Japan Pharmaceutical Manufacturers Association

Transcription

1 Japan Pharmaceutical Manufacturers Association

2 Message Message from the President, Japan Pharmaceutical Manufacturers Association Isao Teshirogi, Ph.D. President, Japan Pharmaceutical Manufacturers Association The Japan Pharmaceutical Manufacturers Association (JPMA) is an organization whose membership consists of the 69 research and development (R&D) oriented pharmaceutical manufacturers. We strive to play a significant role in improving health and welfare of peoples of Japan and the world through the R&D of innovative pharmaceutical products with a high level of utility. Since its foundation in 1968, JPMA has made significant contributions to global healthcare through the R&D of groundbreaking novel drugs in medical care with the motto, Realize patient-centered care. The Great East Japan Earthquake struck on March 11, In an immediate response, JPMA collaborated with the Japan Medical Association, the Federation of Japan Pharmaceutical Wholesalers Association and other concerned parties to deliver the necessary drugs speedily to the regions struck by the disaster. Our member companies are also engaged in various forms of aid, such as donating relief money in the hope of speeding up the recovery efforts. JPMA has learned from this experience and is now developing a manual concerning drug supplies and how to collect and share information in the event of a large-scale disaster, as well as creating a stronger network with concerned parties. JPMA has also acted to address drug shortages due to quake related damages to manufacturing plants, and, endeavored to build a stable system to supply high quality drugs to every patient, in the disaster zone or elsewhere. The pharmaceutical industry is recognized in the government s New Growth Strategies as a crucial industry to carry the Life Innovation Strategy towards a Healthy Country towards realization of a Healthy Long-Living Society, and is expected to increase its international competitiveness in order to expand into the global market. We aim for further improvement in our R&D potential, which is already in a top level in terms of global standards, and intend to contribute in healthcare in Japan as well as globally, through the creation of groundbreaking novel drugs as well as medicines that meet the unmet medical needs (which means there is no current effective treatment). Meanwhile, advancing globalization has required businesses to fulfill their social roles from a global perspective. Along with strict adhesion to legislations, a trusted business that carries society s expectations must hold a high ethical stance to undertake its social missions. In November 2010, the International Organization for Standardization (ISO) published the ISO26000, a guide concerning the social responsibilities of organizations. JPMA has formulated the Transparency Guideline to promote more transparent corporate activities with those involved in healthcare. In addition, we are improving our system to support each member company s progress in their efforts through revision of the Charter for Good Corporate Conducts and Compliance Program Guidelines. JPMA identifies the global environmental issue as one of the most significant corporate social responsibility (CSR) issues. We promote industry-wide voluntary efforts in such specific areas as chemical substance management, global warming prevention and waste management. We have developed concrete numerical targets: concerning CO2 emissions control and global warming prevention, Reduce CO2 emissions by 23% from FY 2005 level by FY 2020 and, concerning waste disposal, Final disposal amount of industrial wastes to an almost 65 percent reduction by FY 2015 on the quantity in FY We will continue to actively promote respective member companies actions to reduce CO2 emissions through energy saving and fuel conversion, and achieve resource saving and proper waste management. JPMA will strive to maintain an industry that contributes to the health and welfare of people worldwide and an industry that contributes to Japan s economic growth, and actively promote environment and safety related actions. We will facilitate reciprocal communication between us and the various stakeholders, especially our patients, so that we can meet the expectations of society. 1

3 2011 ENVIRONMENTAL REPORT Message from the Chairman, Environment & Safety Committee Akihiro Tasaka Chairman, Environment and Safety Committee, JPMA The mission of Japan Pharmaceutical Manufacturers Association (JPMA) membership is to deliver superior pharmaceutical products, and thus contribute to the health and welfare of people of the world. Meanwhile, JPMA proclaims in its Charter for Good Corporate Conducts, Actions to tackle environmental issues are the common task of the human race, which we take on our own initiative as a requirement to act and continue to exist as a corporation. The efforts for environmental issues are growing in importance in business operations of pharmaceutical manufacturers, and becoming essential for the growth of a company while achieving better sustainability. Establishment of the Environment Committee in 1996 was the very beginning of the JPMA s actions in its systematic and continuing efforts to tackle global environmental issues. Currently, the activities of the Environment and Safety Committee are centered around three expert subcommittees, the Environment Expert Subcommittee, the Occupational Safety & Health Expert Subcommittee, and the Global Warming Prevention Expert Subcommittee, including such actions as monitoring the status of member companies through questionnaire surveys, and information gathering and educational activities by lectures and technical training courses. Respective expert subcommittees have established the Process Safety Study Group, the Business Vehicle Accident Prevention Study Group and the Kyoto Protocol Comprehensive Action Study Group, to tackle the issues which the member companies directly face. Furthermore, our Environmental Safety lectures and seminars have provided a wider perspective and vision by inviting outside lecturers to improve the level of sustainability management of the member companies. The outcomes of those activities are published to the member companies by the Annual Achievement reports and Environment News, and to our stakeholders by the JPMA newsletters and other means. All of these actions are promoted by voluntary efforts of the committee and expert subcommittee members. In addition to the JPMA s current target for prevention of global warming, to control the mean total CO2 emissions from pharmaceutical manufacturers over the first five-year period (FY ) pledged under the Kyoto Protocol below that of the FY 1990 baseline, JPMA has taken a part in Nippon Keidanren s Commitment to a Low Carbon Society alongside our parent organization, the Federation of Pharmaceutical Manufacturers Associations of Japan (FPMAJ) to formulate the CO2 emissions target for The Great East Japan Earthquake and the nuclear power plant accident have forced change in the government s energy policies and may require us to review our targets. Nonetheless, we believe the highly efficient use of energy and the energy-saving measures we have promoted throughout the pharmaceutical industry will become a more important management issue in the future, in terms of energy management. In FY2011, JPMA and FPMAJ have developed a target for the final disposal amount of industrial wastes toward FY 2015 as a part of our efforts towards creating a society with a sound material cycle. As a member of the industrial sector, we will further direct our continous efforts in energy saving / global warming prevention and proper waste management measures. We recognize the protection of biodiversity, the adequate disposal of general medical wastes and the environmental impacts by drugs as the issues we, the pharmaceutical industry, are required to address. These are not only issues that require industry-wide efforts, but also need collaboration with the stakeholders to solve. The Environment and Safety Committee intends to promote mutual understanding with our stakeholders through communication and continue our actions. Since 1999, JPMA has published the annual Environment Report and distributed it among many stakeholders. The Environmental Report 2011 delivers content about the aforementioned environmental protection, health and safety actions, and achievements by JPMA. It would be deeply appreciated if we could receive our readers candid feedbacks. 2

4 Period / Scope of this Report, Editorial Policy, Table of Contents Editorial Policy The purpose for publishing this Environmental Report is the dissemination of information about actions taken by the Environment & Safety Committee of the Japan Pharmaceutical Manufacturers Association, to the respective member companies, and society in general. The Environmental Report contains articles about the progress of and relevant activities conducted towards the Action Plan adopted by the Environment & Safety Committee General Assembly. The information used in these articles is collated from reports submitted by respective member companies or provided by those supported committee s actions. Information collection and analyses are conducted by the respective Expert Subcommittee and collated and/or summarized at the Steering Committee. The editor hopes this Environmental Report will be positively reviewed by our respective member companies and by society, and used effectively as a communication tool. Scope of this Report JPMA has a membership of 69 companies (as of November 1, 2011). The membership list can be found on page 30. Please note that the performance data collected mainly from 67 member companies in 2010, but some data include data from companies belong to other associations under FPMAJ. Period of this Report Performance data were collected and collated for the entire FY 2010 (from April 2010 to March 2011). Information on each group s activities up to as late as November 2011 may also be included. Date of Publication December 2011 (Planned Publication of Next Issue: December 2012) This report is also available at our website. (JPMA Website; About Activities of JPMA; JPMA Publication; free Publications) (Japanese version) (English version) Contents Organizational Structure Planning/Progress Global Warming Prevention Resource Conservation & Waste Management Chemical Substances Management Occupational Safety & Health Management Stakeholder Engagement Training & Motivation History of Environmental and Safety Initiative

5 Organizational Structure 2011 ENVIRONMENTAL REPORT Japan Pharmaceutical Manufacturers Association The Japan Pharmaceutical Manufacturers Association (JPMA) is a voluntary association comprising 69 research-oriented pharmaceutical companies (as of November 1, 2011). JPMA, established in 1968, has been contributing to advancing global healthcare through the development of innovative ethical drugs, facilitating sound development of the pharmaceutical industry through proactively establishing policies and recommendations in response to globalization and enhancing public understanding of pharmaceuticals. Environment & Safety Committee The Environment & Safety Committee, established in 1996, sets targets for global environmental conservation and occupational safety and health, and supports member companies pursuing environmental, health and safety policies. The Committee prepares an annual plan to clarify the targets with numerical values and support to attain them through facilitating the exchange of information between member companies and hosting the technical training courses and seminars. Through these activities, we try to assist to attain targets, and follow-up the situation annually. It is also recognized as an important role of the Committee to collaborate with various stakeholders in the effort to tackle the environment and occupational safety and health issues, which are common tasks for the pharmaceutical industry. Thus, the Committee endeavors to strengthen communication with outside parties. Organization The Environment & Safety Committee consists of committee members and technical committee members who participate in the following: the General Assembly, Planning Conference, Steering Committee and Expert Subcommittees. The General Assembly is held annually in April to govern basic policies, establishing the business plan for each fiscal year, and other businesses. The Planning Conference, consisting of a chairperson, deputy chairpersons, and a secretariat, assigns and coordinates Expert Subcommittee tasks, handles government administration-related matters, and reports to and communicates with the Board of Directors. The Steering Committee consists of a chairperson and vice chairperson of each Expert Subcommittee, Planning Conference members, and others, and is responsible for implementing the business/project plan and coordinating other matters of general business. Within each Expert Subcommittee, the technical committee members are assigned to working groups, each of which engages in a particular task described in the business/project plan, and these groups conduct investigations, plan training courses, prepare various reports, and/or other relevant tasks. Expert Subcommittees consist of Environment Expert Subcommittee, Occupational Safety & Health Expert Subcommittee and Global Warming Prevention Expert Subcommittee. They are grappling with environment and occupational safety & health themes. Compliance Committee Japan Pharmacetical Industry Legal Affairs Association Promotion Code Committee Review Board of Ethical Drug Product Information Brochure Distribution Improvement Committee JPMA Organization President General Assembly Board Directors [Standing B/D] Environment & Safety Committee Vice Presidents Auditors Council on Planning & Policy Drug Evaluation Committee ICH Project Quality & Technology Committee Biopharmaceutical Committee Regulatory Affairs Committee Intellectual Property Committee R&D Committee Environment & Safety Committee (General Assembly) Steering committee Secretariat Planning Conference International Affairs Committee Environment & Safety Committee Public Affairs Committee International Trade Committee Expert Subcommittees Environment Expert Subcommittee Occupational Safety & Health Expert Subcommittee Global Warming Prevention Expert Subcommittee Consumer Consultation Review Committee Consumer Patient Advocacy Consultation Groups Review Committee Committee Office of Pharmaceutical Industry Research(OPIR) Center for Pharmaceutical Publication 4

