This webinar featuring Mina Frost, General Counsel for Sano Genetics, provides an insightful overview of the legal and ethical intricacies involved in precision medicine. Mina expertly explores the complexities of patient privacy, data protection, and the regulatory landscape that govern precision medicine.
The link to the full webinar is here; a brief summary is below for reference.
Mina Frost
Mina Frost is a global legal expert with over 20 years of experience specialising in healthcare law. Based in London, she is a US-qualified lawyer known for her agile approach to risk management, good governance, and ethical design thinking. Frost has played crucial roles at pharmaceutical giants like GSK and Abbott Laboratories, including being the first Global Privacy Officer at both companies. Her expertise extends to digital risk, particularly as healthcare expands digital-led drug discovery. And, as a special needs mom, her personal experiences add profound insight to her professional contributions in the healthcare and pharmaceutical sectors
Precision medicine tailors healthcare and treatments to individual patients based on their genetic or biomarker information. This approach not only enhances the effectiveness of treatments but also reduces the potential for adverse side effects. Mina highlighted the critical role of regulatory bodies such as the FDA in the US and the European Medicines Agency in Europe, which oversee the approval process for targeted therapies and ensure patient safety.
One of the key legal considerations in precision medicine revolves around the collection and use of genetic data. Mina emphasised the importance of ethical data management, informed consent, and maintaining patient confidentiality. She pointed out the challenges of navigating global data protection laws, such as GDPR in the EU and HIPAA in the US, especially when conducting multinational research. These laws demand strict compliance regarding consent, data subject rights, and the secure handling of health and genetic information.
Mina also touched upon the legal protocols and ethical considerations for clinical trials in precision medicine. She stressed the need for clear communication with participants about the research process, potential risks and benefits, and the specific use of their genetic data. The role of Institutional Review Boards (IRBs) in overseeing the ethical conduct of trials was highlighted, along with the importance of trial registration for transparency and accountability.
This webinar underscored the notion that precision medicine is not just a technological or medical advancement but also a field deeply intertwined with legal and ethical challenges. Navigating this landscape requires a thorough understanding of the regulatory requirements, a commitment to patient privacy, and an ethical approach to genetic data management.
As precision medicine continues to evolve, the collaboration between legal experts, regulatory bodies, healthcare professionals, and patients will be paramount in advancing personalised therapies while safeguarding patient rights and data privacy. We are proud that Sano's commitment to addressing these challenges head-on exemplifies the proactive approach needed to realise the full potential of precision medicine in improving patient outcomes.