Not long ago it was considered one of the most significant risks to the medicines supply chain. MHRA led the way in Europe and in 2007 produced an anti counterfeiting strategy paper and held regular workshops with law enforcement and pharma industry participation to create a Falsified Medicines watch list and shared intelligence.
With the development of the Falsified Medicines Directive and the adoption in 2019 of the system of verification and decommissioning the threat of falsified medicines was considered minimal. As a consequence most of the earlier MHRA proactive activity ceased.
Now with no GB verification / decommissioning FMD system and the NI participation in EU FMD due to end at the end of 2024, what does the future look like?
Realistically there is no likelihood of a replacement UK wide system in the next 5 years. The UK will be one of the few developed economies without a system to identify individual medicines packs as genuine.
So how concerned should we be about the risks of falsified medicines infiltrating the UK supply chain?
As could be expected the highest risk of falsified products remains in supplies from rogue pharmacies and in the illicit market. A typical example being seen recently prosecuted by the Police with help from Pfizer.
Products prepared in these illicit labs tend to be unsophisticated copies and would not be intended to be passed off as genuine medicines and should not pose a threat to UK patients collecting their prescriptions.
What sort of products are being falsified that the legitimate supply chain should be concerned with?
As a reminder the UK/EU definition of a falsified medicine is:
Any medicinal product with a false representation of:
(a) its identity, including its packaging and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;
(b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or
(c) its history, including the records and documents relating to the distribution channels used.
The targeting of life saving medicines that falls in the (a) and (b) definition of a falsified product is the worst case scenario. Fortunately there have been no recent cases where there is any evidence of this type of product getting to UK patients through the supply chain.
However, being aware of what is in the market remains important. An alert issued in April from WHO on falsified Defitelio, a product used to treat severe veno-occlusive disease in adult and paediatric patients undergoing haematopoietic stem cell transplantation. The falsified product was presented in UK/Ireland packaging and found in the UAE. As can be seen in the photos it looks like a genuine product on first view and includes a 2D Unique identifier.
What we have seen in the UK are multiple incidents that meet the definition (c) that relates to the history of a product, where genuine product has been stolen and reintroduced to the supply chain and on to patients. Examples from the last few years include medicines stolen in Italy and supplied through the UK . Medicines stolen from the UK supply chain have also been reintroduced to the UK wholesale chain. Stolen products being stored and transported inappropriately prior to being reintroduced to the supply chain does present a real hazard to patients.
What can be seen from the lists of stolen products are that they are wide ranging, from high value oncology products to fast moving lower value in demand products such as inhalers.
Is the UK supply chain secure?
The first line of defence for the supply chain remains the robust qualification of suppliers by wholesalers. Unfortunately the weak link will always be the human factor. Falsified medicines will enter the supply chain as some companies will, through greed or incompetence fail to qualify their suppliers and put patients at risk.
The additional batch checking required for imports from the EU by the Responsible Person for import does add an additional layer of protection for products used in the parallel import market.
Reverting to the EU FMD system isn’t a panacea here. It is weak when it comes to stolen medicines as it is unlikely that a pack's unique identifier is recorded and can be linked to a stolen shipment. When a pack is verified later on it shows that the identity is correct.
MHRA will react to any intelligence and rapidly trace supply chains of any suspected products, but of course by this point a falsified pack could be with a patient.
My view is that it’s inevitable that further cases of falsification in the UK will occur.
What lessons have been learnt?
One thing that stands out is that Brexit has changed the UK dynamic for falsified products.
There was a direct flow of stolen high value medicines like Stelara, Tysabri and Privigen to EU wholesalers. Now that parallel exports to the EU have stopped, this trade should end also.
What is left is the supply of the in demand lower value medicines. The supply of a stolen quantity of Symbicort or Seritide Evohaler is more challenging to spot as these sorts of products are regularly traded in volume and supplied across multiple wholesalers prior to reaching a pharmacy.
What additional steps could wholesalers take to protect the supply chain?
Many companies SOPs in relation to falsification focus on looking at packaging and identifying changes. MHRA published a blog in 2019 on preventing falsified medicines that provides guidance that continues to be true in relation to checks by goods in staff and due diligence that companies should adopt.
Consider audits of suppliers and look in detail at their supplier qualification and due diligence processes. Many companies send out questionnaires to suppliers, but these rarely ask challenging questions beyond 'do you have an SOP for qualifying suppliers?'
Asking about how new suppliers are approved or rejected, how are deviations relating to suppliers are investigated by the RP, how many active suppliers do they have, how frequently are the reviewed, have any suppliers been removed - all questions that could be asked to provide additional reassurance.
If you are a wholesaler that buys medicines not from the MAH or via the reduced wholesaler model, then consider asking for the pedigree of the product. This for me is the next step that should be taken by some companies. Asking suppliers to provide redacted evidence the products were originally obtained from an MAH or similar that accompanies sales up the supply chain is good evidence the product is genuine. Probably not for every transaction but for new suppliers or periodically as part of due diligence.
None of these steps are easy, but the costs for the companies that have to manage the fallout of buying falsified products and repairing their reputation with customers is a high one.
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