中华人民共和国卫生部关于审批国外药品临床试验的规定

作者:法律资料网 时间:2024-07-26 01:40:44   浏览:9857   来源:法律资料网
下载地址: 点击此处下载

中华人民共和国卫生部关于审批国外药品临床试验的规定

卫生部


中华人民共和国卫生部关于审批国外药品临床试验的规定

1988年2月2日,卫生部

一、国外药品在中国进行临床试验,必须按照中华人民共和国卫生部《关于国外药品在中国注册及临床试验的规定》,由国外厂商向卫生部药政局提出书面申请,经批准后方可进行。
二、申请进行药品临床试验时,申请者必须说明该项研究的目的,并提供以下资料:
1.该药品在申请者所在国或他国(地区)注册或获准进行临床试验的证明文件。
2.关于生产该药品的厂家符合药品生产质量管理规范(GMP)的证明。
3.药品的技术资料:
(1)药品名称(包括商品名、国际非专利名称、化学名)、处方组成、剂型、活性成分的名称和结构以及确证结构的依据;
(2)药品的来源及生产方法;
(3)稳定性实验资料;
(4)药品的质量标准及检验方法;
(5)临床前药理、毒理、药物代谢动力学研究资料(菌苗、疫苗须提供生物制品菌毒种特性、制品的安全性和免疫原性研究资料等);
(6)已在国外进行的临床试验的资料;
(7)该药品的使用说明书和样品;
(8)其他有关该药品的资料。
4.拟在中国进行的临床试验的方案。
以上每项资料均须附有中文摘要或综述,其中药品的质量标准和使用说明以及拟在中国进行的临床试验的方案必须附有完整的中文译本。
三、国外药品经批准在中国进行临床试验,由卫生部药政局指定临床药理研究机构和医院进行。申请者可就参加临床试验的单位提出建议,由卫生部药政局确定。
四、临床试验的病例数由申请者提出建议,但对于为在中国注册或为取得《进口药品许可证》的药品,其病例数则视情况而定,如该药品已在申请者所在国(地区)注册,病例数应在50例以上(对照组另设);如该药品未在申请者所在国(地区)注册,但已在其他国家(地区)注册,病例数应在100例以上(对照组另设);如该药品尚未在申请者所在国(地区)及其他国家(地区)注册,则病例数应在300例以上(对照组另设)。特殊病种的病例数视情况而定。
五、卫生部药政局在批准进行临床试验并指定临床单位后,通知申请者和参加临床试验的单位,卫生部药政局将指定一个机构代表临床试验单位与外商进行谈判、签订合同,并配合卫生部药政局做好临床试验的组织协调及服务性工作。
六、申请者应免费提供所试药品(包括对照品及必要的试剂),并附有该批药品质量检验合格的报告。对于尚未在申请者所在国(地区)注册的新药,尚须经中国药品检验机构检验,合格者方可使用。
七、申请者应按照每种类别的药品和病例数提供临床研究费用,具体数额由卫生部药政局指定的机构与申请者商定。如药品经中国药品检验机构检验,将参照《药品审批监督检验收费标准》收取检验费。
八、临床试验的技术负责单位应根据申请者的要求并按照卫生部有关临床试验的指导原则制定临床试验计划,报卫生部药政局备案后执行。
九、在临床试验过程中,临床单位必须严密注意用药者的情况,确保用药者的安全。如由于药品本身的原因而造成不良后果者,由申请者承担责任,并赔偿一切损失。
十、临床试验结束后,临床单位应将临床试验总结报告报卫生部药政局,抄送申请者。
十一、由于我国医疗、科研的需要而应用国外药品进行临床试验(病例数不应超过20例),由国内的单位提出申请,并按本规定第二条报送资料,经卫生部药政局批准后进行。
十二、本规定由中华人民共和国卫生部药政局负责解释。
十三、本规定自公布之日起实施。


下载地址: 点击此处下载
Chapter IV
Function of Panels: Art. 11 of the DSU


OUTLINE


I Introduction
II Application of Art. 11 as a General Standard of Review
III Review in “neither de novo nor total defence”
IV Allegation against Panels’ Standard of Review
V Exercise of Judicial Economy





I Introduction
The function of panels is expressly defined in Art. 11 of the DSU, which reads as follows:

“The function of panels is to assist the DSB in discharging its responsibilities under this Understanding and the covered agreements. Accordingly, a panel should make an objective assessment of the matter before it, including an objective assessment of the facts of the case and the applicability of and conformity with the relevant covered agreements, and make such other findings as will assist the DSB in making the recommendations or in giving the rulings provided for in the covered agreements. Panels should consult regularly with the parties to the dispute and give them adequate opportunity to develop a mutually satisfactory solution.”

