Brexit's Impact on UK Medicine Supply

What Changed

Regulatory Divergence

The UK's MHRA became fully independent from the European Medicines Agency (EMA) on 1 January 2021. This means:

• New medicines need separate UK approval (though the MHRA can use international reliance procedures)
• UK-specific packaging, leaflets, and batch testing are required
• Some smaller manufacturers have chosen not to seek separate UK authorisation, reducing the range of products available

Customs and Border Controls

Medicines crossing the UK-EU border now face customs declarations, regulatory checks, and potential delays. While pharmaceutical shipments are generally prioritised, the additional bureaucracy adds time and cost to the supply chain.

Northern Ireland Protocol

The unique position of Northern Ireland — effectively remaining within the EU's regulatory framework for medicines — has created complexity. Medicines supplied to NI must meet EU standards, while those for Great Britain follow MHRA rules. This dual regime increases costs for suppliers serving the entire UK.

Parallel Trade Disruption

Before Brexit, parallel traders would buy medicines cheaply in one EU country and sell them in another where prices were higher. This trade helped fill supply gaps. Post-Brexit, parallel trade between the UK and EU has largely ceased, removing one buffer against shortages.

Mitigating Actions

The UK government took several steps to prevent medicine supply disruption:

• Transitional provisions allowing EU-approved medicines to remain on UK market
• MHRA recognition routes for medicines already approved by EU, US, or other trusted regulators
• Investment in UK-based batch testing and quality assurance capacity
• Continued cooperation with EU on safety monitoring (pharmacovigilance)

Impact Assessment

Five years post-Brexit, the medicine supply impact has been:

• Less catastrophic than feared — Operation Yellowhammer preparations and transitional provisions prevented a cliff-edge
• More costly — additional regulatory and logistics costs are passed through the supply chain
• Reduced product range — some niche and specialist medicines are no longer available in the UK because manufacturers haven't sought separate MHRA approval
• Slower access to new medicines — some new treatments reach UK patients later than EU counterparts

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