Preventing Air and Water Pollution

As a pharmaceutical company handling various chemical substances, the Daiichi Sankyo Group considers proper management of chemical substances as an important initiative and issue.  To prevent air and water pollution, the group company plants outside of Japan, including Daiichi Sankyo Pharmaceutical (Shanghai), Daiichi Sankyo Europe (Germany), and Daiichi Sankyo Brasil Farmaceutica regularly monitor their emissions to ensure compliance with the laws and regulations of each country and region. In Japan, the Group has established voluntary control standards that are stricter than legal requirements and properly monitors the emissions at plants and research & development (R&D) centers in Group companies.

Preventing Soil and Groundwater Contamination and Countermeasures

The Group makes efforts to prevent soil and groundwater contamination at plants and research centers. In Japan, when an investigation is required based on the Soil Contamination Countermeasures Act and related prefectural ordinance, we conduct the appropriate investigation according to the laws and regulations on discussion with the governmental offices.
Furthermore, we also conduct investigations according to the laws and regulations even in the cases where mandatory regulations do not apply, such as the closing of offices and change of using purpose.
If contamination occurs, we report it to the related government offices and properly disclose information to members of the surrounding community, and take appropriate measures, such as prevention of diffusion and purification according to the extent of contamination. The offices that have already taken measures, such as purification, continue to monitor and report the result of analysis to governmental offices and community members.

Progress of Measures for Soil Purification

Office Overview
The site of former Yasugawa plant (Yasu City, Shiga)
We have been continuously monitoring the groundwater since we completed on-site environmental improvement work in 2006. As a result, contamination was found in part of the soil.
We are currently conducting a soil investigation in consultation with regulatory authorities to perform appropriate purification work. We also confirmed the presence of mercury used as a material for pesticides that exceeded environmental standards on the grounds of the former plant site in 1993.
Since then, we have installed a robust underground storage facility in adherence to regulatory guidance to manage the soil appropriately. Although there have been no reports of leakage or health issues to date, we decided to remove the storage facility in view of increasing safety and security in the region and in response to requests from the local community. We issued a press release announcing our decision in April 2020, and we are conducting removal work in consultation and coordination with all concerned parties.
During excavation, we take due care not to affect the surrounding environment through measures such as temporally setting up negative-pressure tents that cover the entire storage facility to prevent soil from scattering.

Prevention of Noise, Vibration, and Offensive Odors

We conduct appropriate measures and continuous monitoring to comply with the laws and regulations related to noise, vibration, and offensive odor.

Appropriate Management and Emission and Transfer Control of Chemical Substances

We manage chemical substances that may adversely affect human health or the ecosystem based on the PRTR*1 system provided in the Act on Confirmation, etc. of Release Amounts of Specific Chemical Substances in the Environment and Promotion of Improvements to the Management Thereof.
There was no transport, import, export, or treatment of waste that was deemed hazardous or any transport of waste that was shipped internationally as described in the terms of the Basel Convention Annex I, II, III, and VIII.

*1Pollutant Release Transfer Register

Emission/Transfer Chemical Substances in FY2022 (Group in Japan)

(Unit: metric ton; mg-TEQ for dioxins)

Substance
(Annual handling amount of 1 or more metric tons)
Handling Amount Emission
(except for emission into soil)
Transfer Amount
Air Public Water Sewage Out of Offices
Air
Acetonitrile 1165.1 0.7 0.0 0.0 1165.1 0.0
Toluene 776.5 0.4 0.0 0.0 776.0 0.0
Cyanamide 8.7 0.0 0.0 0.0 0.0 7.2
Triethylamine 121.8 0.4 0.0 0.0 121.5 0.0
N-Hexane 2.1 0.0 0.0 0.0 2.1 0.0
Total 2074.1 1.5 0.0 0.0 2064.7 7.2
Dioxins - 0.000 0.000 0.000 0.000 0.000

Storage and Usage of PCB Contaminants

Usage

Types of PCBs Quantity (units)
Capacitors 0
Fluorescent lamp ballasts, etc. 0

Storage

Types of PCBs Quantity (units)
Heavy PCB Light PCB Total
Capacitors 0 0 0
Fluorescent lamp ballasts, etc. 0 0 0
Mercury lamp ballasts 0 0 0
Other electric devices 0 0 0
Other polluted products 0 0 0

* All PCB devices, etc. were properly disposed of by FY2021.

