The EU Whistleblower Directive has introduced sweeping compliance obligations for healthcare and life sciences companies operating in Europe. Through our interdisciplinary Global Life Sciences (GLS) platform, Sidley helps clients across the healthcare and life sciences ecosystems navigate these requirements with confidence.
Sidley’s GLS EU Whistleblower team delivers:
Strategic Compliance Design: We help healthcare and life sciences companies build internal reporting systems, both at the local level and global level, that comply with the EU Directive and national laws. From whistleblower policies to secure reporting channels and escalation protocols, we tailor frameworks to each client’s structure and risk profile.
Cross-Border Program Implementation: Sidley supports the rollout of whistleblower programs across multi-jurisdictional operations—navigating national variations, data transfer restrictions, language localization, and integration with HR and compliance functions across the EU and beyond. We offer general training to companies on their obligations under the EU Directive and national laws, as well as tailored trainings to employees responsible for receiving and handling internal reports.
Investigation Management and Risk Mitigation: When reports surface, we guide clients through internal investigations with discretion and regulatory sensitivity. We advise on privilege, documentation, regulator engagement, and litigation exposure—while protecting confidentiality and guarding against retaliation. We facilitate communications between companies, the whistleblower, and, where needed, competent authorities to ensure that internal investigations are conducted in compliance with applicable confidentiality and governance requirements.
Regulatory Insight Across the EU: With lawyers in key EU jurisdictions, we offer clear, jurisdiction-specific guidance on implementation, enforcement trends, and regulator interaction—grounded in practical knowledge of healthcare and life sciences operations.
Governance and Culture: We align whistleblower programs with broader compliance requirements, ethics frameworks, and transparency initiatives. Our team partners with boards and executives to strengthen governance, support accountability, and foster a culture of trust.
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Healthcare and life sciences companies face heightened anti-corruption risks in today’s climate of global enforcement and regulatory scrutiny. From clinical trial sponsorships and distributor arrangements to government pricing, procurement, and market access, healthcare and life sciences companies must navigate a complex landscape of local and international anti-bribery laws—particularly in emerging markets where interactions with government officials are frequent and unavoidable.
Our services. Sidley’s Global Life Sciences (GLS) Foreign Corrupt Practices Act (FCPA) and Anti-Bribery team advises healthcare and life sciences clients across the full spectrum of anti-corruption risks. We are well-versed in laws that relate to dealing with government officials and authorities around the world. With more than 90 lawyers in 14 offices worldwide, we draw on the firm’s global capabilities and highly skilled practitioners to:
- defend clients in multinational government investigations, including by the U.S. Department of Justice (DOJ), U.S. Securities and Exchange Commission (SEC), State Attorneys General in the U.S., and foreign law enforcement and regulatory authorities;
- conduct internal investigations;
- create and implement compliance programs;
- perform compliance risk assessments;
- conduct due diligence on potential merger and acquisition targets, joint venture partners, and high-risk third parties; and
- counsel clients on compliance issues that arise from international licensing, sales, and marketing.
Our unique strengths. Sidley’s GLS FCPA and Anti-Bribery team brings to clients:
- Sector-Specific Experience: We represent clients throughout the healthcare and life sciences industry, including pharmaceutical and biotechnology companies, medical device manufacturers, digital health platforms, clinical laboratories, hospital systems, and private equity investors. Our anti-corruption advice is informed by a deep understanding of Food and Drug Administration (FDA), Centers for Medicare & Medicaid Services (CMS), European Medicines Agency (EMA), and other life sciences and healthcare regulatory frameworks, enabling us to provide holistic guidance on anti-corruption matters.
- Regulatory Agency Insight: Over the course of their careers, our lawyers have built relationships of mutual respect with the DOJ and SEC, the U.S. agencies with principal authority to enforce the FCPA. Our team features prominent practitioners and former officials from the DOJ and SEC, who bring an insider’s perspective to a wide range of FCPA and anti-corruption matters.
- Cross-Border Coordination: Our team has handled FCPA matters involving corporate activities in more than 100 countries. We regularly advise companies on managing corruption risks in clinical trials, regulatory approvals, government-sponsored healthcare programs, and third-party arrangements involving distributors, consultants, and local agents. Our international offices offer on-the-ground support in jurisdictions that present the greatest enforcement risk for healthcare and life sciences companies. In Europe, we advise on U.K. Bribery Act compliance and EU privacy regulations that affect internal investigations. In Asia, our lawyers in China, Japan, Singapore, and across Southeast Asia have led numerous anti-corruption investigations involving government interactions, distributor oversight, sample handling, and promotional conduct. We are one of the few firms authorized to practice local law in Singapore, offering seamless service in key Asia Pacific markets.
Contacts
Healthcare and life sciences companies operate in a high-stakes regulatory environment where securities enforcement matters can quickly escalate. Sidley’s Global Life Sciences (GLS) platform combines deep sector knowledge with one of the country’s most respected SEC enforcement practices to guide clients through sensitive investigations, compliance challenges, and litigation risk.
Sidley’s GLS SEC Enforcement team offers:
- Sector-Specific Regulatory Defense: We represent public and pre-IPO healthcare and life sciences companies, boards, officers, and investors in SEC, DOJ, FINRA, and state AG investigations involving accounting and financial reporting, insider trading, FCPA, Regulation FD, and disclosures, including those related to clinical trials, regulatory approvals, transactions, cybersecurity, and other market-moving statements.
- Insight from Former Government Officials: Our team includes former senior officials from the SEC, DOJ, and FINRA, providing clients with strategic clarity and credibility in enforcement and compliance matters.
- Integrated Litigation and Compliance Counsel: We work seamlessly with Sidley’s FDA, healthcare regulatory, and white collar teams to manage parallel investigations, conduct internal investigations, and resolve matters involving accounting, governance, or scientific disclosures.
- Proactive Risk Management: We help life sciences clients conduct risk assessments, implement comprehensive compliance programs, conduct internal investigations, remediate disclosure practices, and prepare for regulatory and investor scrutiny—especially in connection with IPOs, restatements, and corporate transactions.
- Recognized Excellence: Sidley has been named “Law Firm of the Year” for Securities Regulation and Litigation – Regulatory Enforcement by U.S. News – Best Lawyers multiple times. Our practice and our lawyers are regularly ranked by Chambers USA for securities enforcement, regulatory, and compliance leadership.
Contacts
Lara Shalov Mehraban
Ike Adams
Learn more about our SEC Enforcement and Regulatory practice.