This provision suggests that the function of panels is to make an objective assessment such as to assist the DSB in making the recommendations or in giving the rulings provided for in the covered agreements. However, how do panels fulfill their functions as provided in Art. 11 of the DSU? It is the issue that we will touch on in this chapter. In this chapter, the author explores on the standard of review issue under the WTO, i.e. “an objective assessment”; as well as on the exercised judicial economy principle developed in panel’s review.
With regard to the standard of review issue, the GATT/WTO dispute settlement procedures have increasingly confronted questions concerning the degree to which an international body, under the GATT/WTO, should “second guess” a decision of a national government agency concerning economic regulations that are allegedly inconsistent with an international rule. It seems clear that the international agreement doesn’t permit a national government’s determination always to prevail, otherwise the international rules could be easily evaded or rendered ineffective. But should the international body approach the issues involved without any deference to the national government? It has been argued in the GATT/WTO proceedings that panels should respect national government determinations, up to some point. That “point” is the crucial issue that has sometimes been labelled the “standard of review”.1
Of course, this issue is not unique to the GATT/WTO. Naturally, the standard-of-review issue is one that many legal systems face. “The standard-of-review question is faced at least implicitly whenever sovereign members of a treaty yield interpretive and dispute settlement powers to international panels and tribunals. Moreover, as national economies become increasingly interdependent, and as the need for international cooperation and coordination accordingly becomes greater, the standard-of-review question will become increasingly important.” 2 And “it can be seen that the standard-of-review question is a recurring and delicate one, and one that to some extent goes to the core of an international procedure that must (in a rule-based system) assess a national government’s actions against treaty or other international norms”. 3
However, for the immediate purpose, we want to focus below on the more particular question of the proper standard of review for a WTO panel when it undertakes to examine a national government’s actions or rulings that engage the question of consistency with the various WTO agreements and are subject to the DSU procedures.

II Application of Art. 11 as a General Standard of Review
Under the WTO jurisprudence, it’s demonstrated that Art. 11 of the DSU has been applied as a general standard of review. Art. 11 suggests that the function of panels is to make “an objective assessment” so as to assist the DSB in making the recommendations or in giving the rulings provided for in the covered agreements.
For example, in US-Shirts and Blouses (DS33), the Panel rules that, “although the DSU does not contain any specific reference to standards of review, we consider that Article 11 of the DSU which describes the parameters of the function of panels, is relevant here”. 4
And the application of Art. 11 as a general standard of review under the DSU is analyzed systematically in EC-Hormones (DS26/DS48) where the Appellate Body rules that: 5
“The first point that must be made in this connection, is that the SPS Agreement itself is silent on the matter of an appropriate standard of review for panels deciding upon SPS measures of a Member. Nor are there provisions in the DSU or any of the covered agreements (other than the Anti-Dumping Agreement) prescribing a particular standard of review. Only Article 17.6(i) of the Anti-Dumping Agreement has language on the standard of review to be employed by panels engaged in the ‘assessment of the facts of the matter’. We find no indication in the SPS Agreement of an intent on the part of the Members to adopt or incorporate into that Agreement the standard set out in Article 17.6(i) of the Anti-Dumping Agreement. Textually, Article 17.6(i) is specific to the Anti-Dumping Agreement.
[…]
We do not mean, however, to suggest that there is at present no standard of review applicable to the determination and assessment of the facts in proceedings under the SPS Agreement or under other covered agreements. In our view, Article 11 of the DSU bears directly on this matter and, in effect, articulates with great succinctness but with sufficient clarity the appropriate standard of review for panels in respect of both the ascertainment of facts and the legal characterization of such facts under the relevant agreements […]”
In sum, for all but one of the covered agreements, Art. 11 of the DSU sets forth the appropriate standard of review for panels. As stated on more than one occasion, Art. 11 of the DSU, and, in particular, its requirement that “a panel should make an objective assessment of the matter before it, including an objective assessment of the facts of the case and the applicability of and conformity with the relevant covered agreements”, sets forth the appropriate standard of review for panels examining the consistency or inconsistency of alleged measures under the WTO jurisprudence. And the only exception is the Agreement on Implementation of Article VI of the General Agreement on Tariffs and Trade 1994, in which a specific provision, Art. 17.6, sets out a special standard of review for disputes arising under that Agreement(to be discussed in subsequent chapter).6

