Regulating Health Innovations

Description

In this course, students will practice a wide range of skills—from paraphrasing legal texts and presenting arguments clearly, to weighing regulatory options available to lawmakers based on different, sometimes competing interests (e.g. legal and social norms and values, the limits of science and technology). Students will foster key attitudes such as intellectual curiosity, analytical thinking, and an openness to evidence from other disciplines (e.g. sociology, economics, ...) to examine how legal frameworks work in practice. These competencies will be applied to explore and critique how the EU regulates breakthrough healthcare innovations. Objectives: Breakthrough healthcare innovations, such as immunotherapy, AI-driven medical devices, 3D-printed organs, and gene-editing therapies, have the potential to transform patient care. However, they also present significant legal, regulatory, and ethical challenges. How can we regulate such technologies in a way that maximizes their benefits while safeguarding public health, protecting individual rights, and ensuring fair access, competition and innovation? This course explores the regulation of these technologies within the EU, focusing on medical devices, pharmaceuticals, and biotechnologies. Students will learn the "why" and "how" of regulating health technologies, examining regulatory theories, instruments, and models, and analyzing the ethical, health and economic dilemmas these regulations create. Through case studies and real-world examples, students will enhance their legal reasoning and build strategies for regulating innovative consumer products. Using EU law as a "regulatory laboratory," this course provides students with the tools to critique and influence the future of healthcare innovation. Identify and explain regulatory concepts used in the approval and monitoring of health technologies. Apply knowledge of EU regulatory frameworks for health technologies to determine how different laws affect a product's market entry and compliance requirements. Analyse regulatory choices for health technologies on the basis of regulatory concepts. Critically evaluate whether EU regulatory measures for health technologies adequately address the risks and concerns of EU stakeholders (e.g. industry, consumers, …) and EU principles and values.