卫生部


卫生部关于颁布《中华人民共和国药典》1985年版的补充通知
卫生部


《中华人民共和国药典》1985年版，我部已于1985年11月12日颁布，现就执行中的有关问题补充通知如下：
一、凡《中华人民共和国药典》1985年版收载的品种，自执行之日起，有关生产、供应、使用、和检验等单位，必须按本版药典规定进行检定，各该药品的原规定即停止执行。1986年4月1日前生产的药品，可按原规定进行检验。
二、对《中国药典》1977年版收载，而1985年版未列入的品种，且各地仍生产使用的，请各省、自治区、直辖市卫生厅（局）于1986年5月底前将品种名单、生产厂和对该品种标准的意见汇总寄药典委员会，由该会根据各地意见组织修订为部标准，报我部审核颁布。中药
材可由省、自治区、直辖市根据地区用药习惯，参照1977年版药典，修订为省、自治区、直辖市药品标准，需作部标准者，亦可提出意见报药典委员会。
三、凡中成药品名与《中国药典》1985年版收载的品名相同而处方不同者，原则上按药典规定执行。如有特殊情况，生产单位须提出继续生产的理由，于1986年5月底前报省、自治区、直辖市卫生厅（局）重新审批，并修改名称或注明××方，以资区别。审批件要抄报药典委
员会。
四、对《中国药典》1985年版收载的品种，在执行中如发现需要进行修改者，由提出修改单位向省、自治区、直辖市卫生厅（局）提出修改依据和实验数据，转报我部核定。
五、对《中国药典》1985年版收载的品种，省、自治区、直辖市卫生厅（局）可结合本地情况补充制订以下规定：
1．根据生产、检验和管理等需要，补充有关制剂的附加剂、稳定剂、包衣等规定。
2．根据临床使用的需要，增加常用制剂的规格。
以上补充规定连同制订说明均须报药典委员会备案。
六、为了更好地按《中国药典》执行，凡药典中规定使用的仪器设备，省级药检所应尽快配备。
七、《中国药典》1985年版所收载药品名称与1977年版不一致的，应以1985年版名称为正名。生产环节的原名称标签、包装材料可用至1986年12月31日；销售、使用完为止。
出口药品可使用原惯用名称。
八、《中国药典》1985年版未标出“麻、剧、限剧”药品字样。此类药品按国务院、卫生部各有关规定管理。



1986年3月4日

The Draft Constitution and Human Rights Protection in European Union

周大勇 (Zhou,Dayong)

1 the general introduction of the draft constitution in aspect of the human rights
2 short review of the human rights protection in European Union
3 the new points in aspect of human rights in the draft constitution
3.1 common values
3.2 incorporation of the Charter of fundamental rights
3.3 other changes could affect the human rights
4 arisen questions
4.1 the protection different from under the Convention
4.2 the two courts system and its application
5 conclusions in a historical view




1 general introduction of the draft constitution in aspect of the human rights

“Conscious that Europe is a continent that has brought forth civilization; That its inhabitants, arriving in successive waves from earliest times, have gradually developed the values underlying humanism: equality of persons, freedom, respect for reason” Extract from the preamble to the draft Constitution

In past 16 years, the European Union (EU hereafter) has marked itself through a series of changes. From The Single European Act, in which the Union committed itself to create a single market and at the same time establish on its territory the freedom of movement of people, goods, services as well as capital, to Maastricht Treaty, which brought the Union into reality and led to common foreign policy and cooperation in the area of justice and internal affairs as a higher level cooperation among Member States. Then the following Amsterdam (1997) and Nice (2001) Treaties, strengthened cooperation in foreign and security policy and placed Justice and Home Affairs matters and established the frame for the Union as a legitimate institution, in which people from different nations integrated in a large region would have common historical direction and splendid future before them. Just before the door of enlargement of the Union, it was argued that the Union has to improve democracy and transparency as well as efficiency, in order to outlines the EU’s purpose and competence clearly and streamline structures so as to prevent paralysis, therefore a new constitution for the Union is determined to replace the EU's series of key treaties in passed over the last 50 years as a single document .

