PHM5006 – Ethics, Regulation and Managerial Economics In Precision Medicine

Course Overview

To ensure delivery and utility of quality healthcare in Precision Medicine, this course will guide students on the critical considerations – ethics, regulation and economics, that will affect healthcare accessibility to patients.

Ethics: An overview of ethical values, analysis, and reflection that can inform the development, promulgation, and use of genomics and big data science in precision medicine will be taught. We will first provide an ethical framework with practical steps for guiding decision-making and then teach students how to apply to case studies.

Regulation: An overview of the underlying principles in the regulation of health products in precision medicines that guide  responsible and well-informed decision for the patients, and uphold the need for safe, quality and efficacious interventions will be taught.

Economics: A brief overview of microeconomics, the types of questions it addresses, the tools it employs, and uses in the context of precision medicine will be taught. Basic concepts in economics, including demand, supply, market equilibrium, and elasticity will be included. Basic principles of decision making, and useful tools for identifying the choice that strikes the best balance between benefits and costs, and various degrees of price discrimination will also be covered.

Learning Outcomes

For the respective themes, by the end of the course, the students should be able to:

Ethics:

  • Identify ethical values at stake in precision medicine and related sciences
  • Demonstrate an understanding of the purpose and processes of ethical deliberation
  • Apply ethical reasoning to specific case studies in precision medicine

Regulation:

  • Explain the need and mechanism of health products regulation in ensuring the safety, quality and efficacy of medicines
  • Identify the responsibilities of various stakeholders involved in health products for precision medicine

 

Economics:

  • Understand the basic microeconomic concepts and skills to apply those in practice
  • Perform first, second and third degree price discrimination given the demand curve

Course Outline

Ethics:

  • Big Data Ethical Framework
  • Data privacy, consent & anonymization
  • Transparency, bias, accountability & trustworthinessI
  • Return of results/incidental findings
  • Genetic discrimination and group harms

 

Regulation:

  • Role of regulations in healthcare and product life cycle management
  • Regulatory frameworks and key regulatory organisations for health products in precision medicine
  • Principles in regulatory decision-making
  • Overview: Regulation of biotherapeutics, advanced therapies and in-vitro diagnostic devices
  • Post-market activities – Roles for various healthcare stakeholders in monitoring health products in precision medicine

 

Economics:

    • Demand and supply
    • Price elasticity
    • Cost Benefit analysis
    • Price discrimination

Course Requirements

Course Coordinators

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