Protecting pharmaceutical products

The incidence of counterfeit drugs in Europe is increasing. With seizures of fake or substandard drugs topping 2.7 million items, Authentix’s Jim Rittenburg, Mondi Packaging’s Carsten Lange and SICPA’s Mark Davison sat down to discuss ways to avoid the risk of counterfeits in the supply chain.

NGP. Why is it so important to implement authentication technologies for protecting pharmaceutical products and their packaging?

MD. The most important reason is consumer protection. If the problem of counterfeit drugs is allowed to grow then patient safety will be jeopardised further and public trust in the drug industry will be eroded. Secondly, forward-thinking drug companies view this as an investment in revenue protection. I am convinced that the return on investment is positive, across the whole corporation and in the longer term. However, the financial benefit of authentication technologies is generally felt in the sales organisation, whereas the implementation cost is felt on the manufacturing side, so this message sometimes gets lost. Thirdly, in the current unclear legislative climate, those companies who firmly take the initiative are likely to have a big influence on government and regulatory standards. This is preferable to having unworkable control measures imposed from outside, perhaps in the wake of a tragedy associated with counterfeit drugs.

CL. Pharmaceutical products have to be protected via an optimised security system, where the packaging can and should play a key role. The packaging then not only protects and authenticates the pharmaceutical product, but also provides assurance as part of the logistical chain as a whole.

JR. The availability of low cost, high quality printing and packaging equipment has simplified the job of producing excellent counterfeit copies of pharmaceutical products. Authentication technologies enable simple, rapid, and definitive means for differentiating the genuine product from the fake. Having the capability to easily authenticate products and their packaging, at any time and at any location, provides an important component of a manufacturer’s product surety program. Using these tools, manufacturers as well as third party inspectors can be proactive and reactive to monitor and investigate the integrity and authenticity of products moving through the supply chain.

NGP. What measures are you taking to ensure the safety of patients and the security of pharmaceutical brands?

CL. Because Mondi Packaging is an innovative company, the security elements we incorporate into our packaging are generally unfamiliar to the rest of the packaging market, which means they are also unfamiliar to the parties that constitute threats. Within our organisation, the handling of these security elements is always carried out in accordance with international quality standards, which in turn ensures that only our customers get guaranteed packaging that incorporates our security elements.

JR. To protect patients and pharmaceutical brands we employ state of the art authentication technologies and comprehensive programmes to manage the application of the technology. This means establishing a strong foundation to the authentication program with oversight to ensure that all security materials, product packaging and product, as well as the various waste streams, are tightly controlled. These programmes ensure patient safety and the integrity of pharmaceutical brands by offering increased communication about the risks posed by counterfeiting technology along with the implementation of proactive market monitoring activities.

MD. We are working closely with governments and with drug and healthcare companies to implement a range of security measures which are tailored to the specific circumstances. We always advocate a layered approach, where multiple security features are combined to give a strong measure of protection. The approaches we use include various overt technologies as well as covert features and forensic taggants. We also use our experience gained in other industries, such as banknotes and value documents, to bring insight into the pharmaceutical security field. Pharmaceutical packaging should be seen almost as a value document such as a passport, validating the drug contents of the pack, and not just as commodity board and foil to be sourced as cheaply as possible.

NGP. Packaging, labeling and even counterfeit-resistant technologies can themselves be counterfeited. How serious is the counterfeiting threat to the European drug market?

MD. It is almost impossible to prevent counterfeiting if the criminal has unlimited time and resources, but the aim is to make it too difficult to be worthwhile. This requires investment, vigilance and regular changes and upgrades to security features. A good analogy is with household security – a determined burglar can force entry into most houses, but he prefers those with weak locks and no alarm system. The counterfeiting threat in Europe is real and increasing. If we take sensible precautions in a timely manner then the problem can be controlled, but if we ignore the problem then it will grow and may get out of control.

JR. The European drug market is unquestionably under threat from counterfeit products. The Internet provides a large source of uncontrolled drug distribution into Europe. In addition, the parallel trade industry and associated repackaging that occurs in Europe weakens the integrity of the supply chain, and often alters the look and packaging of the pharmaceutical products. This provides a favorable environment for counterfeits to enter the supply chain. Over the past six months, a number of major counterfeit events have occurred in Europe highlighting the reality of this threat.

CL. Counterfeiting is definitely a serious threat to the European drug market, because over time the competitive advantage of security elements in packaging tends to disappear. This is somewhat similar to the situation we see in the world of IT, where virus and anti-virus programmes tend to cancel each other out on an ongoing basis.

NGP. Biopharmaceutical packaging professionals can’t afford to waste time sorting through products and technologies that don’t meet the industry’s stringent requirements, so what are you doing to streamline the process?

JR. Packaging professionals should network with their counterparts in the industry to develop an understanding of what technologies are currently being used and have been commercially proven. Based on the experience we have gained in implementing major product surety programmes, we have developed guidelines of best practices and recommended operating procedures that we share with industry. We have also put significant effort into communicating with agencies such as FDA and EMEA to convey common questions that we hear from industry. Through this process we have been able to get written guidance from these organisations that help industry to better understand grey areas in the current regulations that pertain to inclusion of authentication technologies.

