Life Science Compliance Update



November 2017: Life Science Compliance Update

Written by , Posted in November 2017 LSC Update, This Month in Compliance

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November 2017 LSCU Cover

Issue Summary

This month, Life Science Compliance Update has a SPECIAL ISSUE devoted to FOCUS ON THE PATIENT. To open the issue, we explore the critical issue of ACCESS TO MEDICINE and the growing impact of CORRUPTION and what the pharmaceutical industry can do to the help. Continuing the theme of access, we examine the changing environment around EXPANDED PATIENT ACCESS to INVESTIGATIONAL MEDICINES and the balancing act this causes for life science companies.

Next, we continue our series EXPANDING THE FRONTIER examining how companies should consider working with PATIENT ADVOCACY GROUPS and the impact of the latest ENFORCEMENT decisions in the AEGERION cases. Finally, we round out this issue with a look at the latest TRANSPARENCY developments including new OPEN PAYMENTS data, new initiatives in SOUTH KOREA and CANADA, and finally the latest STATE and LOCAL government efforts to expand transparency requirements.

Special Issue: Focus on the Patient


Why it matters – Pharmaceutical compliance, Anti-corruption and Access to Medicine
Luca Genovese and Danny Edwards, The Access to Medicine Foundation

Access to medicine continues to be out of reach for an estimated two billion people worldwide. While it is clear that corruption plays a role in that problem, the true scope and cost of global health corruption is unknown. This article examines what pharmaceutical companies do and what role they should play in eliminating corruption as part of the equation of ensuring access.


Increasing the Tension – Expanding Patient Access to Investigational Medical Products
Maureen Lloyd a Health Industries, Risk and Regulatory Director and Dixil Francis a Health Industries, Risk and Regulatory Manager at PWC

Expanding patient access to therapies currently being tested but not yet marketed is both increasingly challenging and important. However, despite the many challenges, changing regulations and industry association guidelines have increased pressure on manufacturers to develop or expand their access to medicines programs. Therefore, it is clear that improving appropriate patient access to investigational medical products remains a prominent objective for the life science industry. This article explores the changing environment surrounding expanded patient access and the practical implications facing life science companies trying to balance competing concerns.


The Expanding Frontier Part 2 – Navigating the Complexity of Patient Advocacy Groups
Chad A. Morin, Senior Director Healthcare Compliance, bluebird bio

Although many Patient Advocacy Groups have been around for more than 20 years, it has only been in the past couple years that they have had a substantial impact. It is clear that engaging with and assisting PAGs can provide a shared-value to patients. However, doing so is not a simple matter, and this article explores some of the many factors that companies should consider.


The Expanding Frontier Part 3 – PAGs in Light of the Aegerion Cases
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

There is no doubt that Patient Advocacy Groups play an important and substantial role in shaping the healthcare landscape. It also is true that it is not a simple matter for life sciences companies to work with these groups. This article examines the recent trio of cases involving Aegerion to ascertain what it says about the government’s enforcement stance and how that it may shape the future of industry/PAG interactions.


Transparency Perhaps a Falling Star in the U.S. But Rising Internationally
Kaitlin Fallon Wildoner, Esq., Senior Staff Writer, Life Science Compliance Update

While interest in transparency seems to be waning in the U.S., it continues to rise internationally with Canada and South Korea. This article will examine the latest numbers from U.S. Open Payments and the efforts of Canada and South Korea.


Coming Soon to a State or Even City Near You – Part 2 Spend Disclosure & Much More
Nicodemo (Nico) Fiorentino, Esq., Manager, Research & Compliance, for G&M Health LLC

In 2017, the pharmaceutical industry has been hit hard by the increasing number jurisdictions proposing, passing, and implementing numerous compliance requirements ranging from annually reporting payments and other transfers of a value provided to health care professionals, listing or licensing sales representatives and other employees, being prohibited from offering certain discounts, and facing “gift” limitations and restrictions. These jurisdictions include the City of Chicago (representative licensure and disclosure), Nevada (representative listing and disclosure), California (discount prohibition), Maine (“gift” limitations and restrictions), and New Jersey (proposed regulation to limit and cap meals and restrict consulting agreements). With another major election year ahead of the industry, the pharmaceutical industry will be an easy target. In fact, states will use the success of the previous year, combined with the pricing debate and the opioid crisis, to push through legislation and regulations.

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