Opening Remarks from the Co-Chairs

FIRESIDE CHAT

DOJ and SEC Enforcement Updates in the Life Sciences Context: Key Updates on Individual Accountability, Measuring Past Misconduct, and Self Disclosure

• How DOJ’s continued focus on individual accountability creates particular risk for employees and executives of life sciences companies, given the volume of corporate/HCP interactions and transactions
• How DOJ intends to weigh types of past misconduct
• The significant carrots DOJ is offering for voluntary self-disclosures and why this is distinctly important for life sciences companies
• Key metrics DOJ will use by to assess a company’s commitment to fostering a culture of compliance
• Recent SEC life science litigation outcomes and lessons learned

Life Sciences and the Continuing Compliance Challenges of Ephemeral Messaging: DOJ’s Increasing Oversight and How to Resolve the Most Complex Dilemmas

Considering increased DOJ oversight, how are life sciences companies reviewing ephemeral business communications policies and procedures as well as emerging privacy, security, and employment law scrutiny?

• The new expectations for retaining business records and correspondence
• 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 use of messaging apps to company-owned
• The three biggest ephemeral messaging dilemmas for life sciences:
• Mitigating WeChat messaging and document sharing 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 practices for data localization, collection, and review

Extended Networking Break

SPONSOR/CRO BEST PRACTICES ROUNDTABLE

Clinical Trials: The Latest on Managing Unique, Evolving Bribery Risk Factors for Sponsors and CROs

• Ensuring partners in global clinical trials are developing processes to determine the legitimacy of and need for clinical trials
• What CROs are doing to prevent improper payments, and reduce bribery risks when interacting with government officials, and seeking clinical trial and marketing approvals
• Sponsor obligations to assess and monitor CRO anticorruption compliance: How much due diligence and oversight can be done while remaining at arm’s length during the clinical trial
• How to go about bridging the legal/technical divide when launching a trial
• Bridging the commercial/medical affairs divide
• Executing health economics and outcomes studies that can evaluate the impact of a drug’s use on variables such as medical costs and patient quality of life
• Knowing where the money is going: Effective monitoring and auditing plans for foreign clinical trials
• Mitigating bribery risks when engaging local doctors
• Explore different types of data and stage-gate approaches that can be used to assist with decision-making for allocating resources
• Discuss whether the same model and thought processes can be applied when deciding to kill a program
• Establishing effective due diligence processes and oversight over all third parties involved in your clinical research plans

Life Science Sector Considerations for Measuring the Effectiveness of Compliance Programs: Real-World Takeaways for Updating Your Program Amid the Latest DOJ Guidance and Enforcement Posture

Amid increased DOJ enforcement postures and industry standards, it is critical that life sciences companies rededicate themselves to ensuring that their compliance programs are fully developed, implemented and pressure-tested to confirm that they are functioning effectively and working to surface issues when they arise.

• DOJ’s focus on the development of compliant culture as the antidote to corporate crime: Perspectives on designing and operationalizing a compliance culture that passes DOJ muster
• Assessing your compliance controls in an era of remote work
• Where does FCPA compliance 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
• PhRMA code changes
• U.S.-specific benchmarking on related to speaker programs and off-site engagement
• OIG Code of Conduct
• A deep dive into areas that present a high level of compliance risk: Coding and billing
• Implementing additional compliance program standards around improper inducements, kickbacks, and self-referrals
• Responding to potential violations and determining the appropriate corrective action
• Creating and disseminating clear disciplinary standards
• CMS reporting:
• Recommendations for preparing for 2023 reporting submissions
• Guidance for expanded nature of payment categories

Networking Luncheon

HYPOTEHTICALS AND POLLING

Navigating China’s Life Sciences Business Landscape and Your Risk Profile: The Top 5 Most Vexing Questions and Best Practices for Navigating Grey Areas

The life sciences market in China remains strategically important with its predicted growth and market size. However, the business environment within China will likely continue to change and shift due to geopolitical tensions, macroeconomic and policy changes. To help build or maintain a successful life sciences business in China, what compliance questions should multinationals be addressing about the realities of operating in China, and navigating known and unknown risk factors?

• China’s structural transformation of its healthcare system and critical compliance implications for life science companies
• Navigating potential fraudulent expenses: Fapaio fraud and various schemes for misusing them
• Navigating WeChat communication landmines: Document sharing, data retention
• Data protection and privacy laws in China: Balancing global data privacy laws with DOJ and SEC expectations for FCPA compliance
• Mitigating new compliance risks posed by China’s new social credit system
• What go-to-market considerations are most important to craft a winning strategy in response to China’s health reforms?
• How multinationals are evolving their programs in response to global trade tensions relating to China

Life Science Employee Compensation and Clawbacks: Compliance Program Best Practices Amid Increased DOJ Oversight

DOJ will be evaluating companies’ compliance programs to see whether they use positive and negative compensation incentives to create a compliance culture. How should life science companies be structuring their employee compensation packages to improve compliance culture and better position themselves in potential criminal investigations?

