The effects of urgently needed overseas drugs on the launch delay of new drugs in China

A new study published in Pharmacoeconomics and Policy investigated the effectiveness of China’s Urgently Needed Overseas Drug (UNOD) policy, which aims to expedite access to innovative drugs for patients with unmet medical needs. Analyzing data from 2012 to 2019, the research reveals that the UNOD designation did not significantly reduce launch delays for new drugs compared to the United States.

Dr. Xingyue Zhu, the principal investigator of the study, underscores the need to rectify the disparities in pharmaceutical accessibility for patients, “The UNOD initiative was crafted to narrow the divide between China and developed nations regarding the availability of cutting-edge medications. Nevertheless, our findings reveal that the initiative has not yielded the anticipated results.”

The research utilized a meticulous analytical methodology, incorporating instrumental variables to mitigate potential biases in the selection of UNOD medications. “By adjusting for variables that could affect drug launch delays, we were able to ascertain the actual influence of the UNOD initiative,” Dr. Zhu elaborates.

An unexpected revelation was the minimal effect of the UNOD initiative, even though it prioritizes medications with substantial clinical advantages. Zhu posits that this could be attributed to the overlap with other pre-existing policies, such as the Technical Guideline on Accepting Data from Overseas Clinical Trials of Drugs. “This preceding policy already permitted the utilization of international trial data for drug approval in specific instances, which might have diminished the distinct benefits of the UNOD initiative,” she remarks.

The research outcomes have important ramifications for future policy formulation. Dr. Zhu suggests that more precise incentives, such as lowered registration fees or extended market exclusivity, could be introduced to entice pharmaceutical developers and promote the submission of UNOD applications. Furthermore, investigating advantages in drug pricing and reimbursement could further augment the initiative’s efficacy.

###

Contact the author: Xingyue Zhu, Department of Pharmacy Administration, School of Medicine and Health Management, Guizhou Medical University, Guiyang, China, zhuxingyue@gmc.edu.cn

The publisher KeAi was established by Elsevier and China Science Publishing & Media Ltd to unfold quality research globally. In 2013, our focus shifted to open access publishing. We now proudly publish more than 200 world-class, open access, English language journals, spanning all scientific disciplines. Many of these are titles we publish in partnership with prestigious societies and academic institutions, such as the National Natural Science Foundation of China (NSFC).