The world is a far less certain place today than it was just a decade ago. In this changing environment pharmaceutical companies have moved from being regional to global entities, which have significantly increased risks within our industry.
Historically, the “risk management” function within a company dealt almost exclusively with insurance issues. Today it is more appropriately pared together with the “security” function of a company. The focus of that security function has been not only on protection, but also on prevention, early sensing, and the execution of wellorchestrated programs to mitigate the impact of illicit disruptions.
Senior pharmaceutical security officials understand that designing and implementing robust security and risk management practices are essential, as well as fundamental, to operating businesses that supply critical, consumable, health products.
That being said, it’s virtually impossible to execute and maintain such complicated programs alone. Most of us in the pharma security discipline came from some form of government, law enforcement, and/ or military backgrounds - where resources were plentiful and easy to access. When we left to find “fame and fortune” in private industry many of those instant sources of important intelligence weren’t so easy to obtain anymore.
For that reason we, amongst ourselves, advocated the creation of security support groups – sharing those important former contacts, as well as security best practices and intelligence – to better protect our employers and the public that they/we serve. This article will describe five of the principal groups within our industry that do just that.
Pharmaceutical Security Institute (PSI) www.psi-inc.org. The Pharmaceutical Security Institute (PSI) is a not for profit organization established and supported by the security directors of thirty international, researchbased and generic pharmaceutical manufacturers.
PSI’s President Thomas T. Kubic, a former FBI Deputy Assistant Director, identified the members’ opinion that “Counterfeiting is viewed as a serious public health menace promoted by criminals with little regard for the health and safety of patients which requires a combined public – private sector response.”
PSI, in coordination with its members, regularly collects and analyzes information related to the counterfeiting, illegal diversion and theft of pharmaceuticals. This information is then disseminated to law enforcement and drug regulatory authorities. Many security directors and their staff work daily with the authorities to stem the flow of illegal, unapproved and dangerous medicines.
PSI offers a range of services to both international and national authorities including strategic intelligence products which define the nature and scope of this criminal problem and operational intelligence in support of major investigations against transnational organized crime groups. PSI regularly arranges testing of suspect medicines through wellestablished contacts among the laboratory personnel of its members. As needed, PSI has facilitated law enforcement efforts during searches by securing the participation of expert level manufacturing representatives at the time of the search.
PSI also conducts training seminars. In 2014 they did so in over thirty countries, working in close collaboration with the national authorities and international organizations. Collectively, the PSI President, the Regional Directors and analysts reached over 3,000 law enforcement, customs and drug regulators during trainings and seminars in 2014.
National Biopharmaceutical Security Council (NBSC) www.nbsconline.org The NBSC is a not-for-profit organization, funded by member companies, which are represented by one or more members of their corporate security staff, as well as other respective internal business units. The current Chairman of the group is Doug Liptak of Sanofi. Doug has a law enforcement background but has spent the majority of his working life in Corporate Security for pharma.
All of the member companies in the NBSC are in the business of research and development, manufacturing, marketing, and sales of ethical human biological, animal health, and/or pharmaceutical products.
The mission of the Council is to provide a forum of selected biopharmaceutical and pharmaceutical security professionals whose combined expertise will be in developing, organizing, and coordinating the sharing of security related knowledge and best practices throughout the pharmaceutical industry, both domestically and internationally.
The NBSC seeks to identify and evaluate risks affecting the sector, including, but not limited to: product integrity, diversion, theft, counterfeiting, supply chain security, information security, intellectual property misuse and theft, personnel security, workplace violence and extremist groups. The NBSC facilitates the development and sharing of industry best practices through networking, collaboration and educational programs at its annual general membership meeting, and on other occasions throughout the year.
The NBSC encourages cooperation and collaboration with law enforcement, regulatory agencies, rule-making bodies and organizations (both public and private) that share similar goals to increase consumer and patient confidence that the medications, therapies and vaccinations that member companies develop, manufacture, market, and distribute, are safe and have the efficacy that healthcare professionals and patients expect both in the United States and throughout the world.
Pharmaceutical Cargo Security Coalition (PCSC) www.pcscpharma.com In late 2005 two, full trailer load, pharmaceutical cargo thefts occurred in New Jersey - involving two different pharma manufacturers. Each loss was sizeable, involving millions of dollars’ worth of products. The thefts occurred essentially a week apart, along roughly the same stretch of highway; however neither company had any knowledge of the other’s loss.
In March of 2006 two men, Ken Obriot (from what was then Wyeth) and Bob Monteiro, from Pfizer, decided to call for a meeting to discuss what was becoming a noticeable increase in these large-scale pharmaceutical product thefts. That first meeting, hosted by Monteiro at a Pfizer facility in New Jersey, had approximately 36 invited guests.
