SPEAKER_01 0:16

In one week of operations, there were millions of illicit and fake medicines sold online and seized, but also thousands of illicit pharmacies that could be shut down. So the problem is real and is actual.

Federica Santoro 0:37

Welcome to Drug Safety Matters, a podcast by Uppsala Monitoring Center, where we explore current issues in pharmacovigilance and patient safety. In this first episode, Fighting the Fakes, we dive into the world of substandard and falsified medicines, a growing threat to public health in all parts of the world. What are they? How do they spread? And more importantly, what can we do to stem their flow? According to the World Health Organization, one in 10 medical products in low and middle-income countries is substandard or falsified. For the criminal networks that control the business, falsified medicines mean money. Lots of it, in fact. In a year, revenues can soar up to 200 billion US dollars. But for the scores of unsuspecting patients who are fed illegal and dangerous products, consequences can be dire. As many as 200,000 people may be dying from falsified medicines each year. And that's probably an underestimation. So how do we fight this deadly international scourge? My name is Federica Santoro, and my guest today is French police officer Aline Planson. For years, Aline fought pharmaceutical crime by heading a dedicated task force at Interpol, the world's largest police organization. More recently, she founded a nonprofit organization called PMEDS to raise awareness of falsified medicines and the health risks they pose. How big of a problem are falsified medicines globally?

SPEAKER_01 2:26

It's a huge problem. Falsified medicines are spread out everywhere in the world. There's no one country that doesn't have problems with falsified medicines in the supply chain and outside the supply chain. It touches every therapeutic category, so consumers and patients can be confronted with fake antibiotics, painkillers, vaccines, what we called life-saving uh medicines, but they are also confronted with products uh for uh losing weight or against hair loss or even uh these lifestyle products.

Federica Santoro 3:15

What risk do substandard and falsified medicines pose to health? Because in the best case I imagine they'll just lack efficacy, right? They'll simply not work for the intended purpose. But in the worst case?

SPEAKER_01 3:31

The good case of lack of efficacy cannot be good when you've got a heart attack or when you've got hypertension or when you've got chronical disease uh or HIV when you need to take a treatment every day. This is the least of the bigger problems. And the problem also is um the public health issue, definitely is the major threat posed by falsified and substandard medicines, as well as the problem of a resistance of medicines. And the uh latest studies show that, for example, if you take an anti-malaria product that is substandard, it will take longer to get cured than before. But longer means that the disease will get stronger at the end, so the death will be higher. So there is a very uh big concern from the health community about this resistance and the impact of substandard and falsified medicines on resistance.

Federica Santoro 4:46

Of all substandard and falsified medicines reported to WHO, the most common are antibiotics. That is extremely concerning because antibiotics are not quite like other medicines. When a medicine like a statin or an arthritis drug is of low quality, that only really affects the patient who's taking it. But inappropriate use of antibiotics reduces their effectiveness for everyone else. Falsified antibiotics contain inert ingredients such as chalk or talk and therefore show no or little therapeutic effect. That means they will not kill microbes as efficiently as they should, but rather encourage the reproduction of drug-resistant strains, so contributing to the spread of antimicrobial resistance. Let's go back to the basics for a second. What is the difference between substandard and falsified medicines? We often refer to them as SFs collectively, but how do we distinguish between the two?

SPEAKER_01 5:45

The major distinction is the uh criminal intent. So substandard medicine is a medicine that doesn't comply with the quality of the substance that it's supposed to have inside. The uh falsified medicines is uh medicines that fruitulently, so there is a criminal or fraudulent intent to mislabel or to mislead about the identity of the source of the product.

Federica Santoro 6:16

There are many reasons why people buy falsified medicines. Some are looking for cheaper products to save money, others like the ease of buying online and never check if the website they're buying from belongs to a legitimate pharmacy or not. Some people refuse to ask their doctor for prescription medicines and would rather get them from a vendor who doesn't ask too many questions. Others will stick to a product they've been using for years, even if it was never approved by a health authority. And more often than not, people will buy falsified medicines simply because they don't know they're fake. Tell me a little bit about the difference between high income countries and low income countries. You said the problem affects the whole world, but do you see differences in the kinds of products that are more likely to be falsified in certain countries based on the income levels?

