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Pharma Manufacturing with external stakeholders are best-positioned to maximize the market value of their goods and services. In doing so, they also preserve, perhaps enhance, brand and company equity. In establishing such a culture across your company, it is important to begin with a humbling awareness which is counterintuitive to business leaders who pride themselves in knowing their products, customers, competitors, and markets incredibly well. Unfortunately when it comes to counterfeits, even the best "brand protectors" in the industry will be quick to say, "We don't know what we don't know." For this reason, it is imperative for ethical and reputable companies to focus on risk assessment, preventive business practices, and immediate response to known incidents with appropriate root-cause analyses. This also implies having well-documented procedures and proper attention to organizational expertise to manage incident reporting, legal and enforcement efforts, and systemwide communications. In the pharmaceuticals supply industry, it is easy to understand why we suffer from lack of knowledge of the problem. This lack of business intelligence is attributable to four common supply chain realities: 1. The majority of trade occurs "downstream" from companymanaged operations where the transparency and control of our goods is limited to information obtained from trading partners and customers. 2. Ownership of goods typically transfers to the intermediary (distributor) or directly to the end customer early in the supply chain. Unless there is a contractual or legal obligation for trading partners to share such detail with the manufacturers, visibility to further transfers is limited to syndicated sources of data. 3. With few exceptions, there is no industrywide network of tracking or tracing products through the supply chain (socalled pedigree, or chain, of custody systems) to record the time, value, and place of product transfers. 4. The quality of the counterfeiters' work has become so sophisticated that the product and/or its packaging is often indistinguishable from the genuine product and can pass through to consumption or administration by a practitioner without detection. As a result of these conditions, all industry stakeholders must develop and implement monitoring systems to look for and uncover fakes anywhere in the supply chain. But this is no easy task, since the pathways of the counterfeiter are varied, inconsistent, and largely underground. Due to the inability of business leaders to accurately estimate how counterfeit goods are affecting revenue from traditional internal data systems, we must take a top-down approach from the World Health Organization statistics in order to build a credible "Case For Action" within our scope of operations. There are at least two ways of addressing this need for quantifying the unknown: (1) it is not unreasonable to assume that your highvolume, high-profit brands are being "violated" at a 2 percent to 3 percent rate when combining all illicit trade categories or (2) treat the aggregation of all counterfeiters as being equivalent to a second-tier competitor, taking away some of the natural demand that exists for your products. The latter approach works particularly well among marketers who enjoy staging campaigns to win market share. There are other qualitative factors that can refine your internal estimate of counterfeits when comparing your company to the industry average (until more reliable business intelligence is obtained): • Does your company's drug portfolio include any of the highly counterfeited product categories (e.g., lifestyle drugs, antimalarials, or statins)? • What is your relative market share and price point in specific high-risk categories? • Do you have effective safeguards currently in place? • What is your relative penetration and operational presence in emerging markets compared to that in more regulated markets? • Do you have product security contracts and auditing procedures with your key distributors? • Can you apply your incident history to determine the degree and scope of your brands which are being targeted by counterfeiters? The key message though is, regardless of how you sculpt the known data into an assessment of the business opportunity, ANY counterfeit trade of your brands or any sale of a genuine but diverted product that has been mishandled, stored improperly, or allowed to expire places a patient at risk. For this reason, you must maintain a culture of governance that reinforces a "NO TOLERANCE" policy on illicit trade worldwide. 5 KEY ESSENTIALS TO A STRONG COMPANY CULTURE OF INTOLERANCE TO BRAND VIOLATIONS Preaching a company commitment to anticounterfeiting policies and practices will not stop counterfeit drug trade, but it's a start. In fact, I have prepared five basic ingredients to a strong company culture to reinforce your "no tolerance" message with strategies, actions, processes, metrics, and assessments, all aimed at brand protection and patient safety and all starting with the commitment of the company's C-suite leaders: 1. senior management commitment and accountability 2. cross-functional governance and policy stewardship 3. brand protection functional expertise 4. widely adopted set of supply chain best practices 5. measurement systems and data analytics. Management Commitment. As in most companywide culture initiatives, it is vital to have the CEO or president address the September 2013 LifeScienceLeader.com 37