Under leading of former French President and master draftsman Valéry Giscard d'Estaing, the European Convention set about its work of drafting the European Union's first ever full-fledged constitution. With the convention's work completed, the draft must now be finalized by an Intergovernmental Conference of European leaders that is expected to complete deliberations by the end of the 2003. As far as our topic is concerned, noticeably modifications come out in the constitution contract, first of all, the incorporation of the Charter of Fundamental Rights, which we will discuss later. In the beginning it is meaningful to consider the statues of the draft constitution in the progress course of the Union. The Union desires to bring peace and prosperity, to promote economic and social progress through continuously integrating market and expanding freedom under light of united institution and social systems . These goals, however, are the foundation of development and protection of human rights . That means, if we regard human rights as a series right which realized at first in peaceful and law-ruling society, then the Union has already kept on entrenching to appreciate these goal from beginning on, and now by means of perusing such goal in a larger region through enlargement, the EU’s influence extent to broader area and more people.

The draft constitution then in such context should be viewed as another historical phase in the process. Because the promoting of well-being and fortune of people depend not only on the development of economic situation and adding some single freedom clauses into the governmental documents, but also upon the entire politic system and background in which we live. Without governing based on democratic and effective institutional structure, and especially a ripe legislation and judiciary mechanism, the realization and protection of human rights could only be on the paper. This is also one of the motive caused the Declaration on the future of the European Union which committed the Union to becoming more democratic, more transparent and effective, in order to pave the way for a Constitution in response to the expectations of the people of Europe . In this perspective, one shall recognize the Constitution as a moving forward step of the whole EU institutionalization targeting its goal, so that to discuss the Constitution in connection with the human right protection, it is helpful to review the human rights protection in Europe and, especially in EU.

2 short review of the human rights protection in European Union

The protection of human rights has been internationally come to life in the Universal Declaration of Human Rights in 1948 (UDHR) with reorganization of disregard and contempt for human rights have resulted in barbarous acts which have outraged the conscience of mankind and respect for inherent dignity as well as the equal rights of all members of the human. This declaration states explicitly that the rights and freedoms of humans have to be guaranteed without distinction and destruction by any group, state or person. These principles were broadly accepted by European countries, considering the origin of the EU (EC) and the historical separation in Europe after WWII, we denote only the contracting countries of European Community.

For the Member States of EC, the Council of Europe has been up to now the most important instrument, which established in 1949 as a result of the Congress of Europe in The Hague , and took for the basic of the human rights protection. The Council accepted the principles of Universal Declaration of Human Rights and integrated it into The European Convention for the Protection of Human Rights (the Convention hereafter), which and its 12 Protocols turned out to be the significant resource for Human Rights protection in Europe. Because of the existence of the Convention, the other two organizations established in the same age aftermath of the Second World War, i.e. OEEC and the European Communities didn’t include relevant clauses for Human Rights protection into their founding treaties. Since it was agreed at that time, the Council of Europe would focus on the protection of human rights, fundamental freedoms and democratic values, whereas the OECD and the European Communities were to be concerned with the economic restoration of Europe. The reason of separate organizations was based on a view to avoiding economic excuses for future inhumanity. Another reason came from the thought, which believed that the process of economic integration set forth in the Community Treaties could not lead to a violation of human rights. Furthermore, the original Member States in the Treaty of Rome feared, that the inclusion of a "bill of rights" in the Treaty might have brought about an undesirable expansion of Community powers, since it could lead Community institutions to interpret their powers as extending to anything not explicitly prohibited by the enumerated guarantees.

Under the regime of Council of Europe, a lots of achievement of human rights improvement has been reached , yet along with the development and expansion of EU, another mechanism on protection of human rights which does not totally rely on the Council of Europe has derived out on one hand, on the other hand being lack of provisions ruling human rights protection in the Treaty establishing EC did not prevent the EC and the later European Union from providing care for the protection against the violations on human rights. Naturally, how could a swelling supranational organization as EC, which has been continually strengthening its power in all social aspects, does not involve in human rights issues especially when the consciousness of human rights nowadays become more significant both in international and national stages? Regarding to EU, The protection system has been formed in three aspects.