III Review in “neither de novo nor total defence”
In EC-Hormones (DS26/DS48), in the view of the European Communities, “the principal alternative approaches to the problem of formulating the ‘proper standard of review’ so far as panels are concerned are two-fold. The first is designated as ‘de novo review’. This standard of review would allow a panel complete freedom to come to a different view than the competent authority of the Member whose act or determination is being reviewed. A panel would have to ‘verify whether the determination by the national authority was…correct (both factually and procedurally)’. The second is described as ‘deference’. Under a ‘deference’ standard, a panel, in the submission of the European Communities, should not seek to redo the investigation conducted by the national authority but instead examine whether the ‘procedure’ required by the relevant WTO rules had been followed”.7 In this respect, the Appellate Body rules that:8
“So far as fact-finding by panels is concerned, their activities are always constrained by the mandate of Article 11 of the DSU: the applicable standard is neither de novo review as such, nor ‘total deference’, but rather the ‘objective assessment of the facts’. Many panels have in the past refused to undertake de novo review, wisely, since under current practice and systems, they are in any case poorly suited to engage in such a review. On the other hand, ‘total deference to the findings of the national authorities’, it has been well said, ‘could not ensure an 'objective assessment' as foreseen by Article 11 of the DSU’.”
The ruling is confirmed on many other occasions. For example, the Panel on US-Underwear (DS24) finds that: 9
“In our opinion, a policy of total deference to the findings of the national authorities could not ensure an ‘objective assessment’ as foreseen by Article 11 of the DSU. This conclusion is supported, in our view, by previous panel reports that have dealt with this issue, and most notably in the panel report on the ‘Transformers’ case.
The panel in the ‘Transformers’ case was confronted with the argument of New Zealand that the determination of ‘material injury’ by the competent New Zealand investigating authority could not be scrutinized by the panel. The ‘Transformers’ panel responded to this argument as follows:
‘The Panel agreed that the responsibility to make a determination of material injury caused by dumped imports rested in the first place with the authorities of the importing contracting party concerned. However, the Panel could not share the view that such a determination could not be scrutinized if it were challenged by another contracting party. On the contrary, the Panel believed that if a contracting party affected by the determination could make a case that the importation could not in itself have the effect of causing material injury to the industry in question, that contracting party was entitled, under the relevant GATT provisions and in particular Article XXIII, that its representations be given sympathetic consideration and that eventually, if no satisfactory adjustment was effected, it might refer the matter to the CONTRACTING PARTIES, as had been done by Finland in the present case. To conclude otherwise would give governments complete freedom and unrestricted discretion in deciding anti-dumping cases without any possibility to review the action taken in the GATT. This would lead to an unacceptable situation under the aspect of law and order in international trade relations as governed by the GATT’.”
