Over the past few years, I have attended several international conferences where Medicines Supply Chain professionals and officials from various governmental and intergovernmental agencies have gathered to exchange experiences and views on how best to safeguard society and their supply chains from the ravages of fake and substandard medicines.
Interestingly, I have noted on every occasion, the different interpretations (and subsequent disagreements) concerning the definitions used to describe this problem. My humble view is, this has not helped to align the different organisations tasked with resolving this growing problem. Surely, it shouldn’t be a stretch to collectively gain agreement on clearly defining and understanding the common problem that they are all trying to individually solve, and then craft a standard, ‘fit for purpose’ and joined up approach to resolving it – and to do so across the entire global supply chain? This lack of alignment continues to provide opportunities for bad actors to exploit the situation. The reality is, with all the available, tried and tested best practices, global standards and proven technologies, this relatively easily resolvable ‘manmade’ health challenge should not have been allowed to grow into the global health emergency that it is today.
At a personal level, if you find yourself having to take a medicine that has been prescribed for you by a trusted and qualified medical professional to prevent a disease, cure a malady or simply provide symptomatic relief, you might reasonably expect it to deliver the promised results. However, what happens if the product not only doesn’t work, but also causes an unexpected and adverse reaction? Well, your first thought might be that you have a natural intolerance to that recommended medicine, or perhaps you have a reaction from taking another medication at the same time, that could be contraindicated? You might be right, but it could also depend on where you are in the world when you take that medicine.
Unfortunately, in some places, particularly in Low to Middle Income Countries, it is more than likely that the medication might be ineffective or harmful because inappropriate levels of the correct active ingredients are present in the medicine, or even completely absent. Worse still, other ingredients may have been combined during manufacture to physically imitate the genuine medicine, which could be pharmacologically unrecognisable from the specification of the original, legitimate and approved medicine. In extreme cases these medicines could be lethal! It is this last scenario that causes an estimated one million deaths every year across the world. A figure that is growing.
Less lethal variants of these rogue medicines prolong diseases and can lead to an increase in morbidity and unnecessary suffering for the tens of millions of people who unwittingly consume them. Less obvious, is the emotional and economic impact on the families and businesses that depend on these recipients being able to rapidly return to health after taking a medication. Just to make things worse, these types of medicine have their highest prevalence amongst the poorest and most vulnerable people in society and are taken at a time when people are at their most fragile.
Fake medicines have reached such a level of sophistication that many are now almost indistinguishable from the authentic ones. An enormous amount of money is made against comparatively little investment by organised criminal networks to manufacture and distribute these medicines to the public. The criminals then have ‘peace of mind’, acting with relative impunity where protective legislation, effective enforcement and countermeasures are not sufficiently in place. In some parts of the world, fake and substandard versions of essential medicines generate more revenue for organised crime networks than the trade of illicit recreational drugs, prostitution and human trafficking. So not only are people suffering, but the criminals are reaping huge profits at their victims’ expense, whilst growing their nefarious networks.
Just to emphasise the point, if you take the definition of a crime against humanity as being ‘a deliberate act, typically as part of a systematic campaign, that causes human suffering and death on a large scale’ then we are into the ‘territory’ occupied by some criminal organisations that indiscriminately and knowingly peddle toxic and falsified medicines as part of a systematic and geographically extensive ‘business’ campaign to maximise profit at the expense of people’s health -and at worst their lives! Frankly, this is the scale of the problem and why it is important to know about fake and substandard medicines. It is also critical to collectively agree how to generally define these products so eclectic organisations responsible for their removal from the supply chain can implement a common and effective solution to finally do so.
Up to this point, I have used the term fake and substandard. In common parlance, medications that are pharmacologically different from the licensed ingredients’ specification of a genuinely approved medicine are termed substandard medicines. Whereas products that deliberately attempt to fraudulently impersonate a genuine medicine, but are not created by the legitimate manufacturer, or approved by the national medicine regulator or have a different (or even similar) unlicensed formula, are referred to as fake medicines.
With so many interpretations and synonyms for fake or even substandard it was recently deemed appropriate to try to simplify and standardise the terminology so that different organisations mandated to effectively remove these types of medicines, could apply the new terminology to get the desired results under national laws and their own organisational charters. A key aim here was simply to reduce any legal ‘loopholes’ that could be exploited by criminals leveraging poorly defined legal terms to describe these medicines. Today, governments introducing novel laws or iterative changes to existing legislation to mitigate the fake medicines problem, now have access to a standard terminology recognised and accepted by the global community to facilitate both national and transnational enforcement and prosecution.
