At a recent strategy day for health and life science in Northern Ireland, some of the comments included: ‘No-one is representing Northern Ireland at the UK or EU tables’; ‘We can’t make critical business decisions’; ‘How can we attract investment and remain competitive with the current regulatory uncertainty?’
The health and life science sector has been recognized as a high growth area, but the current uncertainty and lack of a clear regulatory strategy is taking its toll.
The Health Innovation Research Alliance NI (HIRANI) is one of the UK cluster organisations and was established in Northern Ireland in 2019 to provide leadership to align Northern Ireland’s health and life science ecosystem with the UK government life sciences vision.
Brexit hastened the need for a joined up national cluster strategy and although the UK government has recognised the excellent and important contribution of life sciences in the UK, reassurances are still need on the status of funding, availability of talent, regulations, and other legislation to ensure the UK clusters can remain competitive, nowhere more so than in NI where an uncertain climate remains.
Due to its unique location, Northern Ireland must abide by European and UK regulatory rules, yet there is no leadership and no-one taking on the role of regulatory advocate for NI in either the UK or the EU, leading to a deprioritisation of issues facing NI at a time when advocacy for this unique area is needed more than ever.
Without this advocacy, risks to this sector, and to the NI economy remain critical.
Some of the most worrying outcomes include the sector not delivering on its potential and the ambitions of its economic ‘10X’ strategy including attracting foreign direct investment into its city deals.
There will also be a loss of investment, with the associated loss of up to 1,000 jobs and globally recognised companies moving out of NI and possibly the UK.
Subsidiary business, supporting the health and life sciences will be unable to raise financial support resulting in loss of investment to the innovation pipeline and there will be a substantial reduction in access of NI patients to innovative medicines and devices due to the risk of regulatory dealignment with GB.
This could cause a decrease in recruitment to clinical trials.
During the pandemic, 1.4% of Northern Ireland citizens participated in clinical trials, the highest across the UK.
A further concern is Northern Ireland needs will not be considered by the UK government in its current Regulatory for Growth Strategy which could result in platforms and processes being developed for the sector which are unfit for use in NI.
A NI seat at the table of the European Medicines Agency, whose regulatory processes Northern Ireland must follow, will be lost meaning the inability to horizon scan for future EU regulatory changes and how these will impact Northern Ireland.
Strategic regulatory leadership is essential to address uncertainty and ensure NI, and indeed the UK, can exploit additional opportunities such as dual access to markets.
There is need for better collaboration across UK health and life science clusters, allowing them to showcase the UK and compete at an international level.
Northern Ireland offers a unique UK position and opportunity, but it needs to be recognised as such by both local and national government.
By Joann Rhodes, CEO, and Dr Siobhan McGrath, Chief Operating Officer, at Health Innovation Research Alliance Northern Ireland.
