A Pandemic, a Treatment, and the Impact to a Brand Protection Program
Associate Director, Brand Protection, Gilead Sciences, Inc.
At Gilead, we are inspired by the opportunity to address unmet medical needs for patients living with life-threatening diseases around the world. Starting as early as January 2020, Gilead has focused on deploying our resources and decades of antiviral expertise to help patients and communities fight what would come to be known as the coronavirus pandemic. As of mid-November, Gilead is the only company with an anti-viral FDA-approved treatment for COVID-19. Getting here presented unique challenges to Gilead’s Anti-Counterfeiting and Brand Protection Team (ACT) and many of those challenges persist today.
The nature of Gilead’s products makes ensuring authenticity and safety of our medicines fundamentally important. Early in 2020, as news that a new novel coronavirus was identified in China and began to make its way across the globe, so did interest in a Gilead’s investigational antiviral compound referred to as remdesivir as a possible treatment for this new virus. Living our company’s credo of “doing what’s right,” ACT very early on put measures in place to get ahead of the potential onslaught of incidents and inquiries relating to remdesivir. Like many brand protection programs, the foundation of our program is rooted in four pillars:
With this firm foundation, we were able to quickly build a patient protection program for remdesivir. Because remdesivir was an investigational compound with no proprietary brand name and no stockpile of supply to address a possible worldwide demand, we were facing a perfect storm for counterfeiters and fraudsters.
Overnight, Gilead and remdesivir took centerstage in the pandemic. Criminals and fraudsters were eager to exploit the fear and desperation felt across the world. Our foresight, dedication and commitment to patient safety, and relationships with relevant stakeholders prepared us for the long hours and months ahead in helping to bring branded Veklury® (remdesivir) safely to patients.
With the world’s interest in remdesivir, we were contacted by law enforcement (LE), industry colleagues and regulatory agencies from around the world. ACT prepared and educated our LE partners with basic, essential information on remdesivir — what it is and what it isn’t — so that they could easily spot fakes and fraud. We met with colleagues from the industry to share our learnings and to date, continue to partner as an industry. ACT worked with our internal colleagues, e.g., regulatory affairs, government affairs and others to help educate the Ministries of Health and similar officials from around the world on remdesivir.
Collaboration is key to successful programs, in particular, when you are moving at lightning speed such as in the case of a pandemic. Ensuring ACT representatives were at the table from the beginning with leaders from various departments within Gilead was extremely important. It proved to be especially important when it came to supply and license agreements, packaging security features for remdesivir, and educating commercial teams and senior leaders on how quickly knock-off products called “remdesivir” were available for purchase online.
In collaboration with our packaging partners, prevention efforts (both covert and overt) were deployed to help deter and identify counterfeits for the clinical and Emergency Use Authorization product that was available to patients and of the future branded remdesivir. ACT was also heavily involved in supply contracts to ensure strong supply chain security terms were incorporated.
ACT employs an engaged intelligence program (EIP) in an effort to detect counterfeits and diverted Gilead medicine. EIP gives us real-time information on what products bearing Gilead’s trademarks and their quantity are being offered and traded by illegitimate sellers. We quickly added remdesivir to our program so that we could track the development and evolution of the illegitimate market for “remdesivir.” We also added the compound name to our online monitoring and enforcement program to submit take downs against illegal online offers of prescription medicines.
Our investigative and enforcement strategy is always motivated by keeping patients safe from falsified and substandard medicine. With remdesivir, our focus seemed to always be shifting. At the outset of the pandemic, remdesivir was still an investigation compound and not readily available. Online chemical companies were the only online source of remdesivir — albeit remdesivir active pharmaceutical ingredients (API), which is an unfinished product unsuitable for human use. We were familiar with these types of outlets as all sorts of compounds are available for purchase in small quantities for research purposes. Because they listed “remdesivir” for sale, these chemical companies were quickly targeted by those looking to source it for patients. Ensuring that these chemical companies were not selling API for patient use became one of our first priorities. Next, generic manufacturers started to come online claiming to offer the world’s first generic remdesivir causing us to adapt and reassess our strategies and priorities. It wasn’t long thereafter that we started to identify counterfeit remdesivir in Gilead branded packaging. That is, counterfeit packaging that looks nothing like the genuine packaging for remdesivir but uses the compound name “remdesivir” and the Gilead corporate logo trademark. This again required us to shift focus and re-prioritize.
The past several months have been challenging but we’ve learned so much. Having a nimble program that can change priorities very quickly was key to making sure that we were addressing matters of the highest priority. One thing that has been highlighted during the pandemic is industry and governments eagerness to collaborate to protect patients from the onslaught of COVID-related fraud and counterfeits. We hope this sense of partnership and collaboration in putting patients first will outlast the pandemic and reshape how we can better address counterfeits and brand protection together.
DISCLAIMER: The views and opinions expressed here are of those of the author and do not necessarily reflect the official policy or position of Gilead Sciences, Inc.
THE BRAND PROTECTION PROFESSIONAL |DECEMBER 2020 | VOLUME 5 NUMBER 4
2020 COPYRIGHT MICHIGAN STATE UNIVERSITY BOARD OF TRUSTEES