Disclosure based on the TCFD Recommendations

A father and child ride bikes, illustrating Astellas’ focus on sustainability issues.
A father and child ride bikes, illustrating Astellas’ focus on sustainability issues.

Governance

Supervisory structure

Executive structure

Sustainability issues are recognized as top priorities for Astellas, with key performance indicators (KPIs) established and monitored. For climate change, progress is assessed through greenhouse gas emission reduction targets and KPIs, which are aimed to be met by 2030. The adoption of renewable energy is also a crucial metric for measuring progress. The Sustainability Committee, chaired by the Head of the Sustainability Department and reporting to the Chief Strategy Officer (CStO), manages the Environmental Action Plan. The Committee reviews Astellas' Environmental Action Plan every five years to ensure its continued relevance and to suggest improvements as needed. Additionally, the Committee evaluates long-term plans for greenhouse gas reduction initiatives and the content of the Company’s TCFD disclosures.

Strategy

To identify and prioritize the issues that are most important to society and our business, Astellas carries out a materiality assessment and uses it to guide our sustainability efforts. Under the Astellas Materiality Matrix, reviewed in the fiscal year ended March 2022, climate change and energy are recognized as “very important” in their significance for both society and Astellas.

 

Astellas’ Environmental Action Plan sets out short-term and medium-term targets for our activities regarding the key points of the Company’s Environment, Health & Safety Guidelines. Astellas renews action plans on a rolling basis, by reviewing progress and conditions during the previous year and incorporating findings into the action plan for the following year. The plans outline efforts put in place to reduce the environmental burden and ensure the Company acts with integrity in reducing potential risks in order to protect enterprise value.

 

An in-house cross-functional team for disclosures was established to conduct a scenario analysis. The team analyzed Astellas' business and climate-related risks and opportunities, on the assumption that transition risks would materialize under a 1.5°C scenario for climate change and physical risks would materialize under a 4°C scenario. The time horizons examined were short-term (3 years), medium-term (10 years), and long-term (20-30 years). Since FY2021, we carried out climate risks and opportunities analysis on an annual basis. In FY2024, the team conducted a physical risk analysis of key locations for Astellas and its value chain. The results of the analysis were reviewed by the Sustainability Committee.

Climate-Related Risks Potential Impacts Financial Impacts Affected Period Astellas’ Resilience
Transition Risks (risk materializing at 1.5 °C increase)
Policy and Legal
Increased pricing of GHG emissions (costs if paying a carbon tax) Business sites that have not introduced renewable energies may have to add payment of a carbon tax to their costs. 1.1 billion yen in FY2030 assuming a carbon tax of $100 per ton Medium to long-term

Some of the electricity consumed at the business site is generated internally by using renewable energy sources such as wind power and solar power. Switch to purchasing energy derived from renewable sources at business sites is being promoted. The purchase of carbon credits to reduce Scope 1 emissions and measures to control costs associated with the purchase will be issues for consideration.

Purchased goods and services (Scope 3 Category 1) may be subject to carbon tax, which increases the burden when added to the procurement price. 10 billion yen in FY2030 assuming a carbon tax of $100 per ton Medium to long-term

Scope 3
Category 1: We will work on optimizing the use of raw materials. By formulating a supply chain sustainability roadmap, CO2 emission data of purchased products will be analyzed and emission reduction will be prioritized.

Obsolescence and impairment loss on existing facilities accompanying GHG emission regulations Possibility of being asked to discard facilities due to strengthening of environmental regulations. Refrigeration equipment using freon gas. Vehicles that use fossil fuel may no longer be available in some countries after 2035. No significant impact Medium to long-term There are no existing facilities or assets that we are required to dispose of at this moment. Regarding freon gas, we will take appropriate measures that comply with laws and regulations. From 2030 onwards, we need to respond to a required change in automotive vehicles (shift from internal combustion engines to electric motors / EVs and fuel cells). Shift to EVs for sales fleets and trucks and modal shift of transportation will have an impact on business operations.
Technology
Costs to transition to lower emissions technology Costs arise when investing in low emission equipment. 1.2 billion yen based on past climate-change investment plan Near to long-term Select and invest in efficient projects to reduce the carbon tax burden. Explore non-investment alternatives, such as power purchase agreement, for significant projects like solar panel electricity generation.
Market
Increased cost of energy and raw materials Rising energy and raw material prices lead to higher costs exacerbated by inflation. An increase of 10 yen per 1 kWh unit of electricity will increase the cost burden by 2 billion yen. Near to long-term

Increase of electricity and energy costs consumed at business sites due to regulatory changes would be an issue in the future.

