ENVIRONMENTAL REPORT 2014 - JPMA · 2019-09-18 · 3. Making effort to promote international...

ENVIRONMENTAL REPORT2014

Japan Pharmaceutical Manufacturers Association

Message

1 Japan Pharmaceutical Manufacturers Association Environmental Report 2014

Message from the President, Japan Pharmaceutical Manufacturers Association

Masayo Tada President, Japan Pharmaceutical Manufacturers Association

The Japan Pharmaceutical Manufacturers Association (JPMA) is an organization of R&D oriented pharmaceutical manufacturers, who strive to make contributions to improve the health and welfare of the people of Japan and the world through development of innovative pharmaceutical products and sound advancement of the pharmaceutical industry.Recent years have seen remarkable advancement in medical care, including pharmaceutical products that have made significant contributions to improving people’s health and quality of life. However there are still many diseases without established treatment. To R&D oriented pharmaceutical manufacturers who belong to JPMA, it is the most important mission to develop safe and efficacious innovative new drugs that will meet unmet medical needs and to deliver them to patients through medical institutions.

Since last year the government has advanced its financial growth policies driven by “Japan Revitalization Strategy”. In the area of healthcare, the “Act on Promotion of Healthcare Policy” and the “Act on the Independent Administrative Agency of Japan Agency for Medical Research and Development” were passed at the Diet in May this year, while a cabinet decision was made in July to endorse a revised version of, “The Healthcare Policy.”

This move to elevate the Headquarters for Healthcare Policy into a statutory body to implement strategic and sustainable plans has been welcomed by the pharmaceutical manufacturing industry. The industry will continue to work actively to strengthen the partnership with the government and academia further, to vitalize our innovation and to commit itself to the sustainable research and development of innovative new drugs to resolve unmet medical needs.

Meanwhile as corporate activities have become more globalized, pharmaceutical manufacturers in Japan, a new drug-creating country, are expected to exercise leadership and to make contributions to solve various problems facing the global health, in Japan as well as many other countries around the world.

In the light of the situation described above, JPMA will actively endeavor to meet the following important challenges in FY 2014:1. Ensuring compliance and improved transparency in corporate activities,2. Making contribution to improve quality of healthcare/economic progress through promoting innovation,3. Making effort to promote international cooperation and to improve global health4. Promoting proactive disclosure of information and advancing mutual understanding with stakeholders

We live at a time when such environmental issues as global warming and waste issues are becoming serious and complex. The corporate sector is now required to fulfill its corporate social responsibilities by reducing the burden on the environment and contributing to the building of a “sustainable society” where the environment and economy can prosper side by side. JPMA has identified the following focus tasks for our voluntary actions concerning various challenges related to protecting the environment and occupational safety and health: 1. Energy Saving and Global Warming Countermeasures, 2. Resource Conservation and Waste Management, 3. Chemical Substances Management, and, 4. Occupational Safety and Health Management. In particular, concerning the actions for Energy Saving and Global Warming Countermeasures, the Federation of Pharmaceutical Manufacturers' Associations of JAPAN (FPMAJ) set a renewed numerical target in conjunction with Keidanren’s Commitment to a Low Carbon Society: “Reduce CO2 emissions by the pharmaceutical industry by 23% from the FY 2005 level by FY 2020”, and JPMA started its efforts in FY 2013 in collaboration with FPMAJ. JPMA will promote proactive actions of its member companies to reach the target for FY 2020.In addition to actions to make our society a low carbon society, JPMA will also promote various organization-wide actions for the environment such as the 3R (Reduce, Reuse & Recycle) actions for building a society with a sound material cycle, as well as efforts aiming to reduce occupational accidents and to provide workers a safe and comfortable work environment.

JPMA will continue to make contributions for the “health and welfare of people worldwide” and “Japan’s economic growth,” and will actively promote environment and safety-related actions. We will facilitate dialogue with our stakeholders, especially our patients, so that we can meet the expectations of society for our industry.

ENVIRONMENTAL REPORT

2014ENVIRONMENTAL

REPORT

2014

2Japan Pharmaceutical Manufacturers Association Environmental Report 2014

Message from the Chairman

Teruyuki Tosaka, Ph.D. Chairman, Environment & Safety Committee, JPMA

Emission or discharge of any harmful or potentially harmful chemical substances into the environment should be kept at a minimum regardless of the existence of a rule or regulation. It is said that some tens of millions of chemical substances may make some kind of impact on the ecosystem. The number of such recognized substances is increasing every year. However, the impact(s) that discharge or emission of those substances has on the ecosystem and/or human health has yet to be assessed, with some exceptions. In response to this situation, the Ministry of Environment is currently reviewing the statutory introduction of a new technique called Whole Effluent Toxicity (WET) utilizing a biological response (bio assay) as regulations concerning effluent discharge from factory etc., which would put more emphasis on the impacts on the ecosystem than existing methods. A similar system, though it may have a different name or is done on a different scale, has already been introduced mainly by developed western countries as part of the regulations concerning effluent discharge. The Environment & Safety Committee has held workshops for several years, inviting leading researchers of WET from the National Institute for Environmental Studies and other institutes. In addition, some of the JPMA member companies have already been trialing WET assessment.

The Environment & Safety Committee is in its 19th year since the establishment of the former body, the Environment Committee. The committee has seen several organizational changes of its expert subcommittee structure due to changes in the external environment and review of the details of activities. Currently the three expert subcommittees: the Environment Expert Subcommittee, the Global Warming Countermeasures Expert Subcommittee and the Occupational Safety & Health Expert Subcommittee, form the core of the voluntary activities by some 70 members from respective member companies. Some parts of our activities are not only disseminated to member companies, but are accessible to members of the society through the publication of the Environmental Report, etc. Although some information obtained from the questionnaire survey results can only be accessed internally by the Environment & Safety Committee members, we intend to make as much information as possible available to society for a better understanding of the committee activities.

As actions against global warming, the Keidanren’s Commitment to a Low Carbon Society, targeting for emission reduction in FY2020, started in FY 2013. Although the introduction of the latest energy saving machines and facilities and switching of energy sources will definitely play a major role, it seems that improvement of the energy efficiency of existing machines and facilities will be the key to attaining the target. Keidanren’s Commitment to a Low Carbon Society has just started, but we are already formulating the Action Plan for a Low Carbon Society Phase II plan (with a FY 2030 target) in response to a request from Keidanren. We also intend to look at our future efforts to reduce quantities of usage and discharge of fluorocarbons, which are used as refrigerants and have high global warming potential (GWP) among the greenhouse gasses.

Our ongoing efforts for the 3R actions to control waste have attained the final disposal output reduction target. However, to achieve further reduction, our efforts will not only be directed to Recycle (to convert wastes into resources again), which is often relying on an external contractor, but also to Reduce (reduction of waste itself) and Reuse. Furthermore, even in Japan, a country blessed with abundant water resources, we still recognize the importance of water resources on a global scale and intend to review resource conservation actions including the reduction of water used in the scope.Study reports have indicated the respective frequencies and severities of Time Lost Occupational Incidents and No Time Loss Occupational Incidents in our industry are considerably lower when compared with the entire manufacturing sector or all chemical industry. However, as we have not completely grasped the near-miss cases that could potentially become serious (hiyari-hatto or “near-accident” cases), we will not be satisfied with the current state of our efforts and will strive to take actions for occupational safety and health, including efforts to prevent business vehicle accidents and maintain mental health.

The Environmental Report 2014 is the 16th volume since the inaugural first volume that was published in 1999. We hope that the Environmental Report helps our stakeholders gain a better understanding of our actions.


Period / Scope of this Report, Editorial Policy, Table of Contents

JPMA has a membership of 72 companies (as of April 1, 2014). The membership list can be found on page 30. Please note that the performance data collected mainly from member companies in 2012, but some data include data from companies belong to other associations under FPMAJ.

The Environmental Report is compiled with the intention of widely informing society about the actions of the Environment & Safety Committee of the Japan Pharmaceutical Manufacturers Association (JPMA), in order to raise our profile in society and to be utilized as a tool of communication. It is also hoped that this publication will help respective member companies in their activities. Editing of the Environmental Report is in accordance with the Action Plan endorsed by the Environment & Safety Committee General Assembly. The Steering Committee is responsible for compiling the data, such as the status of actions by the Steering Committee and Expert Subcommittees, the status of progress towards the numerical targets, as well as the information provided by respective member companies or those parties that supported the activities of the Environment & Safety Committee.

【Editorial Policy】

December 2014 (Planned Publication of Next Issue: December 2015)

This report is also available at our website.

(JPMA Website; “About Activities of JPMA; JPMA Publication; free Publications)

http://www.jpma.or.jp/about/issue/gratis/eco/eco2013.html (Japanese version)

http://www.jpma.or.jp/english/Library/Environmental /2013.html (English version)

【Date of Publication】

【Scope of this Report】

Performance data were collected and collated for the entire FY 2013 (from April 2012 to March 2013). Information on each group’s activities up to as late as October 2013 may also be included.

【Period of this Report】

C o n t e n t s

Organizational Structure

Planning/Progress

Global Warming Countermeasures

Resource Conservation & Waste Management

Chemical Substances Management

Occupational Safety & Health Management

Stakeholder Engagement

Training & Motivation

History of Environmental and Safety Initiative

4

5

8

12

15

18

24

27

29


2014Organizational Structure


Environment & Safety Committee

(General Assembly)

Steering Committee

Secretariat

Planning Conference


Environment Expert Subcommittee

Occupational Safety & Health Expert Subcommittee

Global Warming Countermeasures Expert Subcommittee

Expert Subcommittees


The Japan Pharmaceutical Manufacturers Association (JPMA) is a voluntary association comprising 72 research - oriented pharmaceutical companies as of April 1, 2014. The JPMA, founded in 1968, has been committed to the motto: “Realization of patient–oriented healthcare”. We have contributed to the advancement of global healthcare through the R&D of innovative ethical drugs for clinical care and have also been engaged in multi-facetted enterprises, including the actions to aid finding solutions to various challenges commonly faced by those in the Pharmaceutical Industry and to deepen concepts related to pharmaceuticals, and interna-tional collaboration. We have also strived forfacilitating a sound develop-ment of the pharmaceutical industry through proactive formulation of policies and stronger lobbying, initiatives to adapt to global ization and an enhanced publicity framework.The JPMA also extends its role to assume a major influence in the principal global pharmaceutical markets: Japan, US and Europe, as one of the

tripartite pharmaceutical organizations alongside PhRMA, the Pharmaceu-tical Research and Manufacturers of America, and the European Federa-tion of Pharmaceutical Industries and Associations (EFPIA). We are currently working as an active principal member of the International Confer-ence on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, an initiative lead by Japan, the US and Europe for harmonization of drug regulations. Furthermore, as a member association of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the JPMA is engaged in actions to address various global medical and/or pharmaceutical challenges, including control of global endemics, infectious disease control in develop-ing countries, the issue of access to drugs and intellectual property rights as well as the challenge of counterfeit drugs. JPMA is developing global activity in order to contribute to treatment of patients in the world, facilitating information exchange and cooperation with each member organizations.

Organization


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 of action plan 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.

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 action plan for each fiscal year and mid term range, 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 member who is appointed by chairperson of the Committee, and is responsible for implementing the action 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 and implementation of training courses, prepare investigation reports, and/or other relevant tasks.

Expert Subcommittees consist of Environment Expert Subcommittee, Occupational Safety & Health Expert Subcommittee and Global Warming Countermeasures Expert Subcommittee. They are grappling with environment and occupational safety & health themes.

JPMA Organization

Vice PresidentsPresident

General Assembly

Board Directors [Standing B/D]

Auditors

Council on Planning & Policy

Compliance Committee

Code Committee

Review Board of Ethical Drug Product Information Brochure

Distribution Improvement Committee

Pharmaceutical Industrial Policy Committee

Drug Evaluation Committee

ICH Project

Quality & Technology Committee

Biopharmaceutical Committee

Regulatory Affairs Committee

Intellectual Property Committee

R&D Committee

Center for Pharmaceutical Publication

International Affairs Committee


Public Affairs Committee

Patient Cooperration Committee

Consumer Consultation Review Committee

Japan Pharmacetical Industry Legal Affairs Association

Office of Pharmaceutical Industry Research(OPIR)

Environment & Safety Action Plan

5

Planning/Progress


Chemical Substance Management


Reduce CO2 emissions generated by the pharmaceutical industry by 23% from the FY 2005 level by FY 2020

Reducing the final disposal volume of industrial wastes in fiscal 2015 by about 65% from fiscal 2000

Since FY 1997, we have made voluntary efforts to reduce the atmospheric release of harmful atmospheric pollutants such as dichloromethane, 1,2-dichloroethane, and chloroform, towards attaining our voluntary numerical reduction targets. We revised the numerical targets in FY 2001 (the second period plan) and FY 2005 (the third period plan) following attainment of the previously set target. In FY2007, the final year of the third term of the action plan, based on analyses of the data for the year, it was deemed that these actions achieved the primary objective. Consequently, no new numerical targets shall be set, but existing efforts still continue.

