The Action Plan in 2008 was approved at the General Assembly of JSMI which was held on May 12th, 2008 in Tokyo. The Action Plan defines the following three points as our main objectives of this year.
(1)
Promotion of PR activity for OTC medicines for consumers in order to appeal its role.
(2)
Revitalization of the market by means of promotion of Rx-to-OTC switch.
(3)
Promotion of the Self-Medication in Asia-Pacific region.
To achieve these objectives, our committees and working groups proceed with the following 12 items and report their progress up to Strategic Council of JSMI.
(1)
Promotion of Self-Medication by means of PR activity on OTC medicine
(2)
Promotion of proper advertising practices
(3)
Accurate response to the deregulatory change of Sales System in 2009
(4)
Making the strategic explanation for contribution of OTC medicines to the society with back-up data
(5)
Close collaboration with retail associations, etc.
(6)
Securing the acceleration and the transparency of approval process
(7)
Revision and renewal of "Approval Standards"
(8)
Promotion of Rx-to- OTC switch
(9)
Development of preventive medicines for metabolic syndrome and lifestyle-related diseases
(10)
Further use of Kampo medicines and herbal preparations
(11)
Enhancement of pharmacovigilance system
(12)
Expansion of the international relationship
2. "Guideline for Sales Promotion Tools" was revised
In accordance with the revision of "Guideline for advertisement", the Guideline for Sales Promotion Tools presenting efficacy of OTC medicines had been revised.
The outline of the guideline is as follows.
(1)
Only the efficacy data which was attached to the dossier is available for the sales promotion tools and the data sources must be clearly described.
(2)
Emphasis on the efficacy, assurance of safety, or slander on the other companies' products is prohibited.
(3)
Member company have to create the sales promotion tools based on their in-house administration rules, and they also have to be reviewed by their in-house compliance -related department before distribution.
(4)
When the sales promotion tools are created and distributed, the member companies should promptly report to the Promotion Code Committee office of JSMI.
Additionally, the size and tools of sales promotion such as leaflet and POP are defined in this Policy.
3.JSMI's opinion was imparted to MHLW
Meeting on "Promotion of the Pharmaceutical Industry Policy" was held to follow-up the New Vision for the Pharmaceutical Industry, which had been driven by the Ministry of Health, Labour and Welfare (MHLW).
At the meeting, Mr. Uehara, Vice-Chairman of JSMI, expressed his hope that the government should give countenance to the embodiment of the action plans for the promotion of self-medication noted below.
1) Utilization of OTCs in the new areas of medicine
- To build an environment that enables consumers to have more choices by enlightening the self-medication and supplying more effective OTCs to the market
- To promote the development of switch OTCs
- To widen the application of OTCs to lifestyle-related diseases including metabolic syndrome
- To form a network of cooperation among the related medical societies, pharmaceutical societies, pharmaceutical industry (consisting of manufacturers of original new drugs), OTC industry, and other related parties, in order to address these issues and promote cooperation under the leadership of the government.
2) Enlightenment of the Self-Medication as national issues
With the enforcement of the new retailing system for OTC medicines, a national approach to enlighten the Self-Medication should be conducted for promoting consumers' health and more efficient use of the healthcare resources.
3) Support to appropriate promotion of the Self-Medication in the Asia-Pacific region
In response to the proposition by JSMI, the MHLW rep stated, "Considering that switch OTCs have been steadily increasing, the governmental efforts to build a scheme for more conventional Rx-to-OTC switching should be forwarded."
= Conference document submitted to MHLW from JSMI =
Approaches toward advancement of the Self-Medication made by JSMI
1
Drawing up, promotion and result verification of the priority subjects for JSMI by the established Strategic Council on Undertaking Activity
2
Permeation and Edification of the Self-Medication
- Edifying the Self-Medication on national papers and conducting campaigns for proper use of OTC Medicines
- Distributing "Self-Medication Handbook" more than 200,000 copies every year
- Producing and distributing side readers for school teachers and instructional video materials to support education for OTC medicines at high schools and junior high schools
- Organizing educational seminar and/or forum for consumers toward the Self-Medication and Self-Care
- Providing information of the Self-Medication by means of Information-Technology, such as "OKUSURI KENSAKU", a search tool for OTC medicines on JSMI website.
3
Development of new environment of OTC medicines supply
- Making efforts of member companies to develop and supply OTC medicines addressing which will meet consumers' needs by utilizing Rx-to-OTC switch and others including prevention of lifestyle-related disease. Moreover, proposing candidate ingredients for Rx-to-OTC switch, conducting actual condition survey toward facilitation of the approval process, and preparing related basic data are also important.
- Facilitating relationship among consumers, physicians, pharmacists and other healthcare professionals to promote proper practical use of OTC medicines as part of enlightenment of the Self-Medication/Self-Care to consumers being potential lifestyle-related disease
- Developing voluntary standards for advertisement and conducting practical review of ads
4
Support for permeation of the Self-Medication in Asia-Pacific countries - Building cooperation and communication with WSMI and its affiliated associations
