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Questions and considerations for pharmaceutical companies in designing and executing strategies to curb the incidence of fake drugs.
The issue of counterfeit medicines is one that continues to blight the global pharmaceutical landscape. Despite the innovative breakthroughs made by individual drug manufacturers, and the giant advances made by the sector collectively, the damage caused by counterfeiters continues to cast a shadow—one which is killing innocent people.
The problem is a real one. In addition to triggering a rising number of deaths, plus causing life-changing injuries to many more, counterfeit medicines threaten the very integrity of the biopharma sector. And let’s not lose sight, too, of the fact that it continues to bite into the profits of companies who are having to work harder than ever to combat these ongoing threats. This issue affects us all. All of us working for the pharma industry specifically, and the life sciences industry more broadly, are on the frontlines when it comes to the battle against the forgers. We all have a role to play in ensuring that pharma packaging is watertight when it comes to security—both literally and figuratively. Let’s examine the issue in some depth, and look at the latest trends in the fight against counterfeit medicines.
The latest forgery statistics
Recent figures from the Pharmaceutical Security Institute show that the number of counterfeit medicines is on the rise.1 The data reveals that nearly 6,000 pharmaceutical crime incidents were recorded in 2021, up 38% from the year before and are at the highest amount since records began 20 years ago.
The greatest number was recorded in North America (2,442) followed by the Asia Pacific (1,747), Latin America (770), the Near East (705), Eurasia (646), Europe (374), and Africa (187). This order is largely due to how well countries in these regions are effectively identifying pharmaceutical crime through law enforcement activity and inspections by drug regulatory agencies.
According to the World Health Organization, roughly 10% of medical products circulating in low- and middle-income countries are substandard or falsified.2 In sub-Saharan African nations, notes the United Nations (UN), this share is believed to be even higher, rising closer to 19-50%.3 However, the actual number of incidents of fake drugs being manufactured and distributed is likely far higher, considering the many cases where counterfeits have not been detected or reported.
Indeed, nearly half a million people are estimated to be killed by counterfeit medicines in sub-Saharan Africa every year, which was also noted by UN data.3 Of these, 267,000 deaths are believed to be linked to falsified or substandard antimalarial medicines, while a further 169,271 are connected to falsified or substandard antibiotics for severe pneumonia in children.
Why are medicines so attractive to forgers?
There are many reasons why criminals are looking at fake medicines as a way of illegally earning money.
One reason is the rise in online pharmacies. Unlike a physical store, drugs brought via the internet provide no physical shop to return to, and nowhere for disgruntled consumers to take the matter further. It is much easier for perpetrators to lurk undetected in cyberspace, sending out their dangerous products from an unidentified location.
To be clear, this is not a criticism toward regulated, legal online pharmacies. They provide a valuable service for many people and are now established as part of the fabric of the healthcare system in many geographies. However, the modus operandi does provide criminals with the means to distribute their goods in a manner that means they are much less likely to be traced.
It is also incredibly hard to spot forgeries. The only real way to know if a drug is counterfeit is through chemical analysis done in a laboratory. Sometimes, counterfeit drugs differ in size, shape, or color, or are sold in poor-quality packaging, but they often appear identical to the real product, which makes them especially dangerous.
How to spot forged medicines
Most people will not have a laboratory in their home that can be used to analyze medicines. However, if in doubt about the authenticity of medicine, there are some clues to look out for. Interpol provides the following useful checklist, one that we strongly believe people should be made much more aware of.4
However, while it is important to make people aware of how they can spot forgery, the pharma sector also has a duty to ensure it is doing all it can to proactively act against the forgers.
One of the main elements to controlling the number of forged drugs in the world is regulation. More countries are realizing the importance of regulating their pharmaceutical production process, and much like a snowball effect, momentum is gathering. After the EU Falsified Medicines Directive (FMD) went into effect in February 2019 and the US introduced legislation in November 2017 as part of the Drug Supply Chain Security Act (DSCSA), it’s concluded that more than 75% of global medicines were covered by some form of track-and-trace regulations by 2019.
The growth of serialization continues. For example, traceability legislation has recently been mandated in the Middle East and North Africa (MENA) to combat the growing problem of counterfeit medicines. If MENA-based pharmaceutical companies fail to achieve compliance, they face being fined or even getting barred from product launches, which could potentially lead to significant business and financial implications.
Environmental, social, and governance (ESG) is something that most pharmaceutical manufacturers are committed to in a world that today knows much more about the damage that the collective industry has done to the world over many years. In addition to protecting the environment generally, ESG can also provide enormous benefits when it comes to the specific battle against forged medicines.
One critically important piece of legislation is the 2030 Agenda for Sustainable Development,5 adopted by all UN member states in 2015. It provides a shared blueprint for peace and prosperity for people and the planet, now and into the future. At its heart are the 17 sustainable development goals (SDGs), which are an urgent call for action by all countries developed and developing in a global partnership. They recognize that ending poverty and other deprivations must go together with strategies that improve health and education, reduce inequality, and spur economic growth, while tackling climate change and working to preserve our oceans and forests.
All drug manufacturers should be familiar with the SDGs and should be doing all they can to carry them out. It is our collective duty and one that should not be ignored.
As an example, track-and-trace systems can help companies meet SDG No. 3: Good health and wellbeing. These tools can potentially achieve this by allowing access to genuine, safe, quality, and affordable medicines and vaccines for everyone.
Tightening the supply chain
There is now a move toward local production and sourcing through the repatriation of supply chains into Europe and the US. This repatriation is a big deal for the future of the pharma sector. It signals confidence in the capabilities of Europe and the US, resulting in ongoing investment. This will result in job creation and a renewed interest in Europe and the US as a global center to produce essential pharmaceuticals.
Added to the current shift toward a much more agile, local supply chain are the benefits resulting from digitalization. The rapid uptake of digital barcode scanning systems, combined with the very latest technology, has made supply chains increasingly secure, giving fraudsters a much smaller window of opportunity to ply their dangerous trade.
The time is now
The reality is that forged medicines will always be produced somewhere in the world. However, there is a formula which, although not a magic one, will go a long way to limiting the impact of this criminal activity.
Regulation is key to this formula. Indeed, a blend of track-and-trace regulation, along with ESG regulation, will enable the pharmaceutical sector to launch a huge fight back. In addition, localizing the supply chain and the endless possibilities offered by new technologies, will create a powerful defense in the ongoing battle against fake medicines.
Those who produce counterfeit drugs are directly impacting the lives millions of people. As a sector, we have a duty to combine our resources and knowledge to help protect patients. It won’t happen overnight—but by working together, we can help turn the tide.
1. Fleck, A. Counterfeit Drugs on the Rise Globally. Statista. May 24, 2023.
2. 1 in 10 Medical Products in Developing Countries is Substandard or
Falsified. World Health Organization. November 28, 2017. https://www.who.int/news/item/28-11-2017-1-in-10-medical-products-in-developing-countries-is-substandard-or-falsified
3. Fake Medicines Kill Almost 500,000 Sub-Saharan Africans a Year:
UNODC Report. United Nations. February 1, 2023. https://news.un.org/en/story/2023/02/1133062
4. Fake Medicines Can be Counterfeit, Contaminated, or Mislabeled.
Don’t Take the Chance. Interpol. https://www.interpol.int/en/Crimes/Illicit-goods/Shop-safely/Fake-medicines
5. Transforming Our World: The 2030 Agenda for Sustainable Development. United Nations. https://sdgs.un.org/2030agenda
About the Author
Alf Goebel is the CEO of Advanco.