6 Planning/Progress Environment & Safety Action Plan The Environment & Safety Committee General Assembly is held annually in April to discuss and decide the annual and midterm action plans, taking into account progress made in the previous fiscal year and current trends in society. In FY 2010, Expert Subcommittees were set to work in four project areas consisting of Global Warming Prevention, Resource Conservation & Waste Management, Chemical Substance Management, and Occupational Safety and Health. These subcommittees promoted each activity according to the plans. Some issues were difficult for a single company to resolve. To help those member companies facing the challenges, the Environment & Safety Committee gathered pertinent information from external parties and experts, so that the necessary tasks could be clarified and solutions found. The Environment & Safety Committee also periodically publishes information bulletins, investigational reports, technical information dossier, etc., to make findings accessible and to assist our member companies actions on the environment, occupational safety and health. Followings are numerical targets set by the Environment & Safety Committee for each respective area. Our actions towards occupational safety and health mainly involve investigation of the member companies efforts regarding the state of work-related accidents and incidents, the management of emplpyees health, mental health management, measures to prevent business vehicle accidents, etc. Findings are then disclosed to the member companies. Global Warming Prevention Control CO2 emissions in FY 2010 (mean level of the first commitment period (FY ) under the Kyoto Protocol) to below FY 1990 level. * Since FY 1997, we have continued our efforts in this area, encouraging the main organization and companies under the umbrella to take part in the Follow-up to the Keidanren Voluntary Action Plan on the Environment. In accordance with the provision made under the Kyoto Protocol in which the stipulated target was reduced emissions, our target has been set to reduce CO2 emissions below FY 1990 level. Resource Conservation & Waste Management Up to 20% reduction of final disposal amount of wastes by FY 2010 (compared to the FY 1990 performance) Final Disposal Rate : to be 5% or less by FY 2010 Waste generation : 10% reduction in FY 2010 compared to the FY 1990 performance * Since FY 1998, as part of our waste reduction efforts, we have set numerical targets for the final output of waste and quantity to be recycled into resources. The action plan has progressed smoothly, and we have now introduced a system in which, once an existing target is attained, a new numerical target is set. Chemical Substance Management We have endeavored to reduce atmospheric emissions of harmful atmospheric pollutants such as dichloromethane, 1,2-dichloroethane, and chloroform since FY1997. As in our efforts for Resources Conservation and Waste Management, we employ a method in which the target figures are reviewed when the existing targets have been attained; as well as extending the range. FY2007 was the final year of the Third Term Action Plan and, as the result of analyses of the data for the year, it was deemed that these actions achieved the primary objective, therefore, no new numerical targets shall be set but existing efforts shall be continued. State of Progress of Action Plans The Environment and Safety Committee implements its activities following action plans developed annually and for the mediumterm by each Expert Subcommittee in their respective areas such as measures to prevent global warming, measures to reduce waste, measures to reduce atmospheric emissions of harmful atmospheric pollutants, and promoting occupational safety and health activities. Meanwhile, for the matters related to reinforcing partnerships with superior industrial bodies, the national government and the society, the Planning Conference liaises with relevant expert subcommittee to facilitate information sharing and exchanges of opinions. The following explains the state of progress of the Environment and Safety Committee activities in FY

7 2011 ENVIRONMENTAL REPORT Global Warming Prevention The state of progress in this area attained 1.5% (21,000 tons) above the base year and 0.5% (8000 tons) reduction to the previous year. Last year, it was reported we attained below the target figure at first time although single fiscal year last year. However, the change of member companies made the values for FY2009 and FY2010 a little above the base year. We will continue our efforts towards attaining the numerical targets of mean level of the first commitment period ( ) under the Kyoto Protocol. Resource Conservation and Waste Management In terms of the volume of waste for final disposal, the final disposal rate or the waste generation output, the target has been attained, and our action plan for the period ending FY2010 has already been deemed complete in FY 2010 as well as FY The proactive actions by our member companies toward attaining the numerical targets are also visible in this area. We will continue our efforts in waste reduction. A new action plan for the period ending in FY2015 was settled in FY2010 and initiated from FY2011. Chemical Substances Management With regard to the third term action plan aiming to reduce atmospheric emissions of dichloromethane, 1,2-dichloroethane, and chloroform, the numerical targets were already attained in FY2007. Based on these achievements, JPMA deemed that our primary objective was sufficiently achieved for our voluntary control plan of harmful atmospheric pollutants. We will continue to promote among our member companies further voluntary action for reductions, as well as to prepare for new action. JPMA action plans for resource conservation, waste management and chemical substance management have progressed smoothly. On the other hand, with regard to the global warming prevention, our performance has fallen short of the numerical target due to factors such as production increases, etc. However, after hitting a peak in FY2004, the CO2 emissions reduction initiative was back on track. The CO2 emissions for FY2010 remained on the same level as FY2009, and surpassed 1.5% (21,000ton) of the base year. JPMA will continue to collaborate with the Federation of Pharmaceutical Manufacturers Associations of Japan (FPMAJ) in our efforts to achieve the numerical target of the average of the first commitment pledged period, through requesting member companies to take more proactive actions and actively assisting their efforts through facilitating information sharing and hosting technical training courses related to energy saving technologies. Future issue Endeavor to protect biodiversity The Tenth meeting of the Conference of the Parties to the Convention on Biological Diversity (COP 10) was held in Nagoya in 2010, where decisions were made concerning the international efforts in year 2010 and after (Aichi targets) and the agreement was reached concerning Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization. (The Nagoya Protocol). JPMA hosts technical training courses and seminars every year in order that the member companies can conduct business activities in harmony with natural environment. We hosted a series of lectures related to biodiversity in FY 2010, such as Biological diversity and sustainable business operation by pharmaceutical manufacturers and Environmental impact by drugs and their risk management. In addition, according to the COP 10 agreement, we have also started considering a plan to develop a guideline on conduct for the pharmaceutical industry regarding protection of biodiversity. As wide relationships between biodiversity and environmental protection activities, we intend to take into consideration the direction of future actions by the Environment and Safety Committee when developing our principle on this matter. 6

8 FY2010 Action Plan: Summary of Progress and Achievement Topics FY2010 Working Plan FY2010 Activities and Achievement Energy Saving & Global Warming Prevention Numerical targets Reduce CO2 emissions in FY2010 (mean level of the first commitment period under the Kyoto Protocol) to below FY1990 level. Action plan Follow-up for the Keidanren Voluntary Action Plan Host a technical training course on energy saving Compile information on global warming prevention Develop a post-kyoto CO2 emissions reduction plan Promotion of effective use of business vehicles used by MRs Request top managements of member companies to attain the target of CO2 emission Numerical targets The CO2 emissions exceeded 1.5% above the target figure in FY1990 Action plan Conducted the follow-up survey in collaboration with FPMAJ and reported this to the Keidanren Hosted the 14th technical training course Facilitated information gathering/exchange and study tours on global warming prevention Developed a post-kyoto plan through collaboration with FPMAJ Resource Conservation & Waste Management Numerical targets Up to a 20% reduction of final disposal amount of wastes by FY2010 (compared to the FY1990 performance) Final disposal rate: to be 5% or less by FY2010 Waste generation: 10% reduction in FY2010 compared to the FY1990 performance Action plan Follow-up for the Keidanren Voluntary Action Plan Study to develop a waste reduction action plan after FY2011 and its feed-back to the member companies Host the technical training course to promote 3R activity Investigation of municipal solid medical wastes Support member companies to improve the packaging for pharmaceutical products Numerical targets Final disposal amount of waste to landfill: reduced to 5.4% compared to the FY1990 performance Final disposal rate: 1.9% Waste generation: 28.8% reduction compared to the FY1990 performance Action plan Conducted a follow-up survey in collaboration with FPMAJ Settled next mid-term target of waste reduction in association with the FPMAJ Conducted information gathering about municipal solid medical wastes in collaboration with the FPMAJ Chemical Substance Management Conduct PRTR and VOC survey Study technologies for reduction of atmospheric emissions of chemical substances and their feed-back to the member companies Study environmental risk assessment of pharmaceutical products Study on chemical process safety Conducted PRTR and VOC survey for the member companies, and fed them back to the member companies PRTR substances emitted to the atmosphere in FY2010 were reduced 74% against the level of FY2002 The total air emissions of VOCs were 2,553 tons Conducted information gathering about environmental impact of pharmaceutical products and hosted a technical training course Conducted process safety studies and hosted lectures and a study tour for risk assessment of chemical processes Occupational Safety & Health Other Issues Conduct survey on activities for occupational safety and health, and feed them back to the member companies Study actions for maintaining and improving employees health Host a technical training course on occupational safety and health, and feed them back to the member companies Study and develop measures to prevent business vehicle accidents, and feed them back to the member companies Dispatch timely an appropriate information on environment, safety and health such as Environmental Report and Environment News Collaboration and communication with stakefolders as well as among the industry Study on biodiversity and feed it back to the member companies Host an environmental & safety lecture, and an environmental & safety seminar and so on Conducted survey on relationship between the OHSMS introduction rate and the occupational incident rate, and fed it back them to the member companies Hosted a technical training cource about occupational safety and health Conducted a study and survey on the state of accident prevention and vehicle accidents involving business vehicles Published Sammary of Laws and Regalations on Occupational Safety and Health, and distributed to the member companies Published Environmental Report 2010 Published 4 Issues of Environment News Distributed Achievement Reports 2010 to the member companies Information sharing and collaboration with other JPMA committees and participation in FPMAJ Environmental Committee Hosted a lecture on biodiversity Considered to prepare a guideline for biodiversity (a tentative name) Hosted an environmental & safety lecture and an environmental & safety seminar 7

