The Internationalization Of Exclusivity Of Pharmaceutical Trial Data And The Response Of Developing Countries

Based on the close relationship between drugs and public health and their special public attributes,most countries have established a drug marketing approval/registration system.Under this system,pharmaceutical companies are required to submit test data on the safety and efficacy of drugs to the drug registration authority and to be reviewed and approved by the drug registration authority before they can be marketed and sold.At the same time,in order to avoid the waste of social resources caused by repeated tests,simplified application procedures can be applied to the marketing of generic drugs,which only require the submission of bioequivalence certificates.These simplified application procedures allow generic companies to indirectly use the test data submitted by the original drug companies to seize the market at a lower cost and price.To avoid such "free-rider" behavior,the United States and the European Union have taken the lead in establishing a system of exclusive protection for drug trial data and are actively expanding it at the international law level.The Agreement on Trade-Related Aspects of Intellectual Property Rights("TRIPS Agreement")was an initial attempt at such expansion,but the TRIPS Agreement ultimately did not explicitly establish exclusive protection obligations due to strong resistance from developing countries.After the initial attempts were not fully successful,the U.S.and the EU adopted a forum-shifting strategy and actively promoted the globalization of exclusive protection of drug trial data through bilateral trade agreements("FTAs").However,such exclusivity protections will lead to delays in bringing generic drugs to market while incentivizing innovation,and their rapid expansion in international law could exacerbate the access dilemma in developing countries and threaten public health.In view of this,this paper will analyze its specific manifestation and characteristics in internationalization and its impact on developing countries,and discuss the response strategies for developing countries on this basis.The first part of this paper introduces the basic concept of exclusive protection of pharmaceutical trial data.This part firstly explains the meaning and origin of the exclusive protection of drug trial data and its commercial value.The core of the exclusive protection is to restrict the drug registration authority from relying on the trial data submitted by the right holder to approve its competitors’ drug marketing applications in order to protect the commercial value of the trial data and thus stimulate pharmaceutical innovation.Secondly,this paper compares the system of exclusive protection of drug trial data with patent protection and trade secret protection(which are the traditional means of protecting intellectual property rights of pharmaceutical companies)and points out its special features.The second part of the paper analyzes the internationalization of the exclusive protection of pharmaceutical trial data.This part firstly introduces the protection of undisclosed information under the TRIPS Agreement.As an initial attempt to expand the strategy of developed countries,the TRIPS Agreement adopts the ambiguous concept of "unfair commercial use" and does not clearly establish the obligation of exclusive protection.Secondly,this part analyzes how the U.S.and European regions use trade pressure to force developing countries to accept exclusive protection obligations through FTAs and unilateral trade measures in the post-TRIPS period,and summarizes the development trend of the specific content of experimental data exclusive protection in the post-TRIPS period.Finally,this part points out that the exclusive protection of experimental data will directly enhance the monopoly position of originator drugs in developed countries,which will lead to higher drug prices and inequitable distribution of supply and will exacerbate the problem of drug accessibility;at the same time,since the exclusive protection of experimental data is not subject to patent compulsory licensing,this may lead to limitations on the flexibility of developing countries to respond to urgent public health crises.The third part of this paper explores coping strategies for developing countries.Developing countries should be aware that,while exclusive protection of drug trial data will exacerbate the access dilemma and public expenditure burden,in the long run,it will also provide incentives for originator companies to develop new drugs for health problems in developing countries and for the growth of indigenous innovative drug companies.Therefore,developing countries should approach the protection of drug trial data exclusivity based on their own national conditions.Developing countries should actively use legislative flexibility to optimize the design of the relevant system,limit the definition of the concept and add reasonable exceptions for the purpose of public interest protection,in order to weaken the actual exclusive effect of the exclusive protection system and achieve a balance between pharmaceutical innovation and drug accessibility.The last part of this paper discusses the current status and improvement of legislation on the exclusive protection of pharmaceutical trial data in China.According to the current effective legislation in China and the published consultation drafts,the scope of exclusive protection in China is relatively broad,and it is proposed to grant exclusive protection to biological products and orphan drugs in addition to chemical drugs,and the overly broad scope of exclusive protection may lead to overwhelming public expenditure in China in the short term;the disclosure system of pharmaceutical trial data in China does not fully comply with the provisions of the TRIPS Agreement,and there is In addition,China has not set up exceptions for the non-reliance system,which is not conducive to responding to public crises.Therefore,this part suggests that China should first reduce the scope of exclusive protection,and then expand the scope in a gradual manner according to the practical situation;optimize the way of disclosure of test data to ensure the transparency of test data information;set up a compulsory license for non-reliance obligation can enhance China’s ability to deal with public health crisis and increase the bargaining power with pharmaceutical companies.