FCPA & Anti-Corruption for the Life Sciences Industry

Amid increased global enforcement postures and compliance program standards, it is critical that multinational life sciences companies ensure that their programs are pressure-tested (and re-tested) toward mitigating individual/corporate liability risks and strengthening corporate culture.

• Global anticorruption enforcement efforts and comparisons to the FCPA:
  • The UK Economic Crime and Corporate Transparency Act
  • EU Anti-Corruption Directive
• The interplay of GDPR with anti-corruption compliance efforts
• Assessing compliance controls in an era of remote and hybrid work
• Where do global anti-corruption efforts intersect with data privacy compliance requirements?
• How to evaluate your training and controls by means other than audits
• Ensuring that your program is aligned on paper and in practice

The tools required for effective third-party management for life sciences companies continue to change. Added to this is the reality that certain jurisdictions present unique, heightened risks and obstacles to tailoring your program to each specific context. This session will allow candid discussion and life-science-specific benchmarking around third-party risks and evolving compliance and geopolitical realities.

• Updating best practices for a risk-based program tailored to a specific country/region
• Strengthening contractual agreements with distributors and sub-distributors
• When and how much to train distributors and sub-distributors
• Strengthening your due diligence with tier one and tier two distributors and resellers and contractual risk flagging process and procedures
• How to vet distributor past-history around prior accusations, improper affiliations, and the strength of their own compliance programs
• On the ground obstacles to monitoring third party conduct, including distribution and sub-distribution networks
• Knowing how far down the supply chain to go: When to stop
• Concrete examples of addressing resistance to follow-up questions after an initial questionnaire

With the vast amounts of data stored on servers and in the cloud, and the ever-increasing sophistication of threat actors, life science organizations must contend with a complex multinational regime of data protection laws. The sheer number of them — and the differences in definitions, standards and exceptions between them — presents a challenge for an organization when a data breach occurs.

• Complying with the GDPR’s breach notification obligations
• US: Navigating a handful of federal laws, including breach notification provisions
• UK Data Protection Act
• Brazil’s data protection regime (LGPD)
• Navigating China’s 2023 update of its Personal Information Protection Law (PIPL)
• DOJ’s Civil Cyber Fraud Initiative: Using the FCA to enforce cyber requirements
• Cyber breach security and prevention, particularly for medical device companies:
  • Reviewing remote access protocols
  • Segmenting data into different networks
  • Understanding ransomware demands and reporting

• DOJ’s M&A Safe Harbor Policy: Steps to take when you discover FCPA violations
• The benefits and practicalities behind self-disclosure:
  • Specific requirements as to the timing of disclosure and remediation
  • Remediation and restitution: Potential criminal exposure at the target company
  • What constitutes a “reasonableness analysis?”
  • Misconduct discovered during “bona fide, arms-length M&A transactions”
• Spinoff mergers:
  • Assessing the scope of risk relative to whole company acquisitions » Allocating assets and liabilities between the parties
  • Third party and regulatory consents

Topics will include:

• When donations can cross the FCPA line
• Responding to scrutiny over improper influence of healthcare providers through travel, gifts, entertainment — particularly in sponsorship of educational meetings and conferences
• When it is appropriate to retain a foreign healthcare provider for advisory services and compensate for their time
• Virtual calls, mobile app meetings and their associated compliance risks, as well as the value of engaging HCPs on the virtual stage
• Using HCPs as social media influencers
• Sending HCPs to industry conferences
• What level of due diligence is now required before outreach to an HCP?
• How companies are operationalizing controls around HCP conflicts of interest

• Trends and specific challenges related to FCPA-related whistleblower complaints
• Step-by- action plan for handling the complaint, interviews and litigation risk
• Whistleblowers that continue to bring False Claims Act actions against life sciences companies, particularly those that lack the fundamental controls necessary to comprise adequate healthcare fraud and abuse compliance programs
• Asia Pacific-related whistleblower report trends: Meeting confidentiality obligations and local law requirements
• Whistleblower risks when implementing reductions in the workforce
• EU Whistleblower Protection Directive: Key Considerations for the Life Sciences Sector
  • fostering internal, rather than external, reporting
  • encouraging individuals to report centrally, while ensuring that the worker also has the option to report locally
  • Retaliation:
    • retaliations including “psychiatric or medical referrals”
    • continuing to monitor its relationship with a whistleblower and to keep records of management decisions

How are life sciences companies reviewing ephemeral business communications policies and procedures, as well as emerging privacy, security, and employment law scrutiny? Don’t miss this critically important session as we discuss:

• The new expectations for retaining business records and correspondence
• Use of emojis as an emerging messaging risk: Corporate malfeasance and cross-cultural complications
• Data privacy issues that can affect compliance with DOJ data retention policies
• How the life sciences industry is updating messaging app policies, procedures, and monitoring
• When to restrict or prohibit the use of messaging apps to company-owned
• The three biggest ephemeral messaging dilemmas for life sciences: » Mitigating WeChat messaging and document sharing and retention risks when operating in China
  • Reviewing data privacy policies and regulations: Ensuring that all business communications can be reviewed in high-risk jurisdictions like China, Latin America, and India
  • Implementing internal investigations

• The corruption landscape in key emerging markets, including recent headlines and scandals
• China’s new laws and regulations aimed at both bribe payors and recipients
• India’s slew of legislative and regulatory developments impacting compliance requirements and investigative procedures
• Africa’s anti-corruption enforcement trends and how they are threatened by an uptick in political transitions
• The importance of including key contractual provisions and audit rights and mechanisms