As well as claiming the lives of many people around the world, the Covid-19 pandemic that has gripped us for more than 18 months has instilled a tremendous amount of fear into the public.

While the health, social and economic consequences have indeed been dire, human ingenuity fast-tracked the development of vaccinations and treatments, which have prevented many more lives from being lost. It triggered the start of a recovery, and helped to allay much of the fear held within societies and communities. However, the crisis has also shone a spotlight on another dangerous side effect – fake medicine.

“It is a very serious threat,” outlined Gianluca Esposito, head of the Council of Europe’s Action Against Crime Department, in an interview on the Council of Europe’s website.

“It is already a serious threat in normal times. Covid has exacerbated that threat and the risk for individuals is very high… There is [a] large circulation of everything from fake masks to kits to miracle cures.

“These things, at the very least, are misleading. They provide you with misleading information. At worst, they can actually be extremely detrimental to your life and to your health. This is a very serious threat to public health, and this is something governments should take very seriously.”

Fake news

This is a view reflected by global pharmaceutical giant Novartis, which is taking steps to counter the counterfeiting problem.

Daniel Fritz, a supply chain technology architect at the company, spoke about the challenge, and how Novartis, along with several other major players, is coming together to find solutions.

“With the advent of novel medicines, it was unfortunately predictable that fake medicines would become an issue for patients, health authorities and governments across the globe,” he says.

“However, even prior to Covid-19, the issue with fake medicines and the devastating impact that this has on the quality of care that patients receive, and the detrimental impact – mental and financial – that this has on patients’ families, was and still is a major issue across many markets.”

Creating easily identifiable layers of authenticity within packaging could hold the key to fighting back against medicrime of this nature. Packaging includes what consumers see, open and read (often in the form of small paper leaflets) before taking the medicine inside. It is this process that confirms to them whether the product is authentic, and many may not even contemplate that what they have just acquired is fake.

Novartis is working closely with other pharmaceutical companies and public partners as part of the PharmaLedger consortium. Sponsored by the Innovative Medicines Initiative (IMI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) under the Horizon 2020 programme, it seeks to build a trusted patient-centric platform where the patient is empowered to manage and retrieve trusted information pertaining to their healthcare needs.

In total there are 29 partners, including 12 major pharma companies, with the aim to accelerate blockchain solution adoption in the industry for the benefit of patients.

Fritz takes us back to the beginning with perhaps the most critical component of pharma packaging – the leaflet. “In order to achieve this ambitious goal, it was necessary to select a starting point and a use case in order to show what was possible.”

That starting point was the ‘simple’ leaflet that is included in every pack of medicine. This ‘simple’ leaflet is actually not so simple, as it turns out. It contains valuable information for the patient on how to take the medicine, potential side effects – public information that is available from many sources, some legitimate (health authority websites for example) and, unfortunately, some illegitimate. “The answer to this,” reassures Fritz, “is the barcode and the anti-counterfeiting technologies – overt and covert – that are built into most pharmaceutical products.”

The concept of electronic leaflets is not new, and there are solutions whereby a barcode on the packaging of pharma products provides the leaflet upon scanning.

However, that system is still open to abuse. The majority of existing solutions can and unfortunately are often used to essentially legitimise fake medicines – the barcode on a fake pack of medicine directs the user to a legitimate source of information, thereby giving the patient the impression that the pack of medicine is genuine.

Data, according to Fritz, is the answer. Novartis and the PharmaLedger team have been working on a solution that uses the available data in the barcode to perform checks on the authenticity of the pack it is attached to. Thanks to serialisation techniques, packs of medicine are given a unique serial number, often presented on packaging in the form of a QR-style code.

“So, what makes this barcode so special?” Fritz asks. “Actually, the barcode itself is not special – what is special is the data that it contains. The barcode has the GTIN [the global trade item number] – the product, basically – the batch number, the expiry date and also a serial number.

“Using this data, the PharmaLedger ePI solution is able to determine if the manufacturer produced this pack of medicine and then, based on the outcome of these checks, the patient could be provided with an electronic leaflet or perhaps a message or warning about the pack’s provenance.

