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Coronavirus: Eine Vielzahl von Tests und Studien zur Umwidmung bereits zugelassener Medikamente werden durchgeführt. Diese könnten bereits gefälscht werden.

Coronavirus prognosis: 5 theses on counterfeit drugs

In our last blog post we provided a detailed forecast on counterfeit drugs in view of the current crisis caused by the outbreak of coronavirus. Here are some additional thoughts, summarized in 5 theses on coronavirus and counterfeit drugs… as well as the blockchain.

With the blockchain, companies can not only protect their supply chain against counterfeit drugs. In addition, everyone could easily check with their smartphone whether a purchased product is original or fake.

With the application of blockchain technology in the pharmaceutical sector, Europe can now seize the opportunity to become a global blockchain pioneer. CEO Arman Sarhaddar’s contribution to the future of a Blockchain Europe has now been published by the renowned blockchain news platform Industry of Things as well.

The recent corona-apps to donate data should also be based on blockchain technology, as this is the only way to ensure optimal data security and protection against hacker attacks.

  1. Thesis 1: Counterfeit drugs of the year 2020
  2. Thesis 2: Counterfeiting market in developing countries
  3. Thesis 3: Drug repurposing: Using the already approved to fight corona
  4. Thesis 4: The lack of cybersecurity 
  5. Thesis 5: Blockchain for supply chains

 

coronavirus Heilmittel coronavirus impfstoff, corona arzneimittelfälschungen, counterfeit drugs

Battling coronavirus… and counterfeit drugs that have not yet been thought of.

 

Thesis 1: Vaccines and drugs to treat corona patients will be the drugs of the year… and so will counterfeit drugs.

 

The examples of Viagra and antibiotics (see below) show that popular and urgently needed drugs are counterfeited particularly frequently, of course. The demand for the remedies against coronavirus is huge and the supply will inevitably lag behind.

For even if all conceivable production facilities are mobilized and pharmaceutical companies work together instead of competing with each other (as is usually the case), production will need one thing above all: time.

While the first million, let alone the first billion, of drugs are produced, at the same time counterfeiters will produce imitations and counterfeit drugs cheaply on a massive scale. These can quickly be sold online through illegal distribution channels.

Moreover, as soon as the first corona drugs leave production, the counterfeiters will be able to infiltrate the supply chains of pharmaceutical manufacturers and sell potentially dangerous counterfeit drugs in the legal distribution chain.

Fake drugs could potentially cause more damage than the coronavirus itself. But it is not only human lives that are at stake. The producers of the coronavirus drugs are only partially rewarded with fame and heroism, because the counterfeit drugs, that made it into the legal distribution chain, will cause massive damage to their image, which will compensate for every good deed.

 

Thesis 2: On the counterfeiting market of developing countries, cheap counterfeit drugs appear as unrivaled “better” offers.

 

The demand for coronavirus cures will come from all countries equally and counterfeiters will proceed exploiting the poor. They are already taking full advantage of the counterfeit market in poor countries:

About 30% of the drugs in Asia or South America and up to 50% in Africa are counterfeit drugs.

Poor countries have many loopholes, such as the complete lack of import controls due to lack of personnel in some cases, through which counterfeit drugs can be distributed without any difficulty.

Counterfeit drugs can easily be offered at a lower price. For poor countries and many of their institutions, these seem to be “better offers” and the originals in comparison are no longer a competition.

coronavirus Heilmittel coronavirus impfstoff, corona arzneimittelfälschungen

Every 2nd or 3rd drug in Africa is a fake! Taking medicine in poor and developing countries seems to be a game of chance. Whoever only catches the despicable fake without any active ingredient can be considered lucky. According to the WHO, 60 % of all counterfeit drugs contain no active ingredients, while about 16 % contain completely different active ingredients. These are mainly counterfeit antibiotics – the most needed medicines.

 

For comparison:

Industrialized nations are safer from counterfeit drugs due to appropriate drug law controls and close cooperation between manufacturers, wholesalers, pharmacies and the authorities. Nevertheless, we do not remain unaffected by large-scale counterfeiting crime: In the United States, around 1.5 million counterfeit birth control pills containing too little active ingredients were seized.

Another example is Sildenafil, better known as Viagra: In 2006, 2.5 million fake Viagra pills were seized in the EU alone. In 2007 there were 3.4 million. [Source]

The “professional” counterfeiters who have successfully infiltrated legal distribution channels in Europe or the USA before will be those to occupy the coronavirus niche of the counterfeit market.

