Risks and challenges of the EU expansion
周大勇 (Zhou,Dayong)
I. Introduction
For several years now the European Union is discussing a possible enlargement, because several European countries have applied for membership in the EU. These are especially the former socialist countries in Eastern Europe, that have clearly turned towards the west since the collapse of the iron curtain. These countries are Bulgaria, the Baltic countries Latvia, Lithuania and Estonia, Poland, Romania, the Slovak Republic, the Czech Republic, Slovenia and Hungary.
In addition Turkey, Cyprus and Malta are trying for quite some time already to join the EU. These application are not to be accepted without any further deliberation because they do bring along some risks and the consequences are hard to distinguish therefore these countries are not very expected joining the European Union in the near future and will therefore not be included in the following evaluation.
II. Risks and challenges
If we wants to evaluate the risks and challenges of an upcoming enlargement of the EU, we should first take into account experiences gained during previous expansion which were to some extent comparable. Here the southern expansion from 1986 should be mentioned where two economically pathetic countries sought admission to the then European Community. The admission procedure of these two candidates, being Spain and Portugal, were lengthy and considered very problem bearing. Especially the amount of produce that would add to the already existing agricultural over-production of the Community was seen to be a problem since it would increase the load on the European budget.
But seen from a global economical perspective the joining of Spain and Portugal was overall positive for the EC and the two countries, although Spain struggled with a further rise of unemployment and disparities within the Community were further amplified.
The disparities within the Union will most certainly increase when it comes to an eastern expansion, but the agricultural problem will not be an issue, because the candidates have not got their focus on agriculture, already because of their communist heritage which focused on industry rather than on agriculture or the tertiary sector.
In case of the approaching expansion towards Eastern Europe the Union will have to resolve several problems, the most severe being without any doubt the financial one that will go along with the extension, estimated to be ?5 - ?6 billion annually, just for the technologically underdeveloped agriculture in the new member states.
The financial problem will also lead to a temporary discontent among the population of the existing members, since the financial load on the countries will cause budget cuts because the new members will undoubtedly belong to the payees rather than the payers. Especially the Mediterranean members, for instance Italy, Spain etc. fear cuts in their subsidies particularly the agricultural ones, and agriculture is already making up the biggest part of the EU′s budget.
Of course it is also to be questioned whether with the joining of economically weak countries the economies of the "richer" members are not weakened.
What should be taken into consideration as well is the impact the joining will have on the population of the candidates, especially considering the rights they will gain when they are citizens of the European community. They do then have the right to settle and work anywhere within the community, this could lead to a large amount of people pouring into the old member countries trying to seek work there and make their living. And since most of the European countries are already struggling with high unemployment the high rates could be pushed up further and the discontent among the population could worsen, especially against the background of Neo-Nazis in Germany and other countries such as Britain or Italy. Off course this would only be a temporary problem, which would solve itself over time as the new members develop economically, but still this could prove to be a major issue.
Of course their comes also a minor problem along with the expansion, this problem being even more languages than the twelve, already being used, in which EU communications would have to be carried out adding to the already huge administrative body of the European Union and also causing further costs of the EU.
But because the expansion represents a political necessity one should also take into account the positive aspects caused by such a historic event. With the expansion the continent would take a huge step towards the ethnic integration within Europe, different cultures would be facing each other and could also profit from each other. Also the global competitiveness of the EU against the USA and Asia would improve and another step towards global peace would be undertaken.
III. Changes in administration
It is obvious that an expansion potentially including ten countries would not be feasible without fundamental institutional reforms.
For instance with the existing structure of the Union which allocates most of the power to the European Council, where each member state has one vote, it would be imaginable that smaller members would have a majority over the larger members. Except for Poland, which is by population comparable to Spain and would consequently be a large member, all other candidates are relatively small in size an population.
Another point is that with more than twenty members the decision finding and making process needs to be completely reconsidered, so it represents the actual size of the member countries in terms of population rather than giving each member a veto and especially one single vote. The existing voting and weighting system is also already making the decision finding process a painfully and lengthy one, another ten different opinions added to this would make it virtually impossible to come to an agreement that at least partially satisfies all members and is therefore being supported and not vetoed against.