JPMA first took part in the Keidanren Voluntary Action Plan (Global Warming Countermeasures) in FY 1997, formulating its own Voluntary Action Plan for global warming countermeasures with a target posted for FY 2012. Despite our continuing industry-wide concerted efforts to reduce CO2 emissions , we were unable to attain the target due to the less favorable electricity conversion factor in the aftermath of the Great East Japan Earthquake and the nuclear plant accident. Since FY 2013, JPMA has worked towards attainment of the target for the new action plan, Action Plan for a Low Carbon Society, strengthening the partnership with the follow-up working group, established under FPMAJ Environ-ment Committee, and striving to make steady progress on the FPMAJ Action Plan for a Low Carbon Society.

Since FY 1997, JPMA has taken part in the Keidanren Voluntary Action Plan on the Environment (Sound Material–Cycle Society), by setting its own numerical targets and striving to reduce wastes. So far JPMA has made steady progress in reducing the respective indicators: the amount of final disposal, the final disposal rate (quantity of waste disposed in the end against total quantity of waste initially generated, indicated as a percentage), and the amount of waste generated in the first place and has attained the respective targets. For the voluntary action plan for the fourth period, started in FY 2011, FPMAJ, collaborated to set a common numerical target, and they have engaged in continuing proactive actions to reduce the level of final disposal output.

The Environment & Safety Committee deliberates and votes to adopt the annual and midterm action plans in the General Assembly held in April, taking the status of progress in the previous year and current legal and societal trends into consid-eration.

In FY 2013, the committee continued from the previous fiscal year to identify Global Warming Countermeasures, Resource Conservation & Waste Management, Chemical Substance Management, and Occupational Safety and Health as focus project areas and implemented actions as planned. In addition, The Environment & Safety Committee has strived for gathering information from external organizations and experts including such challenges that were difficult for a single company to resolve and such issues that should be handled by the Committee itself. By compiling reports on those activities and

information and making them accessible in periodical publica-tions such as information bulletins, investigational reports, a technical case information dossier, etc., we help our member companies’ actions to protect the environment and promote occupational safety and health.

We set numerical targets on the following environmental challenges in FY 2013 and promoted actions. In addition, concerning occupational safety and health, we collected performance data from the member companies and investi-gated the status of their efforts concerning issues such as the status of occupational incidents, status of business vehicle accidents and actions. The outcomes were compiled in the report and published to facilitate sharing of information among the member companies.

Japan Pharmaceutical Manufacturers Association Environmental Report 2014


2014

Action Plans: State of Progress


The amount of CO2 emissions in FY 2013 was 1,810,000 tons, which was 24% (560,000 tons) less than the total emissions of 2,370,000 tons in the base year 2005 and 4.7% (90,000 tons) less than the previous year, achieving the FY 2020 target of 1,830,000 tons by 20,000 tons.

To tackle the increasing energy demand due to the expanding pharmaceutical market, the industry has made proactive efforts such as increasing production efficiency and

introducing cutting-edge technologies and achieved reduction in CO2 emissions. In addition to ongoing efforts for switching energy sources, we will continue to strive towards attaining the target through sharing information on energy saving efforts by the member companies among industry organizations, introducing cutting-edge technologies and improving manufacturing processes.

JPMA has worked alongside FPMAJ in the Keidanren Volun-tary Action Plan on Environment (Sound Material–Cycle Society). Since FY 1997, JPMA has conducted a follow-up survey to monitor members’ efforts to reduce industrial waste generation and the quantity of final disposal from the compa-nies participating in the Voluntary Action Plan through an annual survey. Since FY 2011, JPMA’s follow-up survey has included a survey on the level of industrial waste generation and details about methods of disposal, in addition to the reduc-tion in the quantity of output to landfill sites (final disposal

output). The final disposal output in FY 2013 was 5,000 tons, which was 2,000 tons less than the previous fiscal year and a reduction of 83% of the base year level (FY 2000), continuing attainment of the target. We intend to strive, not only for continuing attainment of the target but also for a higher level of reduction in the quantity of final disposal, through sharing technical information and motivational activities by the member companies.

The targets for the third period of the Voluntary Action Plan, whose aim is to reduce atmospheric releases of dichlorometh-ane, 1,2-dichloroethane and chloroform, were attained in FY 2007. This achievement let JPMA conclude the original goal was sufficiently achieved. Following that achievement, instead of setting new numerical targets, JPMA has decided to continue with its efforts as well as follow-up monitoring. The total quantity released into the environment in FY 2013 of Class 1 Designated Chemical Substances stipulated by the Chemical Substance Release Monitoring and Management

Promotion Act (commonly known as the PRTR Act) was 342 tons (80% less than the FY 2002 level), which is 64 tons less than the previous fiscal year. The combined quantity of the 101 volatile organic compounds (VOCs) released into the atmosphere was 2,272 tons, 302 tons less than the previous fiscal year. We will endeavor to have member companies share technical information and to promote ongoing voluntary reduction efforts at member companies, as well as to consider setting new numerical targets.

The JPMA action plans for resource conservation and waste management, and chemical substance management have progressed smoothly. Our actions for prevention of global warming have made good progress since the start of the Action Plan for a Low Carbon Society in FY 2013

JPMA member companies will continue to advance such industry-wide actions as actions for global warming countermeasures and for a sound material–cycle society. Especially with regard to the actions for global warming

countermeasures and resource conservation and waste management, JPMA will work as a part of the collaboration by other organizations under the umbrella of FPMAJ and make maximum efforts towards attainment of action plan targets. Meanwhile, concerning chemical substance management and occupational health and safety, we intend to continue with respective surveys to monitor the current state of respective member companies, as well as to strive for industry-wide improvement through sharing information on effective countermeasures.

◆ Global Warming Countermeasures

◆ Resource Conservation & Waste Management

◆ Chemical Substances Management

In the Environment & Safety Committee, respective expert subcommittees develop and implement an annual action plan and midterm action plan that determine how actions are advanced for global warming countermeasures, resource conservation & waste management, chemical substance

management, and occupational health and safety. The Planning Conference liaises with relevant expert subcommittees to act as the channel of communication with umbrella industrial organizations, the national government and the society.The following summarizes the state of progress of the Environment & Safety Committee activities in FY 2013.


2014

FY2013 Action Plan: Summary of Progress and Achievement

Planning/Progress


Topics FY2013 Working Plan FY2013 Activities and Achievement

Energy Saving & Global

Warming Countermeasures

Resource Conservation &

Waste Management

Chemical

Substance Management

Occupational

Safety & Health

Numerical targets

Other Issues

●●●

●●

●

Action plan

Reduce CO2 emissions in FY2010 (mean level of the first commitment period under the Kyoto Protocol) to below FY1990 level.

Follow-up for the Keidanren Voluntary Action PlanHost a technical training course on energy savingCompile information on global warming countermeasuresDevelop a post-Kyoto CO2 emissions reduction planPromotion of effective use of business vehicles used by MRs

●●

●

●●

Conduct PRTR and VOC surveyStudy technologies for reduction of atmospheric emissions of chemical substances and their feed-back to the member companiesStudy environmental risk assessment of pharmaceutical productsStudy on chemical process safetyStudy on handling highly active pharmaceutical substances

●

●

●

●

Conducted PRTR and VOC survey for the member companies, and fed them back to the member companies　PRTR substances emitted to the atmosphere in FY2013 were reduced by 80% against the level of FY2002　The total air emissions of VOCs in FY 2013 were 2,272tonsConducted information gathering about environmental impact of pharmaceutical products and hosted a technical training courseConducted process safety studies and hosted lectures and a study tour for risk assessment of chemical processesFormed a Section on Handling of Highly Active Pharmaceutical Substances, and has facilitated sharing of information

●

●

●

●

Conduct survey on activities for occupational safety and health, and feed them back to the member companiesStudy actions for maintaining and improving employees’ health and feed them back to the member companiesHost a technical training course on occupational safety and health Study and develop measures to prevent business vehicle accidents , and feed them back to the member companies

●

●

●

Conducted survey on the state of the occupational incident, and fed it back them to the member companiesHosted a technical training cource about occupational safety and healthConducted a study and survey on the state of accident prevention and vehicle accidents involving business vehicles

●

●

●●

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 industryHost a technical training course on biodiversityHost environmental & safety lectures, and environmental & safety seminars and so on

●●●

●

●

Published Environmental Report 2013Published 4 Issues of Environment NewsDistributed Achievement Reports 2013 to the member companiesInformation sharing and collaboration with other JPMA committees and participation in FPMAJ Environmental CommitteeHosted an environmental & safety lecture and an environmental & safety seminar

Progress

●

●●

●

●

●

Action plan

The CO2 emissions reduced 24% to the base year 2005

Conducted the follow-up survey in collaboration with FPMAJ and reported this to the KeidanrenHosted the 17th technical training courseFacilitated information gathering /exchange and study tours on global warming countermeasuresCondacted the survey on the fuel consumption of business vehicles and introducing rate of hybrid cars and electric carsStarted up the Action Plan for a Low Carbon Society Request for participating in the action plan Disclosure of the names of the participating companies Implementation of a preliminary survey on energy

Numerical targets

●●●

●

Action plan

Almost 65% reduction of final disposal amount of wastes in FY2015 against that in FY 2000

Follow-up for the Keidanren Voluntary Action PlanHost the technical training course to promote 3R activityStudy on municipal solid medical wastes and feed them back to the member companiesSupport member companies to improve the packaging for pharmaceutical products

Progress

●

●

●

Action plan

Final disposal amount of waste in FY 2013 : reduced by 83% compared to the FY2000 performance

Conducted a follow-up survey in collaboration with FPMAJ, Japan Generic Medicines Association, Japan Self-Medication Industry and Japan Kampo Medicines Manufacturers Association and reported this to the KeidanrenConducted information gathering about municipal solid medical wastes in collaboration with the FPMAJ

-

---

-


2014

1. Establishment of reduction targets for domestic business operation up to the year 2020

Method of estimation, etc.

Action Plan for a Low Carbon Society: State of Progress in FY 2013

JPMA takes part in Keidanren’s Action Plan for a Low Carbon Society in partnership with FPMAJ, and since FY 2013, we have monitored the level of CO2 emitted by the companies taking part in the Action Plan for a Low Carbon Society and the status of their efforts to follow up their commitment. The organizations taking part alongside JPMA in this Action Plan include Japan Generic Medicines Asso-ciation (JGA), Japan Self-Medication Industry (JSMI), The Intravenous Solutions Society, Japan Kampo Medicines

Manufacturers Association, Pharmaceutical Drug Proces-sors Association, External Pharmaceutical Association, Japan Direct-Selling Pharmaceutical Manufacturers Asso-ciation and Japan Association of Vaccine Industries. The data used in this report are compiled from the responses received from the member companies of those nine organi-zations. The FPMAJ Action Plan for a Low Carbon Society has the following four objectives and targets:

1

JPMA has joined Keidanren’s Commitment to a Low Carbon Society and works alongside FPMAJ in monitoring, reporting and publishing the levels of CO2 emissions and efforts by the members.

Through its technical training course on energy saving and global warming countermeasures, JPMA facilitates information sharing and exchange on future energy policies and actions to address global warming.

1. Establishment of reduction targets for domestic business operation up to the year 2020

2. Strengthened cooperation with other interest groups

3. Contributions on the international level

4. Development of innovative technologies

Reduce CO2 emissions by the pharmaceutical industry by 23% from the FY 2005 level by FY 2020

1

2

Scope of the Survey CO2 emissions from energy use at plant or research laboratories in Japan

Number of companies whose data are collated: 89 Coverage: 25.5%

Domestic sales made by the companies whose data are compiled: ¥9,503,500,000,000 Coverage: 80.2%

Estimation based on the table provided in Keidanren Follow-up Survey form, using the FPMAJ progress monitoring factor* for grid electricity

Method of survey and estimation

CoverageNumber of companies

Sales


8

JPMA has joined Keidanren’s Commitment to a Low Carbon Society and works alongside FPMAJ in monitoring, reporting and publishing the levels of CO2 emissions and efforts by the members.

Through its technical training course on energy saving and global warming countermeasures, JPMA facilitates information sharing and exchange on future energy policies and actions to address global warming.

1

2

JPMA’s Actions

TargetReduce CO2 emissions by the pharmaceutical industry by 23% from the FY 2005 level by FY 2020

Target

The following shows the state of progress of each objective/target.

* FPMAJ progress monitoring factor:

FY 2010 and before: The carbon emission factor after adjustment for “carbon emission factor accompanying electricity use at consumer end”, as indicated by Keidanren

FY 2011 and 2012: A factor indicated by Keidanren in FY 2011, which converts the generator end alternative carbon emission factor to the consumer end factor in the scenario if the Great

East Japan Earthquake had not occurred: 0.927 t-C/10000 kWh (3.4 t-CO2/10000 kWh)

FY 2013 and later: The carbon emission factor target for FY 2020, published prior to the Great East Japan Earthquake by the Federation of Electric Power Companies of Japan:

0.900 t-C/10000 kWh (3.3 t-CO2/10000 kWh)


Impacts from global warming, such as melting glaciers and extreme weather events, are worrying. If global warming advances at the current pace, such phenomena as increas-ingly frequent heat waves, changes in ecosystems and the spread of tropical diseases are expected to occur, posing a major threat to human kind. The fifth report of the Intergov-ernmental Panel on Climate Change (IPCC) stated, “It is extremely likely that more than half of the observed increase in global average surface temperature from 1951 to 2010 was caused by anthropogenic activities.” The

government, corporations, organizations and individuals must unite and consider what each of them can do to mitigate and adapt to the impacts. JPMA intends to utilize the range of knowledge and expertise gained through the past efforts for the Keidanren Voluntary Action Plan for the Environment between 1997 and 2012 and to act for global warming countermeasures following the new Keidanren’s Action Plan for a Low Carbon Society, started last business year (FY 2013), as well as to fulfill its accountability to the stakeholders.


