FCPA/Anti-Corruption Compliance in Pharma/Life Sciences Industry
The U.S. and international enforcement authorities have demonstrated continued focus on the life sciences industry for FCPA and anti-corruption violations as shown by prominent international investigations and intensified government compliance outlooks. This emphasis is critical for mid-market businesses with underdeveloped compliance programs. Clinical research organizations, hospitals and providers also have high enforcement risks due to healthcare globalization.
Life sciences companies should know how to respond to this daunting climate and, eventually, battle anti-corruption risk factors confronting the industry. This includes more than just direct relationships with government. It also extends to third party, supply chain and distribution relationships, all of which expose industry participants to FCPA risk.
In this two-hour, live webcast, a panel of distinguished professionals and thought leaders organized by The Knowledge Group will help the pharma/life sciences industry understand the fundamental and complex aspects of this significant topic. They will provide an in-depth discussion of the various FCPA/anti-corruption compliance issues every pharma/life sciences company should know. Speakers will also offer the audience best practices in developing and implementing an effective compliance and risk management program.
Key topics include:
- FCPA/anti-corruption in pharma/life sciences industry: Current trends
- Notable cases for guidance
- Common anti-corruption risks
- Best compliance practices
- According to the 2016 BDO Life Sciences RiskFactor Report, The vast majority (92 percent) of life sciences companies cite threats to international operations and sales, up four percentage points from 2015. During this presentation we will discuss:
- Best practices for organizations to consider when dealing with different factors that increase their risk of exposure to bribery and corruption (ie. business conduct rules, regulations and cultural norms)
- Key considerations an organization needs to be able to identify and address the risks factors related to the Foreign Corrupt Practices Act (FCPA) and other anti-bribery regulations
- The implications of the new FCPA pilot program for Life Sciences organizations
DLA Piper LLP
- FCPA interest and action by enforcement authorities continues at a significant level in 2016 with respect to the pharmaceutical industry – including as reflected in recent resolutions with AstraZeneca, Novartis, Nordion, and SciClone.
- Other countries and regulators are also taking notice – and applying scrutiny to practices that may fall afoul of similar laws in their own jurisdictions – including notably in China and the UK.
- The number of touch points for interactions by companies in this industry with health care providers, pharmacies, distributors, wholesalers, regulatory agents, government officials, tender specialists, clinical research organizations, medical product suppliers, and health care organizations and medical education groups are numerous. In addition, the broad geographic footprint and heavy “boots on the ground” sales force add to heightened risks.
- As a result, many companies are making significant changes in their approach to compliance and anti-corruption policies, including by fundamentally altering how they engage with those in the health care industry and what transfers of value are provided to them.
- The evolving nature of “best practices” to detect noncompliance and violations of law or company policy is critical; similar to their handling of good manufacturing practices (GMP), companies should be aware of and working to ensure that they are developing the right tools and approaches to detect new schemes, and using metrics and electronic tools to assist with a heightened level of monitoring.
Richards Kibbe & Orbe LLP
- So how can participants in the pharmaceutical industry best position themselves and prepare for what is now inevitable regulatory scrutiny in this environment? How do best practices in the anti-bribery context translate to effective risk mitigation when the regulators come calling? Even the most advanced ABAC compliance and third party risk management programs only address part of the risk.
- Participants in the pharmaceutical company should take steps now to ensure that they can be proactive later – in the event of a regulatory inquiry. Such preparation may include:
- Establishment and testing of ethics hotlines and whistleblower procedures;
- Specialized training for employees and compliance personnel dealing with high risk third parties, such as distributors and sales agents in high risk markets;
- Development of an audit trail of compliance efforts;
- Establishment of a protocol for prompt review and resolution of red flags including:
- Identification and escalation
- Safeguarding of relevant information
- Consideration of self-reporting
- Evaluation and implementation of appropriate remedial measures
Who Should Attend:
- Legal Counsel
- Health Care Providers
- Medical Device Regulatory Officers
- Pharmaceutical Regulatory Officers
- Senior Management in the Life Science and Healthcare Industries
- General Counsel in the Life Sciences and Healthcare Industries
Pei Li Wong is a Managing Director in BDO Consulting, leading the firm’s Asia Forensic Desk with substantial experience conducting forensic investigations, due diligence and compliance reviews throughout Asia and elsewhere involving Asian businesses. Her experience includes numerous Foreign Corrupt Practices Act (FCPA) and UK Bribery Act investigations, as well as matters involving allegations of financial reporting fraud and employee misconduct. She is fluent in Chinese (Mandarin and Cantonese).
