Human tissue research
Our mission is to create effective medicines that help people around the world live healthier and more fulfilling lives, and we use cutting-edge science and technology to accomplish this. We have established an R&D system designed to drive daily progress on our goal of providing society with much-anticipated medicines as quickly as possible.
Science and technology related to the life sciences have made remarkable progress in recent years. By using the decoded human genome and advanced technology exemplified by the production of induced pluripotent stem cells (iPS cells), scientists have made it possible to reveal the causes of disease and the mechanisms of action of medicines which have been unknown. This technological progress is also leading to profound changes in the process of R&D.
The use of specimens taken from humans, such as blood, tissue, cells, human genetic material, and iPS cells (collectively called "human tissues" below) has also made it possible to elucidate the phenomena in human body which are undiscoverable in animals. The conventional approach was to use animal models to predict a drug's efficacy and side effects, followed by assessment in clinical trials. Recently, by using human tissues in addition to animal models, researchers are able to develop more effective medicines with a clear mechanism of action and fewer side effects.
Research using human tissues is therefore becoming essential to the creation of useful medicines. On the other hand, it requires special ethical considerations. For this reason, we established the Rules for the Research Ethics Committee on Uses of Human Tissues on October 20, 2005 (revised on August 9, 2007) and set up a Research Ethics Committee for Uses of Human Tissues in the Drug Research Division. The rules require ethical considerations including paying due consideration to human dignity, giving sufficient explanation in advance to the providers of human tissues and obtaining their voluntary agreement (i.e., informed consent), rigorously protecting personal information, and fairly reviewing the research plan (e.g., the significance and necessity of using human tissues and the potential degree of social contribution of the research).
We have articulated a clear standard for ethics review, and have been reviewing research plans in accordance with this rule, in advance of each research project using human tissues. We have also posted the Rules for the Research Ethics Committee on Uses of Human Tissues and the membership of the committee on our website.
Ethical considerations in animal experimentation
In order to verify safety and efficacy in the process of creating new drugs, it is imperative that animal testing be conducted in compliance with all laws. At Sumitomo Dainippon Pharma, we believe that the animal testing process must be based on scientific rationale, and we make every effort to ensure that all testing is carried out with consideration of animal welfare and respect for animal life.
In animal experimentation, Sumitomo Dainippon Pharma follows in-house procedures that conform to Japan's Act on Welfare and Management of Animals and the Basic Policies for the Conduct of Animal Experiments in Research Institutions under jurisdiction of the Ministry of Health, Labour and Welfare. Our Institutional Animal Care and Use Committee strictly reviews all experimental protocols, including outsourced tests, in terms of the "4Rs" (adding an additional "R" for the "responsibility" of those carrying out and commissioning the testing to the conventional "reduction" of the number of animals used, "replacement" with alternative testing methods, and "refinement" to relieve pain and distress). As part of our efforts to maintain and improve the ethical and scientific integrity of our animal experimentation, we also continually implement in-house inspection and assessment of the animal testing process.
Sumitomo Dainippon Pharma has earned the Center for Accreditation of Laboratory Animal Care and Use (CALAC)* accreditation as an animal testing facility in compliance with the basic policies of the Ministry of Health, Labour and Welfare. CALAC, an arm of the Japan Health Sciences Foundation, evaluates animal testing research institutions under the jurisdiction of the Ministry for appropriate conduct in line with the Ministry's basic policies.
* CALAC is an organization within the Japan Health Sciences Foundation that conducts third-party inspections and evaluations of animal experimentation and other work at animal testing research institutions under the jurisdiction of the Ministry of Health, Labour and Welfare. CALAC determines whether such facilities are conducting appropriate experiments based on a scientific perspective, while promoting voluntary ethics management of animal testing programs and considerations of animal welfare.
Ethics in Procurement
- 1Balanced and fair transactions with our business partners
- We will enter into and maintain transparent transactions, while striving to always create business opportunities with new business partners based on balanced, fair and free competition.
- We will enter into transactions by observing mutual benefit and establishing trustful relationships.
- 2Reasonable selection of suppliers
- In the selecting suppliers, we will base determinations on economic rationality, with comprehensive consideration of suppliers' management base stability, quality, price, supply stability, technical development, environmental stance, etc.
- We will not enter into a reciprocal transaction for the direct purpose of selling Sumitomo Dainippon Pharma's products and services.
- 3Mutual evolution
- Through sound transactions with business partners, we will strive for mutual evolution while deepening mutual understanding.
- 4Thorough compliance with laws and regulations and protection of confidentiality
- We will prevent the illegal acquisition or leaking of confidential and proprietary information of Sumitomo Dainippon Pharma and business partners, while complying with not only relevant law, rules and regulations but also the letters and spirits.
Safety and Health
Basic Safety and Health Policy
Sumitomo Dainippon Pharma will ensure that workplace environments are safe and comfortable for individual employees to work in so that all directors and employees can have peace of mind and concentrate on their work, allowing them to maximize their autonomy and creativity. In all of our business activities, we will pursue safety and health companywide and seek to ensure the safety of our employees and promote and maintain their health. We will also work to ensure the safety and health of the communities in which we operate and all outside parties in our workplaces.
- While continuing to strive to conduct business activities free from accidents and disasters, we will ensure the safety of our employees.
- In addition to abiding by laws, regulations and other requirements for occupational safety and health, we will make continuous efforts to improve our standards of safety and health management.
- Through education and activities that raise awareness about safety and health, we will seek to improve the safety and health awareness of all employees.
- We will work to help employees maintain physical and mental health and to create workplace environments where people can work with peace of mind.
Corporate Citizenship Activities
Sumitomo Dainippon Pharma's stance on philanthropic activities
In its Declaration of Conduct, Sumitomo Dainippon Pharma declares its intent to "7. Build harmonious relationships withsociety," and we engage in social contribution activities befitting a good corporate citizen.
Specifically, with our social activities centered on diseaseawareness and education support, environmental conservation, and donations and aid, we have identified the following pivotal categories as our basic thoughts on social contribution activities.
- Constant awareness by employees that Sumitomo DainipponPharma runs its business supported by the trust of society
- Understanding and respecting diverse values and cultures of regions and peoples
- Fulfilling responsibilities and contributing as a member of society conscious of building harmonious relationships with society.
We have further established systems that allow each employee to better take part in philanthropic activities.