Ethical Manifesto of IPHARMAUNION
1. Principle of Patient Priority
In all activities related to clinical trials and access to investigational therapies, the safety, rights, and well-being of patients take absolute priority.
We do not engage in any actions that may:
- compromise study protocol integrity
- influence informed consent
- distort clinical data or outcomes
2. Scientific and Regulatory Integrity
We ensure that all processes are conducted in accordance with applicable regulatory requirements of the Russian Federation and EAEU countries, as well as internationally recognized Good Clinical Practice (GCP) standards.
All interactions with regulatory authorities, clinical sites, and sponsors are conducted in compliance with applicable laws and ethical frameworks.
3. Transparency of Operations
We maintain transparency across all key stages of clinical trial execution, including:
- interaction with clinical sites
- patient recruitment processes
- documentation and reporting
- communication with study sponsors
We do not engage in hidden intermediary arrangements and ensure traceability of all operational activities.
4. Independence of Clinical and Medical Decision-Making
We do not interfere with the independent medical judgment of investigators and do not influence clinical decisions.
Decisions regarding patient inclusion, treatment administration, and clinical evaluation are made solely by qualified investigators in accordance with the approved study protocol.
5. Fair Competition and Business Ethics
We adhere to principles of fair competition and do not engage in practices aimed at:
- disparaging other market participants
- misleading representation of services
- unfair promotion or inducement practices
6. Alignment with International Standards
Our operations are aligned with internationally recognized pharmaceutical industry ethical and compliance standards, including principles of AIPM and IFPMA.
We adapt our processes to local regulatory requirements while maintaining global standards of quality, ethics, and compliance.
7. Responsibility as a Local Operator
Acting as a local operator of clinical trials, we assume responsibility for the operational execution of studies within the EAEU region, including:
- coordination with clinical trial sites
- regulatory submissions and interactions
- management of local trial operations
- ensuring protocol adherence at the operational level
8. Principle of Professional Accountability
We recognize that clinical research requires a high level of responsibility toward sponsors, investigators, and patients.
Every operational decision is assessed in terms of:
- clinical justification
- regulatory compliance
- ethical implications
9. Unacceptable Practices
The company strictly prohibits:
- manipulation of clinical trial data
- interference with investigator independence
- unauthorized influence on study outcomes
- breaches of personal data confidentiality
10. Purpose of Activity
Our mission is to support the development of a transparent, professional, and sustainable clinical research infrastructure in the EAEU region, enabling international biotechnology companies to conduct clinical programs in a predictable and ethically compliant environment.