First of all, the legislation in the Member States of EU. Since there were no Member States of EU (EC) which accedes to the Community without being a member of the Council of Europe, and according to the Convention, it impose obligations on the Member States that they should ensure that the internal laws and practices comply with the human rights standards set out in the instruments. Very member states in EU have recognize the principles derived from the Convention and incorporated them somehow into national laws, most importantly, provided constitutive protection as the basic legal resource for human rights protection. For example in Germany, Basic Law (Grundgesetz) Art 1 to 19 deliver explicit provisions even beyond the Convention; the same case as Part VIII (§71-85) in Constitution of Denmark ; in Britain the Act of Human Rights came into force on 2 October 2000 steers extending a ways, in which the Convention can be used before domestic courts. Certainly, according to the classic human rights lessons, the basic protection of human rights could only be afforded at the national level through national legislation and excise of authoritative power.

Secondly, the institutions and legislation at the EU level acts also with high respect to the human rights protection. The EU has showed its commitment to human rights and fundamental freedoms and has explicitly confirmed the EU's attachment to fundamental social rights ever since its establishment.

The Amsterdam Treaty established procedures intended to secure their protection. It was ascertained, as a general principle, that the European Union should respect human rights and fundamental freedoms, upon which the Union is founded. For the first time a procedure is introduced, according to which severe and continuing violations of Fundamental Rights can lead to suspension of voting and other rights of a member state, if the Union determined the existence of a serious and persistent breach of these principles by that Member State. As to the Candidate countries, they should also respect these principles to join the Union. Furthermore, It has also given the European Court of Justice the power to ensure respect of fundamental rights and freedoms by the European institutions. In accordance with the inner requirement for the implementation of development cooperation operations, in order to reach objective of developing and consolidating democracy, EU also need its rule respecting for human rights. Such cases we have are for instance the EU Council’s regulation on human rights, Council Regulation (EC) No 975/199 and Council Regulation (EC) No 976/1999 for example, are aimed at providing technical and financial aid for operations to promote and protect of civil and political rights as well as economic, social and cultural rights etc.

Likewise, at their meeting in Cologne in June 1999, EU leaders declared that in respect to the current stage of progress of the European Union, the fundamental rights applicable at Union level should be pushed forward, namely be consolidated in a Charter and thereby made more evident. They argued, that the legal resources of human rights protection come from not only the European Convention of Human Right, but also from various international conventions drawn up by the Council of Europe as well as the United Nations and the International Labor Organization, they also include EU treaties themselves and from the case law of the European Court of Justice. As a result, a Charter of Fundamental Rights of the European Union (the Charter hereinafter) was sketch out, which highlighted the EU’s respect for human rights, for fundamental freedoms and for the principle of democracy through listing more rights a more precise definition of the common values comparing the early documents including the Convention. We will continue to concentrate on the Charter in point 3 since it has been integrated in the draft Constitution as an outstanding achievement.

Finally, the opinion and case-law of European Court of Justice (ECJ hereafter) also have immense impact on the establishment of the instrument of human rights protection within EU.

Although the jurisprudence developed by the ECJ recognizes the Convention as the standard-setter in cases in which the Court has to consider and decide a human rights issue, since there were no relevant legislation existed in the frame of the Community, the ECJ furnish itself power in this aspect by means of case-law. Earlier in 1974, the ECJ first made reference to the ECHR in the Nold judgment, in which the ECJ emphasized its commitment to fundamental human rights based on the constitutional traditions of the Member States’ fundamental rights form an integral part of the general principles of law which the Court enforces. In assuring the protection of such rights, the Court is required to base itself on the constitutional traditions common to the Member States and therefore could not allow measures, which are incompatible with the fundamental rights recognized and guaranteed by the constitutions of such States. The ECJ declared, that the international treaties on the protection of human rights in which the Member States have cooperated or to which they have adhered could also supply indications which may be taken into account within the framework of Community law.

That implied, even without clear regulations in the treaties, the remedy against violation on human rights could also be provided within the framework of the Community in respect for the common traditions applied to the Member States, and in connection with we have mentioned about the Member States’ above, the principles and resource applied to the Member States derived from the Council of Europe. Thus a EU standard could be established by transform a rating comparison of the members’ legal systems to the case-law in ECJ in respect for human rights.