Fighting fake medicines

Published on 05/06/2020

Hope and despair may sometimes look just the same with no one realizing the difference until it is too late. 

Théophile Sebgo knows all about this tragic chasm. During his youth in Burkina Faso some 25 years ago, his father told him never to buy medicines from street market dealers who would offer their wares at a discount to pharmacies and where the poor would generally get their medical treatments. His father, a police investigator, knew it was the only safe way to escape the potential risk of buying a fake medicine with its potential deadly consequences.

“I never forgot the warning from my father”, Théophile Sebgo remembers. “Initially, I didn’t really understand why he was so insistent about this. But once I started to grasp the risk, I wanted to know more, and so I started to study pharmaceutical engineering and specialized in identifying fake and substandard drugs.”

That one day he would work as a field investigator and forensics manager traveling the globe for Novartis was not on the cards when he started his studies in Morocco and later in France. In his early days, even when he joined the company roughly 10 years ago as a PhD student, Théophile worked predominantly in the lab, running a gamut of tests to establish whether drug samples he received from all corners of the globe were false or genuine.

Starting around 2010, the development of mobile spectrometers partly changed this laborious work regime. The new tools, which use light waves to identify the constituent materials of a drug, could be carried around as a sort of mini-lab and provide analysis for some drugs in a short period of time. 

“This was a huge leap for our industry,” Sebgo remembers. “In the past, it was expensive and time-consuming to ship samples to laboratories, where researchers would work for a long time before they could establish the quality of a medicine and send results back to authorities.”

While the first mobile spectrometers have been in use for around 10 years, a new generation of small handheld mobile tools, which can be connected with an iPhone, are set to give the anti-counterfeit efforts at Novartis a timely boost.

While the speed of technology is breathtaking, so is the criminal energy of counterfeiters. The latest available figures from 2018 show pharmaceutical crimes at an all-time high, with new counterfeit incidents growing by 35 percent year on year, according to the Pharmaceutical Security Institute. 

In January 2020, the World Health Organization (WHO) released its list of Urgent Global Health challenges for the next decade and expressly mentioned falsified and substandard medicines as a priority focus area under the “Expanding Access to Medicines” challenge.

“One reason for this trend is that falsifying medicines is such a lucrative business,” says Stanislas Barro, head of the Novartis anti-counterfeit unit, which runs operations across the globe. “You do not need a large factory to produce a substantial amount of fake drugs. Sometimes it is enough to produce fake pills manually and have printing plates that mimic the packaging of the original.” 

Pat Bush and Luis Reveiz, who monitor the Americas for Novartis, had recently tipped off authorities about a major illicit drug heist in Columbia. Footage from this heist shows a small band of criminals working with an antiquated pill machine – enough to produce fake drugs with a market value of millions of dollars.

Usually, such pills have no active ingredient and are often made from starch, with only the shape and color corresponding to the actual medicine. In the worst case, materials such as arsenic and printer ink are found in such fake drugs, which can have serious consequences for patient safety. Packaging, meanwhile, is often done so professionally that it is nearly impossible for patients to differentiate fake packs from the originals.

Criminal gangs that sell these drugs in street markets, through online pharmacies or even manage to smuggle them into the official supply chain operate with cynical success. The global value of trafficked goods is staggering. According to the World Customs Organization, fake and potentially harmful pharmaceuticals worth USD 200 bil­lion are sold every year. In low and middle-income countries, 1 out of 10 drugs is estimated by the World Health Organization to be falsi­fied – with some estimates running even higher. Children are especially at risk as antibiotics and antimalarials are often falsified. 

For Barro, an experienced anti-counterfeit expert, who studied criminal law and worked in Asia and the Middle East before he joined Novartis in 2017, the only way to stem this tide is to ramp up technological expertise within the anti-counterfeit unit and speed up collaboration with law enforcement and health authorities. 

“Internally, the anti-counterfeit unit is well-established within Novartis and we have a strong cross-functional team in place across all regions, which we are expanding at the moment,” Barro says. “But a crucial element of our work is to expand our technological expertise as well as deepen our collaboration with local authorities and heighten awareness of the anti-counterfeit challenges to accelerate the detection and prevention of falsified medicines.”