The WHA (the governing body of the WHO) now uses the term falsified and not fake. The abbreviated definition being ‘falsified medical products deliberately and fraudulently misrepresent their identity, composition, or source.’
According to the WHA’s definition, ‘substandard medical products (also known as out-of-specification products) are authorised (normally by National Regulatory Authorities) but fail to meet their quality standards or specification.’
These new definitions focus solely on the public health implications of Substandard and Falsified (SF) products and do not cover the protection of intellectual property rights.
Additionally, in 2017, the WHA agreed to replace the terms ‘Substandard/Spurious/Falsely Labelled/Falsified/Counterfeit’ (SSFFC) with Substandard and Falsified (SF) products. This new terminology aims to establish a common understanding of what is meant by substandard for medical products and to facilitate a more thorough and accurate comparison for analysing data.
Further sub definitions of these illicit or rogue medicines focus on the legal status for the use of that drug within a country or any infringement of the intellectual property rights of their registered owners or creators.
‘Counterfeit Medicines are medicines that do not comply with intellectual property rights or infringe trademark law’.
'The "illegal diversion” of medicines is defined as the unlawful channelling of a regulated pharmaceutical from legal sources to the illicit marketplace'. For example, medicines may have been manufactured by the genuine (authentic) manufacturer in compliance with the regulations of the intended country of use and packaged accordingly. However, the packaging may later have been illegally changed by a third party and been sent (diverted) to a different country where perhaps regulations for the use of that dose and medication do not exist and are therefore non-compliant with that nation’s laws. Other scenarios include the repurposing of previously discarded and now recovered packaging of previously legitimate medicines to host medications sourced from a third country. There are also several other possible scenarios.
Perhaps a little confusingly, the term diverted medicine can also be used to describe a Prescription diversion, where prescriptions intended for one patient are falsely diverted to another.
It is encouraging that the SF term has now been clearly defined and generally accepted. A structured and common approach to understanding the size, nature and scope of problems created by SF medicines across different supply chains should now (arguably) move forward. This could help to act as a prelude to finally resolving the global SF dilemma, particularly for those organisations who previously relied heavily on amassing all available data around specific sub definitions of fake medicines as a prelude to addressing the problem.
So now we know why the use of a commonly accepted terminology is important. It can save lives by ensuring that the eclectic organisations charged with removing these substandard, falsified, diverted and counterfeit medicines can in principle now agree how to collectively move forward in implementing common solutions that are ‘joined up’ and enforceable under each appropriate organisation’s mandate, for each type of medicine without losing sight of the bigger fake medicines picture. We also know why addressing this problem now is so critical, since the scale, sophistication, geographical diversity and variety of affected categories of medicine are all increasing at the expense of patient health and economic growth whilst criminality continues to flourish.
In an ideal world, all the neutral, trusted, respected and empowered organisations responsible for national and transnational medicines safety, would adopt a common, proven, best practice and global standards-based approach to resolving this totally ‘man-made’ health problem.
Such a global approach coupled with a trusted, secure and interoperable global system that could act as a baseline for all countries but be flexible enough to respect appropriate and individual sovereign laws (and standards), would in my humble view, be the most effective solution for all Medicines Supply Chain Stakeholders everywhere, from the creators of any genuine medicine through to the people they ultimately serve.
1. The Size and Scope of the SF Problem:After recently and personally contacting a broad range of intergovernmental and academic institutions to try to quantify the scale of the SF medicines problem at both a global and country level, it became clear that there is no commonly accepted and ‘up-to-date’ estimation of the size of the SF problem. Interestingly, pre-pandemic estimations vary significantly between researchers, speakers and authors from $10Bn-$30Bn at the low end to $200Bn-$400Bn+ at the higher end. Perhaps the more widely quoted figure of $200Bn is a more indicative figure. More importantly, there is a consensus that post pandemic, the number of SF medicines in circulation are significantly increasing across the world.
‘The elephant is clearly in the room’; it just can’t be accurately measured at present. This should not preclude responsible organisations from acting now to reduce and prevent the spread of SF medicines both nationally and internationally. Instead, it should be a rallying call for all affected and invested Supply Chain Stakeholders to step up their proactive SF prevention activities and to do so at pace.
2. Declared Interests: The company that I represent is Solidsoft Reply which is the de facto global leader in providing National and Supra-National Medicines Verification and Traceability Solutions that protect patients and medicines supply chains across the European Union and Low-to-Middle Income Countries from SF medicines. We are fully committed to fighting the current global pandemic of fake medicines and saving lives using global standards, best practices, and the development of ‘fit for purpose’ technologies and experience-driven services. Visit Solidsoft Reply.