9 2011 ENVIRONMENTAL REPORT As an Executive Officer Responsible for the Environment and Safety Committee The Japan Pharmaceutical Manufacturers Association (JPMA) is a body of 69 R&D-oriented pharmaceutical manufacturers. President Teshirogi of Shionogi & Co., Ltd. has taken over the chairmanship in FY We take our actions aiming to deliver better drugs to patients faster. In concrete terms, the members of our over 10 committees such as the R&D Committee, Drug Evaluation Committee, Intellectual Property Committee, and the Office of Pharmaceutical Industry Research (OPIR) develop various proposals, and conduct a range of investigation activities. One such committee is the Environment and Safety Committee. It has been three years since I was responsible for the Environment and Safety Committee as an executive officer. Initially, I knew little about the committee, which was deeply involved in global environmental issues and occupational safety and health, and the committee members discussions did not make much sense to me. My first job was a joint project with Tokyo Metropolitan Government in an social experiment to validate various measures to reduce exhaust gases emitted from business vehicles. Although I must have imposed many burdens for the frontline sales reps at the companies of the standing directors of the board, we achieved a great outcome and received recognition from the TMG. I can still recall my expression of great appreciation to everyone at the participating companies as if it were yesterday. After having served three years in this position, I now well understand words and abbreviations such as heat pump, PRTR, and VOC. However, I still have a lot to learn, and whenever I attend a meeting, I come across another opportunity to learn and feel a renewed sense of excitement. I would like to express my sincere gratitude to everyone at the committee who offered me guidance and support during those years. This volume will give you a detailed account of the activities that the Environment and Safety Committee is engaged in. I only mention what is unique in this committee and the points of difference from other committees. Many committees allocate a considerable portion of their time and work to preparing proposals towards smoother Hiroaki Nakatani Senior Managing Director, Japan Pharmaceutical Manufacturers Association and more efficient business operations for pharmaceutical manufacturers. In contrast, our stance at the Environment and Safety Committee is to meet global standards and national standards, and take up the role of the front runner and lead the country, and to demand the member companies to tackle global environmental and occupational safety and health issues ahead of others. Fortunately, I can confirm that the member companies are accepting and meeting this challenge squarely while making progress in the committee activities. Given that nowadays voices are raised loudly in the name of CSR, our committee plays a very important role like all other committees though it looks unique. Lastly, I have a request to the members of the Environment and Safety Committee. Corporate social responsibility has ever been increasing. And now with over seven billion people living and going about their business activities, we can almost hear the Earth screaming out. It is often difficult for us to loudly hear about the voices of environmental and safety efforts. However, for our future generations, and the continuation of healthy corporate activities, I would like everyone in the committee to consider deeply, propose and endeavor to lead the companies and society. My gratitude goes to all of the members of the committee for being engaged in this monumental task, and I hope for even greater actions in the future. 8

10 Global Warming Prevention JPMA recognizes global warming prevention as the most important mission in its efforts to protect the global environment and participated in the Keidanren Voluntary Action plan in In 1999, we developed and announced a reduction in total CO2 emissions as a target in the JPMA voluntary environmental action plan. JPMA is continuing its efforts in the reduction of CO2 emissions, working towards the common target. The CO2 emissions of pharmaceutical manufactures had been increased with market of pharmaceuticals, since the target was settled. However with the peak in FY2004, they changed to decline. The value in FY2010, middle year of the first commitment period ( ) under the Kyoto Protocol was surpassed by 1.5% of the base year (1990). We will continue our active efforts toward attaining the target. JPMA s Actions JPMA takes part in the Follow-Up Action for the Japan Business Federation s (Nippon Keidanren) Voluntary Action Plan on the Environment. Through collaboration with the Federation of Pharmaceutical Manufacturers Associations of Japan (FPMAJ), JPMA monitors, reports and publishes the levels of CO2 emissions and efforts by the members in the prevention of global warming. JPMA hosts an annual Energy Saving / Global Warming Prevention Technical Training Course to facilitate information sharing and opinion exchanges between JPMA member companies and energy saving technology related businesses, academic experts and government administration personnel. We conduct multi-perspective studies in the form of study groups on comprehensive action for the Kyoto Protocol. Target Control CO2 emissions in FY2010 (mean level of the first commitment period ( ) under the Kyoto Protocol) to below FY1990 level 1. Voluntary Action Plan on the Environment (Global Warming Prevention Edition) JPMA carries out Follow-Up Action according to the Keidanren (Japan Business Federation) Voluntary Action Plan for the Environment every year in partnership with FPMAJ since FY1997. As an effort to expand voluntary action plan participation, we requested the Japan Generic Medicines Association (JGA) and Japan Self-Medication Industry (JSMI) to ask their members to take part in a survey on the Follow-Up Action since FY Scope of the Survey and Methodology for Follow-up Action Scope of the Survey The scope of the survey is energy use and CO2 emission levels at manufacturing facilities and laboratories in three associations, JPMA, JGPMA and JSMI. Methodology A questionnaire survey was conducted and the data returned by each company was then compiled for each fiscal year. The calculation of the quantity of energy used and the CO2 emissions level was conducted using the formula provided in the Keidanren Voluntary Action Plan for the Environment Follow-Up Action survey form. The CO2 emissions level from electricity use was calculated using an adjusted electricity carbon emissions coefficient. 2 Responded Companies Responses from a total of 98 companies including 62 JPMA members and 36 JGA or JSMI members were received. The validity of the data submitted from these companies was assessed and 66 companies were deemed fit to be compiled in the Follow-Up Action Survey. The companies who responded were deemed unfit to be part of the survey since they did not have energy profile data of the base year, FY1990. The 66 companies that were subject to the Follow-Up Action Survey Analysis account for 17.6% of the pharmaceutical manufacturers in Japan. However, their sales performance of the 66 companies covers 80.6%. 9

11 2011 ENVIRONMENTAL REPORT 3 State of Progress in FY2010 CO2 emissions The quantity of CO2 emissions that was discharged in FY2010 was 1,536,000 tons, which was reduced by 0.5% (8000 tons) against that of FY2009, but 1.5% (21,000 tons) over the FY1990 level. The causes for any increase or reduction in emissions levels were analyzed as: 1,003,000 tons of the increase due to production growth, 840,000 tons of the reduction due to energy saving measures and a further142,000 tons of the reduction due to a change in the emissions coefficient effecting the calculation. The CO2 emissions per sales unit have been improved with years. The index number of CO2 emissions per sales unit in FY2010 is when that in FY1990 is taken as unity. Although we reported the quantity of CO2 emissions in FY2009 was 4.5% below that of FY1990 in the Environmental Report issued last year, the quantity in FY2010 was surpassed a little against the target. This mainly ascribes to the change of member companies; a company left the association, and some new companies joined this Voluntary Action Plan. This change markedly affected the total CO2 emissions and reductions of Pharmaceutical Manufactures. Besides we do not have grasped how much extent the earthquake on March 11, the Great East Japan Earthquake affected on the CO2 emissions of FY2010. If so, it may be slight when the date of the earthquake is taken into consideration. CO2 emissions CO2/10,000 t Against the base year (%) Fiscal year Emissions (/10,000 t) Against the baseline year (%) CO2 emissions per sales unit (tons/100 million yen) CO2 emissions per sales unit Index number Fiscal year CO2 emissions per sales unit Index number 2. Efforts for Global Warming Prevention 1 State of Progress in FY2010 The pharmaceutical industry needs to meet strict international control standards in research and development, manufacturing and distribution. Consequently there are ever increasing energy expenditures for air conditioning facilities, etc. We take efforts to reduce energy for measures to switch energy source (convert fuel) and introduce highly efficient appliances. Measures implemented in FY2010 for energy savings and global warming prevention cost a total of 3,424,000,000 in capital and expenditures. The principle measures that were implemented and their CO2 emissions reduction effects are summarized in the table on the next page. 10

12 Table 1. Cases of Measures Implemented in FY2010 and their effects on CO2 emissions reductions Measures implemented in FY2009 Cases Reduction(t-CO2) Energy source switching (from diesel, kerosene to city gas supply, propane, electricity, and the like) 14 9,426 Installation of highly efficient machines 28 8,256 Review of facility or machinery operational procedures and control methods (start up, stopping, schedule, intermittent, number of machines in operation, and so forth) 27 3,914 Reduction of radiation loss by insulation of machinery and pipes 16 4,031 Modification of operational standard values Improved manufacturing efficiency(e,g. manufacturing yield improvement) 19 1, Installment of inverter(for ventilator fans, pumps, agitators, lighting, or other equipment) 21 1,409 Improvement of employees consciousness of energy saving by intra-company activities 8 96 Implementation of measures to prevent leakage(plumbing repairs, switching to mechanical seals ) Note) Figures are the total number of reported cases of measures and their CO2 reduction effects submitted by the respective companies JPMA promotes the energy source switching as the most effective among several measures. CO2 emission reduction is accumulated to 180,000 tons with 82 cases for 5 years since FY Efforts in the office The following table shows the status of efforts against global warming made in offices. The efforts, such as periodical energy monitoring and recording, establishing rules about air conditioning temperatures, Cool Biz and Warm Biz, encouraging people to turn off unused equipment and unnecessary lights, have been introduced in over 80% of offices, while the efforts for developing an energy-saving promotion organization and employee education have steadily increased the rate of introduction to reach above 70% in FY It seems that energy-saving activities have been firmly established in offices. Table 2. Status of efforts in offices for energy saving and prevention global warming Rate of introduction (%) Fiscal Year Developing energy-saving promotion organization Implementing employee education Implementing periodical energy monitoring and recording Use of external services such as energy diagnosis Establishing rules on air conditioning temperature Cool Biz and Warm Biz Encouraging to turn off unused equipment and unnecessary lights Detailed zoning of air conditioning areas Replacement of lighting fixtures to energy-saving ones Blocking of sunlight through glass windows Restrictions on elevator use Purchasing green-source electricity Greening of rooftop space Introduction of wind power generation Introduction of photovoltaic power generation Introduction of waste power generation Introduction of fuel cells Installation of cogeneration system

13 2011 ENVIRONMENTAL REPORT 3. JPMA New Voluntary Action Plan (Action Plan toward a Low Carbon Society) As the current voluntary action plan based on the Kyoto Protocol will be completed within two years, JPMA collaborated with the FPMAJ to develop a new post-kyoto action plan (for FY ). Demand on medicines is expected to increase by further progress of aging society. Consequently, we think attainment of the new numerical targets while absorbing the energy increase from increased productions will require a considerable effort. JPMA Environment and Safety Committee will continue its partnership with other industrial bodies under the FPMAJ and promote the efforts based on the vision of the newly developed Action Plan toward a Low Carbon Society. Summary of the Action Plan toward a Low Carbon Society in pharmaceutical Industry Reduction target Reduce CO2 emissions from pharmaceutical industry by 23% from FY 2005 level by FY Scope covered by the Action Plan CO2 from energy use, emitted by manufacturing plants and R&D facilities Study Group Activities Activities of Kyoto Protocol Comprehensive Action Study Group The Great East Japan Earthquake of March 2011 and its catastrophic aftermath forced the Japanese government to revise Japan s energy policies concerning electricity supply and their environmental implications. The National Policy Unit has been charged with conducting the review. The review of domestic measures for FY 2013 will be complete by summer of JPMA thinks that attaining the target in this fourth year of the first commitment period under the Kyoto Protocol is crucial, but attainment of the numerical target seems difficult at the present time. The Kyoto Protocol Comprehensive Action Study Group has been active in learning measures and policies concerning global warming prevention, responses to legal regulations, providing information on energy saving, and visits various facilities to learn. Specific activities after February 2011 include a visit to Itano plant of Otsuka Pharmaceutical Co., Ltd. and Panasonic Ecology System Co., Ltd., and implementation of study session on The current status and future of the energysaving measures on air conditioning unit and Energy management system ISO / FDIS The pharmaceutical industry has decided the post-kyoto target (for FY ) of Reduce CO2 emissions from pharmaceutical industry by 23% from FY 2005 level by FY In the future, The Environment and Safety Committee is required to make maximum efforts for attaining the target and take further actions. Our group will continue to investigate and study measures for prevention of global warming and take actions to share useful information with our member companies. Visit to Panasonic Ecology Systems Co., Ltd

