IPI Winter 2020

Page 86

Logistics & Supply Chain Management

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 84 INTERNATIONAL PHARMACEUTICAL INDUSTRY

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 Winter 2020 Volume 12 Issue 4


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Articles inside

The Challenge of Global COVID-19 Vaccine Distribution Demands a New Approach

16min
pages 96-101

How the War on COVID-19 is Driving Innovation in Temperature-controlled Packaging – and Beyond

12min
pages 92-95

COVID-19 Vaccine: Unique Distribution Challenges Call for a Unique Monitoring Approach

5min
pages 90-91

In Highly Regulated Industries your Labelling must Speak for your Product – Compliance is Non-negotiable!

6min
pages 82-85

Working Together to Beat the Drug Counterfeiters

10min
pages 86-89

Exploring Pharmaceutical Packaging’s Top 2020 Trends

7min
pages 80-81

HPMC and the Value of Vegetarian Hard Capsules

7min
pages 74-75

Managing the Mass-Production of Tablets with Efficient

8min
pages 70-73

Preserving the Parenterals of Tomorrow

9min
pages 66-69

Causes of Punch Tip Wear and How to Avoid Them

12min
pages 76-79

The Importance of Anonymised Unstructured Data in Advancing Medical Research and Patient Outcomes

11min
pages 40-43

Completing the Puzzle Technology in Decentralised Clinical Trials

9min
pages 56-59

Designing for Success: A Multi-stakeholder Approach to Clinical Development to Optimise Patient Access

14min
pages 44-47

What Is Preventing the Industry from Providing Electronic Product Information?

20min
pages 48-55

The Rabbit and the Horseshoe Crab

10min
pages 32-35

Powerful, Large-scale Analytics brings Single-cell Omics into Clinical Reality

12min
pages 36-39

Optimising Device Design for New Generation Biologics

7min
pages 24-25

Putting Translation Central to the MDR Shift

9min
pages 18-19

Editor’s Letter

4min
pages 8-9

Critical Challenges and Potential Solutions to Optimise Downstream Bioprocessing Production

11min
pages 28-31

The Heightened Case for IDMP in the Light of COVID-19

7min
pages 26-27

Truth Matters: Why Science Journalism Has Never Been So Important

5min
pages 16-17

Clinical Requirements under EU MDR: Understanding the Changes

17min
pages 20-23

Brexit White Paper

15min
pages 10-15
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