放射性药品管理办法(附英文)
国务院
放射性药品管理办法(附英文)
1989年1月13日，国务院
第一章 总 则
第一条 为了加强放射性药品的管理，根据《中华人民共和国药品管理法》（以下称《药品管理法》）的规定，制定本办法。
第二条 放射性药品是指用于临床诊断或者治疗的放射性核素制剂或者其标记药物。
第三条 凡在中华人民共和国领域内进行放射性药品的研究、生产、经营、运输、使用、检验、监督管理的单位和个人都必须遵守本办法。
第四条 卫生部主管全国放射性药品监督管理工作。能源部主管放射性药品生产、经营管理工作。
第二章 放射性新药的研制、临床研究和审批
第五条 放射性新药是指我国首次生产的放射性药品。药品研制单位的放射性新药年度研制计划，应当报送能源部备案，并报所在地的省、自治区、直辖市卫生行政部门，经卫生行政部门汇总后，报卫生部备案。
第六条 放射性新药的研制内容，包括工艺路线、质量标准、临床前药理及临床研究。研制单位在制订新药工艺路线的同时，必须研究该药的理化性能、纯度（包括核素纯度）及检验方法、药理、毒理、动物药代动力学、放射性比活度、剂量、剂型、稳定性等。
研制单位对放射免疫分析药盒必须进行可测限度、范围、待异性、准确度、精密度、稳定性等方法学的研究。
放射性新药的分类，按新药审批办法的规定办理。
第七条 研制单位研制的放射性新药，在进行临床试验或者验证前，应当向卫生部提出申请，按新药审批办法的规定报送资料及样品，经卫生部审批同意后，在卫生部指定的医院进行临床研究。
第八条 研制单位在放射性新药临床研究结束后，向卫生部提出申请，经卫生部审核批准，发给新药证书。卫生部在审核批准时，应当征求能源部的意见。
第九条 放射性新药投入生产，需由生产单位或者取得放射性药品生产许可证的研制单位，凭新药证书（副本）向卫生部提出生产该药的申请，并提供样品，由卫生部审核发给批准文号。
第三章 放射性药品的生产、经营和进出口
第十条 放射性药品生产、经营企业，必须向能源部报送年度生产、经营计划，并抄报卫生部。
第十一条 国家根据需要，对放射性药品实行合理布局，定点生产。申请开办放射性药品生产、经营的企业，应征得能源部的同意后，方可按照有关规定办理筹建手续。
第十二条 开办放射性药品生产、经营企业，必须具备《药品管理法》第五条规定的条件，符合国家的放射卫生防护基本标准，并履行环境影响报告的审批手续，经能源部审查同意，卫生部审核批准后，由所在省、自治区、直辖市卫生行政部门发给《放射性药品生产企业许可证》、《派湫砸┢肪笠敌砜芍ぁ贰Ｎ扌砜芍さ纳⒕笠担宦刹蛔忌⑾鄯派湫砸┢贰?