14 Resource Conservation & Waste Management Ten years have passed since efforts were started to move from socio-economic activities based on mass production / mass consumption / mass disposal towards a society with a sound material cycle for protecting environment and recycling materials properly. (Basic Act on Establishing a Sound Material-Cycle Society: effective on January 2001) During this period, JPMA has developed its own voluntary action plan for the environment (with waste disposal reduction targets) and taken actions under it in an effort to reduce not only the final disposal amount but also to control the generation of wastes, as well as conducted investigations into the status of waste generation and disposal. FY 2010 is the final year of the JPMA Voluntary Action Plan for the Environment. We have attained all of the targets regarding final disposal amount, final disposal rate and waste generation. However, our efforts to reduce waste as much as possible are essential for building a sound material-cycle society striving for more effective use of resources. We, JPMA, will continue to develop voluntary action plans for the environment and actively take actions to manage our wastes. JPMA s Actions JPMA has developed voluntary targets to save resources and reduce waste, and has been implementing various 3R activities to achieve them. Target Up to 20% reduction of final disposal amount of wastes by FY 2010 (compared to the FY 1990 performance) Final Disposal Rate: to be 5% or less by FY 2010 Waste Generation: 10% reduction in FY 2010 compared to the FY 1990 performance 1. Voluntary Action Plan for the Environment (Sound Material-Cycle Society): State of Progress Final Disposal Amount of Wastes (Figure 1) Due to our member companies efforts in reducing their generation and recycling wastes, the final disposal amount has been steadily reduced to attain the target, up to 20% reduction in FY2005. The final disposal amount of wastes in FY2010 was as low as 3,100 tons (4.4% against that in FY1990) 1 2 Final Disposal Rate (Figure 2) The final disposal rate of wastes in FY 2010 was 1.9% as well as FY As was the case with the final disposal amount, this indicator has already reached the target in FY (1000 tons) % Figure 1 Final Disposal Amount of Wastes (% against the amount in FY 1990) 100% () 30 Figure 2 Final Disposal Rate 80 90% 80% % 60% 20 50% % 15.8% % 6.3% 6.6% 5.4% 4.4% Target 20.0% Actual 40% 30% 20% 10% 0% Target Actual 13 3 Wastes Generation (Figure 3) In spite of increasing sales of pharmaceuticals due to the rapidly aging society, waste generation has gradually decreased in recent years. The waste generation in FY 2010 was 169,700 tons (40.3% reduction against the FY 1990 generation). (1000 tons) Figure 3 Waste Generation 100% 103% 87% 88% 87% 86% % (% against the amount in FY 1990) 60% % Target 90% % 80% 60% 40% 20% 0 0% Actual * A questionnaire was sent to each of 69 JPMA member companies (at the time of survey). The responses received from 60 companies were collated, and the data were normalized with the survey cover rate based on the pharmaceutical sales. The survey rate in FY 2010 was 96.0%

15 2011 ENVIRONMENTAL REPORT 2The New Voluntary Action Plan for Pharmaceutical Industry In The 2nd Fundamental Plan for Establishing a Sound Material- Cycle Society (March, 2008), the government has developed a reduction target for FY 2015 of a Final disposal amount reduction to almost 60 percent of the amount in FY Nippon Keidanren (Japan Business Federation) has reviewed and considered a higher target than that of the government, and developed the overall industrial quantitative reduction target for FY 2015 of Final disposal amount reduction in industrial wastes to almost 65 percent of the amount in FY In response, JPMA has collaborated with the FPMAJ in the review of a new future target for resource conservation and waste management for pharmaceutical industry and developed the following quantitative target for FY 2015, the same target year as that in the Nippon Keidanren target. JPMA has achieved a steady reduction in the final disposal amount since FY 2000 through our various enlightening actions and member companies efforts toward reduction of the final disposal amount. Taking into consideration the future market growth of the pharmaceutical industry, attainment of the new target should be possible through additional measures for reduction and continuing our bottom up efforts to this end. Toward that goal, we will continue to provide information about successful cases of waste reduction and the latest technical information (including expansion of recyclable wastes) for member companies, and support them. Newly developed quantitative target for pharmaceutical industry Reduction target Reduction of final disposal amount of industrial wastes in 2015 by almost 65 percent of the quantity in FY 2000 TOPICS Chairman s Award for Contribution to Promotion of Reduce, Reuse & Recycle in FY 2011 : Fuji plant of Janssen Pharmaceutical K.K. and Saga plant of Otsuka Pharmaceutical Co., Ltd. received the chairman s award at 3R Promotion Contributor Awards in FY It is our great honor to receive the award for Fuji plant of our company regarding 3R promotion actions in waste disposal. This award means our continuing efforts are highly appreciated. Our employees carrying out these actions were also greatly encouraged by this award. Our factory has implemented proactive actions since 2006 with the motto, for more environmental-friendly waste disposal, to promote the 3Rs, reduce the disposal amount to be landfilled, select a facility that provides better quality service, and treat active pharmaceutical ingredients properly. During these five years, I believe that we have achieved the initial targets, including developing our systems. Concretely, the proportion of 3Rs (reduce, reuse, recycle) in our waste treatment was, 32%, 17% and 51%, respectively, making a total of 99% in At the same time, the quantity Saga plant of our company has received the Chairman s Award for Contribution to Promotion of Reduce, Reuse & Recycle in FY This award is presented to an organization that has engaged in the 3R actions for wastes (reduce: to minimize generation, reuse: to use repeatedly, and recycle: to recycle for other use) and achieved a significant outcome. The award is presented by the Council for Promotion of Reduce, Reuse & Recycle and was created in We are very pleased that we received the milestone 20th award. The theme of our award was Attainment of zero emissions through reduction in organic solvents use by improving process and recovery, and promotion of recycling various wastes, and our efforts focused on the manufacturing of active pharmaceutical ingredients. Our process improvement achieved 1.5 times of production batch size without changing the quantity of solvents used while promoting recovering the organic solvents, both of which actively reduced the solvent quantity used. We have achieved a solvent recovery rate of of disposed waste per production unit base became 57% against the previous year s performance, and the cost of disposal was reduced to two-thirds,generatingsome economic effects. In addition, behind those achievements were the large contributions from our improvement activities regarding safety & health, quality and production efficiency, which have also been implemented at the plant. We will continue our actions to become a Mr. Yuichiro Kurosaki Fuji Plant, Janssen Pharmaceutical K.K. more environmental-friendly plant under your kind future guidance. Mr. Koji Tada Saga plant, Otsuka Pharmaceutical Co., Ltd. over 78%. In addition, we have strived to reduce landfilled wastes. As a result, the amount of directly landfilled wastes was zero, while our defined recycling rate (quantity recycled / {final disposal amount + quantity recycled}), including residues from the industrial waste disposal services, attained zero emissions (over 99.0%) for five consecutive years (FY 2010 achievement: 99.37%). Saga plant has expanded in the Saga Plain, which nurtured by its bountiful nature. In the future, we intend to carry out environmentalfriendly production activities to build a society coexisting with the nature. We would be grateful for your assistance

16 Chemical Substances Management Various kinds of chemical substances are used in the pharmaceutical industry for the research, development, and manufacturing of pharmaceuticals contributing to people s health. Some of those chemicals may have a harmful impact on human health and/or the ecosystem if discharged into the environment. Consequently, we recognize that reducing the quantity of such harmful chemical substances discharged into the environment is one of major issues in the pharmaceutical industry, and voluntary programs on chemical substance management have been implemented. We also promote the research activities on process safety in order to prevent environmental pollution and fire caused by chemical substances used for manufacturing pharmaceuticals. PRTR Survey 66 JPMA member companies handled 11,222 tons (a 14% reduction compared to the amount in FY 2009) of 462 class 1 substances, of which 437 tons (35% reduction) were released into the atmosphere, 15 tons (15% reduction) into public water, and nil into the soil. We also promote the research activities on safety. JPMA s Actions JPMA has conducted a voluntary PRTR survey actions in FY 1997 to monitor the quantity of emissions to the environment and transfers of the designated chemical substances handled in the pharmaceutical industry, and the survey results have been disclosed. Since FY 2007 we have also investigated the use of volatile organic compounds (VOCs, Note 2). In terms of the annual usages, toluene (3,173 tons), dichloromethane (1,843 tons), acetonitrile (1,415 tons) and N.N-dimethylformamide (1,233 tons) were the four biggest substances in this order. Regarding the air emissions, the two biggest substances were dichloromethane and toluene, both amounting to 350 tons. These were followed by acetnitrile chloroform and N.N-dimethylacetamide in this order (see figure 1). Total of the air emissions of these five substances comprised 72% of the total air emissions. Figure 1Air emissions of PRTR substances Chloroform 18 Acetonitrile 23 N,N-dimethylacetamide 9t Others, 37 Toluene 76 Dichloromethane 274 (tons) Figure 2Changes in environmental emission of PRTR substances Atmosphere Water Actual JPMA member companies have continuously reduced the emissions of PRTR substances to the environment. They have been steadily reduced since FY We succeeded in a 74% reduction of emissions by FY 2010 against the level in FY 2002, (see figure 2). Note 1) Chemical substances stipulated in the Act on the Confirmation, etc. of the Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof (PRTR Act) Note 2) Volatile organic compounds (VOCs) are one of the causes of suspended particulate matters and photochemical oxidants Note 3) Survey covered a total of 205 business establishments belonging to JPMA member companies, their affiliated or related companies 15

17 2011 ENVIRONMENTAL REPORT VOC Survey The amendment of the Air Pollution Control Act brought in a provision to control the atmospheric releases of volatile organic compounds (VOCs). Although the member companies hardly have facilities applied by this regulation, JPMA conducted an survey on the annual usage of VOCs among the member companies. The VOCs in the survey included the 100 main VOCs stipulated by the Ministry of Environment, plus n-propyl alcohol, which is widely used in the pharmaceutical industry. In FY 2010, 33 substances were handled in quantities of one ton or more anuualy, and in total 39,242 tons (a 25% decrease compared to the amount in FY 2009) were handled. The four biggest substances were methanol, acetone, ethanol, and ethyl acetate, listed in decreasing order (see figure 3). The total air emissions of VOCs were 2,553 tons. The biggest five substances were ethanol, ethyl acetate, dichloromethane, methanol, isopropyl alcohol, acetone in decreasing order (see figure 4). These six substances comprised 93% of the total emissions of VOCs. Figure 3Annual usage of VOCs (in FY2010: Note 3) Figure 4Air emission of VOCs (in FY2010: Note 3) Isopropyl alcohol 1,521t Dichloromethane 1,834t Acetonitrile 1,415t Toluene 3,173t Others 5,095t Ethyl acetate 4,652t Ethanol 5,892t Methanol 9,362t Acetone 6,298t Toluene Acetone 76t 143t Isopropyl alcohol 146t Methanol 170t Others 108t Dichloromethane 274t Ethyl acetate 307t Ethanol 1,329t TOPICS Efforts for the Biodiversity Conservation Since the formation of the earth, 4.6 billion years have passed, and now some 30 million species of organisms live in support of each other. According to information provided by the United Nations, the human race has accelerated the rate of species extinction by about one thousand times in the last several hundred years. Also, it claimed that % of mammalian, bird and amphibian species are now facing the risk of extinction. If biodiversity continues to decline, it has been claimed that the human race will face various problems, such as a water shortage and a food crisis. Under these backgrounds, United Nations on Conference on Environment and Development held in Rio de Janeiro in 1992, adopted the Convention on Biological Diversity. The convention has three following objectives: (1)The conservation of biological diversity (2)The sustainable use of its components (3)The fair and equitable sharing of the benefits generated by utilization of genetic resources For those objectives, the Basic Act on Biodiversity came into force in June 2008 in Japan, and in March 2009, the Declaration of Biodiversity by Nippon Keidanren (Japan Business Federation) was developed and published. Those moves were followed by the Tenth Meeting of the Conference of the Parties to the Convention on Biodiversity in the City of Nagoya in October 2010, where the Nagoya Protocol concerning access to genetic resources and the fair and equitable sharing of benefits generated by their utilization and a new ten year Strategic Plan for 2011 on (the Aichi Target) were adopted. JPMA Environment and Safety Committee hosts the annual environmental technology training course in January every year. The FY 2010 program was titled The current status of chemical substance management and the future the challenge of zero-emissions aiming to reduce atmospheric emissions of chemical substances, while the title for FY 2011, environmental impact of drugs and its risk assessment, indicates its focus on the issues of the environmental discharge of drugs, and has attracted a lot of social interests. Both topics concerned the environmental discharge of chemical substances, and, had the content deeply related to protection of the ecosystem, or, conservation of biodiversity. In the future, we are required to have more awareness of the biodiversity in conducting our business activities. We will need wide-ranging efforts including procurement of raw materials, waste water discharge, chemical substance management, and the prevention of global warming. Depending on the type of industry and company, efforts for biodiversity will vary. Under these backgrounds, JPMA is considering to develop the JPMA Guideline of Conduct Concerning Biodiversity (proposed title), to promote the member companies efforts in conservation of biodiversity