 

However, we do not envisage a significant increase in the cost of raw materials for drug production due to climate change. We will reduce the impact of rising fossil fuel prices by using renewable energy-derived power.

Physical Risks (risk materializing at 4 ℃ increase)
Acute
Increased severity of extreme weather events such as floods Operations halt at our business sites due to floods or other factors.Raw material and product supply is delayed due to damage in the supply chain caused by floods or other factors.

500 million yen

 

Referred to the flood countermeasures of the Toyama Technical Center.

Near to long-term

The planned investment for the Toyama Technology Center's flood response was estimated to be 500 million yen and comprises the following

 

- Install a 3m waterproof wall around the power receiving building

 

- Construction of substation equipment with a structure of 3m or more

 

- Purchase of generators If similar measures are required, a similar amount of investment will be considered.

Chronic

Changes in precipitation patterns

 

Rising mean temperatures

Droughts will affect the operations of our plants and supply chain, resulting in delays in product shipments.

 

Rising average temperatures will have an impact on energy costs accompanying operation of air conditioners at business sites.

No significant impact Near to long-term According to IPCC AR6 SPM SSP3-7.0 scenario, global sea level change in 2050 relative to 1900 is less than 0.5m. This level of change has no significant business impact. Changes in precipitation patterns do not have a material impact on Astellas’ operations.
Climate-related opportunities Potential Financial Impacts Affected Period Astellas’ response
Resource efficiency

Use of more efficient production and distribution processes

 

Use of recycling

Reduced operating costs Near to long-term In order to maintain a stable supply of pharmaceuticals even during pandemic of infectious disease or natural disasters such as earthquakes, storms, and flooding, three logistics centers are operated in Japan. In European countries and the United States, warehouses shared by multiple pharmaceutical manufacturers are being used to streamline the distribution process. We collect exhaust heat from air conditioning units at Japanese manufacturing plants and research sites and use it to pre-heat the air supply to improve heat efficiency.
Energy source Use of lower-emission sources of energy Reduced exposure to GHG emissions and therefore less sensitivity to changes in cost of carbon Near to long-term Shifted boiler fuel from liquid fuel to gaseous fuels. We are moving ahead on introducing hybrid and electric vehicles in our sales fleet. We are working on using wind power generation and biomass boiler system at Kerry Plant in Ireland.
Products and markets

Development and/or expansion of low emission goods new products and services

 

Access to new markets

Increased revenues through access to new and emerging markets Near to long-term For the spread of infectious disease in endemic areas due to temperature change and the need for new drugs for infectious disease treatment assumed by the problem of antimicrobial resistance, collaboration with the phage biologics researches course at a university to create engineered bacteriophages, could be viable solution. Climate change can change the geography of the morbidity associated with and severity of epidemics. Heart disease, respiratory disease, etc. may also increase.

1.5℃ scenario: Refer to IPCC 6th Assessment Report (AR6) Summary for Policymakers, “Global Warming of 1.5℃” (IPCC special report), “Net Zero by 2050” (IEA). To achieve significant reduction of greenhouse gas emissions, implementation of several measures such as carbon prices and the spread of EVs are assumed.

4 ℃ Scenario: Refer to SSP3-7.0 of IPCC 6th Assessment Report, Working Group I, Summary for Policymakers (SPM), released in August 2021. As extreme weather, we assumed an increase in the frequency of high temperatures, heavy rains, and droughts.

