Michele Tagliaferri

The scope of Michele’s practice is reflected in his recent representations, including:

Life Sciences Regulatory and Compliance Counseling

• Advising a number of U.S.-based multinational pharmaceutical companies with respect to early access and continued access regulations under EU law and (in collaboration with local counsel) under the laws of a dozen of ex-EU national laws.
• Assisting several pharmaceutical manufacturers in responding to FDA Form 483s, Warning Letters, and Untitled Letters, as well as with developing site remediation work plans.
• Reviewing pharmaceutical companies’ promotional materials for compliance with applicable regulations.
• Advising a multinational pharmaceutical company on a variety of EU regulatory and compliance issues, including establishing early access programs, using social media, interacting with patient associations and physicians, and complying with EU sustainability laws.
• Assisting a U.S.-based biotech company with developing advisory board agreements in line with legal requirements in a number of jurisdictions.
• Assisting various multinational pharmaceutical companies with drafting and negotiating agreements with distributors across the globe.

Investigations and Enforcement Defense

• Conducting a privileged GMP/data integrity investigation for a multinational pharmaceutical company into allegations of GMP violations at the company’s manufacturing site in Romania.
• Conducted numerous internal FCPA/ABAC investigations for major pharmaceutical and other companies involving activities in Eastern Europe, the Middle East, and Latin America (e.g., Argentina, Brazil, Belarus, Belgium, Bulgaria, China, Colombia, Germany, Greece, Iran, Poland, Russia, Saudi Arabia, Turkey, and Ukraine).
• Assisted a Danish pharmaceutical company with a regulatory investigation into allegations of off-label promotion practices by the company’s Greek and Italian subsidiaries.
• Represented a global pharmaceutical company in criminal and data privacy investigations by various EU authorities into allegations of GDPR and criminal law violations related to the government affairs practice of the client, advising on best strategy to address and mitigate the legal and reputational implications raised by the enforcement actions.
• Conducted a regulatory investigation into suspicions of GMP/data integrity violations at the client’s manufacturing sites in Italy.
• Represented a Spain-based multinational company in a DOJ investigation and an internal investigation into allegations of improper payments by employees of its Italian subsidiary.
• Conducted dozens of regulatory and compliance investigations for major pharmaceutical and other companies involving activities in Eastern Europe, the Middle East, and Latin America (e.g., Argentina, Brazil, Belarus, Belgium, Bulgaria, China, Colombia, Germany, Greece, Iran, Poland, Russia, Saudi Arabia, Turkey, and Ukraine).
• Conducted an internal investigation for a multinational beverage company into allegations of improper sales practices by company employees in Belgium, Germany, and France.
• Assisted various multinational companies with assessing the implications of the EU Whistleblowing Directive on their EU subsidiaries and implementing the required internal controls and governance changes to ensure compliance with applicable national laws without increasing U.S. enforcement risk.
• Counseling dozens of life sciences companies on corporate compliance program development and best practices, including risk assessments, program reviews, employee training, and policy/procedures.
• Conducted risk assessments for multinational life sciences companies at affiliate sites, including in China, Colombia, Germany, India, Poland, Russia, Saudi Arabia, Singapore, and Taiwan.
  

ESG/Sustainability

• Advising various companies on the scope, applicability, and implications of the EU Omnibus Package amending the EU Corporate Sustainability Reporting Directive (CSRD) and the EU Corporate Sustainability Due Diligence Directive (CS3D).
• Advised a U.S. multinational company on the scope of a number of EU sustainability laws, including the CSRD and the CS3D.
• Advised a Japanese pharmaceutical company on compliance with the German Supply Chain Act (LkSG) and on the recommended preventive and remedial measures.
• Advised a pharmaceutical company on the development of a supplier code of conduct and the contractual clauses required in agreements with business partners to comply with the proposed CS3D.
• Advised a Swiss company on requirements imposed by the EU Batteries Regulation.
• Advised a UK biotech company on the requirements and implications of the EU Fluorinated Gases Regulation.
• Advised a U.S. multinational company on the requirements and implication of the EU Carbon Border Adjustment Mechanism (CBAM).
• Advised a leading multinational medical device company on the applicability of the CSRD and the proposed CS3D to the company’s operations, as well as on specific reporting options under the CSRD.