关于加强县以下农村药品零售企业药学从业人员培训工作的通知

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关于加强县以下农村药品零售企业药学从业人员培训工作的通知

国家食品药品监督管理局


关于加强县以下农村药品零售企业药学从业人员培训工作的通知

国食药监人[2004]545号



各省、自治区、直辖市食品药品监督管理局:

  为认真贯彻全国人才工作会议精神,加强农村药学实用人才队伍建设,积极推进县以下药品经营企业监督管理工作和农村两网建设,按照《药品管理法》、《药品管理法实施条例》及《药品经营许可证管理办法》(第6号局长令)规定,现将加强农村药品零售企业药学从业人员培训相关工作通知如下:

  一、培训目的
  加强农村药品零售企业药学从业人员培训,不断提高药学从业人员的道德素质、法律素质和专业素质,努力培养一批农村药学实用人才,为加强县以下药品经营企业监督管理工作和农村药品监督网络、供应网络建设提供智力支持和人才保障,切实方便群众购药,加强用药指导咨询,保障公众用药安全有效。

  二、培训对象
  在县以下农村药品零售企业工作,并符合下列条件的药学从业人员:
  (一)具有高中以上(含高中)文化程度,西部和经济欠发达地区可根据实际情况,适当安排初中以上(含初中)文化程度;
  (二)身体健康,品行良好,具有一定的药学实践经验;
  (三)未取得执业药师、从业药师资格。

  三、培训内容
  按照国家食品药品监督管理局委托国家食品药品监督管理局执业药师资格认证中心编写、印制的《县以下农村药品经营企业药学从业人员培训大纲》(以下简称《大纲》)要求,培训内容由药事管理法规与药学职业道德和药学服务知识与技能两部分组成。

  四、培训形式
培训形式和手段可根据实际灵活多样,可采取面授、函授、远程教育、业余学习等多种形式。在确保培训质量和成效的前提下,为药学从业人员提供经济、方便的培训形式,减轻经济负担,缓解工学矛盾。

  五、培训要求
  (一)各省、自治区、直辖市食品药品监督管理部门应结合本地区实际情况,制定具体培训及考核办法,并按照《大纲》要求组织实施培训及考核工作。要注重考核内容的统一,保证培训及考核质量。
  (二)县以下农村药品零售企业的药学技术业务负责人首次培训应当完成60个学时,经考核合格后方可上岗从业。以后每年应当完成30个学时的培训,经考核合格后方可继续从业。具体培训内容、学时数及有关要求见《大纲》,各省、自治区、直辖市食品药品监督管理部门可根据本地区实际情况,从《大纲》中自主选取、安排首次和后续培训的内容。
  (三)其他从业人员的培训内容、学时数及考核由各省、自治区、直辖市食品药品监督管理部门参照《大纲》要求做出具体规定。
  (四)未经培训或经培训考核不合格人员不得上岗从业。
  (五)经培训考核合格的药学技术业务负责人应当履行以下职责:
  1.处方的审核和监督调配;
  2.为消费者进行用药的咨询和指导消费者选购、使用药品;
  3.负责药品质量管理;
  4.报告药品不良反应情况;
  5.指导其他从业人员的工作。

  各级食品药品监督管理部门要认真贯彻落实全国人才工作会议精神,牢固树立人才资源是第一资源、人人可以成才、以人为本的观念,加强农村药学实用人才队伍建设,加大培训力度,激励农村药学实用人才快速成长,建立健全农村药学实用人才服务体系,为加强县以下药品经营企业监督管理工作和农村两网建设提供智力支持和人才保障。


                            国家食品药品监督管理局
                            二○○四年十一月十七日



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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

关于印发《国家中医药管理局“十一五”重点专科(专病)建设项目重点病种临床诊疗方案审核工作方案》的通知

国家中医药管理局


关于印发《国家中医药管理局“十一五”重点专科(专病)建设项目重点病种临床诊疗方案审核工作方案》的通知

国中医药医函〔2008〕16号


各有关单位:
根据工作计划安排,各国家中医药管理局“十一五”重点专科(专病)建设项目报送了重点病种临床诊疗方案。为做好重点病种临床诊疗方案审核工作,我司制定了《国家中医药管理局“十一五”重点专科(专病)建设项目重点病种临床诊疗方案审核工作方案》和《国家中医药管理局“十一五”重点专科(专病)建设项目重点病种临床诊疗方案审核工作表》。现印发给你们,请按照《国家中医药管理局“十一五”重点专科(专病)建设项目重点病种临床诊疗方案审核工作方案》要求组织开展审核工作,按期将经审核修改后的重点病种临床诊疗方案、审核报告和专题评价分析报告寄送中国中医药科技开发交流中心。

附件:1.国家中医药管理局“十一五”重点专科(专病)建设项目重点病种临床诊疗方案审核工作方案

2.国家中医药管理局“十一五”重点专科(专病)建设项目重点病种临床诊疗方案审核表



二○○八年三月三日
附件1

国家中医药管理局“十一五”重点专科(专病)
建设项目重点病种临床诊疗方案审核工作方案

按照国家中医药管理局“十一五”重点专科(专病)项目建设的有关要求,各省(区、市)中医药管理部门和有关单位组织各重点专科建设项目报送了重点病种临床诊疗方案。为做好重点病种临床诊疗方案审核工作,现制定有关工作方案。
一、审核范围
全部615个重点专科建设项目。按专业划分如下:
序号 专 业 项目数量 其 中 诊疗方案数量
专科数量 专病数量
1 心血管科 42 37 5 116
2 脑病科 69 54 15 177
3 肝病科 29 29 0 87
4 肾病科 28 27 1 82
5 血液病科 10 10 0 30
6 脾胃病科 31 28 3 87
7 肺病科 15 13 2 41
8 老年病科 8 8 0 24
9 糖尿病 25 20 5 65
10 风湿病 20 14 6 48
11 外 科 30 20 10 70
12 皮肤科 16 14 2 52
13 肛肠科 28 28 0 84
14 肿瘤科 27 24 3 75
15 妇产科 26 20 6 66
16 儿 科 19 19 0 57
17 骨伤科 95 77 18 249
18 针灸科 33 32 1 97
19 推拿科 15 14 1 43
20 眼 科 18 12 6 42
21 耳鼻喉科 9 8 1 25
22 康复科 17 16 1 49
23 精神疾病科 5 5 0 15
合 计 615 529 86 1681

