How regulators and NGOs are bringing the threat of fake medicines to light
If recent world events are anything to go by, there is a growing awareness that anything read on the internet should be taken with a pinch of salt. Why is it that people are still prepared to trust the internet when it comes to their health? Ben Hargreaves examines the rise of fake medicines and the different ways in which the pharmaceutical and healthcare industries are fighting back.
In the pharmaceutical industry, packaging preserves goods that are to treat the health of the patient who need to be able to trust the product they are taking. With almost all other goods, if they are found to be damaged, they can be returned for a refund. With pharmaceutical products, if the materials are faulty, the patient’s long term health can be put at risk.
Reducing the threat to the legitimate supply chain is exactly the aim of the Falsified Medicines Directive (FMD). One of the major changes that will be enacted by the FMD is the compulsory serialisation of medicinal products. This involves each product leaving the supply chain being labelled with a Global Trade Item Number, Batch Number, Expiry Data and Serialised Number – as well as a National Reimbursement Number, depending on whether it is required by the country. There will also be a GS1 2D Data Matrix Code that will be scanned – a code that has the potential to provide more than just verification of a product; some have discussed the possibility of it providing information to patients when scanned with a smartphone and there could likely be further developments on this in the near future.
This requirement necessitates major changes in the way products are produced and have until February 2019 to comply with the new track and trace regulations. Serialisation will mean that, as the product is scanned, it can be traced at the beginning and the end of the supply chain, to the pharmacist who eventually supplies the product to the patients. One of the main concerns is the amount of data that will be involved, with serialised products generating 1,000 times the data storage requirements and 10,000 times the transaction volumes of current products. This level of data is further complicated by the optional National Reimbursement Number that was intended to ease the process for countries that already use the system, but has been adopted beyond this pool by some overeager regulators.
It is a process so laborious that much discussion has taken place at recent conferences about how seriously the measures are to be taken; there have even been those that have reportedly hoped that Brexit may negate the necessity of having to follow the FMD regulation. The answer to such a hope is resoundingly negative from those in the know. The procedure is an essential shift towards making the supply chain increasingly secure.
Thinking outside the box
Of course, the pharmaceutical industry has not been complacent when it comes to security within its own supply. Recent innovations have included a permanent emulsion acrylic adhesive, an adhesive that is doubly-strong compared with common alternatives. What this means is if anyone attempts to access the medicine, for any reason, there will be fibre tear on the packaging, making it immediately evident that the seal has been broken. From a design perspective, this method could be detrimental to a brand’s image, quite literally, with damage to the box.
This is why some companies prefer to use security seals that can be produced using transparent materials. The design doesn’t infringe on the labelling of the product and the seal can be broken without any unsightly tearing of the fibre. With this said, there could be counter-claims suggesting that breaking of the seals is not as evident.
However, both styles are among changes that signal the growing impetus to make life more difficult for those intent on meddling within the legitimate supply chain and, on a wider level, part of the retaliation against the damaging effect of fake medicines. This is one of the most worrying results of the rise of fake medicines: the potential for public confidence in medicines to collapse.
The scourge of fake medication entering the market is a prevailing issue and increasing measures are being to minimise the problem. The true nature of the problem is being revealed as more and more investigations are carried out, but, while the legitimate supply chain still faces problems, danger to public health is emerging from other sources.
The World Health Organization (WHO) estimates that between 1% and 10% of European medicines are fake – a figure that can rise as high as 30% in other areas of the world. The issue is not simply the money that is being made from these drug rings, but what the medication is being replaced with. With the internet now being a go-to location to purchase products, regulators and non-governmental organisations are facing a battle of how to inform the public of the danger of taking the cheaper and more convenient medicine.
The key is in the detail
The primary point of concern at the heart of attempts to combat fake drugs is the public’s health. With this said, the nuance of the debates around how best to protect the public has led to some complications that need to be ironed out first. One recurring question surrounding the topic will quickly introduce one of the key, if somewhat cyclical, debates regarding fake medicine is what do we refer to them as? It is human nature to desire precision within language, yet, with a topic that stresses the need to reach out to and to educate the public, it can lead to confusion. At a recent conference Pharmafocus attended, every speaker referred to fake medicine by using the term ‘counterfeit’. WHO has a bizarrely long title for such substances: substandard, spurious, falsely labelled, falsified and counterfeit (SSFFC) medical products. The EMA breaks down the broader term into two different entities with distinct meanings, defining falsified medicines as “fake medicines that are designed to mimic real medicines” and counterfeit medicines as “medicines that do not comply with intellectual-property rights or that infringe trademark law.” The FDA refers to them as counterfeit medicine. Some industry figures speaking on the topic seem much more comfortable with the terms ‘counterfeit’ and ‘fake’, as these seem to be the references that communicate most clearly with the public.