• Compensation arrangements for positions that pose higher risks of compliance issues:
• Senior executives
• Sales professionals who interact with HCPs
• Sales professionals who frequently interact with HCPs who are government officials
• Implement compensation structures that reward and incentivize compliant behavior
• Considering compliance-promoting behavior during employee performance reviews
• Implement compensation structures that penalize compliance failures: Claw back the compensation
• Integrate compliance efforts into company functions
• Compensation committees
• Employee performance evaluations
• Does DOJ’s proposed compensation-based incentives and penalties need some additional thought and analysis?

Networking Break

HYPOTEHTICALS AND POLLING

The Grey Areas of G&E, Donations, Sponsorship and Hospitality in High-Risk Markets: What Companies are Now Doing to Strengthen Policies

Don’t miss this practical, interactive session that will delve into the most vexing “on the ground” dilemmas. Through use of hypothetical scenarios, the expert speakers will impart best practices for effective compliance decision-making amid a host of grey areas.

Topics will include:

• Interacting with healthcare professionals and patient associations
• When donations can cross the FCPA line
• Responding to scrutiny over the 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
• Best practices for mitigating FCPA risk while staying on top of local legal requirements
• What level of due diligence is now required before outreach to an HCP?
• How companies are operationalizing controls around HCP conflicts of interest

Close of Day One

Opening Remarks from the Co-Chairs

CHIEF LEGAL OFFICER INTERVIEW

ENTERING AND OPERATING IN HIGH-RISK MARKETS

Engaging with Foreign Governments and Providers: Special Considerations for Gaining Access to Government Formularies and the Sale of Drugs and Medical Supplies, Devices and Vaccine Procurement

• HCPs as government officials and how to mitigate risk when they may be wearing two hats
• The importance of including key contractual provisions, including audit rights, subcontractor notification requirements, annual compliance certifications, and mechanisms for billing for pass through costs
• Use of third-party intermediaries and the special risks they present in helping gain access to foreign markets
• The proper role of political contributions and/or lobbying outside the United States

Networking Break

New Challenges for Brazil and the Life Sciences Industry: Market Entry Due Diligence for Public/Private Ventures

Brazil’s increasingly global ties in the life sciences sector provide growth opportunities for domestic and international firms. But as a contentious Brazilian presidential election comes to an end, what will happen in the Brazilian health sector? This session will outline key market change predictions and pitfalls to consider before launching a Latin American life sciences endeavor.

• Complex and ever-evolving health technology assessments
• Initial price-setting and annual readjustment mechanisms

In-House Counsel and Chief Compliance Officer Panel: Perspectives on What to Look for from Outside Counsel

Lunch

Effective and Compliant HCP Relations in Practice: How Life Sciences Companies are Weighing Operationally Efficient Processes Against Required Checks and Balances

Operationalizing compliant HCP engagement strategies: Creating top-down approved policies, SOP’s, and work instructions for transparency for different country and different state reporting

• The omni-channel public/private HCP experience: Virtual calls, mobile app meetings and their associated compliance risks as well as the value of engaging HCPs on the virtual stage
• Defining the difference between public and private HCP engagement
• Assessing what is “fair market value” for HCP services for in-person and virtual settings
• How to connect internal and external meetings where HCPs are involved and how
• Practical solutions for boosting the internal and external customer experience
• Transparent reporting mechanisms
• On-going risk monitoring
• Integration with enterprise risk management (ERP) systems
• How often to conduct risk assessments: How much is too much?
• The intersection of legal and compliance: Understanding the risks of the federal Anti-Kickback Statute for HCP engagements and transparency
• Examples of key violations and investigations involving interactions with HCPs

New Considerations for Your Self-Disclosure Calculus Amid DOJ Cooperation Credit Enhancements

Using the DOJ’s voluntary self-disclosure protocol to report potential compliance violations offers life science companies potential cooperation credits. However, when companies are evaluating whether to self-report violations of the FCPA, what points should they carefully consider around the potential benefits of voluntary disclosure and how do these outweigh the risks?

• What constitutes a voluntary self-disclosure?
• What DOJ benefits is a company entitled to receive (or have forgiven) considering a self-disclosure?
• DOJ’s seriousness about developing voluntary self-disclosure systems across the Department, systems that will have important consequences for all corporations going forward

Break

The Africa Opportunity: Market Growth Drivers, Entry Challenges, and What it Takes to Win

• Focus on where the growth is: GDP and cumulative country growth data
• Shaping sales teams: Ensure a high degree of flexibility to ensure responsiveness to the needs of local markets
• Forge local partnerships in private and public sectors: The importance of including key contractual provisions and audit rights and mechanisms for billing for pass through costs
• Addressing supply chain challenges: Route-to-market as a strategic lever

Conference Concludes