Anti-monopoly Regulation Of Drug Product Lifecycle Management Strategy

Drug product life-cycle management strategy refers to a series of measures taken by pharmaceutical enterprises to prolong the monopoly period of the blockbuster drug market and maintain the monopoly position.In recent years,because of the anti-competitive intention highlighted by these strategies,multinational anti-monopoly law enforcement agencies have intervened to launch anti-monopoly investigations.China,as one of the major drug consumers in the world,the behavior of multinational pharmaceutical enterprises will inevitably have a negative impact on the development of China’s pharmaceutical industry.In order to ensure the development space of domestic pharmaceutical enterprises and promote the transformation and upgrading of China’s pharmaceutical industry,our country must always guard against the implementation trend of drug product life-cycle management strategy.By combing the causes of the drug product life-cycle management strategy and the problems existing in the anti-monopoly regulation of the drug product life-cycle management strategy in our country,and drawing on the practical experience of various countries,this study puts forward the feasible measures to improve the anti-monopoly regulation of the drug product life-cycle management strategy in our country.First of all,the basic theory of drug product life-cycle management strategy is clarified by conceptual analysis.First,sort out the meaning and types of drug product life-cycle management strategies,which mainly include patent evergreening,reverse payment agreement and product hopping;second,the high difficulty of new drug research and development,low-cost generic drug competition,defects in the patent system and market failure in the pharmaceutical industry are the fundamental reasons for the frequent use of drug life cycle management strategies.Third,drug product life-cycle management strategies may produce anti-competitive effects that reduce the innovation motivation of brand drug companies,hinder the follow-up innovation of generic drug companies and damage the interests of consumers.Secondly,the normative analysis method is used to sort out the current situation of anti-monopoly regulation of drug product life-cycle management strategy in China.At present,China mainly regulates the drug product life-cycle management strategy through patent law,drug supervision system and anti-monopoly law.There are still three problems in these systems: the incomplete balance of interests related to drug patents,the lack of certainty and pertinence of the anti-monopoly review system and the limitations of the anti-monopoly legal relief system.Thirdly,the case analysis method is used to sort out the anti-monopoly practice of drug product life-cycle management strategies in various countries.Drug product life-cycle management strategy mainly involves horizontal monopoly agreement and abuse of market dominant position.The anti-monopoly review of horizontal monopoly agreement should be carried out from three aspects: whether there is competition,whether it has the purpose or effect of restricting competition and whether it meets the exemption conditions;the anti-monopoly review of abusing the dominant market position should be carried out from four aspects: defining the relevant market,whether it has the dominant position in the market,whether there is abuse and whether it has the effect of restricting competition.Finally,the path of anti-monopoly regulation of drug product life-cycle management strategy in China is put forward.First,improve the patent law and strengthen source control.Establish a prior consent system for drug patent examination to improve the quality of drug patent authorization;improve the system of balancing the interests of drug patents,ensure the substantive validity of drug patents,improve the efficiency of drug examination and approval,and shorten the period of patent authorization examination;improve and implement the patent link system to speed up the examination of patent invalidation.Second,improve the drug regulatory system to ensure the supply of generic drugs.Promote the alternative use of generic drugs,establish the legal system of generic drug substitution,give full play to the initiative of doctors and pharmacists,establish hierarchical medical insurance payment standards,improve generic drug consistency evaluation standards,and expand the scope of generic drug replacement;improve the listed drug catalogue collection system,complete the publication of patent information,improve the listed drug catalogue set objection system.Third,formulate anti-monopoly review guidelines to promote orderly competition.Take ensuring consumers’ access to low-cost generic drugs as the basic goal of anti-monopoly review,and establish the review principle of giving priority to typed treatment and supplemented by systematic analysis;follow the review framework to conduct anti-monopoly review of drug life cycle management strategies belonging to different types of monopoly behavior;improve the legal liability system of anti-monopoly,improve the administrative liability system of anti-monopoly law,and strengthen the implementation of civil liability of anti-monopoly law.We will improve the implementation system of the domestic anti-monopoly law and strengthen international anti-monopoly law enforcement cooperation.