Research On The Exclusive Protection Of Drug Test Data

The drug test data refers to the clinical performance of the pharmaceutical company in terms of drug performance,efficacy,toxicology,etc.,obtained in order to prove the effectiveness,production feasibility,tolerability and safety of the drug before the drug is submitted for marketing.The drug test data,which contains both great commercial value and the attributes of quasi-public products,has received attention from the government,academia and the pharmaceutical industry.Data exclusivity is one of the protection modes of drug test data.It aims to provide a fixed period of exclusive protection for the drug test data of the original drug.During this protection period,the government and its related institutions that are responsible for drug supervision and management are prohibited.The test data approves the listing application for generic drugs.Data exclusivity is a new intellectual property protection rule in the field of medicine.It overlaps with traditional intellectual property protection and is parallel,which to some extent compensates for the inadequacies of traditional intellectual property rules on drug test data protection.If the system is used properly,it will not only encourage the innovative research and development of drugs,but also provide more and better drugs to the public,thus ensuring the realization of public health goals.Data exclusivity originated in the United States.In order to encourage the development and investment of new drugs in the country,and to solve the dilemma of low drug accessibility,the United States passed the revolutionary "Pharmaceutical Price Competition and Patent Period Recovery Law" in the medical field in 1984,and two members who proposed the bill.It is called the "Hatch-Waxman Amendment".The amendment has two levels of innovation: First,it has eliminated the practice of providing clinical trial data for all drug applications,and began to allow generic drugs to demonstrate the dosage form,quality,and applicable symptoms of the original drug through bioequivalence tests.It has consistency in active ingredients and specifications,and allows generic drug manufacturers to obtain listing applications;secondly,it gives exclusive protection for the limited period of original experimental drug data to extend the protection period of drugs under the impetus of Western intellectual property powers,the Agreement on Trade-Related Aspects of Intellectual Property Rights incorporates the obligation to protect experimental data,becoming the first and only one International multilateral treaty governing drug test data.As a compromise product of North-South negotiations,the TRIPS Agreement is too general for the protection of test data,leading to a very different understanding between developing and developed countries.Developing countries usually regard drug test data as a trade secret,advocate protection through unfair competition law,and do not establish a special protection mechanism;developed countries advocate exclusive protection for experimental data for a limited period of time.During the protection period,the government is prohibited from approving the listing application of generic drugs based on the experimental data of innovative drugs.The data exclusivity is similar to patent protection and has a "double-edged sword" effect.On the one hand,data exclusivity can guarantee the economic value of the clinical trial data of the original drug applicants,and thus encourage the research and development and investment activities of innovative drugs.However,on the other hand,due to the exclusive right of data protection granted to innovative drugs for a limited period of time,blocking the passage of generic drugs into the market in a timely manner,it is easy to cause the price of the original drug to remain high,greatly reducing the availability of drugs.To a certain extent,it may affect public health.Although the TRIPS Agreement does not require WTO members to provide exclusive protection for drug trial data,in recent years,European and American drug intellectual property powers have been forcing developing countries to build data exclusive protection systems through bilateral,regional or multilateral trade negotiations.The standard for the protection of intellectual property rights of drugs.As of December 31,2018,out of the many countries that have concluded free trade agreements with the United States,35 countries have established a system of exclusive protection for drug trial data.In addition,in 2011,the International Federation of Pharmaceutical Manufacturers Associations(IFFPA)examined the national legislation on the protection of test data on a global scale.There are 65 countries that have established data exclusive protection systems,including the United States,Switzerland,developed countries such as Japan,Europe and the United States also include developing countries that are relatively backward in North and South America and Africa,such as Egypt,Jordan,and Peru.It is not difficult to see that it is an irresistible trend to provide exclusive protection for drug test data.As the largest developing country in the world,China faces pressures of trade negotiations with Western intellectual property powers and industry pressure to encourage innovation in pharmaceutical products.At the same time,in view of China’s huge population and tight medical resources,promoting the production and listing of high-quality generic drugs has become an important task in China’s medical reform.On April 25,2018,the State Administration of Drug Administration of China promulgated the "Implementation Measures for the Protection of Drug Test Data(Provisional)(Draft for Comment)",soliciting opinions from the public on the specific implementation of drug test data protection,which indicates that China Committed to exploring and improving the rules for the protection of drug test data.Under such circumstances,how to draw on the legislative experience of exclusive protection of experimental data from various countries to construct a system of exclusive protection of test data in line with China’s national conditions has become an urgent need for the development of theory and practice,and it is also the significance of this paper.