context: The National Medical Products Administration issued 'Implementing measures for drug trial data protection', operationalising a data exclusivity regime that has existed on paper since the PRC's WTO accession in 2001 but never functioned due to undefined key concepts. The measures prohibit the Centre for Drug Evaluation from accepting or approving generic registration applications that rely on originator clinical trial data during the exclusivity period, effectively ending the longstanding practice of cost-free data reliance that has enabled ultra-low-cost generic replication.
The measures aim to protect undisclosed trial data submitted by applicants when seeking drug marketing approval, with protection categories covering innovative drugs, improved new drugs and generic drugs.
A pharmaceutical intellectual property expert who spoke to Yicai said the draft is well-calibrated, drawing on international experience while accounting for PRC conditions. It could encourage earlier launches of new global drugs in the PRC, incentivise drug companies to pursue new indications and guide domestic generic firms to fill clinical gaps, the expert added.
On overseas-approved drugs not yet marketed in the PRC the draft provides that the data protection period equals six years minus the time elapsed between the domestic application acceptance date and the date of first overseas approval. The incentive structure is straightforward: the earlier a drug enters the PRC market relative to its overseas launch, the longer the data protection it can receive. Encouraging multinational drug companies to prioritise the PRC when planning global launches is what the measure is designed to do, argued Xiao Shen 肖申 former US FDA senior clinical reviewer. Xiao nonetheless cautioned that the approach is uncommon in other jurisdictions and called for thorough industry consultation during the comment period.
Data protection is a key institutional arrangement to encourage biopharmaceutical innovation, and clinical trials account for over 70 percent of drug development costs, Bi Jinquan 毕井泉 former Chinese People's Political Consultative Conference standing committee member and China Centre for International Economic Exchanges chair had previously argued.
On the relationship between trial data protection and the patent system, experts noted the two regimes are independent and run in parallel. A generic company that successfully challenges a patent must still wait for the originator's data protection period to expire before obtaining marketing approval, described by one expert as 'two walls of protection' that must both be cleared before a generic can enter the market.
The draft specifies that during the data protection period, the National Medical Products Administration will not accept applications from other parties that rely on the protected data for the first five years; in the sixth year, applications may be accepted but approval withheld until the protection period expires. Setting a non-acceptance period helps deter duplicative drug development and gives applicants time to carefully assess research priorities and competitive conditions, argued Yang Yue 杨悦 Tsinghua University School of Pharmaceutical Sciences researcher.