The amount of CO2 emissions in FY 2013 was 1,810,000 tons, which was 24% (560,000 t-CO2) less than the total emissions of 2,370,000 tons in the base year 2005 and 4.7% (90,000 tons) less than the previous year. This figure clears the FY 2020 target of 1,830,000 t-CO2 by 20,000 t-CO2.

After removing the impact of a change in grid electricity carbon emission factor (242,000 t-CO2) and changes in the reference thermal potential and carbon emission factor for fuel types following a revision of General Energy Statistics (54,000 t-CO2) from the reduction made by FY 2013 from the FY 2005 emission level (560,000 t-CO2), the actual reduction achieved was 260,000 t-CO2. Had no action been taken to prevent global warming since 2005, the estimated CO2 emissions for FY 2013 (BAU) would be 2,810,000 t-CO2, which means a reduction by FY 2013 against BAU would be 1,000,000 t-CO2. The actual level of reduction (by industry’s efforts) after removing the change

in grid electricity carbon emission factor and the effect of General Energy Statistics revision is 700,000 t-CO2.

As seen in Table 1, the volume of production (sales) has steadily grown every year, with the FY 2013 figure 1.27 times that of the FY 2005 level. The CO2 emissions

sales unit base index does not follow this trend but continues its declining trend.

Examples of actions taken in FY 2013A unique aspect of the pharmaceutical industry is the high ratio of energy used to quality assurance, from the R&D stage to manufacturing and sales phases. An especially notable point is the high ratio of base load energy to meet the GLP and GMP requirements. There is also a relatively high dependency on electricity (the ratio of electricity in total energy used in FY 2013 was approx. 59%), and electricity to total energy ratio shows a further tendency to increase.

In order to promote member companies’ introduction of

highly efficient machinery and switch to alternative energy sources with lower CO2 emissions, JPMA has facilitated information sharing on examples of the actions member companies took and technical information on energy-saving machinery and devices. The total amount of investment made in FY 2013 for energy-saving facility upgrades was ¥ 5,350 million. The main actions taken are summarized in Table 2. We plan to continue promoting the introduction of highly efficient machinery and devices, as well as switching of energy sources.

CO2 Emissions in FY 2013 and the changes2

Actual BAU Target

FY 2005

FPMAJ progress monitoring factor (consumer end)(t-C/10000 kWh)

CO2 emissions (10,000 t-CO2)

CO2 emissions ratio against

FY 2005 level

Sales (¥ 100,000,000)

Sales ratio against

FY 2005 level

CO2 emissions sales Unit base

index

FY 2006

FY 2007

FY 2008

FY 2010

FY 2009

FY 2011

FY 2012

FY 2013

FY 2020 Target

1.152

1.118

1.236

1.017

0.955

0.957

0.927

0.927

0.900

0.900

237

230

237

205

187

188

184

190

181

183

1.00

0.97

1.00

0.86

0.79

0.79

0.78

0.80

0.76

0.77

74,675

75,310

77,749

78,842

84,988

83,081

89,129

90,917

95,035

Table 1. Changes in CO2 emissions based on FPMAJ progress monitoring factor and sales volume

Figure 1. Changes in CO2 emissions

237 230 237

205188 187 184 190

181

281

183

0

50

100

150

200

250

300

2005 2006 2007 2008 2009 2010 2011 2012 2013 2013BAU

2020 target

CO

2 em

issi

on le

vel (

10,0

00 t-

CO

2)

(FY)

�1,000,000 t(including changes from emission factor change)

�560,000 t�540,000 t(23% reduction)

1.00

1.01

1.04

1.06

1.14

1.11

1.19

1.22

1.27

1.00

0.96

0.96

0.82

0.69

0.71

0.65

0.66

0.60



2014

2. Strengthened cooperation with other interest groups

It has been noted that the level of CO2 emissions from business vehicles is relatively high in the pharmaceutical industry. That is why the industry is actively introducing highly fuel-efficient cars such as hybrid and electric cars,

which has seen a steady decrease in total CO2 emissions and per-unit CO2 emissions (CO2 emissions from one business vehicle).

In addition, such measures to control emissions from distribution as third party logistics (3PL), shared distribution and modal shift have been introduced.

Furthermore, JPMA runs a technical training course on energy saving and global warming countermeasures to facilitate the sharing of information on trends related to the policies of energy saving and global warming countermeasures and the informa-tion on advanced technologies between industry organizations.

We believe taking actions with our products is an essential aspect of our efforts to prevent global warming in the pharma-ceutical industry. One typical example of such actions is our initiative to reduce fluorocarbon use in metered dose inhalers (MDIs). As fluorocarbons cause greater greenhouse effects than CO2, the reduction of their use is strongly desired. Although

previously chlorofluorocarbon (CFC) was used in MDIs, its role in the destruction of the ozone layer became an issue, which led to the move to switch to an alternative hydrofluorocarbon (HFC). After completing the switch from CFC to HFC in 2005, it was revealed HFC also has a strong greenhouse effect, which motivated us to work towards reduction by setting an HFC release reduction target (of 150 tons, a 72% reduction from the estimated HFC release level of 540 tons in FY 2010). As a result of our efforts to develop powder-based inhalers and improving existing product technology, we have achieved a major reduc-tion as seen in Table 4, far exceeding our own target. Although the quantity of inhalers dispatched will continue to increase as cases of asthma or chronic obstructive pulmonary disorder (COPD) are anticipated to increase, we will strive to reduce HFC use by promoting powder-based inhalers and improving existing products.

Energy source switch

Global warming countermeasures action examplesNumber of cases

Installation of highly efficient machinery

Recovery of lost heat by heat exchanger

Review of facility or machinery operation and / or control procedures

Installation of inverter unit

Introduction of cogeneration technology

Reduction of heat loss by insulating machinery and pipes

Reduction of no-load transformer losses (better power factor achieved with condenser)

Introduction of energy monitoring system

13

51

7

17

31

1

20

5

3

Amount invested (¥ 1,000,000)

2,202

1,453

121

149

268

760

107

46

70

Effects on CO2 emission reduction(t-CO2)

16,554

4,379

3,454

2,315

1,219

1,800

974

248

150

Table 2. Examples of actions taken in FY 2013 and their CO2 reduction effects

Figures based on compiled data from the 49 companies that provided gasoline usage dataFi b d il d d t f th 49 i th t id d li d t

Total number of business vehicles

FY 2005

Number of hybrid vehicles

Number of electric vehicles

Quantity of gasoline used

Total CO2 emissions

Quantity of diesel used

CO2 emission per-unit

(units)

(units)

(units)

(kL)

(1,000 t-CO2)

(kL)

(t-CO2/unit)

36,352

168

0

69,414

161

1

4.4

Table 3. Status of CO2 emissions from business vehicles

10

ObjectivesObjectivesWhile striving for more efficient means of transporting drugs, e.g. shared distribution, we will promote the introduction of highly fuel-efficient cars into business vehicle fleets and the use of public transport in urban areas. In addition, as well as to endeavor to share information on energy saving between the industry organizations, we will educate and motivate employees to improve their awareness of global warming and energy saving and encourage them to take actions at work as well as at home.

2009

38,651

6,623

50

67,562

157

1

4.1

2010

39,832

10,882

58

67,263

156

0

3.9

2011

40,349

14,236

57

65,547

152

0

3.8

2012

40,677

17,465

51

63,464

147

0

3.6

2013

40,241

19,337

95

61,053

139

0

3.5

2005

Year

2006

2007

2008

2010

2009

2011

2012

2013

110.8

Actual quantity released is the sum of HFC-134a and HFC-227ea

Actual release (t)

112.7

103.0

107.6

102.8

88.7

88.4

81.1

74.2

244.5

CO2 equivalent (1,000 GWP t)

236.7

217.6

237.0

233.5

186.1

187.9

169.3

154.3

Table 4. Changes in actual HFC release levels and CO2 equivalent



2014

The 18th Technical Training Course on Energy Saving and Global Warming Countermeasures

On Friday, October 3, 2014, the Environment & Safety Committee hosted the 18th Technical Training Course on Energy Saving and Global Warming Countermeasures at Otemachi 1st Square Conference (Otemachi, Chiyoda-ku, Tokyo), attended by some 110 people. The Technical Training Course on Energy Saving and Global Warming Countermeasures has been held annually since FY 1997, with the aim of helping JPMA member companies make progress in their actions for energy saving and global warming countermeasures.The theme for the 18th training course is “Pharmaceutical Industry’s Energy Policies towards a Low Carbon Society” in the light of the new Basic Energy Plan in the post-Great East Japan Earthquake era. We invited speakers from the Ministry of Economy, Trade and Industry and the Ministry of the Environment, who respec-tively provided presentations on trends related their respective policies titled "Recent Trends of Energy Saving Policies” and “Towards Greenhouse Gas Reduction in 2020 and Beyond”, respectively. We also invited a speaker from The Energy Conservation Center, Japan, for a talk titled “New Trends in Energy Saving Measures Seen in the Energy Saving Award and Others”. From the private corporate sector, we invited speakers from Maekawa MFG Co. Ltd., member companies Astellas Pharma Inc., Dainippon Sumitomo Pharma Co., Ltd., and Taiho Pharmaceutical Co., Ltd., to present reports respectively titled “Recent Trends in Refrigerants and Effective Use of Industrial Heat Pumps”, “Framework to Advance Global Warming Countermeasures and Approach to Investment”, “Recently Introduced Energy Saving Facility at Research Centers” and “Taiho Pharmaceutical’s New Factory (Kitajima Plant)”. In the light of international and domestic movements whose severity is expected to increase, the Environment & Safety Committee intends to continue our support for the efforts by JPMA member companies and related companies towards a Low Carbon Society, through offering the opportunities to share information about measures for energy saving and global warming countermeasures and respective companies reports on own actions.

Global Warming CountermeasuresENVIRONMENTAL

REPORT

2014

11

3. Contributions on the international level

Japan is ahead of the rest of world in the reduction of HFC use in MDIs. By exporting this technology overseas, we

believe we can make a global-scale contribution to the reduction of greenhouse gases.

It is anticipated we will see further globalization in the pharmaceutical market and more drugs manufactured overseas. We believe we can make contributions in lessening the burden on the environment and reduction of energy use overseas by exporting our cutting-edge drug manufacturing technologies.

4. Development of innovative technologies

There are companies that are taking such actions as short-ening and optimizing the reactive process to reduce usage of raw materials, reagents, solvents and energy, and/or down-sizing the analytical process that uses organic solvents (liquid chromatography). Our challenge is to share

and promote such efforts within the industry. Furthermore, looking towards the year 2050, we believe we need to develop the kind of manufacturing technologies that contribute to the reduction of the greenhouse gases in product life cycles.

Aiming to lessen the burden on the environment and ensure safety over the long term and to take long-term actions to prevent global warming, we will strive to develop what can be called green chemistry technologies as a part of drug manufacturing technologies, which will minimize the use of organic solvents, as well as to make the drug manufacturing process more energy efficient.


Objectives

Objectives


2014Resource Conservation & Waste Management

12

JPMA’s Actions

JPMA takes a part together with FPMAJ in Keidanren’s Volun-tary Action Plan on the Environment (Sound Material–Cycle Society). Since FY 1997, JPMA has conducted an annual follow-up survey to monitor the status of actions such as reducing wastes generation and final disposal by the member companies that participated in the voluntary action plan. Since FY 2011, JPMA has set numerical targets for reducing the final disposal of industrial wastes, as well as continuing with follow-up surveys of industrial waste genera-tion and details about method of disposal, in addition to final disposal.

The final disposal volume in FY 2013 (Figure 1) was 5,000 tons, which was 2,000 tons less than the previous fiscal year and a reduction by 83% against the level in FY 2000, continuing attainment of the target.

Meanwhile, the survey of member companies on anticipated final disposal in FY 2015 has indicated the level would be worse than the current status without continuous initiatives

for further reduction, only attaining a 66% reduction against the level in the base year. It means each member company needs to continue with their actions for reduction, not only for continu-ing attainment of the numerical targets but also to achieve a higher level of reduction of final disposal volume.

1. Voluntary Action Plan on the Environment (Sound Material–Cycle Society): State of Progress

JPMA is participating in the follow-up survey to the Voluntary Action Plan on the Environment, having jointly set targets in partnership with FPMAJ towards a Sound Material–Cycle Society, as well as monitoring the status of actions by member companies and reporting to Keidanren

Until last year, we reported on JPMA member companies’ actions. However, this report will cover the actions for a sound material cycle society by the four organizations under the umbrella of FPMAJ, in order to align the scope of study subjects to that to be reported to Keidanren as follow-up to the Voluntary Action Plan on the Environment (Sound Material–Cycle Society). Please note the actual data stated in

this report have been adjusted with the coverage, obtained by dividing respective companies’ reported sales figures with Japan’s total drug sales figure. The actual coverage in FY 2013 was 84.3%. Since measured value includes waste to be sold as a valuable recourse as well as legal industrial waste, we express simply “waste” in this section.