 

Thesis 3: The counterfeiters may already have started to manufacture counterfeit drugs of those pharmaceuticals that are eligible for repurposing.

 

Thanks to global supply bottlenecks, the trade in counterfeit medical equipment is already increasing dramatically.

In addition to the development of new drugs against the coronavirus, a large number of clinical studies are being conducted to repurpose existing drugs like antiviral medicine, that originally has been developed to treat other diseases.

This is because it is more likely that a drug that has already been approved will bring the desired cure first. A completely new drug needs much more time to be available to the general public.

Coronavirus: Eine Vielzahl von Tests und Studien zur Umwidmung bereits zugelassener Medikamente werden durchgeführt. Diese könnten bereits gefälscht werden.

On average, the development of a new drug costs approximately 1 billion euros, because it has to go through a much longer process: from development and clinical studies, through drug law controls and initial approval, to production… which has to begin with the establishment of the production facility. A drug that has already been approved does not have to go through all of the above steps again, a production facility is ready to use and a certain amount of a the drug is already available. [Source]

Currently, fake COVID-19 drugs are no longer an exception on the internet. But mass distribution of counterfeit drugs will begin when people are officially informed that an effective remedy against the coronavirus is available.

And this process of information via media and news has already begun. For example, it has become known that the common Japanese flu drug Avigan has a very good chance of being effective against coronavirus – and Germany has already stocked up on millions of packages.

Of course, this is what the counterfeiters know as well, and they might have already started producing. Counterfeit drugs of these promising drugs can easily brought to the market thanks to the knowledge conveyed by the media and news.

Just think about it for a second: How many people have already searched the Internet for a way to purchase a pack of Avigan? And how much are they willing to pay to get such a promising drug?

 

Thesis 4: The counterfeiters will find it easy to get the necessary information from pharmaceutical companies and their distribution partners because of a lack of cybersecurity.

 

For one thing, the problem is the use of computers at home, from which many home office employees currently access the internal servers of companies. But, given the crisis, those who can stay home should of course stay home.

At this point, companies must ensure that information security and data protection is guaranteed on every PC in every home office.

However, it is not only home computers, but also the trend towards corona apps, which has now arrived in Germany. The Robert Koch Institute (RKI) provides an app to “donate data” and emphasizes that it is a voluntary donation of personal data, which is stored and evaluated pseudonymously using an user ID for each individual.

However, the controversial measure has prompted criticism from data protection experts. Although some degree of privacy is guaranteed, the collected data is stored centrally and is therefore not sufficiently protected against hacker attacks.

A blockchain solution could help by storing the health-related personal data in a decentralized database and thus make the data unhackable.

 

Thesis 5: Europe has a chance to become the leader in the field of blockchain now – by using blockchain to make supply chains counterfeit-proof.

 

Arman Sarhaddar, the inventor of the ivault Blockchain, already reported for Blockchain Insider about the chances of Europe to become a global blockchain pioneer. Now Industry of Things has published his insights as well. We already published a translation of his article for our English readers here: Europe as blockchain pioneer (with ivault leading from the front)

It is the second contribution of our CEO on the renowned platform for blockchain experts. In the first one he reported on counterfeit products in the supply chain:

“Tracking and tracing of ingredients is crucial, especially in the medical sector. […] Customers of medicinal products and pharmaceuticals want to be sure that they have not purchased a counterfeit. For them, the quality of the ingredients plays an essential role and in case of damage, the weak point must be clearly identifiable.”

Europe now has the opportunity to take the role of a global blockchain leader by implementing the most intelligent solution for the supply chain management of pharmaceutical companies: the blockchain.

This technology not only offers the most effective protection against counterfeit drugs entering the supply chain. It also simplifies the detection of counterfeits and the tracing of the weak spot, as it provides the highest possible supply chain transparency for the manufacturer.

But that’s not even all of it: On top of that, every buyer could check the authenticity of a purchased drug by scanning a QR code on the product packaging via an app on his or her smartphone. This way, each individual can tell if a drug could be a fake.

For comparison:

Current methods for increasing protection against counterfeits are intelligent and complex – after all, counterfeiters should not succeed in producing authentic counterfeit drugs – but they are not necessarily practical and neither are they very efficient.