SPEAKER_01 7:10

Um every country is touched, but it's true that they can be touched differently. And in low income countries, the health systems developed differently than the higher income countries. And uh what we see is uh more street markets or illicit markets or informal markets as we called. And people there that are selling medicines may not have the qualification or health qualification as a pharmacist in a in a shop, a pharmacist shop. So patients would go there because they would not have any other access, or because they believe the medicines will be cheaper, or because they have the habit to go to street markets. And then here uh you've got lots of different medicines that can be sold because the source of the medicine is not controlled as it is in uh legitimate uh markets and in pharmacies. So the chance for consumers in those informal markets to get a fake medicine is higher. Now in higher income countries, the major problem is internet. You've got consumers that can be reached through internet via different channels, social networks, uh, via small ads or also spam that comes into their email. And then they would wish to buy online pharmaceuticals, sometimes thinking it's safe and they will know go into any danger. But a few years back, WHO stated that 50% of the medicines bought online was illicit or was fake. So the danger is really high. The uh operations that Interpol led in coordination with uh the customs, with uh Europol and the private sector partners, uh, called Pangea Operation to tackle illicit online sales of medicines, shows that in one week of operations there were millions of illicit and fake medicines sold online and seized, but also thousands of illicit pharmacies that could be shut down. So the problem is real and is actual.

Federica Santoro 9:55

Let's continue talking about technology a little bit, because I understand it can pose a huge problem, right? And you mentioned all these online pharmacies and internet resellers, right? There's a huge potential for uh falsification there. But can technology help at the same time? And I'm thinking about smart ways to track medical products. How does that help solve the problem, perhaps?

SPEAKER_01 10:23

Sure. Um technology has goods and bads. First, technology can allow access to good online pharmacies that are legitimate in countries, and it um it develops a lot. And second, the track and trace technologies definitely are tools that can help secure the circulation of medicines in legitimate supply chains. And in that extent, we can think about the recent implementation of the falsified medicine directive that obliged the European Union members to put a data matrix on each pack of medicines that is sold in the EU market. So this code on each of the box of medicine will allow to check if this medicine is authentic. So definitely technology is also good to try and track fake medicines.

Federica Santoro 11:36

Harnessing emerging technologies such as blockchain and artificial intelligence could help too. In the UK, data company Pharma Trust uses blockchain to trace medicines through the global supply chain. The main advantage of this technology, which was originally created to buy and sell Bitcoin, is that it creates an incorruptible record that cannot be altered. The US Food and Drug Administration has also embraced this approach and is now piloting blockchain to track medicine distribution across supply chains. Other companies are using artificial intelligence to give consumers instant information about what they've bought. Nigerian startup RXAL, for example, has created a handheld scanner that can authenticate medicines in real time. The device assesses the drug's compound and cross-checks it with a cloud-based database of information of what the drug should contain. The results are then sent back to an app on the consumer's phone. The app also shows users where else in the city the medicine's been tested so they can see where bad batches and bad suppliers are. So far, the technology is available in a handful of countries in Africa, Southeast Asia, and the Americas. Why do substandard and falsified medicines spread so much? What are the main risk factors for their emergence and their spread?

SPEAKER_01 13:03

It is spread because it is highly lucrative. The criminals generate a lot of money, and the estimate of value made by the organized crime per year is between 98 and 200 billion US dollars. So the money generated is really high, and the risks to go to jail is very low because there is an inadequacy of penal laws, of administrative sanctions, and criminals are playing with the inadequacy of laws to uh make their traffic international and to try and avoid any kind of sanction.

Federica Santoro 13:50

What is the business model we are looking at for substandard and falsified medicines? Are we looking at a few large criminal enterprises or is it different?

