Abstract: China’s healthcare reform aims to provide affordable and equitable basic healthcare for all by 2020. Access to medicines is an essential part of the healthcare. The efforts of promoting access to medicines have been moving from meeting the needs of the basic healthcare, towards increasingly dedicated resources to offer breakthrough therapies. Looking at access to novel medicines from a health system perspective, and placing the changes China has made into that system context, this paper makes a comprehensive review of the progress of access to novel medicines in China. The review drew on two sources of information, which included desk review of published and grey literature, and key informant interview. Five hurdles were identified which create barriers of access to novel medicines, ranging from regulation and financing of medicines, intellectually property rights protection, and development of innovation capacity, to other health system components. Multiple policies have been implementing in China to remove the multiple access barriers gradually. Universal access to medicines has been moving from towards the basic common conditions to the world breakthrough technologies. We see cause for optimism, but recognize that there is a long way to go. Achieving broader and better access to modern medicines for Chinese patients will require multiple and coordinated government efforts, which would need to target the whole lifecycle regulation of novel medicines with a health system perspective, from balancing IP protection, strengthening R&D and public health, to appropriate regulatory approach and financing mechanism, and to supply chain management, as well as smart use.
Keywords: access to novel medicines, regulatory, affordability, IP, R&D, health system