1. One example is the counterfeit protection securPharm

“During the production process, the marketing authorisation holder affixes the safety features to each pharmaceutical package. The data of the unique identifier (serial number, product code, batch number, expiry date) are applied to the pack in clear text and in the form of the Data Matrix Code and uploaded to the centralised database of the pharmaceutical industry. Before the pharmaceutical is dispensed to the patient, the Data Matrix Code is scanned for authentication, thereby reconciling the pack data with the data in the system.”

The one big mistake is that the data is stored centrally and can therefore be easily manipulated by sophisticated hackers. Counterfeit drugs in the legal distribution may not be recognized because the data has been tampered with.

The blockchain, in contrast, stores data in a fundamentally different way: data is distributed among nodes (computers) in a global network. This is the key feature of blockchain technology: It is a decentralized database.

Thus the blockchain creates much more information security. The blockchain is virtually unhackable. All entries are individually encrypted on the computers, changes must be confirmed by all computers in the system, so that data cannot be manipulated anymore.

2. Merck is protecting products with Securalic Reveal:

“Securalic® taggants use hidden markers to authenticate products from the inside out. This smart approach to anti-counterfeiting involves concealing tiny identifiers inside a variety of materials that tell people where the materials really come from. It’s a bit like giving products or even materials like plastics, coatings, or inks their own unique fingerprint. And because all of our taggants are strictly monitored and handled through a restricted supply chain, it is virtually impossible for unwanted parties to even know they’re there.”

The microscopically small particles can be added, for example, to printing inks for product packaging or other materials. But how practical is such a process?

BUT it requires a special detector device to check the product for authenticity. This device must be in the possession of producers, wholesalers, small pharmacies and even the individual buyer to really guarantee product safety – which is neither very realistic nor a practical solution.

On top of that: If a fake turns up how can you trace back where it came from?

With the blockchain, in contrast, it is possible for each individual consumer to check a product’s autheticity on every smartphone. Thus blockchain not only ensures optimum brand protection, but also product and patient safety.

Such a high level of protection against counterfeits can only be provided by the blockchain and nothing else. The blockchain thereby serves as an effective deterrent against counterfeiting crime, because it is easy to trace back where counterfeits have entered the supply chain.

To our knowledge there is no other system that is more practicable and effective. The only hurdle left for Europe to position itself as a blockchain leader: We must act NOW.

 

Arzneimittelfälschungen-Coronavirus

Coronavirus prognosis 2020: From fake news to counterfeit drugs

Fake news about the coronavirus is circulating as well as fake food supplements and the first counterfeit pharmaceuticals, which for example make claims of the sudden discovery of a miracle cure for the novel COVID-19 virus. They brazenly exploit the uncertainty and fear of many people in the current situation. But a much greater danger awaits us…

This forecast deals with the global problem of trade in counterfeit drugs: The marketability of the first coronavirus cures and vaccines, on which researchers and doctors are working intensively, will not only bring hope and healing, but will also open up an extremely profitable niche in the counterfeiting market.

Counterfeiters will soon find ways to imitate original coronavirus medicine and sell counterfeits both online and through the legal distribution chain. The following 3 facts support this forecast and more than clearly demonstrate the danger:

  1. Trade in counterfeit drugs has long been an established and highly professionalized organized crime, responsible for billions in losses and deaths.
  2. The fear and insecurity of people caused by the coronavirus pandemic is already being exploited by dubious online sellers.
  3. The first coronavirus-related counterfeits already became known: Counterfeit medical equipment is now among the top sellers online!

 

Arzneimittelfälschungen-Coronavirus

Coronavirus cure or coronavirus vaccine – when will they be ready for the market? And when will the first counterfeit drugs appear?

 

1. Trade in counterfeit drugs has long been an established and highly professionalized organized crime, responsible for billions in losses and deaths.

 

Trade in counterfeit drugs has become one of the biggest global problems: According to the World Health Organization (WHO), about 15 percent of all drugs worldwide are suspected to be fake, in Asia and Africa the figure is as high as 30 to 50 %. In German pharmacies and clinics, it is estimated that almost every 100th drug could be counterfeit.

