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.


关于代位权的几个问题研究

王瑜


【内容提要】随着经济的快速发展，债权代位权制度在我国的法律中从无到有。但是有关其内容和性质的争议却远没有停息，本文从代位权的历史出发，试图阐明代位权的有关问题。
【关 键 词】代位权 内容 性质 行使

一、代位权的性质
传统民法上的代位权制度认为代位权是指债务人对第三人享有权利却不行使，使其将来的偿债财产应该增加而未增加，危及债权实现，债权人以自己的名义代替债务人行使权利的权利。
代位权是一种什么性质呢？首先，这种权利不需要征得债务人的同意，债权人直接根据法律的规定就可以行使，似乎可以直接将其指称为形成权。其次，代位权很像民事中的代理，但债权人是以自己的名义代行权利，与代理的特点存在明显差异。台湾有学者将其称为以行使他人权利为内容的管理权，也有人认为它是从属于债权的一种特别权利，属广义的形成权。再次，代位权本身并非一种独立存在的权利，而是一项依附于债权的权能，称为代位权能。再次，代位权看似债权人向第三人为请求，第三人负有协助的义务。似乎与请求权很接近。这也是最容易产生的认识。
其实，代位权已经超越了债权相对性而直接指向第三方甚至可以再次代位。因此它从一开始就被赋予了迥异于债权请求权的内核。但它也并非要与物权的追及效力相混淆，相反，代位权跨越法律关系双方而针对第三人，和物权的追及效力是有本质不同的。有了债权，不一定就具有代位权。因此把代位权定义为债权的一项权能，似乎于理不通。
故而笔者认为，代位权就是一种形成权。它仅仅需要债权人单方作出代位的意思表示即可发生法律认可的效力，其产生并不依靠第三人的行为。它不依赖债务人和次债务人的协助而行使。虽然要以债权人与债务人之间的债务关系作前提，但是代位权并不因为这个债权的产生而绝对存在。换句话说，有了债权并不一定存在代位的可能。代位权的真正前提，在于债务人怠于行使自己的权利危害了债权人的利益，由债权人做出代位的意思表示。我们也不能把权利的生成和权利的实现混为一谈。代位权因为债权人的表意即存在，而代位权的实现，才依赖债权人之外的人之行为，比如债务人和次债务人的行为。这是代位权和强制执行权的区别所在。有人错将代位权误解为请求权的根源也在于此。
二、代位权的内容
《合同法》第73条规定：“因债务人怠于行使其到期债权，对债权人造成损害的，债权人可以向人民法院请求以自己的名义代位行使债务人的债权，但该债权专属于债务人自身的除外。”合同法解释依照合同法第七十三条的规定，规定了代位权行使的实质要件：（一）积极要件：1、合法性，2、因果性，3、期限性，4、货币性；（二）消极要件：债务人的债权不是专属于债务人自身的债权。
从我国现在合同法及司法解释的条文不难看出，我国法律所认可的代位权限定在债权，并且主要是金钱性质的债权。这样的规定是否具有合理性呢？目前我国就可以代位的权利范围，简言之有两种观点：一种是主要限定为债权]。另一种是依照传统民法的观点，认为不应当对代位权的范围作出过大限制，只要这种代位确有必要。甚至有的学者已经对代位权的范围做了一个广泛的列举。从各国立法的规定来看，《法国民法典》第1166条规定“债权人得行使债务人的一切权利和诉权。”日本和我国台湾地区的立法和理论中，除了债权之外，还包括物权及物上请求权；除了请求权之外，还包括形成权，甚至债权人代位权、撤销权本身又可以成为代位权的标的；并且不仅限于私法上的权利，甚至包括一些公法上的权利。代位的内容非常广泛。
作为一个前提性的问题，首先应该探讨的是代位权的设置究竟为什么？有学者认为代位权制度其根本目的是为了保护债权人。不可否认，债务人不实现自己的到期债权，其行为危害到债权人，法律赋予了债权人以代位权。但其终极目标并不仅仅是保护债权人债权利益的实现。如前所述，代位权基于诚实信用和公序良俗而生，其目的站在整个市场交易的高度，它“是通过重新定位各方利益 ，平衡各方关系达到保护交易安全的目的。”这种利益的范围理解不限定为债权。代位权的作用，在于保障债权人不因为“债务人应行使权利并能行使而不行使”从而遭受损失。这种损害并不要求是债务人不行使债权所带来的损害，只要债权人的权利因为债务人的行为而有受损可能即可。