18 Study Group Activities Process Safety Study Group The Process Safety Study Group started its activities in April The group is now in its fifth year and has 19 members from 12 companies. The original objectives of the group are acquiring knowledge and improving skills about safety assessment in developing manufacturing processes of active pharmaceutical ingredients (API), scale-up, and production reviewing. In addition to these, we have also focused on legal responses concerning novel chemical substances regulated by Industrial Safety & Health Law and Chemical Substances Control Law and proper handling of pharmacologically highly active chemical substances in contracted tests, which are necessary knowledge relevant to process study. We have shared information with member companies, and promoted accident prevention, safety measures and legal compliance. Though we had to cancel the workshop in March 2011 due to the catastrophic Great East Japan Earthquake, We hosted three workshops since December Focusing on process safety of highly hazardous oxidation reaction, dust explosive property of chemical substances and its safety measures, compliance with international laws concerning transportation of dangerous materials, and legal requirements on manufacturing and import, experts provided lectures and trainings, who were invited from chemical manufacturers and research laboratories. In addition, in August 2011, the Environmental Technology Co., Ltd. allowed us to visit and observe a demonstration at their dust explosion testing facility. We were also able to observe the dust explosion testing facility designated for highly active phamacuetical substances. Other activities include information sharing by the group member companies, such as case studies and responding for process safety issues. We also provided the results of the questionnaire survey conducted for the group member companies in FY 2010 on standards of risk assessment of dust explosion and safety measures at milling processes. We will continue our group activities to help members acquire practical knowledge and share information. Summary of acitivities of Process Safety Study Group from December 2010 to August 2011 Title Speakers and organizations 17th 18th 19th 1. Lecture Assurance of safety and quality of manufacturing process by oxidation reactions 2. Case study by one of the group member companies Registration of novel chemical substances based on Industrial Safety and Health Law 1. Lecture Regulation of chemical substances in Japan and overseas, with a focus on the Chemical Substances Control Law 2. Lecture United Nations recommended tests 1. Lecture Introduction to a new product and case studies on reaction kinetics analysis 2. Facility tour and lecture (Environmental Technology Co., Ltd.) Tour to the dust explosion testing facility designated for highly active pharmaceutical substances and other facilities, and a seminar on dust explosion Tour to the dust explosion testing facility designated for highly active pharmaceutical substances Difference between MIKE3 method and the method by Environmental Technology Demonstration of dust explosion test Demonstration of ignitability test Other measuring devices Yasuhiro Takahashi Senior Research Chemist, Synthesis Research Dept. Chemical Research Laboratories Nissan Chemical Industries Co., Ltd. Isao Itoh Deputy Director, Chemical Safety Service Division, Sumika Chemical Analysis Service, Ltd. Yasuhiro Suzuki Assistant General Maneger, Material Hazard Laboratory, Japan Carlit Co., Ltd. Sakira Kaneko President and CEO PalMetrics Kouji Hayashi President, Representative Director Environmental Technology Co., Ltd. 17

19 Occupational Safety & Health Management 2011 ENVIRONMENTAL REPORT Pharmaceutical companies are involved in people s lives and health. It is a part of our missions to create and maintain a work place environment for our employees that is safe, healthy and comfortable to work in. In order to achieve this, JPMA has conducted studies on and promotional activities for occupational safety and health. Especially in recent years, we have been engaged in proactive actions to detect and handle risks that threaten occupational safety and health before an incident happens. JPMA s Actions JPMA aims to create a safe environment, in which every employees, not limited to those at manufacturing or R&D facilities, can work in a physically and mentally healthy condition. JPMA has conducted studies in occupational safety and business vehicle accidents. In addition, JPMA has held a seminor regarding mental health issues of employees and prevention of traffic accidents by business vehicles. 1. Relationship between Status of Occupational Incidents and Implementation of Risk Assessment Our FY 2010 survey on occupational safety and health received responses from 58 (327 facilities) out of 67 JPMA member companies. The survey newly includes an investigation on incidents that do not require day off work as a result of the incidents in addition to an investigation on incidents that require day off work as previous (excluding those that occurred during commuting). The number of occupational incidents that did not require day off work was 577 cases in FY Among those, the number of incidents that occurred at sales offices was the largest at 311 cases, followed by 139 at manufacturing plants. Those two types accounted for 78% of the total number of incidents. Many of the cases at the sales offices were vehicle accidents. Therefore, Environment & Safety Committee has organized the Business Vehicle Accident Prevention Study Group (described later) to investigate various countermeasures based on information including new technologies to prevent accidents and actions by member companies, which has been applied to activities of member companies. Figure 1. Number and percentage of injuries that did not require a day off work in FY 2010 Head offices R&D facilities 45 cases (8%) 64 cases (11%) Manufacturing plants 139 cases (24%) Others (Distribution, etc.) 18 cases (3%) Total : 577 cases Sales offices 311 cases (54%) The number of occupational incidents resulting in injuries that required at least one day off work (excluding those occurred during commuting) was 141 cases in FY Among those, the number of incidents that happened at sales offices was the largest at 59 cases, followed by 45 cases at manufacturing plants. Those two types accounted for 74% of the total number of incidents. This combined percentage is almost comparable to that for incidents that did not require a day off work. However, the sales offices have a smaller percentage of incidents that required a day off work than those that did not require a day off work (54% that did not require a day off work vs. 42% that required a day off work). The opposite tendency was seen in the manufacturing plants (24% that did not require a day off work vs. 32% that required a day off work). This indicates that the manufacturing plants experience more serious cases of occupational incidents. When comparing percentages in other facilities, Others (Distribution, etc.) also has a higher percentage of incidents that required a day off work (3% that did not require a day off work vs. 6% that required a day off work). Though the number of the cases was small, this is also a type of facility that requires caution. Figure 2. Number and percentage of injuries or deaths that required a day off work in FY 2010 R&D facilities 12 cases (9%) Head offices 17 cases (12%) Manufacturing plants 45 cases (32%) Others (Distribution, etc.) 8 cases (6%) Total : 141 cases Sales offices 59 cases (41%) 10 18

20 According to our survey, the total number of lost work days due to occupational incidents in all facilities was 2,361 days in FY In terms of facility type, the highest number was 1,419 days lost at the manufacturing plants, followed by 594 days lost at the sales offices. The manufacturing plants had a 2.4 times higher number of lost work days than the sales offices. The occupational incidents that occurred at a manufacturing plant required more days off work. This survey item also showed more serious incidents occurring there than at other facilities. Head offices 281 days (12%) Figure 3. Number and percentage of lost work days due to occupational incidents in FY 2010 Sales offices 594 days (25%) R&D facilities 41 days (2%) Others (Distribution, etc.) 26 days (1%) Manufacturing plants 1,419 days (60%) Total2,361cases The occupational incident rate that required at least one day off work was 0.54 in FY 2010, which is smaller than the figures of 0.98 in the entire manufacturing sector and of 0.72 for the entire chemical industry (FY 2010 survey by MHLW). In terms of facility type, the highest rate was 1.05 at Others (Distribution, etc.), followed by 0.79 at manufacturing plants, 0.54 at sales offices, 0.42 at R&D facilities and 0.28 at head offices. Others (Distribution, etc.) accounts for slightly more than 3% of the total number of employees, including affiliated companies. Based on the incident rate, it is the type of facility with a high rate of occupational incidents that required a day off work. Occupational incident rate that required at least one day off work Figure 4. Occupational incident rate that required at least one day off work per facility type in FY Manufacturing plants 0.42 R&D facilities 0.28 Head offices Total manufacturing sector: 0.98 Total chemical industry: Sales offices 1.05 Others (Distribution, etc.) 0.54 Total Note: The rate number of injuries or deaths by occupational incidents total work hours 1,000,000 The survey item for the incident severity indicating seriousness of an occupational incident showed an overall severity of in FY 2010, with the severity of at manufacturing plants being significantly high. As previously discussed, the occupational incidents that occur at a manufacturing plant seem more serious than other types of facilities. MHLW s occupational incident statistics for FY 2010 showed a severity of 0.09 in the entire manufacturing sector and 0.04 for the entire chemical industry. Compared to those, the figures for the pharmaceutical industry is lower. Even so, we still need to continue our efforts toward achieving zero occupational incidents. Severity Figure 5. Severity per facility type in FY Total manufacturing sector: 0.09 Total chemical industry: Manufacturing plants R&D facilities Head offices Sales offices Others (Distribution, etc.) Total Note: Severity number of days off work total work hours 1,000 19