The climate change physical risk geographical analysis

IPCC reports [1] have pointed out that extreme weather events due to climate change are on the rise. However, there is a high degree of uncertainty as to how the transition to a decarbonized society will proceed, and it is difficult to predict the impact this will have on Astellas' business in the future. We conducted a scenario analysis on the impact of physical risks (flood, wind, wildfire, heat) on the value chain, including our own business locations, manufacturing contractor locations and logistics center locations.

 

The Company's offices, manufacturing facilities, and research centers, as well as value chain locations, were appraised. Most sites included in scope are in East Asia, North America and Europe. The definitions of short-term, medium-term and long-term are the same as those in the risk opportunity analysis, with the long-term corresponding to Astellas' Net Zero target year (2050). The climate scenarios referenced were three: a scenario in which the global average temperature rise since the Industrial Revolution is limited to below 2°C (SSP1-RCP2.6), a scenario in which it increases by 2-3°C (SSP2-RCP4.5), and a scenario in which it exceeds 4°C (SSP5-RCP8.5).

Results of the risk matrix analysis

In the risk matrix analysis, the Astellas facility with the highest risk was the Shenyang Plant. In the 4°C scenario, increased risks of flood, heat, and precipitation in 2050 were detected as potential issues. 

 

Note: The impact of the physical risks were analyzed based on where each site locates at a 90-meter grid resolution and thus currently-installed risk mitigations were not taken into considerations; therefore, actual impact could be different from the estimated loss herein.

Current risk vs change of risk in present day vs future (2050) under a >4°C scenario

The Risk Score is a normalized estimate of the average risk posed by each hazard. It is calculated using the one to three hazard metrics depending on the hazard under a 4°C scenario. For example, precipitation risk refers to 1-day maximum precipitation in a 1 in 100-year event, and wildfire risk refers to the annual wildfire probability.

Key hazards that have the potential to impact to Astellas

Precipitation
An increase in instances of heavy downpours across all sites is included in this analysis. At the location of Yaizu Technology Center, heavy rainfall of a once-in-50-year level was estimated at 357 mm per day in the 2020 model and 398 mm in the 2050 model using the 4°C scenario.

Changes in maximum precipitation per day with the highest risk

Site Name Location Max precipitation in one day >4°C scenario (mm)
10-year return 50-year return
Modelled 2020 baseline 2050 % change Modelled 2020 baseline 2050 % change
Yaizu Technology Center Japan 252 279 10 357 398 12

Flood
The location of Toyama Technology Center is particularly concerning due to the potential for floods reaching up to 8.5 meters, which could occur once in a hundred years. Astellas should assess the flood risk measures at high-risk sites to consider they are reasonably prepared to address potential  flood risks by 2050.


Heat waves
Heat is not currently a major risk to Astellas, on a scale of 1-100, the average current risk is 29. However, it has been suggested that heat risk may become apparent in the 4°C scenario by 2050. At the location of Astellas Gene Therapies Sanford, it was estimated that in 2050, the number of days per year with maximum temperatures exceeding 35°C will be 41. Worker productivity can be significantly impacted by heatwaves if buildings are not sufficiently cooled.

Astellas sites for days above 35°C in 2050 under a >4°C scenario

Site Name Location Days above 35°C per year % Change from Baseline
Astellas Gene Therapies- Sanford USA 41 78

High winds
Strong winds can cause extensive damage to buildings if they are not designed to withstand these storms. However, Japan has stringent building regulations which ensure that structures are designed to withstand wind speed loads that are determined based on their location, height and intended use.

Sites with wind gusts over 200 km/h in 1 in 100-year events in 2050

Site Name Location Wind Gusts
Yaizu Technology Center Japan 232

Others
Cold has the highest current risk score, however the risk becomes much lower for all sites by 2050. Wildfire is of concern at one 3PL site and Hail/Thunderstorms do not pose a high risk to any locations.

Financial impacts

An assessment of the financial impact on Astellas was conducted for four hazards (flood, wind, wildfire and heat). For flood, wind and wildfire the results are in the form of Average Annual Loss, which is the aggregated, probability-weighted, impact across all the return periods. For heat the results are in the form of Productivity Losses which are based on the days that maximum temperatures exceed >35°C.


