As the largest net exporter of pharmaceuticals in the EU and one of the largest in the world and given that most of the world's largest pharmaceutical and medical device companies have substantial operations in Ireland, it is clear that the industry will be significantly impacted by Brexit.
At a recent meeting hosted by the Irish Health Products Regulatory Authority (HPRA), Ireland's Competent Authority, representatives from industry, government and the regulator discussed the potential effects of Brexit on the sector.
Overall, the general message was pragmatism and preparation. The HPRA reaffirmed that it is open for business and will assist the industry through their Brexit planning. However, stark warnings were issued to companies to approach them early to discuss their plans, and avoid a backlog of applications on the eve of Brexit, currently set to be March 2019. A key concern and driver behind these messages is to ensure continued supply of medicines post-Brexit.
Some of the other key issues identified at the HPRA meeting and which life sciences businesses should be working on right now are outlined below.
To market medicinal products in the EU it is a requirement to have a marketing authorisation (MA), which may only be held by entities established in the European Economic Area (EEA). MAs can be granted by the European Commission or the national authorities.
Centralised MAs granted by the European Commission allow companies to market products throughout the EU under that single MA which, at the moment, includes the UK. When the UK leaves the EU, UK companies can no longer hold these MAs as they will no longer be an entity established in the EEA. To continue to market the product throughout the EU, the MA must be transferred to an entity established in the EEA.
When the UK leaves the EU, products may no longer be placed on the UK market on the basis of MAs granted via the current EU regulatory framework. Conversely, the national MAs granted by the UK competent authority, the MHRA, may not be recognised by other EU Member States for the purposes of placing products on their markets as part of mutual recognition or decentralised procedures.
The HPRA confirmed that it is happy to take over the role of Reference Member State (RMS), at no additional cost, for products where the UK MHRA is currently the RMS and the HPRA is a Concerned Member State.
While the EU and the UK may adopt some form of mutual recognition...