Criminal Activity On Falsified Medicines “On The Rise” Says Novartis Anti-Counterfeit Head

Criminal activity surrounding the manufacture, distribution and sale of falsified medicines is “on the rise” as a global health problem in many developing countries and in rich nations – especially online – but efforts to stem the growing health threat will require robust collective action by all stakeholders, a leading Novartis official warned Friday in Geneva.

“Stakeholder engagement is critical,” Stanislas Barro, global head of anti-counterfeiting at Novartis Pharma AG, told a panel against falsified medicines. The event, co-hosted by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) an industry umbrella group, and the Graduate Institute in Geneva, wrapped up a week of advocacy that raised awareness of counterfeit and substandard medicines under the theme “Fight the Fakes.”

Stanislas Barro participating in a workshop at the “Fight the Fakes” event.

“We do believe that success and progress, will come from stakeholder engagements. As many resources as we want to invest in investigation and enforcement, success will come from collective action, a public-private partnership to foster effective collaboration.”

Barro said that’s a key focus for Novartis and argued, “We need to train properly law enforcement and health authorities in the markets because it’s a complex area. There’s quite a bit we can share with them and there’s quite a bit they can share with us. We need to develop this effective relationship.”

For Novartis, a private sector company trying to combat falsified medicines, governance, Barro said, “is crucial” for making progress, and pointed out the Novartis steering committee on falsified medicines includes half of the top 10 executives of the company – including the heads of ethics, risk and compliance, legal, business assurance and advisory, global health and corporate responsibility.

A spate of reports by national and international bodies and enforcement agencies, including Interpol, the World Health Organization, and industry watchdog groups, have documented the growing reach of falsified medicines and the high risk they pose for individual patients in many health settings.

In 2019, the WHO has to date issued 11 medical product alerts concerning falsified medicines and vaccines. They have included alerts over falsified ICLUSIG, used to treat leukemia, Amoxicillin, Augmentin, used to treat bacterial infections, Quinine Bisulphate, meningitis vaccines and vaccines against rabies.

Nicola Magrini, secretary of the WHO Expert Committee on the Selection and Use of Essential Medicines, told Health Policy Watch that many of the drugs on the WHO Essential Medicines List have been falsified, and said shortages of essential medicines can be drivers for falsification.

“So, we can raise our hand and say let’s try and find some coordinated mechanism to provide the drugs safely,” said Magrini. Now, WHO now has a double mechanism of not only maintaining a public falsified medicines database, but also keeping a shortages database.

The WHO official said it’s also “absolutely horrifying” that the WHO logo has been used by criminals to show that the falsified medicines are guaranteed by WHO. There are published pictures and warnings against any drug with a WHO logo on it, he said.

Global Efforts to “Fight the Fakes”

A report by Interpol, the Lyon-based International Criminal Police Organization, published on “Operation Pangea” – a global operation which seeks to disrupt online sales of counterfeit and illicit health products – says that since its launch in 2008 the operation has “removed more than 105 million units (pills, ampoules, sachets, bottles and so on) from circulation and made more than 3,000 arrests.” The operation has included the seizure of 1.1 million packages, and the shutdown of 82,000 websites, it says in the report published in November.

Interpol agents conducting inspections of health products in Costa Rica.

In October 2018, a week of ” Operation Pangea” XI action brought together police, customs and health regulatory authorities from 116 countries and focused on delivery services manipulated by organized crime networks. The massive operation resulted in the seizures of 10 million units, valued at $14 million, 859 arrests, and 3,671 web links closed down, including websites, social media pages, and online marketplaces.

During the operation, Interpol says, 500 tonnes of illicit pharmaceuticals were seized worldwide, including anti-inflammatory medication, painkillers, erectile dysfunction pills, hypnotic and sedative agents, anabolic steroids, slimming pills and medicines for treating HIV, Parkinson’s and diabetes.

Barro told participants the Internet is critical in the fight against fake medicines and noted the company is cooperating with the rest of industry through the Pharmaceutical Security Institute (PSI) on programmes doing online monitoring and enforcement on targeted countries and online pharmacies, regularly.

