Fake formulations: How pharma is fighting counterfeit drugs
Lu Rahman looks at the anti-counterfeiting measures pharmaceutical companies are having to undertake to fight the rise of fake drugs.
The threat that counterfeit medicines pose to the global pharmaceutical sector is immense. From fake formulations to issues in the manufacturing process, some industry figures believe we could be looking at revenue losses up to as much as 27 billion euros in Europe alone.
Ensuring integrity of products can be a challenge for many pharmaceutical businesses. There are European and US regulations to adhere to as well as additional global regulations. Business models and supply chain operations can differ from one contract manufacturing organisation (CMO) to another, adding an extra layer of complexity to the issue of adherence. However, we know that supply chain security is crucial in the fight against fake products and protecting consumers and manufacturers.
From last year, the EU Falsified Medicines Directive (EU FMD) Safety Features Delegated Regulation, made the serialisation of licensed drugs in Europe a legal requirement.
According to the guidance from Gov.uk, these safety features are “a unique identifier (a 2D matrix code and human readable information) which will be placed on medical products that can be scanned at fixed points along the supply chain” and anti-tampering technology on the pack.
The unique identifier is a “a product code which allows the identification of at least the name of the medicine, the common name, the pharmaceutical form, the strength, the pack size, and the pack type; a serial number which is a numeric or alphanumeric sequence of a maximum of 20 characters randomly generated; a batch number and an expiry date”.
In The US, the Drug Supply Chain Security Act (DSCSA) had a compliance cut-off point in 2018. Despite Brexit, it looks as though FMD is here to stay, in the short term at least, so adherence is vital if you want to sell your products in Europe.
Implications for pharma manufacturing
These changes have had implications for pharmaceutical manufacturing - financial, as well as organisational. The two-part process of FMD for example, means that pharmaceutical companies must send serialisation data back to Europe via a barcode system as well as place a tamper-proof seal on every package. The impact of this on businesses has been immense, requiring a re-think of major elements within an organisation - financial, manufacturing operational, IT, regulatory, for example. The scale of data integration required should not be under-estimated either, particularly for those businesses where IT infrastructure has not been a key priority.
The benefit of partnership
The key to successful serialisation can often be found in partnership with a company that has industry expertise, longevity and drug serialisation expertise. Contract development & manufacturing organisations (CDMO) understand the challenges facing clients and have the knowledge to help them deal with the issues that come when working within global regulatory frameworks. CDMOs understand the need for supply chain transparency and how damaging fake goods are to the global pharmaceutical market.
When choosing a serialisation partner, it’s important that they understand your exact needs. It’s not a ‘one-size fits all’ approach that you want but a tailored solution that works well for your business and one which can accommodate changes to your global reach should that be required and understands European, US or other regional regulations.
It’s also a good idea to examine your potential partner’s approach and preparation. One of the requirements of the EU FMD is that serialisation data is submitted to the European Hub of European Medicines Verification Organisation (EMVO). How far down the line with that process are they and what expertise have they drawn upon to ensure complete success? We know that some companies are still in the pilot stage of submission to the EU Hub.
Compliance is a crucial aspect of the pharmaceutical supply chain. Choosing the right serialisation expertise and working with a valued and well-organised partner can make a huge difference to your overall experience.
The role of anti-counterfeiting technology
The International Hologram Manufacturers Association (IHMA), is a good source of expertise in this field and highlights an industry report that indicates continued growth for anti-counterfeiting packaging technologies.
According to the IHMA, the ‘Anti-counterfeiting, Authentication and Verification Technologies’ report signals the added expertise holography brings to the authentication of packaging products.
Coming at a time when international business is struggling with the impact of the coronavirus pandemic, the trade body says the report offers reassurance that the market for packaging authentication technologies will remain strong for the next few years.
The worldwide market for holograms is expected to grow by an estimated 27% over the next five years, at a time when the global anti-counterfeiting packaging market is expected to reach US$ 133720 million by the end of 2026.
Companies looking to protect their products against brand piracy and reduce the levels of counterfeiting are adopting advanced authentication and verification technologies.
And technological innovation within the anti-counterfeiting, authentication and verification technologies market is a major factor contributing to the growth of the market, says the IHMA.
Commenting on the report, IHMA chair Dr Paul Dunn stated as brand owners face a range of threats, suppliers are developing and adopting integrated platforms that allow brands to comprehensively address physical retail, supply-chain and online threats.
“Digital solutions are a clear and growing addition to authentication solutions, sometimes in isolation, but within the holographic industry it’s the combination with packaging track and trace systems among other solutions, that’s seen as the foreseeable future. In doing so, the opportunities for holograms to be at the forefront will drive sector growth.”