Estimated total financial loss from flood, wind, heat and wildfire is ¥3bn in 2050 under a >4°C scenario. Flooding accounts for almost two thirds of total direct loss (¥1.97bn) and 67% of this is from one site, Toyama Technology Center. The potential loss from flooding at Toyama accounts for 44% of direct total loss from all hazards combined. High wind speeds account for just over one third of the total direct loss (¥0.99bn). Loss from building damage accounts for 66% of the total losses. The sites associated with the highest financial impact are located in areas frequently hit by typhoons. Despite heat being one of the most significant climate hazards to Astellas under a >4°C in 2050, the financial impact from the risk is limited (compared to other hazards). This is due to the fact that all of Astellas’ sites have been fitted with adequate HVAC systems that are updated and maintained regularly.

Toyama Technology Center is expected to incur over ¥1.5 billion in losses primarily due to flooding in 2050 under a >4°C scenario. The bar charts below illustrate the top ten sites for total loss across Astellas-owned sites excluding Toyama, indicating that acute wind and flood events significantly impact Astellas-owned sites.

Top ten sites for potential loss (excluding Toyama Technology Center)

Risk Management

Processes for identifying and assessing climate-related risks

Risks within divisions, such as transition risk, physical risk, and reputational/legal risk related to climate change, are analyzed by Sustainability Committee, which is comprised of members from Commercial, Technology & Manufacturing, Research, HR, Procurement and Sustainability. Risks are regularly monitored once a year. Once risks have been identified, their impact and probability of occurrence are analyzed.

 

Risks that affect the entire company, such as emerging regulatory risks, are analyzed by the TCFD cross-functional team (“E (Environment) Working Group”), which is comprised of members from Finance, Technology & Manufacturing, Research, Procurement, Supply Chain Management, Corporate Strategy and Sustainability. The cross-functional team conducts climate-change scenario analyses by utilizing scenarios provided by institutions such as the IPCC. The physical risk geographical analysis described in the Strategy section was also performed by this team. The impacts of the transition to a low-carbon society, such as burden of carbon taxes are also analyzed.

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Finance

Technology & Manufacturing icon

Technology & Manufacturing

Research icon

Research

Procurement icon

Procurement

Supply Chain Management icon

Supply Chain Management

Sustainability icon

Sustainability

In addition to identifying risks based on organizational and scenario analysis as described above, identifying risks on a business operation and business partner basis makes it possible to pick up risks that would otherwise be overlooked in the analysis. We conduct EHS assessments as risk analysis for business operations, and Third Party Lifecycle Management (TPLM) as risk analysis for business partners. As an internal expert of EHS, Sustainability regularly conducts EHS assessments of manufacturing sites and research facilities. The EHS assessment evaluates the environment, health and safety in general, and if risks are found, a plan for corrective and preventive action (CAPA) is requested. EHS assessments are also conducted for major suppliers as well as internal department. TPLM is the risk mitigation framework covering all stages of the business partner relationship, which includes planning, due diligence, contracting, ongoing maintenance and transition. A global approach was established by Legal, Ethics & Compliance and Procurement to proactively address and mitigate supplier risk for multiple domains such as: EHS, which verifies that the practical aspects of environmental protection and safety have been implemented in the work environment.

Processes for managing climate-related risks

Integration into the overall risk management

Metrics and Targets

Metrics to assess climate-related risks and opportunities

We use GHG emissions (Scope 1, 2, 3), water resource productivity, waste generation amounts to measure the potential financial impact of climate-related risks and opportunities. GHG emissions are positioned as an important indicator because they are related to transition risks and failure to achieve GHG emission reduction targets will lead to increased carbon tax burdens and worsening reputational risks. On the other hand, reducing GHG emissions due to improvements in energy efficiency can be seen as an opportunity. Increasing water resource productivity is a countermeasure to increasing water stress due to climate change and is related to physical risks. Promoting waste management is also a measure against reputational risk.

Scope 1, 2, 3 emissions performance data

Targets to manage climate-related risks

EHS Management

Astellas' fundamental approach to the environment and the health and safety of its employees is detailed in the Astellas EHS Policy. Furthermore, Astellas is committed to organizational and ongoing efforts to uphold this approach, as outlined in the Astellas EHS Guidelines. Additionally, Astellas has established medium-term targets for its key priorities within its EHS Action Plan and is actively working to achieve those targets.

