The majority of illicit pharmaceutical seizures made from organised crime networks operating in western countries have historically been mostly made up of prescription medication used for recreational or lifestyle purposes. During investigations intended to crackdown on the illegal sale of counterfeit medicines or prescription drugs that have been diverted from legitimate supply chains, law enforcement agencies operating in western nations often come across treatments such as erectile dysfunction tablets, slimming pills, painkillers, hypnotic and sedative agents, and anabolic steroids. In the developing world, it is often a different story.

Earlier this month, Europol revealed that a crackdown it had led on the sale of illicit pharmaceuticals across 16 countries last year resulted in the seizure of some 13 million doses of counterfeit or smuggled medicines. In total, these were estimated to be worth some €165 million ($185.4 million). Europe’s law enforcement agency said its MISMED 2 operation also revealed that prescription drugs used to treat major illnesses such as cancer and heart conditions are now being sold illegally in Europe.

While all available evidence points to this being an emerging trend in the west at present, the sale of fake versions of medicines that are intended to treat serious conditions has long been a significant problem in poorer countries. A report published yesterday in the American Journal of Tropical Medicine and Hygiene outlined the scale of the issue, warning that falsified and substandard medicines are now associated with hundreds of thousands of deaths, mainly in young children living in developing nations. Medics estimate that the availability of poor-quality drugs could be resulting in the deaths of as many as 250,000 children every year from malaria and pneumonia alone.

Falsified and substandard medicine is also thought to be costing the global economy as much as $200 billion a year, while is at the same time contributing to increasing antimicrobial resistance, according to the study. The report’s authors said the majority of deaths linked to these bogus drugs take place in nations where the criminal gangs behind the illicit trade are able to operate relatively untroubled by state surveillance, quality control and regulation. The fake medicines often sold in these regions, many of which are said to originate from countries such as China and India, have been known to contain toxic ingredients such as arsenic, paint and printer ink.

A separate study published by the World Health Organisation (WHO) in November 2017 revealed that 10% of all pharmaceutical products circulating in low and middle-income countries at that time were either fake or of substandard quality. Noting that of the majority of the 1,500 reports of substandard or falsified medicine it had received since 2013 related to antimalarials and antibiotics, the UN agency said most of the counterfeit drugs (42%) to which it had been alerted over the study period were circulating in Africa, followed by the Americas (21%) and Europe (21%).

WHO noted that organised criminal gangs were behind the growing trade in counterfeit and smuggled pharmaceuticals, observing that Interpol had claimed these groups use the profits made from bogus and substandard drugs to fund other types of illegal activity. Unveiling the report, WHO Director General Dr Tedros Adhanom Ghebreyesus said: “Substandard and falsified medicines particularly affect the most vulnerable communities. Imagine a mother who gives up food or other basic needs to pay for her child’s treatment, unaware that the medicines are substandard or falsified, and then that treatment causes her child to die.”

Authorities in some countries are taking steps to help protect patients from fake drugs. In Kenya, regulators last month announced plans to launch a new system that will allow members of the public to check whether their medicines are genuine using their mobile phones. The system, which was announced by the Kenya Pharmacy and Poisons Board at the beginning of February, will see both locally-produced and imported medicines assigned unique identifier QR codes that can be scanned with mobile phones to verify their authenticity. While this does little to prevent counterfeit medication making its way into the country in the first place, it does offer patients a means by which they can ensure they are not consuming drugs that might do them harm.

With counterfeit drugs intended to treat life-threatening conditions now emerging as a problem in the west, as evidenced by news of Europol’s MISMED 2 operation and a recent alert issued by WHO over a fake cancer drug circulating in Europe and the Americas, it has become clear that a global response is required to the problem. As well as making it easier to track medicines to ensure they have been sourced through legitimate supply chains, authorities must also increase the penalties faced by those involved in the illicit pharmaceuticals trade once they are caught.

Moreover, as many of the drugs that are counterfeited for markets in both the developing world and the west are made by huge pharma giants based in wealthy countries, it is incumbent on these businesses to come together with governments and law enforcement agencies around the world to work on a joined-up solution to an illegal trade that is killing hundreds of thousands across the globe every year.

