Pharmaceutical companies around the world are facing increased scrutiny of their data reliability in clinical trials and transparency for the relation between corporate activities and medical institutions. In addition to complying with laws and ordinances, Shionogi aims to maintain the trust of society by observing the industry’s self-imposed norms. As an additional measure, we have formulated original guidelines based on even higher ethical standards. Shionogi has formulated “Transparency Guidelines for the Relationship between Corporate Activities and Medical Institutions,” “Transparency Guidelines for the Relationship between Corporate Activities and Patient Associations,” and “The Shionogi Code of Practice,” in order to maintain high ethical standards and transparency. This includes the appropriate disclosure of funding provided to medical professionals and medical institutions.

Shionogi established the Shionogi Group Anti-Corruption/Anti-Bribery Policy on April 1, 2014. In the same year, to enhance the effectiveness of the Policy, it conducted a questionnaire survey and interviews on all of its organizations and group companies to identify the risks of anti-corruption and anti-bribery problems. Reflecting the results of the surveys, the Guidelines for the Prevention of Corruption/Bribery for Shionogi Business Partners were formulated, which have been being applied to date.

Also, we periodically provide education mainly on the Unfair Competition Prevention Act (Article 18), the US Foreign Corrupt Practices Act (FCPA) and the UK Anti-Bribery Act for all employees (including part-timers and contract employees). Departments that have many opportunities to come in contact with healthcare providers, who are quasi-government employees, are considered as high-risk organizations, and we conduct education for such departments concerning the Shionogi Prescription Drug Promotion Code and the like on a regular basis.

In the drug discovery research, Shionogi has a policy entitled “Ethical Considerations in Animal Experiments,” which sets out to ensure that proper consideration is given to animal welfare by scientifically verifying that animal-use protocols are in accordance with the internationally recognized “principles of the 3Rs.” To further enhance the quality of animal experimenters, Shionogi also conducts regular education and training sessions for the employees involved, on appropriate methods for animal experimentation as well as for the breeding and upkeep of experimental animals. 

In addition, in order to ensure the proper conduct of animal experiments, we have continuously acquired accreditation by AAALAC International, an international third-party assessment organization that promotes the humane care and use of laboratory animals.

When it comes to clinical development, SHIONOGI makes it the top priority to ensure the safety of participants in clinical trials while also striving to ensure transparency through appropriate disclosure in accordance with our Clinical Trial Data Transparency Policy. In addition, SHIONOGI assumes ultimate management responsibility for ethical conduct in clinical trials, complying with ICH guidelines and the laws and regulations of each country where trials are conducted, and conducting clinical trials scientifically and medically under ethical consideration. These standards apply to all trials sponsored by SHIONOGI, including trials conducted overseas and those involving external contractors (such as CROs). Even when external contractors are involved, SHIONOGI conducts regular monitoring under its own responsibility to verify quality and regulatory compliance. Furthermore, prior to the initiation of clinical trials, SHIONOGI conducts risk/impact assessments taking into account the potential impact on participants, the purpose of the trial, scientific validity, the balance of anticipated risks and benefits, ethical considerations, and the relevant laws and regulations in the countries and regions where trials are conducted.

For employees involved in clinical trials, SHIONOGI provides ongoing role-based education and training to ensure thorough ethical consideration and compliance with relevant laws and regulations, thereby enhancing understanding and awareness regarding participant protection, data integrity, and transparency. Furthermore, SHIONOGI appropriately manages and oversees ongoing clinical trials with due consideration for participant safety and trial quality, and takes necessary actions when issues arise to ensure ethical integrity and reliability. In addition, SHIONOGI has established the Research Ethics Committee and the Clinical Trial Ethics Committee, which are composed of external experts and representatives from the general public, to ensure that each phase of new drug R&D is conducted scientifically and medically under ethical consideration.

When patients with serious or life-threatening conditions for which no treatment options are available have limited access to investigational drugs due to inability to participate in clinical trials or other reasons, SHIONOGI is committed to providing unapproved drugs through managed access programs from the perspective of caring for patients without impeding pharmaceutical development. In providing unapproved drugs, SHIONOGI gives priority in principle to the use of drugs for clinical trial purposes, taking into account patient safety, the balance of potential risks and benefits of treatment, and compliance with regulatory requirements. Specific conditions of provision and operational details are handled appropriately in accordance with the SHIONOGI Group Policy on Provision of Unapproved Drugs.

Shionogi has established rules for the operation and management of public research expenses and the prevention of research improprieties in accordance with the Guidelines for Management and Auditing of Public Research Expenses at Research Institutes and the Guidelines for Response to Improper Conducts in Research Activities established by the Ministry of Education, Culture, Sports, Science and Technology, the Ministry of Health, Labour and Welfare, and the Ministry of Economy, Trade and Industry.

Based on these regulations, the system is defined as follows.

The Chief Administrative Officer will lead our group's compliance policy and regulations to promote the prevention of research fraud.

Shionogi has established an internal reporting system comprising an internal reporting desk and an external reporting desk. We are making every effort to have this system known and used not just by employees but also by third parties, to promote the early discovery as well as prevention and amelioration of compliance violations.

To provide an avenue for consultation on compliance issues, Shionogi furthermore provides all directors and employees with emergency and helpline contact details including those for the reporting desks.