In short, for the panel to adopt a policy of total deference to the findings of the national authorities could not ensure an “objective assessment” as foreseen by Art. 11 of the DSU. This conclusion is supported, in our view, by previous panel reports that have dealt with this issue. However, panels do not see their review as a substitute for the proceedings conducted by national investigating authorities, either. For example, in Argentina-Footwear (DS121), the Panel doesn’t consider that they have the mandate to conduct a de novo review: 10
“This approach is consistent with the reports of panels reviewing national investigations… The panel on United States - Anti-dumping Duties on Import of Salmon from Norway concluded that it should not engage in a de novo review of the evidence examined by the national investigating authority.
The panel on United States - Underwear followed this approach by noting, however, that it did not see its ‘review as a substitute for the proceedings conducted by national investigating authorities or by the Textiles Monitoring Body (TMB). Rather…the Panel's function should be to assess objectively the review conducted by the national investigating authority, in this case the CITA. We draw particular attention to the fact that a series of panel reports in the anti-dumping and subsidies/countervailing duties context have made it clear that it is not the role of panels to engage in a de novo review. In our view, the same is true for panels operating in the context of the ATC, since they would be called upon, as in the cases dealing with anti-dumping and/or subsidies/countervailing duties, to review the consistency of a determination by a national investigating authority imposing a restriction under the relevant provisions of the relevant WTO legal instruments, in this case the ATC. …’
Accordingly, the panel on United States - Underwear decided, ‘in accordance with Article 11 of the DSU, to make an objective assessment of the Statement issued by the US authorities … which, as the parties to the dispute agreed, constitutes the scope of the matter properly before the Panel without, however, engaging in a de novo review. … an objective assessment would entail an examination of whether the CITA had examined all relevant facts before it, whether adequate explanation had been provided of how the facts as a whole supported the determination made, and, consequently, whether the determination made was consistent with the international obligations of the United States’.