Astellas Environment, Health & Safety Policy

The Astellas EHS Policy reflects the company’s overarching position on EHS issues. This policy is applicable to all domestic and international group companies and serves as the foundation for all our corporate activities.

Schematic illustrates a strategy tied to Astellas’ VISION to be on the forefront of healthcare change to turn innovative science into VALUE for patients.

Rules of conduct governing environment and safety activities

Astellas EHS Guidelines

The Astellas EHS Guidelines set forth unified standards that identify Astellas' aspirations in its EHS activities.

 

The guidelines qualitatively describe our aims, and concrete numerical targets, including their deadlines, will be stipulated through short- and medium-term action plans that will be updated every fiscal year. We ask outsourced manufacturers to cooperate in implementing the guidelines through assessments and other actions

  1. Appoint the specific management representatives or statutory managers related to the EHS, security, disaster prevention, etc. and clarify their roles, authorities and responsibilities.
  2. Identify the specific laws/regulations and legal reform trends that apply to the Company related to the EHS, security, disaster prevention, etc. and clarify the clauses/standards applied and respond, with no omissions, to the legal requirements in surveys, measurements, notifications to authorities etc.
  3. Establish higher standards, targets and rules voluntarily, and maintain higher control level to fulfill company’s legal responsibilities. 
  4. Incorporate Astellas’ policy, guideline and action plan into the EHS activities at each business place consistently. 
  5. Establish procedures for creation/storage of records and legal notification concerning EHS, security and disaster prevention.

  1. Construct the EHS management system and promote its activities systematically and intentionally. 
  2. Identify the perspectives of environmental burdens and occupational health and safety risks and make the objectives/targets by appropriate evaluation methods. Moreover, mitigate these burdens and risks continuously. 
  3. Aim to receive the third-party certification of management systems with consideration for environmental burden due to our business activities, occupational health and safety risks, influences to regional society and social demands. 
  4. Communicate and inform employees of the information related to the EHS issues timely and appropriately. Collect and analyze the accidents inside/outside Company, near misses and KAIZEN suggestions from employees, and develop the preventive action. 
  5. Implement the internal audits periodically to assess the operating level of management systems and compliance level with related laws/regulations and Company rules/procedures and improve the management systems based on audits’ findings. 
  6. Establish systems to hand down the skills, knowledge and experiences from experts to others related to the EHS, security, disaster prevention, etc. 
  7. Establish systems to prevent accidents and trouble issues by providing risk/hazard notification to contractors related to consignment businesses inside the workplace.

  1. Establish procedures to assess the EHS risks related to accidents, disasters and malfunctions etc., and identify the perspectives of EHS risks and strive to mitigate risks. 
  2. Prioritize the identified risks at each site and implement to mitigate risks continuously. 
  3. Analyze the impact on the Company and the social influence due to accidents occurred at Company and/or other companies. Minimize risks from the business continuity and social responsibility points of views. 
  4. Establish systems that clarify the roles of employees regarding the identified accidents or disasters and confirm their effectiveness regularly. 
  5. Prepare systems for making contact and methods of response for both inside and outside the Company that clarify the roles of employees regarding accidents and emergencies and confirm their effectiveness regularly. 
  6. Strive to build and maintain good communication with regional societies and provide information properly about emergency responses and environmental risk.

  1. Establish manuals for the operation and maintenance of facilities.
  2. Establish manuals for safety inspection of facilities and conduct legal/ voluntary inspections periodically.
  3. Strive to mitigate safety risks resulting from structure/function of facilities, including clearing obstacles from work places and displaying information about prediction of risk in an easy-to-understand format.
  4. As necessary, develop work environments that consider people with disabilities, including the promotion of barrier-free facilities and the installation of alarms for hearing-impaired.
  5. Strive to maintain/control facilities which might cause physical injuries such as electrification, explosion, fall, entanglement in an operating machine, and vehicles such as forklift.
  6. Establish standard for safe driving and rules for walking on the premise. Indicate them in an easy-to-understand format and communicate to employees and visitors.
  7. Proactively substitute mercury-free products for mercury products that are used in various facilities and equipment and proceed with introducing the latest mercury-mitigated technology in the cases that mercury has to be unavoidably used.