21 2011 ENVIRONMENTAL REPORT The survey for the rate of implementation of an occupational safety and health risk assessment in FY 2010 showed that 45% of all facilities have implemented the risk assessment, including 72% of the manufacturing plants, 60% of R&D facilities, 17% of head offices and 11% of sales offices. Manufacturing plants have higher implementation rate of the risk assessment, and the percentage tends to increase. The contributing factors for this trend is that workers at manufacturing plants highly understand the necessity of implementing the risk assessment because they have relatively high risks due to their machines, equipment, and chemical substances, and they have many routine operations. It is thought that proper understanding of risks for safety and steady implementation of risk assessment does not only prevent occupational incidents, but it helps us to mitigate and take actions effectively when a disaster or an accident happens, by illustrating the strength and weakness of each facility. Implementation rate of RA (%) Figure 6. Implementation rate of Occupational Safety and Health Risk Assessment (RA) per facility type in FY % 70% 60% 50% 40% 30% 20% 10% 0% 72% Manufacturing plants 60% R&D facilities 17% Head offices 11% Sales offices 36% Others (Distribution, etc.) 45% Total The relationship between the rate of occupational safety & health risk assessment implementation and the occupational incident rate showed that implementation of the risk assessment could halve the occupational incident rate (frequency of occurrence) (Overall mean rate: 1.1 for RA not implemented vs. 0.4 for RA implemented). Implementation of the risk assessment is effective in lowering the occurrence of occupational incidents. It is expected that more facilities implement risk assessment in the future to reduce their occupational incidents. We will continue to study the relationship between occupational incidents and implementation of the risk assessment. Figure 7. Relationship between Risk Assessment implementation and occupational incident rate that required at least one day off work per facility type in FY 2010 Occupational incident rate RA not implemented RA implemented Manufacturing plants Others (Distribution, etc.) R&D facilities Head offices Sales offices 10 20

22 2. Status of Traffic Accidents by Business Vehicles and Countermeasures Business vehicles are essential for activities of MRs. A survey on the management/system for the business vehicles and the status of accidents by them was conducted for the sixth time. The responses from 56 companies (with a total of approximately 51,000 vehicles) were analyzed. The Business Vehicle Accident Status of Accidents The mean liable accident rate (the number of accidents divided by the total number of vehicles) was 21.5%, a slight increase compared to FY 2009, keeping high rate. The rate of accidents resulting in an injury or death was 2.4% for all kinds of vehicles and has remained at the same level for the past three years. Prevention Study Group, now into its third year, has engaged itself in activities such as a case study presentation on accident prevention measures by the member companies and the introduction of safe-driving support devices by external lecturers. With regard to leased vehicles, the liable accident rate was 25.7% in FY 2010, still on a slight increasing trend for the past three years. However, the rate of injury-causing accidents was 2.7%, slightly lower than FY Figure 8. Status of liable accident rate FY2008 FY2009 FY Figure 9. Status of accidents resulting in injury or death FY2008 FY2009 FY All vehicles Leased vehicles Vehicles owned by MRs Concerning tendency (increase or decrease) in the number of accidents at the companies over the past three years, the number of companies responded Considerably increased or Increased decreases, while the number of companies responded No change increases. The number of companies 0.0 All vehicles Leased vehicles Vehicles owned by MRs responded Decreased or Considerably decreased is almost the same. Overall, the trend of the accidents is improving. Many of the companies with an increasing trend named the reason as an increase of younger staff including new recruits. 100% 75% 50% Figure 10. Trend of accidents Considerably decreased Decreased No change Increased Considerably increased Figure 11. Main reasons for accident increase Increase of at fault accidents in a parking lot Increase of accidents by new graduate MRs Increase of accidents by young staff 25% 0% FY2008 FY2009 FY2010 Increase in the number of young MRs 0.0% 5.0% 10.0% 15.0% 20.0% 25.0% In the past three years, the liable accident rate by new MRs within 12 months of their first assignment was around 80% (number of liable accidents by new MRs divided by the number of vehicles driven by new MRs). This must be considered a very high figure, given the overall liable accident rate was around 20%. As seen previously, the great portion of the accidents were minor, in which a half of them occurred in a parking lot. However, some had the potential of resulting in a serious accident. Therefore, countermeasures for younger staff are urgently needed. 100% 80% 60% 40% 20% Figure 12. Rate of liable accidents by new MRs 0% FY2008 FY2009 FY

23 2011 ENVIRONMENTAL REPORT In addition, the number of MRs by the number of incidents for those experienced liable accidents was surveyed this year, as a part of the one year tracking study of all vehicles and new graduate MRs in FY The all-vehicle data showed about 15% of those who experienced a liable accident were involved in multiple accidents, while the FY 2009 new graduate MR tracking study found that about 40% of those in a liable accident were involved in multiple accidents. Measures for MRs involved in multiple accidents is one of critical factors in accident prevention. It is thought that we need to take actions further not only from the technical aspects, but also from the administrative aspects. All vehicles New graduate MRs Figure 13. Number of liable accidents and MRs involved 0% 20% 40% 60% 80% 100% Once Twice Three times Four times or more Efforts for Safety The figure 14 shows the implementation rate for each countermeasure and their effects at the 56 member companies. Trainings for new graduate MRs, special trainings at the time of employment and special trainings for those who had multiple accidents were implemented at many of the companies with tangible outcomes. In terms of actions for employees who had an accident, an individual face to face guidance by an immediate superior and a penalty system according to the severity of the liable accident were introduced at many companies, and found to be effective. The number of companies that have introduced a safety driving support device such as a drive recorder is still low, but the companies introducing the devices, have had a considerably tangible effect. Figure 14. Implementation rates of countermeasures and their effects at the member companies Driving ability assessment and course for prospective new MRs before officially joining company Driving ability assessment and course for new MRs during the orientation period after joining company Practical driving training in actual car and/or lectures for new MRs at the newly assigned location Special lectures for MRs with multiple accidents Specific lectures, such as driving skills on snow at time of assignment to a new location or transfer to another area Self directed learning courses (e-learning) and/or video training courses (%) Face to face guidance by an immediate superior Face to face guidance by other superiors Mental health care service provided after accidents (counseling, etc.) Punitive measure depending on severity of liability accidents Reflection to job performance assessment Individual commendations Divisional commendations Periodic vehicle inspection (at least annually) Periodic driver license inspection (at least annually) Company-wide monitoring of number of illegal cases Company-wide monitoring of details of illegal cases Guidance provided by head office to MRs involved in illegal cases Drive recorder (video camera to record driving) Safety recorder (to monitor driving habits) Corner sensor (prevention of accident at parking lots) Percentage of companies implementing the measure (%) Percentage of companies reporting effectiveness of the measure (%) No effect (%) GPS navigation device (assist driving in unfamiliar area) Rear-view monitor (prevention of accident during backward driving at parking lots) 10 22

24 3. Efforts for incident prevention and promoting employees health In July 2011, the occupational safety and health technical training course was held at JPMA, focusing on prevention of business vehicle accidents, prevention of occupational incidents at our facilities, and mental health issues. The experts working actively in the respective frontlines were invited to give us lectures. Mr. Kaizuka from InterRisk Research gave a lecture titled Business s actions for effective reduction of traffic accidents, including the reality of many companies with difficulty for reducing vehicle accidents, its contributing factors and, based on that knowledge, the effective measures to reduce accidents. The lecture by Professor Takano from Keio University was titled Accident prevention strategy through promoting a safety culture. After explaining organizational management factors behind occupational incidents, he summarized the outcomes of past studies and practices, showed that a safety culture consists of eight elements, and also showed the practical strategies and specific action plans for the major elements. Dr. Maruta, the occupational health physician of Hitotsubashi University gave us a lecture titled Mental health in the workplace and return-to-work programs. She showed the current state of mental health issues in the workplace, companies measures and return-to-work programs. Her lecture included how to manage actual cases and points to be aware of, based on her experiences as a psychiatrist having treated many cases. The training course was very useful for improving occupational safety and health programs at member companies, having many enthusiastic questions and comments. TOPICS Summary of Laws and Regulations on Occupational Safety and Health (Fifth edition) Compliance with occupational safety and health related laws and regulations is one of the most fundamental requirements for us. However, the Industrial Safety and Health Act and related legal regulations provides wide varieties of contents, and are complex. Therefore, JPMA has compiled a summary of laws and regulations on occupational safety and health, and distributed it to the member companies as a useful material for responsible staffs of the member companies. In response to the changes and progress to related laws and regulations, a complete revision was made to the summary of laws and regulations on occupational safety and health (fourth edition) compiled in FY The fifth edition was published and distributed to the member companies in March 2011 in a booklet form as well as in an electronic file. Considering the ease of use by responsible staffs, the electronic version had a key word search function built in and could be customized to meet the needs of each company. It is expected that this initiative will help raise the level of occupational safety and health management at each company. Study Group Activities Business Vehicle Accident Prevention Study Group In the interest of ensuring occupational safety of MRs, corporate social responsibilities and compliance, prevention of business vehicle accidents is identified as a perpetual issue in the industry. The Business Vehicle Accident Prevention Study Group investigates the member company s situation regarding the accidents and efforts for accident prevention, and offers opportunities for the members to obtain information on accident prevention from various external sources, expecting that those actions will lead to an overall vehicle accident reduction in the industry. Activities Conduct the detailed review of the FY2010 questionnaire study and its outcomes Case study presentations by the member companies Introduction of devices and equipment for accident prevention Conduct the FY 2011 survey and analyses of the results Suggestion on accident prevention management Experience on Safety Driving SkillCentral Training Academy for Safe Driving, Japan Safety Driving Center, Hitachinaka City, Ibaraki 23

25 Stakeholder Engagement 2011 ENVIRONMENTAL REPORT Partnership with the Federation of Pharmaceutical Manufacturers Associations of Japan The Federation of Pharmaceutical Manufacturers Associations of Japan (FPMAJ) was founded in 1948 with the mission of contributing to the sound development of the pharmaceutical industry and improving the guality of life of people around the world. FPMAJ currently consists of 14 organizations with different business categories and 19 prefecture-based regional organizations. FPMAJ Board of Directors presides over various committees and councils, each of which conducts investigations and studies in its respective specialties and develops proposals as required. The Environment Committee is one of those committees, whose role is to work in partnership with the Ministry of Health, Labour and Welfare (MHLW) and external industrial organizations and councils, such as Keidanren, and deals with issues such as the prevention of global warming, resource conservation & waste management and other environmental issues specific to pharmaceutical industry to meet legal requirements and society s demands. Actions of the FPMAJ Environment Committee Mr. Seishi Takenawa Chairman Environment Committee FPMAJ Among the environmental issues, FPMAJ Environment Committee has participated in the Keidanren Voluntary Action Plan regarding to global warming and resource conservation & waste management, with targets for FY 2010 from its beginning, and monitored and reported the progress annually to Keidanren. In addition, concerning the prevention of global warming, MHLW has separately conducted an annual review, requiring us to make positive efforts to attain the action plan. Furthermore, as the Keidanren Voluntary Action Plan will enter its final year, Keidanren has developed a new voluntary action plan and requested member bodies to participate in the plan. In response to this request, FPMAJ has developed its own new action plan and commenced the actions in partnership with Keidanren in FY Aside from these, issues specific to the pharmaceutical industry, such as medical waste disposal, and other environmental issues such as actions for biodiversity, are becoming more important. Status of progress of FY 2010 Action Plan Concerning the prevention of global warming, based on the Keidanren Voluntary Action Plan on the Environment, FPMAJ and JPMA have been jointly involved in the follow-up program for the action plan since The follow-up survey performed during FY 2011 (on FY 2010 performance) showed a 0.5% reduction of CO2 emissions against the previous business year, although it failed to attain the numerical target, the performance of 1990, surpassing by 1.5%. The reason for the failure to attain the numerical target in this year s survey is stated on page 6. The review by MHLW in FY 2010 noted the difference of efforts for the action plan among the member companies, and requested further efforts to increase the number of participating companies. Incorporating the newly developed Action Plan toward a Low Carbon Society into our vision, we intend to facilitate and support industry wide actions by the pharmaceutical industry. We have also participated in the Keidanren Voluntary Action Plan on the Environment (Sound Material-Cycle Society) since FY We have established three numerical targets for Industrial waste generation, Final disposal amount of industrial wastes and Final disposal rate of industrial wastes, and strived to attain them. The FY 2011 survey (on FY 2010 performance) showed that all of the three targets were attained. We expect to strengthen our cooperative framework by Japan Pharmaceutical Manufacturers Association (JPMA), Japan Generic Medicines Association (JGA) and Japan Self Medication Industry (JSMI) with the new voluntary action plans. FY 2011 Action Plan for FPMAJ Environment Committee (important issues) Prevention of Global Warming Conduct the follow-up survey on the Keidanren Voluntary Action Plan on the Environment. Respond appropriately to the annual review for FPMAJ Voluntary Action Plan by MHLW. Conduct educational and motivational activities towards the launch of the new Voluntary Action Plan and deal with related issues. Information Gathering Gather information about environmental issues such as biodiversity whose impact is considered to be significant. Resource Conservation and Waste Management Conduct the follow-up survey on the Keidanren Voluntary Action Plan. Encourage participation in the new Voluntary Action Plan and establish the framework for follow-up survey. Gather information about general medical wastes and communicate with concerned third parties. Summary of New Voluntary Action Plans (developed in FY 2010) New Voluntary Action Plan in relation to prevention of global warming (FPMAJ Action Plan toward a Low Carbon Society) Reduction target: Reduce CO2 emission by 23% from FY 2005 level by FY 2020 Period: Between FY 2013 and FY 2020 Scope: CO2 New Voluntary Action Plan in relation to Resource Conservation and Waste Management Reduction target: Reduce final disposal amount of industrial wastes in 2015 almost 65 percent of the guantity in FY 2000 Period: Between FY 2011 and FY 2015 Scope: Industrial wastes generated by manufacturing plants and R&D facilities 10 24