第十三条 《放射性药品生产企业许可证》、《放射性药品经营企业许可证》的有效期为五年，期满前六个月，放射性药品生产、经营企业应当分别向原发证的卫生行政部门重新提出申请，按第十二条审批程序批准后，换发新证。
第十四条 放射性药品生产企业生产已有国家标准的放射性药品，必须经卫生部征求能源部意见后审核批准，并发给批准文号。凡是改变卫生部已批准的生产工艺路线和药品标准的，生产单位必须按原报批程序经卫生部批准后方能生产。
第十五条 放射性药品生产、经营企业，必须配备与生产、经营放射性药品相适应的专业技术人员。具有安全、防护和废气、废物、废水处理等设施。并建立严格的质量管理制度。
第十六条 放射性药品生产、经营企业，必须建立质量检验机构，严格实行生产全过程的质量控制和检验。产品出厂前，须经质量检验。符合国家药品标准的产品方可出厂，不符合标准的产品一律不准出厂。
经卫生部审核批准的含有短半衰期放射性核素的药品，可以边检验边出厂，但发现质量不符合国家药品标准时，该药品的生产企业应当立即停止生产、销售，并立即通知使用单位停止使用，同时报告卫生部和能源部。
第十七条 放射性药品的生产、供销业务由能源部统一管理。放射性药品的生产、经营单位和医疗单位凭省、自治区、直辖市卫生行政部门发给的《放射性药品生产企业许可证》、《放射性药品经营企业许可证》，医疗单位凭省、自治区、直辖市公安、环保和卫生行政部门联合发给的《放射性药品使用许可证》，申请办理订货。
第十八条 放射性药品的进出口业务，由对外经济贸易部指定的单位，按照国家有关对外贸易的规定办理。
进出口放射性药品，应当报卫生部审批同意后，方得办理进出口手续。
进口的放射性药品品种，必须符合我国的药品标准或者其他药用要求。
第十九条 进口放射性药品，必须经中国药品生物制品检定所或者卫生部授权的药品检验所抽样检验；检验合格的，方准进口。
对于经卫生部审核批准的短半衰期放射性核素的药品，在保证安全使用的情况下，可以采取边进口检验，边投入使用的办法。进口检验单位发现药品质量不符合要求时，应当立即通知使用单位停止使用，并报告卫生部和能源部。
第四章 放射性药品的包装和运输
第二十条 放射性药品的包装必须安全实用，符合放射性药品质量要求，具有与放射性剂量相适应的防护装置。包装必须分内包装和外包装两部分，外包装必须贴有商标、标签、说明书和放射性药品标志，内包装必须贴有标签。
标签必须注明药品品名、放射性比活度、装量。
说明书除注明前款内容外，还须注明生产单位、批准文号、批号、主要成份、出厂日期、放射性核素半衰期、适应症、用法、用量、禁忌症、有效期和注意事项等。
第二十一条 放射性药品的运输，按国家运输、邮政等部门制订的有关规定执行。
严禁任何单位和个人随身携带放射性药品乘坐公共交通运输工具。
第二十二条 医疗单位设置核医学科、室（同位素室），必须配备与其医疗任务相适应的并经核医学枝术培训的技术人员。非核医学专业技术人员未经培训，不得从事放射性药品使用工作。
第二十三条 医疗单位使用放射性药品，必须符合国家放射性同位素卫生防护管理的有关规定。所在地的省、自治区、直辖市的公安、环保和卫生行政部门，应当根据医疗单位核医疗技术人员的水平、设备条件，核发相应等级的《放射性药品使用许可证》，无许可证的医疗单位不得临床使用放射性药品。
《放射性药品使用许可证》有效期为五年，期满前六个月，医疗单位应当向原发证的行政部门重新提出申请，经审核批准后，换发新证。
第二十四条 持有《放射性药品使用许可证》的医疗单位，在研究配制放射性制剂并进行临床验证前，应当根据放射性药品的持点，提出该制剂的药理、毒性等资料，由省、自治区、直辖市卫生行政部门批准，并报卫生部备案。该制剂只限本单位内使用。
第二十五条 持有《放射性药品使用许可证》的医疗单位，必须负责对使用的放射性药品进行临床质量检验，收集药品不良反应等项工作，并定期向所在地卫生行政部门报告。由省、自治区、直辖市卫生行政部门汇总后报卫生部。
第二十六条 放射性药品使用后的废物（包括患者排出物），必须按国家有关规定妥善处置。
第五章 放射性药品标准和检验
第二十七条 放射性药品的国家标准，由卫生部药典委员会负责制定和修订，报卫生部审批颁发。
第二十八条 放射性药品的检验由中国药品生物制品检定所或者卫生部授权的药品检验所承担。
第六章 附 则
第二十九条 对违反本办法规定的单位或者个人，由县以上卫生行政部门，按照《药品管理法》和有关法规的规定处罚。
第三十条 本办法由卫生部负责解释。
第三十一条 本办法自发布之日起施行。
MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS
Important Notice: (注意事项)
英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民
共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.