The panel on United States - Shirts and Blouses also stated that ‘[t]his is not to say that the Panel interprets the ATC as imposing on the importing Member any specific method either for collecting data or for considering and weighing all the relevant economic factors upon which the importing Member will decide whether there is need for a safeguard restraint. The relative importance of particular factors including those listed in Article 6.3 of the ATC is for each Member to assess in the light of the circumstances of each case’.
These past GATT and WTO panel reports make it clear that panels examining national investigations in the context of the application of anti-dumping and countervailing duties, as well as safeguards under the ATC, have refrained from engaging in a de novo review of the evidence examined by the national authority.”
However, as emphasized by the Appellate Body, although panels are not entitled to conduct a de novo review of the evidence, nor to substitute their own conclusions for those of the competent authorities, this does not mean that panels must simply accept the conclusions of the competent authorities. In this respect, the phrase “de novo review” should not be used loosely. If a panel concludes that the competent authorities, in a particular case, have not provided a reasoned or adequate explanation for their determination, that panel has not, thereby, engaged in a de novo review. Nor has that panel substituted its own conclusions for those of the competent authorities. Rather, the panel has, consistent with its obligations under the DSU, simply reached a conclusion that the determination made by the competent authorities is inconsistent with the specific requirements of the covered Agreement. 11
  不便管辖原则是指享有管辖权的本国法院在受理案件后,发现另一享有管辖权的外国法院对案件的审理更为便利及公正,从而拒绝行使管辖权或有条件地中止本国管辖权的制度。[1]不便管辖原则也称不方便法院原则或非方便法院原则。
不便管辖原则主要适用于跨国主体间的民商事诉讼,其根源在于全球经济日益融合,超越国界的经贸往来、资本流动、技术转移、销售服务等领域产生的矛盾和冲突。就国际交往的主体而言,一方面,各国努力维护主权,通过立法等手段扩大管辖范围,追求本国利益最大化。另一方面,经济全球化进程的不断加快、生产要素的全球化配置与重组以及生产、投资、金融、贸易在全球范围内的大规模流动,使得国家间的依存关系和程度进一步加剧,使得各国不得不在一定程度上对利益的追求有所收敛。反映在管辖权方面,各国一方面表现出“争”的一面,即存在着争夺、扩大管辖权的倾向;另一方面,也表现出“让”的一面,即在积极寻求管辖权的合作与限制。在不愿放弃立法上“争”的一面的情况下,通过司法上的“让”也可以进行较好的平衡。不便管辖原则实际上代表了司法过程中“让”的理念。[2]
一、对不便管辖权原则的司法认知
对普通法系的英国、加拿大、美国、澳大利亚等国适用不方便法院原则进行考察,在适用原则上存在以下共同之处:第一,国外必须存在一个可替代的法院。第二,是否便于当事人诉讼。第三,法院一般有权作出中止诉讼或者拒绝管辖的决定。[3]
但是,不同国家对不便管辖适用原则的差异性也是非常重要的。因为,即使类似案情的案件,适用不同的不便管辖原则也会导致不同的结果。不便管辖原则在适用方法上的不同主要表现在:在对是否适用该原则的证明责任上,由被告证明的主体和内容不同。如,英国和加拿大的适用标准是可替代法院“明显更合适”,被告以不便管辖原则为由请求驳回原告诉讼请求的,需要证明有“明显更合适”的法院存在,而对于原告,则必须证明其选择的法院是有特殊的理由。美国和加拿大则不然,被告以不便管辖为由请求驳回诉讼的,需要证明受理案件的法院“明显不合适”。在澳大利亚,不便管辖原则只有在本国法院是“明显地不合适”时,才能适用;在美国,适用的标准是本国法院“严重地不方便”。
不便管辖原则在我国的借鉴或吸收属于法律移植问题,法律移植必须明确一个基本问题,即移植的法律与原则是否为一国国情所接纳。出于一国主权利益的考虑,我国与其他国家一样,在立法中同样存在过度管辖的问题。我国有关涉外管辖权的规定,主要存在于民事诉讼法及相关的司法解释中,这些管辖根据几乎包括了合同和其他财产权益纠纷的所有重要方面。因此,就一项具体的与中国有关的合同纠纷或者其他涉及财产权益的纠纷而言,大都无法脱离我国法院的管辖。与此同时,在扩张我国法院管辖权的同时,也带来了平行管辖与平行诉讼管辖权的积极冲突问题。为了应对司法实践中出现的类似问题,2005 年最高人民法院发布了 《第二次全国涉外商事海事审判工作会议纪要》,该纪要第 11 条规定,内地法院在审理涉外商事纠纷案件过程中,如发现案件存在不便管辖的因素,可以不方便法院原则裁定驳回原告的起诉。不方便法院原则的适用需符合如下条件:(1)被告提出适用不方便法院原则的请求,或者提出管辖异议而受案法院认为可以考虑适用不方便法院原则。(2)受理案件的我国法院对案件享有管辖权。(3)当事人之间不存在选择我国法院管辖的协议。(4)案件不属于我国法院专属管辖。(5)案件不涉及我国公民、法人或者其他组织的利益。(6)案件争议发生的主要事实不在我国境内且不适用我国法律,我国法院若受理案件在认定事实和适用法律方面存在重大困难。(7)外国法院对案件享有管辖权且审理该案件更加方便。[4]该规定对司法实践中处理涉外管辖权冲突的案件提供了指导原则。
二、对不便管辖原则的司法应用