In the EU member states, a considerable increase in trade in counterfeit drugs has been observed in recent years – despite strict regulations. In Europe alone, the pharmaceutical industry loses more than 10 billion euros a year, according to Europol and EUIPO (losses of retailers such as pharmacies not included):

EUIPO – The economic cost of IPR infringement in the pharmaceutical industry

Die EUIPO veröffentlichte diese Statistik:Die EUIPO veröffentlichte diese Statistik: Für die EU als Ganzes wird die Gesamtwirkung von Fälschungen auf 4,4% des Umsatzes oder 10,2 Milliarden Euro geschätzt. Dies ist eine direkte Schätzung der Umsatzverluste, die den rechtmäßigen Herstellern und Großhändlern von Arzneimitteln in der EU jedes Jahr aufgrund von Fälschungen entstehen.

EUIPO published these figures: For the EU, the total impact of counterfeit drugs is estimated at 4.4 % of sales or 10.2 billion euros.

 

For the criminals profits are much higher than in common drug trafficking. However, theft and resale of drugs and counterfeiting drugs are no longer the exclusive domain of dubious online providers. In German pharmacies, too, more and more stolen drugs, decanted, diluted and manipulated, are reappearing. In particular, more and more drugs are being stolen from Italian hospitals, such as the cancer drug Herceptin from Roche in 2014.

The manipulated Herceptin ampoules eventually turned up in German pharmacies. Counterfeiters were also able to smuggle these counterfeit drugs into Finland’s and Great Britain’s legal distribution channels seemingly without any difficulty. And this means huge sums were falling into the counterfeiters’ hands: 150 mg of the complex preparation against breast cancer is worth about 850 €!

The cancer drug has a biological half-life of 2-12 days and must be transported at a temperature of -20°C. It is rather inconceivable that the counterfeiters have paid attention to the correct storage temperature and corresponding transport conditions, so that the active ingredient contained will have lost most of its potency.

The counterfeiters have already built up a highly “professional” network – not only online – which seems to function smoothly. They also seem to be far ahead of the current, sometimes frighteningly outdated security systems of manufacturers and legal sellers. These experts will certainly not hold back in selling counterfeit coronavirus pharmaceuticals, because the estimated profit could exceed all previous prospects.

There is an enormous need for action at this point and it is precisely in relation to the coronavirus crisis that action must be taken NOW. Appropriate precautions must be taken as a matter of urgency even before the first drugs and vaccines against coronavirus will leave production, so that the counterfeiters cannot shamelessly exploit this situation and – in the worst case – lead to more fatal incidences.

In addition to the billions lost and the enrichment of the criminals at the expense of the health or even lives of victims, the companies’ reputation is affected as well. In the past, doctors and pharmacists often switched to preparations from other manufacturers as soon as cases of counterfeit drugs became known. The image damage caused by counterfeiters’ activity is clearly not the fault of these companies, but it takes years, perhaps decades, to rebuild their reputation usually with more investments in marketing and advertisements.

But in the meantime the counterfeiters do not sleep.

 

They will take one drug after the other for counterfeiting purposes and obviously it can hit the same company several times (and more certainly, it will, since counterfeiters will target them again and again thanks to their knowledge about how to steal products and reenter a company’s supply chain). Just take a look at the websites and landing pages of the big pharmaceutical companies (31.03.2020):

  • Bayer is warning of possible medical counterfeits in the legal distribution chain (in addition to counterfeit drugs sold through unauthorised distribution channels): 

“Warning about counterfeiting in the legal distribution chain:
Xarelto® 20 mg film-coated tablets in pack size N2 (28 tablets), lot BXHVHC3 in the Polish-Slovak style, are most likely counterfeit. If you have such a package, please contact us immediately.”

  • Pfizer does not provide information on counterfeit drugs on its German website. But it is no secret that the popular blue Viagra pill – Pfizer’s successful recipe for treatment of erectile dysfunction – is the most faked drug to date. Or at least one of them… The German newspaper BILD expresses it – as always – in a particularly radically way: “Rat excrements and lead paint in fake Viagra pills! That’s how dangerous the plagiarisms are.” Unfortunately, in many people’s minds, Pfizer has become the one big pharmaceutical company that represents the negative side of the pharmaceutical industry as a whole… The well-known company is struggling with massive reputation damage. Therefore, it is sometimes completely overlooked when the company is doing something good.
  • More current examples you will find among the Food and Drug Administration’s list: FDA alerts.

Both Bayer and Pfizer are on the front lines in the fight against the coronavirus. Bayer is already warning about criminals who are taking advantage of the current situation and the fear of the public on its landing page for counterfeit drug warnings. Pfizer outlines a five-point plan to battle COVID-19, calling on the entire pharmaceutical industry to cooperate in battling coronavirus instead of continuing to compete with each other. Together with BioNTech, they are also developing a vaccine against COVID-19.

