FCPA & Anti-Corruption for the Life Sciences Industry

During this session, gain critical updates on where thigs are headed on the enforcement front-from FCPA, Healthcare Fraud, False Claims, DEI, expected new DOJ Guidance and beyond.

Part 1: Big Shifts in Compliance Program, Spend and Risk Ranking?

• How life sciences companies are digesting big DOJ and SEC developments, and the ripple effect across their organizations
• Breaking down the immediate and projected long-term impacts of President Trump’s Executive Order and AG Bondi’s memoranda, and how life sciences companies are responding
• Evaluating how life sciences companies are reviewing their compliance frameworks, rethinking their risks (including global anti-corruption risks), and repositioning their spend to align with new DOJ and SEC priorities
• What grey areas of the new administration’s directives are creating the most questions for life sciences companies?
  • Will FEPA enforcement see an uptick?
• Identifying shifts in emerging risks in global markets and adjusting due diligence, third-party oversight, and internal controls accordingly

Part 2: Unintended Consequences for U.S. and Foreign Multinationals?

• Has the seismic shift in FCPA enforcement resulted in U.S. companies becoming “soft targets” for bribes?
  • Should companies strengthen their gifts and entertainment policies because of this?
• Will foreign companies find themselves increasingly under the FCPA microscope?
• The practical impact of new enforcement priorities on the mitigation of new, unexpected risk factors

Part 1: The Impact of China’s New Healthcare Anti-Bribery Guidelines and Rising Trade and Geopolitical Tensions

• Examining new healthcare anti-bribery guidelines in China and understanding their impact on life sciences companies
• Assessing how the new Trump administration’s policies and tariffs are influencing US-China relations, regulatory scrutiny, market access, and cross-border enforcement risks
• Analyzing corruption risks stemming from China’s increased scrutiny of value-based pricing (VBP) and medical education practices

Part 2: Best Practices for Tackling the Latest Risks and Challenges to Business Operations in China

• Aligning risk management with divergent U.S. v. Chinese enforcement priorities
• Adapting to increased regulatory uncertainty: Practical steps for companies to ensure operational resilience, ethical business practices, and compliance with both U.S. and Chinese laws
• First-hand accounts of navigating complex, high-risk scenarios
• Key takeaways from recent enforcement actions in China and what they indicate about the future of life sciences anti-corruption risks

While there has been a shift in FCPA enforcement priorities, the business rationale and global enforcement risks do not lessen the importance of staying the course on ethics and compliance. At the same time, life sciences companies are rethinking their self-disclosure risk calculus, whistleblower policies, employee training, messaging and corporate compliance strategies. During this highly anticipated panel, gain an inside look at how life sciences companies are taking stock of where we are—and how they driving the compliance message home during these unprecedented times.

• How new DOJ enforcement priorities have affected life sciences companies’ organization-wide culture of compliance and employee monitoring across departments
  • To incentivize or not? Does the current landscape require a new approach to preserving organization-wide buy-in?
• Your Self-Disclosure Calculus: Weighing the risks and rewards of voluntary self-disclosure in 2025 and beyond: How shifting policies may impact corporate decisions to self-report misconduct
• The Future of Whistleblowing: Reevaluating compliance and internal reporting mechanisms: steps companies should take now to address whistleblower-driven investigations
• Best practices for strategic risk management – how life sciences companies can adapt to a changing enforcement environment while maintaining ethical business practices
• Forecasting the future of whistleblower incentives: will SEC, DOJ, and global whistleblower programs continue to drive enforcement actions?
• The future of the DOJ’s whistleblower reward programs and voluntary self-disclosures
• Will financial incentives for whistleblowers be scaled back?

• Understanding how life sciences companies are using AI to enhance real-time monitoring, detection of red flags, and mitigation of new, heightened enforcement risks
• Best practices for leveraging AI for third-party due diligence, policy enforcement, and streamlining compliance workflows to meet DOJ expectations
• Balancing Innovation with Compliance: Addressing AI transparency, accountability, and ethical considerations in compliance programs
• The limits of AI for risk mitigation and enforcement
• First-hand accounts of how life sciences companies are proactively using advanced analytics to identify and mitigate corporate risks including corruption
• Best practices for integrating data insights into anti-corruption policies, monitoring, and reporting
• Key metrics and benchmarks to evaluate the success of data-driven compliance initiatives in the life sciences sector

Despite the recent pause in U.S. FCPA enforcement, life sciences companies must remain vigilant in ensuring the strength of their anti-corruption compliance programs given the enduring anti-corruption enforcement mandates of the SFO, AFA, PNF, Swiss Prosecution and more. Many expect international authorities to fill the “prosecution void” left by the seismic U.S. shit in FCPA priorities.

This session will examine key takeaways from recent global anti-corruption cases, uncover common risk areas for life sciences companies, and provide actionable strategies to enhance your anti-corruption program.

As regulatory agencies intensify efforts to combat fraud and abuse in the life sciences sector, companies are preparing to weather a new era of enforcement risk. From increased scrutiny on billing practices, financial arrangements and kickbacks, to the expanded use of alternative legal theories, this panel will explore recent fraud and abuse enforcement trends, and discuss how life sciences companies should rethink their risk exposure, policies, procedures and internal investigation programs.

Topics of Discussion Include:

• What recent cases and policy shifts reveal about emerging fraud and abuse trends and government priorities
• The latest initiatives from the Department of Justice, HHS-OIG, and other regulatory bodies
• How agencies are using the False Claims Act, Anti-Kickback Statute, and wire fraud laws to target fraudulent misconduct in the life sciences sector
• Proactive Compliance Strategies: steps life sciences companies should take now to strengthen internal controls, mitigate risks, and ensure regulatory alignment

Pharmaceutical, biotech and medical device companies share many corruption risks, but there are nuanced differences in their dealings with third parties due to the nature of their industries.  Benefit from the opportunity to participate in expert-led focus groups which will analyze the distinctive third-party risks for the pharmaceutical, biotech and medical device industries, as well as mitigation strategies tailored to the specific risks of each industry. Topics to be addressed include:

Pharmaceutical/Biotech

• Interactions with HCPs in the context of prescribing medications: Mitigating risks centered around promotional activities, speaker fees, or gifts to influence prescribing behavior
• Oversight of distributors, agents and contract sales organizations to manage risks around speaker programs and payment of marketing fees
• Best practices for spotting suspected issues by third-party intermediaries in the procurement of recurring, high-volume drug supply agreements
• New corruption and more red flags to look for when monitoring pharmaceutical product distribution networks
• Protecting against high-risk exposures stemming from patient assistance and access programs and discount schemes

Medical Device

• Working closely with HCPs during installation, use and maintenance of devices: mitigating risks of improper incentives or payments disguised as training, consulting or service fees
• Mitigating bribery and more risks associated with government-run tendering and procurement processes for high-value medical equipment: Managing agents and distributors in this process
• Corruption risks associated with device maintenance and servicing contracts with third-parties or government officials: Compliance tips and traps, contractual provisions to protect yourself, implementing oversight over third-party distributors, etc.