  1. Address “Green Chemistry” proactively and facilitate the development of processes/products which take account of reduction in environmental burdens, effective use of resources, and occupational health and safety.
  2. In case of product design, development, process improvement, construction/introduction of facility, or licensing-in/licensing-out of products, implement the assessment based on the “EHS Assessment Guideline,” and appropriately reflect results in them.
  3. Examine the control method and operating condition of facilities in consideration of environmental burdens at the commercialization /production stage and occupational health and safety.

  1. Execute systematic education and training to raise consciousness of employees concerning EHS and to facilitate activities for environmental conservation and occupational health and safety.
  2. Execute education and training periodically on the assumption of emergency situations such as accidents, disasters and breakdown/malfunction of equipment.
  3. Execute systematic education and training to raise knowledge and skill of employees in charge of the business whose environmental impacts are large and dangerous/hazardous.
  4. Execute timely education and training for new or relocated employees including workers of business partners, part-time and temporary employees.
  5. Develop specialists, statutory representatives and statutory qualified people in EHS according to the appropriate plan.
  6. Define roles, authorities and responsibilities of managers concerning EHS clearly, moreover execute education and training to raise their skill and awareness.

  1. Identify that various types of biodiversity that we are fortunate to possess in our own businesses and workplaces and implement initiatives to continuously preserve them.
  2. Identify that various types of biodiversity that our own businesses and workplaces harm and implement initiatives to reduce any negative impacts.
  3. Establish a system for promoting the conservation of biodiversity and formulate the objectives and targets with a medium- to long-term perspective.
  4. As necessary, cooperate with stakeholders (including public bodies, NGOs/NPOs, and neighboring residents, etc.) to address the conservation and sustainable use of biodiversity based on the size and characteristics of each workplace.
  5. Endeavor to educate and illuminate employees who have been inspired that the conservation of biodiversity and the sustainable use of its components is important.

  1. Promote all-hands energy/resource conservation activities in all business activities.
  2. Astellas is committed to achieving its greenhouse gas (GHG) emission reduction targets generated by energy use, including by introducing equipment and processes that support the conservation of energy and resources, and by rigorous control of the air-conditioning temperature.
  3. Strive to achieve efficient logistics management and cooperate with logistics companies in systematically reducing GHG emissions.
  4. Strive to reduce the number and efficiently utilize the vehicles used in business, including sales activities, and promote the reduction of GHG emissions generated from vehicles.
  5. Ensure a variety of energy sources, including by promoting the use of direct/indirect renewable energy.
  6. Identify the chlorofluorocarbon (CFCs) gas leakage amount from sources such as freezer storage units, air-conditioning units, etc., and strive to systematically reduce the amounts.
  7. Give priority to those which take account of energy/resource conservation in case of installation of facilities, equipment, vehicles, raw materials, technologies etc.

  1. Strive to achieve zero emission of hazardous chemical substances and pharmaceutical products to the environment by properly identifying the volumes of these substances and products handled/produced, released into the air, water and soil, and transferred.
  2. Provide employees with a healthy work environment by measuring the working environment on a regular basis to prevent employees’ exposure to hazardous substances.
  3. Build a database and management system of information on chemical substances (Safety Data Sheets), including the safety of chemicals and of products developed in-house, and the physicochemical properties to disseminate to the employees. Also rigorously manage chemical substances, including the proper storage, use, and disposal of them.
  4. Establish a management system of chemical substances and conduct regular stocktaking and internal audits to ensure legal compliance and safety risk mitigation.
  5. Create procedures regarding the proper management, use, and disposal of hazardous substances that especially need to be controlled, including poisonous substances/drugs, CFCs, PCBs, narcotics, psychotropic drugs, radioactive substances, mercury, and bio-hazardous substances, and disseminate to employees.
  6. Regularly carry out special health checks on all employees who engage in operations treating substances designated as hazardous either by law or in the company’s own regulations and take necessary measures appropriately. Keep records of employee operating times and any abnormalities and store them appropriately.
  7. In case of transferring of chemical substances to other organizations, or outsourcing of transportation, storage, or disposal of chemical substances, provide information on environmental impacts, safety data, and contact telephone number and address for use in an emergency. Establish procedures against accidents and emergencies.