The counterfeiters are unlikely to hesitate to take advantage of this… They have already had great success with Pfizer products and can easily go for it again!

2. The fear and insecurity of people caused by the coronavirus pandemic is already being exploited by dubious online sellers.

 

Apart from false reports on the coronavirus pandemic, that are based on political or religious interests, fake news have one intention in particular: to promote sales. Warnings of dubious health promises are also prominent online but these are few compared to the vast amount of sellers that are trying to take advantage of people’s fears.

Among others there is the false claim, that the “active ingredient chlorine dioxide” helps against coronavirus. This is a conventional bleaching agent, the oral intake of which can be very dangerous and harmful to human health.

The coronavirus market is booming for food supplements as well, as people are insecure and are looking for complementary preparations to support their immune system in its defence against the virus. Vitamin preparations and other products are being counterfeited. The new Golisan blog entry is mainly about dietary supplements that are aggressively advertised with the keyword corona.

“Other products are also aggressively advertised with corona hashtags
… from sweaters and socks to handmade Disney articles on Etsy – on this platform, for example, products relating to coronavirus have already been removed. The major marketplaces Amazon and Ebay are taking action against the corona traders as well. Amazon has already blocked and deleted tens of thousands of corona articles and sellers, that are trying to make a profit out of the uncertainty of customers by advertising their products with usurious prices.”

But the petty criminals, from food supplement counterfeiters to sellers on Social Media, Etsy and others, are far from being the real danger. These examples only show that all over the world there is a great willingness to engage in dubious online trading and turn a profit out of the crisis.

The real danger, however, is that the big counterfeiters will soon take the initiative. And this is only half a prognosis, because it’s a fact, that they are already doing so:

@europol.eu is posting about the current situation: thousands of online sellers and counterfeiters are trying to exploit people fears of coronavirus

Europol is posting about the current situation: thousands of online sellers and counterfeiters are trying to exploit people’s fears of getting sick and infecting loved ones. Unfortunately, there a only few such posts that are almost completely drowned in fake news and exploitative advertisements of face masks, disinfectants and a few weeks ago even pasta, that has been traded with like it was cocaine.

 

3. The first coronavirus-related counterfeits already became known: Counterfeit medical equipment is now a top seller online!

 

Coronavirus has already opened up this very profitable niche in the counterfeiting market: Criminals use the high demand in hygiene products driven by the coronavirus outbreak as a new business opportunity. The trade in counterfeit protective masks and other medical accessories has taken on radical, hardly scalable proportions in the past few weeks. According to Europol, about 34,000 counterfeit surgical masks were recently seized during a worldwide police operation.

The counterfeiters also fake antiviral drugs, for which, however, no effect against coronavirus has been proven so far. Europol has already seized 4.4 million units of illicit pharmaceuticals worldwide and 2.500 links have been taken down (including websites,  online marketplaces, adverts and social media).

But cybercrime doesn’t stop there. Many employees of large companies currently work on their less well-secured home computers and access employers’ networks from there. The lack of cybersecurity makes it much easier for counterfeiters to gain access to confidential data and valuable internal information during the coronavirus crisis, which can be misused in every conceivable way. This can be as easy as stealing the graphic designers’ coronavirus pharmaceutical packaging design.

The trade in counterfeit medical equipment not only demonstrates how fast counterfeiters can act, but also demonstrates the real danger: How many doctors in hospitals are unknowingly working with counterfeit masks that are permeable to the virus, at this very moment? How many medical assistants will infect themselves and others through fake equipment?

How many human lives are at stake?

Conclusion

 

What we need is a revolution in the fight against counterfeiting and an efficient solution that will enable us to detect counterfeit products such as counterfeit drugs, and, on the other hand, to verify the authenticity of original drugs and prevent major damage.

Arman Sarhaddar, CEO and Founder of Vault Security Systems AG and the new brand ivault, is sure that with the innovative application of blockchain we can drastically reduce the frightening numbers of counterfeit drugs. Many pharmaceutical companies already have QR codes on their packaging, but what is missing is the registration of their products in the blockchain, which offers the highest possible product safety and data security.

If Europe wants to be a blockchain pioneer, now is the time to implement a blockchain solution to solve this problem, because Blockchain technology does indeed provide the optimal solution.