In the global pharmaceutical market, new drug R&D never stops. Technological innovations have made it possible to design treatments for what have been regarded as severe and intractable diseases, and groundbreaking drugs with the capability to provide fundamental cures continue to enter the market. These inventions not only expand the scope of available treatments, but also demand fundamental changes in regulations, medical cost calculations, and health systems, at an increasingly accelerated pace. The fiscal sustainability of health systems is a pressing issue faced by each and every nation today, and accountability is required of all stakeholders to ensure it. New drugs carry great uncertainty in terms of clinical effectiveness, fiscal impact, and cost-effectiveness. Risk Sharing Agreements on these drugs attest to the importance of sharing fiscal risks. As risks are determined and shared in relation to the aggregate health expenditure, payers and the industry alike, as well as the medical community and the public, should participate and share risks. It is high time for us to start serious discussions on how to ensure that all participants are held accountable for their behavior and decision-making, particularly by enforcing the self-regulation of medical practitioners, reforming the National Health Insurance payment system, and making coverage and its continuation dependent on technology evaluation.
Ⅰ. Introduction 1 1. Research Background and Purpose 3 2. Research Structure and Method 4
Ⅱ. Trend of Recent Pharmaceutical Developments and Health Policy Issues 7 1. Trend of Pharmaceutical Developments 9 2. Pharmaceutical Innovations in Progress 10 3. Future Pharmaceuticals and Health Policy Issues 16
Ⅲ. Analysis of New Drugs approved in Korea 21 1. Current Status and Characteristics 23 2. New Drugs in Korea: Use and Spending under the NHI 31
Ⅳ. Governance on New Drugs 35 1. Research Plan 37 2. Governance on New Drug Approval 40 3. Governance on New Drug Coverage 43
Ⅴ. Health Policy and Governance for Enhancing the Capability of the Health System to Manage Future Pharmaceutical Innovations 47 1. Challenges 49 2. Health Policy and Governance for a More Capable and Responsive Health System 51