The UK Bribery Act– Upping the Ante on Anti-Corruption/Anti-Bribery Enforcement

is being presented by Jamie L. Kendall, Esq., Senior Director, with Compliance Implementation Services and airs on Thursday, February 9th, 2012. For more details or to register, please visit our site at www.fxconferences.com

Since 1977, international pharmaceutical manufacturers have had to ensure their local affiliates abide by the Foreign Corrupt Practices Act (FCPA) when interacting with government officials. Just this past April, Johnson & Johnson came to settlement terms with the SEC for FCPA charges to the tune of $48.6 million stemming from allegations of bribing and providing kickbacks to public doctors in Europe and Iraq.

In 2010, the United Kingdom threw its hat into the anti-corruption/anti-bribery ring by enacting the UK Bribery Act, which went into effect July 1, 2011. In an interview with the Daily Telegraph the day it went into effect, the director of the UK Serious Fraud Office emphasized the intention to use the UK Bribery Act to go after non-UK corporations. While most companies may be familiar with best practices to avoid criminal investigations and civil penalties under the FCPA, the UK Bribery Act creates an additional layer of scope and raises the floor of compliance by including parties and actions not contemplated by the FCPA.

Pharmaceutical companies with UK connections will no longer be able to rely on anti-corruption policies and procedures that were predicated solely on FCPA compliance. Indeed, such policies and procedures must now account for the wider net that the UK Bribery Act casts. The enactment of the UK Bribery Act increases fraud and abuse risk exposure and an understanding of its provisions and how it differs from the FCPA is essential for creating a comprehensive compliance policy.

This presentation provides attendees with an overview of the differences between the UK Bribery Act and the FCPA and emphasizes the wider scope the UK Bribery Act represents in the anti-corruption/anti-bribery regulatory and legal framework.

Government Enforcement on Medical Affairs and Commercial-Related Activities

is being presented by Jamie L. Kendall, Esq., Sr. Director, with Compliance Implementation Services, LLC and airs on Wednesday, September 7th, 2011. For more details, or to register please visit our site at www.fxconferences.com

Corporate Integrity Agreements (CIAs) serve as intelligible “tea leaves” as the government’s focus on commercial-related activities continues to lead to medical affairs activity scrutiny. Who would have thought that CIAs executed over the past several years related to commercial activities should be construed as putting the pharmaceutical industry on notice that the government would be shifting its focus to include medical and scientific affairs activities? As the rise of recent off-label investigations and subsequent CIAs continue to become public, it is clear from CIA provisions that the government will be heavily scrutinizing medical affairs departmental activities.

Recent trends within the industry provide for a period of unprecedented change. The increase in high-profile government investigations leaves little room for mistakes within the medical and scientific affairs arena, as well as within the pharmaceutical industry in general. As CIA provisions serve as “tea leaves,” all companies within the industry are on notice that proper proactive compliance initiatives across all business units are essential.

This presentation provides attendees with an in-depth look at the government’s enforcement focus on medical affairs activities through settlements and CIA provisions, offers a commercial and medical affairs activity overlap discussion, best practices, and a discussion around off-label marketing and the evolving role of the medical science liaison.