SPEAKER_01 14:01

The type of uh organized criminals involved in uh falsified medicines uh is uh two types we can uh we can say. One uh type of uh organized criminal is based on uh opportunity, so he will be approached by another type of criminal and supply and support according to its criminal skills. So it can be a printer or it can be a designer or he can be a distributor or importer, and um he will take the uh occasion to make money out of the system. And the second type is more uh sophisticated organized crime criminals that are uh dedicated to uh falsify uh medicines or um former narco trafficans that saw the opportunity also to to go into this uh this type of uh of crime and really have the full chain of organized from manufacturing to distributing.

Federica Santoro 15:09

The manufacturing and distribution of medicines today is a complex and globalized affair. To produce a single pill, companies might source active ingredients from multiple countries and ship them via several ports to the point of manufacturing. The medicine might then be packaged and repackaged in various other countries and ultimately sold via an internet pharmacy. Fakes or substandards could enter the chain at any point in the process and anywhere in the world. So international coordination is essential. So tell me about the work you did at Interpol and what does Interpol have to do then with substandard and falsified medicines? I think people don't usually make the association between the two.

SPEAKER_01 15:51

Back then I used to create and develop an international program to address pharmaceutical crimes. And the intention was to coordinate operations, was to organize seminars that gathered police, customs and regulatory authorities, but also to raise awareness through seminars and raising awareness initiatives. The reason is that back then WHO was worried and concerned about falsified medicines growing problem, and saw that regulators, when they came and crossing a case of falsified medicines, they would have information, but they would not have the power of investigation. And so the intention was with Interpol globally to raise awareness among the police and to uh to investigate those crimes more than before. And that was the intention of the past 12 years that I've been working on uh on this issue.

Federica Santoro 17:01

And how did it go? Have you seen then an increase in the number of like operations you've been you've been running in the field and of criminals that you've been stopping?

SPEAKER_01 17:12

Yes, we've been running dozens of operations in the field, and we saw that the cooperation between the police, uh, customs and regulators that was not a given at a start, uh, got improved completely with our prisons, but also without us when uh when Interpol was not there in countries, that exchange of information got improved and uh an awareness on the uh justice uh side was also uh operating. So, to give you um uh just a sample, with the uh Pangaea operation, it started with uh three countries, and then at the end 115 countries got uh involved when I was in charge. Uh so there was more and more countries willing and tackling this issue.

Federica Santoro 18:06

And a global and concerted effort, at least an international and concerted effort, makes a lot of sense to me given the fact that we are an increasingly connected and globalized world. So that makes sense. What other actions are being taken around the world to tackle the problem?

SPEAKER_01 18:24

At the uh international level, WHO has been uh very uh active and he's in the front line of addressing pharmaceutical uh crimes or falsified and substandard medicines. They've created a specific task force and also encouraged cooperation between uh regulatory authorities. They also created a reporting alert system that uh can be used by um by the regulatory authorities when they come across a substantial and falsified medicines problem. At the uh European level there is a convention that uh took place and it's called the Medicrime Convention. It's the first and only international treaty convention that criminalizes the uh falsification of medicines. It's been uh endorsed in 2010 uh thanks to Moscow, where they the Russians supported and pushed the uh adoption of the Medicrime Convention. And since then, twenty-eight countries signed the convention and not only European countries but also African countries and uh fourteen countries ratified, which means put this uh convention into their law. And at the uh European Union level, the uh Commission they published uh in 2008 the Falsified Medicines Directive, which protects patients against uh falsified medicines with uh a lot of measures uh including the uh serializations and many uh yeah, there are many layers into these directives. There are initiatives uh that have been uh undertaken by NGOs and um declarations notably, and I'm thinking about the Chirac Foundation with their Cotonou appeal in 2009. They capture uh heads of states and uh major players internationally to uh raise awareness on falsified medicines. There are also um researchers that have been very concerned and doing a lot of efforts to uh get reports on quality medicines, and I'm thinking about Warn and the IDDO networks. So they are a bunch of uh international organizations or regional organizations but also uh public and private sector.