  1. Promote the 3Rs (Reduce volume of withdrawal; Reuse; Recycle), including water, raw materials, packaging materials, and other equipment.
  2. Aim the "zero" volume of landfill disposal due to appropriate waste management, such as waste sorting, recycling, minimizing the volume of raw material use, etc.
  3. Ensure appropriate selection of suitable waste treatment companies and contracts in case of outsourcing of waste treatment and build a relationship of trust by regular communication.
  4. Concerning outsourcing of waste transportation, provide information on environmental impacts, safety data, and contact telephone number and address for use in an emergency. Establish procedures against accidents and emergencies.

  1. Apply voluntary control items and values for air/water pollution substances (including bioassay tests) to minimize the environmental impacts.
  2. Concerning regulated air, water, and soil pollutants, ensure necessary actions such as measurements, record, consideration, and report.
  3. Strive to move the underground pipes to above-ground and maintain the condition of underground tanks to prevent leakages.
  4. Develop preventive actions in response to the emission of pollutants into the air, water, or soil environment even in the case of accidents and emergencies. Moreover, introduce backup systems against the events that might cause major environmental impacts.

  1. Identify the source of sensory nuisances and take appropriate countermeasures to aim at zero complaints from neighboring residents and employees.

  1. Appoint representative responsible for ensuring good communication between the Company and public bodies, industry groups, and neighboring residents, and establish a risk communication system to communicate with society.
  2. Build relationships of trust with the local community by regularly communicating on EHS initiatives in the workplace.
  3. Contribute to regional societies by proactively joining in local activities, including culture, sports, and other social contribution activities.
  4. Develop systems such as opening up a Company facility as an emergency refuge area in the event of a disaster in response to a request from the region.
  5. In case of construction of new buildings or the extension/renovation of existing buildings, consider environmental balance and keep harmonized appearance.

  1. Evaluate and identify risks related to the EHS issues in the supply chain (raw materials procurement, production, logistics, and sales), and strive to maintain and improve corporate values by avoiding reputation and supply chain disruption risks.
  2. Identify the impact of accidents or disasters on business partners and the business, and raise the level of risk management while conducting mutual cooperation. Moreover, as necessary, take risk diversification measures.
  3. Conduct assessments, both regularly and from time to time, of risks related to EHS on business partners (written surveys, on-site audits, etc.), and give priority to transactions with low-risk business partners. As necessary, take risk countermeasures such as requiring improvements to be made by business partners for whom there is a concern about risk.
  4. In purchasing of raw materials, equipment, and fixtures, consider their function and environmental impact comprehensively, and prioritize products whose environmental burden are lower.

Promotion of Environmental Sustainability Risk Management and Governance

Fundamental policies and action plans relating to the environment are important issue in sustainability in which Astellas is engaged. Responses to various environmental issues and the formulation of action plans are discussed by the Sustainability Committee. Committee members include employees that are heads of functional units* across departments. The details of committee discussions are reported to the Chief Strategy Officer (CStO), who oversees matters concerning sustainability. Climate change initiatives and more transparent disclosure are a regular agenda item for the Board of Directors as a strategic target, and the Committee reports to the Board of Directors on disclosures in line with TCFD recommendations, including assessments of climate change risks and opportunities, as one aspect of its sustainability activities.

 

The system works by having the management of risks related to the environment monitored in terms of sustainability by functional units and reports periodically made to the CStO, who issues instructions as necessary. The Executive Committee,† chaired by the President and Chief Executive Officer, or the Board of Directors discuss and determine how identified risks are to be addressed in accordance with the importance of the issue in question.

 

In response to matters concerning its environmental management systems, Astellas has acquired ISO 14001 certification covering all its commercial production sites in Japan and outside Japan as well as ISO 45001 certification for occupational health and safety at its European production sites.

