Pharmacogenetics helps us understand the relationship between an individual's genetic make-up and the way medicines work for each person. This book reviews the use of pharmacogenetics across all stages of the health innovation cycle from research through to uptake by doctors and patients. It focuses on how to optimise the use of pharmacogenetics to deliver effective innovations for public health, and design policies that enhance their economic and social benefits. The book argues for large-scale studies to validate the biomarkers that underpin pharmacogenetics and policies to share the cost and risk of using pharmacogenetics to improve the use of existing medicines. Governments and others need to align regulatory, reimbursement and other incentives and work with industry to measure better the impacts of pharmacogenetics. Health systems need to take positive steps to adapt to the use of pharmacogenetics and ensure that health professionals receive adequate training.
Acronyms Executive Summary Chapter 1. Introduction to the Policy Issues -Introduction -Reducing risks, balancing benefits -The pharmaceutical context -The clinical context -The regulatory and ethical contexts -The framework for the OECD pharmacogenetics and health innovation project -Structure of the report Chapter 2. The Supporting Infrastructures for Pharmacogenetics -What are pharmacogenetics and pharmacogenomics?
-Technological developments -Advancing pharmacogenetics through knowledge networks and open innovation -Human genetic research databases: privacy and security issues -Target identification and validation -Conclusions -References Chapter 3. Pharmacogenetics and Drug Development -Trends in pharmaceutical innovation -The pharmaceutical R&D pipeline problem -Pharmaceutical industry R&D expenditure: the high cost of clinical trials -Reducing the size of clinical trials -Conclusions -References Chapter 4. Business Models for Pharmacogenetics -The blockbuster model and pharmacogenetics -Challenges and opportunities for the pharmaceutical industry -SMEs and the biotechnology sector -The device and diagnostics industry -Challenges in co-development of drugs and tests -Creating and capturing value from pharmacogenetics -Conclusions -References Chapter 5. Physician and Patient Demand for Pharmacogenetics -The health-care context -The role of pharmacogenetics in evidence-based medicine -The role of physicians -Physicians and the challenge of integrating information -Patient demand -The issue of access -Health-care systems -Education and workforce development -Conclusions -References Chapter 6. Regulatory Authorities and Reimbursement Mechanisms -The regulatory authorities -Labelling of pharmacogenetic drugs -Linking pharmacovigilance with pharmacogenetics -The impact of reimbursement systems on pharmacogenetics -Evidence-based coverage policies -Challenges for capturing the value of pharmacogenetics -Using economic evaluation techniques in assessing pharmacogenetics -Conclusions -References Chapter 7. Conclusions