Rich Quelch, global head of marketing, Origin, looks at how Brexit will affect regulatory bodies in the UK and how this impacts pharmaceutical packagers.
Brexit
Like every industry, the pharma sector is poised on the edge of its seat in anticipation of a final agreement on Brexit.
The UK will officially leave the European Union on March 29th (if all goes to plan) and the terms of the exit will dictate how British pharma firms can trade with and market their products to Member States and the rest of the world.
Marketing authorisation for products in the EU is currently governed by the European Medicines Agency (EMA), based in London. The immediate consequence of Brexit is that the EMA will relocate to the Netherlands, with the likelihood of losing key members of staff and adding complexities when it comes to remits and responsibilities.
The EMA is currently working on the eventuality of a no-deal Brexit, which would leave the UK classed a ‘third country’, meaning they’ll no longer be able to engage as a ‘co-rapporteur’ in the marketing authorisation process of products in the EU.
The UK currently contributes heavily to the regulation of EU medicine approval - used as a reference Member State in 45% of decentralised EU medicine approvals – so, Brexit will see the supply chain impacted. Plus, the UK exports a significant amount of products to the EU, and a no-deal eventuality would impact the £11.9 billion of medicinal exports and put the EU market under strain.
A no-deal agreement would also see the responsibility for human medication marketing in the UK fall on the Medicines and Healthcare Products Regulatory Agency (MHRA). It would require new laws and systems for packaging, labelling and patient information leaflets to ensure high standards and safety, putting stress on regulatory bodies to ensure they’re prepared.
The problem is, the MHRA approval process is largely industry-funded and would struggle to sustain itself on only the fees paid for the review of medicine in the UK. It could see the number of authorisations granted drop, unless funding could be secured from the health budget or public funding.
It will, however, provide a platform for the MHRA to establish itself as a global leader in medicine regulation, including marketing authorisation and packaging. The MHRA already contributes heavily to the EU workload and will look to grow its authority as it undertakes greater responsibility in the case of a no deal Brexit, where the UK looks to begin trading in new markets.
Alone, the UK is a much less appealing market though, representing just 3% of the global pharmaceutical market compared with the EU’s 22%. As the UK looks to expand its trading opportunities it may struggle, with attractive countries like USA, China and Russia signing mutual recognition agreements with the EU.
The UK government is preparing for future customs arrangements with the EU, hoping to minimise disruption post-Brexit. However, Brexit will inevitably add costs which could cause businesses to move elsewhere and result in damaging border delays. This will cause serious problems for time-sensitive medicines which require delivery in as little as 24 hours in many cases, potentially leaving patients without vital medication.