Navigating human genetic resources regulations now a core competency for pharmaceutical companies

Optimizing human genetic resources (HGR) governance and adopting a data-driven operating model are critical for pharmaceutical companies in China's changing regulatory environment, according to Deloitte's report Safeguarding Biopharma R&D – New heights in China's human genetic resources management.

Introduced in July 2019, the Regulations on the Management of Human Genetic Resources of the People's Republic of China – the country's first comprehensive set of HGR regulations – emphasize the importance of compliance and provide more transparency on the scope of HGR studies subject to review and approval.

They make all studies categorized as international collaborations subject to HGR compliance. In other words, pharmaceutical multinationals' human-based research in China must obtain additional HGR approvals, in addition to regular approval by the National Medical Products Administration.

"We expect HGR policies will continue to strengthen as a result of the government's priority of protecting HGR security and China-based innovation. HGR management excellence is now a key capability within the R&D function of pharmaceutical multinationals conducting China-based research and domestic players with globalized R&D operations and partnerships," says Jens Ewert, Deloitte China Life Sciences & Health Care Leader.

With development and innovation surging in China's biopharma industry, the number of international studies with a China component and corresponding HGR applications have steadily increased over the past five years. However, more than 20% of these applications were not approved by the HGR, with the average approval rate falling since 2019's HGR regulations. This shows that as the government strengthens its intention to ensure the proper use of HGR and IP, it is adding complexities to the implementation of R&D programs that require active navigation.

"To secure study approvals and ensure compliant execution, companies must accurately interpret current policies and anticipate future developments to adapt to changes in the regulatory requirement with more agility," adds David Xie, Deloitte China Life Sciences & Health Care Consulting Director. "We suggest they focus on effective policy interpretation, localization of R&D capabilities, robust communication and engagement with HGR-related stakeholders, and proactive legal and compliance risk mitigation."

Specifically, R&D organizations should establish optimized HGR governance that instills a cohesive approach to HGR oversight. Equally as important is adopting the right HGR operating model, with a committed leadership team. Moreover, companies should create HGR-related KPIs and use data to measure and improve HGR productivity and compliance.

"China's HGR regulations present additional compliance barriers for foreign-involved, China-based R&D programs. Navigating these regulations will require companies to establish a proactive mindset, a fungible operating model, and the right data-driven solutions for continuous enhancement of HGR management capabilities. To succeed, R&D organizations must urgently build HGR management excellence as a core competency," says David Xie.