26 Actions by the Fluorocarbon Issue Working Group Metered dose inhalers (MDI) are mainly used in the treatment of asthma and chronic obstructed pulmonary diseases (COPD). Traditionally, the specified fluorocarbons, chlorofluorocarbons (CFCs), was predominantly used in MDI. However, in the interest of protecting the ozone layer, FPMAJ established a Fluorocarbon Issue Working Group in FY 1997 to promote the conversion from CFCs to a fluorocarbon alternative, hydrofluorocarbons (HFCs) to reduce CFC emissions by the inhaler use. As a result, since the first HFC-contained MDI was developed in FY 1997, use of CFC-contained MDI had declined and became zero by the end of FY 2005, and the original goal was achieved. However, following that, HFCs were also found to have a greenhouse effect. In respect to the prevention of global warming, reducing atmospheric emissions of HFCs became a new issue. Therefore, in FY 1998, we established a numerical target for FY 2010 and have tackled technological development for reduction of HFCs emissions. FY Numerical target Notes FY 2010 HFCs emissions estimated to be 540 tons Estimated based on the quantity shipped in FY 1996 To control HFCs emissions of 405 tons or less in FY % reduction of the projected figure To control HFCs emissions 180 tons or less in FY 2010 Revision based on a new technological development To control HFCs emissions 150 tons or less in FY 2010 Revision based on the trend of the new technology introduction Change of HFCs emissions As therapies by inhaler has come to wide use, the number of prescriptions for MDI increases year by year. The quantity used in FY 2010 was about 2.4 times of that in FY 1990 and about 1.4 times of that in FY Since FY 1997, HFCs aerosol inhalers and the powder inhalers not using fluorocarbon gases have been developed, gradually replacing the CFC-contained inhalers. In FY 2005, the CFCs emissions from the inhaler use had become zero. Then, following that, due to the wider use of powder inhalers and improved mist aerosol inhaler technology, HFCs emissions has been reduced since FY HFCs emissions in FY 2010 were 88.7 tons, achieving the numerical target (150 tons). When CFC and HFC emissions are converted to the CO2 equivalent using the global warming potential, the CO2 emission has steadily decreased since FY The FY 2010 emission show an approximately 89% reduction from the FY 2000 level. Emissions (tons) Unit ,000 30,000 25,000 20, ,206 22,085 22,702 Fluorocarbon emissions Use of MDI 23,767 CFC HFC Target FY 26,151 30,215 29,664 CO2 emission converted (10,000 tons) CO2 emission converted from fluorocarbon emission CFC-CO2 HFC-CO FY 15,000 10,000 12,554 5, FY CFC -contained inhalers Others HFC -contained inhalers Total DPI inhalers 25

27 Training & Motivation 2011 ENVIRONMENTAL REPORT The JPMA Environment & Safety Committee intends to raise awareness and find efficient solutions to the issues through the facilitation of information sharing among the JPMA members, by hosting seminars and technical training courses with invited outside speakers, as well as through the presentation at courses and workshops of case studies of the members actions in protecting the environment. The Committee also issues a periodical publication, Environment News, conducts various studies on JPMA members action for the environment and occupational safety and health and compiles these into booklets, etc, and distributes the information collected from the member companies. Publication of Study Reports The Environment & Safety Committee General Assembly is held annually in April to discuss and determine an annual action plan concerning Environment and Occupational Safety and Health related matters for the streamlined implementation of these actions. The respective Technical Subcommittees conduct questionnaire surveys, etc., to monitor progress in attaining the targets and to identify issues and tasks, and also prepare reports of the outcomes as a form of feedback to the member companies. The committee also takes part in the Keidanren Voluntary Action Plan (both the Global Warming Prevention Edition and Sound Material Cycle Society Edition), through follow-up studies on the state of progress and action by the members; compiling the data and information obtained into a report and periodically reporting this to Keidanren. Publication of Environmental Reports The Environment & Safety Committee has anually published an Environmental Report from FY1999 to provide a summary of our members efforts and actions for the environment and occupational safety and health. The Environmental Report discloses information about the pharmaceutical industry s efforts for the environment and occupational safety and health as a means to fulfill our responsibility to provide an explanation to stakeholders. The report is also expected to be a tool for communication between the member companies and the society. Japan Pharmaceutical Manufacturers Association ENVIRONM ENT AL REPORT 2009 Japan Pharmaceutical Manufacturers Association ENVIRONMENTAL REPORT 2010 Publication of Environment News The Environment & Safety Committee issues Environment News, which includes summaries of Environment and/or Occupational Safety and Health related Seminars and Technical Training Courses for easy access by the member companies. This information is uploaded to PRAISE-NET, the intranet shared between the Federation of Pharmaceutical Manufacturers Associations of Japan, the Osaka Pharmaceutical Association and the Tokyo Pharmaceutical Association, so that the information is widely distributed in the pharmaceutical industry. Publication of Case Reports The Environment & Safety Committee surveyed how the member companies tackled with Energy Saving and Global Warming Protection, issued a booklet as Case study of Energy Saving and Global Warming Protection, and distributed it to the member companies in 2008 to promote the global warming protection activity. We also surveyed employees incident of member companies form 2008 to 2009, compiled a booklet as Case study of Employees Incident 2009 including 156 astual cases, and distributed to the member companies. In addition, Summary of Laws and Regulations on Occupational Health and Safety and their outline were listed and distributed to the member companies in

28 Publication of Achievement Report The Environment & Safety Committee organizes the information obtained through various research activities conducted by the respective technical groups, or at lectures, seminars and Technical Training Courses, and collates it into a CD-ROM for distribution to the member companies. This arrangement enables the members to access a wide range of information about the seminars, technical training courses, or other occasions that their personnel were not able to attend. This is a means for the respective member companies to find information about the activities of the Environment & Safety Committee and to apply it effectively in their own activities. It should be noted that this Achievement Report is created through the cooperation and understanding of many lecturers and speakers at the seminars, Technical Training Courses, etc. Study Group Activities The respective JPMA expert subcommittees have study groups, in which the member companies that do not participate in the expert subcommittees can still participate in areas requiring technical expertise. Currently, three study groups are working actively: Kyoto Protocol Comprehensive Action Study Group, Process Safety Study Group and Business Vehicle Accident Prevention Study Group. Environment and Safety Lecture, Environment and Safety Seminar and Technical Training Courses The Environmental & Safety Committee holds an annual environment and safety seminar, lecture and technical training courses for management and staffs involved in environment, safety and health issues. These activities help the member companies improve their technical measures and management program regarding environment, safety and health. Environment and Safety Lectures and Technical Training Courses (January October 2011) New pollutants originated from urban effluent in aqua-ecosystem: interests and actions Prof. Hiroaki Tanaka Research Center for Environmental Quality Management, Kyoto University Environmental Technical Training Course (January 2011) Lectured on the historical progress of measures and technologies for protecting aqua environment. In addition, explained the new pollutants recently attracting attention: its understandings and actions for parties concerned. Biological diversity and corporate environmental management by pharmaceutical manufacturers Business s actions for effective reduction of traffic accidents Mr. Eiichro Adachi Research Chief, The Japan Research Institute, Limited Mr. Kiyoshi Kaizuka Chief Consultant InterRisk Research Institute and Consulting, Inc. Environment and Safety Lecture (April 2011) Occupational Health and Safety Technical Training Course (July 2011) Understanding changes in social situations following the conclusion of the Tenth Meeting of the Conference of the Parties to the Convention on Biological Diversity, a lecture was given on the impact of biodiversity issues on pharmaceutical manufacturers and the actions required for improving their competitiveness, including information disclosure and concerns to corporations. Lectured on effective measures to reduce vehicle accidents, based on the reality of many companies with difficulty for reducing the accidents: Firstly, pointed out the importance of commitment by top management, and of establishing a good human relationship between the management and workers; In addition, showed that neglecting minor errors and stereotyped safe-driving education are other factors preventing reduction of the accidents. Accident prevention strategy through promoting a safety culture From occupational incidents to organizational accidents Mental health in the workplace and return-to-work programs Prof. Kenichi Takano System Design Management Keio University Dr. Noriko Maruta Occupational health physician Health Center Hitotsubashi University Lectured on the importance of promoting a safety culture in organizations for incident prevention, and the points and case studies for promoting a safety culture. Pointed out that a declined morale (loyalty to company), weakening of human relationships, a profit-first attitude and declined motivation are major obstacles to promote a safety culture. In addition, explainined policies and concrete action plans to deeply consider and maintain the administration programs, which are easy to change compared to the engineering actions. Workers are increasingly taking days off work and/or sick leave for mental illness. Showed how to manage them and the points to consider when an employee suffers from depression. Also explained early symptoms of depression, actions for them, collaboration of concerned parties upon a diagnosis of depression, and practical procedures for sick leave. In addition, showed points to consider when returning to work, as well as personnel management such as systems for sick leave and support. Prevention of global warming in the present and future, considering the post-quake social and economic changes Energy Saving / Global Warming Prevention Technical Training Course (October 2011) Ryosuke Imai Section Chief Office for Low Carbon Society Policy and Coordination Division Global Environment Bureau Ministry of Environment Explained the current state of international negotiations and the future actions in Japan after the catastrophic quake. Also showed that Japan s stance is a steady implementation of the Cancún Agreement while maintaining the aim of building a fair and effective international framework as an ultimate goal concerning the international negotiations. In addition, explained that the renewable energies should be one of major energy sources in terms of the energy policies. Post-quake energy-saving policies Perspective of energy policies after the earthquake - from a business point of view Environmental innovation efforts at Panasonic Fumiaki Ebihara Assistant Manager Energy Efficiency and Conservation Division Agency for Natural Resources and EnergyMinister of Economy, Trade and Industry Mr. Tsutomu Sasaki Deputy Chief Researcher The Japan Research Institute, Limited Yoshiaki Kitamura Unit manager Panasonic Environmental Systems & Engineering Co., Ltd. Explained that the future energy policies should consider safe & relief as well as stable & economic supply, and environmental adequacy. In terms of the innovative energy environment strategy, developing numerical targets for short, medium and long terms would be considered. Also, showed the approach for the Fundamental Energy Plan in the next fiscal year. Explained the results of investigation on energy policies before and after the earthquake. Less dependency on nuclear electricity generation would increase the electricity price by 20% compared to the current price. Future energy-saving program would be one of critical business issues rather than programs on each facility in the present. Explained energy-saving efforts in the Panasonic Group: inclusion of energy saving programs into top management targets, visualization of energy use, conducting professional audit and disclosure of related information by top-down approach. In addition, showed some examples of technological progresses. 27