按照有关要求,每个重点专科建设项目报送3个重点病种临床诊疗方案,每个重点专病建设项目报送1个重点专病临床诊疗方案,共计1681个诊疗方案。
二、审核要点
(一)病名确定内涵外延是否明确规范。
(二)所参照的诊断标准是否恰当,是否行业内公认。
(三)中医治疗
1.针对病种临床实际治疗情况,中医治疗方法应按疾病发展过程分阶段(分期)进行整理,分段(分期)是否明确,相对应的措施是否合理。
2.治疗措施的适用范围、使用方法是否明确。
3.疗效水平的初步评估是否合理。要有明确的疗效评估方法,可用相关研究课题予以支撑,也可用本项目一定数量的观察病例加以说明。各单位的疗效评估方法不要求必须一致。
4.该治疗方法是否为临床实际使用的治疗方法,是否有照搬照抄教科书及相关诊疗规范的内容。
(四)中医治疗的难点分析
1.中医治疗方法目前尚不能完全解决或无办法解决的情况分析是否符合实际。
2.针对中医治疗难点的中医应对措施的前瞻性分析是否确切,本病种的主攻方向、创新研究思路和攻克难点的措施方法是否符合实际情况,是否可行。
三、审核方式
将全部重点病种临床诊疗方案按专业划分,由23个协作组牵头单位组织开展审核工作。审核工作可分四个阶段进行。
第一阶段,各协作组牵头单位将本专业的重点病种临床诊疗方案按病种分配至本协作组内的各协作分组,由协作分组牵头单位组织专家开展审核工作,并将专家审核意见报送协作组牵头单位。
第二阶段,各协作组牵头单位对各协作分组报送的专家审核意见进行汇总、整理,并将专家意见反馈各重点专科建设项目,督促各重点专科建设项目根据专家意见对诊疗方案进行修改。
第三阶段,各协作组牵头单位收集、汇总各重点专科建设项目修改后的诊疗方案,组织专家做简要审核并形成审核报告,随同审核修改后的诊疗方案一并寄送中国中医药科技开发交流中心。
第四阶段,各协作组牵头单位对本协作组主攻病种(即各协作分组的重点病种)诊疗方案进行汇总、整理、分析后,形成专题评价分析报告寄送中国中医药科技开发交流中心。专题评价分析报告应包括以下内容:
1.对主攻病种中医治疗的现状进行总体分析,按疾病发展过程对中医治疗方法进行整理,并对中医治疗方法的疗效水平作出初步评估。
2.对中医治疗方法目前尚不能完全解决或无办法解决的情况进行分析。
3.针对上述情况提出本病种的主攻方向、创新研究思路和攻克难点。
四、审核时间安排
(一)2月下旬~3月下旬 各协作组牵头单位主持召开协作组工作会议,研究布置重点病种诊疗方案审核工作和协作组其他工作。
(二)3月下旬~4月上旬 完成第一阶段任务。
(三)4月上旬~4月下旬 完成第二阶段任务。
(四)5月30日前 完成第三阶段任务,将重点病种临床诊疗方案和审核报告寄送中国中医药科技开发交流中心。
(五)6月30日前 完成第四阶段任务,将主攻病种的专题评价分析报告寄送中国中医药科技开发交流中心。
五、审核要求
(一)各协作组、协作分组牵头单位要切实负起责任,制定好工作计划,各牵头单位要提供必要的人力、物力和财力支持。
(二)审核专家要认真填写《国家中医药管理局“十一五”重点专科(专病)建设项目重点病种临床诊疗方案审核表》,不得漏项、缺项。
(三)各协作组牵头单位要于2008年3月20日前将审核工作计划、各协作分组审核专家组成员名单报送国家中医药管理局医政司。
(四)专家审核意见要全部录入计算机,随同专家审核表原件一并寄送中国中医药科技开发交流中心。

附件2

国家中医药管理局“十一五”重点专科(专病)
建设项目重点病种诊疗方案审核表

项目单位:
项目名称:
重点病种1:

审核要点 基本要求或主要审核内容 主要不足及建议
病 名 病名确定内涵外延是否明确规范
诊 断 所参照的诊断标准是否恰当,是否行业内公认
中医治疗 中医治疗方法是否按疾病发展过程分阶段(分期)进行整理,分段(分期)是否明确,相对应的措施是否合理
治疗措施的适用范围、使用方法是否明确
治疗方法是否为临床实际使用的治疗方法,是否有照搬照抄教科书及相关诊疗规范的内容
疗效水平的初步评估是否合理,是否有明确的疗效评估方法
难点分析 中医治疗方法目前尚不能完全解决或无办法解决的情况分析是否符合实际
解决措施 针对中医治疗难点的中医应对措施的前瞻性分析是否确切,本病种的主攻方向、创新研究思路和攻克难点的措施方法是否符合实际情况,是否可行
总体意见
专家签名: