Richard Phillips discusses the implications of Brexit for the Medical Technology industry.

The UK’s decision to withdraw from the European Union (EU) has sent shockwaves around the world. The economic and commercial implications of the referendum result are profound, none more so than for UK industry.

For the UK’s medical device sector, the impact will be huge. The sector has a unique make up: a diverse industry with a mix of large and small companies, a rapid product cycle with new devices and technologies regularly hitting the market, and a regulatory system that has been coordinated at the EU level for over 20 years.

The big questions surrounding the UK’s relationship with the EU are yet to be decided, but there are real and immediate implications for the MedTech industry. Trust and understanding in the regulatory system is crucial to product development, a significant shift in the process will have a major impact on industry. The revision of the current system has been well publicised, something the Medicines and Healthcare Regulatory Agency (MHRA) has been heavily involved with. Alongside this is Glenys Wilmott MEP who oversees the passage of relevant legislation through the European Parliament.

The Association of British Healthcare Industries (ABHI) has a clear message to the Government as they enter into negotiations: we must maintain a unified regulatory system and access to the single market.

Regulatory divergence would have severe consequences for the medical device industry. The establishment of a standalone process in the UK would be both complicated and expensive for regulators, and would likely mean an increased administrative burden and extra cost for industry. For companies exporting to the EU it would mean the extra hurdle of complying with two separate systems – an EU regulatory system on top of a new UK system.

Access to the single market is crucial for industry. For small companies exporting to the EU is likely to be a huge part of their business. Losing this will see many companies struggle to survive. For global businesses based in the UK the connection with Europe will have influenced their decision to come here and many of their systems, such as sales, administration and training, will be shared with Europe. The UK’s relationship with the EU must support these types of relationship and ensure companies based in the UK can operate seamlessly across the EU.

Beyond any practical concerns the new Government must look forward and put in place the structures necessary to support innovative industries like medical technology. The first step in this process should be the publication of the Accelerated Access Review (AAR) and ensuring that it delivers on its aim of supporting more collaborative relationships between industry and the NHS.

The NHS will also have to get serious about building long term, value-based relationships with industry. In doing this the UK could become a hot bed of innovation that will support economic growth through international investment and the development of SMEs. A key element of any long term value based discussion should focus on procurement and the impact of current activity. The NHS is currently focussed on reducing the number of suppliers, which is particularly damaging for SMEs, especially at a time of general uncertainty and limited growth opportunities. In doing this the NHS is in danger of missing out on innovation, especially in low volume or highly specialised areas.

NHS funding remains a critical issue. The issue of investing £350m a week in the NHS was much debated during the referendum; this figure may now need to become a reality.  NHS England Chief Executive, Simon Stevens, has already called on Government to deliver the ‘better funded’ NHS promised during the campaign. In doing this the Government should look at how funding can be used for transformational projects that will have positive long term consequences for the NHS.

For the Med Tech industry the short term challenges posed by Brexit are clear. And in turn the message to Government is also clear: tariff free access to the EU market and a unified regulatory system is essential. In doing this the Government can deliver the public’s desire for Brexit at the same time as maintaining an innovative and successful MedTech sector.

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