“The question often asked is if this code could be copied and then put on to different packs. The answer is yes, it could be copied – however, that is where the overt and covert anti-counterfeiting technologies come into play.”

In order for the solution to work as effectively as possible, all pharma packaging needs to become serialised. In many markets, barcodes just contain the GTIN, batch number and expiry date, meaning there are limited numbers of checks that can be performed in order to evaluate if the pack is genuine or fraudulent.

Patient-centric packaging

Standardising barcodes on packaging is a central part of the Novartis and the PharmaLedger consortium’s remit, with patient centricity as a guiding principle. They realise that creating individual apps to scan barcodes on packaging produced by different pharma manufacturers is unviable, as it would limit the effectiveness and reach of the solution that requires as wide an uptake as possible to stamp out fake medicines. As a result, the PharmaLedger solution being developed allows the same app to scan products from competing pharmaceutical companies, presenting information in a consistent and user-friendly way. And beyond aiding the authentication process, the PharmaLedger ePI solution and associated universal app carry a number of additional benefits. Firstly, recalls can be managed at a batch or serial number level, operating in conjunction with existing recall procedures. Secondly, batch specific leaflets can be created and updated – for example, when an excipient changes. Third, it opens the possibility of extending shelf life through dynamic expiry date management. This is especially the case with new products – the more stability data that is forthcoming, the more possible it becomes to extend expiry dates on products.

Collaboration is critical

This is all enabled by blockchain technology, what Fritz describes as a ‘team sport’. “In order to achieve the very ambitious goal that we have set, then internal company politics and inter-company politics cannot be allowed to come into play,” he explains. “Novartis SMEs are working in collaboration with public and private industry partners as part of the PharmaLedger consortium in order to achieve this goal.

“Within Novartis, the SMEs come from various internal functions such as supply chain, IT, engineering, quality, compliance, regulatory, legal and communications.

“With such a diverse range of SMEs, it is important that everyone takes responsibility and ownership for their part of the puzzle. Ultimately, we need to find solutions to each of the problems, not just problems to each of the solutions.”

And there is still a long way to go until PharmaLedger achieves its ambitious goal. Several challenges will need to be overcome, such as technology adoption and how to reach those who do not have a smartphone or reliable internet connection. However, the greatest set of challenges will centre around shifting mindsets towards digital.

“The existing procedures and processes have been embedded in the pharmaceutical sector for many years, and they are there to protect the patient,” Fritz says. “These procedures and processes need to remain, but we need to bring them into the digital era while still maintaining the protections that they bring for the patient.

“It is incumbent upon us all to eradicate fake medicines from the supply chain for all markets, and to empower consumers with patient-centric solutions that meet their needs, and not just the needs of the pharmaceutical companies, health authorities and governments.”

Focus on vaccines

As well as exacerbating the problem of counterfeit medicine, the Covid-19 pandemic triggered a huge and rapid vaccination roll-out that forced packaging companies to respond in kind.

The scale and speed of distribution is unprecedented, and the variety of vaccines produced created a complex spectrum of transport, storage and distribution requirements, which at the extreme end involves temperatures as low as −80°.

Packaging companies responded equally fast to these changing dynamics. For example, many companies created tailor-made corrugated trays with inserts and buffers to keep vials secure during transport and handling.

There is also a role for packaging to play in terms of counterfeiting and tampering – it must be easy to use for medical staff, who rely on anti-counterfeit features to help identify potentially fake or tampered vaccines.

About PharmaLedger

Spanning 36 months, PharmaLedger has the following stated objective: “The goal of the project is to provide a widely trusted platform that supports the design and adoption of blockchain-enabled healthcare solutions while accelerating delivery of innovation that benefits the entire ecosystem, from manufacturers to patients.”

The programme started in January 2020, before the Covid-19 crises gripped much of the world, and is being conducted in three main stages:

  • Year one: Design and foundations
  • Year two: Development and deployment
  • Year three: Validation and sustainability.

It is expected that the project will conclude by December 2022.