* JPMA, Japan Generic Medicines Association, Japan Self-Medication Industry and Japan Kampo Medicines Manufacturers Association

Final disposal volum Ratio against base year (%)

Figure 1. Changes in final disposal volume

100.0

22.5 25.528.5

22.816.9

35.0

0

20

40

60

80

100

0

10

20

30

40

50

2000 2009 2010 2011 2012 2013 2015

Ratio against base year (%)Final disposal volume (1,000 tons)

(FY)

19

57887

29


From before promulgation of the Basic Act on Establishing a Sound Material - Cycle Society in 2001, the JPMA has developed its own voluntary action plan for the environment and set numerical targets to guide our actions for reduction of waste. The JPMA also conducted studies on how wastes are generated and disposed. So far, we have made steady progress in reducing the amount of final disposal output, the final disposal rate (quantity of waste disposed in the end against total quantity of waste initially generated, indicated in percentage), and the amount of waste generated in the first place. Together with FPMAJ, we set a common new target for the amount of final disposal output in the plan for the fourth period, started in FY 2011.The results of our FY 2013 survey on the status of waste generation

and disposal by respective companies in four organizations* under the umbrella of FPMAJ, which promote action towards attainment of the target, showed that our targets set in the JPMA Voluntary Action Plan for the Environment were again achieved for the second year running, following FY 2012, owing to our various motivational promo-tion activities for the reduction of final disposal output and efforts by our member companies. We believe it is essential to continue our efforts to reduce waste as much as possible and strive to build a sound material cycle society for more efficient use of available resources. We will continue proactive waste management actions so that we will continue to attain future JPMA Voluntary Action Plan targets.

Reducing the final disposal volume of industrial waste in fiscal 2015 by about 65% from fiscal 2000

TargetReducing the final disposal volume of industrial waste in fiscal 2015 by about 65% from fiscal 2000

Target


13

The volume of waste generated (Figure 3) was reduced by 19,000 tons from previous fiscal year to 253,000 tons, which was 67% of the FY 2000 figure. This reduction was thought to be caused by changes in product lineup, and changes in operation of effluent processing facilities leading to less sludge. The ratio of final disposal in the volume of wastes generated (Final Disposal Rate) was 2.0%, improved by 0.5 points from the previous fiscal year.

The survey of member companies on the projected volume of final disposal in FY 2015 has found that, although actions taken to reduce waste generation would result in about 3,000 tons less than the current level, the final disposal ratio will remain at about 2.6%. This seems to be an indication of the effect of reduction in the volume of wastes generated (the denominator) as well as the higher ratio of matter difficult to recycle contained in the volume of wastes gener-ated.

Table 1 shows changes in per-unit waste generation, obtained by dividing total quantity of waste generation with the sales figure. In FY 2000, 4.4 tons of wastes were generated for every hundred million yen, but, the declining trend ever since has led to the rate of 2.1 tons per hundred million yen in FY 2013. We believe this result indicates respective member companies’ efforts to effectively use resources to build a Sound Material–Cycle Society.

2. Waste Generation Volume and Final Disposal Rate (as references)

Figure 4 shows the flow of processing and disposal of wastes, based on the responses to the survey received from member companies.

The wastes generation can be broken down into 140,000 tons eventually recycled, 5,000 tons eventual disposed of and 108,000 tons reduced through such processes as incineration.

As seen in this flow chart, what is important for the reduction of final disposal is thorough sorting to reduce the quantity

going directly to final disposal as much as possible and to increase the quantity for recycling as much as possible. In addition, reduction of the quantity as much as possible even for those requiring intermediate processing for such a purpose as detoxifying, as well as recycling the residue generated as a result of such processing as much as possible will result in a reduction of final disposal volume.

The 140,000 tons of waste eventually recycled is the equivalent of 55% of the waste generated, effectively used as resources for certain uses.

3. Flow of Waste Processing and Disposal

Figure 2. Breakdown of final disposal output into waste types

Sludge35.4％

Waste plastic31.9％

General office waste8.3％

Others8.8％

Waste paper 1.4％Waste oil 3.5％

Waste acid and alkaline solutions 4.1%

Waste glass or pottery 6.6%

Waste generation volume Final disposal rate

Figure 3. Changes in volume of waste generation and final disposal rate

Table 1. Changes in per-unit waste generation

0

2.0

4.0

6.0

8.0

0

600

500

400

300

200

100

2000 2009 2010 2011 2012 2013

Final disposal rate (%)waste generation volume (1,000 tons)

(FY)

29

253

272259204222

378 2.02.5

3.23.7

3.0

7.8

Sales(¥ 100 million)

2000

85,580

4.4

2009

94,980

2.3

2010

113,432

1.8

2011

106,516

2.4

2012

116,137

2.3

2013

118,567

2.1Quantity of generation (ton)/Sales(¥100 million)

* Drug sales according to government statistics (Survey of State of Pharmaceutical and Medical Device Industries), showing the figure from previous year’s data, excluding FY 2000

Figure 2 shows a breakdown of waste types in the final disposal output. Plastic waste (32%), sludge (35%) and general office waste (8.3%) together make up 76% of the total. Some of those may not be recycled easily because active pharmaceutical substances may contaminate plastic packaging or become discharged with sludge during drug manufacturing or at the R & D stage. Our survey of member companies revealed their efforts to recycle those three types of wastes such as more strict sorting, conversion to solid fuel or utilization of incinerated ashes as cement ingredient.



2014

Actions for Conservation of Biodiversity

Guideline for Conduct

Fundamental Philosophy

1

2

The 5th Workshop on Environmental Technologies was held on January 27, 2014, at the JPMA conference room (Nihonbashi, Chuo-ku, Tokyo) with some 60 people attending. This workshop has been held since FY 2009 on general environmental issues. Following enforcement of the Basic Act on Biodiversity in June 2008 and, the Declaration of Biodiversity by Nippon Keidanren (Japan Business Federation) in March 2009, JPMA formulated the

Fundamental Philosophy and Guideline for Conduct Concerning Biodiversity in January 2012, prescribing the fundamental philosophy and four-point guideline for conduct to promote member companies’ actions for protection of biodiversity. In accordance with the fundamental philosophy and four-point guideline for conduct, the workshop this time round was held on the theme, “What actions to take for protection of biodiversity as a pharmaceutical manufacturer”, to promote activities at member companies.

Firstly, the outcome of the Questionnaire on biodiversity conducted prior to the workshop, answered by the member companies of the Environmental Subcommittee of the Environment and Safety Committee, was reported, which took the form of a presentation concerning JPMA member companies’ awareness of the current state of biodiversity and state of their actions. This was followed by presentations by two JPMA member companies sharing their exemplary actions: “Managing the environment by using a biodiversity load index” by Astellas Pharma Inc., and “Protection of biodiversity using WET*1 and LIME2*2” by Takeda Pharmaceutical Co., Ltd.

Then, Dr. Ikuko Matsumoto of the Institute for Global Environmental Strategies gave a talk titled “Integrated corporate actions for the protection of biodiversity from a life cycle based perspective”, discussing international standardization of actions concerning biodiversity and ecosystem services (such as ecological footprints, etc.), the stable supply of raw ingredients and

cost reduction by efficient use of ecosystem services.

Finally, Mr. Toru Hattori, a director of CEPA Japan, gave a talk titled “Biodiversity promotion and publicity frontline” on the Convention on Biodiversity, the development of a program to promote and publicize from the general public level and a proposal on lifestyle.

JPMA intends to make contributions to the development of a sustainable society through fulfilling its social responsibilities for the protection of biodiversity.

14

Consideration to conserving the global environment, gratitude for the bounties of nature and harmonization of business activities with the natural environment, are included in the declaration

Fundamental Philosophy and Guideline for Conduct Concerning Biodiversity

Promoting actions for the prevention of global warmingSustainable use of resources

3

4

Reducing chemical substance risks to the environmentBuilding a foundation for conserving biodiversity

*1 WET: a technique for effluent management utilizing biological responses*2 LIME2: a technique for life-cycle-based environmental impact assessment to calculate costs of damage

Figure 4. Flow of Processing and Disposal of Wastes

(unit: 1,000 tons)

Quantity of direct recycling Quantity processed Quantity reduced Quantity of residue after processing

Directly to final disposal

53Processed internally within company 36 34 2

2

Processed by contractor 163 75 88

Total 199 108 91

Quantity recycled

87

Recycled internally within company 0.4 Final disposal output

Recycled at monetary value 40 3

Given away free 13

Recycled at cost 87 Total quantity of final disposalTotal 140

5

Quantity generated

253

Total quantity of recycling

(Recovery of solvents, composting, fuel, etc.) (Sorting)

(Ash, etc.)

(Converting into raw ingredient, etc.)

(Solidifying, insolubilizing, etc.)


15


63 JPMA member companies handled 12,529 tons (a 4% reduction compared to the amount in FY 2012) of 462 class 1 substances (PRTR substances, Note 2), of which 334 tons (17% reduction) were released into the atmosphere, 8 tons (33% increase) into public water, and nil into the soil. In terms of the annual usages, toluene (4,392 tons), acetonitrile (2,282 tons), dichloromethane (1,361 tons),

Figure 1　Annual usage of PRTR substances in FY 2013

JPMA member companies have continuously reduced the emissions of PRTR substances to the environment. They have been steadily reduced since FY 2002. We succeeded in a 80% reduction of emissions by FY 2013 against the level in

FY 2002 (Figure 3). Every year, not less than 96% of total environment waste is occupied by waste released into the atmosphere.

1. PRTR Survey

n-hexane (821 tons), and N,N-dimethylformamide (748 tons) were the biggest substances in this order (Figure 1). Regarding the air emissions, dichoromethane, toluene, acetonitrile, chloroform and n-hexane were the biggest sabstances in this order (Figure 2). Total of the air emissions of these five substances were 304 tons, and comprised 91% of the total air emissions (334 tons).

Figure 2 Atmospheric release of PRTR substances in FY 2013

* Survey covered a total of 206 business establishments belonging to JPMA member companies, their affiliated or related companies


Figure 3　Changes in environmental emission of PRTR substances

1,800

0

400

600

200

800

1,000

1,200

1,400

1,600

50

1693

1361

1240

851 734 701 696 668 441 474

5043

3230 21 18 15

15 8

2,000

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

334

8

2013

400

6

2012(FY)

(tons)

Atmosphere Water

Toluene4,392 tons

Acetonitrile2,282 tons

Dichloromethane 1,361tons

N,N-dimethylformamide748 tons

N-hexane821 tons

Others2,925 tons

Dichloromethane150 tons

Toluene88 tons

Acetonitrile26 tons

Chloroform25 tons

N-hexane15 tons

Others30 tons


Various types of chemical substances are used in the pharma-ceutical industry for research, development and manufacturing of pharmaceuticals that contribute to people’s health. Some of those chemicals pose a potentially harmful impact on human health and /or the ecosystem if discharged into the environment. Consequently, JPMA recognize the importance of proper control

of those chemical substances, and actively advocate voluntary actions to properly manage chemical substances.We also promote the research activities on process safety in order to control environmental pollution, fire outbreaks, explosions and other dangers caused by chemical substances used for manufacturing pharmaceuticals.

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 1).

Note 1)

Note 2)

Volatile organic compounds (VOCs) are one of the causes of suspended particulate matters and photochemical oxidantsChemical 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”

16


2014

Figure 4. Quantity of VOCs handled in FY 2013 Figure 5. Atmospheric release of VOCs in FY 2013

Figure 6. Changes in atmospheric release of VOC substances

The amount of 101 types of VOCs released into atmosphere has declined since FY 2008. The total quantity released into the atmosphere in FY 2013 was about 12% less than the previous year. When compared with FY 2008 data, it is a 27% reduction. (Figure 6)

The Air Pollution Control Act has a provision to control the atmospheric releases of volatile organic compounds (VOCs). Although our member companies have few facilities regulated by legislation regulation, the JPMA still conducts an annual survey on their usage of VOCs. Our survey collects the data of the quantity each company handled and the quantity released into the atmosphere for each of the 100 main VOCs stipulated by the Ministry of the Environment, plus n-propyl alcohol widely used in the pharmaceutical industry (101 items in total).In FY 2013, 38 substances were handled in quantities of one

2. VOC Survey

ton or more during the year. In total, 51,739 tons (a 34% increase from the previous fiscal year) were handled. The most commonly handled substances were acetone methanol, ethanol, ethylacetate and toluene, in that order (Figure 4). The total quantity of VOCs released into the atmosphere was 2,272 tons. The most released substances were ethanol, ethylacetate, isopropyl alcohol, methanol, dichloromethane, acetone, in that order (Figure 5). These six substances made up 91% of the total quantity of VOCs released into atmosphere.

Owing to the voluntary efforts by the member companies to control the release of VOCs into the atmosphere, the amount of 101 types of VOCs released into the environment has been less than that in FY 2008. JPMA conducts a questionnaire survey every year on how the atmospheric release of chemical substances is managed, intending to promote further voluntary actions by the member companies by studying the specific details of member companies’ actions and sharing the information.

In addition to the actions for physical aspects, such as installation of a solvent recovery unit and/or filtering unit, our member companies have implemented various actions including those for non-physical aspects such as using an alternative to organic solvent and making changes in the production process. (Table 1)

3. Actions to Reduce Atmospheric Release of Chemical Substances

Acetonitrile2,282 tons

Acetonitrile26 tons

Installation of solvent recovery unit

Actions implemented

Use of alternative to organic solvent (switching to water-based product, etc.)

