Increasingly, the world is looking at China with interest and confidence, as China opens a new chapter in its rich history. The Chinese Self-Medication Industry (CSMI) association is therefore proud to host the WSMI 6th Asia Pacific Regional Conference, between October 26th - 29th 2004, in Beijing, China.

"The rich conference programme will commence with an overview of health policy in China, and the role of self-medication. This will be followed by a review of the social, market and regulatory situation in China, providing an overview of the very latest developments for overseas delegates".

In line with the CSMI President's greetings, Mr. Yeung, in his presentation, put emphasis on the fact that a full support of the Chinese competent authorities has been extended to, among others, the unique availability of Diaoyutai State Guesthouse, Beijing, as the lodging accommodations as well as the Conference venue.

Needless to explain, Diaoyutai State Guesthouse is by far the prestigious and most ideal place, where the six-way talks were held last year, therefore, Mr. Yeung, in anticipation of a great demand for the rooms, strongly recommended that reservations be made as soon as practical.

In response to the great zeal shown not only by CSMI but also by Mr. Yeung, who, JSMI firmly believed, achieved a great deal as a Public Relations Ambassador entrusted by CSMI, the JSMI Secretariat circulated to its member manufacturers "REGISTRATION FORM" and "APPLICATION FORM FOR HOTEL ACCOMMODATION and TOURS" attached to the CSMI First Announcement, encouraging them to participate in the Conference in the hope that a larger attendance would lead to a more remarkable success of the Conference.

 

OTC Retailing Deregulation- Shifting into Quasi-drugs Regarded as Solution
On December 16, 2003, at its 4th meeting, "Working Group" of "Task Force on the selection of medicines presenting no major safety issues" (Chaired by Hiroshi Saito, Professor Emeritus, Tokyo University) compiled and submitted its report to the Ministry of Health, Labour and Welfare (MHLW).

MHLW, having based its arguments on the report, issued its final policy with specifics shown below:

(1) "Working Group", after having scrutinized nonprescription medicines (13,000 item belonging to 85 categories), selected approximately 350 items belonging to 15 categories.

The majority of those items shall be shifted to quasi-drugs without undergoing reformulation and partial changes to their contents.

(2) These items shall be allowed to be sold at general retail outlets on condition that precautions for use, warnings, directions, etc. are printed on the outer containers or wrappers of the items.

(3) The procedures for the said shifting shall be "regarded as having been appropriately and duly performed" without needing to file specific applications thereof. The shifting shall be completed in approximately six months.

The JSMI Website has been updated since the issuance of its final policy by MHLW on December 16 and, at present, carries Report NO.4, "On preparations for shifting to quasi-drugs".

As of the end of January, there has been published no official announcement as yet concerning the products (brand) names while the JSMI Website is ready for carrying the particulars to be announced by MHLW.

JSMI has been requested by MHLW to design and submit drafts of labelling (in plain terms and suggested printing type) on the outer containers or wrappers of the items in each category.

The Categories as Selected (←click here)


Report Compiled on"Access to OTC at Midnight and in the Early Morning"
Ministry of Health, Labour and Welfare (MHLW), having formed a panel of pharmaceutical experts in October last year, held meetings six times in order to intensively discuss whether it is legal or illegal to allow selling nonprescription (OTC) medicines at midnight and in the early morning when pharmacists are not physically present at retail outlets while using videophones linking retail outlets to pharmacists.

On January 22, the panel compiled and released a final report which calls for authorizing such sales from April on condition that the following requirements are met.

As legal formalities, the Cabinet Order having relevance to the issue needs to be revised as accordingly prior to the commencement of the videophone-based OTC drug sales.

Additionally, the report remarks that those requirements are subject to review for possible modifications one year after the enforcement thereof.

1: The time zone specified as "At midnight and in the early morning" shall be:

From 10 p.m. through 6 a.m.

2: The scope of medicines shall be:

Nonprescription medicines to the exclusion of Specified Drugs, Poisonous drugs, and Powerful drugs.

