Managing Regulatory Risks for Life Sciences in APAC: Key Trends in 2026

Regulatory risk for life sciences companies in APAC is accelerating, driven by geopolitical developments and intensifying enforcement. The newly enacted U.S. BioSecure Act introduces complex restrictions for companies with China exposure, raising challenges for cross-border operations. At the same time, Chinese regulators are sharpening scrutiny in key areas such as HCP fee-for-service arrangements, third-party sponsorships, and charitable patient support programs, reshaping compliance expectations on the ground.

Five Core Themes for In-House Legal Counsel

The panel highlighted five broad themes for in-house legal teams working across compliance, disputes, and transactions:

1. The BioSecure Act introduces a phased but strategic shift in regulatory risk

The U.S. BioSecure Act represents a structural change in how regulatory risk is assessed for life sciences companies with China exposure. While implementation will be gradual (with key elements rolling out through 2026–2027 and a transition period for existing arrangements), companies should treat this as a forward-looking risk requiring early preparation. The evolving designation of “Biotechnology Companies of Concern” further reinforces the need for continuous monitoring and scenario planning.

2. “Federal nexus” is the key lens for assessing exposure

Regulatory risk under the BioSecure Act is not determined by geography alone, but by whether business activities are connected—directly or indirectly—to U.S. federal contracts, grants, or funding. Companies should undertake detailed exposure mapping across business lines, supply chains, and counterparties to distinguish federal-facing activities from others. This mapping may impact operational decisions, including supply chain diversification, contractual protections, and structural separation of activities.

3. Due diligence and counterparty monitoring must be enhanced and ongoing

Heightened regulatory scrutiny requires a shift from static due diligence to continuous, risk-based monitoring, particularly for counterparties with potential designation risks. This includes deeper verification of suppliers and partners, use of local knowledge where needed, and proactive monitoring of geopolitical and regulatory signals. Robust due diligence is critical not only for compliance, but also for defensibility in the event of regulatory inquiry.

4. Patient support programs are a focal point for multi-dimensional enforcement risk

Patient assistance and support programs are under increasing scrutiny, particularly where their structure or operation may blur the line between charitable support and commercial influence. Regulatory focus extends beyond anti-corruption to include unfair competition, tax benefits, data privacy (including cross-border data flows), and accounting integrity. Authorities are examining whether such programs influence prescribing behavior, involve improper beneficiary selection, or misuse tax-exempt frameworks, often through coordinated, multi-agency reviews.

5. Anti-corruption enforcement across APAC is converging on value transfer, transparency, and control effectiveness

Across the region, anti-corruption enforcement is increasingly focused on whether there is improper value transfer influencing healthcare decision-making, regardless of the form it takes (e.g., fee-for-service arrangements, sponsorships, donations, or research funding). Regulators are adopting more forensic, data-driven approaches, examining end-to-end flows of funds, products, and data, and extending scrutiny to third parties. Effective compliance therefore requires strong internal controls, aligned incentives, and transparent documentation across the full value chain.