As the date for Great Britain’s referendum on whether to leave the European Union approaches, the pre-referendum debates have only marginally touched on the area of healthcare: with both sides claiming that voting for the other side would result in less funding for the National Health Service. No attention has focused on what the consequences of a British exit would be in terms of its leadership in the world of pharma.
It is fair to say that Britain currently punches above its weight in terms of areas such as intellectual property law and courts, marketing authorisations and health technology assessment. The European Medicines Agency – the EU’s body for centralised marketing authorisation of medicines – is located in London. Meanwhile the Unified Patent Court, due to be created in 2017 as part of the long-awaited EU-wide unified patent system, is meant to have its Life Sciences division based in London.
A vote to leave the European Union would certainly mean the European Medicines Agency (EMA) relocating to another EU country, resulting in the loss of around 600 full-time jobs in London. Perhaps Leave campaigners would argue that Great Britain should do its own drug reviews – and that in fact more domestic jobs can be created if the UK was no longer part of the EU centralised approval system. That may be the case, but what would be the cost of going through a separate drug review process in the UK for pharmaceutical companies? And how many would opt to delay a UK marketing authorisation application, relegating the UK to a second-tier market in terms of launch sequencing?
Alternatively, should the UK adopt the example of Norway and become a member of the European Economic Area (EEA), it would find itself in a situation where EMA marketing authorisations are binding for the UK. However, in that case as the UK would no longer be a member of the EU it would have no voting rights in EMA scientific opinions.
Meanwhile, the creation of the UPC is expected to come into effect … with or without the UK. The Life Sciences division of the court would not be based in the UK in case of a vote to leave the European Union. But more significantly the UK would be outside the EU patent system and it may be necessary for pharmaceutical companies to seek patent protection in the UK separate from the Unified Patent protection. EU trademarks would not be valid in the UK if it exits the EU either. The need for separate patent filing and trademark protection filing in the UK would put pressure on smaller and medium-sized pharmaceutical companies.
In addition, UK scholars would no longer have access to EU research funds. The UK may also lose its attractiveness as a location for clinical trials: unless the UK enters the EEA, pharmaceutical companies would need to file a separate application for clinical trials conducted in the UK in addition to EEA trials.
A final and very serious consideration, I would mention, is that if the UK exits the EU and does not become part of the EEA pharmaceutical companies may have to consider relocating their European pharmacovigilance operations – many of which are now based in the UK – to an EU or EEA member state.