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Due in part to the US subprime mortgage crisis of the summer of 2007, the global economy has tumbled downwards. The prices of crude oil and commodities including grain and raw materials have started to drift upward. Environmental issues have been becoming increasingly more evident.
Since last fall, the financial systems of US and other advanced economies have headed towards a systemic financial meltdown as day after day stock markets are in a free fall - money markets are shutting down and giant corporations are going under further driving the world economy crisis. Corporations are requesting national measures be taken to tackle this financial crisis but the economic outlook remains totally unclear.
This tumble of the world economy has also greatly affected the Japanese economy and many industries are finding themselves in a very tough business environment.
The current state of medical services in Japan is also in disarray as they face complicated social problems related to the life and safety of Japanese citizens due to weaknesses in medical emergency response; shortage of obstetricians and pediatricians; an increase in medical malpractice; reductions and/or discontinuances of medical facilities; and so on.
JIRA, under these critical circumstances, will monitor the severe economic environment striving to improve medical services in Japan and do our best to contribute to establish a well prepared society for the people of Japan in the field of medical diagnostic systems by implementing the changes that our society needs.
JIRA is presently concerned with two significant issues that will involve a lot of work and include several matters that will call for quick action.
The first issue is the cognizant change of value evaluation of modern imaging systems.
In recent years, rapidly-evolving diagnostic imaging devices and system technologies have dramatically improved the accuracy of diagnosis for cancer, cerebral infarction and cardiac diseases, leading to earlier diagnosis and treatment with consequential significant improvements in the modernization and quality of healthcare. These improvements have positively impacted on people’s perception of the value of medical imaging.
On the other hand, various challenges have recently become evident in the Japanese healthcare system, including difficulties in achieving a balance between higher medical costs and social burden, problems in the medical service fee system as well as the shortage in medical staff with the result being an increased burden on those staff remaining. These challenges seem to have deterred Japanese medical institutions from modernizing, expanding and upgrading the medical imaging systems in their facilities. The medical imaging system market in Japan, after showing solid growth for several years, reported an 11% reduction in 2007 compared to the previous year and remains stable in the first half of 2008, when compared with the same period in 2007. I am concerned that this trend of curbing medical expenses has lowered the value recognition of medical imaging.
Against this background, we continue to develop a favorable environment for the creation of new products and applied technologies through a collaborative relationship among industry, government and academia, and these innovations could elevate the value of medical imaging. At the same time, we stimulate activities to bring to the fore a broad range of social values to which medical imaging system could contribute, including safety, security, patients’ QOL as well as improvements in medical care generally.
The second issue is that we are facing drastic changes in the market environment of medical imaging systems industry.
The Japanese government has recently announced several policies which could greatly influence the medical device industry, including the “5-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices” and the “New Medical Device/Medical Technology Industry Vision” which are based on the Basic Policies 2007. A major step forward introduced through these policies is that medical devices are to be recognized as distinct from pharmaceuticals and therefore need specific handlings based on their particular characteristics. The main characteristic of medical devices is their “diversity.” The across-the-board handlings appropriate to pharmaceuticals are not sufficient for medical devices, which need specific handlings according to their characteristics such as their associated risk levels. Our association will be engaged in the establishment and promotion of the medical device policy in cooperation with other concerned industrial associations including The Japan Federation of Medical Devices Association (JFMDA). We will also engage in our own activities to present clear and specific requests and proposals to input into medical device policies so that they will be in conformity with the specific characteristics of particular medical devices.
Furthermore, in today’s trend towards globalization, the advancement of global harmonization and increased international competition has affected the structure of the medical imaging systems industry. We will further intensify our activities from a global perspective including participating in international exhibitions and international conferences for harmonization and as well as taking up cooperative activities with overseas industry organizations.
Recognizing the two main issues I have just referred to, JIRA member companies will work together to implement the following “JIRA action policies” for 2009.
1. Promotion and proposals for the appropriate evaluation of the medical imaging system
JIRA has been engaged in various activities for the appropriate evaluation of the value of medical imaging systems. We launched a “bridge project” for the appropriate evaluation of medical imaging in 2007 to provide a new appreciation of the value of diagnostic imaging and propose a reconstruction framework for an ideal medical service fee system. In this project, we put forward general ideas on a rational medical service fee schedule by demonstrating that a medical imaging system brings value to “patients and their families,” and “doctors and their facilities” as well as greatly contributing to people’s health and the financial viability of healthcare insurance. This year, from this perspective, we are going to lobby in concert with other organizations for government to realize the following proposals.
(1) Clarification and codifying of the maintenance costs form to ensure the safety of patients
Consider the application of the “medical device safety maintenance fee” for diagnostic imaging equipment or make regulations requiring that “the maintenance cost is covered by certain medical insurance points”, any of which could boost awareness of the costs and the significance of maintenance which will be an effective way of ensuring patients safety.