Whole Document (法规全文)
MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS
(Promulgated by Decree No. 25 of the State Council of the People's
Republic of China on January 13, 1989 and effective as of the date of
promulgation)
Chapter I General Provisions
Article 1
These Measures are formulated to strengthen the control of radioactive
drugs in accordance with Pharmaceutical Administration Law of the People's
Republic of China (hereinafter referred to as the Pharmaceutical
Administration Law)
Article 2
"Radioactive drugs" refer to any forms of radionuclide or their tagged
drugs that are used for clinical diagnosis or in radiotherapy.
Article 3
All units or individuals in the People's Republic of China are required to
abide by these Measures when they are engaged in research work,
production, business, transportation, consumption, examination,
supervision and administration work related to radioactive drugs.
Article 4
The Ministry of Public Health is in charge of the supervisory and
administrative work of radioactive drugs while the Ministry of Energy is
in charge of the administration work concerning the production and sale of
radioactive drugs.
Chapter II Examination and Approval for the Development and Cli- nical Research of New Radioactive Drugs
Article 5
"New radioactive drugs" refer to those radioactive drugs that are made in
China for the first time. The annual plan of any drug research units for
the development of new radioactive drugs must be submitted to both the
Ministry of Energy for the record and to the health administration
department at the provincial, autonomous regional or municipal (directly
under the Central Government) level. Then an itemized plan made by the
latter shall be presented to the Ministry of Public Health for the record.
Article 6
The development of a new kind of radioactive drug includes the research
work in its technological process, quality requirements,
preclinicopharmacological study and clinical study;
The research unit, when designing the technological process for a new
drug, must study the physical and chemical properties, purity (including
pureness of radionuclide), testing method, pharmacology, toxicity, nuclein
animal dynamics, radiospecific activity, dosage, pharmaceutical forms and
stability of that radioactive drug. Furthermore, the research unit must
make a study of radio-immunity analysis container with respect to its
scalability, range, specificity, accuracy, precision and stability.
New kinds of radioactive drugs shall be classified in accordance with the
provisions for the examination and approval of new pharmaceuticals.
Article 7
Before the newly developed radioactive drug is put to clinical test or
verification, an application together with the data and sample must be
submitted to the Ministry of Public Health in accordance with the
provisions for the examination and approval of new pharmaceuticals.
The newly developed radioactive drug may be used for clinical study at an
appointed hospital only after its application has been examined and
approved by the Ministry of Public Health.
Article 8
After completion of clinical study of a newly developed radioactive drug,
the research unit must submit an application to the Ministry of Public
Health for examination and approval.
The latter shall consult the Ministry of Energy before granting a New Drug
License.
Article 9
Before a newly developed radioactive drug is put to production, the
production unit or the research unit that holds a license for the
production of radioactive drugs must submit an application together with a
copy of New Drug License and sample to the Ministry of Public Health.
After examination and verification, the Ministry of Public Health shall
issue them document of approval.
Chapter III The Production, Sales, Import and Export of Radio- active Drugs
Article 10
The enterprises that produce or sell radioactive drugs are required to
submit their production plan and business plan to the Ministry of Energy
and a duplicate to the Ministry of Public Health.
Article 11
The State shall, according to the actual conditions, make sure that
radioactive drugs be produced at designated pharmaceutical factories which
shall be located rationally over the country. Applications for the setting
up of any enterprises to produce or sell radioactive drugs must be
approved by the Ministry of Energy before the preparations start in
accordance with related provisions.
Article 12
Requirements for the setting up of enterprises to produce or sell
radioactive drugs are that they must have the necessary conditions as
stipulated in Article 5 of the Pharmaceutical Administration Law and that
they must meet the essential standard of radio hygiene protection set by
the State. They are also required to submit a report on environment impact
to the Ministry of Energy and the Ministry of Public Health for
examination and approval and then the health administration department in
their province, autonomous region or municipality directly under the
Central Government shall issue them "License for the Production Enterprise
of Radioactive Drugs", "License for the Business Enterprise of Radioactive
Drugs". No enterprises without the license shall be permitted to engage in
the production or sale of radioactive drugs.
