Trafficking of pharmaceutical products takes place on a large scale and is highly lucrative for the organised crime groups involved.
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The European Medicines Agency (EMA) has announced that it will conclude evaluation of the first conditional marketing authorisation application for a coronavirus vaccine before the end of the year.
Several EU Member States have already published their vaccination plans. Europol urges increased vigilance among Member States and third-party countries on the possible involvement of criminals in the vaccine development and distribution process.
In April this year, Europol announced the potential harm of offline and online scams offering alleged versions of the coronavirus vaccine. Projections were also made in relation to the announcement of a genuine vaccine and the reaction of organised crime to adapt its methods to meet demand.
These projections were later confirmed in Europol’s November report, where it was identified that the distribution of substandard and counterfeit pharmaceutical products, including preventative coronavirus vaccines had remained a consistent pandemic-related criminal activity.
Owing to the pandemic, the demand for influenza treatments has been higher than usual and there are risks of shortages in numerous countries. This high demand may encourage people to seek the vaccine elsewhere. For this reason, once the legitimate vaccine enters the market, counterfeit versions of the brand are expected to circulate rapidly to meet the high demand.
It is feared that criminals will share disinformation to defraud individuals and companies alike. There have already been cases of advertisements on dark web marketplaces using the brands of genuine pharmaceutical companies that are already in the final stages of testing.
These counterfeit vaccines may pose a significant risk to public health if they are ineffective or toxic, given their production in labs without the required hygiene standards. These fake vaccines may circulate on illicit markets or be introduced to the legal market for distribution.
The World Health Organization detected a falsified influenza vaccine in Mexico in October
2020. The fake vaccine had a different batch number and expiry dates than genuine
products. The alleged manufacturing pharmaceutical company confirmed that they
did not produce or distribute this product.
Once a legitimate vaccine enters the market, counterfeited versions of the specific vaccine brand are expected to circulate rapidly. Similar to the fake influenza vaccine encountered in Mexico, counterfeit coronavirus vaccines may represent a significant public health threat if they are ineffective at best or toxic at worst, given their production in underground labs without hygiene standards.
Fake vaccines may even have a wider-reaching impact if new outbreaks emerge in communities assumed to be vaccinated. Counterfeit vaccines may circulate on illicit markets or be introduced to the legal market, as occurs regularly with other counterfeit pharmaceuticals. The expected high demand for coronavirus vaccines will likely attract organised crime groups
seeking to capitalise on the pandemic situation and subsequent vaccination campaigns.
For example, criminals may resort to illegally refilling empty vials. Therefore, procedures for the correct disposal of vials by grinding or incineration will have to be properly enforced.
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Finally, when demand exceeds supply, criminals seek to divert pharmaceutical products from the legal market due to the substantial profits on offer. High demand may prompt some people to seek out alternative sources of the vaccine rather than official government-sanctioned vaccination programmes.
Genuine coronavirus vaccines will be highly valuable commodities and their supply chains (storage, transportation and delivery) will be at risk of being targeted by criminals seeking to obtain these pharmaceutical products. Organised crime groups might target transit containing coronavirus vaccines for hijacking and theft.
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Transport associations are preparing for the large-scale logistical effort of transporting and distributing the vaccines taking into consideration security risks. Diversion from the legal market may also pose risks to public health, as vaccines found outside the cold chain are not considered safe.
Europol actively encourages Member States to share any relevant information on criminal activities related to coronavirus or flu vaccines. ■