The HPRA has recently announced its firm commitment to protect the availability of medicinal products for Irish patients and the integrity of the market despite the UK's impending exit from the European Union (“Brexit”).
The HPRA has established an internal working group to ensure that they are prepared for the UK’s withdrawal currently set for 29 March 2019. The HPRA has said that strong working relationships will be maintained and fostered with their UK colleagues so as to ensure that both medicinal products and medical devices continue to be supplied, uninterrupted to the Irish healthcare industry.
HPRA RESPONDS TO AN IMPENDING ‘BREXIT’
In addressing the imminent shift within the EU, the HPRA intends to hold a stakeholder meeting to discuss their approach to potential Brexit scenarios and to understand the concerns and requirements of different stakeholder groups. This meeting, which will focus on medicinal products, will take place on the afternoon of 31 August 2017. Further infomation and registration details can be found on their website.
In addition to the stakeholder meeting and in an effort to maintain the availability of medicinal products, the HPRA has requested marketing authorisation holders (“MAHs”) that hold a marketing authorisation in Ireland for a product where the UK is the Reference Member State or a Concerned Member State, to respond to a survey. The objective of this survey is to determine the products that may be affected by Brexit. MAHs can submit their responses to email@example.com.
WILL THE HPRA ASSUME A GREATER ROLE POST-BREXIT
One possible and potentially significant outcome of the UK’s departure from the EU regulatory framework is the ability for the HPRA, and indeed other EU regulatory agencies, to assume a greater role in EU regulatory activities.
The HPRA is a highly respected regulatory agency in the EU which is evident from the number of rapporteurships and other key leadership roles it plays within the European Medicines Agency (“EMA”). In an effort to strengthen its role, the HPRA has committed to increasing its contribution, particularly in the assessment of centralised and decentralised marketing authorisation applications, inspections and expanding its role in the regulation of medical devices. This, coupled with Ireland's bid to relocate the EMA to Dublin, which has huge potential to strengthen the expertise within the HPRA, could result in the HPRA becoming a leading regulatory authority in the EU.
Overall, the HPRA’s strong pledge to devote time and expertise to this issue can only be welcomed by the industry and regulators alike and the initiatives employed by the HPRA are helpful steps towards easing the potential limbo which may exist within the life sciences industry post Brexit.