Article 13
The term of validity of "License for the Production Enterprise of
Radioactive Drugs" and "License for the Business Enterprise of Radioactive
Drugs" is five years. If needed, the enterprises engaged in the production
or sale of radioactive drugs shall make a new application six months
before the expiration to the health administration department which shall,
in accordance with Article 12 of these Provisions, issue them a new
license.
Article 14
Before an approved pharmaceutical enterprise produces radioactive drugs
with specifications already set by the State, it must forward an
application which has to be examined and approved by the Ministry of
Public Health in conjunction with the Ministry of Energy. If any changes
in the technological process and specifications of the drugs previously
approved by the Ministry of Public Health are to be made, the
pharmaceutical factory shall be required to go through the same procedures
for approval.
Article 15
The production and business enterprises of radioactive drugs are required
to employ technical personnel who are qualified for the work and to have
safety and protection facilities as well as waste gas, liquid and material
disposal facilities. They must also have a strict quality control system.
Article 16
The production and business enterprises of radioactive drugs are required
to set up quality inspection offices. The entire process of production
must be put under strict qualify control and inspection.
All radioactive drugs are subject to quality testing. Only the products
that meet the State pharmaceutical standard shall be allowed to be shipped
out from the factories. Products that are not up to the standard are not
allowed out of the factory. As for the drugs with short half-life
radionuclide previously approved by the Ministry of Public Health, they
may be shipped out from the factory while having sample testing. If the
drugs are found to be below the State pharmaceutical standard, the factory
must stop the production and sale of the drugs immediately and inform
consuming units to stop using the drugs without delay. A report about the
case must be submitted to both the Ministry of Public Health and the
Ministry of Energy.
Article 17
The production, supply and sale of radioactive drugs are under the unified
administration of the Ministry of Energy.
When ordering these stuff, the pharmaceutical factory must furnish a
License for the Production Enterprise of Radioactive Drugs while the
business unit must present a License for the Business Enterprise of
Radioactive Drugs issued by the health administration department at the
provincial, autonomous regional or municipal (directly under the Central
Government) level. As for the medical treatment unit, they must order
these drugs with a License for the Use of Radioactive Drugs jointly issued
by the public security department, the environment protection department
and health administration department at the provincial, autonomous
regional or the municipal (directly under the Central Government) level.
Article 18
The import and export business of radioactive drugs shall be handled by
the units appointed by the Ministry of Foreign Economic Relations and
Trade in accordance with the State provisions related to foreign trade.
Prior to the import or export of radioactive drugs, an application must be
made and be examined and approved by the Ministry of Public Health.
Imported radioactive drugs are required to meet the State standards for
pharmaceuticals or other medical requirements.
Article 19
Imported radioactive drugs are subject to sample examination by the State
Administration for the Inspection and Testing of Pharmaceuticals and
Biological Products or by an inspection and testing institution of
pharmaceuticals authorized by the Ministry of Public Health. Only those
drugs that have met the State standards are allowed to be imported. As for
the drugs with short half-life radionuclide previously approved by the
Ministry of Public Health, they may be put to use upon being shipped in
while having import inspection. If the import inspection unit finds the
quality of imported drugs not up to the standard, they must inform the
consuming units promptly to stop using the drugs. A report about the
quality problem must be submitted to both the Ministry of Public Health
and the Ministry of Energy.
Chapter IV The Packaging and Shipment of Radioactive Drugs
Article 20
The packaging of radioactive drugs must be safe and reliable, and up to
the standards for the quality requirements of radioactive drug. There must
be protection devices that will match different radio dosages. The
packaging is required to consist of packing and inner packaging. There
must be trade mark, label, specifications and marker of radioactive drugs
on the packing and a label on the inner packaging. On the label there must
be name of the drug, radiospecific activity and packings.