A changed "legislature" would also keep the democratic thought that the entire EU is based on alive and not vanish it like the existing system.
What should also be pointed out is the fact that an increase in members could lead to new coalitions within the Union and also increase competition among the individual countries. There are even critics that fear that an eastern expansion could lead to a shift in power towards the reunified Germany, since the potential new members are already heavily bound and leaning towards Germany.
What should also be considered is a change in European agricultural policy, which should actually be reformed already. The system of milk quotas, subsidies etc. which subsidises an over-production in many areas, just not to infuriate the farmers, because smaller farms would not be able to survive without the subsidies and the entire face of the European primary sector would change is completely outdated. This system could definitely no longer be kept up with even more farmers to support.
IV. Successful without absorbing the new members?
It is obvious that this question needs to be answered with a clear no. The existing members of the EU are already being absorbed by it and they have all chosen this faith. The goals of the European Union do state the loss of sovereignty in the areas of economic and currency politics, the latter one already realized, also in the political areas of social politics, education, research, consumer protection, health and also environmental issues. Now one could argue how many of these goals need to be realized in order for the EU to be successful, from the British point of view for example the cooperation in economic issues and the creation of the single market have already been enough, considering their opinion towards the Maastricht treaty.
If one would see it from the British point of view the EU could be successful without absorbing the new members, but since most other countries would like to see the above mentioned goals implied and would like to realize the dream of de Gaulle, Adenauer and others of "the United States of Europe", the new members would surrender a huge part of their sovereignty and consequently would be absorbed by the EU, especially considering that they will join in a couple of years at the earliest when European integration will hopefully have advanced beyond the point it is today.
Another point one could consider is what would happen if the European integration would further advance up to the point of the United States of Europe without any new countries joining. This would create another superpower alongside the USA and the then non-members would live in the shadow of the EU or whatever its name would be by that time and also be absorbed by the enormous power, in any terms, of their big neighbour just like the Caribbean, Canada and Mexico, even the entire Americas are by the USA. So the conclusion drawn by this could be that the central and eastern European countries would be better off in any case if they joined the EU even if they had to surrender much of their sovereignty.
Sources:
(1) http://www.europa.eu.int/ (March 17th, 2001)
(2) http://idw.tu-clausthal.de/public/zeige_pm.html?pmid=26445 (April 5th, 2001)
(3) Informationen zur politischen Bildung: Europäische Union (BpB, 1995)
(4) Microsoft Encarta 98
(5) Mittel- und Osteuropa auf dem Weg in die Europäische Union (Werner Weidenfeld, Verlag Bertelsmann Stiftung, 1996)
(6) http://www.e-politik.de/beitrag.cfm?Beitrag_ID=559 (April 1st, 2001)
进口医疗器械检验监督管理办法
国家质量监督检验检疫总局
总局第95号令《进口医疗器械检验监督管理办法》2007.6.8
第95号
《进口医疗器械检验监督管理办法》已经2007年5月30日国家质量监督检验检疫总局局务会议审议通过,现予公布,自2007年12月1日起施行。
局长
二〇〇七年六月十八日
进口医疗器械检验监督管理办法
第一章 总 则
第一条为加强进口医疗器械检验监督管理,保障人体健康和生命安全,根据《中华人民共和国进出口商品检验法》(以下简称商检法)及其实施条例和其它有关法律法规规定,制定本办法。
第二条本办法适用于:
(一)对医疗器械进口单位实施分类管理;
(二)对进口医疗器械实施检验监管;
(三)对进口医疗器械实施风险预警及快速反应管理。
第三条国家质量监督检验检疫总局(以下简称国家质检总局)主管全国进口医疗器械检验监督管理工作,负责组织收集整理与进口医疗器械相关的风险信息、风险评估并采取风险预警及快速反应措施。
国家质检总局设在各地的出入境检验检疫机构(以下简称检验检疫机构)负责所辖地区进口医疗器械检验监督管理工作,负责收集与进口医疗器械相关的风险信息及快速反应措施的具体实施。
第二章 医疗器械进口单位分类监管
第四条检验检疫机构根据医疗器械进口单位的管理水平、诚信度、进口医疗器械产品的风险等级、质量状况和进口规模,对医疗器械进口单位实施分类监管,具体分为三类。
