Medicines are the most common medical intervention used across the UK and Europe. Unfortunately, falsified or fake medicines are entering global supply chains and have become a leading public health concern worldwide. It is, therefore, vital that there are systems in place to stop the manufacturing and trade of falsified medicines that may contain ingredients (including active ingredients) that are a non-pharmaceutical grade, at incorrect dosages or even contain no active substance. These counterfeit medicines are a leading threat to public health globally with seizures by authorities increasing substantially each year.
The UK is currently part of the Falsified Medicines Directive (FMD), an initiative to significantly reduce the exposure of patients/consumers to counterfeit medicines; however, with a no-deal Brexit becoming a real possibility, NHS patients could become more exposed to the potentially life-threatening dangers of fake medicines than their European counterparts.
How are patients currently protected in the EU?
On 1st July 2011, the EU adopted a new directive called the FMD whose aim is to significantly reduce the exposure of patients to counterfeit medicines. This pan-European directive introduced a range of safety measures to ensure that prescription medicines in the EU are genuine and that the buying and selling of these medicines are adequately controlled. The FMD provide coordinated, EU-wide measures based around 4 key pillars:
1 - Stricter regulations on the import of active substances
2 - Strengthened supply chain and regulations for wholesale distributors
3 - An EU-wide identifier to show legal online pharmacies
4 - Compulsory safety measures (i.e., unique identifiers and anti-tampering devices (ATD) on the outer packaging)
Introduction of additional safety features to the outer packaging of medicines is the biggest change within the FMD. This new directive came into effect on 9th February 2019 and requires that all bodies supplying medicines for human consumption include a unique two-dimension barcode, to verify and authenticate the product throughout the supply chain, and an ATD. Even though the new safety features are now a legal obligation throughout all EU/EAA states (except Greece and Italy), medicines without these safety features released prior to the 9th February can still be dispensed.
What happens in the event of a no-deal Brexit?
With billions of doses of medicines travelling through the EU, this new directive ensures that European patients will have the strongest protection from falsified medicines in the world. This world-first initiative will improve the security of the medicines supply chain across Europe, ensuring that patients can be confident that the medicines they are consuming are both authentic and safe. However, the MHRA indicated in December last year that in the case of a no-deal Brexit, the UK will no longer participate in the FMD. Additionally, the UK will no longer be able to access the EU’s central data hub preventing pharmacies from uploading, verifying, and decommissioning the unique identifiers of any type of medicine. Unanswered questions also remain regarding the UK’s continued access to European databases such as the clinical trials database and system that flags medicine safety warnings.
With the threat of a no-deal Brexit becoming ever more real, the UK may no longer be part of the safest medicines system in the world, leaving NHS patients more exposed to the dangers of fake medicines than their European counterparts. In case of a no-deal, an alternative ‘national system’ similar to the FMD will need to be developed to ensure the protection of the UK patient population. Without any system in place, falsified medicines could continue to flood the UK market and put patient safety at risk.
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