The specifications must indicate the name of the producer, license number,
batch number, main composition, date of manufacture, half-life of
radionuclide, indications, administration, dosage, contraindication,
expiry date and precautions in addition to name of the drug, radioapecific
activity and packings.
Article 21
The shipment of radioactive drugs shall be handled in accordance with the
rules formulated by the State transportation and postal departments. No
unit or person shall be allowed to carry along radioactive drugs on any
means of public transportation.
Chapter V The Use of Radioactive Drugs
Article 22
If a medical treatment unit desires to set up a radiologic department or a
radioisotope department, it is required to employ technical personnel who
are qualified for radiotherapeutic work after special technical training.
Without prior technical training no personnel shall be allowed to use the
drugs in radiotherapy.
Article 23
When a medical treatment unit uses radioactive drugs, it must observe the
rules formulated by the State concerning radioisotope hygiene and
protection. The health administration department, the public security
department and the environment protection department at provincial,
autonomous regional or municipal (directly under the Central Government)
level shall issue a certain grade of License for the Use of Radioactive
Drugs according to technical skill and professional level of the
radiological personnel and equipment of the medical treatment unit. No
medical treatment unit without a license is allowed to use radioactive
drugs clinically.
The term of validity of a License for the Use of Radioactive Drugs is 5
years. If needed, the medical treatment unit must make a new application 6
months before the expiration of its license to the health administration
department which, after examination and verification shall issue it a new
license.
Article 24
Before a medical treatment unit holding a License for the Use of
Radioactive Drugs starts the preparation of any forms of radioactive drug
for clinical use, it is required to submit an application with the data
concerning pharmacology and toxicity of the radioactive drug, according to
the characteristics of the radioactive drug, to the health administration
department at the provincial, autonomous regional or municipal (directly
under the Central Government) level for approval and to the Ministry of
Public Health for the record. That form of radioactive drug can be used
only in the medical treatment unit.
Article 25
The medical treatment units that hold a License for the Use of Radioactive
Drugs are required to conduct clinical quality testing of the radioactive
drugs and find out their undesirable reactions and submit regular reports
to the health administration department. The health administration
department at the provincial, autonomous regional or municipal (directly
under the Central Government) level shall then present an itemized report
to the Ministry of Public Health.
Article 26
Waste material of radioactive drugs (including patients' excrement) must
be properly disposed of in accordance with the State regulations.
Chapter VI The Standards for Radioactive Drugs and Their Testing
Article 27
The Pharmacopoeia Commission under the Ministry of Public Health is
entrusted to formulate and revise the State standards for radioactive
drugs and then submit it to the Ministry of Public Health for examination
and approval before it is promulgated.
Article 28
The State Administration for the Inspection and Testing of Pharmaceuticals
and Biological Products or an inspection and testing institution of
pharmaceuticals authorized by the Ministry of Public Health is entrusted
to inspect and examine radioactive drugs.
Chapter VII Supplementary Provisions
Article 29
Any unit or individual that violates these Measures shall be penalized by
the health administration department at or above the county level in
accordance with the Pharmaceutical Administration Law and other rules and
regulations.
Article 30
The right to interpret these Measures resides in the Ministry of Public
Health.
Article 31
These Measures shall go into effect as of the date of promulgation.