While the anti-counterfeit team at Novartis includes experts in criminal law, they have no legal powers of enforcement. In their day-to-day work, they monitor and investigate local markets, including the rapidly rising online pharmacies, and report confirmed incidents of falsified medicines to both local health and law enforcement authorities, as well as the WHO. They also actively cooperate with Interpol and the World Customs Organization on joint cross-country enforcement operations. 

“In one case, we received reports that a cancer patient in a hospital in Bogota had suddenly experienced a worsening of his condition despite receiving his normal medical regimen,” said Luis Reveiz from the Novartis anti-counterfeit team in the Americas, as he explained how a typical case might evolve. “We quickly established that it was a fake medicine and could trace its origin and were able to work together with authorities to identify the criminal gang.”

Such success stories happen time and again. In 2019 alone, Novartis investigated 268 incidents of suspected falsified medicines, a 23 percent increase year on year. This led to 61 enforcement operations and the seizure of more than 2 million falsified medicines by health authorities as published in the 2019 Novartis in Society report.

The team also helped authorities crack down on 11 illegal pharmaceutical manufacturing facilities around the world, including a large-scale assembly workshop in China that was producing and distributing counterfeit cardiovascular drugs. Furthermore, the team also partnered with Europol in its Operation Viribus, which led to 234 arrests.

The team also elaborated a methodology to systematically measure the patient safety impact of any falsified medicine tested through forensic means. Since 2017, they ascertained that over 90 percent of  the falsified medicines tested would have caused serious harm, which could have potentially killed patients.

Digital technology, meanwhile, will prove another accelerator for the team to track down falsified medicines, Stomislas Barro says.

While Novartis is leading an industry effort on using blockchain technology to further secure its supply chain and has already imple-mented serialization and tamper-evident features on medical packag-es, the anti-counterfeit team is now rolling out and testing a new gen-eration of mobile spectrometers under the brand name Authentifield by Novartis. These tools are not only relatively simple to use but are also affordable, hence enabling global deployment and local detection.

“This will be really important for us going forward to locally monitor our own portfolio of drugs, ranging from malaria and sickle-cell treat-ments to products that are part of the Novartis Access program, in low and middle income countries and to report incidents in good time,” said Barro. “We are doing our best to prevent patients from being misled into buying fake drugs.”

A first roll-out of the device took place in 2019 in Ghana, where Théophile Sebgo was instructing some 50 colleagues from Sandoz and Novartis. “It was quite a hot afternoon and our colleagues were pretty busy at the time, as they were preparing the launch of a major sickle-cell disease program in the country,” Sebgo remembers. “But it was all worthwhile, as the colleagues have tools at their disposal to quickly check whether a suspicious sample is real or fake.”

Real impact

Just a few years earlier, when Théophile Sebgo was conducting a market investigation in Cameroon, such a tool may have saved lives. Back then, Sebgo used an older version of a mobile spectrometer, which was too unwieldy to carry around in the city or in a street mar-ket. During one market check, he hit upon fake samples that he had collected at a small hospital in Yaoundé. He remembered that, behind him, a woman and her child had been waiting to receive a malaria medication, most likely fake too.

“Had I had the chance to check the drug on the spot, it could have made a difference”, Sebgo said. “It saddens me to think about this episode. But at the same time, I know that we are making big strides in our fight against counterfeit drugs, especially in regions such as Africa and Asia.”

While Novartis is speeding up efforts to fight falsified medicines – Barro’s team will roll out more mobile spectrometers in the years ahead if the tools are shown to have an impact – government efforts around the globe are also taking action. In late January, the Republic of the Congo, Niger, Senegal, Togo, Uganda, Ghana and The Gambia joined the Lomé Initiative in an attempt to criminalize the trafficking of falsified and substandard drugs and to ensure Africans have access to quality medicines.

“Given my experience in Burkina Faso as a child and during my professional career at Novartis, this move in Africa is a major step in the fight against fake medicines,” said Théophile Sebgo. “However, there can be no complacency. As our efforts become more sophisti-cated, the criminal organizations too are becoming more refined. We must stay alert and keep up the fight.”

More information:

Novartis in society report (PDF)