不便管辖原则并非天生就属于普通法系,它原本就是一种自由裁量权,一种为人类法治历史所证明的任何国家司法都不可或缺的东西。这一自由裁量权的最大功效就在于通过灵活性的做法,实现了个案的公平和正义。这种司法主权的有条件让渡体现了一国司法制度的自信、开放与包容。我国在司法实践的层面上,已经将不便管辖原则应用于具体的个案,并取得了良好的法律效果和社会效果。江苏省高级人民法院在汉城工业株式会社(以下简称汉城工业)与宇岩涂料株式会社(以下简称宇岩涂料)、内奥特钢株式会社(以下简称内奥特钢)票据追索权纠纷一案[5]中,明确适用不方便法院原则,维持了苏州中院一审以不方便法院为由驳回汉城工业对宇岩涂料、内奥特钢起诉的裁定。江苏省高级人民法院认为,本案涉及国际民事诉讼中不方便法院原则问题,虽然宇岩涂料、内奥特钢在苏州有可供扣押的财产,苏州中院作为可供扣押财产所在地人民法院对本案有管辖权,但是本案可以适用不方便法院原则。首先,汉城工业变更票据追索权纠纷诉讼后,内奥特钢、宇岩涂料明确提出管辖权异议,认为本案应由韩国法院管辖。其次,本案当事人之间不存在选择中国法院管辖的协议。第三,双方之间的票据追索权纠纷也不属于我国法院专属管辖的案件。第四,本案不涉及我国公民、法人或者其他组织的利益。第五,本案所涉票据出票、背书、付款行为地均在韩国。内奥特钢、宇岩涂料在韩国破产,涉及破产财产范围、破产重整计划的内容和执行、内奥特钢民事行为能力认定等,应适用韩国法。我国法院审理此案存在案件事实认定、法律适用上的困难。最后,本案各方当事人住所地均为韩国,即案件中与诉讼有关的各种因素集中于韩国,本案由韩国法院审理更加方便、适当。因此,苏州中院依据不方便法院原则裁定驳回汉城工业的起诉并无不当。
最高人民法院在 1992 年国际油污赔偿基金(以下简称 1992 年基金)与三星重工、三星物产船舶污染损害追偿管辖权纠纷一案中首次适用了不方便法院原则。该案的基本案情是:河北精神船务有限公司所有的“河北精神” 轮于 2007 年 12 月 6 日载运了 26 万余吨的原油,在韩国海域内与三星物产株式会社(以下简称三星物产)所有而由三星重工业株式会社(以下简称三星重工)租赁经营的“Samsung No.1”轮发生碰撞,致原油大量泄漏,造成油污损害。1992 年基金遂向宁波海事法院起诉,要求三星重工和三星物产予以赔偿,并申请冻结三星重工在我国境内投资设立的三星重工业(宁波)有限公司及三星重工业(荣成)有限公司的所有股权及投资收益。三星物产和三星重工在答辩中认为,宁波海事法院没有管辖权,即便具有管辖权,亦属于不方便法院。宁波海事法院作为一审法院认为:三星重工在宁波有可供扣押的财产,故宁波海事法院享有管辖权。相比国内案件,本案在审理中虽有一定难度,但尚未达到重大困难的程度,故本案不适用不方便法院原则。三星重工和三星物产不服,向浙江高院提起上诉。浙江高院审理认为:宁波作为可供扣押财产所在地之一,宁波海事法院依法享有管辖权。本案船舶碰撞和油污损害的主要事实发生在韩国,案件所涉的证据材料基本以韩语记载,并且韩国主管机关已对碰撞和油污事实进行了调查,有关事故的刑事案件和民事案件也已经在韩国当地法院进行审理或已经作出了判决,故本案符合不方便法院原则的各项条件,驳回了 1992 年基金的起诉。1992 年基金仍不服,向最高法院申请再审。最高法院在(2011)民申字第 400 号民事裁定中认为:三星重工在宁波有可供扣押的财产,根据民事诉讼法第二百四十一条之规定,宁波海事法院对本案享有管辖权。对于是否适用不方便法院原则的问题,最高法院认为,船舶碰撞和油污损害的事实发生在韩国领域内,有关油污基金和海事赔偿责任限制基金已在韩国设立,且依照船舶碰撞损害赔偿纠纷法律适用之一般规则,本案应适用韩国法律,因此,在认定事实和适用法律方面,韩国法院比中国法院更为便利。就本案管辖权而言,本案各方当事人之间未就纠纷协议选择中国法院管辖,且案涉纠纷属于一般侵权案件,并非中国法院专属管辖案件。据此,虽然中国法院依法取得管辖权,但在三星重工、三星物产提出管辖权异议的情况下,中国法院综合各方面因素,放弃行使管辖权并不违反中华人民共和国民事诉讼法关于法院管辖权的规定。虽然 1992 年基金主张本案由韩国法院审理可能会产生不公正的结果,但并未提供充分的证据予以证明。因此,1992 年基金关于本案不应适用不方便法院原则的再审申请理由并不充分,不予支持。
笔者认为,上述两起案件的裁定理由,符合《第二次全国涉外商事海事审判工作会议纪要》 中所确立的不便管辖的指导原则。
三、不便管辖原则在我国的本土化
改革开放以来,我国已经从较为单纯地引进外资,发展国内产业,逐步转变为资本走出国门的阶段。资本的对外扩张,更加快了我国融入世界经济的过程。如果单纯强调司法主权和司法对抗,忽略了司法礼让和协调,不仅无助于实现维护本国和本国当事人利益之目的,反而可能会更多地使本国法院的判决遭到域外法院的拒绝承认与执行。从此意义而言,不便管辖原则正契合了公正、效率、司法经济以及国际协调、国际礼让的理念,避免当事人挑选法院和一案两审等管辖权冲突,将那些与本国缺乏太多实际联系,而且调查取证、当事人及证人出庭困难、诉讼成本高昂的案件交由其他可替代的更合适便利的法院管辖。
在考察国外对该原则适用条件的基础上,结合我国法院的司法实践以及对该原则的司法认知度,笔者认为我国法院适用不便管辖原则应符合以下标准:
不存在有效的排他性协议管辖的情形。协议管辖是以当事人意思自治为基础,通过司法主权对当事人意思自治的尊重,使司法管辖权在当事人意思自治下得到合理的分配,尤其在实现管辖权的确定性、可预见性以及减少管辖权冲突、使判决得到顺利承认与执行方面,其优越性和独立价值得到了充分体现。协议管辖本身就是双方当事人博弈、利益妥协的产物,所确定的法院自然是双方共同选择的结果。如果存在有效的协议管辖,则不宜以不便管辖原则为由拒绝管辖。
不存在我国法律规定的专属管辖情形。一般而言,一国会在影响到国家公共利益的案件中采用专属管辖。因此,若存在我国法律规定的专属管辖的情形,不便管辖原则便没有适用的空间。
以不便管辖为由请求驳回诉讼的被告,负有证明受诉法院是明显不方便审理法院的义务。对被告所举证据的审查应着重考察以下几个因素:1. 审理地点相对于当事人的住所而言是否存在不方便。2.证据的特性以及所处的位置,包括文件、证人以及获得证据所需要的程序是否存在不方便。3.采取财产保全等强制措施的可行性以及难易程度。4.案件争议发生的主要事实是否在我国境内。5.是否能够证明存在查明与适用外国法的困难。6.是否存在案件在合理期限内难以审结的问题。7.判决被他国承认与执行的可能性。
案件不涉及我国重要的公共政策及国家利益。司法主权的行使必须以保障国家利益为前提,当案件涉及一国重要的公共政策与国家利益时,如涉及领土与海洋权益的管辖权案件,不应放弃司法管辖权。
涉及我国公民、法人或者其他组织利益的,应将另一适格法院能否实现实体公正作为必要的考察因素。上述最高法院的会议纪要将案件不涉及我国公民、法人或者其他组织的利益作为适用不便管辖原则的必要条件。其实,这种情况在实践中很少发生,即使上文中提及的我国法院适用不便管辖原则的两起案例,实际上也与我国内地法人企业和我国企业在香港注册登记的公司存在着利益联系。在包头空难美国诉讼案中,美国加州地方法院适用不便管辖原则不支持中国遇难家属在美国诉讼的主要理由是:美国加州对本案没有足够的利益联系,中国的法治环境足以审理此案。实际上,包头空难美国诉讼案中一个重要被告人便是发生事故的飞机发动机制造商---美国通用电气公司,美国加州法院并未因涉及美国公司利益而接受管辖,相反通过论证认为中国的法治环境也能使该案得到公正合理的解决,美国公司的利益不会受到损害。反观纪要的规定,只要涉及我国公民、法人和其他组织的利益,不分原因和利益大小,均由我国法院管辖并审理的理念,有待检讨。



