JPMA's policy & Activities for Fisical Year 2008 (April 2008-March 2009)

1. Strengthening policy proposal and utilizing Government and Industry Policy Dialogues (GIPDs)

1. The JPMA will better utilize GIPDs to facilitate the proposal and realization of policies on issues related to the pharmaceutical industry, such as improvement of the infrastructure for drug development and reinforcement of the international competitiveness of the Japanese pharmaceutical industry.
2. JPMA's related committees, the Office of Pharmaceutical Industry Research (OPIR), and the Secretariat will work together to provide support and cooperation concerning policy proposals and discussions during GIPDs.
   
3. We will hold discussions on our policy proposals with related regulatory authorities to facilitate smooth implementation of the action plans adopted in the 5-Year Strategy for Innovative Medicines and New Pharmaceutical Industry Vision.
4. We will make efforts to stimulate understanding of related organizations (Japan Business Federation or Nippon Keidanren, Japanese Medical Association etc.) and policy makers over a wide range of issues such as health insurance, healthcare costs, taxation, and intellectual property.

2. Addressing national health insurance (NHI) drug price issues

JPMA Pharmacoeconomics Project at Keio University Graduate School

1. The JPMA will work toward to the proposal for the new NHI drug price system, developed by the new task force established for the purpose, in cooperation with the Drug Price Study Group of the Federation of Pharmaceutical Manufacturers & Associations of Japan (FPMAJ).
2. We will work toward realizing the proposal for the new NHI drug price system as early as possible through discussion in GIPDs and advocacy to concerned parties.
3. We will continue to provide support and cooperation to the management of the Education and Research Program of Health Economics, which we established at Keio University Graduate School. We will support the establishment of guidelines to evaluate the value of innovation appropriately and the development of human resources.

3. Reinforcing the infrastructure for research and development

1. Through coalition with and support from related committees, the JPMA will make concrete policy proposals and follow-ups for the major issues contained in the 5-Year Strategy for Innovative Medicines, including integrated management and operation of R&D activities, budget allocation, outcome evaluation, cultivation of venture enterprises, and improvement of infrastructure to facilitate venture enterprises through a multi-departmental governmental approach.
2. To cope with new drug development technologies in the post-genomic age, we will make efforts to improve the infrastructure for drug R&D involving proteomics, toxicogenomics, molecular imaging, and model animal with emphasis on the establishment of safety biomarkers as a technology platform.
3. We will identify and put into practice policy measures to promote and implement new drug development from life science research at universities and other research institutions.
4. We will hold discussions with the National Institute of Biomedical Innovation so that the views of the pharmaceutical industry are reflected in its activities.

4. Improving clinical trial and research systems

1. Regarding the New 5-Year Activation Plan of Clinical Trials, developed to improve the clinical trial and research systems, the JPMA will follow up major actions to ensure their steady implementation and make proposals for improvement.
2. We will hold discussions regarding clinical trials in Japan with related governmental bodies and other organizations over how to achieve global competitiveness including costs and to improve the infrastructure and systems related to clinical trials.
3. We will take measures to promote regulatory science and communication to evaluate advanced technology, e.g., biomarkers, and its application to surrogate endpoints.
4. We will study critical paths for R&D, risk management planning, conditions for approval and optimum ways of post-marketing surveillance to propose new policies for reinforcing and improving safety evaluation and assurance from the R&D stage through the post-marketing stage.
5. We will hold discussions with overseas regulatory authorities and related organizations to promote Asian and global clinical trials to achieve simultaneous development and approval of new drugs in Japan, USA, Europe, and other countries, and to develop new regulatory procedures and policies for improvement.

5. Improving the governmental new drug approval examination system and pharmaceutical regulations

Booklets to promote clinical studies

1. Regarding improvement of the Pharmaceutical and Medical Devices Agency's (PMDA) clinical trial consultation services and regulatory approval procedures, the JPMA will follow up the status of action goals and the implementation of the roadmap and annual plan which were agreed at the timing of the increase of PMDA fees.
2. We will follow up implementation of the actions for improvement proposed in the report from the "Committee for Facilitating Smooth Supply of Effective and Safe Drugs."
3. We will follow up the issues for implementation of the revised Pharmaceutical Affairs Law enforced in April 2005. We will also hold discussions with the regulatory authorities, under coalition with the Federation of Pharmaceutical Manufacturers Associations of Japan (FPMAJ).
4. We will collect up-to-date information on global trends of the pharmaceutical regulations and hold discussions with the related governmental bodies on desirable systems for pharmaceutical regulation.
5. We will continue to send delegates to and cooperate with the related committees of IFPMA. We will also follow up global trends in R&D and pharmaceutical regulations of vaccines and biopharmaceuticals for the treatment of cancer.

6. Promoting public understanding of the pharmaceutical industry and strengthening public relations activity

JPMA website homepage (Japanese/English)

Policy proposal discussion at a seminar

Medical facility tour

1. The JPMAwill reinforce public relations activity to healthcare consumers, media, opinion leaders, and others to achieve extensive recognition of a "visible industry" and an "industry contributing to global healthcare." We will also disclose and disseminate information more timely through further improvement of the JPMA website.
   Particular emphasis will be on promotion of public understanding of the roles of the pharmaceutical industry.
2. We will distribute information more timely and hold meetings such as Media Forum and Policy Seminar to facilitate better understanding of policies and issues of the pharmaceutical industry.
3. We will promote dissemination of information to healthcare consumers via media and events. We will actively continue educational campaigns for young people on issues related to drugs. We will also promote information disclosure of registrations and results of clinical trials and other issues related to drugs under development.
4. We will continue to support patient groups with activities for the realization of "patient-centered healthcare."

