What Is the EU AI Act? Understanding the Implications for Pharmaceutical and Biotech Industry

Introduced in 2024, the EU Artificial Intelligence Act is a groundbreaking regulatory framework designed to ensure the safe, ethical and responsible use of artificial intelligence (AI) across all sectors, including pharmaceuticals. The Act introduces a risk-based approach, classifying AI systems according to their potential impacts on health and safety, with high-risk applications in drug development and patient care subject to stringent requirements around risk management, transparency, data governance and human oversight.

Key Principles for the Pharmaceutical Industry:

• Patient Safety: AI systems used in diagnostics, drug development and treatment must adhere to rigorous safety and ethical standards.
• Data Governance: Companies are required to maintain high-quality, unbiased datasets and robust data management practices, safeguarding patient privacy and data integrity.
• Transparency & Accountability: Documentation and explainability of AI decision-making processes are essential for regulatory compliance and building stakeholder trust.
• Human Oversight: Healthcare professionals must be able to intervene and override AI decisions, ensuring patient outcomes remain paramount.
• Collaborative Innovation: The Act encourages innovation and knowledge sharing, enabling companies to develop advanced AI solutions for personalized medicine while ensuring compliance.

Practical Steps for Pharmaceutical Companies to Meet Compliance:

• Implement comprehensive data governance and risk management frameworks.
• Ensure transparent documentation and reporting of AI systems.
• Foster a culture of compliance through regular training and clear accountability.
• Establish mechanisms for human oversight in high-risk AI applications.

Risks & Opportunities:

Non-compliance may result in fines and reputational harm, while compliance could incur significant implementation costs. However, adherence to the Act enhances trust, fosters innovation and opens new market opportunities across Europe and beyond.

Global Comparison:

Unlike the EU’s unified and prescriptive approach, North America adopts sector-specific guidelines, and China focuses on security and rapid AI deployment. The EU AI Act sets a global benchmark for ethical AI and governance.

The EU AI Act entered into force on August 1, 2024, but is being implemented in phases, with full applicability planned for 2026.

For more details or support in preparing for the EU AI Act, be sure to contact your internal legal or compliance team. For questions regarding Scientist.com’s compliance provisions, including more info on our award-winning COMPLi® platform, contact us at compliance@scientist.com.