Orphan drug policy analysis in China
Meilin Liu1, Yanqin Lu1,2, Junfeng Li1
1Key Laboratory for Biotech-Drugs of National Health Commission, Biomedical Science College and Shandong Medicinal Biotechnology Centre, Shandong First Medical University and Shandong Academy of Medical Sciences, Ji'nan, Shandong, China.
Frontiers in Pharmacology
|June 28, 2024
Summary
China is enhancing orphan drug policies to improve access and affordability for rare disease patients. These initiatives include expedited drug development, tax incentives, and expanded insurance coverage, aiming to bring more treatments to those in need.
Area of Science:
- Pharmacoeconomics
- Health Policy
- Rare Disease Research
Background:
- Rare diseases present diagnostic and treatment challenges globally.
- China faces a significant burden of rare diseases due to its large population.
- A critical shortage of orphan drugs leads to unmet medical needs and financial hardship for patients.
Purpose of the Study:
- To analyze China's current orphan drug policies.
- To evaluate measures for improving orphan drug accessibility and affordability.
- To propose policy recommendations by comparing with international best practices.
Main Methods:
- Review of China's orphan drug policies focusing on accessibility and affordability.
- Analysis of incentives for drug development and registration.
- Examination of financial support mechanisms and insurance adjustments.
- Comparative analysis with policies in the US, EU, Japan, and Australia.
Main Results:
- China has implemented policies including tax incentives, data protection, market exclusivity, and expedited review processes.
- Financial support measures include tax reductions, special funds, medical assistance, and insurance adjustments.
- The national medical insurance catalog now covers 95 orphan drugs as of March 2024, increasing patient access.
Conclusions:
- China's orphan drug policies have advanced significantly in improving drug accessibility and affordability.
- Further policy enhancements, informed by international comparisons, are crucial.
- These improvements aim to provide more treatment options and hope for rare disease patients in China.
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