Although we are, on paper, a young company, we have already established a robust governance framework, with a broad range of supporting policies, standard operating procedures and guidelines, such as our Code of Business Conduct, driving a culture of integrity.
Idorsia is proud to be working in a highly regulated industry, with codes of conduct, guidelines and regulations designed to protect patients, healthcare professionals and the reputation of the industry. We are a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA). The EFPIA and Idorsia are fully committed to complying with the highest ethical standards under EFPIA and National Codes.
To ensure that our employees understand how important it is to work in a compliant, ethical and transparent manner, Idorsia has implemented a number of policies and guidelines covering the breadth of its business areas. Access to these documents is ensured for all employees via an electronic quality management system. Policies which are relevant to other stakeholders are available on this page.
Sound corporate governance and high standards of ethical behavior are essential to the company’s success, as well as in maintaining the trust and confidence of our stakeholders. Corporate governance at Idorsia is designed to promote the long-term interests of our shareholders, maintain internal checks and balances, strengthen management accountability and foster responsible decision‑making.
Our Legal & Compliance function seeks to drive a culture of integrity, with the following priorities:
- communicate clearly to employees
- focus on key compliance risk areas
- improve compliance behavior through training and support
- ensure that employees can raise concerns and that these are properly addressed
- ensure fair and objective investigations of potential policy breaches
An example of best practice in governance is our Code of Business Conduct, which underpins our commitment to integrity and sets out fundamental rules for interacting with others as we drive our business forward. Supporting policies, standard operating procedures and guidelines provide more detail on how our high-level commitments are to be applied in practice.
All Idorsia employees have undergone mandatory training to ensure compliance with the Code.
The Idorsia Code of Business Conduct is at the foundation of our corporate culture and defines the core principles and ethical standards by which we create value in our company. It is the responsibility of every Idorsia employee to be familiar with and to comply with our Code. We are proactive in establishing policies and practices that support strong corporate governance and transparency. These policies and practices are continually reviewed and enhanced as appropriate.
Employees of Idorsia and its worldwide affiliates are responsible for always demonstrating honesty, integrity and respect in their work activities, obeying applicable laws and regulations, and adhering to Idorsia policies and procedures. Idorsia is committed to a work environment that encourages honest discussion of issues and concerns about legal compliance, company policy, and business conduct. Employees who learn of, or suspect, a legal, ethical or policy violation must raise it with their supervisor, the Corporate Compliance Office, or through the Global Compliance Helpline. Idorsia does not permit sanctions against anyone who, in good faith, raises issues, concerns or allegations of compliance violations or unethical conduct. Idorsia will investigate all allegations of misconduct and, where appropriate, take disciplinary and corrective action, up to and including termination of employment.
Anti-Corruption & Anti-Bribery
Full compliance with applicable laws in all the regions where Idorsia operates is crucial to our success. Idorsia’s position is clearly stated in its Anti-Corruption and Anti-Bribery Policy: We take a zero-tolerance approach to bribery and corruption and are committed to acting professionally in all our business dealings and relationships wherever we operate.
We implement and enforce effective systems to counter bribery. We will uphold all laws relevant to countering bribery and corruption in all the jurisdictions in which we operate. All Idorsia employees are required to undergo training on this policy.
Labor & Human Rights
Idorsia respects the rights of its employees as set out in the Universal Declaration of Human Rights, and we fully comply with all relevant laws, rules and regulations governing labor, employment and the employment relationship in all the countries where we operate.
We respect the right of all employees to join a legally recognized employee association, and we comply with all laws relating to employee representation. We strive to maintain an open dialogue with all our employees and their representatives.
Due to the nature of our business and the location of our operations, the risk of child or forced labor is minimal. We do, however, remain vigilant for unexpected issues that may arise – not only in our own operations but also in relation to our procurement practices.
Privacy & Data Security
Idorsia understands the importance of protecting personal information and applying the highest ethical and regulatory standards. We are committed to respecting our stakeholders’ privacy and safeguarding their personal information. Idorsia’s data protection policy covers all personal data on study participants, healthcare professionals, customers, suppliers and employees.
To ensure the integrity and privacy of personal and health-related information provided to us, we use state-of-the-art information security programs, focusing on protection of sensitive information and detection of unauthorized access.
