On The Construction Of China's Medicine Evaluation Advisory Committee Systems

In present era, risk society and high risk products are challenging the capability of the government in its administrating the public affairs. Accordingly, the administrative power, representing the public interests, has become more technical in its implementation process. As a response to such a trend, appropriate adoption of advisory committee, a procedural mechanism, is the inevitable result of modern administration which emphasizes rationalism, technicality and professionalism. The advisory committee constitutes a new dialogue and interests gaming platform among the government, the general public and the experts by diversifying the participating parties.Medicine advisory committee, one type of the administrative advisory committees, means a collegiate organization and a set of corresponding procedural mechanism which are legally established by administrative authorities and responsible for reviewing and advising upon certain issues in medicine evaluation. It features legal, administrative, organizational, advisory and procedural characteristics as well as a technical mechanism with democratic nature. Its appearance and development has been accompanying the development process of constitutional government and democracy practices, over which period liberalism has transit into deliberation, the order-obeying relationship between administration parties has changed into mutual trust and cooperation. Its orientation of public participation and acceptance of public wisdom accords perfectly with the historical trend. Ultimately medicine evaluation advisory committee is a mechanism style administrative procedure, which is supposed to justify the administration process by limiting the arbitrary discretion powers, achieving scientific evaluation and balancing different interests. By encouraging the public participation, it can also promote the publicity and transparency of the administrative activities which in turn can strengthen the supervision upon administration.Medicine evaluation advisory system can only be operated on certain organizational vehicles. Under the"Committee Mode", the advisory body has its own independent will and therefore enjoys a relatively independent status and voice in its interaction with administrative authorities which control the approval power of medicines. However, the"Experts Database Mode"as established by China's current State Measures for Administration of Medicine Evaluation Experts is lack of such a relatively independent advisory vehicle. Thus, it is advisable that our country's medicine evaluation advisory system be reconstructed by adopting the medicine evaluation advisory committee practices, which have been proved to be a success in countries and regions like the United States, European Union and Japan. By designing appropriate procedures, various resources are to be consolidated based upon such vehicle of medicine evaluation advisory committee.Advisory power is a kind of administrative power as well as a discourse power. The advisory procedures, once specified in laws and regulations, will have a direct binding power upon the administrative authorities, which shall deliver full respect to the advisory opinions though they are not obligated to accept them. In administrative permission of medicines, the medicine evaluation advisory committee undertakes the function of reviewing the technical issues. Their advice, though constituting no final decision, casts substantial effect upon the administrative result and therefore shall be subject to strict supervisions.In current legal systems of our country, we cannot find a law for medicine evaluation advisory committees. The advisory committee system, as a pre-decision formality for administration, is by itself in a state of not integrated and complete. An administrative procedures code shall be adopted to cover the advisory rules in administration practices, avoid unnecessary legislative overlaps and conflicts and create legal basis for inferior regulations. For the purpose of further perfecting our country's administrative advisory committee system, we shall endeavor to enhance the transparency of advisory practices, assure the universality of the participating parties, strengthen the effect of the advisory committee's advice upon the final administrative decisions, set up a principle of appropriate debate and study the specific government employee system of the United States.Along the history, administration consulting has been deemed as a topic in administrative management study rather than in administrative law field. Therefore, in academic classifications, administrative consulting has not entered into the study field of our country's administrative law science. Over the recent years, however, this part of study has attracted attentions from some scholars. This thesis is such an attempt, within the administrative law scope, to review the construction of our country's medicine evaluation advisory committee system by adopting the study methods of empirical analysis, historical study, comparative study, documental analysis and value analysis, etc. However, subject to the limitations of this thesis'form and length as well as my personal capability, this thesis is far from being perfect in many aspects, e.g. study of the medicine evaluation advisory practices in other countries, discussions upon advisory expert liabilities and arrangement of publicity and confidentiality issues in consulting process. In particular under the topic of public participation, the substantial and procedural participation of the experts and common persons as well as the extend of their respective participation turn out to be a quite complicated issue, which can only be left for further study in future.