不予支持赔偿请求的四种情形
戴洪斌
赔偿请求人向人民法院赔偿委员会提起司法赔偿请求，有相当部分不被支持，或者不予受理，或者决定不予赔偿。未予确认、侵权在前、赔偿范围和免责情形等四个方面，是其重要的原因。以下对此作一分析。
一、不被支持的四种情形
（一）被诉职权行为未经依法确认
国家机关及其工作人员行使职权行为未被依法确认的赔偿申请，应不予受理。最高人民法院《人民法院赔偿委员会审理赔偿案件程序的暂行规定》第二条规定：“赔偿请求人依法向赔偿委员会申请造成赔偿决定的被侵权事项，应当先经过依法确认。根据赔偿法第二十条第二款的规定，被要求确认的机关不予确认的，赔偿请求人有权申诉。赔偿委员会不受理要求确认的申诉案件。”对侵权行为的确认，是进入国家赔偿的前置程序。如对相关司法行为没有进行依法确认，未确认为违法，则无法进入下一国家赔偿程序，赔偿请求人就无法获得赔偿救济。人民法院赔偿委员会没有确认职能，不能审查国家赔偿确认申请，无权办理国家赔偿确认案件。被诉职权行为未经依法确认，赔偿请求人直接向人民法院赔偿委员会提起赔偿申请，按照相关法律规定，人民法院赔偿委员会不能审理；并且，人民法院赔偿委员也无审理国家赔偿确认案件的职权，只能针对赔偿请求人提出的赔偿申请作出不予受理决定。即使当时审查不严作了受理，在后来的审理程序中，也要予以驳回。
（二）被诉职权行为发生于国家赔偿法实施前
被诉职权行为发生于国家赔偿法实施前，而申请到人民法院赔偿委员会要求赔偿的案件，在国家赔偿法开始实施的前几年较多。最高人民法院《关于< 中华人民共和国国家赔偿法>溯及力和人民法院赔偿委员会受案范围问题的批复》第一条规定：“根据国家赔偿法第三十五条规定，国家赔偿法1995年1月1日起施行。国家赔偿法不溯及既往。即：国家机关及其工作人员行使职权时侵犯公民、法人和其他组织合法权益的行为，发生在1994年12月31日以前的，依照以前的规定处理。发生在1995年1月1日以后并经依法确认的，适用国家赔偿法予以赔偿。发生在1994年12月31日以前，但持续至1995年1月1日以后，并经依法确认的，属于1995年1月1日以后应予赔偿的部分，适用国家赔偿法予以赔偿；属于1994年12月31日以前应予赔偿的部分，适用当时的规定应予赔偿；当时没有规定的，参照国家赔偿法的规定应予赔偿。”国家赔偿法不溯及既往原则，遵照了法律的时间效力的精神，也符合中国的实际情况。因为以前历史时期形成的大量问题，经过多年不懈努力，基本得到了解决。如果国家赔偿法可以溯及既往，过去已经妥善解决、平息了的问题，可能将因此规定而引发大量的国家赔偿诉讼，其负面效应并不好。国家赔偿法确定的不溯及既往的原则，并未堵塞过去时期个别遗留问题的解决渠道和途径，仍然可以按照当时的政策精神来妥善处理。经过这么多年的国家赔偿案件处理，大力宣传国家赔偿法，再就发生于国家赔偿法实施前司法行为而提起国家赔偿的明显少多了。
（三）不属于国家赔偿范围
司法机关的职权行为造成赔偿请求人损失，按照国家赔偿法的规定，只赔偿直接损失，对于司法机关职权行为造成的间接损失和可得利益，以及精神损害，则没有纳入国家赔偿范围。另外，还有应通过其他途径解决的，也不属于国家赔偿范围。国家赔偿的范围明确，纳入了赔偿范围的才予赔偿。凡没有纳入赔偿范围的，则不予赔偿。属于这种情形的案件较多。国家赔偿法第三章第一节专门规定了司法赔偿的赔偿范围。其第十五条、第十六条对刑事赔偿的范围作了明确规定。国家赔偿法第三十一条、最高人民法院《关于民事、行政诉讼中司法赔偿若干问题的解释》第二条至第五条，也规定了人民法院在民事诉讼、行政诉讼过程中，违法采取对妨害诉讼的强制措施、保全措施或者对判决、裁定及其他生效法律文书执行错误，造成损害的，也应予以赔偿的赔偿范围（非刑事司法赔偿）。
