Antitrust Regulation Of Reverse Payment Agreements In The Pharmaceutical Industry

The pharmaceutical industry is an important industry related to the people’s livelihood,and the protection of drug patents is crucial to the research and development of pharmaceutical companies.It is very difficult to research and develop drugs,which requires huge amount of money and professional medical talents,as well as a long time cost in the whole research and development cycle.Therefore,after the successful development,obtaining the patent right to monopolize the drug for a certain period of time is the incentive for pharmaceutical companies to develop and innovate,but at the same time,this also makes the drug market appear to be continuously monopolized by patented drugs.In recent years,the development of generic drugs has been overwhelming,and their efficacy is similar to that of the original drug,which,together with their low price,has made the drugs more affordable to more people and brought great benefits to public health.As a result of this market game between originator and generic drugs,reverse payment agreements were born.Reverse payment agreements are concessions made by generic companies to delay the entry of generic drugs into the pharmaceutical market in order to maintain the monopoly of patented drugs by giving the generic companies a quid pro quo for their benefits.Such agreements cause the disorder of competition in the pharmaceutical market,and the ultimate adverse consequences will be partially borne by consumers and national public health expenditure.At present,China has begun to show the first signs of reverse payment agreement,if the agreement is widely used by drug companies,the situation of healthy competition in the drug industry will face the risk of being broken.Therefore,the urgent problem we are facing now is: how to regulate the reverse payment agreement.This paper summarizes the experience of antitrust regulation of reverse payment agreements in Europe and the United States,and proposes countermeasures for China to establish the antitrust review principles of such agreements in light of China’s national conditions.In the legislation,we will improve the legal provisions in the field of pharmaceuticals,introduce the antitrust guidelines for the pharmaceutical industry and refine the relevant provisions of the patent linkage system.In law enforcement,we will regulate the antitrust enforcement in the pharmaceutical industry,build a professional enforcement team for reverse payment agreements,and establish a filing and review system for settlement agreements.Judicially,we improve the private enforcement system of anti-monopoly in China,add punitive damages and broaden the qualifications of litigation subjects,so as to build a system to regulate reverse payment agreements in China’s anti-monopoly law,protect the sustainable and stable development of the pharmaceutical industry and safeguard the public health interests.