罕见病药品供应中的市场独占权及其法律限制

On the Market Exclusivity of Orphan Drugs Supply and Its Legal Limits

罕见病药品因投资大、研发难、需求少而一度较少得到药企关注,因而被称为"孤儿药"。美国、欧盟等国家和地区通过制定专门立法来激励企业投入孤儿药的研发和生产,其中最有力的措施是市场独占权制度,即某种药品一旦被认定为孤儿药,药企便获得了一定时期的市场独家经营权。市场独占权可视为一种法定垄断,它大大降低了企业的后顾之忧,使得更多的孤儿药被开发出来。不过,市场独占权制度在实践中也容易被滥用,进而导致孤儿药超高定价、市场独占权重复获得、制药企业利润惊人等一系列问题。我国孤儿药产业还处于起步阶段,需要在立法中引入市场独占权制度以发挥其激励作用,但同时要建立孤儿药价格干预机制,合理设置孤儿药认定标准,严格市场独占权授予条件,为市场独占权设置例外,并在实践中允许根据市场情况变化适时调整市场独占权的保护期间。

Drugs for rare diseases have once received lttle attention from pharmaceutical companies due to the large investment,dificult research and development,and insignificant demands,so they are called"orphan drugs".The United States,the European Union and other countries and regions have formulated specialized laws to encourage enterprises to invest in the R&D and production of orphan drugs.The most powerful measure is"market exclusivity",which means that once a drug is designated as an orphan drug,the related enterprises will obtain the right of market exclusivity for a certain period of time.Market exclusivity can be regarded as a legal monopoly,which greatly reduces the worries of enterprises and enables more orphan drugs to be developed.However,market exclusivity is easy to be abused in practice,which leads to a series of problems such as excessively high pricing of orphan drugs,repeated acquisition of market exclusivity,and astonishing profits for pharmaceutical enterprises.The orphan drug industry in China is still in its infancy.In the future law-making related to orphan drugs,market exclusivity needs to be introduced to stimulate the development of orphan drugs.At the same time,a price intervention mechanism for orphan drugs must be established,and orphan drug identification standards must be set reasonably.Moreover,the conditions must be set strictly for the grant of market exclusivity,some exceptions of market exclusivity must be allowed,the protection period of market exclusivity should be adjusted in a timely manner according to the changes of market conditions.