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

December 2025
ComplianceGeneral

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.

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Authors

Portrait image of Fabiana Lacerca-Allen
Fabiana Lacerca-Allen
Chief Compliance Officer, Cipla, USA

M. Fabiana Lacerca-Allen has over 30 years of experience in legal and compliance roles, working for leading American companies such as Aimmune, Elan, Mylan, Bristol-Myers Squibb Company, Microsoft, Merck, and AT&T. She has counseled and litigated in the field of international business transactions and international environmental law. She has extensive experience in the pharmaceutical industry in leadership roles in charge of legal and compliance teams. She has counseled and represented clients on a broad range of questions, including strategic business initiatives ensuring compliance with laws and regulations, and corporate policy. Ms. Lacerca-Allen has provided legal support and strategic advice on opportunities and trends in law particularly within the government sector, as well as with major and strategic corporate accounts. Fabiana has established policies and oversight on key areas of compliance affecting international markets, and she has been able to positively impact the perception of compliance, creating compliance training programs and relevant standard operating procedures and has been involved in validating and aiding due diligence in the compliance industry, frequently being requested as speaker and participant in forums. She has been recognized in the industry by Hispanic Executive Magazine in 2013, http://hispanicexecutive.com/2013/fabiana-lacerca-allen/; recognized as 2015 Women in Leadership, Inspiring Leaders: http://www.theguardian.com/women-in-leadership/2015/may/12/know-who-you-want-to be-kidnapped-with-and-four-more-tips-for-leaders; served as Chair to the Bay Area Ethics & Compliance Association (BECA); and served as Co Chair for CBI, an Advanstar company serving the Life Sciences industry. Ms. Lacerca-Allen was invited to join the Gioja Research Institute while she was a student researching on environmental law. She was recipient of 1992 UCLA’s tuition waiver based on merit and recognition, and she represented UCLA in the Roscoe Foundation National Essay Contest submitting a paper on Global Warming. About your organization Aimmune was created in response to a united call to action from the leading minds and key stakeholders in food allergy who met at an advocacy-sponsored research retreat in 2011 to reach consensus on the direction of food allergy treatment research. Among the outcomes of the retreat, the group concluded that a standard oral immunotherapy (OIT) approach needed to be established, and associated products needed to be developed. When no pharmaceutical company showed interest in developing an OIT treatment, the food allergy community formed Aimmune. Today, Aimmune is working to fulfill the 2011 shared vision of developing a peanut allergy treatment and making it available to allergists for patients worldwide.

Valentina Lacerca-Allen
Title Marketing/ Communication Specialist, Ethiprax LLC., USA

Nico Valentina is driven to use marketing and communications as tools for advocacy, visibility, and change. She is committed to amplifying voices that are too often unheard, particularly within the LGBTQ+ community, and to creating inclusive, authentic messaging that makes a real difference. Guided by a public-service mindset, she believes communication is most powerful when it is rooted in empathy, integrity, impact and respect.

Companies

Cipla logo

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. logo

Ethiprax LLC.

Ethiprax was founded in 2007 to help life sciences and related healthcare companies manage ethics and compliance risk.

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