Evaluation of the Environmental Impact of Pharmaceutical Products

The Daiichi Sankyo Group conducts the necessary environmental impact assessments for its pharmaceuticals based on the guidelines of relevant countries and implements measures as appropriate.
The Group realizes that one of the sustainability risks associated with its business activities is the possible negative impacts of pharmaceutical manufacturing and its by-products on the environment. There have been incidents in the past in which by-products of pharmaceutical manufacturing were detected in rivers and other natural environments. The Group aware that social concern is rising with regard to this issue as well as its potential environmental repercussions. The Group watches closely such social responses and the global trend toward promotion of initiatives for EPS*1 by the European Federation of Pharmaceutical Industries and Associations (EFPIA).
We believe that we need to continuously coordinate with governments, industry organizations, and research institutions to examine more appropriate risk evaluations and risk management.

*1Eco-Pharmaco-Stewardship: Voluntary initiatives to prevent environmental impacts throughout the lifecycle of pharmaceuticals and eco-friendly product management.

Environmental Impact Assessment of the Manufacturing Processes

As the changes in manufacturing processes for pharmaceutical products are regulated by pharmaceutical related laws and regulations, such changes require considerable time and effort. Accordingly, it is important to discuss and evaluate changes not only from the view of quality and cost, but also from a wide range of perspectives including impact on the environment.
When developing manufacturing processes for new products, the Daiichi Sankyo Group uses LIME (Life-cycle Impact assessment Method based on Endpoint modeling), a type of LCA (Life Cycle Assessment) to quantitatively evaluate the impact on the environment in each development stage (i.e., start of research, clinical, and commercial stages of manufacturing process development). We integrate toxic and hazardous substances used in manufacturing, energy consumption during manufacturing, and waste discharged during manufacturing into a single assessment target. This LCA assessment is conducted on new products. The coverage rate of products that have been fully or partially assessed since 2020 is approximately 2/3 of all new products. This approach is based on the concept of eco-friendly green chemistry. Through this approach, we aim to create manufacturing processes that are considerate of the sustainability of the natural environment by developing new synthetic processes, preventing pollution, and reducing resource and energy consumption.
For manufacturing processes that produce waste, we discuss and evaluate methods through which the waste can be collected and reused as well as methods of treating this waste that are highly safe and have a low environmental impact.
The result of this research leads to a great reduction of the environmental impact of the final manufacturing process (industrialized manufacturing method) compared with the impact when this research had just begun.

Environmental Supply Chain Management

Choice of raw material or components that have a lower environmental footprint
・To reduce the environmental impact of our synthetic APIs, we evaluate the environmental impact of manufacturing processes for each product at each development stage. At the beginning of product development, the assessment values of manufacturing processes are calculated to identify items with high values in toxicity and hazardousness, energy consumption, and emissions.
・Manufacturing processes are continuously improved and evaluated by re-calculating the impact values at each development stage through the EHS (Environment, Health, Safety) management program.
・To reduce the environmental impact in material procurement and manufacturing process development, we have started using a process analysis tool to quantify the CO2 emissions in manufacturing process for biopharmaceuticals.
・We are promoting a switch from petroleum-derived plastics to biomass plastics for packaging materials to reduce the environmental burden. We have already switched to biomass materials of plastic bottles for solid oral dosage and syringe trays.
Direct operation, production & manufacturing
・The Daiichi Sankyo Group promotes the optimization of the EMS in accordance with the Standard for the Daiichi Sankyo Group’s Environmental Management Systems. Production sites that use large amounts of energy for manufacturing in Daiichi Sankyo Group have acquired the international standard for the EMS (Environmental Management System), ISO14001 certification. Our ISO 14001 certification rate is now 89.2% (based on CO2 emissions).
・At all sites, including the production sites, we set annual environmental targets for energy, water, and waste and work to reduce them.
・For waste-related cases, we are working to reduce waste from expired inventory by standardizing raw materials through platforming of the manufacturing process for the development of biopharmaceuticals.
・In addition, when concluding a quality contract, we request suppliers to submit SDS to confirm information on chemical substances contained in raw materials (properties, hazards, toxicity, and handling, etc.).
Distribution, storage and transportation
・Regarding commercial distribution, we are promoting the following initiatives: (1) use of solar power generation systems at warehouses, (2) reduction of CO2 emissions during transportation through joint delivery, and (3) switch to recyclable pallets.
・For safe handling of products, we share SDS (Safety Data Sheets) with drivers and business partners who ship our products.
Use phase – operation and servicing/maintenance
・We are reducing trial progress delays and clinical trial materials expiries by sharing clinical trial materials across multiple protocols, thereby reducing the waste rate.
・In addition, we have reduced the amount of expired control drugs by optimizing the procurement of control drugs in clinical trials (procurement of smaller quantities, more frequently, and drugs with longer expiration dates).
End of life management
・Daiichi Sankyo Healthcare Co., Ltd. conducted a demonstration experiment of the “After use PTP Sheet Recycling Program” from October 2022 to September 2023 in collaboration with TerraCycle Japan and in cooperation with the City of Yokohama. In the demonstration experiment, collection sites were set up at 60 locations in pharmacies, drugstores, hospitals, and public facilities in Yokohama City. As a result, the amount collected sheets was equivalent to 1.08 million sheets (1,077 kg). This project aims to enhance awareness that used PTP sheets are recyclable resource and to build the system for resource recycling.