7. Addressing drug distribution issues

1. On the basis of the urgent proposal "Improvement of Ethical Drug Distribution" issued by the Council for Improvement in the Distribution of Ethical Drugs, the JPMAwill seek active cooperation with relevant organizations to facilitate resolution of the issues related to drug distribution.
2. We will promote standardization of bar coding of oral and topical drug preparations in cooperation with FPMAJ to ensure safety and improve traceability of drugs.

8. Contributing to environmental & occupational health and safety

1. The JPMA will further promote voluntary actions to prevent global warming and to control waste and chemicals appropriately.
2. We will make efforts to promote investigation, collection, and supply of information on labor safety and health regulations and management systems, and to provide qualitative support to labor safety and health activities.
3. We will take appropriate measures to meet the global trend for environmental protection and to improve disclosure of information on environmental safety on the JPMA website.

9. Strengthening international coalition and cooperation

JPMA publication on environmental issues 2008

1. The JPMA will participate in and cooperate with the activities of IFPMA and its committees. We will take actions to ensure compliance with the revised marketing codes on drug access and intellectual property issues; to facilitate information disclosure of registration and results of clinical trials; and to disseminate knowledge about the International Conference on Harmonisation (ICH).
2. We will provide support the formation and activities of Japanese companies' overseas subsidiaries in cooperation with pharmaceutical associations in other countries such as the Association of the British Pharmaceutical Industry (ABPI), the German Association of Research-Based Pharmaceutical Companies (Verband Forschender Arzneimittelhersteller [VFA]) and the French Pharmaceutical Manufacturers Association (Les Entreprises du Médicament [Leem]), and similar associations in China and India.
3. To continuously support business activities in China, including clinical development, we will hold discussions with related governmental bodies, in cooperation with the Ministry of Health, Labour and Welfare (MHLW).
4. We will implement international cooperative actions based on the policies of related international bodies, such as dealing with the issue of counterfeit drugs in Asia in cooperation with IFPMA and through participation in WHO's International Medical Products Anti-Counterfeiting Taskforce (IMPACT) initiative.

10. Contributing to international harmonization of regulations

Seminar in Indonesia, 2005

1. Through the framework of ICH and in cooperation with MHLW, the JPMA will make efforts to facilitate international harmonization, including discussion on optimum regulations for innovative technologies such as genomic drug development, ensuring the safety of new drugs at the development stage, dealing with new quality assurance systems, and reviewing existing guidelines.
2. Regarding the Mutual Recognition Agreement of Good Manufacturing Practice (GMP) with the European Union, we will take actions to achieve early expansion of applicable products.
3. In cooperation with regulatory authorities, academic societies, related industrial organizations and research institutions, we will make efforts to strengthen the current regulatory system to deal with issues related to international harmonization of regulations.
4. We will also hold discussions with related governmental bodies on the Pharmaceutical Inspection Co-operation Scheme (PIC/S) in order to standardize GMP and its surveillance system.

11. Promoting protection of intellectual property

WHO's Intergovernmental Working Group

1. The JPMAwill hold discussions with related governmental bodies and other organizations to cooperatively achieve the goals set in the Intellectual Property Promotion Plan, with emphasis on data protection, research tool patents, patents on medical treatments, extension of patents, and copyright.
2. In coalition with related governmental bodies, IFPMA and pharmaceutical associations of foreign countries, we will follow up trends of WHO's Intergovernmental Working Group on Public Health, Innovation, and Intellectual Property. We will send delegates to relevant conferences so that our views will be reflected in WHO's policies.
3. We will reinforce dissemination of information to facilitate understanding of issues related to intellectual properties in the field of life sciences, through the holding of events such as the Life Science Intellectual Properties Forum.

12. Ensuring corporate ethics and compliance with statutes

Revised Promotion Code

1. The JPMA will take measures to facilitate further understanding of the JPMA Member Company Charter, JPMA Compliance Program Guidelines, and Ethical Drug Promotion Code to ensure thorough compliance by pharmaceutical companies with ethics and statutes.
2. Regarding the Revised Promotion Code, we will provide education and training to facilitate better understanding and compliance.

13. Preparing for a pandemic influenza

1. As a guide to prepare for a pandemic of new strains of influenza in the future, the JPMA will draw up a Business Continuity Plan (BCP) including countermeasures against new strains of influenza and distribute the plan with member companies. We will review this plan as needed to address any changes in the situation.

14. Strengthening policy research capacity; Office of Pharmaceutical Industry Research (OPIR)

Booklets from the Office of Pharmaceutical Industry Research

1. The Office of Pharmaceutical Industry Research, serving as a think tank for the pharmaceutical industry, has been analyzing and studying medium and long-term issues of the industry. In coalition with domestic and overseas research institutions, this office has been undertaking surveys and studies which lead to the proposal of new policies. The researches include analysis of the current status and future perspectives of the entire pharmaceutical industry.