Ethical considerations for human drug research
The company conducts research on humans, obtains human derived test materials and information, and carries out research using those materials with the consent of participants through appropriate responses in accordance with the Declaration of Helsinki* and the relevant laws, regulations, and guidelines of each country.
Researchers also undergo ethical education and training related to bioethics, genome research, and clinical research, and the Company strives to respect the human rights and protect the personal information of the people who cooperate in this research.
Also, in line with the Ethical Guidelines for Medical and Biological Research Involving Human Subjects, the Company has created a Research Ethics Investigation Committee, which includes outside experts, to impartially and fairly inspect the ethicality and scientific validity of research plans.
* The Declaration of Helsinki is a set of ethical principles regarding human experimentation that governs doctors and other professionals involved in medical research
Ethical considerations for the use of animals in experiments
Animal experiments are essential in the research and development of drug to promote human health.
The Company has an internal committee that inspects all experiments from the perspective of the 3R principals-refinement (reduction of animal distress), replacement (substitution of animal experiments with alternatives), and reduction (decrease in the number of laboratory animals used)- based on the Act on Welfare and Management of Animals (animal welfare legislation) and the “Basic Policies for the Conduct of Animal Experimentation in the Institutions under the Ministry of Health, Labor and Welfare” to ensure that animal experiments are carried out appropriately from a scientific perspective that considers the animals’ welfare.
Regular independent inspections are also done to confirm that the conditions related to the raising of laboratory animals and animal experiments are in regulatory compliance.
Surveys are conducted and certification is obtained from the Japan Pharmaceutical information Center’s Center for Accreditation of Animal Experimentation Institutions, a third-party organization based on guidance from the Ministry of Health, Labor and Welfare.
Biotechnology and countermeasures against biohazards
KYORIN Pharmaceutical Co., Ltd. has established rules based on the "Cartagena Law" in order to properly carry out genetic recombination experiments, and an in-house committee reviews the contents of each experiment.
In addition, in order to properly handle pathogens, we have established rules that comply with the "National Institute of Infectious Diseases Pathogen Safety Management Regulations", and an internal committee examines the handling of each pathogen.
The committee regularly educates workers involved in these studies in an effort to prevent experimental accidents and legal violations.
Use of genetic resources
KYORIN Pharmaceutical Co., Ltd. complies with the purpose of the Convention on Biological Diversity, the opportunity to acquire genetic resources under the Nagoya Protocol, and the rules for fair and equitable distribution of benefits arising from its use.
Since the environmental, biodiversity, and human impacts of the use of new recombinant organisms have not been clarified, we comply with the Cartagena Protocol and regulations to conserve biodiversity, give consideration to ethics and handle it carefully.
Respect for subjects’ human rights, security of personal information, and maintenance of trust during clinical trials
The Company carries out clinical trials in line with the Declaration of Helsinki and relevant laws and regulations governing clinical trials of pharmaceuticals, including good clinical practice (GCP), with full consideration given to protecting the human rights and personal information of trial subjects, to confirm that candidate substances for new drugs are effective and safe.
Clinical trial plans are approved after inspection for ethicality and scientific validity by internal and external committees.
Moreover, clinical trials are carried out after the subjects are fully informed about items including the objectives of clinical trials and their methods, anticipated merits and demerits, and compensation in the event of damage to their health.
Confirmation that subjects understand the details and have given their consent to participate is required. In addition, employees involved in clinical trials receive education and training, and clinical trial institutions are monitored to ensure that the clinical trials are appropriately carried out in compliance with GCP.
The Company also strives to manage clinical trial data properly to ensure that the subjects’ privacy is protected. In addition, it regularly confirms that clinical trials done externally are carried out in conformity with the same standards.
Disclosure of information related to clinical trials and trial results
We are working to improve transparency by disclosing clinical trial plans and results.
Plans for clinical trials led by Kyorin are posted on a clinical trial database available to the general public. Going forward, we will create an environment that allows appropriate access to clinical trial data by researchers and others who might use that data, discloses information to maximize the value of clinical trial data, and plays roles in advancing science and promoting innovation.
We are currently considering methods for information disclosure.
Policies for the disclosure of clinical trial data will be released as they are finalized.
Increased access to investigational new drugs
Some patients with serious or life-threatening diseases have tried all the treatments currently available to no effect but are unable to receive treatment with investigational new drugs because they are ineligible to participate in clinical trials.
Taking into account patients who wish to receive investigational new drugs but are unable, for various reasons, to do so, from a humanitarian perspective we have formulated a “rule on the request for an extended clinical trial” that lays out the procedure for providing investigational new drugs to patients when requested by a medical institution for reasons other than clinical trials or by a regulatory authority.
Handling of intellectual property
Appropriate protection of intellectual property is important for maintaining competitiveness while meeting unmet medical needs, and we have formulated internal guidelines for handling intellectual property.
In research and development, we are working proactively to protect intellectual property and concentrating our investment in acquiring intellectual property rights to create an intellectual property portfolio that contributes to business continuity.
We are also emphasizing IP (intellectual property) landscape activities based on an analysis of patent information to share intellectual property information with research divisions and help build a research and development pipeline for the future.