国家医药管理局 国家工商局


关于集体、私营企业和个体工商户零售药品的规定

（1989年12月2日国家医药管理局、国家工商局国药联经字（89）第493号印发）

一、为保持药品（不包括中药材、中药饮片，下同）市场的繁荣与稳定，进一步加强对集体、私营企业和个体工商户（包括个人合伙，下同）零售药品的监督管理，保护其合法权益，引导其健康发展，以满足人民防病治病的需要，特制定本规定。
二、集体、私营企业和个体工商户只准从事药品零售，不得经营药品批发业务。但国营医药商业网点未下伸的边远地区，可委托具备条件的集体或医疗单位代批发业务。
三、申请零售药品的企业和个体工商户，必须按照《药品管理法》和《药品管理法实施办法》规定的审批程序和要求，经审查同意和核准发证照后，始得经营。
四、审查经营药品零售的内容：
（一）市场需要和合理布局；
（二）经营范围与必备零售药品经营目录：
（三）规章制度；
（四）与经营规模和经营范围相适应的从业人员、资金、场所、设备、储藏设施和卫生条件；
（五）经营药品零售企业，必须具有药士以上技术职称的人员负责药品质量检测。经营药品零售的个体工商户、私营企业从业人员须经地、市以上医药管理部门考核药品知识，并取得合格证。
五、集体、私营企业和个体工商户不得经营麻醉药品、精神药品、毒性药品和放射性药品以及医疗单位配制的制剂。
六、县以上医药管理部门负责制定本地区零售药品经营目录。集体、私营企业和个体工商户应当按照核定经营目录在所在地区经营。不得无故脱销核定的经营目录品种和超越经营范围经营。
七、经营药品所需货源，凭《企业法人营业执照》或《营业执照》，向县以上医药管理部门指定的当地国营医药商业批发单位按批发价格进货，销售执行国营医药商业零售牌价。
八、药品生产企业不得向非国营医药企业销售药品。药品经营企业或个体工商户不得向非法经营药品的单位或个人售药或进货。
九、经营药品的企业或个体工商户必须遵守国家有关法律、法规和政策，守法经营，照章纳税，服从国家有关机关的监督管理。严禁制售伪劣、过期失效、淘汰以及无批准文号和注册商标的药品。
十、违反以上规定的，视情节轻重，由主管部门会同工商行政管理机关按照国家有关规定予以警告、罚款、没收非法所得、责令停业整顿、吊销营业执照等处理。触犯刑律的移送司法机关依法追究当事人的刑事责任。
十一、本规定同样适用于事业单位、社会团体、各种学会、协会、基金会群众组织和个体医生附设的对外销售药品药柜。
十二、本规定自发布之日起施行。各省、自治区、直辖市可依据本规定具体实施办法。


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)