Installation of removal and/or active charcoal filter(s)

Changes in process (production process and/or method of analysis)

Installation of exhaust fume processing unit

Upgrading of combustion unit

Others (such as terminating or contracting out manufacturing)

Table 1. Cases of actions to reduce the atmospheric release of chemical substances

Number of cases

9

7

4

3

2

3

6



Ethanol7,654 tons

Methanol10,180 tons

Methanol185 tons

Acetone11,744 tons

Ethyl acetate7,580 tons

Toluene4,392 tons

Toluene88 tons

Dichloromethane1,361 tons

Dichloromethane150 tons

Isopropyl alcohol 1,745 tons Others

4,801 tons

Ethanol11,84 tons

Ethyl acetate237 tons

Isopropyl alcohol195 tons

Acetone124 tons

Others83 tons

0

1,000

1,500

500

2,000

2,500

3,000

3,500

2008 2009 2010 2011 2013

3,1182,887

2,583 2,6652,574

2,272

2012 (FY)

(tons)



2014Chemical Substances Management

17

Summary of Process Safety Study Group Workshops Held between December 2013 and October 2014Title Speakers and organizations

1. Lecture: “Potential risks of chemical processes and safety assessment technologies”

Yoichi KunitohGroup LeaderSafety Engineering and Environmental Integrity GroupEngineering and Production Technologies LaboratoryMitsubishi Chemical Group, Science and Technology Research Center, Inc.

Dr. Yoshiyuki Masui,Director, General ManagerR&D Dept. and Manufacturing Dept.Shionogi Pharma Chemicals Co., Ltd.

2. Case sharing (by a study group member company)

28th February

29th September (2-day program)

30th October

　　　　PM: Study trip and lecture (Tokushima Itano Factory, Otsuka Pharmaceutical Co., Ltd.)1. Lecture: “Report on action for OEL”2. Tour of the pharmaceuticals wing3. Tour of plant: Soylution [sic] wing4. Tour of plant: Biotope

　　　　AM Study trip and lecture (Shionogi Pharma Chemicals Co., Ltd.)1. Company overview2. Facility information (Wings C-1, D-2 and C-4)

Yoshio ChuManagerDepartment of Environment and SafetyTokushima Headquarters.Otsuka Pharmaceutical Co., Ltd.

3. Section activity report on the year by Section for Handling of Highly Active Pharmaceutical Substances

Astellas Pharma Inc.

3. Lecture: “Wing D-2 for manufacturing of highly active pharmaceutical ingredients”

2. Case sharing (by a study group member company)

Makoto TakagiChemical Development Center CMC Development Laboratories Shionogi & Co., Ltd.

Otsuka Pharmaceutical Co., Ltd.

2. Panel discussion: “Let’s consider Anticipate and Act for Safety” Dr. Ryoji Makino, Kunio MatsukuraResearch Institute of Science for Safety and Sustainability.National Institute of Advanced Industrial Science and Technology (AIST)

4. Tour of plant: highly active pharmaceutical ingredient wing (D-2) and spray dry wing (C-4)

4. Report on Process Safety Study Group FY 2014 Activity Plan

1. Lecture: “How to view static charges in investigation into the cause of a fire and explosion accident”

Yasuaki Hagimoto(Former Director Second Department of Forensic Science National Research Institute of Police Science)

Day-1

Day-2

　　　　PM: Study trip and lecture (Second Toskushima Factory, Otsuka Pharmaceutical Co., Ltd.)1. Tour of Capacity Development Research Institute, effluent processing plant and incinerator

Day-2


Group Activities Process Safety Study Group

The Process Safety Study Group started its activities in April 2007. In FY 2014, the group has welcomed members from two more companies, now with 21 members from 17 companies. The basic objective of the group has been to acquire knowledge and to improve skills concerning safety assessment in developing the manufacturing processes of active pharmaceutical ingredients (API), scale-up, and reviews for industrial production. In light of the recent spate of chemical plant accidents, the group has hosted lectures by experts covering commentary on such accidents and how to prevent such accidents, and facilitated information sharing and panel discussions. Also, because of the recent trend of more companies developing anti-cancer drugs, thus having to handle highly active pharmaceutical substances, there has been more interest in exposure risks for the workers and how to contain those highly active pharmaceutical substances. To address this issue, the group hosted a study trip in September 2014, with the help of two companies: Shionogi Pharma Chemicals Co., Ltd. provided a lecture on the handling of highly active pharmaceutical substances and a tour of their environmental facilities: Tokushima Itano Factory and Second Tokushima Factory. The group appreciated those companies providing a significant opportunity for information sharing. The group has also facilitated information sharing by the group member companies, including sharing of case studies on safety assessment and how issues were handled. Furthermore, a new initiative started last year, when 14 members from nine companies gathered to form the Section on Handling of Highly Active Pharmaceutical Substances. Since then, the section has facilitated sharing of information on standards and facilities at respective companies and how handling of those substances was practiced. Their final goal (currently, 13 members) is to provide resources and information useful for JPMA member companies as sources of reference through such actions as collating case study reports and developing a summary of approaches to containment. The section intends to cover a wide variety of topics such as manage-ment standards, techniques of management, facilities, effluent processing, management of air-conditioning, facility performance assess-ment, washing, protective gear, and so on. Based on the status of actions in respective topics by respective companies, the section intends to summarize such information as the basic information, information on required actions and information that can be shared.The group will continue with its group and section activities to help members acquire practical knowledge in process research and share information.


2014Occupational Safety & Health Management

18

The 60 out of 72 JPMA member companies responded to our questionnaire survey about the rate of occupational accidents reported in FY 2013 (excluding those occurred during commuting) and provided data covering some 139,009 employees. This survey again included the section for accidents that did not require a day off work as a result of the accidents in addition to questions about the accidents that required a day(s) off work. The FY 2013 survey also sought data about the types of accidents.

Altogether, 510 cases of No Time Loss Occupational Accidents occurred in FY 2013. Over the past 3 years, numbers of accidents have slightly declined: 596 cases in FY 2011 and 547 cases in FY 2012.The workplace type that reported the highest number of such accidents was sales offices with 242 cases (47%), followed by manufacturing plants with 141 cases (28%), R&D facilities with 57 cases (11%), head offices with 54 cases (11%) and others with 16 cases (3%). Sales offices have made up 50% or more in the No Time Loss Occupa-tional Accidents category for 3 years in row, with 305 cases (51%) in FY 2011 and 271 cases (50%) in FY 2012.To address this situation, the Environment & Safety Committee has established the Business Vehicle Accident Prevention Study Group for investigation and analysis of the current status and for facilitation of information sharing and educa-tional and/or motivational actions concerning new accident prevention technologies and countermeasures at each company, continuously.

Figure 1. Accidents that did not require a day off work in FY 2013: Numbers and percentages of accident by workplace type

Figure 2. Accidents that required a day(s) off work in FY 2013: Numbers and percentages of accident by workplace type

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.

No Time Loss Occupational Accidents in FY 2013 (Figure 1)

1

In FY 2013, the number of Time Lost Occupational Accidents was 90. There were 100 cases in FY 2011 and 133 cases in FY 2012. The workplace type that reported the highest number of accidents that required a day off work was sales offices with 49 cases (54%), followed by manufacturing plants with 24 cases (27%), head offices with 11 cases (12%), R&D facilities with 3 cases (3%) and others with 3 cases (3%). Accidents at sales offices and manufacturing plants accounted for 81% of the total number, increased from the FY 2012 level (73%). However, FY 2013 saw a major decrease in the number of Time Lost Occupational Accidents at R&D facilities (from 21 cases (17%) in FY 2012). The percentage of Time Lost Occupational Accidents to the total occupational accidents (Accidents that did not require a day off + Time Lost Occupational Accidents ) is approx. 17% for head offices and sales offices, approx. 15% for manufacturing plants, 5% for R&D facilities, and approx. 16% for others. Except for R&D facilities, there were no large differences between facility types.Although task details and work environment vary, there is no difference in the likelihood of an occupational accident becoming a Time Lost Occupational Accident at any business facility. There-fore the same diligent exercising of safety cautions is required.

Time Lost Occupational Accidents in FY 2013 (Figure 2)

2

1. Status of Occupational Accidents and Categorization of their Type

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 healthycondition. JPMA has conducted studies in occupational safety and business vehicleaccidents. In addition, JPMA has held a seminor regarding mental health issues of employees and prevention of traffic accidents by business vehicles.

Sales offices242 cases（47%）

Manufacturing plants141cases（28%）

57 cases（11%）

Head offices54 cases（11%）

Others16 cases（3%）

R&D facilities

Total ： 510 cases

Sales offices49cases（54%）

Manufacturing plants24cases（27%）

3cases（3%）

Head offices11cases（12%）

Others3cases（3%）

R&D facilities

Total ： 90 cases


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 occupa-

tional 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


19

The total number of work days lost (Total Work Days Lost) following occupational accidents in FY 2013 was 1,053 days, which was better than the 1,216 days in FY 2011 and the 1,741 days in FY 2012. Following the decrease in the number of cases of Time Lost Occupa-tional Accidents, it was also noted that serious accidents (long-term Time Lost Occupational Accidents) also declined.The type of workplace with the highest number of Total Work Days Lost was manufacturing plants losing 543 days (52%), followed by 261 days (25%) lost for sales offices, while R&D facilities lost 62 days (6%). Manufacturing plants and sales offices accounted for 76% of the Total Work Days Lost, showing a similar trend noted in Time Lost Occupational Accidents (81% of all).

The Occupational Accident Severity Score indicates the seriousness of an occupational accident suffered. The Occupational Accident Severity Score for JPMA in FY 2013 was 0.004, which was lower than 0.005 in FY 2011 and 0.006 in FY 2012. According to the MHLW FY 2013 Occupational Accidents Statistics’ data, the Occupational Accident Severity Score for the entire manufacturing sector was 0.10 and 0.12 for the entire chemical industry. Our figure was considerably lower than those, suggesting JPMA membership suffered less severe accidents than other businesses in the manufacturing sector. Per-workplace scores were 0.010 for manufacturing plants, the highest, then 0.002 for R&D facilities, 0.003 for head offices, 0.002 for sales offices, and 0.001 for others. Although we did not suffer as many severe accidents as other industry types, it is thought that our

manufacturing plants are more prone to severe occupational incidents when compared with other workplaces, therefore caution is required.

Figure 3. Number and percentage of Total Work-Days Lostin FY 2013 (Lost Work Days)

The Time Lost Occupational Accidents Ratio indicates the frequency of incidents that required at least 1 day off work. This rate for the whole of JPMA was 0.34 in FY 2013, which was lower than 0.38 in FY 2011 and 0.49 in FY 2012. According to the MHLW, the FY 2013 Occupational Accidents Statistics’ data showed that the Time Lost Occupational Accidents Ratio was 0.94 for the entire manufacturing sector and 0.82 for the entire chemical industry. Our figures were lower than those figures. In terms of workplace specific data, the highest figures were found for 3 types of workplaces: manufacturing plants at 0.43, sales offices at 0.44 and others at 0.45. It is thought that the workplaces categorized as “others” tend to have a smaller number of employees; therefore the number for Time Lost

Occupational Accidents (3 in FY 2013) will have more impact on the Ratio.

Figure 5. Occupational Accident Severity Rate in FY 2013

Total Work Days Lost in FY 2013 (Lost Work Days; Figure 3)3

Time Lost Occupational Accidents Ratio (Figure 4)4

FY 2013 Occupational Accident Severity Score (Figure 5)5

0.010

0.002 0.003

0.002

0.004

0

0.002

0.004

0.006

0.008

0.010

0.012

The FY 2013 study found a similar pattern for the most common types of Time Lost Occupational Accidents to that in the previous year: The 3 most common types were “motor accidents (on road)” (40 cases, 44% of all cases for Time Lost Occupational Accidents), followed by “falling over” (22 cases, 24%) and “being caught between objects or in a machine” (8 cases, 9%). However, the “recoil of movement or forced operation (lower back pain, etc.)” category seen more in FY 2012 (25 cases or 20%) had a greatly reduced figure of 6 cases making up 7% of the total in FY 2013. This can be said to be an effect of the measures to prevent lower back pain implemented by respective companies, following the revision of the “Guideline to prevent lower back pain in workplace” by MHLW, which came into force in June of last year.

The data by workplace type show that the 24 cases for Time Lost Occupational Accidents occurred at manufacturing plants were mainly either “being caught between objects or in a machine” (7 cases, 29%), “falling over” (5 cases, 21%) and “recoil of move-ment or forced operation (lower back pain, etc.)” (3 cases, 13%). The 3 cases that occurred at R&D facilities were 1 case each for “falling over”, “recoil of movement or forced operation (lower back pain, etc.)” and “motor accident (on road)”. In contrast, the majority that occurred at sales offices (49 cases) were “motor accident (on road)” (35 cases, 71%), followed by “falling over” (7 cases, 14%).The most common causes for Time Lost Occupational Accidents were “motor accident (on road)” and “falling over”, a trend contin-ued from the previous year, making up 69% of all accidents. We need to continue our actions to prevent these types of occupa-tional accidents.