29 History of Environmental and Safety Initiative 2011 ENVIRONMENTAL REPORT 1968 The Japan Pharmaceutical Manufacturers Association was founded. Related Technology Liaison Group was established to undertake technological reviews on pollution issues around factories (in principle, waste water issues) 1978 Related Technology Liaison Group was reorganized to the Factory Waste Water Regulatory Measures Review Group 1979 In collaboration with the concerned authorities and agencies, an Environment Action Review Group was established for adopting the government administration s intentions, communicating the industry s ideas, exchanging information within the industry and the confirmation of a common direction for the environmental action among the members 1996 An Environment Committee was established. Five Subcommittees (Planning Subcommittee, Chemical Substances Subcommittee, Environment Management Subcommittee,Resources Conservation & Waste Management Subcommittee and Energy Saving & Global Warming Prevention Subcommittee) were internally organized and systematic action on global environmental issues was initiated. The first period atmospheric emissions reduction plan for harmful atmospheric pollutants such as dichloromethane, 1,2-dichloroethane and chloroform was settled on Participated in the Keidanren Voluntary Action Plan for the Environment implemented the Follow-Up Action and settled a CO2 emissions reduction target. Initiated an energy use survey among the member companies Settled Action Plans on wastes generation and final disposal amount of waste Settled Guidelines for the Voluntary Action Plan for the Environment by Pharmaceutical Manufacturers, which clearly stated JPMA s efforts on environmental issues. Published an Environment Report Restructuring of the Committee organization from a five to a four subcommittee regime (Chemical Substances Subcommittee, Environment Management Subcommittee, Resources Conservation & Waste Management Subcommittee and Energy Saving Global Warming Prevention Subcommittee) alongside the newly created Steering Committee. The second period atmospheric emissions reduction plan for harmful atmospheric pollutants (dichloromethane, 1,2-dichloroethane and chloroform) was settled on Committee activities expanded to occupational safety and health. Renamed the Environment & Safety Committee. Study Groups were organized as places for activities beyond the subcommittees Review the target of final disposal amount of wastes (tighten the rate of reduction from 70% to 80%) 2005 The third period reduction plan for air emissions of harmful atmospheric pollutants (dichloromethane, 1,2-dichloroethane and chloroform) was settled on New numerical targets for the final disposal rate and waste generation were introducedto a Waste Reduction Action Plan, in addition to the final disposal amount of wastes Subcommittees reorganized from a four-subcommittee regime (Chemical Substances Subcommittee, Environment Management Subcommittee, Resources Conservation & Waste Management Subcommittee and Energy Saving & Global Warming Prevention Subcommittee) to a three-subcommittee regime (Environment Subcommittee, Occupational Safety & Health Subcommittee and Global Warming Prevention Subcommittee) 2010 Participated in Nippon Keidanren s commitment to a Low Carbon Society, targeted in FY2020, and settled a reduction target of total CO2 emissions. The target for the period from FY2011 to FY2015 as the final year for the Keidanren s Voluntary Action Plan on the environment (Sound Material-cycle Society) was settled

30 Progress of Our Voluntary Action Plans Area of Action Year of Planning Action Plan Contents Year Attained FY2001 (First Period Plan) Final disposal amount: 70% reduction against that in FY1990 FY2002 Action for Resource Conservation and Waste Management FY2003 (Second Period Plan) FY2006 (Third Period Plan) Final disposal amount: 80% reduction against that in FY1990 Final disposal amount: 80% reduction in FY2010 against that in FY1990 Final disposal rate: 5% or less in FY2010 Waste generation: 10% reduction in FY2010 against that in FY1990 FY2005 FY2007 FY2010 Final disposal amount : almost 65% reduction in FY2015 against that in FY2000 Established a plan FY1996 (First Period Plan) Dichloromethane: 30% reduction compared to the amount in FY1995 1,2-dichloroethane: 30% reduction compared to the amount in FY1996 Chloroform: 30% reduction compared to the amount in FY1996 FY2000 Chemical Substances Management Action to control Air Emissions FY2001 (Second Period Plan) Dichloromethane: 60% reduction compared to the amount in FY1995 1,2-dichloroethane: 50% reduction compared to the amount in FY1996 Chloroform: 30% reduction compared to the amount in FY1996 Formaldehyde: reduction efforts Benzene: reduction efforts Tetrachloroethylene: reduction efforts Acetonitrile: reduction efforts FY2004 FY2005 (Third Period Plan) Dichloromethane: 20% reduction compared to the amount in FY2003 1,2-dichloroethane: 20% reduction compared to the amount in FY2003 Chloroform: 20% reduction compared to the amount in FY2003 FY2007 Global Warming Prevention FY1997 Control the total CO2 emissions in FY2010 to below in FY1990 level Ongoing FY2010 Reduce CO2 emissions by 23% from FY 2005 level by FY 2020 Established plan Members of Planning Conference and Steering Committee of Environment & Safety Committee Chairperson Akihiko Tasaka TAKEDA PHARAMACEUTICAL CO., LTD. Planning Conference Deputy Chairperson Seishi Takenawa Tadashi Nishikimi ASTELLAS PHARMA INC. PFIZER JAPAN INC. Satoru Kobayashi DAIICHI SANKYO CO., LTD. Chairperson Teruyuki Tosaka CHUGAI PHARMACEUTICAL CO., LTD. Steering Committee Environmental Deputy Chairperson Deputy Chairperson Satoru Kobayashi Masayuki Takagishi DAIICHI SANKYO CO., LTD. SHIONOGI & CO., LTD Expert Subcommittees Occupational Safety & Health Chairperson Deputy Chairperson Tadashi Nishikimi Hirotsugu Yokoi PFIZER JAPAN INC. ASAHI KASEI PHARMA CORPORATION Global Warming Prevention Chairperson Deputy Chairperson Deputy Chairperson Seishi Takenawa Junichi Taniguchi Jun Yamamoto ASTELLAS PHARMA INC. OTSUKA PHARMACEUTICAL CO., Ltd. DAIICHI SANKYO CO., LTD. Member nominated by Chairperson Takeshi Oigawa Meiji Seika Pharma Co., Ltd. Secretariat Akira Kusai JPMA 29

31 2011 ENVIRONMENTAL REPORT JPMA Member Companies (listed in alphabetical order): 69 Companies as of November 2011 ABBOTT JAPAN CO., LTD. AJINOMOTO PHARMACEUTICALS CO., INC. ASAHI KASEI PHARMA CORPORATION ASKA PHARMACEUTICAL CO., LTD. ASTELLAS PHARMA INC. AstraZeneca K.K. BAXTER LTD. BAYER YAKUHIN, LTD. BRISTOL-MYERS K.K. Celgene K.K. The CHEMO-SERO-THERAPEUTIC RESEARCH INSTITUTE CHUGAI PHARMACEUTICAL CO., LTD. DAIICHI SANKYO CO., LTD DAINIPPON SUMITOMO PHARMA CO., LTD. EISAI CO., LTD. ELI LILLY JAPAN K.K. FUJIMOTO PHARMACEUTICAL CORP. FUSO PHARMACEUTICAL INDUSTRIES, LTD. Genzyme Japan K.K. GlaxoSmithKline K.K. HISAMITSU PHARMACEUTICAL CO., INC. JANSSEN PHARMACEUTICAL K.K. JAPAN TOBACCO INC. KAKEN PHARMACEUTICAL CO., LTD. KISSEI PHARMACEUTICAL CO., LTD. KOWA Company, Ltd. KRACIE PHARMA, LTD. KYORIN PHARMACEUTICAL CO., LTD. KYOTO PHARMACEUTICAL INDUSTRIES, LTD. KYOWA HAKKO KIRIN CO., LTD. MARUHO CO., LTD. MARUISHI PHARMACEUTICAL CO., LTD. Meiji Seika Pharma Co., Ltd. MINOPHAGEN PHARMACEUTICAL CO. LTD. MOCHIDA PHARMACEUTICAL CO., LTD. MSD K.K. MYLAN SEIYAKU LTD. NIHON PHARMACEUTICAL CO., LTD. NIPPON BOEHRINGER INGELHEIM CO., LTD. NIPPON CHEMIPHAR CO., LTD NIPPON KAYAKU CO, LTD. NIPPON SHINYAKU Co., Ltd. NIPPON ZOKI PHARMACEUTICAL CO., LTD. NOVARTIS PHARMA K.K. NOVO NORDISK PHARMA LTD. ONO PHARMACEUTICAL CO., LTD. OTSUKA PHARMACEUTICAL Co., Ltd. PFIZER JAPAN INC. POLA PHARMA INC. sanofi-aventis K.K. SANTEN PHARMACEUTICAL CO., LTD. SANWA KAGAKU KENKYUSHO CO., LTD. SEIKAGAKU CORPORATION SENJU PHARMACEUTICAL CO., LTD. SHIONOGI & CO., LTD. TAIHO PHARMACEUTICAL CO., LTD. TAISHO PHARMACEUTICAL CO., LTD. TAKEDA PHARMACEUTICAL CO., LTD. TEIJIN PHARMA Limited TEIKOKU SEIYAKU CO., LTD. TERUMO CORPORATION TOA EIYO LTD. Toray Industries, Inc. TORII PHARMACEUTICAL CO., LTD. TOYAMA CHEMICAL CO, LTD. UCB JAPAN CO., LTD WAKAMOTO PHARMACEUTICAL CO., LTD. YAKULT HONSHA CO., LTD. ZERIA PHARMACEUTICAL CO., LTD

32 Japan Pharmaceutical Manufacturers Association Torii Nihonbashi Building, 3-4-1, Nihonbashi-honcho, Chuo-ku, Tokyo , Japan TEL FAX URL: Planned and Complied by Environment & Safety Committee