最高人民法院的解释将代位权的客体限定在“具有金钱给付内容的到期债权”。支持这种观点的学者认为，金钱给付性质的债权便于履行，不会造成不必要的繁琐程序，并且可以维护债务人合法的权利[15]。笔者认为这种观点值得商榷。首先，代位权要保障债权人的利益，如果以金钱性质的债权限定可代位的权利范围，会极大地限制债权人行使代位权的积极性和可能性。保障交易的动态安全，需要给予交易人以合理的信赖利益和安全感。过窄的代位范围使得人人惶惶不安，谁还敢放心地享有债权、进行交易呢？这无疑大大降低了债的保全措施和财富流动的效率。其次，这种规定有可能促使人们在商品交换中，“根据趋利避害的原则而趋向于尽量避免以金钱为给付内容，代之以其它标的，因为这样会使行为人受到代位权追究的机会减少” [16]突破债法相对性理论建立代位权，保障社会交易的动态安全，如果代位权的适用范围被大大收缩，反倒为交易人所规避，相信不是立法者的初衷。
介于上述原因，笔者认为，可以代位的权利应该可以包括(1)财产性质的实体权利； (2)保全债务人既得权利的形成权，比如撤销权、抗辩权（3）对债务人的权利状态存在影响的程序性权利，比如登记权、诉权等等。
相对于非实体性质的形成权和程序性权利而言，较有争议的部分在于财产性质的实体权。
财产性质的实体权利通常包括债权和物权请求权。债权可以代位基本没有争议，但对于物权请求权的代位可能，学界却是声音不一。反对物权可代位的观点认为，只有债权人与债务人及债务人与第三人之间的法律关系都是债的关系时，代位权人才可能向第三人主张权利。如果债务人对第三人拥有的是物权，则代位权人根本不可能越过债务人向第三人主张物权，否则理论上会陷于自相矛盾。债务人享有的物权，大都要经过登记产生，在绝大多数情况下，即使物权人怠于行使权利也不会导致他物权的消灭，所以没有必要行使代位权。赞同物权代位的学者认为，代位权可以针对物权及物权请求权行使， “如果债务人享有抵押权、质权、留置权，债权人均可代位行使请求人民法院拍买抵押物、质物、留置物”按照民法基本理论，债务人应该以自身的所有财产作为债务的一般担保。债务人的财物即使为他人所占有、使用、收益、处分，其财物仍然是其债务的担保。不为债务人自己所占有的物，其权利非自愿丧失的风险也必然增大。虽然有学者指出我国的所有权等没有消灭时效规定，为他人占有并不会丧失对财物享有的物权。但是，物客观丧失的可能性仍然是存在的。而这种风险必然会导致债务人担保财产的减少，因而损害债权人债权的实现。当第三人对债务人的财产进行客观消耗和处分时，债权人无法靠行使撤销权来加以挽救。这种情况不能事后补救，而要预先向第三人进行干涉。代位权存在的理由就在于债务人不行使自己的权利而可能无法履行债权人的债权，法律赋予债权人介入债务人与第三人法律关系的资格以保证债权人自己权利的稳定。对于介入的法律关系究竟是债权法律关系还是物权法律关系，从代位权设置的目的来说，是不受到影响的，即只要这一法律关系的变化影响到债权人与债务人之间债权关系，债权人即可行使代位权。
三、代位权的行使
在传统民法中，代位权行使的效果归属于债务人，代位权人不得径行满足自己债权；而在我国，依《解释》第20条，代位权行使的效果直接归属于债权人。我国的法律规定代位权只能以诉讼行为行使，不允许债权人以直接行使的方式向次债务人主张 。这样的规定曾引来许多学者的反对。介于篇幅所限，笔者仅针对我国现行《合同法》和司法解释的规定作简要阐释。代位权的行使有赖于债权人的积极行为，如果按照传统民法认可的方式，代位权的行使结果是向债务人履行，无疑会减少债权人选择代位权的动力。债权人代替怠于行使权利的债务人接受履行，并将接受的结果归入债务人的责任财产之中，其效果要比直接向债务人履行有效得多。有人可能担心这样债权人仍然没有从行使代位权中获得优先于其他债权人的地位。笔者认为，首先，债权人维护自己的债权的行为并不会过分考虑是否有其他债权人分享。因为如果自己不行使，其后果只会更糟。至于债务人的财产即使通过代位后仍然不能在众多债权人之间完全分配时，法律确实有必要对行使代位权的债权人予以优先关怀。立法设计上可以就此情况设定债务人被代位财产优先受偿制度。这种设计是否符合传统法理姑且不论，现代民法中捍卫合法利益而直接创设法定优先权在立法上已有先行者，比如建设工程价款优先受偿权。当然，具体操作有待进一步梳理。

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作者：王瑜，西南政法大学国际法专业04级研究生