医疗器械进口单位可以根据条件自愿提出分类管理申请。
第五条一类进口单位应当符合下列条件:
(一)严格遵守商检法及其实施条例、国家其他有关法律法规以及国家质检总局的相关规定,诚信度高,连续5年无不良记录;
(二)具有健全的质量管理体系,获得ISO9000质量体系认证,具备健全的质量管理制度,包括进口报检、进货验收、仓储保管、质量跟踪和缺陷报告等制度;
(三)具有2名以上经检验检疫机构培训合格的质量管理人员,熟悉相关产品的基本技术、性能和结构,了解我国对进口医疗器械检验监督管理;
(四)代理或者经营实施强制性产品认证制的进口医疗器械产品的,应当获得相应的证明文件;
(五)代理或者经营的进口医疗器械产品质量信誉良好,2年内未发生由于产品质量责任方面的退货、索赔或者其他事故等;
(六)连续从事医疗器械进口业务不少于6年,并能提供相应的证明文件;
(七)近2年每年进口批次不少于30批;
(八)收集并保存有关医疗器械的国家标准、行业标准及医疗器械的法规规章及专项规定,建立和保存比较完善的进口医疗器械资料档案,保存期不少于10年;
(九)具备与其进口的医疗器械产品相适应的技术培训和售后服务能力,或者约定由第三方提供技术支持;
(十)具备与进口医疗器械产品范围与规模相适应的、相对独立的经营场所和仓储条件。
第六条二类进口单位应当具备下列条件:
(一)严格遵守商检法及其实施条例、国家其他有关法律法规以及国家质检总局的相关规定,诚信度较高,连续3年无不良记录;
(二)具有健全的质量管理体系,具备健全的质量管理制度,包括进口报检、进货验收、仓储保管、质量跟踪和缺陷报告等制度;
(三)具有1名以上经检验检疫机构培训合格的质量管理人员,熟悉相关产品的基本技术、性能和结构,了解我国对进口医疗器械检验监督管理的人员;
(四)代理或者经营实施强制性产品认证制度的进口医疗器械产品的,应当获得相应的证明文件;
(五)代理或者经营的进口医疗器械产品质量信誉良好,1年内未发生由于产品质量责任方面的退货、索赔或者其他事故等;
(六)连续从事医疗器械进口业务不少于3年,并能提供相应的证明文件;
(七)近2年每年进口批次不少于10批;
(八)收集并保存有关医疗器械的国家标准、行业标准及医疗器械的法规规章及专项规定,建立和保存比较完善的进口医疗器械资料档案,保存期不少于10年;
(九)具备与其进口的医疗器械产品相适应的技术培训和售后服务能力,或者约定由第三方提供技术支持;
(十)具备与进口医疗器械产品范围与规模相适应的、相对独立的经营场所。
第七条 三类进口单位包括:
(一)从事进口医疗器械业务不满3年的进口单位;
(二)从事进口医疗器械业务已满3年,但未提出分类管理申请的进口单位;
(三) 提出分类申请,经考核不符合一、二类进口单位条件,未列入一、二类分类管理的进口单位。
第八条 申请一类进口单位或者二类进口单位的医疗器械进口单位(以下简称申请单位),应当向所在地直属检验检疫局提出申请,并提交以下材料:
(一)书面申请书,并有授权人签字和单位盖章;
(二)法人营业执照、医疗器械经营企业许可证;
(三)质量管理体系认证证书、质量管理文件;
(四)质量管理人员经检验检疫机构培训合格的证明文件;
(五)近2年每年进口批次的证明材料;
(六)遵守国家相关法律法规以及提供资料真实性的承诺书(自我声明)。
第九条 直属检验检疫局应当在5个工作日内完成对申请单位提交的申请的书面审核。申请材料不齐的,应当要求申请单位补正。
申请一类进口单位的,直属检验检疫局应当在完成书面审核后组织现场考核,考核合格的,将考核结果和相关材料报国家质检总局。国家质检总局对符合一类进口单位条件的申请单位进行核准,并定期对外公布一类进口单位名单。
申请二类进口单位的,直属检验检疫局完成书面审核后,可以自行或者委托进口单位所在地检验检疫机构组织现场考核。考核合格的,由直属检验检疫局予以核准并报国家质检总局备案,直属检验检疫局负责定期对外公布二类进口单位名单。
第三章 进口医疗器械风险等级及检验监管
第十条检验检疫机构按照进口医疗器械的风险等级、进口单位的分类情况,根据国家质检总局的相关规定,对进口医疗器械实施现场检验,以及与后续监督管理(以下简称监督检验)相结合的检验监管模式。
第十一条 国家质检总局根据进口医疗器械的结构特征、使用形式、使用状况、国家医疗器械分类的相关规则以及进口检验管理的需要等,将进口医疗器械产品分为:高风险、较高风险和一般风险三个风险等级。
进口医疗器械产品风险等级目录由国家质检总局确定、调整,并在实施之日前60日公布。
第十二条 符合下列条件的进口医疗器械产品为高风险等级:
(一)植入人体的医疗器械;
(二)介入人体的有源医疗器械;
(三)用于支持、维持生命的医疗器械;
(四)对人体有潜在危险的医学影像设备及能量治疗设备;
(五)产品质量不稳定,多次发生重大质量事故,对其安全性有效性必须严格控制的医疗器械。