In a somewhat bizarre statement issued yesterday, the European Commission declared that the EU’s years-long migration crisis has been brought to an end. Issuing a factsheet that sought to dispel a number of “myths” about the problems caused by illegal migrant entries to the 28-nation bloc, the Commission pointed out that the number of irregular migrants attempting to make the journey across the Mediterranean fell to its lowest level for five years in 2018. In an effort to debunk “misinformation, untruths and fake news” that paint refugees and migrants as “terrorists and criminals”, the Commission claimed that the majority of those who would like to travel to the EU are now being prevented from doing so in neighbouring countries, noting how efforts made by Brussels to protect members states’ borders and crack down on people smuggling gangs have had the desired effect.

While it is obviously good news that the number of migrants attempting to reach EU countries is on a consistently downward trajectory, some might suggest that it might be slightly premature to declare the crisis over, particularly those who experience the sharp end of illegal immigration on the ground.

Along with its “myth-busting” factsheet, the Commission also published a list of measures it claims must be taken immediately to ensure the crisis it says is over is kept under control. Seemingly contradicting its Pollyannaish effort to play down the significance of the problem, the Commission yesterday demanded that Morocco be provided with additional support after a significant rise in the number of migrants attempting to reach Europe via the Western Mediterranean route, which became the most popular way to illegally enter the EU in 2018. It also warned that more needs to be done to improve the “appalling” conditions in which EU-bound migrants are forced to live in squalid detention camps in Libya, and urged that the ongoing situation requires “continuous, determined action”, including the tackling of the drivers of irregular migration, and stronger border management.

Only last month, EU border protection agency Frontex said in a risk report that although illegal migrant entries to Europe fell for the third year in a row in 2018, migratory pressure on the 28-nation bloc’s external borders will remain relatively high over the next 12 months, so much so that it is planning to boost control measures by hiring more staff and upgrading the technology it uses to detect and prevent illegal migrant entry attempts. The agency said that while entries fell 27% to 150,114 in 2018, the pressure on Spain has continued to rise over the last year thanks to more people attempting to enter Europe via the Western Mediterranean route. In a preface to Frontex’s latest annual risk analysis report, the agency’s boss, Fabrice Leggeri, said: “Despite the falling migratory pressure in the Central Mediterranean, the fight against criminal smuggling networks at the external borders remains in our focus.”

At the end of December, a statistical update from the International Organisation for Migration (IOM) revealed that the number of migrants entering Europe via the Mediterranean topped 100,000 for the fifth year running in 2018. According to the agency, a total of 113,145 migrants entered Europe by sea from the start of the year until 19 December, which was down from 168,258 in 2017, and 359,160 in 2016. While this was obviously a sharp fall, the majority of right-minded people would most likely still consider that number of migrants attempting to reach Europe illegally over the course of a year a crisis, particularly when taking into account the fact that 2,262 lost their lives while making the journey in 2018. And while the pressure might have eased across entry points in southern Europe, the movement of migrants within the EU is still a major issue. UK Home Secretary Sajid Javid was forced to cut short his Christmas holiday in December and declare a “major incident” after a large uptick in the number of mostly Iranian migrants attempting to cross the English Channel in dinghies.

While it may be the case that the far right has sought to capitalise on fears relating to the number of migrants attempting to reach Europe over the past four years, and that it is true that this has resulted in the dissemination of “fake news” stoking these worries, any attempt to argue that the migrant crisis is in any way “over” is naïve at best. It is a fact that the number of entry attempts are down, but huge numbers of people are still attempting to reach Europe in search of a better life, with thousands dying each year while doing so. Downplaying the scale of the problem for largely political reasons while continuing to ignore the EU’s failure to control its borders is both disingenuous and highly irresponsible.

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The European Union is set to implement a system to track and trace tobacco products all along the supply chain this May, in line with the Tobacco Products Directive it passed in 2014. According to EU officials, the scheme meets a mandate from the WHO Framework Convention on Tobacco Control (FCTC) Protocol to Eliminate Illicit Trade in Tobacco Products, to which the EU is a party.

Track and trace systems have the potential to be vital tools in the fight against the illicit tobacco trade. Under-the-table smokes are “the commodity of choice” for organised crime groups, deprive governments of badly-needed tax revenue, and undermine public health initiatives by making tobacco products available at cheap prices, most importantly to highly price-sensitive groups such as young people.