Federica Santoro 21:19

WHO's Alert System for Substandard and Falsified Medicines, the Global Surveillance and Monitoring System, was launched in 2013. Since then, more than 700 regulatory personnel in 150 countries have been trained to report incidents, and over 2,000 reports have been received via the electronic rapid alert form. After they come in, alerts are distributed worldwide so other countries can investigate the same products and mount a response. However, despite WHO's efforts, the perception of fake medicines remains low. People tend to associate false With luxury items such as bags and shoes, not medicines. In a 2015 survey on patients' perception of substandard and falsified medicines, only 12% of Americans said they felt they had enough information. 53% of them had never even heard of fake medicines. So much remains to be done to raise awareness of the problem. Let's talk about awareness. So you said you worked on raising awareness when you were at Interpol, and now you founded the PMEDS educational program. What do you do there?

SPEAKER_01 22:36

The intention of the uh PMETs is around three axes, and the major one is called FMETS, is a centralized data hub supplied directly by the patient and victims. It's a network of certified pharmacists to assist patients and collect data and transfer this data via FMET modules on the data hub. So the intention is to have as much information as possible on the falsified medicines world and to secure a highly quality data hub so patients can get more information about falsified medicines and this information also can be shared with the key healthcare community if needed. The second axis is called good meds and the intention is to uh uh respond to the needs of the victims of falsified medicines and to uh to deliver an authentic medicine against the falsified medicines when it's authentified. And the last axis is called S meds and it's um educational programs for schools and universities.

Federica Santoro 23:57

How do falsified medicines impact people's trust in medicine and healthcare in general? And can you think of an of an example you've witnessed during your career where the availability of falsified products made people lose trust in medicine?

SPEAKER_01 24:16

The fact that a patient can be confronted with the medicines that he didn't want and that can even kill him instead of curing him is a key issue. And the more weaknesses will be identified in health systems, the more patients will lose trust. So people are concerned for themselves but for their families and for their children. And one example I have in mind is we did an operation in Eastern Africa, including Uganda. And at the end of the operation that was very successful in terms of identifying criminals and seizing falsified medicines, the authorities raised awareness on it through the media. And unexpectedly, the panic wind was very high from the citizens, and the regulatory authorities received a lot of calls and even visits from people that were very concerned about them and their family being impacted by these falsified medicines. So it's a very sensitive subject for people, and the way and the key messages to be sent is very important, as the intention is not to have people losing trust in healthcare, but to have people being more aware of the possible danger and threats that is around them and be more responsible in how they get their treatments.

Federica Santoro 26:09

And finally, to conclude, what can I, as a regular citizen and perhaps a patient at some point in my life do to curb the problem?

SPEAKER_01 26:19

First the important thing is to buy your medicines in authorized points. So it means supply chain that is legal. So if you want to buy online with internet, it's fair enough. But please go on a legitimate e-pharmacy, something that is recognized by your state, by your country, then um go to a pharmacist if you don't want to buy online. So that is the key um priority message I would say as a citizen. If you travel and if you've got any doubt, then you can always log online and look for information on possible um fake medicines or advice. Or if you don't have, you go to see a doctor that would possibly give you some uh advice and answer your questions. Don't think that the whole world is safe with medicines when you know people look alike in in white blues and uh because it's uh just uh not the case. The um number of victims estimated globally is uh over 200,000 per year, and it is only the tip of the iceberg. So be aware that it exists and go to legitimate supply chain. Thanks for coming here today.

Federica Santoro 27:55

Thank you for having us. That's all for now, but we'll be back soon with more conversations on medicine safety. If you don't want to miss future episodes, subscribe to Drug Safety Matters wherever you get your podcasts. And do let us know what you think about the show. Look for Uppsala Monitoring Center on Facebook, LinkedIn, or Twitter, and join the conversation there with the hashtag Drug SafetyMatters. Thanks for listening.