Research On The Legal System Of Management Of Orphan Drugs In China

In China, the number of patients with rare diseases is huge, but they are often neglected and can not get enough concern and love. According to the data from WHO, there are about ten million patients with rare diseases in China, but less than5%of the diseases can be effectively treated. As a result, many patients meet with the problem that they either have no medicine to deal with their diseases or they can’t afford them. In recent years, many experts, media and NPC delegates are calling for new policy and legislation to improve the treatment and health rights of people with rare diseases.On the basis of analyzing the characteristics of orphan drug, according to the classification of orphan drugs, the paper analyzed obstacles that hinder the popularity of orphan drug in the three phases of R&D, approval and marketing. Further more, a sum up of the problems has been made regarding the policies of orphan drugs. Orphan drug research and development requires a large investment with long cycle and high risk. Special approval of orphan drugs lack detailed rules for its implementation. The demand for orphan drugs is relatively small, which leads to low enthusiasm of companies. Prices of patented medicines are very high, while the effectiveness of generics is not high. All these questions need to be solved through the legal and administrative actions.In order to deal with problems in China, the paper introduces and highlights the ways of how orphan drugs are treated in the United States, European Union, Japan, Taiwan and simple comments have been made on the effectiveness of its orphan drug system. The paper sorts out our orphan drug management ideas, aiming to inspire orphan drug research and development in China and maximize patients’ rights. Finally, proposals for the establishment of the orphan drug system have been made according to national conditions.