Types of Time Lost Occupational Accidents (Figure 6)6

0.001

Figure 4. Frequency of accident requiring a day(s)off work in FY 2013 by workplace type

0

0.10

0.20

0.30

0.40

0.50

0.60

0.70

0.80

0.43

0.09

0.19

0.44 0.45

0.34

Manufacturing plants543days（52%）

Sales offices261days（25%）

183days（17%）Head offices

R&D facilities62days（6%）

Others4days（less than 1%）

Total：1,053days


Manufacturing plants

R&D facilities Head offices Sales offices Others Total

Rat

io

Entire manufacturing sector: 0.94Entire chemical industry: 0.82

Rat

io

Manufacturing plants

R&D facilities Head offices Sales offices Others Total

Entire manufacturing sector: 0.10Entire chemical industry: 0.12


2014

20

Figure 7. Number of days off work at the Accidents

Figure 8. Age of workers in Accidents that required a day(s) off work

Figure 9. Years of experience of workers when Accidents occurred

We conducted a follow up survey on Time Lost Occupational Accidents (90 cases in total) that occurred in FY 2013 concerning the number of days lost, age and years of experience of persons injured in accidents by major types of accidents (e.g. “motor accident” and “falling over”) and overall accident occurrence. The number of days off taken for Time Lost Occupational Accidents, as seen in Figure 7, was found to be up to 3 days in 48 cases (55%) and between4 and 9 days in 12 cases (14%), together 69% of all cases needed fewer than 10 days off to recover. On the other hand, there were 12 cases (14%) of accidents that resulted in 31 or more days off work. Patterns identified for respective accident types include motor accidents, for which fewer than 10 days off were needed in 89% of the cases; however, for accidents caused by falling over, only 43% needed fewer than 10 days off work, while 33% needed 30 or more days off work.

The data on the years of work experience of the person injured are shown in Figure 9. The pattern identified is 28% for those with less than 3 years experience, 16% for those with more than 3 but less than 5 years, then 16% for those with more than five but less than 10 years experience. Therefore, 60% of those injured in accidents had less than 10 years’ work experience. After the first 10 years, the number of cases declines as the person gains mastery of their work until the 30 year of his/her work. But those with 30 or more years of experience again start to have more accidents. In terms of accident types, those with less than 10 years’ experience represent 71% of those injured in motor accidents but only 38% in accidents caused by falling over.

It is considered that we need to take actions tailored for the poten-tial accident type in order to achieve zero occupational accidents.

From the data on age of the person injured, as seen in Figure 8, there is a similar ratio in respective age groups: 24% were in their 20's, 22% were in their 30's, 28% were in their 40's and 24% were in their 50's. When looking at age for different accident types, the younger generation in their 20's or 30's were more likely to suffer a motor accident, making up 71% of the total, while those in their 20's or 30's made up only 14% of accidents caused by falling over, in contrast to 53% for those in their 50's or older.

Time Lost Occupational Accidents Follow-up Survey (Figures 7, 8 and 9)

7

55%68%

29%

14%

21%

14%

16%

8%

19%

2%

5%

14%3%

33%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Total(N=88) Traffic accidents（N=38） Falling over（N=21）



0

5

10

15

20

25

30

35

40

24%39%

14%

22%

32%28%

18%

33%

24%11%

43%

2% 10%

0%

20%

40%

60%

80%

100%

28% 37%

11%

16%16%

16%

16%18%

11%

9%11%

11%

9%8%

16%

8%3%

21%

12% 8%16%

0%

20%

40%

60%

80%

100%

30 days or longer 20-29 days 10-19 days 4-9 days Up to 3 days

In their 60's

30 years or longer

3 or 4 years Fewer than 3 years

20-29 years 15-19 years 10-14 years 5-9 years

In their 50's In their 40's In their 30's In their 20's


Fallin

g off o

r fall

ing do

wn

Fallin

g ove

r

Being c

augh

t betw

een o

bjects

or in

a m

achin

e

Cuts &

abra

sions

Contac

t with

hot o

r cold

objec

t

Contac

t with

harm

ful ob

ject

Traff

ic ac

ciden

ts (o

n roa

d)

Traff

ic ac

ciden

ts (o

thers)

Labo

rator

y anim

al bit

es

Electro

cutio

n

Explos

ion

Bursti

ng Fire

Collisi

on

Collisi

on ca

used

by ot

her p

arty

or ob

ject

Hit by f

lying

or fa

lling o

bject

Floor

or st

air br

eaka

ge w

hen

stepp

ed on

Drownin

g

Avalan

che o

r coll

apse

Recoil

of m

ovem

ent o

r for

ced o

pera

tion

Others

Canno

t be c

atego

rized

Type of accident (22 types)

Acc

iden

t tha

t req

uire

d a

day(

s) o

ff (c

ases

)

Figure 6. Accidents that required a day(s) off work : Type of accidents in FY 2013

Manufacturing plants R&D facilities Head offices Sales offices Others


21

Figure 12. Actions tried at each company and effects (1)

The 14 companies that reported a declining trend identified the main reasons to be imposing a harsher penalty to the person who caused the accident and training (such as e-learning)

Responses to the questions concerning actions by each company and their effects (52 companies) indicated more companies now take such measures as accident reduction directives from executives, providing data to relevant depart-ments and training for managers.

State of Accidents1

The liable accident rate (the number of liable accidents divided by the total number of vehicles) decreased for 2 consecutive years to 20.9% in FY 2013. This is thought to reflect the influence of the approx. 2% decrease in the liable accident rate of leased

vehicles over 2 years. The rate of accidents causing an injury or death was 2.3% for all kinds of vehicles, maintaining almost the same level for 3 consecutive years.

2. Traffic Accidents by Business Vehicles and Accident Prevention

50.0%

48.1%

40.4%

30.8%

30.8% 30.8%

5.8%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Effective

Uncertain

Ineffective

Figure 10. Liable accident rate

0.0％

5.0％

10.0％

15.0％

20.0％

25.0％

30.0％

FY 2011

FY 2012

FY 2013

Figure 11 Rate of accidents causing injury or death

0.0%

0.5%

1.0%

1.5%

2.0%

2.5%

3.0%

FY 2011

FY 2012

FY 2013

20.9%22.1% 21.2%23.3%

25.4%23.7%

8.6%8.6% 8.9%

2.3% 2.3%

1.8%

1.1%

2.6%

2.2%

1.2%

2.4% 2.4%

The 15 companies reported "Largely increase" or "Increase", while 23 companies said “No change”, 14 companies said "Decrease" or "Largely decrease". As 8 companies reported a "Largely decrease", it seems that specific countermeasures have produced results. Number of

companies 6 9 23 6 8

Rate 11.5％ 17.3％ 44.2％ 11.5％ 15.4％

Increase by 5% or more

Increase by 2% or more

No changeDecrease by

2% or lessDecrease by

5% or less

Table 1. Trends in business vehicle accidents (comparison with the previous fiscal year)


Business vehicles are an essential tool for our Medical Repre-sentatives (MR) assigned to provide drug information for medical care. The JPMA conducts an annual survey on the management and the system of business vehicle operation and status of accidents. The ninth survey received responses from 52 compa-nies (with approximately 51,000 vehicles) for analyses. The

Business Vehicle Accident Prevention Study Group, now in its fifth year, is responsible for the annual survey and actively implementing actions such as sharing information of case studies on accident prevention measures and the hosting of lectures by guest speakers.

All vehicles Leased Vehicles Vehicles owned by MRs All vehicles Leased Vehicles Vehicles owned by MRs

Manager training

Sharing of accident information betweenrelevant divisions

Accident reduction directive from executives


2014

22

Liable accident rate for new graduate MRs within 12 months of their first assignment2

It was thought that the percentage of persons who caused a multiple liable accident has a major impact on the accident rate. We used the data for the previous 3 years to compare the percentage of persons who caused multiple liable accidents and the percentage of such accidents in all vehicles (51 companies) as well as in new graduate

In FY 2012, the rate of liable accidents by new graduate MRs within 12 months of first assignment was 81.5%: increased from the previous year and about the same level as that for FY 2010 new graduate MRs within 12 months of assignment. The rate of accidents causing an injury or death has declined to 6.7% over 3 years. Ratio of persons that caused a liable accident among FY 2012 new graduate MRs was 54.0%, 5.0% more than the 49.0% recorded in the previous year.

[State of Accident Prone Persons]

FY2013

FY2012

FY2011

FY2012

FY2011

FY2010

Zero Once Twice or more Zero Once Twice or more

Table 4. Percentage of MRs involved in anumber of liable accidents (all vehicles)

Table 2. Number of vehicles owned by new graduate MRs, number of liable accidents and number of accidents causing an injury or death (FY 2012)

Table 3. Number of new graduate MRs that caused a liable accident (FY 2012)

Once Twice or more

15.1％ 2.6％

14.8％ 2.4％

14.5％ 2.4％

Zero

FY2011 82.3％

FY2012 82.8％

FY2013 83.2％

Once Twice or more

36.0％ 19.6％

32.7％ 16.3％

34.6％ 19.5％

Zero

FY2010 44.0％

FY2011 51.0％

FY2012 46.0％

Rate of liable accidents by new graduate MRs within 12 months

of first assignment (FY 2012)

Rate of accidents causing an injury or death by new graduate MRs within

12 months of first assignment (FY 2012)

81.5％

6.7％

Number ofliable accidents

43

Number of companies

1,284 cases

Number of vehicles

Number of accidents causing

an injury or death

1,575 105 cases





70.9％

6.8％





82.4％

7.1％

Table 5. Percentage of new graduate MRs(within 12 months of first assignment) involved in a

number of liable accidents

Figure 14. Percentage of MRs involved in anumber of liable accidents (all vehicles)

Figure 15. Percentage of new graduate MRs(within 12 months of first assignment) involved in a

number of liable accidents

MRs (43 companies in a 1 year follow-up study).In all vehicles, the percentage of persons who caused multiple accidents was almost unchanged over the 3 years at 2.4%. The figure for new graduate MRs had been on the decline for 3 consecutive years until last year, but increased this year (19.5%).


17.3%

26.9%

5.8%

19.2%

35.3%

21.2%

50.0%

46.2%

13.5%

23.1%

56.9%

1.9%

1.9%

2.0%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Largely effective

Somewhat effective

Ineffective

Face to face guidance by the immediate supervisor,and the introduction of driving suspensions and driving lessons at driving schools are effective.

0% 20% 40% 60% 80% 100% 0% 20% 40% 60% 80% 100%

Number of companies

Number of persons that caused a liable accident

43

FY 2011

938

FY 2012

841

Number of new graduate MRs

in FY 2012

Ratio of persons that caused a liable accident

1,556

FY 2011

49.0%

FY 2012

54.0%


Reflected in performance appraisal

Driving lessons at a driving school

Suspension from driving

Mental health care service available after accident (counseling, etc.)

Face to face guidance by someone other than the immediate supervisor

Face to face guidance by the immediate supervisor


2014Occupational Safety & Health Management

23

Female MRs are permitted to use a leased vehicle for dropping off and picking up their children at/from a child care center. (They are to submit notification with details of route taken in advance.) Other uses are not permitted.Use for non-work purposes is allowed for dropping off and picking up of preschoolchildren under 7 years old or a person with long-term care needs who lives at the same abode, on the condition of accident insurance cover.With regard to dropping off and picking up at/from a child care center or similar facility, it is treated as commuting.Only permitted for dropping off and picking up children at/from a child care center or similar facility as a part of care of the 　children.Private use exceeding 100 km per month requires payment of use charge for the distance travelled to the company.Private use requires recording of actual distance travelled regardless of how far or how close and approval by immediate supervisor for private use in each month.New graduate employees are given permission in their second year and afterSubmission of weekend/holiday use application is mandatoryi)To obtain permission from an immediate supervisor in advance, ii) ¥ 10/km out-of-pocket charge incurred, iii) Only the concerned employee permitted to drive, iv) Giving a healthcare worker a ride is not permitted (but family members are), and, v) Distance for private travel is limited to 200 km one way.A condition that the person has not caused a liable accident in the past 12 months.Permission by an immediate supervisor is essential (application from the person concerned only will not be approved)When private use is allowed, the driver is made aware that the non-work travel distance should not exceed two sevenths of the total distance travelled.

�

�

��

��

��

��


Table 6. Conditions for purpose of use

Table 7. Advance notification or application

Since last year, the survey asked respective companies whether or not they allow the use of leased vehicles for non-work purposes. Out of the 52 companies that answered this question this year, 15 companies (28.8%) answered that they allowed conditional use for non-work purposes. The figure for last year was 14 companies (25.5%) out of the 55 companies answered. This question, as well as being in the interest of occupational health and safety in relation to its implication with worker’s accident compensation insurance, has been included in the survey question in order to provide information for the member companies consid-ering introduction of such a policy in future, in the interest of

recently raised awareness of work–life balance and for supporting women taking active roles.

From the responses to the survey question concerning actions taken by respective companies and their effects (52 companies), it has been identified that such measures as assessment of diving

abilities in new graduate MRs and various courses tailored to their situations were effective. The effects of courses were also identified as an action to help persons who caused multiple accidents.

To the question about policy on advance notification or applica-tion, 14 out of the 15 companies answered that they require it. The 1 company that said “not required” had the distance travelled reported after use.

Out of the 15 companies that permitted use for non-work purposes, 10 companies had no condition, 4 companies had a child-care only condition and 1 company selected “Other purpose” and described the condition of “up to 100 km a month”.

