A quantitative analysis of gene therapy drug policy based on a three-dimensional analytical framework
10.3969/j.issn.1674-2982.2024.10.010
- VernacularTitle:基于三维分析框架的基因治疗药物政策量化分析
- Author:
Yue YAN
1
;
Jia-Miao NIU
;
Zong-Jiu ZHANG
Author Information
1. 清华大学医学院 北京 100084
- Keywords:
Gene therapy drugs;
Policy instruments;
Three-dimensional cross analysis
- From:
Chinese Journal of Health Policy
2024;17(10):68-75
- CountryChina
- Language:Chinese
-
Abstract:
Objective:This study aims to analyze the characteristics and current status of gene therapy drug policy documents and to provide recommendations for optimizing China's gene therapy drug policy system.Methods:A three-dimensional analytical framework of"policy instruments-interactive subjects-policy phases"was constructed using content analysis and word frequency analysis.This framework was applied to the relevant policy documents issued from March 2009 to March 2024,enabling multidimensional classification and cross-comparison.Results:Among the 37 national-level policy documents included,246 text items were identified under the dimension of policy instruments,with supply-based instruments(45.9%)and environmental instruments(41.5%)being more prevalent,while demand-based instruments(12.6%)were less represented.The distribution of policy instruments was skewed,and internal structural differences were observed.In the dimension of interactive subjects,195 text items were identified,with drug manufacturing and R&D enterprises(36.9%),drug regulatory and accreditation agencies(22.1%),patients and subjects(19.0%),medical institutions and healthcare professionals(11.8%),and other government departments(10.2%)playing uneven roles.In the dimension of policy phases,the policies were categorized into three stages:drug R&D,production,and usage,with some policies covering multiple phases.Conclusions and suggestions:The study suggests combining and optimizing policy instruments for balanced application,strengthening demand-oriented policies,considering the needs of different interacting entities to formulate comprehensive policies,promoting cross-subject collaboration for win-win outcomes,and enhancing phase-linkage efficiency to build a comprehensive chain ecosystem for gene therapy drug development.
