Safeguarding against Brexit Strategies

As Hospital Professional News was going to press, a seminar hosted in Dublin by the Health Products Regulatory Authority (HPRA) heard that a key priority for its post-Brexit strategies is to safeguard against disruption to Irish patients’ access to medicines.

The HPRA stated that it is looking at a number of potential scenarios that seek to ensure continued availability of health products to Ireland. The event, attended by over 300 representatives from the biopharma, medtech and life sciences sector, discussed the concerns of different stakeholder groups given the unique context for Ireland in the Europe-wide medicine regulatory environment.

According to Dr Lorraine Nolan, Chief Executive, HPRA, there are distinct issues that face Ireland in any post-Brexit scenario: “Whilst the eventual outcomes of the Brexit negotiations are unknown, what we do know is that there are potentially significant implications for Ireland with its shared market place with the UK. This, combined with the fact that Ireland is a small market, can place pressures on the availability of certain products for our market. The HPRA’s priority is to ensure Irish patients will continue to have access to the medicines that they require post-Brexit and today’s event is about discussing these and other Brexit-related issues with key stakeholders in the sector.”

Speaking ahead of the event, Dr Nolan continued, “The HPRA has established an internal working group which has already started planning for all possible eventualities and outcomes that may occur when the UK withdraws from the EU market. It is our intention to regularly engage with industry representatives and individual companies to offer guidance and support to ensure the continued availability of their products to Irish patients. We have already begun surveying the industry in relation to their intentions regarding marketing their products post-Brexit and this is giving us very useful information for planning purposes.

“As part of this engagement, the stakeholder event will see speakers from industry and regulation come together to share their views on the potential issues Brexit may present in their respective fields. From the perspective of the HPRA, this will allow us to focus our efforts on maintaining the authorisation and supply of existing products, working closely with companies and our fellow regulators across Europe.”

The HPRA has also announced that it will increase its contribution to the European assessments of human and veterinary medicines, in conjunction with other Member States, in order to minimise the impact of the loss of the UK’s significant contributions to the system. It has begun planning and identifying its future resource requirements with the support of the Department of Health and the Department of Agriculture, Food and the Marine.

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