But Novartis, he said, also has its online programme targeting key products, and the volumes are mind-boggling. In the first 10-11 months of this year, alone, he said ” We tried to de-list more than 12,000 listings just concerning our products on commercial platforms “and also tried to enforce more than “2000 robbing online pharmacies.”

Barro said about 90% of online pharmacies “operate illegally” and suggested many may not be authorized in the country and sell prescription medicines without a prescription. However, the problem is, he said, that, ” 60% of this 90% of online pharmacies “do sell falsified medicines and that is the critical part and that’s what is worrying us.”

Analysis of the results of Pangea over the past decade, the report says, also reveals “that at least 11 per cent of medical products sold online are counterfeit and all regions of the world are affected.” Similarly, a regional Interpol initiative, titled “Heera” collaborates with 10 countries in West Africa to target the trafficking of pharmaceutical products in West Africa – resulting in seizures of 95,800 units, worth about $3.8 million in 2018.

In a similar vein, a review by PSI of 4,405 pharmaceutical crime incidents that occurred in 2018, a 25% increase since 2017, found that pharmaceuticals in every category were targeted by criminals and that 1,882 different medicines were involved.

Novartis’ Efforts To Combat Falsified Medicines

Barro, who chairs the working group that oversees the company programme to combat falsified medicines, said in 2018 a study by the company estimated that at least 700,000 patients would have been impacted by falsified medicines from the Novartis treatment portfolio – such as for malaria, oncology products, and cardio-vascular drugs. The projection was based just on what Novartis had seized.

“What we see is just the tip of the iceberg,” Barro stressed.

He also outlined there was a team focusing on pharma intelligence and forensics, and highlighted “they are critical to our day-to-day operations.”

Barro also added that Novartis this year had launched a working group in China and a separate group in Africa, and is planning to launch working groups to combat falsified medicines in the US and India.

To counter the work of criminal networks, he said, Novartis also had case managers in North America, Europe and the Middle East, Africa and India, and in recent months had carried out market surveys in Cambodia, Egypt, India, Mexico, Brazil and Nigeria.

To boost capacity to timely authenticate suspected falsified medicines, Novartis has three authentication spectrometric toolkits (i.e. mobile laboratories) covering the Americas, EMEA, and Asia-Pacific said Barro. This year Novartis launched a new project aimed at empowering low-and-middle-income countries with mobile, cloud-based, cost-effective spectrometric sensors which are now being used in 15 countries as part of “Phase I” with an initial primary focus on its access portfolio with medicines covering therapeutic areas ranging from sickle cell disease, malaria and cardio vascular.

“In the cloud, we have a library of spectrons for each product, or a sort of corresponding DNA, if you wish, if I were to summarize that. So when we test the product-put it on a little sensor-pill or liquid and you test it- It does a comparison of your library of spectra products and it tells you if it is a match or not.”

“We are very excited about this because it is cost-effective, it’s mobile-enabled, and takes only a few seconds – it changes the way we approach detection of falsified medicines.”

Novartis, Barro said, is also leading a consortium at industry level exploring all the applications for blockchain in the pharma industry. “One thing we are excited about is strengthening the supply chain from manufacturing to the patients.”

However, Barro admitted blockchain would only be effective if the industry is aligned – hence the consortium. “We are…trying to align everyone to one industry standard,” he said.

The pharma security expert provided examples of types of criminal activity related to falsified products, some intercepted and tested by Novartis. These included:

  • Non-declared Active Pharmaceutical Ingredients (API) were found in a fake version of the leading Novartis anti-infective anti-malarial called Coartem. A non-declared API (paracetamol) was also found in a fake version of an oncology product used to treat breast cancer.
  • Some counterfeiters of medicines, notably in India, offer to make fakes “to order” with little, or no API, or with something close to the genuine version.
  • Cases of genuine secondary packaging were found, but the contents inside were counterfeits,
  • Stolen tempered products, where the expiration date is changed and the products are put back on the market.
  • Public sector theft with medicines going to hospitals and clinics stolen from their facilities and re-appearing after some time on different markets and sometimes mixed with counterfeits. Because they disappear from the legitimate supply chain and may not meet distribution practices, such as cold-chain storage requirements, they can have a patient safety impact.

 

Image Credits: Interpol, Keshav Khanna/The Graduate Institute of Geneva.