A Study On The Accessibility Of Drugs From The Perspective Of International Law

Access to medicines/drug is an issue relevant to life and health, which is essential to human beings. Access to medicines includes two major aspects:the existence of effective drugs and affordable drug price. Agreement On Trade-related Aspects of Intellectual Property Right (TRIPS) requires its members to provide patent protection to drugs and its processes. The patented drug within its patent protection period is expensive. The high price of the patented drug is one of the major factors that impede the drug access for patients in developing and undeveloped countries. However, the patent protection period of many patented drugs expire since around2011. With the upcoming "patent cliff’, developing generic drugs industry is a practicable choice for improving access to medicines. Compared with patented drugs, generic drug is cheap. More patients could have access to the drugs they need.However, since the development and marketing approval would take a certain long period, it would in fact extend the protection period of patented drugs if the generic drugs manufacturers are only allowed to use the patented drugs after the expiration of the patent protection period. In order to facilitate the marketing process of generic drugs, some countries allow "regulatory review protection/Bolar exception" which does not consider the use of patented drugs by generic drug manufacturers for obtaining data necessary for marketing approval within the patent protection period as an infringement of patent protection. Chapter II would discuss whether the regulatory review protection rule is in compliance with TRIPS.Besides patent protection, the marketing of generic drugs would also be affected by the rules for drug test data protection. TRIPS requires protection of undisclosed information, including undisclosed test data, the origination of which involves a considerable effort, submitted as a condition of marketing approval, against unfair commercial use. However, the developed countries hold the opinion that TRIPS requires the authorities of WTO members not to approve subsequent marketing application of generic drugs based on the test data submitted by the precedent patented drugs ("non-reliance" requirement), in addition to not disclosing the undisclosed testing data ("non-disclosure" requirement). Chapter III would discuss whether such non-reliance requirement is mandatory under TRIPS. Upon analysis of TRIPS, relevant free trade agreements, and legislation in the U.S., European Union and China, the author would hold the opinion that the non-reliance requirement is not mandatory under TRIPS.Relevant laws and regulations in China would be discussed in the last Chapter. Upon analysis of Chinese rules regarding drug patent protection and regulatory review exception, and drug test data protection, the author provides some suggestions with respect of developing generic drug industry, such as enlarging the scope of the regulatory review exception in legislation and legal practice, limiting the scope of drug test data protection, perfecting marketing approval procedures of generic drugs, etc.