26-27 - COUNTERFEIT DRUGS - The battle against counterfeit drugs

PME: What’s behind the rise in drug counterfeiting?
Remi Turbet Delof (RTD): The recent surge, particularly with medications like Ozempic, can be attributed to several factors:

High demand and shortages: Ozempic (semaglutide), a powerful medication from Novo Nordisk used to treat type 2 diabetes, has been a game changer for patients. Intended initially to manage diabetes, semaglutide has garnered massive popularity for its ability to promote quick weight loss in patients. This popularity has sometimes led to shortages, creating an opportunity for counterfeiters to introduce fake products into the market.

Profitability: counterfeit drugs are lucrative for criminals due to the high cost of genuine medications, with substantial profit margins incentivising the production and distribution of counterfeit versions.

Online sales and distribution: the growth of online pharmacies and marketplaces has made it easier for counterfeit drugs to reach consumers, with the anonymity and vast reach of the internet facilitating the sale of fake medications to unsuspecting patients.

Complex supply chains: the global pharmaceutical supply chain’s complexity can make it challenging to track and verify the authenticity of drugs and counterfeiters exploit these vulnerabilities to infiltrate the market.

Lack of awareness: patients may not always be aware of the risks associated with purchasing medications from unofficial sources, making them vulnerable to counterfeit products.

The case of counterfeit Ozempic in Europe, where fake versions contained insulin instead of the active ingredient semaglutide, underscores the dangers presented by counterfeit drugs.

Not only do they pose serious health risks to patients, but they also cause financial losses for manufacturers and damage brand credibility. Combatting this issue requires a concerted effort from pharmaceutical companies, regulators, healthcare providers (HCPs) and patients to ensure the integrity of the drug supply chain and protect public health.

PME: How can patients avoid inadvertently using counterfeit drugs?
RTD: Patients need to be proactive in recognising and reporting any difference in their medicines. Healthcare professionals also need to educate patients about the differences between genuine and counterfeit drugs. Patients should only buy medications from trusted sources, use caution with any online pharmacies, and inspect the labels and leaflets of their prescriptions for any evidence of tampering.

PME: What is currently being done to combat counterfeit drug production?
RTD: This can being addressed in a number of ways:
Strengthened serialisation: in addition to serialisation, augmenting with product authentication technologies provides an additional layer of protection through non-replicable covert and overt technologies for unique identification at the item level.

Aggregation: this can provide an additional check on intrusions in the supply chain, such as counterfeiting or grey markets. Aggregation relationships between parents and children can be compared to the data recorded during the original packaging of the product. Where these relationships differ, it is an alert that the shipment has been tampered with, and corrective action must be initiated.

Change management: recognise that anti-counterfeiting and anti-diversion require a programmatic approach, not just technology deployment through aligning strategy, technology, organisation, training and resources, while forensics can utilise extensive data to investigate and address supply chain threats.

Collaborative efforts: as counterfeit drugs transcend borders, global cooperation is essential to tackle this issue effectively. Pharmaceutical companies, distributors and regulators must collaborate, sharing data on suspicious products and counterfeit trends to bolster detection. Collaborating with companies that are fighting counterfeits in other sectors and leveraging their learnings can also be beneficial.

Public awareness: educating patients will empower them to recognise signs of counterfeits and will encourage them to verify products before use, while reporting mechanisms establishes user-friendly channels for reporting suspected counterfeit drugs. 

PME: What is the role of artificial intelligence and machine learning in tackling counterfeit drug production?
RTD: They both have a significant role to play. Modern solutions encompass a range of technologies designed to ensure the authenticity of pharmaceutical products from production to point of sale, providing intelligent guidance for users during the authentication process.

Serialisation: this process involves assigning unique identifiers to each product unit, facilitating real-time tracking and monitoring across the supply chain. Such granularity makes it difficult for counterfeit or diverted products to blend in unnoticed.

Track and trace: advanced tracking systems enable manufacturers to monitor their products’ journey through the supply chain. This oversight is essential for pinpointing and mitigating instances of diversion or unauthorised distribution.

Digital product authentication: by leveraging existing 1D and 2D barcodes and packaging, modern digital authentication technologies offer a non-replicable, non-additive solution for verifying product authenticity. Utilising an easy-to-use smartphone application, brands and their trading partners can instantly verify product authenticity anywhere in the supply chain, providing an additional layer of security against counterfeiting.

Implementing these technologies is a proactive step towards securing the pharmaceutical supply chain, ensuring that medications reaching patients are safe and effective. The authenticity of medicinal products is paramount and these modern solutions play a pivotal role in maintaining product integrity and protecting public health.

PME: Why is it so important to prioritise sustainability across the pharmaceutical supply chain?
RTD: In today’s global marketplace, sustainability isn’t just a buzzword – it’s a strategic imperative. In the pharmaceutical sector, sustainability extends across the entire life cycle of pharmaceutical products, from research and development to disposal. The goal is to make medicines accessible, affordable and sustainable for everyone.

Consumers, regulatory bodies and stakeholders are increasingly scrutinising the environmental impact of businesses. Key environmental challenges for pharmaceutical companies include high energy consumption, global supply chains, pollution related to pharmaceutical production and packaging waste. By adjusting production processes and supply chains, managing resources such as water, energy and raw materials more efficiently, and deploying circular economy principles, pharmaceutical companies can not only benefit the environment but also enhance their own overall value.

Sustainability also speaks to access to medicines and product quality, ensuring that brands have tools in place to combat counterfeiting and harmful products. Leveraging technology for transparent supply chains enhances traceability and accountability.

PME: How is the industry meeting the demand for transparency across the supply chain?
RTD: Advanced technologies now offer end-to-end visibility, enabling precise tracking and tracing of products. Good manufacturing processes and smart packaging, eg, replacement of physical anti-tamper packaging with digital technologies, minimises waste and inefficiencies. Automation via Industry 4.0 helps to reduce the carbon footprint and companies are increasingly choosing to work with suppliers that prioritise sustainability and are reducing their carbon footprint.

These solutions also play a crucial role in navigating complex regulatory landscapes, ensuring businesses comply with environmental standards and avoid penalties. In an era where consumer trust is paramount, real-time tracking capabilities are vital in verifying product authenticity and origins, thus fostering consumer confidence and loyalty.

PME: What are some of the most significant challenges in ensuring sustainability across the supply chain?
RTD: There are several challenges, including cost, resources, standards and buy-in from the entire ecosystem. One significant challenge is navigating complex regulatory environments and ensuring that supply chain operations comply with environmental standards. Staying ahead of regulatory changes is crucial for avoiding penalties and maintaining a positive corporate image.

PME: How have evolving governmental regulations raised the standards for sustainability across the supply chain?
RTD: Regulations like the EU FMD and the DSCSA in the US were put in place to protect patients from harmful or suspect products and now companies are taking a step beyond compliance to ensure they have ways to monitor counterfeiting and diversion activity.