Initiatives for Biodiversity

The Group’s Basic Environmental Management Policy and the Mid-term Environmental Management Policy stipulate that business activities must consider biodiversity and ecosystem services. The Group has established the Basic Biodiversity Principles and Action Guidelines based on these policies. When this was established, the Group surveyed its initiatives on biodiversity, the use of natural resources, and status of efforts to comply with the Cartagena Protocol both inside and outside of Japan. Additionally, the Group assessed the relationship between its business activities and biodiversity and identified issues through an analysis of the Group’s risks and opportunities. (Please refer to the diagram “Map of corporate activities and biodiversity” below.)
The Daiichi Sankyo Group believes that biodiversity conservation and sustainable use of ecosystem services are essential in performing business. We promote raising awareness and understanding of employees, as well as the strengthening of environmental conservation activities in collaboration with business partners and private groups, to procure materials with less environmental burden, and to socially contribute towards biodiversity conservation.

Basic Biodiversity Principles and Action Guidelines

Basic Policy

  • Our Basic Environmental Management Policy states that, “Safeguarding the environment is the bedrock of all Group operational management.” We have therefore acted to prevent pollution and global warming and contribute to recycling. Through our initiatives, we have used biological resources properly to minimize the impacts of our operations on biodiversity and have sustainably reduced chemical and other discharges.
  • We will continue striving to preserve biodiversity and respect the principles of the Convention on Biological Diversity by adhering to the following
    Biodiversity Action Guidelines, thereby enhancing social sustainability.

Action Guidance

1.
Actively promote to address biodiversity conservation in all business activity
  • Under take ongoing endeavors to avoid or reduce operational impacts on biodiversity, devoting particular attention to lowering the environmental impacts of air and water emissions and wastes.
2.
Identify the biodiversity impacts of ecosystem services, using those services sustainably
  • Recognize the operational importance of ecosystem services while understanding and minimizing their impacts on biodiversity, using those services sustainably.
3.
Use genetically modified organisms responsibly
  • Maintain biosafety by continuing to responsibly use genetically modified organisms in drug discovery and production in keeping with the Cartagena Protocol on Biosafety and national laws and ordinances.
4.
Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization
  • Comply with the Convention on Biological Diversity, the Bonn Guidelines, and other relevant rules to access and utilize genetic resources of the provider countries appropriately and to share benefits arising from their utilization in a fair and equitable manner.
5.
Communicate with stakeholders and improve in-house awareness
  • Foster biodiversity preservation by communicating and liaising better with public and private entities.
  • Educate employees to better understand how operations affect biodiversity and encourage internal and external efforts to safeguard biodiversity.

Map of Corporate Activities and Biodiversity

An enlargeable image opens in a separate window

TNFD disclosure

The Daiichi Sankyo Group believes that biodiversity conservation and sustainable use of ecosystem services are essential in performing business. We promote biodiversity initiatives to achieve the 2030 Nature Positive*1. In May 2024, we registered as a TNFD *2 Adopter *3, which indicates our support for the TNFD recommendations and our commitment to TNFD disclosure. Currently, we are conducting brief evaluation of nature-related risks in our supply chain for our main products, and identifying key issues and conducting a locality analysis. Based on the results, we are aiming for initial disclosure in line with TNFD recommendations by the end of FY2024.

*1Nature Positive:to halt and reverse biodiversity loss to put nature on a path to recovery for the benefit of people and planet

*2Taskforce on Nature-related Financial Disclosures :Task Force established in June 2021 to provide a framework for the management and disclosure of nature-related risks. Final recommendations (v1.0) of the TNFD published in September 2023 to provide a framework for companies and financial institutions to identify, assess, manage and disclose nature-related issues

*3TNFD Adopter:organisations that have committed to start making disclosures aligned with the TNFD Recommendations in their corporate reporting in respect of their financial years 2023, 2024 or 2025.