(2) Proposal towards establishing a new structure for an evaluation system for medical imaging fees
The evaluation system should differ substantially between “general radiography” for initial diagnosis and “CT, MRI, RI examination etc” for diagnostic purposes. The “general radiography” requires two evaluation systems for “analogue imaging” and “digital imaging,” for which we request the creation of a new conception tentatively called a “digital X-ray imaging fee.”
(3) Appropriate assessment of Innovations for the introduction and promotion of IT
Technological innovations in medical imaging devices have shifted from simple “material” to “medical technology software” which can ensure further clinical value and diagnostic accuracy management. The IT innovations should be assessed as future medical technology.
2. Proposal and response to government policies
The Japanese government announced a “Five-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices” in April, 2007 and a “New Medical Device/Medical Technology Industry Vision” in September 2008, both of which are based on the Basic Policies 2007. The main changes brought about by these policies are that medical devices are now recognized as being distinct from pharmaceutical products and in need of specific guidelines according to their characteristics as well as being defined as “medical technology” not just as “materials.”
The “Five-Year Strategy for the Creation of Innovative Pharmaceuticals and Medical Devices” includes the following six priorities: 1) Concentrated Research Financing, 2) Nurturing Ventures, etc., 3) Improvement of the Clinical Research/Trial Environment, 4) Collaboration with Asia. 5) Faster and Better Reviews and 6) Appropriate Assessment of Innovations. JIRA has sent some members to the “5-Year Strategy Promotion Working Group” established in The Japan Federation of Medical Devices Associations, enhancing the alliance with other concerned organizations to promote policy proposals and responses. JIRA has established a “JIRA 5-year strategy promotion WG” for the further development of these activities. This WG will be engaged in activities that include lobbying for tax incentives for research and development of medical devices. Such lobbying will include the abolishment of the upper limit to tax relief available for medical device research and development as well as exploring problems related to the clinical use of medical devices not approved by the Pharmaceutical Affairs Law. This will involve conducting a case study looking at the deregulation of low-risk medical devices such as medical imaging systems, and making active policy proposals towards solving the problems in alliance with other concerned organizations.
Upon establishing the “New Medical Device/Medical Technology Industry Vision,” JIRA made policy proposals through an “advisory body on the promotion of policies for the medical device industry” and as well as attending other hearing and making public statements. As a result, our proposals have been generally followed. Particularly, our proposals have had the effect of reemphasizing the fact that medical devices, unlike pharmaceuticals, are of great variety and that new medical devices can be generated from the improvement of the existing products or in combination with other technologies. Moreover, our proposals have resulted in a better understanding of the necessity for policies with innovational improvements in mind and measures with due consideration paid to the diversity of medical devices such as low-risk and high-risk devices. On the other hand, there remain many problems such as the appropriate assessment of medical devices and technologies and the simplification of the approval procedure for low-risk medical devices. We will enhance our activities so that our opinions will be properly considered and acted upon.
3. Promotion of activities for the “safety and security” of medical devices
During the four years since the implementation of the Revised Pharmaceutical Affairs Law in April, 2005, the regulatory regime for appropriate medical device use has been improved by ensuring consistency between Pharmaceutical Affairs Law and Medical Care Law through the revision of some of the medical regulations. However, according to a “survey on the introduction and security of medical imaging systems etc” conducted by JIRA, the use of medical devices as judged by the regularity of maintenance checks that were being implemented and the renewal years appeared to be in a poor condition from the perspective of “safety and security.”
Regarding the activities for “safety and security,” firstly, JIRA is working to create “equipment handover guidelines”. The “equipment handover guidelines” are prepared for each type of equipment. We will prepare new guidelines for a wide variety of the equipment that JIRA handles, while updating the guidelines already prepared according to technological advancement.
Secondly, JIRA fosters/supports the “Medical Device Information Communicator (MDIC),” specified in Good Vigilance Practice (GVP), who needs to understand the capabilities and features of medical devices and collect and provide information for appropriate medical device use. JIRA is engaged in unique MDIC fostering/support activities including the preparation of training textbooks, and the elevation of the overall education level through training sessions.
Thirdly, in respect of the usage of medical devices by medical facilities, JIRA is promoting “preventive maintenance” by implementing maintenance and periodical checks, as well as providing support and communication activities for preparation of each medical facility’s daily checklists and maintenance check plans based on the startup and shutdown checklists prepared by medical device maintenance engineers.
4. Enhancement of international activities
We will continue to exchange ideas with related industrial associations and organizations overseas (Europe: COCIR; USA: NEMA-MITA; China: CAMDI; Korea: KMDIA and KMDICA). This will involve promoting multifaceted international activities including trade issues related to medical devices, medical service remuneration, international standardization, the global harmonization of regulations on environmental issues, etc. and the exchange of market data, at the same time as strengthening JIRA’s global presence. JIRA will also continue to investigate and provide information for member companies on the regulatory trends regarding medical devices in Asian countries, especially China and Korea where the growth has been most robust.
