Working Together to Beat the Drug Counterfeiters

Alf Goebel, CEO of advanco, which was acquired earlier this year by Parabellum Investments, led by founder and CEO Rami Cassis, analyses how pharmaceutical serialisation providers can step up the fight against drug counterfeiting by adopting a more open and agile supply chain. The problem of counterfeit medicines remains as the new vaccine is rolledout across the globe.

With a new, mutant strain of COVID causing global concern and ongoing issues across the world, the virus remains on the global consciousness, the most high-profile and damaging epidemic in living memory.

We are all living with its consequences, every day. The pandemic is constantly evolving; therefore, the exact long-term consequences are still not clear. However, what we do know is that it needs to be stopped in its tracks as soon as possible. Not only is the pandemic responsible for a high number of deaths across the globe, but its repercussions are also expected to be felt by generations to come from economic and business fallouts.

While we cannot prevent dangerous viruses such as COVID-19 emerging, we need to do all we can to stamp out their damaging effects on society. That is why the world should be grateful to those who have developed a vaccine.

A vaccination programme is now underway across the globe, thanks to a mammoth effort from the pharmaceutical sector which has defied all odds to produce a vaccine in record time. Several efforts have helped this mammoth journey, including the US government’s Operation Warp Speed initiative, which has pledged $10 billion and aims to develop and deliver 300 million doses of a safe, effective Coronavirus vaccine by January 2021.

The World Health Organization is also coordinating global efforts to develop a vaccine, aiming to deliver two billion doses by the end of 2021. As it points out, vaccines save millions of lives each year by training and preparing the body’s natural defences – the immune system – to recognise and fight off the viruses and bacteria they target. If the body is exposed to those diseasecausing germs later, the body is immediately ready to destroy them, preventing illness.

The World Health Organization estimates that immunisation currently prevents up to three million deaths every year from diseases like diphtheria, tetanus, pertussis, influenza and measles. There are now vaccines to prevent more than 20 lifethreatening diseases, with COVID-19 being the latest to join the list as a vaccinepreventable disease.

It can typically take 10 to 15 years to bring a vaccine to market, with the fastest-ever – the vaccine for mumps – still requiring four long years in the 1960s. Vaccines go through a three-stage clinical trial process before they are sent to regulatory agencies for approval – which can be a lengthy process itself.

In short, we should be thankful to the agile teams that have produced a vaccine in record time. We just need to ensure now that attention is given to quick production, attention will then need to focus on quick production, and the agile and smooth distribution of the doses across the entire world. Just as COVID-19 is a worldwide pandemic, the global pharmaceutical sector will need to coordinate well to ensure the vaccine is rolled out in the most efficient manner possible. Problems Caused by Drug Counterfeiters While potential vaccines are being developed, there is a very real issue that we all need to be aware of. It is predicted that 10% of pharma products worldwide are counterfeit, with British researchers estimating that the death toll caused as a result could increase to 10 million people by 2050. Already, the global counterfeit drug market exceeds an eyewatering $75bn – and as the COVID vaccine is rolled-out, these figures are set to explode over the coming years.

Further estimates by the World Health Organization show that between 72,000 and 169,000 children may die from pneumonia every year after receiving counterfeit drugs, and that fake anti-malarial medication might be responsible for an additional 116,000 deaths.

According to the World Health Organization, counterfeit medicines are medicines that are mislabelled deliberately and fraudulently regarding their identity or source. Fake birth control pills, cough syrup for children that contained a powerful opioid, and anti-malarial pills that were actually just made of potato and corn-starch are just a few examples of poor-quality or counterfeit medicines they have identified in recent years.

All kinds of medicines have been counterfeited across the world, both branded household names, and generic, own-label ones.

In addition to the shocking amount of deaths, illnesses and disabilities caused by fake drugs across the world, the impact of counterfeits on legitimate pharmaceutical producers is endless. They include lost sales, costs of protecting brands, loss of reputation, the potential cost of managing the disposal of counterfeits and litigation costs involving counterfeiters and possibly people who were unknowingly victimised by counterfeits.

Counterfeit pharmaceuticals can result in squandered health resources, not only for individual patients, but also for international humanitarian organisations, NGOs and national government programmes. Counterfeiters divert resources away from genuine treatment, robbing limited health budgets of already scarce resources. At the same time, counterfeits can mean losses in corporate taxes and VAT, increased regulatory and enforcement costs for securing the supply chain, and higher healthcare costs to treat the adverse effects of fake drugs.

Environmental problems – a major topic for most industries across the world nowadays – can also be exacerbated by drug counterfeiters. As you would quite rightly expect, the pharmaceutical sector

must abide by strict guidelines to meet environmental protection standards and reduce the amount of chemical waste and by-products that they produce. In direct contrast, the producers of forged drugs often completely disregard the effect that the illegal disposal of toxic chemicals and waste materials can have on the environment around them.

The overall problem of counterfeit pharmaceuticals is so severe that the sector is, quite rightly, stepping up the battle against the fraudsters by ramping up essential serialisation services to caveat the efforts being made to develop a COVID vaccine.