（四）属于国家赔偿免责情形
国家赔偿法第十七条规定：“属于下列情形之一的，国家不承担赔偿责任：（一）因公民自己故意作虚伪供述，或者伪造其他有罪证据被羁押或者被判处刑罚的；（二）依照刑法第十四条、第十五条规定不负刑事责任的人被羁押的；（三）依照刑事诉讼法第十一条规定不追究刑事责任的人被羁押的；（四）行使国家侦查、检察、审判、监狱管理职权的机关的工作人员与行使职权无关的个人行为；（五）因公民自伤、自残等故意行为致使损害发生的；（六）法律规定的其他情形。”《最高人民法院关于民事、行政诉讼中司法赔偿若干问题的解释》第七条规定：“根据国家赔偿法第十七条、第三十一条的规定，具有下列情形之一的，国家不承担赔偿责任：（一）因申请人申请保全有错误造成伤害的；（二）因申请人提供的执行标的物有错误造成伤害的；（三）人民法院工作人员与行使职权无关的个人行为；（四）属于民事诉讼法第二百一十四条规定情形的；（五）被保全人、被执行人，或者人民法院依法指定的保管人员违法动用、隐匿、毁损、变卖人民法院已经保全的财产的；（六）因不可抗力造成伤害后果的；（七）依法不应由国家承担赔偿责任的其他情形。”司法行为虽被依法予以了确认，但是只要符合以上国家赔偿法和最高人民法院规定的免责情形，国家就不承担赔偿责任。这是国家赔偿法对国家承担赔偿责任的例外规定。国家赔偿的免责情形，类型很多，情况不一，也是最容易引起争议的问题。这种情况下，赔偿请求人按照相关规定，依法进入到了国家赔偿程序中来，做了不少工作，后来却被告知因属于国家赔偿的免责情形而不予赔偿，这对他们是一个意外的打击，其将对法制的权威性和严肃性产生怀疑和动摇。
二、做好相关工作的建议
（一）提高认识，切实保护赔偿请求人的诉权
司法赔偿是国家赔偿的重要组成部分。对于司法机关及其工作人员行使职权时行为违法造成的损害给予救济，是司法赔偿的基本功能。给予司法侵权的受害人一定的赔偿，可以缓解和消除司法机关、国家与公民、法人和其他组织之间的矛盾，防止公民、法人和其他组织对司法机关产生不满和对立情绪，有利于国家的稳定和社会的和谐。司法赔偿是对违法司法行为的否定性评价，对司法机关及其工作人员是一种有力的监督，能够进一步提高司法机关及其工作人员的责任感，加强内部管理和监督，有效促进司法机关及其工作人员依法行使司法职权，确保司法权行使的准确性和合法性。要统一思想，提高认识，克服国家赔偿案件麻烦多、干预大的畏难情绪，对赔偿请求人的请求依法应予支持的坚决支持，对于不能支持的要有充分的法律依据，并做好化解和善后工作，切实保护赔偿请求人依法取得国家赔偿的权利。
（二）认真审查，把好立案质量关
严格执行最高人民法院《关于刑事赔偿和非刑事司法赔偿案件立案工作的暂行规定（施行）》，规范国家赔偿案件的立案工作，切实保障赔偿请求人依法申请国家赔偿的权利。对于依法应由人民法院赔偿委员会作出决定的赔偿案件，在收到赔偿申请后，应当依法进行审查，符合下列条件的，应予及时立案：（一）赔偿请求人具备法律规定的主体资格；（二）赔偿义务机关是行使侦查、检察、审判、监狱管理职权的机关；（三）有具体的赔偿请求事项和事实根据；（四）有依法确认的法律文书或者其他材料；（五）符合法定的请求期间，因不可抗力或者其他障碍未能在法定期间内行使请求权或者人民法院赔偿委员会决定延长期间的除外；（六）赔偿义务机关是侦查、检察、监狱管理机关的，作出赔偿决定后或者逾期未作赔偿决定，赔偿请求人申请复议，经复议仍不服或者复议机关逾期未作复议决定的；赔偿义务机关是人民法院的，作出赔偿决定后，赔偿请求人不服的，或者人民法院逾期未作决定的；（七）符合国家赔偿法及有关司法解释对国家赔偿法溯及力的规定。