注释:
作者单位:最高人民法院
[1]宋建立:“关于涉外商事诉讼管辖权冲突解决的几个问题”,载《人民司法.应用》2011 年第 19 期。
[2]吴一鸣:“两大法系中的不方便原则及在中国的合理借鉴”,载《西南政法大学学报》2008 年第 2 期。
[3]宋建立:《国际民商事诉讼管辖权冲突的协调与解决》,法律出版社 2009 年版,第 151 页。
[4]万鄂湘主编:《涉外商事海事审判指导》,2005 年第 2 辑,第 25 页。
[5]江苏省高级人民法院(2010)苏商外终字第 0027 号民事裁定书。基本案情:汉城工业向宇岩涂料供应化工用品、涂料、颜料等化学用品,宇岩涂料则向汉城工业背书转让了出票人为内奥特钢的票据作为货款,但汇票在韩国被银行拒绝付款。内奥特钢经过破产程序并已被注销,宇岩涂料正处于破产重整阶段。宇岩涂料在我国境内设立了外商独资企业苏州同信涂料有限公司;内奥特钢、宇岩涂料在我国境内了设立中外合资企业苏州同信彩色金属板有限公司。苏州中院根据汉城工业申请,冻结了内奥特钢、宇岩涂料在上述两公司的股权。汉城工业遂向苏州中院提起诉讼,要求内奥特钢、宇岩涂料承担票据责任。



出处:《人民司法》2012年第21期