The following is a description of the conditions for use for non-work purposes supplied by the respective companies:

This year’s survey also asked what conditions were set for use for non-work purposes

＜In the case of using for non-work purposes permitted＞No condition

10 4 1

Child care related Other purpose

Required

14 1

Not required

Figure 17. Leased vehicles: whether or not to permit use for non-work purpose

0% 20% 40% 60% 80% 100%

FY 2013

FY 2012

Permitted Not permitted

25.5％ 74.5％

28.8％ 71.2％

Leased Vehicles: Whether or not to Permit Use for Non-Work Purposes4

Main Causes of Accidents3

27.5%

28.8%

26.0%

21.6%

3.9%

42.3%

37.3%

40.4%

46.0%

58.8%

17.6% 2.0%

1.9%

2.0%

1.9%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%


Periodically providing e-training and/or video (at least once a year)

Specific course, e.g. driving on snow at time of assignment to a new post or moving to another area

Special course for accident-prone person

Practical driving training in actual car and/or theory course forFY 2013 new graduate MRs at the new post

Driving ability assessment and course for FY 2013 new graduateMRs during the training period after joining company

Driving ability assessment and course for prospectiveFY 2013 new graduate MRs before officially joining company

Largely effective

Somewhat effective

Ineffective


2014Stakeholder Engagement

24

Teruyuki Tosaka Chairman, Environment Committee, FPMAJ

The FPMAJ Environment Committee has taken part in the Keidanren Voluntary Action Plan right since the outset to meet the challenges of global warming countermeasures and resource conservation and waste management, and continues to monitor and annually report on the status of progress back to Keidanren. In addition, concerning the prevention of global warming, efforts have been made to attain the voluntary action plan target based on the Kyoto Protocol by FY 2012 while complying with the MHLW’s strict annual review and Keidanren’s annual survey. However, the target could not be achieved owing to the

major worsening of the carbon emission factor for grid electricity caused by the Great East Japan Earthquake. FPMAJ formulated a new action plan in partnership with Keidanren (FPMAJ Action Plan for a Low Carbon Society), which started in FY 2013, for which we continue our activities mainly for energy saving.Aside from these, such challenges unique to the pharmaceutical industry as managing medical waste and other environmental challenges, such as actions for biodiversity, have increasing importance.

Nine organizations and 90 companies take part in the FPMAJ Action Plan for a Low Carbon Society as of August 2014. A list of those organizations and companies is available on the FPMAJ website (http://www.fpmaj.gr.jp/documents/201407kankyou.pdf)The first follow up survey in accordance with the Action Plan for a Low Carbon Society (of actual FY 2013 data) was conducted including the new organizational and corporate participants. When using the carbon emission factor as a target for FY 2020, published prior to the Great

East Japan Earthquake by the Federation of Electric Power Compa-nies of Japan (0.33 t-CO2/1000 kWh), a reduction of 24% against the baseline in FY 2005 can be seen, indicating the plan had a good start towards attaining the target. However, as it is anticipated that our energy use will increase for future expansion of the pharmaceutical market, we will need more new actions for energy saving. For details, please see the previous section on Global Warming Countermea-sures (pages 8–11).

Global Warming Countermeasures1

FPMAJ Target

Reduce CO2 emissions generated by the pharmaceutical industry by 23% from the FY 2005 level by FY 2020

Scope� Organizations and companies: FPMAJ member organizations and companies (including companies affiliated to groups)� Divisions: Plants and Research laboratories� Gas type: CO2 emitted from energy use

Assumptions� Carbon emissions factor for electricity in FY 2020 will be improved to 3.3t-CO2 /10000kWh (from 4.2 in FY 2005)� Scale of pharmaceutical market in FY 2010 will be 150% of the scale in FY 2005� The ratio of electricity in energy used will rise to 60% (from 46% in FY 2005)

The Federation of Pharmaceutical Manufacturers’ Associations of Japan (FPMAJ) is comprised of 14 organizations with pharmaceutical manufacturing cooperate membership, each representing a specific operational type (such as drugs for clinical use, drugs for general use, or other operational type) and 17 regional organizations based in their respective prefecture (such as Pharmaceutical Manufacturers' Association of Tokyo and Osaka Pharmaceutical Manufacturers Association). The Environment Committee was established in October 2007, having identified the main challenges as being those of global warming countermeasures, whose regulatory and societal demands for action are becoming stronger every year, and those of reduction and proper disposal of wastes, among the many environmental challenges concerning the entire pharmaceutical manufacturing sector. Members of the FPMAJ Environment Committee have been nominated by the four organizations (two to four members from each organiza-tion) with an environment related committee, among the 14 operation type specific organizations: the Japan Pharma-ceutical Manufacturing Association (JPMA), the Japan Generic Medicines Association (JGA), the Japan Self-Medication Industry (JSMI) and the Japan Kampo Medicines Manufacturers Association (JKMA). The commit-tee works in partnership with MHLW and external industry organizations and councils such as Keidanren to tackle the actions to protect the environment.

Partnership with the Federation of Pharmaceutical Manufacturers’ Associations of Japan

State of Progress of FY 2013 Business Plan

Actions of the FPMAJ Environment Committee

When the Action Plan for a Low Carbon Society was originally formulated in September 2010, it was assumed the factor on electricity would be largely improved towards FY 2020. As the

assumed improvement in the electricity factor is incorporated into the FPMAJ Action Plan for a Low Carbon Society, we plan to revise the current numerical target when this assumption changes.



25

With regard to the actions for waste management, FPMAJ has participated in the Keidanren Voluntary Action Plan on the Environment (Sound Material–Cycle Society) since FY 1997, in an endeavor to reduce the level of landfill volume of industrial waste. The fourth period of the FPMAJ’s voluntary action plan has started in FY 2011 and will conclude in FY 2015; the FPMAJ is working towards the targets.

FY 2013, the third year of the action plan, recorded the quantity of final disposal of industrial wastes as 5,000 tons, which is 2,000 tons less than the previous year and 83% less than the baseline year (FY 2000), indicating the target has continued to be attained. Please see the previous section for Resource Conservation and Waste Management in pages 12-14.

Resource Conservation and Waste Management2

Progressing population aging and advances in healthcare technol-ogy lead to an annual increase in the number of cases receiving home-based care. Consequently, it is anticipated that the quantity of medical waste from home-based care (such as injection needles and infusion fluid bags) will also increase. For proper disposal of increas-ing medical waste from home-based care, it is important for the prescribers (medical and dental associations), the retailers (pharmaceutical association), the manufacturers (pharmaceutical and medical device industries) and those from local governments responsible for management of general waste to share awareness on medical waste from home-based care and to coordinate their actions.Tokyo Metropolitan Government has established a review team for

the proper disposal of medical waste from home-based care in Tokyo to facilitate the concerned parties to share information on medical waste from home-based care and the future direction of proper disposal with consideration to the patients and care givers point of view. The team, whose members are from the concerned parties, has conducted several reviews, in which FPMAJ also took part as a producer representation.For further proper disposal of medical waste from home-based care in future, the team will work together to make progress on methods of disposal less burdensome for the patients, care givers and other people concerned, while giving consideration to individual circumstances.

To conclude this section, here is some introductory information on actions by environment committees of two of the FPMAJ Environ-ment Committee member organizations: JSMI and JGA

Examining proper disposal of medical waste from home based care in Tokyo

FY 2014 FPMAJ Environment Committee Business Plan (Focus Challenges)

� Conducting the follow-up survey in accordance with the Action Plan for a Low Carbon Society and preparation and submission of the report� Actions for follow up of MHLW Low Carbon Society Action Plan� Various actions for extending participation in the Action Plan for a Low Carbon Society by more organizations or corporations, improving follow-up organization, information sharing for attainment of numerical targets and reviews of various challenges

� Conducting the follow-up survey in accordance with the Voluntary Action Plan and preparation and submission of the report� Information sharing for attainment of numerical targets and review of various challenges and improving follow-up organization� Actions for review and revision of Act on Recycling of Containers and Packaging � Gathering of information and provision of information for reduction and proper disposal of medical waste, and maintaining a good relationship with concerned organizations

� Gathering of information on environmental challenges with major impacts on business activities such as biodiversity


Gathering of information

Resource Conservation and Waste Management



2014

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Jun MaedaChairman, Environment Committee, JGA

As an organization under the umbrella of FPMAJ, we have taken a part in the follow-up survey in accordance with Keidanren’s Voluntary Action Plan for Environment since 2008. This survey is conducted according to the provisions of the Kyoto Protocol First Pledge Period: each member company is

requested to respond to the questionnaire, the JGA Environ-ment Committee compiles the questionnaire data and submits it to the JPMA Environment and Safety Committee. Annual survey outcomes are then reported to the JGA Environment Committee and distributed to respective member companies.

As of august 2014, 9 JSMI member companies participated in the FPMAJ Action Plan for a Low Carbon Society, which started in FY 2013. One person takes a part in the working group for Survey of CO2 emissions, as well as one observer, who works with various organizations and performs such tasks as compil-

ing data and report writing. We also continue to request other JSMI member companies that are yet to take part in the Action Plan for a Low Carbon Society to participate.

Following the establishment of the Environment Committee at FPMAJ, JGA established its own Environment Committee in December 2007, with 20 out of 41 JGA member companies registering for participation. Since then, the JGA Environment Committee has worked in cooperating with the FPMAJ Environment Committee, and mainly in conjunction with the Keidanren led Voluntary Action Plan for Environment: Global Warming Countermeasures and Resource Conservation and Waste Management. We intend to take action for the environment based on the environment that surrounds pharmaceutical industries and information sharing.

Actions by the Japan Generic Medicines Association (JGA)

Masafumi TsukanoChairman, Environment Committee, JSMI

As a FPMAJ Environment Committee member organization, JSMI sends three committee members as of August 2014. Our members, working alongside other organizations that joined the FPMAJ Environment Committee, including JPMA, JGA and JKA, take actions to address the environmental issues that concern the entire pharmaceutical industry (such as global warming and waste issues). The Global Warming Waste Action Subcommittee has been formed mainly by the JSMI member companies that are not members of JPMA and is engaged in actions. As only a limited number of companies attend the subcommittee, the meetings have been run jointly with JKA since last year.

Actions by Japan Self-Medication Industry (JSMI)


The Global Warming Waste Action Subcommittee facilitates sharing of the topics discussed at the FPMAJ Environment

Committee and considers actions in the capacity of JSMI.

Global Warming Waste Action Subcommittee

Owing to the switch from the Keidanren Voluntary Action Plan to the Action Plan for a Low Carbon Society in FY 2013, the JGA Environment Committee continues to take part in the follow-up survey as an organization under the umbrella of FPMAJ, towards the posted target to reduce CO2 emissions

generated by the pharmaceutical industry by 23% from the FY 2005 level by FY 2020. Meanwhile, we anticipate future energy increases due to progress in the roadmap aimed by the generic medicine industry, and intend to improve productivity further as well as to strive to increase member companies.

Participation in the Action Plan for a Low Carbon Society

Following production increases by the pharmaceutical sector, the quantity of waste generation has been on the increase since 2010 along with the quantity of final disposal. The JGA Environment Committee, as an organization under the umbrella of FPMAJ, has taken part in the follow-up survey since 2007, and has achieved a

100% recovery rate for two consecutive years. Although wastes are expected to continue to increase as production increases every year, the formation of a sound material cycle is an important challenge to meet for Japan with its limited resources. Therefore we strive to further promote the 3Rs.


Participation to join the Action Plan for a Low Carbon Society

Members attend the seminars on the environment when invitations are received from respective organizations via the FPMAJ Environment Committee. The JSMI Environment

Committee also organizes factory study tours to gather information.

Various seminars and factory study tours


The Environment & Safety Committee General Assembly is held annually in April to discuss and determine an annual action plan concerning Environment Protection and Occupational Safety and Health related matters for the streamlined imple-mentation of these actions. The respective Technical Subcom-mittees 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 pharmaceutical industry also takes part in the Keidanren Voluntary Action Plan on the environment (both the Global Warming Countermeasures 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.

The JPMA Environment & Safety Committee facilitates member companies to share information about cutting-edge technolo-gies and their experience in actions for the environment and occupational safety and health, to raise their awareness and help find solutions. Our seminars and talks include speakers invited from outside, in an effort to provide information on cutting-edge technologies and legal trends in Japan or overseas concerning protection of the environment and occupational

health and safety. The expert subcommittees run technical courses and workshops regularly to offer the opportunities to share information such as technical information and legal trends in specific technical areas and information on cases of member companies’ actions in protecting environment and occupational health and safety efforts. The Committee makes reports of those actions available to the member companies via Environment News and Environment Report.

Publication of Study Reports

Since the inaugural issue published in FY 1999, the Environ-ment & Safety Committee has published an annual Environ-ment Report. The Environmental Report discloses informa-tion about the pharmaceutical industry’s actions for the environment and occupational health and safety as a means to fulfill our account ability to stakeholders. The report is also expected to be a tool for communication between the member companies and society.

Publication of Environmental Reports

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 Manufactur-ers’ Associations of Japan, the Osaka Pharmaceutical Associa-tion and the Tokyo Pharmaceutical Association, so that the information is widely distributed in the pharmaceutical industry. “Environment News” was issued four times in FY2013.

Publication of “Environment News”

Study Group ActivitiesThe Environment & Safety Committee has study groups to provide a place for activities beyond the framework of expert subcommittees. JPMA member companies that do not participate in the expert subcommittees can still partici-pate in the study groups. Currently, two study groups and

one section are working actively: The Process Safety Study Group, Section on Handling of Highly Active Pharmaceuti-cal Substances and the Business Vehicle Accident Preven-tion Study Group.

