论罕见病用药研制政府促进义务

发布时间：2018-01-21 04:49

  本文关键词： 罕见病用药 研制 政府促进 义务　出处：《西南大学》2014年硕士论文　论文类型：学位论文

【摘要】：罕见病是一类长期不为人们熟悉的疾病,用于医治这类疾病的药物由于适用人群小,社会关注度不高,市场预期利润低而长期不为科研机构和制药企业所重视。正是由于这些原因,我国的罕见病用药长期依赖进口,这一情况造成了严重的市场失灵问题。2007年10月1日施行的《药品注册管理办法》和2009年1月7日施行的《新药注册特殊审批管理规定》虽然都规定了对创制新药、治疗疑难危重疾病的新药实行特殊审批,但是由于具体实施细则的缺失,使这些规定长期无法落到实处。一方面,患者因病亟需药品,另一方面作为药品研制主体的科研机构和制药企业,却因风险高、利润低、法律规定的不完善和相关促进制度的缺失而对罕见病用药的研制望而却步。 在现代社会的经济生活中,当面临无法通过市场自行调节来解决的问题时,国家干预就成为了最好的选择。为了进一步促进我国罕见病用药的研制,政府应当在对域内外的相关制度进行研究和借鉴的基础上,多管齐下,做到实体与程序并举,利用国家资金扶持、知识产权保护、建立特殊审批机制等手段初步建立系统的罕见病用药研制政府促进制度并不断进行完善。建立并完善我国的罕见病用药研制政府促进制度是保证人民群众健康的需要,是完善我国社会保障制度的需要,更是政府应当履行的一项重要义务。 具体的制度构建是我国罕见病用药研制政府促进义务的核心和落脚点。在进行具体制度构建时,应当做好相关理论研究,特别是罕见病用药研制政府促进制度涉及到法学、经济学、医学、药事学等多个学科,更应当重视基础理论的研究,如果盲目进行制度建设不但可能浪费本已紧缺的人力和无力还有可能造成相关制度不具备科学性和可操作性而成为“空中楼阁”。由于我国的罕见病用药研制政府促进义务长期缺位,在进行制度构建时更应当慎重,在做好基础理论研究的同时还应当对域外的相关典型制度进行分析和总结,对域外的有益经验进行借鉴和消化,使之进一步本土化更加适应我国的国情从而解决罕见病用药市场失灵问题。 本文共分为四部分： 第一部分为政府促进罕见病用药研制相关基本理论,着重对与罕见病用药研制有关的基础理论问题进行了探讨。具体包括：罕见病的概念、我国罕见病现状、罕见病用药的内涵以及外延、罕见病用药研制的概念以及罕见病用药研制政府促进的概念和意义等。 第二部分为我国罕见病用药研制政府促进义务的现状,该部分对我国现有的与罕见病用药研制政府促进义务有关的法规进行了梳理,在梳理现有法律规定的基础上总结了罕见病用药研制政府促进在立法上存在的不足,并且对这些不足存在的原因进行了分析。 第三部分为域外罕见病用药研制政府促进义务考察与借鉴。主要分为两部分内容,首先对域外有关国家和地区(欧盟、美国、日本和我国台湾地区)的罕见病用药研制政府促进义务进行了考察。其次,在对域外相关制度进行考察的基础上,分析了域外相关制度可供我国借鉴的经验。 第四部分为全文的核心和落脚点,其主要内容为完善我国罕见病用药研制政府促进义务的对策建议。在通过法律明确我国罕见病范围的基础上,利用基金扶持、税收优惠政策、价格调控措施等具体手段降低罕见病用药研制主体的成本和风险从而激励他们进行罕见病用药的研制。
[Abstract]:A rare disease is a kind of long term for people not familiar with the disease, for the treatment of this disease due to drug for the crowd is small, the degree of social concern is not high, the market is expected to low profits and long-term attention to the scientific research institutions and pharmaceutical enterprises. It is for these reasons, a rare disease medication of our long-term dependence on imports, this a situation has caused serious market failure during.2007 October 1st implementation of the "measures on the administration of drug registration and the January 7, 2009 implementation of the" special approval of new drug registration management regulations although provides for the development of new drugs, new drug for the treatment of complicated and serious diseases of the implementation of special approval, but due to the lack of specific rules for the implementation of these Provisions, the term cannot fall the letter. On the one hand, the patients due to need drugs, on the other hand, as the main drug development research institutions and pharmaceutical companies, but because of the high risk, low profits, the law does not The lack of perfect and related promotion system is prohibitive for the development of rare diseases.
In the modern economic life, when faced with not through the market adjust itself to solve the problem, the state intervention has become the best choice. In order to further promote the development of China's rare disease drug, the government should be the basis for research and reference in the relevant system of inside and outside the domain, multi pronged approach to achieve the entities and procedures simultaneously, use of state funds to support the protection of intellectual property rights, establish special approval mechanism establishment of orphan drug system for the government to promote system and constantly improve. Establish and improve China's rare disease drug development to promote the government system is needed to ensure people's health, is to improve the needs of our society security system, is an important duty of the government should perform.
The specific construction of the system is our country's rare disease drug development to promote the core and goal of government obligations. In the construction of the specific system, should do research on related theories, especially the rare disease drug development of the government to promote the system involves the law, economics, medicine, pharmaceutical science, more attention should be given to the basic theory research. If the blind system may not only waste the already scarce human weakness and may also cause the relevant system does not have the scientific and operable and become "castles in the air." due to a rare disease in China with the development of medicine government promote compulsory long-term absence, when constructing the system should be more careful, do a good job in the basic theoretical research at the same time should also analyze and summarize the typical experience of the foreign system, for reference and digest the useful experience of foreign, make it more suitable for further localization The problem of drug market failure of rare diseases should be solved in response to the national conditions of our country.
This article is divided into four parts:
The first part is the government to promote the development of drugs for rare diseases related to the basic theory, focuses on the development of basic theory and issues related to orphan drugs were discussed. Including: the concept of rare diseases, rare disease status in our country, the connotation and extension of rare disease drug development, the concept of drugs for rare diseases and orphan drug development promoted by the government the concept and significance.
绗�浜岄儴鍒嗕负鎴戝浗缃曡�佺梾鐢ㄨ嵂鐮斿埗鏀垮簻淇冭繘涔夊姟鐨勭幇鐘，

本文编号：1450519