News Category: Regulatory news
HPRA Engages with Key Stakeholders to Plan for Future
Thursday 31 August 2017: A seminar hosted in Dublin today by the Health Products Regulatory Authority (HPRA) will hear 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, due to be attended by over 300 representatives from the biopharma, medtech and life sciences sector, will discuss 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."
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 today 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.
Regardless of the nature of the final negotiated UK exit, the HPRA stated that it is imperative to maintain close links with the UK’s medicines agencies in the future given the close proximity of the two markets and the many shared stakeholder companies. Good working relations and engagement between the UK and the European regulatory network will be beneficial to all parties.
Among the organisations speaking at the event are Biopharmachem Ireland, Medicines for Ireland, the Animal and Plant Health Association, IDA Ireland and IBEC, as well as European industry representatives.
ENDS
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ABOUT THE HEALTH PRODUCTS REGULATORY AUTHORITY
The Health Products Regulatory Authority (HPRA) protects and enhances public health and animal health by regulating medicines, medical devices and other health products. The products under its remit include human and veterinary medicines, medical devices, blood and blood components, tissues and cells, organs for transplantation and cosmetics.