Environment and Safety Lecture, Environment and Safety Seminar and Technical Training Courses

Training & Motivation

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report and periodically reporting this to Keidan

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The Environmental and Safety Committee holds an annual environment and safety seminar, for the directors and manage-ment staff who are involved in environment protection, occupa-tional safety and health issues. External speakers are invited to give talks at the seminar, providing us with a wide range of up-to-date information on environment protection and occupa-

tional safety and health. We also run environment and safety lectures and various technical training courses, in which information is given about technology and management in environmental protetion and occupational safety and health. Respective companies’ efforts are presented, so that member companies can improve their levels in their respective areas.


2014

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Environment and Safety Lecture (April 2014)

Energy Saving / Global Warming Countermeasures Technical Training Course (October 2014)

ISO14001: The latest news on its revision and the priority challenges for future environmental management

Takashi YoshidaPresidentGreen Futures, LLC.

Environment and Safety Seminar (November 2013)

Biodiversity according to mites

Integrated corporate actions for diversity from a life-cycle perspective

Kouichi Goka, PhDPrincipal ResearcherNational Institute for Environmental Studie

Ikuko Matsumoto, PhDResearcherInstitute for Global Environmental Strategies

The major points of April's revision of the Energy Saving Act, which intends to deal with a concern of balancing electricity supply and demand as well as strengthening existing measures to promote effective use of energy, were described.MITI's supporting programs for energy saving were also introduced.

The speaker gave a talk on prioritizing and advance preparation for formulating a business continuation plan. To achieve higher business continuation capacity, the firm needs to implement preventative or mitigating measures for issues of physical aspects, especially those that would create a bottleneck, to clarify the organization and role assignment, standards of conduct and means to implement the plan, and to improve risk management abilities of the personnel and organization through training.

The speaker shared his view that the state of workplace as a space for the employees to improve and fully utilize their competence has an important role in strengthening corporate competitiveness. While more companies suffer decline of their workplace functions, the speaker showed from an operational point of view that vitalizing the workplace leads to employees’ sense of fulfillment and enjoyment in their work.

The speaker shared his view that, when considering the measures to take in response to a natural disaster or a global environmental issue, it is important not to try to fight nature but to base your thinking on the philosophy of “Inashi” i.e. Protect Nature. Then nature will protect you, which has been practiced by the Japanese since ancient times.

ISO14001 is scheduled to be revised in 2015. Based on the draft international standards, focus challenges for corporate environmental management were suggested: i) Top management’s involvement in policies and strategies through strategic integration of environment and management, ii) introduction of a value-chain concept and integration into the business process are essential, iii) the corporation improves the social situation and competitiveness at the same time and extends its financial as well as societal values.

Understanding the four significant factors of biodiversity: genes, species, ecosystem and landscape, and protecting biodiversity are necessary for maintaining human society. Meanwhile, human activities pose threats to biodiversity, e.g. i) the destruction and degradation of habitats, ii) uncontrolled catches/harvests and iii) introduction of non-native species. In light of the current state of biodiversity in Japan, the importance of cherishing biodiversity was called for.

As the international consensus is being formed, there is a move by some parties in Europe and international organizations to standardize assessment of biodiversity and ecosystem services across the value chain. It will potentially become the requirement of business operators to perform an assessment on each business type and monitor impacts of its value chain on biodiversity and ecosystem services in such aspects as 1) land use, 2) catches/harvests of natural resources, 3) water use, 4) pollution of water, atmosphere and/or soil, 5) climate change, and, 6) waste.

CEPA Japan advocated the five actions for urban dwellers to take to protect biodiversity: eat, touch, tell, protect and select. An introductory commentary was given on the efforts to promote the five actions such as running a Grand Biodiversity Action Award

Theory of errors aims to provide options for prevention through elucidation of the causes of past incidents and accidents. Undesirable incidents often have common organizational and structural issues. It is important to put what can be learned from past incidents into practice.Eliminating undesirable incidents requires resolving the mechanism that caused them. The speaker presented case studies of serious incidents and emphasized the importance of directly looking into the organizational and/or structural issue(s) that formed the background of the incident.

Scientific findings published in a latest report and the statuses of international dialogue on global warming were described. Japan’s actions against global warming such as the bilateral credit scheme and typical energy saving programs were also described. Japan’s new target is expected to be set not to miss an opportunity.

As new trends in energy-saving measures, success examples from the latest energy saving award, especially example showing the advantage of heat recovery technology from wasted heat were described. Japan is leading heat pump technology and its introduction. The importance of the utilization of heat waste, finding available heat and ensuring “stop when not in use” was emphasized as future energy-saving strategies.

Biodiversity, public education, and promotion frontline

Tetsu HattoriDirectorCEPA JAPAN

Theory of errors in organization Haruhiko HiguchiProfessorPh.D. in Policy StudiesNational Police Academy

Protect Nature. Then nature will protect you

Shirou WakuiProfessorFaculty of Environmental and Information StudiesTokyo City University

Recent trends in energy saving policies

Akifumi KitashimaDeputy DirectorEnergy Efficiency and Conservation DivisionAgency For Natural Resources and Energy Ministry of Economy, Trade and Industry

Towards post 2020 greenhouse gas reduction

Sho TanoueSection ChiefClimate Change Policy DivisionGlobal Environment BureauMinistry of the EnvironmentGovernment of Japan

The issues on refrigerants used in freezer or refrigeration units (destruction of the ozone layer and global warming), characteristics of several refrigerants and situation of the revised Fluorocarbon Act to be enforced in FY2015 were described. In addition, Ecocute, a highly efficient heat pump hot water system using the natural refrigerant CO2, and a hot air heat pump were introduced from a view point of reducing CO2 emission and lowering running costs.

Recent trends in refrigerants and effective use of industrial heat pumps

Hiroaki YonedaEnergy Dept.Mayekawa MFG. CO., Ltd.

New trends in energy saving measures as seen in the Energy Saving Award and other awards

Mitsuo HaradaGeneral ManagerEnergy Conservation Solution Department P. E. JpAPEC EngineerThe Energy Conservation Center, Japan

Environment and Safety Lectures and Technical Training Courses (November 2013 – October 2014)

Environmental Technical Training Course (January 2014)

Occupational Health and Safety Technical Training Course (July 2014)

Business continuation management: its coalface and reality—Strengthening organizational power to overcome the age of crises—

Takeshi ItoCorporate Vice PresidentBusiness Resilience Consulting Div.Fujitsu Research Institute

Lively workplace as an operational challenge

Motohiro Morishima, Ph.D.Professor of Human Resource ManagementGraduate School of Commerce and ManagementHitotsubashi University


29

History of Environmental and Safety Initiative


2013

2008

2012

2011

2010

2006

1968

1978

1979

1996

2001

1997

1998

1999

2003

2005

2002

Voluntary Action Plan on a series of actions for waste reduction was completed in its final year in FY 2010

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)　

A fourth period voluntary action plan for waste reduction towards the final year of FY 2015 was settled on.Fundamental Philosophy and Guideline for Conduct Concerning Biodiversity was formulated to present the JPMA’s stance on biodiversity.

First period Keidanren’s Voluntary Action Plan on glebal warming Countermeasures, tagered in FY 2012, was concluded.

Second period Keidanren’s Voluntary Action Plan on glebal warming prevention, target in FY 2020, was settled on.

“Related Technology Liaison Group” was reorganized to the “Factory Waste Water Regulatory Measures Review Group”　

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

Environment Committee established. Five internal subcommittees were established (Planning Subcommittee, Chemical Substances Subcommittee, Environmental Management Subcommittee, Resource Conservation and Waste Management Subcommittee, and, Energy Saving and Global Warming Countermeasures Subcommittee)Voluntary Action Plan for reduction of atmospheric emissions of harmful chemical substances (three substances) was formulated for the first period, ending in FY 2000

Took a part in Keidanren Voluntary Action Plan (Global Warming Countermeasures)Voluntary Action Plan on actions for global warming countermeasures was formulated for the first period, ending in FY 2012Took a part in Keidanren Voluntary Action Plan for Environment (Sound Material–Cycle Society)

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.

Committee activities expanded to occupational safety and health. Renamed the “Environment & Safety Committee”. “Study Groups” were organized as places for activities beyond the subcommittees.

Restructuring from the five-subcommittee structure to four-subcommittee structure (Chemical Substance Management Subcommittee, Environmental Management Subcommittee, Resource Conservation and Waste Management Subcommittee, and, Energy Saving and Global Warming Countermeasures Subcommittee), as well as establishment of the Planning CouncilVoluntary Action Plan on Actions for Waste Reduction was formulated for the first period, ending in FY 2010Voluntary Action Plan for Reduction of Atmospheric Emissions of Harmful Chemical Substances (seven substances) was formulated for the second period, ending in FY 2004

Voluntary Action Plan on Waste Reduction (provisional proposal) was formulated

Voluntary Action Plan on Actions for Waste Reduction was formulated for the second period, ending in FY 2010

Voluntary Action Plan for Reduction of Atmospheric Emissions of Harmful Chemical Substances (three substances) was formulated for the second period, ending in FY 2007

Voluntary Action Plan on Actions for Waste Reduction was formulated for the third period, ending in FY 2010

Subcommittees reorganized from a four-subcommittee regime to a three-subcommittee regime (Environment Subcommittee, Occupational Safety & Health Subcommittee and Global Warming Prevention Subcommittee)

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2014


ABBOTT JAPAN CO., LTD. AbbVie GKAJINOMOTO PHARMACEUTICALS CO., INC. ALCON JAPAN LTD.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. MERCK SERONO CO., LTD.MINOPHAGEN PHARMACEUTICAL CO. LTD. MITSUBISHI TANABE PHARMA CORPORATIONMOCHIDA PHARMACEUTICAL CO., LTD.MSD K.K.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 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.

JPMA Member Companies (listed in alphabetical order): 72 Companies as of July 2014

Progress of Our Voluntary Action PlansArea of Action



Action to control Air Emissions


Year FinishedYear of Planning

FY1997(First Period Plan)

Dichloromethane: 20% reduction compared to the amount in FY20031,2-dichloroethane: 20% reduction compared to the amount in FY2003Chloroform: 20% reduction compared to the amount in FY2003

Dichloromethane: 60% reduction compared to the amount in FY19951,2-dichloroethane: 50% reduction compared to the amount in FY1996Chloroform: 30% reduction compared to the amount in FY1996Formaldehyde: reduction effortsBenzene: reduction effortsTetrachloroethylene: reduction effortsAcetonitrile: reduction efforts

Control the average CO2 emissions during first commitment period to below in FY1990 level

FY1996(First Period Plan)

Dichloromethane: 30% reduction compared to the amount in FY19951,2-dichloroethane: 30% reduction compared to the amount in FY1996Chloroform: 30% reduction compared to the amount in FY1996

Final disposal amount: 80% reduction against that in FY1990Final disposal rate: 5% or less Waste generation: 10% reduction against that in FY1990

Final disposal amount: 80% reduction against that in FY1990

FY2002

FY2005

FY2010

FY2000

FY2004

FY2007

FY2012

FY2013(Second Period Plan) Reduce CO2 emissions by 23% from FY 2005 level by FY 2020

FY2020(Ongoing)

FY2003(Second Period Plan)

Final disposal amount: 70% reduction against that in FY1990FY2001(First Period Plan)

FY2001(Second Period Plan)

FY2006(Third Period Plan)

Final disposal amount : almost 65% reduction against that in FY2000 FY2015(Ongoing)

FY2011(Fourth Period Plan)

FY2005(Third Period Plan)

Action Plan Contents

Members of Planning Conference and Steering Committee of Environment & Safety CommitteeChairperson

Akihiko Tasaka

Souichi Tamichi

Teruyuki Tosaka

Satoru Kobayashi

Shuichi Satoh

Toru Yamano

Yuko KikuchiTsutomu Konno

TAKEDA PHARAMACEUTICAL CO., LTD.

Shinichi Endo EISAI CO., LTD.

SHIONOGI & CO., LTD

CHUGAI PHARMACEUTICAL CO., LTD.

TAKEDA PHARAMACEUTICAL CO., LTD.Akinori HoshitaniKen Shiizuka

TERUMO CORPORATIONKOWA COMPANY, LTD.OTSUKA PHARMACEUTICAL CO., LTD.JPMA

DAIICHI SANKYO CO., LTD.

Osamu Odai DAINIPPON SUMITOMO PHARMA CO., LTD.

Deputy Chairperson

EnvironmentalChairpersonDeputy Chairperson Masaaki Okada ASTELLAS PHARMA INC.

TAISHO PHARMACEUTICAL CO., LTD.Deputy Chairperson

Deputy ChairpersonChairperson

Deputy ChairpersonDeputy Chairperson

Chairperson

Occupational Safety & Health

Member nominated by ChairpersonSecretariat

Global WarmingCountermeasures

Nobuyuki YasudaYoshiki Torii

MITSUBISHI TANABE PHARMA CORPORATIONPFIZER JAPAN INC.Deputy Chairperson

Steering Committee

Planning Conference

Expert Subcommittees

Planned and Complied by


Torii Nihonbashi Building, 3-4-1, Nihonbashi-honcho,

Chuo-ku, Tokyo 103-0023, Japan

TEL +81-3-3241-0326 FAX +81-3-3242-1767

URL: http://www.jpma.or.jp/


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