The threat posed to the pharmaceutical industry by counterfeit drugs medicines is on the rise – and could be set to get worse unless businesses take action now.
Elementar UK have authored a new commentary on the impact the global pandemic has had on the pharmaceutical industry’s efforts to halt the spread of counterfeit drugs. Pharmaceutical manufacturers and suppliers need to reinvest in a rigorous approach to product testing and quality assurance, backed by the very latest technology, in order to better combat the serious risk that counterfeit drugs are currently posing to public health.
According to data from the World Health Organization1, around one in ten medicinal products sold in low and middle-income countries are falsified. These fake products often contain no active ingredient or the wrong ingredients, failing to treat the diseases for which they are intended, or actively causing harm to the patient in question.
Fake medicines are estimated to cost the pharmaceutical sector €10.2 billion and 37,700 jobs each year in the EU alone, and there is considerable evidence that the COVID-19 pandemic has accelerated this problem.
Rise in demand
In March 2020, Interpol’s Operation Pangea XIII operation against the illicit online sale of medicines resulted in the seizure of counterfeit pharmaceuticals worth more than $14 million across 90 countries, including counterfeit facemasks, hand sanitisers and antiviral medication.
Interpol noted an 18% rise in the amount of fake antiviral medicines seized compared to the corresponding operation in 2018. Additionally, both Interpol and the WHO have noted that sales of fake chloroquine, a drug often touted as a COVID-19 therapy, have seen a major spike, especially in regions such as Africa.
It is clear that the global public health crisis has created a rise in demand for illegally produced medicines, as people turn to illegal online pharmacy services for unproven COVID-19 solutions. At the same time, lockdown conditions have disrupted supply chains and regular testing protocols, making it harder for these fake goods to be detected.
Additionally, for the UK and Europe, this problem could soon be exacerbated further by the impact of Brexit. The Royal Pharmaceutical Society has voiced its concerns2 that the end of the Brexit transition period will mean the UK is no longer protected by the Falsified Medicines Directive (FMD), Europe’s anti-counterfeit drugs legislation.
As of yet, no firm plans have been put in place for what will replace this, prompting concerns that the trade of counterfeit medicines in and out of the UK and into Europe will become even harder to control post-Brexit, further exacerbating the current problems.
Elementar UK is calling on companies to do all they can to equip their labs with tried-and-tested technological solutions for product testing and quality control. This will allow them to maintain efficient, largely automated lab testing processes, in which the microbial integrity of drug samples can be easily assessed and any signs of impurities and irregularities rooted out.
Mike Seed, IRMS sales and product manager for Elementar UK, said: “The pharmaceutical industry is facing a perfect storm when it comes to combating falsified medicines. The pandemic has created conditions in which fake drugs are harder to track and in greater demand than they have been for many years.
“With the end of the Brexit transition period right around the corner, suppliers and manufacturers in the UK especially are likely to see these conditions become even more difficult in the coming months. This is why it is essential for drug companies to grasp this nettle and invest in solutions to protect their supply chain – and the health of their end users.”
He continued: “Using elemental analysers, pharmaceutical labs can detect potential signs of contamination in drug samples, and even identify isotopic fingerprints in particular batches that allow these illegal products to be traced back to their original source.
“What’s more, these systems also have broader applications in pharmaceutical production, allowing manufacturers to validate the purity of the ingredients they are using, and to test whether their equipment has been properly cleaned between production cycles.
“As such, instruments such as these can play a pivotal role in helping the pharmaceutical industry to overcome the unique challenges they are facing in 2020 and beyond. Counterfeit drugs pose a life-or-death threat to vulnerable communities around the world, and only by making full use of all the tools available can this threat be brought back under control.”
Mike Seed is IRMS sales and product manager for Elementar UK.