Pharmacovigilance and Regulatory Affairs

Ethics and Legal Challenges in Drug Safety Surveillance

Ethical and legal considerations are central to the responsible practice of pharmacovigilance. As the scope and granularity of safety surveillance increase, so does the need to protect patient rights, data privacy, and informed consent. Regulatory bodies worldwide enforce strict guidelines to ensure that pharmacovigilance activities comply with legal frameworks such as GDPR, HIPAA, and other national data protection laws. Patient data used in adverse event reporting, signal detection, and post-marketing studies must be collected, stored, and processed with strict confidentiality and transparency. Informed consent becomes especially relevant in the era of digital health tools, real-world evidence, and genetic therapies. Clear communication about how patient data will be used is essential for maintaining trust and ethical accountability. Legal risks also arise from delayed or incomplete reporting, inadequate documentation, and failure to act on identified safety signals. Litigation related to adverse outcomes can lead to reputational damage, financial penalties, and regulatory sanctions. Companies must establish comprehensive compliance programs, legal oversight, and ethical review processes to mitigate these risks. Navigating the intersection of ethics, law, and science requires a multidisciplinary approach, involving pharmacovigilance professionals, legal advisors, ethicists, and regulators. A transparent, proactive, and ethically grounded pharmacovigilance system not only protects patients but also upholds the credibility and integrity of public health efforts.