The dangers to the general public
It is easy to dismiss the danger of fake drugs as a problem consigned to men purchasing erectile dysfunction tablets from the internet, after perhaps being too trusting of the promises being made in their spam email inbox. In fact, the stories that circulate on this topic are some of the most memorable: one being whereby a man who produced fake Viagra (as the most recognisable brand name) learned that his father had been taken to hospital after taking one of his own tablets, which he had accidently created at three times of the strength of the recommended dose. Stories such as these are a great example of the dangers of not just buying but actually trusting those responsible for creating the fake medicine. However, the greater trouble is the vast amount of people the counterfeiters currently do and possibly could affect.
With the unlicensed generics that enter the market, the temptation is clear for a consumer that is comfortable with purchasing everything online; why would you suffer the inconvenience and the cost of going through a legitimate pharmacy when it is possible to purchase the same drug at a discount, delivered to your door? This is the rationale of many, especially young adults, who have become used to ease of purchase through the internet – the difference being that a discount squash racket generally will not find its way into your bloodstream.
According to Interpol estimates released in 2013, one million people per year die from consuming fake medicine. To return to the previous example, fake Viagra is a particularly good drug to produce because of two things: most people aren’t overly keen on admitting that they have purchased erectile dysfunction medication and, within a short time, it should be clear whether the medication is effective or not. This makes it one of most commonly faked medicine in the world, with pills being sold for £2 to £3 in the UK, produced at extremely low costs and vast quantities. The profits are huge, and the dangers are even bigger for the consumer; fake Viagra tablets have been found to be contaminated with rat poison and held together by construction materials.
Better the devil you know?
Another worrying statistic is Interpol’s estimate is that 30% of all medicines worldwide are fake. The recognition of the prevalence of the problem needs to be disseminated widely, particularly among the younger generation. People who have grown up without the internet rarely question purchasing anything they desire online; the risks of buying a medicine from an unknown seller does not ring the necessary alarm bells.
In an attempt to protect the public from purchasing via illegitimate online pharmacies, a common logo has been introduced to all medicine suppliers signposting that the website can legally sell medicines. In theory, this means that an individual is able to ascertain whether a website is legitimate by simply clicking through to check. Unfortunately, there are obvious flaws with this system. One is that websites can simply copy the verification website and dupe viewers into believing it has been registered with the relevant bodies. It is interesting to note that the National Association of Boards of Pharmacy has bought the top level domain name .pharmacy and is rolling this out across the world. The idea here is that once the public get to know that the domain has been thoroughly vetted and checked out and will lawfully sell authentic, licensed medicines in the country that it is serving, then this will provide a much safer place to buy medicines online. However, this brings us to the larger issue and one that reappears time and again: awareness.
How many individuals know that such a link exists? How many will know what it signifies and how many will seek it out? A survey, conducted by Sanofi in 2014, found 90% of respondents named the internet as the primary potential source of dissemination of fake medicines. The same study found that 18% of people claimed to have purchased drugs online and, of those, 78% felt that their purchase was safe. In contrast, 60% of those who said they had never purchased medicines online did not do so because they felt that this method of sale represented a real danger. As can be seen by these statistics, there is some degree of confusion, with the public aware of the source of fake medicine but without an awareness of just how dangerous fake medicines can be. If there isn’t a worry about the potential harm of fake medicine then there is no reason to exercise caution online. There has recently been an increased level of news coverage on the threat posed by fake medicines but more can still be done to raise awareness.
