FCPA Third-Party Risk and Compliance for Pharmaceutical Companies

May 19th, 2016 posted by Aravo Reading Time: 3 minutes
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Around the world, governments are getting stricter about enforcing anti-bribery and anti-corruption regulations such as the U.S. Foreign Corrupt Practices Act (FCPA), the U.K. Anti-Bribery Act, and other national laws modeled on the OECD Anti-Bribery Convention. These regulations forbid bribery and corruption by companies and their third-party partners, including resellers, distributors, and marketing agencies.

Penalties for violating anti-bribery and anti-corruption regulations can be steep. When technology giant Siemens AG was charged with bribery and corruption in 2008, the company ended up paying over $1.5 billion to settle the charges.

Recent FCPA Penalties against Pharmaceutical Companies
More recently several leading pharmaceutical companies have paid tens of millions of dollars in fines to settle charges of FCPA violations brought by the Securities and Exchange Commission (SEC). As the SEC reports:

Increased Scrutiny by the Department of Justice

At the same time the SEC is pursuing civil charges for violators, the U.S. Department of Justice (DOJ) is increasing its staffing and broadening its tactics to investigate potential FCPA violations.

In recent years, the DOJ has:

How Pharmaceutical Companies Can Ensure Compliance with Anti-Bribery and Anti-Corruption Regulations

To avoid penalties for violating the FCPA and similar regulations, pharmaceutical companies need to:

Why a Third-Party Compliance Solution Is Critical

Pharmaceutical companies typically employ thousands or even tens of thousands of third parties to help with researching, developing, marketing, and distributing their products. Tracking all those third parties and ensuring they have not committed regulatory violations is an almost impossible job if data collection depends on Excel spreadsheets, email, or—worse—paper-based forms.

To stay on top of third parties and ever-changing anti-bribery and anti-corruption regulations, pharmaceutical companies need a highly scalable and configurable software-based platform that streamlines data collection, centralizes data analysis, and automatically alerts business managers and compliance teams when laws change, a third party is due for an annual review, or a third party has been found to engage in behavior that merits investigation.

To learn more about recent DOJ and SEC actions and the importance of a third-party compliance solution for pharmaceutical companies, read our new white paper, “Reducing FCPA Risks and Achieving Third-Party Compliance in the Pharmaceutical & Medical Devices Industries“:

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