CL. As a global integrated paper and plastic packaging company, Mondi Packaging operates to the very highest manufacturing standards, which means our packaging materials are ‘right first time’. Moreover, when a new product is launched, we pro-actively invite our market partners to become involved in the whole supply chain discussion.

MD. We don’t take a catalogue-based approach. Our specialists work with customers to bring the most appropriate technologies to bear to solve their specific problems. In many cases, these are SICPA technologies, but we also source, validate and manage non-SICPA solutions if they are more appropriate for the customer problem. We provide a full service that helps time-pressured executives. This often involves providing initial consultancy on security strategy and implementation. We can even provide a fully-implanted product security function, managed by SICPA but based at the customer site. All of our technologies are in use and validated.

NGP. Pharmaceutical manufacturers regularly complain that the re-packaging and re-labeling used by ‘grey importers’ makes their products vulnerable to forgery in the European sector. How do you overcome this issue?

MD. The approach to this issue taken in other regions, notably in the California pedigree legislation, is to say that the pedigree – the specific basic information and transaction history – should follow the contents. This implies that the legitimate importer should have certain obligations to transfer data to avoid a break in the pedigree. It also follows that the tracking data itself – 2D code, RFID tag, etc. – should be protected by security measures which survive the re-packaging process or at least are somehow replaced on the new pack. We are working with various parties to ensure that any coding systems are secure against unauthorised copying. We also advocate that re-packagers should be obligated to use security measures of equivalent standard to the original packaging.

JR. The loss or alteration of the manufacturer’s original labelling or packaging makes it more difficult for a pharmacist or patient to recognise fake product because they now assume that when something looks different it is just a consequence of the parallel trade process. This is well recognised by counterfeiters and provides them with an easy entry point. Manufacturers can consider packaging designs that make repackaging more difficult. These designs would integrate the product more closely with the packaging such that repackaging would damage or detract from the product. The use of well-designed tamper-evident seals can also help reduce repackaging. Additionally, manufacturers can consider increasing their use of multilingual package, label, and insert designs to reduce the need for the parallel trade industry to re-label and repackage products.

CL. As a packaging producer, we can only propose solutions to the pharmaceutical industry where we either integrate the security element into the packaging, so that it cannot be removed like a label, or where we provide labels with adequate security elements.

NGP. What is the best way to avoid the risk of counterfeits in the supply chain?

CL. To completely control the supply chain and to ensure 100 percent transparency from beginning to end.

JR. Legislative changes should be sought to significantly increase the penalties for anyone involved in counterfeiting drug products. Also, regulatory changes should be made to place more control over the parallel trade industry particularly relating to the alteration of original manufacturer’s packaging. A concerted effort in communication should be made to raise the awareness of the public to the incidence and risks posed by counterfeit drug products with emphasis on the risks of purchasing pharmaceutical products through the Internet. The use of overt and covert authentication technologies provide manufacturers, their third party inspectors, and other participants in the supply chain, for example pharmacists and patients, with tools to proactively monitor the integrity of the supply chain and to quickly investigate and respond to incidents of suspect or fake product showing up in the supply chain.

MD. There is no single best solution, but there are many things that must happen in parallel. These include: continuous investment in appropriate counter-measures, including multi-layered material-based and information-based security; rigorous control of all aspects of the supply chain; enforcement activities in full and open collaboration with the appropriate authorities. It is important that authentication and/or secure track and trace should take place all along the supply chain. The chain is only as strong as its weakest link.

BIOS

Authentix
Jim Rittenburg, VP Healthcare and Life Sciences at Authentix, has played a major role in developing the company’s marker systems in the pharmaceutical and spirits industries. He has over 20 years experience in this field. Rittenburg is a respected industry expert on pharmaceutical anti-counterfeiting.

Mondi Packaging
Carsten Lange joined Mondi Packaging in April 2005 as Director of Business Development & Marketing for the Coating & Release division. His main responsibilities in that position are M&A, marketing management and export business management. In April 2006, he assumed additional responsibilities as managing director of Mondi Coating Zeltweg GmbH, one of the division's largest extrusion coating facilities, specialising in flexible packaging materials. Before joining Mondi Packaging, Lange was VP of Sales & Marketing for Sihl AG, a Swiss-based manufacturer of digital imaging materials, and Director of Sales & Marketing for the digital imaging business unit of M-Real and assistant to the CEO of Zanders AG.

SICPA Holding SA
Mark Davison worked at Beecham and subsequently SmithKline Beecham in research, development and production. He then moved into pharmaceutical service industries, in senior business development roles with Charles River Inc. and Quintiles Transnational Inc. He ran his own business consultancy for four years, working for a wide range of clients including pharmaceutical companies, biotech start-ups and the public sector. Before joining SICPA, Davison was VP at Bioaccelerate Inc. and Director of Drug Development Solutions Ltd. At SICPA, he has worldwide responsibility for coordinating and developing brand protection and track-and-trace business in the healthcare and pharmaceutical sectors.