德勤-关注中国人类遗传资源管理-为药企发展保驾护航_16页_485kb

Summary of "Safeguarding biopharma R&D: New heights in China's human genetic resources management"

Core Content

The document provides an overview of the evolving landscape of human genetic resource (HGR) regulations in China, focusing on the implications for biopharmaceutical research and development (R&D) programs. It outlines the key regulatory changes, compliance requirements, and strategic recommendations for multinational pharmaceutical companies (MNCs) and domestic biopharmas conducting research in China.

Main Points

HGR Regulations Overview

• The first comprehensive HGR regulations in China were introduced in 2019, marking a significant shift in the regulatory framework.
• The regulations define HGR as including human genetic resources materials and information, with certain types (e.g., whole blood, tissue biopsy, genetic sequencing data) being of high sensitivity and subject to stricter scrutiny.
• HGR regulations apply to a wide range of studies, including registration studies, exploratory research, and post-market studies.
• All international collaboration studies require HGR compliance, which includes:
  • Applications for international collaboration specifying stakeholders, project planning, IP sharing, and sample size.
  • Applications for collection and storage of HGR by Chinese collaborators.
  • Applications for exportation of HGR samples.
  • Pre-approval for transmitting HGR data to ex-China jurisdictions, including Hong Kong and Macao.

Regulatory Enforcement and Penalties

• The enforcement of HGR regulations has intensified over the past five years, with a declining approval rate and increased penalties.
• Violations can result in delays of up to 1.5 years in R&D programs.
• The upcoming introduction of the Biosecurity Law and potential inclusion of HGR in Criminal Law will further increase the severity of penalties.

Strategic Agenda for HGR Management

• Companies must adopt a proactive approach to anticipate and interpret regulatory changes.
• Key strategic focus areas include:
  • Effective Policy Interpretation: Understanding and adapting to the evolving regulatory landscape.
  • Capabilities Localization: Encouraging the use of local vendors and labs for sensitive HGR activities.
  • Robust HGRAO Communication: Engaging with the HGR Administrative Office to ensure compliance and reduce delays.
  • Proactive Legal and Compliance Risk Mitigation: Implementing internal processes, SOPs, and training to avoid violations.

Key Recommendations

Governance and Operating Model

• Optimized HGR Governance: Establish a cohesive local governance structure to manage HGR oversight effectively.
• Fit-for-Purpose Operating Model: Create a dedicated internal team to handle HGR-related tasks, including policy interpretation, training, and study coordination.

KPIs and Data-Driven Approach

• Explicit HGR KPIs: Define clear metrics for measuring HGR management success, such as approval rates, compliance readiness, and reputation.
• Data-Driven Solutions: Leverage IT systems to track study submissions, manage sample flow, curate source files, and deploy training programs.

Cross-Functional Collaboration

• Internal collaboration across functions (government affairs, clinical development, operations, IP/legal) is essential for effective HGR management.

Implications for MNCs and Domestic Biopharmas

• MNCs must revisit their local vendor strategies and consider partnerships with Chinese labs and data vendors to meet HGR requirements.
• Domestic biopharmas with global R&D operations also need to focus on HGR compliance to align with international standards and avoid penalties.

Conclusion

• HGR management excellence is becoming a critical capability for R&D organizations in China.
• Companies must invest in proactive strategies, internal governance, and cross-functional collaboration to navigate the increasingly complex regulatory environment and ensure successful R&D programs.

Key Information

• The HGR Administrative Office (HGRAO) plays a central role in regulating and reviewing HGR-related activities.
• HGR regulations are designed to protect national security while supporting innovation.
• The document highlights the importance of early engagement with HGRAO and the need for internal alignment to ensure compliance.
• IT solutions and data-driven oversight are crucial for tracking and improving HGR management.

Contacts

• David Xie – Consulting Director, Deloitte China Life Sciences & Health Care
  Email: daxie@deloitte.com.cn

• Megan Qian – Consulting Senior Consultant, Deloitte China Life Sciences & Health Care
  Email: mqian@deloitte.com.cn

• Kylie Dong – Consulting Analyst, Deloitte China Life Sciences & Health Care
  Email: kydong@deloitte.com.cn

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  • Jens Ewert – Industry Leader
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