The solution needs to be based around achieving a much tighter and a much more agile track-and-trace solution. To do this, the hardware and the software among different vendors needs to be much more aligned and should work much more closely together. Although, on the surface, this might seem a bold step within the pharmaceutical sector, we are already seeing some inroads being made, which will help to provide a solution to the dependency on the production of medication in China – and any potential shortage because of the ongoing effects of COVID-19. Strategic Partnerships We are seeing partnerships formed, alliances which are overturning pharmaceutical track-and-trace from a rigid to an agile model, encouraging industry openness while significantly lowering the cost for serialisation services.

One such partnership was announced earlier this year between ourselves and Syntegon. Developments such as these are bringing tremendous value to pharmaceutical companies by significantly lowering the total overall cost and preventing a lock-in effect, allowing vendors to choose different machines from different suppliers, if they choose to do so.

Developments such as these will open out the whole serialisation sector – an essential move to allow us to channel our collective efforts into both stepping up the fight against the drug counterfeiters and optimising the supply chain. Introducing Industry Standards Following on from the introduction of powerful strategic partnerships, the implementation and encouragement of open standards is crucial. Therefore, the establishment of OPEN-SCS, the industry body responsible for promoting common standards across the pharma sector, is another solid step forward in the fight against fake medicines.

OPEN-SCS, which was formed in September 2014, is a working group in the OPC Foundation, whose success speaks for itself. Today, there are more than 4200 suppliers who have created more than 35,000 different OPC products used in more than 17 million applications. The estimate of the savings in engineering resources alone is in the billions of dollars.

OPEN-SCS, of which advanco was a founder member and remains a steeringboard member, has already contributed enormously to the fight against fake medicines. It has officially released three key documents – a use case document which explains typical uses of serialisation and how it fits into the production

STEAMING SOLUTIONS

FOR ALL INDUSTRIES

Steam traps

Pressure regulators

Control valves

Pipeline ancillaries

Special equipment

environment, a specification document that defines the specific services needed for a sterilisation solution and how the EPCIS and GS1 specifications should be used in interoperable solutions, and finally the OPC UA Serialization Companion Specification which defines in extensive detail how to use OPC UA to provide an interoperable solution that will seamlessly fit into a complete serialisation system.

Documents such as these provide an invaluable reference point for the serialisation sector. Not only do they provide a blueprint to how we can arrive at an open, agile supply chain, they also allow us all to work towards lowering the overall total cost of ownership (TCO). Expanding the Importance of Serialisation (Track-and-trace) In the early years of serialisation in the pharmaceutical sector, vendors were busy learning about the sector and focusing on how their own solutions would fit.

Indeed, the return on investment for serialisation was still being calculated – it was seen as a basic cost factor and little more else.

Fast-forward to today and serialisation is now viewed as an essential tool to protect not just patients, but everyone in the valuechain, against falsified and dangerous drugs and medicine – especially while we continue to search for a COVID vaccine.

And it is important to point out that the pharmaceutical sector could be blazing a trail for other industries. For example, food serialisation would technically allow any outbreaks of food poisoning to be nipped in the bud immediately, as the source of all manufacturing could be spotted in an instant. It could also be used in the fight against counterfeiting in most manufacturing sectors, not just the pharmaceutical industry. The COVID Effect Although we have now seen a breakthrough in the fight against COVID-19, the counterfeiters are sure to continue their illicit trade. Therefore, in today’s climate, the need for a watertight, reliable supply chain has never been greater.

Moving forwards, trends to look out for include digital transformation in the serialisation sector, with an increased usage of barcoding helping to reduce errors in dispensing in stressful periods.

Vaccines and test-kits developed to detect the virus will need to be supplied across the world quickly and efficiently – which require more standardisation.

Even when more countries will change production strategies and localise, most of the drugs will continue to be manufactured in China and India, again emphasising the need for an efficient distribution system.

Capital Injection We are seeing increased capital being injected into firms to provide the extra backing and support needed to elevate them onto the global stage.

Such market movements are a clear indicator of the importance of getting pharmaceutical track-and-trace in the very best shape possible, providing the pharmaceutical sector with essential services, ready not just for the introduction of an essential COVID vaccine, but also to provide the overall drugs sector with a watertight method of weeding out the counterfeiters. Conclusion The pharmaceutical serialisation sector is currently in the middle of a transformation as it plays an important part in battling the very real, increasing problem of counterfeit drugs. An increased cash injection, the formation of strategic alliances and the formation of important industry standards are just some of the ways that the sands are shifting.

These are all combining into the overall effect of opening up the serialisation industry, moving it from the previously rigid model to a much more open and agile model. Never before has such a change been needed, a change that will be of vital importance as we all work together to find a solution to COVID-19.

Alf Goebel

Alf is a senior enterprise software sales and marketing executive, with over 25 years’ enterprise software industry experience. He has strong operational experience, specialising in high-growth businesses in Europe and the US. He has extensive experience with Global Partnerships SAP and Lupo Ventures, and has held senior executive positions at a number of leading technology companies, including Snow Software, MSC Software and Software AG.