In addition to her experience in Asia, Pei Li has conducted investigations in Europe, Latin America and other areas identified as high-risk for fraud. She has worked with numerous multinational organizations, as well as their subsidiaries, representative offices and third-party agents in global locations. Pei Li also assists clients to monitor and assess global compliance risks, identifying red flags indicative of threats to an organization’s business operations and internal control structures. She has provided recommendations on remediation procedures and fraud prevention measures, and has helped clients with regulatory inquiries, including matters before the Department of Justice and the U.S. Securities and Exchange Commission. In addition, she has experience in matters involving money laundering, export controls and tax regulations.
Pei Li Wong is a Managing Director in BDO Consulting, leading the firm’s Asia Forensic Desk with substantial experience conducting …
Laura Flippin focuses her practice on government investigations, corporate internal investigations and compliance, anti-bribery and anti-corruption matters, and sanctions and export controls.
She has represented and defended corporations and individuals in a number of industries, including oil and gas, financial, energy, higher education, hospitality and leisure, healthcare, pharmaceutical, engineering and telecommunications. She has appeared in trial and appellate courts throughout the United States in a variety of matters.
Her experience also includes working with clients on sophisticated electronic discovery issues, including preparing for and responding to litigation and government investigations. She has advised and represented companies in a wide variety of compliance matters, including the Foreign Corrupt Practices Act (FCPA), the UK Bribery Act, sanctions and export controls regimes, and the False Claims Act, both in developing and enhancing compliance programs and in responding to government inquiries and investigations. She has also represented telecommunications institutions, government contractors, healthcare providers, life sciences, financial and banking institutions in litigation and investigations involving fraud and compliance issues.
Laura Flippin focuses her practice on government investigations, corporate internal investigations and compliance, anti-bribery and anti-corruption matters, and sanctions and …
William Barry is a partner and member of the Executive Committee at Richards Kibbe & Orbe LLP. He advises clients on a broad range of issues involving securities enforcement, white collar and securities fraud litigation, as well as compliance with The Foreign Corrupt Practices Act, money laundering and insider trading requirements.
Mr. Barry guides clients through the complex issues involved in cross-border transactional due diligence and risk mitigation as well as responding to inquiries from the U.S. DOJ, SEC and other domestic and international regulators regarding issues of accounting fraud, foreign bribery and other financial crimes. He also represents clients responding to competing demands in parallel proceedings, such as internal reviews, government investigations and private civil actions.
Mr. Barry has been recognized in the area of White Collar Criminal Defense by The Legal 500 United States and has been designated as a Certified Anti-Money Laundering Specialist by ACAMS.
William Barry is a partner and member of the Executive Committee at Richards Kibbe & Orbe LLP. He advises clients …
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About BDO Consulting
BDO Consulting, a division of BDO USA, LLP, provides clients with Financial Advisory, Business Advisory and Technology Services in the U.S. and around the world, leveraging BDO’s global network of nearly 60,000 professionals. Having a depth of industry expertise, we provide rapid, strategic guidance in the most challenging of environments to achieve exceptional client service.
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About Richards Kibbe & Orbe LLP
Richards Kibbe & Orbe LLP has long been a go-to firm in the fields of cross-border enforcement, government investigations and criminal defense. We have a proven record of navigating difficult regulatory and criminal issues, from high profile investigations, parallel criminal and regulatory proceedings to the latest hot-button international enforcement situations.
For 25 years, RK&O has helped clients facing potential scrutiny in multiple jurisdictions and confronting severe civil, criminal and reputational penalties. Our highly skilled team draws on the key attributes of the firm: our renowned white-collar practice, our proficiency in regulatory counseling, our ability to seamlessly manage parallel proceedings and our vast cross-border experience.
The RK&O team understands the enforcement perspective and can foresee future challenges lurking around the corner. We deeply understand the importance of international cooperation and the complications of regulatory exposure in multiple jurisdictions.