The MHRA has sought to address this problem and are actively campaigning to increase the public’s knowledge, especially among younger adults. It is currently running a campaign called ‘FakeMeds’ and it has tried to reach a broad audience by employing various means of distributing warnings on the dangers of fake medicine. MHRA spokesperson, Joseph Groszewski, explained its recent efforts: “Our ‘FakeMeds campaign is a three year campaign aimed at tackling the problem of people buying fake or unlicensed medication online. It’s primarily targeted at 18-30 year olds, though we are trying to raise awareness at a widespread level. The main point, first of all, is to raise awareness that people are buying fake medicine online and recent statistics seem to show that up to 50% of all medicines via the internet are either fake or unlicensed. We are trying to change consumer behaviour to make sure that, when they are buying medication online, that it’s safe and from a secure source.”
The MHRA campaign extends beyond simply raising understanding of the particular medicines consumers need to be careful about purchasing. Within this operation, the MHRA has sought to engage the public via television shows: in particular, the MHRA has worked with The One Show, Don’t Tell the Doctor and Coronation Street – with the latter involving a storyline where fake diet pills cause the collapse of a character.
Beyond this, Mike Isles, Executive Director of European Alliance for Access to Safe Medicines (EAASM) and also the Alliance for Safe Online Pharmacy in the EU spoke to Pharmafocus to discuss one of its own innovative methods of educating the public – by creating a fake portal to an online pharmacy: “Our German educational website ran for nine weeks. It was the third most visited pharmacy website and when you clicked to purchase an item, you received a message informing the viewer that it was dangerous they were doing this. More recently, we have been running a similar educational campaign in Italy. Within the website the visitor can answer a short survey that asks important questions about their purchasing motivations. The positive news is that when asked if they would change their behaviour and revert to a more traditional way of obtaining their medicines, armed with the new knowledge about the dangers, 50% said that they would consider changing their behaviour and go to a local pharmacy. We are planning to extend this campaign to France, Germany, Spain and the UK using a Google AdWord campaign and thus make a big impact in raising public awareness about this important subject and change behaviours.”
More profit than the heroin and cocaine market combined
The EAASM German campaign received no less than 182,000 unique visits in the nine week period. The authors estimated that if just 20% of people had gone online and purchased medicines just three times, the website would have reaped sales of £35 million. As can be seen from this figure, the potential profit to be made by supplying unlicensed generics through unlicensed pharmacies is enormous. In fact, the figures are more than most would believe: the World Customs Organization estimated, in 2010, that the global market for fake drugs was worth $200 billion, which compares to the combined heroin and cocaine market worth of $160 billion.
Lynda Scammell, Senior Policy Advisor at the MHRA, highlights how seriously the threat to the public is taken: “The incidences involving counterfeit medicine entering the legitimate supply chain are mercifully rare – less than 20 incidents since 2004. There are strict legal controls over the sale, supply and manufacture of medicine and these apply online as well as offline. The Internet has opened up new ways of purchasing goods and this has extended to medicines. There are millions of websites offering to supply a wide range of medicines, but many sites do so with no medical oversight – no doctor, nor pharmacist. Not only are they breaking the law but medicines can be potent and require the oversight of a medical professional who will know what the best treatment for the public is and can monitor progress. Medicines can cure but can also cause harm – the message is be careful when shopping online.”
Isles stressed that, though the legitimate supply is tightly controlled, more can always be done: “I think that we would all agree that even one breach in the legitimate supply chain is one too many and, of course, it is always going to be very difficult to detect the actual number as criminals are not likely to tell us or leave easy-to-find evidence.”
The security of the legitimate supply chain is essential public’s perception of medicine. This is one of the major worries for the healthcare industry – if consumers no longer have confidence in the product, it will have a damaging impact on a huge scale. The opposite needs to be done on the supply of fake medicines – people need to rapidly lose trust in purchasing medicines from unknown, unlicensed online pharmacies.
Otherwise, the loss of faith in medicine, even if only in a small patient population, could have a serious impact on patients’ health. This is why the work being done from all quarters – those securing the supply chain, those educating the public about the risks of fake medicines, those combatting the production of unlicensed generics and those tackling unlicensed online pharmacies is so important. As more and more people become used to purchasing products online, it will mean that inevitably more people come into contact with these dangerous medicines. There have already been numerous cases in the US, in China and in other developed countries where individuals have used fake or dangerously-produced medicines have died as a result. Any action that could prevent these tragedies is essential and, after talking to those involved in the fight, there is a real belief that the tide is turning, as awareness begins to spread and as actions, such as the FMD, secure legitimate medicine on its route to the patient.