A Q&A with Mark Davison, Principal Consultant & CEO at Blue Sphere Health and author of Pharmaceutical Anti-Counterfeiting.
Mark Davison, Principal Consultant & CEO at Blue Sphere Health and author of Pharmaceutical Anti-Counterfeiting, is well-versed in pharmaceutical anti-counterfeiting. Davison is the founder of Blue Sphere Health, and he advises a variety of entities on how to keep patients safe from the dangers of falsified medicines—drug companies, non-governmental organizations (NGOs), and government bodies.
At Systech’s Uniquity 2015 Conference, Davison’s presentation, titled “When Bad Things Happen: Anti-counterfeiting,” covered a variety of aspects involving counterfeited products and their respective dangers. His first point was a blunt (but important) one: counterfeiters can kill people. Period. This is especially applicable in counterfeited pharmaceuticals and medical devices.
Davison participated in a Q&A, divulging more of his knowledge on the dangers with counterfeits and precautionary steps pharmaceutical manufacturers can take.
Q: At the Uniquity 2015 Conference, you said that counterfeiters don’t exactly duplicate things. Could you elaborate on this and its specific application to the pharmaceutical field?
Davison: The mistake that some technical people make is to assume that bad guys need to duplicate their complicated system or product exactly in order to make money. However, the target audience for fake products is not the manufacturer—it is the consumer. That person has little or no knowledge of what the genuine article should look like in detail. If it looks “about right,” then they will most likely accept it. So the counterfeiter concentrates on the visible things—such as packaging—that get noticed and skimps on the detail that doesn’t.
Q: At the same conference, you had mentioned that the risk of “phony drugs” is much higher outside of the U.S. Could you explain why that is and what is the statistical difference?
Davison: Statistics are hard to find but the evidence is clear from sources like the Pharmaceutical Security Institute. The reason for higher risk in developing countries is things like leaky supply chains, higher prevalence of corruption, lack of enforcement capacity, etc.
Q: At Uniquity, you spoke of online pharmacies often dispensing counterfeit drugs and operating illegally. Is there no current legislation in place to oversee this? If not, what are your thoughts/recommendations as to how this problem can be addressed?
Davison: There are various initiatives that try to provide a safer environment online. The VIPPS scheme in the U.S. and the Common Logo initiative in the EU are both aimed at ensuring that the public can tell whether a pharmacy website is genuine. Unfortunately, counterfeiters are clever and none of these approaches are watertight. The credit card companies, search engines. and internet hosting services are also playing role in reducing the availability of the commercial tools that counterfeiters need—to get noticed, accept payment, etc. More recently, the dark net has been identified as a source of fake drugs. This will be much harder to trace.
Q: You had mentioned at the same conference that not only will counterfeiters recreate things, but they will reuse things (such as needles) as well. What, would you say, is the prominence of recreating vs. reusing pharmaceutical products in the realm of counterfeiting?
Davison: Both activities are prevalent and it comes down to economics. If access to used material is easy, then it makes sense to reuse packaging, needles, devices, etc. In more regulated markets it may be easier to recreate the item. Criminals are opportunists; so, they will do whatever makes them the most money at the least risk.
Q: What are some of the products that counterfeiters often reuse?
Davison: Needles, outer packaging such as cartons, primary packaging such as vials—almost anything that can be made to look like it hasn’t been used.
Q: Are there anti-counterfeiting methods that work better in the pharmaceutical field than other fields, such as retail, food, etc.?
Davison: The same general principles apply across most industries. At Bluesphere, we advocate three main approaches:
- Physical Security: i.e., putting visible and/or invisible features on packaging and product that make it distinctive and harder to copy (and fakes easier to find)
- Digital Security: i.e., making products traceable in the supply chain (serialization, etc.)
- Process Security: i.e., ensuring that your business does everything in a secure way that minimizes vulnerabilities from insider fraud, opportunist crime, counterfeiting, etc.
Q: What is the most commonly counterfeited pharmaceutical product?