During the get-together it was learned that the methodology the criminals were using in each instance was essentially the same. Based on that, it was decided to create an informal group to begin to keep closer tabs on this type of illicit activity – as well as to share intelligence about these crimes and those that committed them.
That agreement led to the creation of a clearinghouse for this type of information, essentially the PCSC itself, where a methodical process of collecting the data, cataloging it, and sharing it with others within the industry, through the periodic “alerts,” began. It wasn’t long before the number of those interested in the informal, ad hoc, group began to grow.
Today the PCSC has over 2,000 “members” from a wide variety of disciplines – all of which are either directly involved in the pharmaceutical industry or support it in some way. There are also members from many law enforcement agencies (Federal, State and Local); government entitles (DEA, FDA, FBI, Department of Health & Human Services; US Customs, Homeland Security; Department of Transportation; United States Marshalls; and industry associations (HDMA, CHPA, PhRMA, NACDS, NABP, etc…) The Chairman of the group is Chuck Forsaith, a 21 year veteran of the New Hampshire State Police who once commanded the State’s Attorney General’s Drug Task Force.
As interest grew another decision, made collectively by the organization, was to sponsor educational seminars at least once, sometimes twice, per year - to discuss and expose progress and best practices in the field of supply chain security. Each meeting is fully sponsored by a different pharmaceutical company and doesn’t cost anything to attend.
American Society of Industrial Security (ASIS) www.asisonline.org. Pharmaceutical Security Council: The American Society of Industrial Security is essentially the largest fraternal order of security professionals/ practitioners in the world. Within the organization are separate and distinct “councils” which are created to address specific security issues/concerns within various industries. One of those councils is the “Pharmaceutical Security Council”.
The purpose of the ASIS Pharmaceutical Security Council is to promote security leadership and cooperation amongst all segments of the pharmaceutical industry. It serves as a progressive source of information, as well as sponsors and supports programs on security issues affecting the industry. The Council, which has had leadership from a number of different industry professionals in the past, is currently chaired by Mike Keenan, who works within the Global Security function at Allergan. Keenan’s background includes roots in government service in the State of New York and over fifteen years in pharmaceutical security management.
Some of the more recent Council activities have included: publishing a Controlled Substance Compliance White Paper; development of cross–council sub-teams to address pharmaceutical transportation security and specialized pharmaceutical investigations guidelines; and conducting an ASIS constituent pharmaceutical risk survey, the results of which are pending.
National Association of Drug Diversion Investigators (NADDI) www.naddi.org The National Association of Drug Diversion Investigators (NADDI) is a non-profit organization that facilitates cooperation between law enforcement, healthcare professionals, state regulatory agencies and pharmaceutical manufacturers in the investigation and prevention of prescription drug abuse and diversion. NADDI also sponsors and conducts specialized educational seminars and conferences.
Established in 1989, the National Association of Drug Diversion Investigators is currently led by Executive Director Charlie Cichon's. Just as Kubic, Liptak, Forsaith and Keenan, Cichon roots are in both industry and government service. Previously he worked for Eli Lilly Corporate Security in the role of brand protection representative for the Americas. Prior to that he served as Chief Compliance Investigator for the Maryland Medical Board, and as a Baltimore City Police Officer in the Criminal Investigation Division.
NADDI's objectives are simple: to improve the members' ability to investigate, and prosecute, pharmaceutical drug diversion. Its principle activities include: cooperative education and training in the specifics of pharmaceutical drug diversion, investigation, prosecution and prevention; sharing investigative information and communicating with a wide variety of interested parties with regard to the nature, scope and impact of pharmaceutical drug diversion; developing more effective measures to combat the drug diversion problem.
In the event you missed it, there are several similar objectives that are of great important to all five of these organizations - and one of the reasons that they (as independent groups) get along with each other so well. Those include:
- Promoting the role and value of the pharmaceutical security profession, throughout the business community, media, government entities and the public.
- Offering advanced education opportunities for pharmaceutical security professionals, industry participants, as well as those that support our unique industry.
- Creating, as well as supporting, opportunities for the collection and dissemination of relevant security intelligence – sharing that intelligence between and among both public and private sectors affecting the pharmaceutical industry
The bottom line is we, as security professionals, are all dedicated to protecting the patient. In the end, when all is said and done, that’s the responsibility we’ve been entrusted with - to ensure that the patient (you, your family, neighbors and friends) all receive the important health care products you need in a safe, secure and timely fashion - and in the condition they were originally intended to be. When you think of it, that’s a pretty hefty responsibility – and why these organizations are so vitally important when it comes to how we do our jobs.