我国进口孤儿药可及性的调查研究

发布时间：2018-06-25 03:10

本文选题：罕见病 + 孤儿药　；参考：《中国药学杂志》2017年08期

【摘要】：目的检索国外上市孤儿药品目录,了解这些药物在我国的上市情况,为提高我国孤儿药可及性提供参考。方法计算机检索已发布孤儿药物管理政策的国家和地区(美国、新加坡、日本、澳大利亚、欧盟、中国台湾地区和韩国)的官方药品管理网站,按事先设计的数据提取表提取已上市孤儿药品信息。检索中国国家食品药品监督管理局网站,查询这些药品在我国的上市和报销现状。药品分类参照《中国药典》(2010年版),疾病分类参照《疾病和有关健康问题的国际统计分类》(ICD-10),医保信息参照《国家基本医疗保险、工伤保险和生育保险药品目录》(2009年版)。结果美国、日本、澳大利亚和欧盟出台孤儿药目录,上市药物共1 133种,覆盖疾病类别26个。抗肿瘤药物,内分泌、营养和代谢疾病用药,血液系统疾病用药位列前三,分别为329种、168种和122种,占所有药物的29.04%、14.83%和10.77%。中国近十年进口国外孤儿药数量持续增长,但数量不及国外上市三成,上市数量最多的为抗肿瘤药物、抗传染病和寄生虫病用药及内分泌、营养和代谢疾病用药。医保报销目录中覆盖孤儿药33种,含甲类5种,乙类28种,占西药报销品种数的2.9%。结论我国进口孤儿药数量虽不断增加,但与国外差距明显。为提高孤儿药物的可获得性和可负担性,保障罕见病患者权益,我们建议国家相关部门:(1)尽快出台孤儿药物管理政策;(2)循证遴选进口孤儿药物清单,建立适合本国国情的孤儿药目录;(3)建立孤儿药进口审批绿色通道,缩短进口时间;(4)激励本土企业的研发积极性,重视孤儿药的研发与仿制。
[Abstract]:Objective to retrieve the list of foreign listed orphan drugs, to understand the listing of these drugs in China, and to provide reference for improving the availability of orphan drugs in China. Methods the official drug management of countries and regions (USA, Singapore, Japan, Australia, EU, Taiwan region and South Korea) that have published orphan drug management policies have been published by computer. The website, according to the pre designed data extraction table to extract the information of the orphan drugs on the market, search the website of the national food and Drug Administration of China, inquire about the status of the listed and reimbursed drugs in our country. The classification reference of the Chinese Pharmacopoeia (2010 Edition), the disease classification reference < disease and the international statistical classification of health problems > (ICD-10) The medical insurance information refer to the national basic medical insurance, the industrial injury insurance and the birth insurance drug catalogue (2009 Edition). Results the United States, Japan, Australia and the European Union issued the orphan drug catalogue, 1133 kinds of listed drugs, covering 26 disease categories, antitumor drugs, endocrine, nutritional and metabolic diseases, and the top three of the blood system diseases. 329, 168 and 122 kinds, accounting for 29.04%, 14.83% and 10.77%. of all drugs, the number of imported foreign orphans continued to grow in China for the last ten years, but the number was less than 30% abroad. The largest number of drugs listed in the market were antitumor drugs, anti infectious and parasitic diseases, endocrine, nutritional and metabolic drugs. There are 33 kinds of orphan drugs, including 5 kinds of class A, 28 kinds of class B, 28 kinds of class B, accounting for the number of Western medicine reimbursement. Although the number of imported orphan drugs in China is increasing, the gap with the foreign countries is obvious. In order to improve the availability and affordability of orphan drugs and protect the rights and interests of the patients with rare diseases, we propose the relevant state departments of the state: (1) the administration of orphan drug administration as soon as possible. Policy: (2) to select the list of imported orphans, establish an orphan drug list suitable for the national conditions of the country, and (3) establish a green passage for the approval of the import of orphan drugs, shorten the time of import, and (4) encourage the R & D enthusiasm of local enterprises, and attach importance to the research and development and imitation of orphan drugs.
【作者单位】：四川大学华西第二医院药学部循证药学中心;出生缺陷与相关妇儿疾病教育部重点实验室;新疆石河子大学药学院;
【基金】：国家自然科学基金资助项目(81373381):中国儿童合理用药评价指标体系的循证研究四川大学华西第二医院新芽基金(kx034)
【分类号】：R95

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