The potential for Brexit-related disruption in Ireland may be high as 60-70% of medicines marketed in Ireland currently either come from or transit the UK. Up to 60% of drugs marketed in Ireland share a common label with the UK. In response to this, the sector has invested significantly in planning to mitigate the impact of Brexit. This planning includes:
In the short-term, Brexit risks include disruption to supply (in spite of mitigation steps), changes to regulatory and quality requirements, data protection concerns for patients and the overlap with other large scale regulatory programs due for completion at the same time (e.g. EU Medical Device Regulation). In the longer term, Ireland and Malta will be the only markets with English language labels in the EU potentially resulting in Ireland not being able to meet the minimum economically viable order quantities for production of products for the Irish market.
We delve into the key challenges that you need to keep top of mind as 31 October approaches.
To date, significant planning has been put in place to lower the risk of disruption to the supply of lifesaving medicines and medical devices to Ireland. However, up to 70% of medicines marketed in Ireland either come from, or through, the UK. There is still a risk that if trade is disrupted at UK ports that supply to Ireland may be impacted. Strategies implemented to mitigate this include:
Centralised Marketing Authorisations (MAs) for medical products and devices held in the UK post-Brexit will no longer be recognised by the European Medicines Agency (EMA). Likewise, MAs approved in other EU or EEA member states will no longer be recognised by the UK regulator (the MHRA). Irish organisations with product Marketing Authorisations in the UK should have transferred these out of the UK so that they are valid in the rest of Europe. In parallel, organisations should be prepared to ensure that MAs held elsewhere in Europe are grandfathered into the new regulatory regime in the UK once it is defined.
Both the UK and the EU will require Quality Control (QC) testing and product release to happen within markets under their regulatory oversight. This has required organisations to move or duplicate quality control testing and product release for the EU and the UK. If they have not done so already organisations should understand the tax, supply chain and regulatory implications of moving or duplicating these activities.
Irish-based organisations will need to assess the data privacy impact of storing the patient data of EU nationals in the UK.
Up to 60% of medicines marketed in Ireland share a common label with the UK. Post-Brexit, sharing a label with the UK will no longer be possible. Both markets will be under different regulatory oversight (EMA for the EU, vs MHRA for the UK). This will leave Ireland and Malta as the only markets with English language labels in the EU. In the future, Ireland may not meet the minimum economically viable order quantities for production of products for the Irish market. This may lead to increased prices or in delays in launching new medicines in Ireland.
While significant planning has currently been put in place some key challenges remain for organisations to:
Each of these challenges are likely to be exacerbated in the event of a no-deal Brexit. PwC has been actively supporting clients in ensuring they are Brexit ready and we are here to support you through the challenges you may face.