第十三条符合下列条件的进口医疗器械产品为较高风险等级:
(一)介入人体的无源医疗器械;
(二)不属于高风险的其他与人体接触的有源医疗器械;
(三)产品质量较不稳定,多次发生质量问题,对其安全性有效性必须严格控制的医疗器械。
第十四条未列入高风险、较高风险等级的进口医疗器械属于一般风险等级。
第十五条进口高风险医疗器械的,按照以下方式进行检验管理:
(一)一类进口单位进口的,实施现场检验与监督检验相结合的方式,其中年批次现场检验率不低于50%;
(二)二、三类进口单位进口的,实施批批现场检验。
第十六条 进口较高风险医疗器械的,按照以下方式进行检验管理:
(一)一类进口单位进口的,年批次现场检验率不低于30%;
(二)二类进口单位进口的,年批次现场检验率不低于50%;
(三)三类进口单位进口的,实施批批现场检验。
第十七条进口一般风险医疗器械的,实施现场检验与监督检验相结合的方式进行检验管理,其中年批次现场检验率分别为:
(一)一类进口单位进口的,年批次现场检验率不低于10%;
(二)二类进口单位进口的,年批次现场检验率不低于30%;
(三)三类进口单位进口的,年批次现场检验率不低于50%。
第十八条 根据需要,国家质检总局对高风险的进口医疗器械可以按照对外贸易合同约定,组织实施监造、装运前检验和监装。
第十九条 进口医疗器械进口时,进口医疗器械的收货人或者其代理人(以下简称报检人)应当向报关地检验检疫机构报检,并提供下列材料:
(一)报检规定中要求提供的单证;
(二)属于《实施强制性产品认证的产品目录》内的医疗器械,应当提供中国强制性认证证书;
(三)国务院药品监督管理部门审批注册的进口医疗器械注册证书;
(四)进口单位为一、二类进口单位的,应当提供检验检疫机构签发的进口单位分类证明文件。
第二十条 口岸检验检疫机构应当对报检材料进行审查,不符合要求的,应当通知报检人;经审查符合要求的,签发《入境货物通关单》,货物办理海关报关手续后,应当及时向检验检疫机构申请检验。
第二十一条 进口医疗器械应当在报检人报检时申报的目的地检验。
对需要结合安装调试实施检验的进口医疗器械,应当在报检时明确使用地,由使用地检验检疫机构实施检验。需要结合安装调试实施检验的进口医疗器械目录由国家质检总局对外公布实施。
对于植入式医疗器械等特殊产品,应当在国家质检总局指定的检验检疫机构实施检验。
第二十二条 检验检疫机构按照国家技术规范的强制性要求对进口医疗器械进行检验;尚未制定国家技术规范的强制性要求的,可以参照国家质检总局指定的国外有关标准进行检验。
第二十三条 检验检疫机构对进口医疗器械实施现场检验和监督检验的内容可以包括:
(一)产品与相关证书一致性的核查;
(二)数量、规格型号、外观的检验;
(三)包装、标签及标志的检验,如使用木质包装的,须实施检疫;
(四)说明书、随机文件资料的核查;
(五)机械、电气、电磁兼容等安全方面的检验;
(六)辐射、噪声、生化等卫生方面的检验;
(七)有毒有害物质排放、残留以及材料等环保方面的检验;
(八)涉及诊断、治疗的医疗器械性能方面的检验;
(九)产品标识、标志以及中文说明书的核查。
第二十四条 检验检疫机构对实施强制性产品认证制度的进口医疗器械实行入境验证,查验单证,核对证货是否相符,必要时抽取样品送指定实验室,按照强制性产品认证制度和国家规定的相关标准进行检测。
第二十五条进口医疗器械经检验未发现不合格的,检验检疫机构应当出具《入境货物检验检疫证明》。
经检验发现不合格的,检验检疫机构应当出具《检验检疫处理通知书》,需要索赔的应当出具检验证书。涉及人身安全、健康、环境保护项目不合格的,或者可以技术处理的项目经技术处理后经检验仍不合格的,由检验检疫机构责令当事人销毁,或者退货并书面告知海关,并上报国家质检总局。
第四章 进口捐赠医疗器械检验监管
第二十六条进口捐赠的医疗器械应当未经使用,且不得夹带有害环境、公共卫生的物品或者其他违禁物品。
第二十七条进口捐赠医疗器械禁止夹带列入我国《禁止进口货物目录》的物品。
第二十八条 向中国境内捐赠医疗器械的境外捐赠机构,须由其或者其在中国的代理机构向国家质检总局办理捐赠机构及其捐赠医疗器械的备案。
第二十九条国家质检总局在必要时可以对进口捐赠的医疗器械组织实施装运前预检验。
第三十条接受进口捐赠医疗器械的单位或者其代理人应当持相关批准文件向报关地的检验检疫机构报检,向使用地的检验检疫机构申请检验。
检验检疫机构凭有效的相关批准文件接受报检,实施口岸查验,使用地检验。
第三十一条境外捐赠的医疗器械经检验检疫机构检验合格并出具《入境货物检验检疫证明》后,受赠人方可使用;经检验不合格的,按照商检法及其实施条例的有关规定处理。
第五章 风险预警与快速反应
第三十二条 国家质检总局建立对进口医疗器械的风险预警机制。通过对缺陷进口医疗器械等信息的收集和评估,按照有关规定发布警示信息,并采取相应的风险预警措施及快速反应措施。
