Blocking the Threat of Counterfeit Medicines

Counterfeit pharmaceutical products are a global issue that has a significant financial impact and, more worryingly, poses potential dangers to patients’ health. “The topic of counterfeit medicines has been a concern for a number of decades, and it affects the Western nations as well as emerging markets,” explains Raja Sharif, CEO and founder of FarmaTrust—a provider of blockchain and artificial intelligence (AI) provenance systems for the pharmaceutical and healthcare sectors.

There is a general belief that counterfeit medicines is a low- and middle-income country issue rather than one that affects Europe and the United States, but if you look over the past five to 10 years, it becomes apparent that there are a lot of counterfeit medicines in Europe, and the issue is getting worse, Sharif continues. In fact, it is estimated by the European Union Intellectual Property Office (EUIPO) that nearly €10 billion of direct sales, within the pharmaceutical sector, are lost through counterfeiting per year (1).

Additionally, there is an increasing prevalence of purchasing medicines online, which is exacerbating the problem of counterfeit medicines. “Absolutely, there has been a trend for online purchases, a trend that was even recognized a number of years ago by Amazon who purchased an online pharmacy, PillPack,” notes Sharif. “But, irrespective of this trend, it mustn’t be underestimated that counterfeit drugs can be infiltrated into the national supply chains.”

Even looking at recent prosecutions by the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom, it is clear to see that counterfeiters are using pill presses bought from China to make and distribute counterfeit medicines in the UK, Sharif underscores. “So, it is not just an online problem; although, online sales are of course much easier and the issue is getting worse, there are also cases of counterfeit medicines being purchased within UK pharmacies as well,” he says.

Legislation to tackle the issue

To tackle the issue of counterfeit medicines within the European Union (EU), a directive was formulated and published setting out various safety features that must be included on pharmaceutical packaging to assure product authenticity (2). “The issue of counterfeit medicines was obviously in discussion for a long time and resulted in what we now call the Falsified Medicines Directive [FMD] regulations in Europe,” confirms Sharif. “Essentially, what this directive allows you to do is to ensure that each packet of medicines is uniquely labelled, and then you scan the labels, which tell you whether there’s a duplicate or whether the product is actually genuine.”

In the United States, anti-counterfeiting measures have been enacted through the Drug Supply Chain Security Act (DSCSA) (3). “Both the EU and US systems generally require unique labelling, which is usually achieved by two-dimensional dot matrix codes,” says Sharif. “Some countries are using Quick Response codes these days as well as tamper-proof packaging, but legislations tend to require the matrix codes as a minimum.”

The main difference between the EU FMD and the DSCSA regulations is that in Europe, the labels are issued on the drug packaging line and then scanning of the unique identifier only happens when the product is scanned out of the pharmacy or hospital, explains Sharif. “Whereas the DSCSA regulations require data collection at each transfer of the chain of custody (i.e., when one company transfers the product to another or one person gives it to another person),” he states.

As there is not a requirement for tracing each step of the product’s transition in Europe, there is a danger that counterfeit products can infiltrate the supply chain. It’s a race to the end, notes Sharif, if a counterfeit product with a duplicate unique label gets scanned first before the authentic product, it will be accepted to the pharmacy or hospital, he asserts.

Through working with the US Food and Drug Administration on blockchain pilots, Sharif reveals that it became apparent that if a product is tracked at each transfer of the chain of custody, not only is it possible to more easily prevent counterfeit medicines entering the supply but the process is more data-rich overall. “So, for data analytics purposes and efficiency gains, the DSCSA regulations are much better,” he adds.

UK at risk?

However, for the UK, which fully exited the EU on 1 Jan. 2021, the EU FMD legislation is no longer applicable. “The Brexit situation means that the UK has actually pulled out of the FMD process,” adds Sharif. As a result of the UK no longer being covered by the European legislation, the country is now exposed as there is no longer the ability to verify the unique labels within the central European verification system, he emphasizes.

