Brexit's trick or treat on patient safety

Despite a delayed Brexit, unpredictability adds further complications to the EU FMD regulation.

After months of operational upheaval in preparation for the EU Falsified Medicines Directive (FMD) enforcement date, pharmaceutical companies are now faced with the huge amount of uncertainty that still surrounds Brexit and the impact it could have on the new regulations.

The sector has been given limited guidance with regards to the UK’s exit from the European Union (EU), meaning pharmaceutical manufacturers have to put contingency plans in place to cover the worst-case scenario.

So, what could Brexit mean for the pharma industry and the safeguarding of patients and medicines? In this Q&A, Staffan Widengren, Director of Corporate Projects at Recipharm discusses what Brexit could mean for EU FMD and the steps companies can take to limit the impact on their wider operations.

How will Brexit affect the FMD regulation?

Widengren: Until 31 October 2019, the new date for the UK’s departure from the EU, British pharmaceutical manufacturers are legally required to comply with the EU FMD legislation. Many CDMOs failed to reach compliance for the 9 February regulatory deadline, meaning they had to stockpile medicines manufactured before this date and are still working to put the required measures in place to deliver serialised products.

Post-Brexit unpredictability adds further complications to this matter. Ideally, following the UK’s exit from the EU, regulatory bodies will continue to work together to ensure a complementary system to the EU FMD is in place in the UK. However, whether this will be achieved, and how quickly this will take effect, remains to be seen.

In conjunction with this, the European Medicines Agency (EMA) and European Commission (EC) have notified the pharmaceutical industry that they will need to adapt processes and cater for the changes to marketing authorisations to ensure validity when the UK leaves the EU. As such, by the end of 2019, any medicinal products intended for the EU market will be required to undergo additional batch testing after being released from the UK to ensure they comply with EU regulations.

The NHS also recently issued a letter to UK pharmacies stating that EU FMD compliance is not necessary until there has been more information and guidance around Brexit, which contradicts the guidance provided by the Medicines and Healthcare Regulations Agency (MHRA) and EMA for pharmaceutical manufacturers.

What are the implications of Brexit uncertainty on patient safety?

Widengren: Without clear guidance on the UK’s intentions, patient safety and the continuity of drug supply are at risk. Pharmaceutical companies are still unsure about how the EU FMD will be managed in the UK following its exit from the EU. Will the UK adopt its own separate system? Will the UK’s supply chain be as stable and secure as Europe’s? The sooner the British government and MHRA shed light on post-Brexit plans the sooner companies will be able to start putting the necessary measures in place to ensure they continue to prevent falsified drugs being released to the market and reaching patients.

What are pharmaceutical companies doing to minimise the impact of Brexit on operations?

Widengren: UK-based pharmaceutical firms have predominantly chosen to implement contingency plans that cater for a ‘no-deal Brexit’ so that they can continue to operate within the EU market, regardless of the outcome.

At Recipharm we implemented a 3-year programme that enables us to successfully supply serialised products to Europe in line with the EU FMD regulations. We will continue to handle all products under EU legislation requirements by reporting serial numbers to the EU hub and national systems until such a time when the MHRA offers clarity on any alternative requirements.

Speaking more broadly, we also set up a Brexit taskforce, which assumed responsibility for minimising the potential impact of the UK’s exit from the EU on our operations. Recipharm will be able to adequately cater for any additional testing and batch release requirements, in turn minimising the potential for drug shortages. Marketing authorisation holders (MAH) supplying to EU countries were told that they could carry out quality control testing in the UK if an exemption submission was made no later than 29 March 2019 enforcement date, meaning that medicinal products would not need to be retested in the EU until the end of 2019. However, the UK parliament recently voted to further delay the departure from the EU until Thursday 31 October.

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