The EU is by no means immune to the parallel trade in tobacco products, which costs the bloc’s governments an estimated €10 to 20 billion a year; illicit smokes make up roughly 10% of European consumption. What’s more, in some areas of the Union, the situation is getting worse. Tobacco smuggling across the Lithuanian-Belarusian border nearly doubled in 2018, and there are grave concerns a no-deal Brexit could lead to rampant illicit trade across the Irish border.

Parliamentary dissent

Against this backdrop, the May rollout of the EU’s track-and-trace scheme is welcome news. Unfortunately, the system the European bloc is planning to implement has already drawn substantial criticism from MEPs and public health bodies, who argue that the scheme is not  independent from the tobacco industry. The WHO Protocol specifies any track-and-trace system must be clearly separate from the tobacco sector’s influence; tobacco manufacturers’ long history of obstructionism and complicity in the smuggling of their own products indicate that they simply can’t be trusted. As recently as 2014, British American Tobacco (BAT) was fined in the UK for deliberately oversupplying overseas markets which it knew would make it into the hands of smugglers.

These various concerns underpinned Romanian MEP Cristian-Silviu Busoi’s January seminar on how to stamp out the parallel tobacco trade. Another, similar, debate will be held on Wednesday, February 27^th, helmed by MEP Younous Omarjee. Both Busoi and Omarjee are suggesting that the Tobacco Products Directive may need to be modified in order to ensure the EU’s track-and-trace scheme is made compliant with the WHO Protocol, a higher legal norm, and does not unduly entrust responsibilities to the tobacco industry.

As Omarjee’s stated in a press release, the MEP “wants to understand why the European Commission is going out of its way to entrust the fight against the parallel trade in tobacco, fed by cigarette manufacturers, to the tobacco lobby and people close to it.”

The WHO’s approach

NGOs present at the January seminar, from the European Network for Smoking Prevention to the European Cancer League (represented by prominent anti-tobacco activist Luk Joossens), agreed that among the many key changes to the Directive would include making sure that data storage providers are not selected and paid by tobacco manufacturers. The International Tax Stamp Association (ITSA), which has challenged the EU system before the European Court of Justice on the grounds that it is in breach of the WHO Protocol, agreed that, among other things, any track and trace system should be placed under the protocol signatories’ direct control. Against the backdrop of this plethora of concerns, the European Commission representative at Busoi’s conference noted that the EU system is up for review in 2021.

Our exclusive new infographic illustrates the shortcomings of the EU track & trace system. Leaving aside the security features aspect of the system, which is controversial in and of itself, the infographic highlighting its numerous discrepancies with the scheme provided for by the WHO Protocol.

The WHO calls for a logical, linear process in which it defines a set of requirements for the Protocol’s parties to enforce. A public, open and competitive tender by the parties to the Protocol is supposed to select the best service providers, entirely independent from the tobacco industry, which then take on the key missions of “track and trace”: generating unique identifier codes, printing or affixing these codes to tobacco products, verifying on the production line that the codes are linked to the right products and providing governments with a database and related alert system. Public authorities, including customs, police forces and the judiciary, then have the means to control tobacco products all along the supply chain and convict those responsible for illicit trade.

Europe’s problematic alternative

In contrast, the European system is highly convoluted. Member states only carry out tenders for the service providers charged with generating the codes, while the European Commission oversees the selection of database providers. Most problematically, the EU scheme requires the tobacco manufacturers to both affix and verify the codes in their factories—two of the most essential steps of tracking and tracing tobacco products. The industry also has a hand in selecting and remunerating both the data storage providers and the auditors intended to oversee the system.

Under this scheme, unlike that outlined by the WHO, separate databases are required, while tobacco manufacturers each select their own preferred partners for data storage, which transfers its data to the secondary repository for public authorities. The involvement of the tobacco industry and its network of preferred suppliers in three of the four core missions in the EU proposal understandably raise serious doubts about whether the data generated by the system will truly be objective, and whether its use by judicial authorities will be efficient in tackling the illicit tobacco trade.

EU Health Commissioner Vytenis Andriukaitis has underlined that tobacco consumption is the single biggest cause of avoidable death in the EU, and expressed his hope that the implementation of track and trace would help Brussels crack down on the illicit trade which furthers it. Unfortunately, as it stands, the EU proposal falls short of what’s needed to effectively regulate the sector —and fails to fulfil the bloc’s obligations under the WHO Protocol.