第三十三条 检验检疫机构需定期了解辖区内使用的进口医疗器械的质量状况,发现进口医疗器械发生重大质量事故,应及时报告国家质检总局。
第三十四条进口医疗器械的制造商、进口单位和使用单位在发现其医疗器械中有缺陷的应当向检验检疫机构报告,对检验检疫机构采取的风险预警措施及快速反应措施应当予以配合。
第三十五条 对缺陷进口医疗器械的风险预警措施包括:
(一)向检验检疫机构发布风险警示通报,加强对缺陷产品制造商生产的和进口单位进口的医疗器械的检验监管;
(二)向缺陷产品的制造商、进口单位发布风险警示通告,敦促其及时采取措施,消除风险;
(三)向消费者和使用单位发布风险警示通告,提醒其注意缺陷进口医疗器械的风险和危害;
(四)向国内有关部门、有关国家和地区驻华使馆或者联络处、有关国际组织和机构通报情况,建议其采取必要的措施。
第三十六条对缺陷进口医疗器械的快速反应措施包括:
(一)建议暂停使用存在缺陷的医疗器械;
(二) 调整缺陷进口医疗器械进口单位的分类管理的类别;
(三) 停止缺陷医疗器械的进口;
(四) 暂停或者撤销缺陷进口医疗器械的国家强制性产品认证证书;
(五) 其他必要的措施。
第六章监督管理
第三十七条 检验检疫机构每年对一、二类进口单位进行至少一次监督审核,发现下列情况之一的,可以根据情节轻重对其作降类处理:
(一)进口单位出现不良诚信记录的;
(二)所进口的医疗器械存在重大安全隐患或者发生重大质量问题的;
(三)经检验检疫机构检验,进口单位年进口批次中出现不合格批次达10%;
(四)进口单位年进口批次未达到要求的;
(五)进口单位有违反法律法规其他行为的。
降类的进口单位必须在12个月后才能申请恢复原来的分类管理类别,且必须经过重新考核、核准、公布。
第三十八条 进口医疗器械出现下列情况之一的,检验检疫机构经本机构负责人批准,可以对进口医疗器械实施查封或者扣押,但海关监管货物除外:
(一)属于禁止进口的;
(二)存在安全卫生缺陷或者可能造成健康隐患、环境污染的;
(三)可能危害医患者生命财产安全,情况紧急的。
第三十九条 国家质检总局负责对检验检疫机构实施进口医疗器械检验监督管理人员资格的培训和考核工作。未经考核合格的人员不得从事进口医疗器械的检验监管工作。
第四十条 用于科研及其他非作用于患者目的的进口旧医疗器械,经国家质检总局及其他相关部门批准后,方可进口。
经原厂再制造的进口医疗器械,其安全及技术性能满足全新医疗器械应满足的要求,并符合国家其他有关规定的,由检验检疫机构进行合格评定后,经国家质检总局批准方可进口。
禁止进口前两款规定以外的其他旧医疗器械。
第七章 法律责任
第四十一条 擅自销售、使用未报检或者未经检验的属于法定检验的进口医疗器械,或者擅自销售、使用应当申请进口验证而未申请的进口医疗器械的,由检验检疫机构没收违法所得,并处商品货值金额5%以上20%以下罚款;构成犯罪的,依法追究刑事责任。
第四十二条 销售、使用经法定检验、抽查检验或者验证不合格的进口医疗器械的,由检验检疫机构责令停止销售、使用,没收违法所得和违法销售、使用的商品,并处违法销售、使用的商品货值金额等值以上3倍以下罚款;构成犯罪的,依法追究刑事责任。
第四十三条 医疗器械的进口单位进口国家禁止进口的旧医疗器械的,按照国家有关规定予以退货或者销毁。进口旧医疗器械属机电产品的,情节严重的,由检验检疫机构并处100万元以下罚款。
第四十四条 检验检疫机构的工作人员滥用职权,故意刁难的,徇私舞弊,伪造检验结果的,或者玩忽职守,延误检验出证的,依法给予行政处分;构成犯罪的,依法追究刑事责任。
第八章 附 则
第四十五条本办法所指的进口医疗器械,是指从境外进入到中华人民共和国境内的,单独或者组合使用于人体的仪器、设备、器具、材料或者其他物品,包括所配套使用的软件,其使用旨在对疾病进行预防、诊断、治疗、监护、缓解,对损伤或者残疾进行诊断、治疗、监护、缓解、补偿,对解剖或者生理过程进行研究、替代、调节,对妊娠进行控制等。
本办法所指的缺陷进口医疗器械,是指不符合国家强制性标准的规定的,或者存在可能危及人身、财产安全的不合理危险的进口医疗器械。
本办法所指的进口单位是指具有法人资格,对外签订并执行进口医疗器械贸易合同或者委托外贸代理进口医疗器械的中国境内企业。
第四十六条 从境外进入保税区、出口加工区等海关监管区域供使用的医疗器械,以及从保税区、出口加工区等海关监管区域进入境内其他区域的医疗器械,按照本办法执行。
第四十七条 用于动物的进口医疗器械参照本办法执行。
第四十八条 进口医疗器械中属于锅炉压力容器的,其安全监督检验还应当符合国家质检总局其他相关规定。属于《中华人民共和国进口计量器具型式审查目录》内的进口医疗器械,还应当符合国家有关计量法律法规的规定。
第四十九条 本办法由国家质检总局负责解释。
第五十条 本办法自2007年12月1日起施行。