Counterfeiters have long profited from the exploitation of consumer trust and ignorance, and operating in an increasingly globalised market has made catching and prosecuting them much harder for authorities. Chris Godfrey speaks with the Medicines and Healthcare Products Regulatory Agency’s head of enforcement, Alastair Jeffrey, to find out what’s new in the war to purge falsified goods from the market and paralyse those perpetrating them.
Last October, the Medicines and Healthcare Products Regulatory Agency (MHRA) seized the UK’s largest ever single haul of cognitive enhancers, or ‘smart’ drugs. The raid amassed 20,000 units and 13 different variants. With a value of £200,000, it’s the clearest sign yet that a lucrative new market has opened up for counterfeiters.
Desperate to pass exams and looking for outside help to do so, university students have made for an obvious target. Through slick, professional-looking websites, criminals are convincing students to purchase everything from Ritalin, to improve focus on essay writing, to Modafinil, used to help them stay awake. But as well as counterfeit versions of known brands, fraudsters are also pushing experimental, untrialled drugs through their websites where they downplay the side effects and hide the risks.
The dangers of buying unprescribed pharmaceuticals over the internet need no introduction, but to the uninformed, particularly student, the professional facade of these online ‘pharmacies’ is reassuring. And as the number taking cognitive enhancers increases, those who don’t run the risk of being left behind. Not willing to accept such a disadvantage, more will turn to them to keep up with the competition. It’s a drug-fuelled arms race that looks set only to worsen. The ease with which websites are set up makes shutting them down a futile task: as one is brought down, two more spring up in its place.
"The internet was a complete game-changer: it’s allowed criminals massive access to a huge number of potential consumers," says Alastair Jeffrey, head of enforcement at MHRA. "What’s on the horizon at the moment is the rise of cognitive-enhancing medicines, which are being seen in quite a number of universities. Dealing with that volume, coming in through that method, is a real challenge for us."
Prior to joining MHRA, Jeffrey spent over three decades working for the Metropolitan Police, where, among other roles, he led surveillance and covert policing command units. Now, his enforcement group has the responsibility for investigating any breaches of medicine or medical device legislation within the UK. Every aspect of both the regulated and unregulated supply chain falls under its jurisdiction, from manufacturing to sale, advertising to importation.
Considering that most falsified products are being imported from outside the purchaser’s country, from websites that can be hosted anywhere, enforcement agencies are often stranded in legislative grey areas. Countering the problems of a global counterfeit network requires collaboration between stakeholders from around the world and across the entire supply chain. As a result, the MHRA now works closely with pharmaceutical and enforcement bodies, including INTERPOL, WHO, the UK Border Force and pharmaceutical wholesalers.
Last October’s record seizure of cognitive enhancers was only made possible after a tip-off from the Norwegian Medicines Agency. When the team intercepted suspicious packages from the UK, destined for Scandinavian customers, it alerted MHRA, which launched the subsequently successful operation. It’s indicative of the way international collaboration is necessary in this era of globalised counterfeiting.
Coordinated effort
Operation Pangea is one of the biggest triumphs for such coordination. The first operation ran in 2008, originally intended as an annual day of action for taking down commercial websites, intercepting suspicious packages, seizing identified counterfeit products and raising consumer awareness. Now in its seventh iteration, more than 100 countries and 193 agencies across the world are involved, with the programme lasting a week.
During the most recent operation in May 2014, Pangea VII, 434 arrests were made, 1,249 investigations were launched and more than nine million illicit products were seized.
The haul, worth over $32 million, included pills for slimming, erectile dysfunction and cholesterol, as well as medication for cancer, colds and malaria. In addition to the seizures, 22,800 adverts for illegitimate pharmaceuticals were removed from social media sites and more than 11,800 websites were shut down.
"A huge amount of effort and activity goes in there, so it’s a good example of how we work collaboratively internationally," says Jeffrey. As well as its involvement in Operation Pangea, the MRHA also chairs a falsified medicines stakeholder group, to assess the risk of counterfeit products entering the UK market.
"We create a watch-list identifying the most prevalent and most likely to penetrate the UK market," says Jeffrey. "Once we’ve done that, the information goes to parties such as the UK Border Force, which will keep a look out on those types of medicines, and to market testers, who can analyse those already in the marketplace to check their legitimacy."
The astronomical rise of social media sites has also presented criminals with cost effective opportunities for increasing visibility and for pedalling their goods to this huge audience. The ergonomics of Facebook and Twitter make them ripe for exploitation, but even platforms like YouTube are being used to sell medicines. In the last year alone, Jeffrey’s team took down more than 18,000 pages from the video-sharing site.
Like any counterfeit product, the key is in the detail. Most websites purporting to be pharmacies will use stock images of concerned medical professionals in white coats and with stethoscopes, which make it easy for consumers to forget that they’re not buying from a controlled environment. For criminals, directing patients to online ‘pharmacies’ and convincing them to buy medicine has never been easier.
"There’s what you would call an affiliate system, which doesn’t really compare to anything in the physical world," says Jeffrey. "It’s a programme where effectively hundreds, if not thousands, of websites will be set up to feed into a pharmaceutical sales page.
"The hosts get paid by the number of people that click into the site, so it’s a phenomenal business model for criminals: it allows them access to huge numbers of consumers for relatively no money."
Taking names
Strategies for limiting the impact include taking domain names down, removing the ability to host websites and working with the financial sector to revoke merchant trading accounts. Jeffrey believes this persistent targeting of websites, hosts and payment facilities has left the UK domain much safer.
"The UK domain is very clean, but you can host a website wherever you want to," says Jeffrey. "That makes it much more difficult for us to deal with. There is a governing body responsible for regulating the internet called the Internet Corporation for Assigned Names and Numbers (ICANN). We can go there to make complaints about websites that are not within the UK and to try to get them taken down.
"We have a dedicated internet infrastructure, where someone is tasked with looking at all the websites selling medicines illegally. We have an intelligence cell that has the ability to provide criminal analysis and undertake test purchases, or covert investigations. There are also our financial investigators, who deal with the monetary aspect of criminality, so we have a fairly large enforcement capability."
In another internationally orchestrated bid to shore up the supply chain, the Falsified Medicines Directive was put in place to harmonise the licensing, manufacturing, and distribution of medicines across the EU. Launched in January 2013, it ensures the integrity of APIs and governs sales made over the internet. It also makes the need for safety features on packaging, such as anti-tampering devices, a requirement. The introduction of a standardised logo will also ensure consumers can be reassured that their buying from a registered supplier almost instantly.
"For me the Falsified Medicines Directive has created a much tighter and more controlled supply chain," says Jeffrey. "The suppliers have now got to be registered, which wasn’t a requirement before. If you’re buying an API, you’re able to ensure that not only is the broker legitimate, but also that they secured it from a legitimate source.
"There are other things that are coming in, too, regarding the sale of medicines at a distance. These won’t necessarily address pharmacies, it could also be supermarkets, but they would all need to adhere to the conditions imposed."
While the directive will help further regulate the licensed European supply chain, it will have a limited impact on those criminals operating in counterfeit hotspots, like India and China. Those feeding the illegitimate supply chain are unlikely to be perturbed by the implementation of high-level legislation. Introducing the packaging safety features, as well as funding the new lines, will also take time for manufacturers to fully engineer and implement all of its requirements. In the mean time it’ll be up to Jeffrey, his team and the wider enforcement community to ensure that the counterfeiting doesn’t get any worse.