Safety & quality of products
Patient safety, through the optimal performance and quality of products, is fundamental to our company’s mission. Idorsia takes seriously its commitment to ensure that our products have and maintain an acceptable risk-benefit profile when used in accordance with the product labeling and good medical practice. The company performs extensive and robust non-clinical and clinical testing to identify the safety and tolerability profile of products and, once approved for use, the products will continuously be monitored through the use of post‑marketing surveillance and spontaneous reports from prescribers and patients. It is the responsibility of all Idorsia employees to promptly report any adverse drug experiences that they become aware of that could be associated with an Idorsia product to the company’s Global Drug Safety Department.
Idorsia is also committed to quality in the manufacturing, packaging and testing of its products. To ensure patient safety, it strives to meet or exceed applicable regulatory authority requirements for current Good Manufacturing, Clinical and Laboratory Practices (cGXPs). Idorsia is required to compile and maintain numerous records and to file reports and applications with various government agencies. Idorsia requires that all employees who prepare information, records or submissions for governmental agencies, or who otherwise deal with such agencies, do so diligently, accurately, completely and with absolute integrity.
Clinical Trials Transparency
Clinical trials are essential to the development of innovative medicines. We are committed to the highest standards of quality and ethical conduct in all our clinical research. Our trials are performed in accordance with internationally accepted guidelines, and protocols are evaluated by independent review boards and ethics committees prior to study initiation. We are also dedicated to improving public health through responsible clinical trial data transparency which – while complying with applicable regulations – respects our proprietary information and patients’ privacy.
With regard to access to medicines outside of a clinical study setting, Idorsia will use a set of criteria to determine whether access to Idorsia’s Discretionary Compassionate Use Program can be provided to the patient, including available clinical data supporting an anticipated acceptable risk-benefit profile for the proposed use, as well as any potential implications for the overall clinical development of the medicine and the possible supply of the requested investigational drug.
We strive to maintain the highest ethical, scientific and clinical standards in all our research activities, and to comply with all national and international standards. Idorsia regularly reviews its research policies to align them with its strategic objectives and with the evolving values and goals of stakeholders.
Regulatory authorities around the world require pharmaceutical companies to test all new drugs before they are launched, and there is no alternative to including some animal testing as part of this process. This is essential both for scientific reasons and to safeguard the volunteers and patients who take part in subsequent clinical trials. As a fundamental principle, we support the “three Rs” in relation to animal testing:
Refinement – Alleviate or minimize impacts to animals by reducing potentially painful or invasive procedures, whenever possible.
Reduction – Use the absolute minimum number of animals required to obtain valid results in each study.
Replacement – Always look for alternative, non-animal-based research methods where possible.
The number of animals used in drug development has dropped dramatically over the past three decades as a result of industry initiatives of this kind. Idorsia has a strong policy on the care, welfare and treatment of animals, and we conduct regular audits to make sure that our expectations are being met, whether the studies are conducted in-house or outsourced.
In addition, we ensure that the use and care of all laboratory animals meets or exceeds relevant local, national and international regulations. Our programs and facilities are subject to unannounced regulatory review and inspections. For sponsored work at contract research organizations, our animal welfare oversight activities include regular on‑site evaluations by our veterinary staff. Idorsia will never use great apes (gorillas, chimpanzees, orangutans and bonobos) in its research.
Health, safety and the environment
Idorsia recognizes that excellence in health and safety performance is integral to an efficient and successful business, particularly in the field of drug discovery. To this end, we have developed environmental, health and safety policies and procedures which employees are obliged to comply with. Employees must also attend required training and perform their jobs in a manner that promotes a safe and healthy workplace while also preserving and protecting the environment. This has never been more applicable than in 2020, as the company pursued its goals in the context of a global pandemic.
Supply chain management
Idorsia is committed to complying with all applicable laws and regulations in terms of managing our supply chain. In 2020, an internal audit was conducted by an external consultancy to review and assess supplier due diligence, bidding, selection and monitoring, as well as the vendor master data and supplier performance evaluation processes and controls. We are pleased to report that no significant issues were detected.
Idorsia’s goal is to be a company known for its open communication by proactively providing a regular flow of relevant information, thereby avoiding rumors, suspicion and mistrust resulting from concealment of information. Our communication is based on facts from evidence and confirmed data. We provide all information in a timely and consistent fashion and treat all stakeholders equally when considering their information needs. Our goal is to provide simultaneous, targeted dissemination of information and news relating to Idorsia. Moreover, in 2020, we reached out to many representatives of our stakeholder groups to better understand the topics that are important to them. More information on our approach to non-financial, or environmental, social & governance (ESG) reporting can be found here.