At the time of writing, a bill concerning UK medicines regulations has gained Royal Assent (the final stage of bill passage in the UK)—the Medicines and Medical Devices Act 2021 (4). This bill is aimed at ways to make the UK more attractive in terms of innovative new solutions and technologies being approved, and it covers not just medicines and medical devices, but other aspects, such as clinical trials, states Sharif.

Sharif believes that a system akin to the US DSCSA would be most beneficial for the UK, to keep up its competitive landscape in terms of pharmaceutical anti-counterfeiting measures. “This route is potentially interesting given the fact that the UK’s regulator, MHRA, has been working closely with FDA and the Australian regulator post-Brexit,” he says.

Much of the work that will be implemented into amendments to regulations and anti-counterfeiting measures in pharmaceuticals is expected to be delegated powers given to the parliamentary ministers, Sharif anticipates. For application, however, Sharif recommends tracking each transfer of custody and even the condition of the medicines as well, as that level of information will give a high level of patient safety.

Additionally, with such a data-rich approach, it is possible to improve demand planning and prevent medicine wastage, Sharif stresses. “For example, there are a lot of medicines that are wasted each year,” he says. “So, if you have a much more efficient ordering process, demand process, and planning process, the National Health Service can be saved billions of pounds, which can be spent on other vital areas.”

Blockchain benefits

A compulsory infrastructure technology should be implemented for anti-counterfeiting measures, in Sharif’s opinion. “One of the areas blockchain is particularly useful is to ensure the immutability and incorruptibility of data,” he says. “So, that means once a record is written, it cannot be changed. The record can be updated, of course, but the information on who updated it, when it was updated, and what the update was itself, will be available.”

Another aspect of blockchain that lends itself to anti-counterfeiting applications is the fact that it is very good at breaking down data silos, Sharif continues. “In a multi-stakeholder environment, such as track-and-trace solutions, you need to be able to allow different companies using different systems to be able to communicate with each other,” he says. “Blockchain is a very good interoperable, technology-neutral kind of solution, and so I would advocate using blockchain.”

In terms of any potential future anti-counterfeiting challenges, such as stricter requirements, blockchain is considered to be ‘future proof’. When looking at tools such as artificial intelligence or machine learning, Sharif highlights that there are potential limitations in terms of data corruptibility. As the solutions are only as good as the data that are input into them, should the data become corrupted then the results being obtained will be bad, Sharif confirms. Whereas, with blockchain solutions, data integrity is assured. Furthermore, blockchain platforms consume less energy than other technologies and will be required for automated processes, such as ordering and supply chain tracking.

A good example of how blockchain can aid with assurances of data integrity, particularly in the landscape of clinical trials, would be to take the recent approvals of COVID-19 vaccines, Sharif notes. MHRA was the first to approve a vaccine, as a result of the innovative way it considered data—assessing the clinical trial results in a rolling review capacity. “Imagine if MHRA could review the data digitally from a data platform with the assurance that the data hadn’t been altered, that would really revolutionize the way clinical trials are performed and data are approved by regulators,” Sharif summarizes.

References

1. EUIPO, 2019 Status Report on IPR Infringement (Alicante, Spain, June 2019).
2. EMA, “Falsified Medicines: Overview,” ema.europa.eu [Accessed 16 March 2021].
3. FDA, “Drug Supply Chain Security Act (DSCSA),” fda.gov [Accessed 16 March 2021].
4. UK Parliament, “Medicines and Medical Devices Act 2021,” bills.parliament.uk, Last Updated 4 March 2021.

About the Author

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

Article Details

Pharmaceutical Technology Europe
Vol. 33, No. 4
April 2021
Pages: 43–44

Citation

When referring to this article, please cite it as F. Thomas, “Blocking the Threat of Counterfeit Medicines,” Pharmaceutical Technology Europe 33 (4) 2021.