Davison: Lifestyle drugs are still popular targets, but the problem is now affecting all types of drug and all therapeutic classes.
Q: What are some of the key difference between traceability standards and implementation of serialization between countries (if any)?
Davison: After years of collective effort, the standards are now much more harmonized than they were. Most of the major countries have systems based on GS1 standards, which makes things much easier for manufacturers. The main outlier is China, which has a specific state system. However, even here there are signs that the next generation system might use global standards.
Q: At the conference, you mentioned that digital fingerprinting is the next big thing in development for technologies in physical packing security. Could you elaborate on what that is/how it works?
Davison: This term typically refers to techniques that record random surface features during production. The item can be scanned later and compared to the stored information to determine authenticity. The ability to use the inherent characteristics of the product or (more usually) its packaging to verify authenticity has a number of advantages.
- It avoids the need for added materials, such as security inks.
- The best fingerprinting technologies are extremely difficult to counterfeit and, in practical terms, generating an exact fake is not likely.
- It allows full control of the security system by the manufacturer.
- It opens the way to mobile verification. I don’t think digital fingerprinting is a silver bullet, but it will certainly be an important weapon in the fight against counterfeits.
Q: What is one of the biggest road blocks that you face with pharmaceutical companies with regards to anti-counterfeiting?
Davison: The evidence for counterfeiting of specific brands is often patchy or non-existent until a quality or safety incident occurs. This can sometimes lead to managers deciding to wait until they have an issue before responding. A more technical issue is that responsibility for preventive anti-counterfeiting activities, such as pack features, lies within the manufacturing division. This function is usually incentivized to reduce cost of goods. Security technologies add immediate cost, with an indirect benefit felt elsewhere on the organization. In order for this ROI to be discussed and captured, the technology buying process should involve customer-facing departments as well.
Q: What are your thoughts on the serialization legislation, such as the DSCSA in the U.S.?
Davison: Serialization will not be cheap or easy, but it has widespread supply chain benefits as well as patient safety upsides. In my view it is also an enabling technology that will help reduce spiraling medical costs by making a stronger link between patients, treatments, outcomes and reimbursement. The U.S. spends 17.4 percent of GDP on healthcare. To start to control this number, we need to use digital technologies such as serialization to help deliver better, more efficient, and financially-accountable healthcare.
Q: In reference to traceability and the implementation of serialization in the pharmaceutical field, do you have any recommendations as to how pharmaceutical manufacturers can prepare?
Davison: Start now! The first key deadline for manufacturers (pack coding in November 2017) is in two years—a blink of an eye in pharma time. Pilot projects, vendor selection, procurement, implementation, etc. will all take time. Don’t reinvent anything. Use consultants and experienced vendors to help you get there quickly. You don’t have time to set up committees and work groups and start from zero.
Q: Do you have any recommendations for pharmaceutical manufacturers—specifically for how they can best be and remain in compliance?
Davison: This is a fundamental change to your business processes, not just a new manufacturing technique. The challenge of serialization is routinely underestimated. So, my advice is start now and set aside people, budget, and time to get the job done. There are some great resources and people out there that will help you get started. Also make sure your business partners are on board—especially your contract manufacturers.
Q: If you could tell professionals in the pharmaceutical field one thing about counterfeiting, what would it be?
Davison: Don’t assume that your products are immune. To paraphrase my good friend David Howard, formerly of Johnson & Johnson, ask yourself two questions for every product:
- To the best of our knowledge, has this product ever been counterfeited or diverted in any market?
- Have we actively and thoroughly checked for counterfeiting and diversion (test buys, etc.)?
If the second answer is no, then the first answer is meaningless.
Almost everything is faked, and Bluesphere customers are often amazed to discover that their low profile specialty product has been a target. Get a clear, proactive product integrity strategy that spans the whole organization. Don’t wait until you have an incident. I would argue that counterfeiting is now such a known and widespread business risk that executives are failing in their fiduciary duty to shareholders if they fail to take steps to mitigate it.