Implementing Effective Compliance Programs in Jurisdictions Where the Rule of Law is Weak

December 2025

Abstract

Multinational organizations increasingly operate in jurisdictions where the rule of law is weak, inconsistently enforced, or subject to political and economic influence. For pharmaceutical and biotechnology companies, these environments present heightened risks involving corruption, data integrity, patient safety, and third-party misconduct. While local laws may exist formally, enforcement mechanisms are often unreliable, selective, or compromised, leaving organizations exposed to significant legal, ethical, and reputational harm.

Authors

Fabiana Lacerca-Allen

Chief Compliance Officer, Cipla, USA

M. Fabiana Lacerca-Allen is a senior compliance and legal executive with over 30 years of experience leading global compliance, legal, and governance programs across the pharmaceutical, biotechnology, and technology sectors. She currently serves as Chief Compliance Officer for Cipla USA and has held senior leadership roles at Aimmune Therapeutics, Elan Pharmaceuticals, Mylan, Bristol-Myers Squibb, Microsoft, Merck, and AT&T. She brings deep expertise in risk-based compliance program design aligned with DOJ and OIG expectations, including third-party risk management, global investigations, data integrity, ethical culture transformation, and crisis preparedness. She regularly advises boards and executive leadership teams on international operations and enterprise governance. Fabiana serves as a Board Director and Audit Committee Member of Shield Therapeutics and holds a risk and governance advisory position with the International Federation of Red Cross and Red Crescent Societies (IFRC). She is also Adjunct Professor at Fordham University School of Law, teaching compliance, ethics, and governance. She is author of Crisis Capable and a frequent international speaker. She previously served as Chair of the Bay Area Ethics & Compliance Association and Co-Chair for CBI (Advanstar). She holds a JD and LLM and conducted academic research in international environmental law through the Gioja Research Institute.

Valentina Lacerca-Allen

Title Marketing/ Communication Specialist, Ethiprax LLC., USA

Nico Valentina Lacerca-Allen is a communications and marketing professional focused on advocacy, visibility, and inclusive storytelling. She is deeply committed to amplifying underrepresented voices—particularly within the LGBTQ+ community—and to creating authentic messaging grounded in empathy, integrity, and meaningful engagement. Nico currently serves as Marketing and Communications Assistant at Ethiprax, supporting digital outreach, social media promotion, campaign development, and audience engagement, including contributions to marketing efforts for Crisis Capable. Her work blends organization, creativity, and strategic communication to strengthen visibility and consistency across initiatives. She is pursuing a Bachelor of Arts in Communication Studies at San Francisco State University and has earned Dean’s List recognition for academic excellence.

Companies

Cipla

Cipla Limited is a leading Indian multinational pharmaceutical company, founded in 1935, focused on developing high-quality, affordable medicines across various therapeutic areas, including respiratory, cardiovascular, and HIV/AIDS. With 46 global manufacturing sites, it produces 1,500+ products and operates in 80+ countries.

Ethiprax LLC.