In 2008, JIRA participated in three international medical equipment exhibitions in China, i.e., the CHINA-HOSPEQ, and the spring and autumn CMEF (China International Medical Equipment Fair) exhibitions. In these exhibitions, we displayed our member companies’ medical devices while introducing JIRA’s activities at our booth. Also in 2008, we established an international exhibition working group and joined the Radiological Society of North America (RSNA) for the first time, which helped our member companies, especially our related device manufacturing companies, to participate in RSNA and make presentations about JIRA. This year, we continue joining various international activities including the RSNA and Asian exhibitions, especially those in China, the country having the greatest potential for growth. These activities are done in order to strengthen JIRA’s presence and member support.
In the DITTA conference, which took place for the duration of the RSNA 2008, there were discussions on the global medical device market trend and the effect of various regulations. JIRA is willing to engage in activities in Asia while allowing/promoting global harmonization with other DITTA members.
Furthermore, we continue to participate in global harmonization conferences such as DITTA, GHTF (Global Harmonization Task Force), and HBD (Harmonization By Doing) in order to realize harmonized and effective regulations for medical devices. We have recently joined the Asian Harmonization Working Party (AHWP) to provide support to neighboring countries.
5. Compliance assurance
In a time of change, compliance can be the backbone of the business operation. With the catchphrase of “Compliance protects you,” we will promote adherence to the Code of Ethics, Compliance Declaration, Charter of Business Behavior, Promotion Code of the Medical Devices Industry, and the Fair Competition Code so that member companies can conduct fair and orderly business.
Regrettably we had to voluntarily restrict a part of our activities last year. With deep remorse for that, we repeatedly required our member companies to engage in “fair and free competition” with enhanced transparency while trying hard to keep all medical institutions and professionals informed about fair trade.
6. Enhancement of JIRA’s basic services
In 2008, JIRA has upgraded and expanded its IT infrastructure in order to strengthen JIRA’s secretariat function and information communication function as well as to streamline our divisions and committees. We have conventionally provided ID and passwords to each member company and this year began to provide additional ID and passwords to each member who belongs to any division or committee. This has enabled members to login to member pages on our website to access the Meeting Support System and JIRA calendar with security ensured. These systems became effective in 2009.
Since its start in 2006, the “Continuous training program,” sponsored by JIRA and three other organizations, has been delivered 9 times in 7 venues nationwide with 1563 participants completing the sessions. JIRA will host the “Continuous training program” this year to provide well-developed training mainly to employees of member companies.
JIRA has introduced new methods to the “JIRA market statistics” for the past two years. These statistics show an increase in the number of the registered companies, a number which now stands at 80 and creates a high value-added market system. In 2009, our market statistics system will introduce an Automatic Processing System using electronic data transfer, to shift to a system which prevents errors and ensures security.
We have conducted a “survey on the introduction and security of medical imaging systems etc” every 5 years since 1988 and annually since 2006. The results have served to provide the evidence for many proposals including activities for the “safety and security” of medical devices.
Recently, the government of Japan has focused on global standardization in line with the Ministry of Economy, Trade and Industry establishing “the goal of international standardization”. The Cabinet has also encouraged further international development of standardization in its long-term strategy initiative “Innovation 25”. JIRA focuses its efforts towards international standardization through active engagement and further participation in the development of an IEC draft standard upon which JIS is based. Participation in the standardization and normalization related to medical imaging systems is a very fundamental activity for JIRA.
JIRA organizes the International Technical Exhibition of Medical Imaging (ITEM), the Exhibition of the Japanese Society for Magnetic Resonance in Medicine, and the Exhibition of the Annual Convention of the Japanese Society of Nuclear Medicine. JIRA will organize ITEM 2009 which will be sponsored by the Japan Radiology Congress (JRC) and held from April 17-19 at Pacifico Yokohama.
We will be updating our website by regularly publishing “JIRA news” and “JIRA news brochures” and by editing and publishing the “Japanese medical diagnostic imaging industries 2009,” in order to provide information and enhance alliances among member companies.
Recognizing the responses to our “21st century project” announced in September 2001 as well as the environmental changes of our association, JIRA is working on the “JIRA future vision project” for the formulation of a structure to organize and solve challenges. We believe this project in 2009 will mark the enhancement of the organization of JIRA both in name and reality.
I have explained our main activities from last year as well as the prioritized activities for this year.
To obtain the maximum results from these activities, understanding and concerted activities by the administration, related academic associations, and related industrial organizations is essential. We would greatly appreciate the understanding and support of all concerned parties.
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