Ecological Footprint

We assess the ecological footprint (EF), an indicator of biodiversity, jointly with experts from the NGO Global Footprint Network, to examine all environmental burdens in the business activities of Group companies in Japan. The assessed EF is used as a comprehensive indicator of environmental burdens, including those related to biodiversity, by reviewing and monitoring long-term changes in the relationship between the reduction of environmental burdens and biodiversity conservation (trade-off) in the Group.
This initiative has been recognized as an action for achieving the Aichi Target (20 targets) that was adopted at COP10 (the 10th Meeting of the Conference of the Parties to the Convention on Biological Diversity in Nagoya) and has been registered on the Nijyu-Maru Project as well. In addition, it was introduced as an example of monitoring biodiversity in the Guidelines for Private Sector Engagement in Biodiversity (Second Edition) issued by the Ministry of the Environment of Japan.

Initiatives for Biodiversity Conservation

Conservation for rare species of plants

To preserve the golden orchid (designated as critically endangered Type II in the Japanese Ministry of the Environment’s Red Data Book) and the silver orchid, we have prohibited entry into the forested area of the property at the Tatebayashi Biopharmaceuticals Center where the plant naturally grows (approximately 1,000 m2). The continued conservation effort has been resulted in an increase in the population of the species and expansion of breeding range.

Golden orchid

Silver orchid

Greening in harmony with the surrounding environment

The Kitamoto Office of Daiichi Sankyo Biotech Co., Ltd. engages in environmental conservation that considers the surrounding natural environment and ecosystem and implements sound insulation and greening in harmony with the neighboring Kitamoto Nature Observation Park.
Recognized for its various diversity-friendly initiatives, the office was given the 7th Sainokuni Green Plan Award in 2015. The award is granted by Saitama Prefecture to facilities that have achieved excellent greening and sound maintenance.
The office continues to engage in environmental conservation through greening and other ecosystem protection measures.

Implementation of WET testing

With the purpose of assessing the impact of water discharged from operation sites, in FY2023, we continued to conduct WET testing*1at all plants and research facilities in Japan (seven operation sites). As a result, we confirmed that the discharged water has no serious impact on aquatic organisms in rivers, etc. In FY2024, we plan to conduct WET testing once at our plants and research facilities in Japan as we do every year to promote appropriate wastewater management and improve the quality of discharged water.

*1Whole Effluent Toxicity Test. A testing method that utilizes the biological responses of fish, daphnia, and seaweed to determine the total toxicity of discharged water

Extracting water for the WET test

Activities to nurture biodiversity

In recent years, the population of pollinators such as honey bees and butterflies has been on a decreasing trend around the world due to the effects of deforestation, agricultural chemicals, global warming, and other issues. At our Pfaffenhofen Plant in Germany, we cooperate with Pfaffenhofen in Bloom -an initiative started by the city of Pfaffenhofen aimed to increase the pollinator population- and we are actively working on encouragement of biodiversity on the plant premises. We are planting many flowers in the approximately 3,200 m2 area as an environment where honeybees and other insects can inhabit. In addition, in April of 2022, Daiichi Sankyo Europe (Munich, Germany), one of our overseas group companies, started planting one tree per every new IT device, and approximately200 trees had already been planted. To promote this initiative, the company has secured enough land in Germany to plant approximately 3,000 trees, thereby working on achieving the Sustainability IT.

Planting in the premises

Afforestation through sustainable IT

Participation in 30by30 Alliance for Biodiversity

The Daiichi Sankyo group participates in 30by30 Alliance for Biodiversity launched in April 2022 by the Ministry of the Environment of Japan. 30by30 is a goal that aims to conserve or protect at least 30% of land and sea by 2030, thereby contributing to the conservation of biodiversity. We will promote initiatives to contribute to 30by30, including the implementation of e-learning programs to raise employee awareness and understanding of biodiversity and the setting of targets for biodiversity conservation.  

Participation in Keidanren Initiative for Biodiversity Conservation

The Daiichi Sankyo group has endorsed the Keidanren Declaration for Biodiversity and Guideline advocated by the Japan Business Federation and the Keidanren Committee on Nature Conservation, and have participated in the Keidanren Initiative for Biodiversity Conservation. We will promote initiatives to contribute to transitioning nature positive world, including the analysis and disclosure in line with TNFD recommendations and the setting of targets for biodiversity conservation, the initiatives to contribute to 30by30, the implementation of programs to raise employee awareness and understanding of biodiversity.