*Organizational units that are constituted to execute business and that directly report to top management.

  • The organization discusses material matters concerning business strategies, product strategies, corporate management, and personnel of the Company and Astellas Group companies
Promotion of Environmental Sustainability Risk Management and Governance

EHS Assessments

Astellas conducts a companywide EHS assessment every fiscal year, in line with the Astellas EHS Guidelines, in order to evaluate the progress of EHS activities throughout the Astellas Group. In fiscal 2024, EHS assessments were conducted at 12 facilities of production and research sites. The status of actions taken to resolve the issues identified in the assessments are confirmed through follow-up assessments in writing and the assessment in the following fiscal year. Societal demands and problem awareness at each site are shared through an exchange of opinions between the EHS Management Department and each site. In this manner, one objective of assessments is to ensure that Astellas’ aspirations are aligned in the same direction. In addition, Astellas conducts assessments of Contracted Manufacturing Organizations (CMOs) in the value chain based on the same guidelines. In fiscal 2024, Astellas conducted on-site assessments of three suppliers, and carried out risk assessments related to such matters as the operational status of wastewater treatment plants and waste storage facilities, employees' working environments and initiatives to prevent employees from being exposed to chemical substances. In cases where items were pointed out, Astellas indicated an improvement proposal, requested a plan for corrective measures to be drawn up, and is currently following up on progress of the improvements based on the corrective measures plan. Astellas continues risk management in the value chain through assessments to maintain an environment that ensures the stable supply of pharmaceuticals.

Product Assessment System

The total environmental load resulting from the production, sale, distribution and disposal of products is determined almost entirely at the research and development stages. With regard to the production and sales of pharmaceutical products, it is necessary to obtain government approval for each product. Since government approval also covers production methods and packaging specifications, when there are changes in either approved production methods or packaging, new approval must be obtained even if the changes are related to work safety or reducing the environmental impact. Therefore, these changes are very time-consuming and costly. Astellas has introduced a product assessment system as a tool that requires efforts to minimize the environmental load at every stage, particularly research and development, production, distribution, and disposal.

Under this assessment system, we examine issues such as the reduction of air pollutant emissions and the excessive use of packaging, safety measures at production sites, the prevention of exposure of employees to hazardous substances prior to the commencement of mass production, including development based on green chemistry, and response to law and regulation requirements.

 

When conducting product assessments, an assessment team conducts EHS assessments in stages for the development of products. The results determine whether the development of the product can move on to the next stage.


Specifically, the assessment must identify raw materials or processes that might have a negative impact on the environment and/or employee health and safety. The progress on remedial measures must be assessed, and action plans evaluated. Countermeasures being considered are evaluated in the subsequent stages of the assessment.

Promotion of Environmental Sustainability Risk Management and Governance

Education and Training

In order to promote further improvements in its EHS activities, the Company acknowledges the critical need to ensure that all employees have a correct understanding of their own roles and responsibilities.


To this end, we are working to develop employees professionally qualified in EHS matters and improve our skill base through a wide variety of training programs, including specialized education for employees engaged in roles requiring specialist knowledge and skills in areas such as environmental conservation or hazardous operations.


We also explain our policies and site rules to construction workers at our business sites, raw materials suppliers and waste transport and disposal contractors, and request cooperation with our EHS activities.

ISO Certification Status of Astellas Production Sites

Company name Commercial manufacturing sites Obtained ISO certification (Month-Year)
Astellas Pharma Inc. Takahagi Technology Center ISO14001 (July 1998)
Yaizu Technology Center ISO14001 (October 2000)
Toyama Technology Center ISO14001 (March 2000)
Takaoka Plant ISO14001 (November 2000)
Astellas Ireland Co., Ltd. Dublin Plant

ISO14001 (March 1997)

ISO45001 (September 2020)

Kerry Plant

ISO14001 (December 2003)

ISO45001 (December 2018)

ISO46001 (September 2024)

ISO50001 (April 2012)

Astellas Pharma China, Inc. Shenyang Plant

ISO14001 (October 2001)

ISO45001 (April 2025)