Safeguarding biopharma R&D – New heights in China's human genetic resources management

Viewpoints / key findings

Safeguarding biopharma R&D – New heights in China's human genetic resources management examines optimizing human genetic resources (HGR) governance and adopting a data-driven operating model are critical for pharmaceutical companies in China's changing regulatory environment.

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.

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. 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.

The winning agenda for HGR management

We expect HGR policies continue to evolve and strengthen in the coming years to accommodate government's top priority of protecting HGR security as well as China-based innovation. HGR management excellence is now a key capability within the R&D function of pharmaceutical multinationals. Deloitte believes companies will have to focus on the following agenda for winning HGR engagement:

• Effective policies interpretation
• Capabilities localization
• Robust HGRAO communication and engagement
• Proactive legal and compliance risk mitigation

Organizing for HGR management excellence

The following principles may help companies overcome these operational challenges and ensure that HGR capabilities can be fully embedded into the R&D organization:

• A sufficiently optimized HGR governance can help instill a cohesive approach to HGR oversight
• A fit-for-purpose HGR operating model should be established
• Be explicit about the HGR-related KPIs in your organization
• One cannot emphasize enough the importance of data-driven

In summary, China's HGR regulations are presenting additional compliance barriers for foreign-involved, China-based R&D programs. Effectively navigating these regulations will require companies to establish a proactive mindset, a fungible operating model, as well as the right data-driven solutions to conduct issue resolution and track outcomes. HGR management excellence is a core competency that R&D organizations must consider building now in order to win tomorrow.