还要切实执行最高人民法院《关于刑事赔偿和非刑事司法赔偿案件立案工作的暂行规定（施行）》第九条规定，严格审查赔偿请求人提出的国家赔偿申请，是否符合立案范围的七种情形。完全符合以上情形的，予以立案受理。不符合的，不予立案。避免因审查不严轻率进入审判程序，再在审理中予以驳回。
（三）做好解释说服，指明救济途径
妥善处理好司法赔偿的来信来访，是创造稳定和谐的社会环境和良好法治环境的有力措施，是促进国家赔偿队伍自身建设、加强赔偿工作的重要内容。要统一思想，提高认识，牢固树立“群众利益无小事”和“司法为民”的思想，切实为人民群众排忧解难，以深厚的感情，妥善处理好每一起群众来信来访。向来访群众和败诉的赔偿请求人释难解疑，做好法律解释工作，阐释人民法院赔偿委员会不支持其主张的法律依据，促使其息诉服判。经审查不应由人民法院或者人民法院赔偿委员会受理的，告知来访群众和赔偿请求人向有关机关申请赔偿。应由其他法院或其他法院赔偿委员会受理的，告知来访群众和赔偿请求人向有关人民法院或有关人民法院赔偿委员会申请赔偿。对于不属于直接损失，赔偿请求人申请赔偿间接损失和可得利益，以及精神损害的，说明不予支持赔偿请求的理由，并做好说服解释工作。对于被申请赔偿的职权行为发生于国家赔偿法实施前的，提示赔偿请求人按照以前的政策规定寻求解决。
（四）加强对下指导，提高赔偿案件办理水平
上级人民法院赔偿委员会要加大对下级人民法院办理赔偿案件的指导力度。指导审查赔偿请求人提出的赔偿申请是否符合条件，审查提起赔偿申请的司法侵权行为是否先经依法确认，审查赔偿申请有关证明材料是否齐全。加强案件办理质量指导，符合规定应予赔偿的依法足额赔偿。对于不应赔偿的，则做好释法工作。还要指导下级人民法院做好对赔偿请求人和来访群众的解释说服工作，晓之以理，动之以情，使之信服人民法院人民法院作出的决定。
（五）重视调查研究，完善法律规定和工作制度
国家赔偿法律需要随着经济社会的发展而发展，不断加以完善。近年来，国家赔偿法的修改一直是社会舆论热点，修正案草案也先后两度亮相。个人认为，需要在以下几个方面加强调查研究，完善相关法律和工作制度：一是要对国家赔偿确认程序和赔偿程序的衔接加强研究，简化申请确认、赔偿和办理程序，切实方便赔偿请求人提起赔偿申请，方便法院工作部门的办理工作，减少赔偿请求人诉累。二是要重视对国家赔偿法实施前侵权遗留问题的处理，依靠地方党政，从政策、民政上，给予受到侵权者以灵活多样的救助，解决赔偿请求人实际困难，保障民生，增加社会稳定和谐因素。三是要逐步扩大国家赔偿范围。随着国家财力增强，法制进程加快，国家赔偿的赔偿范围要逐步扩大。民众也有扩大赔偿范围的强烈呼声，要求给予国家赔偿以充分保护。但这要通过修改国家赔偿法或制定相应司法解释来实现。只有在立法上对赔偿范围作了扩大，国家赔偿实务工作才有法律依据，国家赔偿才能给予更好的保护。四是要重新梳理和认识国家赔偿免责规定，避免再走可以进入赔偿程序而不能实际获得国家赔偿这一“程序游戏”，不要再出现程序上保护而实体上不保护的怪现象，在减少赔偿请求人诉累、维护国家赔偿法严肃性上多下功夫。这是立法部门和司法实务部门要切实研究和解决的问题。