INTERNATIONAL CONGRESS OF
PharmacoGenetics
Ethical, Legal, and Regulatory Frameworks in Personalized Medicine and Pharmacogenetics
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Mina Shirmohammadpour,1 Arman Taran,2 Bahman Mirzaei,3,*
1. Department of Microbiology and Virology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran
2. Department of Microbiology and Virology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran
3. Department of Microbiology and Virology, Faculty of Medicine, Zanjan University of Medical Sciences, Zanjan, Iran
- Introduction: As pharmacogenetics becomes integral to personalized medicine, concerns regarding data privacy, informed consent, genetic discrimination, and equitable access have emerged. Robust regulatory frameworks are needed to guide clinical implementation. Objective: This review explores current legal, ethical, and policy developments surrounding the use of genetic data in pharmacogenomic-driven healthcare.
- Methods: International regulatory documents and peer-reviewed literature from 2010 to 2024 were reviewed, including guidelines from the FDA, EMA, and WHO. Focus was given to patient consent, data security, clinical decision-making, and reimbursement policies.
- Results: Most countries lack comprehensive laws regulating pharmacogenomic data use. Challenges include unclear ownership of genetic data, unequal access to testing, and inconsistent integration into clinical workflows. Notably, the GDPR in the EU and the Genetic Information Nondiscrimination Act (GINA) in the US represent key protections. However, gaps remain in patient education and clinician preparedness.
- Conclusion: Establishing ethical and legal safeguards is essential to ensure trust, equity, and responsible innovation in personalized medicine. Multidisciplinary collaboration is needed to harmonize global standards and bridge the regulatory gap.
- Keywords: Pharmacogenetics, Personalized medicine, Bioethics, Genetic privacy, Health policy, Regulatory frame