3: Kind and properties of the technology of communications shall be:

Videophones and other technology of communications capable of properly performing collection and provision of information on the medicines by way of transmitting animations and voices (Videophones, etc. capable of enabling pharmacists to properly discern complexion and natural physical movements of customers, to judge the necessity to advise them to see a doctor, and to confirm the medicines as directed by pharmacists are handed over to them)

4: Proper supervision by pharmacists physically present at retail outlets during "Normal Ti m e Zone":

Retailers are obliged to have pharmacists physically present on a full-time basis during ordinary operating hours outside the time zone when videophones, etc. are used (hereinafter referred to as "Normal time zone") in order to ensure proper management on the spot such as control of pharmaceuticals and supervision of store clerks.

5: Limits on the time zone when videophones, etc. are used in each business day:

The time zone when videophones, etc. are used shall not exceed ordinary operating hours where pharmacists are physically present on a full-time basis in each business day.

6: Mandatory utilization of videophones, etc.:

At each sale of medicines, provision of information by pharmacists to customers shall be made at each and every retail outlet, with videophones, etc. as specified in the above Item 3 being utilized without fail.

Further, at each and every retail outlet, a staff shall be designated for ensuring the above mentioned provision of information is appropriately done. The staff shall be responsible for encouraging customers to utilize videophones, etc. and ensuring the medicines to be handed over to customers are those directed by pharmacists.

7: Keeping records:

Proprietors of each and every retail outlet shall keep records of the following items and retain them for one year:

(1) Date and time of sale
(2) Names of medicines sold and symptoms worthy of mention
(3) Names of store clerks involved in the sale
(4) Names of pharmacists involved in provision of information via utilization of videophones, etc.

8: Establishment of systems enabling pharmacists to go to their stores to cope with complaints from customers of side effects:

(1) Designation of pharmacists (supervising pharmacists and pharmacists at standby centers included) at each and every store

Establishment of practical countermeasures at each and every store

(2) Preparation and keeping, at each and every store as well as standby centers, of the lists of nearby medical institutions capable of handling, even at midnight and in the early morning, emergencies attributable to side effects

9: Control and supervision by pharmacists of pharmaceuticals and store clerks:

Pharmacists (supervising pharmacists and pharmacists at standby centers included) shall make the rounds of retail outlets at least once at midnight and in the early morning.

Store clerks shall report to standby centers what drugs have been sold, how drugs are displayed, etc.

Proprietors of each and every retail outlet shall retain the reports of the rounds together with the reports as specified in the above Item 7.

10: A sufficient number of pharmacists for customers' education on compliance and provision of information:

(1) A system shall be established whereby a sufficient number of pharmacists are secured so that the Item 6 can be fulfilled and customers' education on compliance as well as provision of information can be properly performed.

(2) Pharmacists at standby centers shall be physically present, in principle, at least once a week during "Normal Time Zone", at the videophone-based retail outlets and provide with them education on compliance and information.

11: Videophone-based sales within the same prefectures:

Retail outlets and standby centers shall be located in the same prefectures.

12: Filing notifications with local public bodies:

Proprietors intending to begin videophonebased sales of medicines shall file with the respective local public bodies notifications describing the following items:

(1) Time zone, during ordinary operating hours, for conducting videophone-based sales at midnight and in the early morning

(2) Locations of standby centers, and locations and names of the retail outlets with which pharmacists at standby centers provide instructions on medicines via videophones, etc.

(3) Names of pharmacists working at standby centers, and reports on their working concurrently with other retail outlets

JSMI, in the capacity of an observer, has been invited to the panel meetings, where, although they do not necessarily address the sale at midnight and in the early morning, the following two noteworthy opinions were given:

(1) It might be advisable to improve Package Inserts and Labeling on the outer containers or wrappers so as to be more easily understood by consumers.

(2) It might be advisable to educate consumers to read carefully Package Inserts.
 

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