Simon Harris (Wicklow, Fine Gael)
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The Health Products Regulatory Authority (HPRA) has increased its fees to all pharmaceutical companies by an average of 8% in 2019. It should be noted that the Authority's last significant fee increase was in 2010. In 2011 and 2012, the HPRA reduced fees, and there were no fee increases between 2013 and 2017. Fees were increased by approximately 2% in 2018.

The impact of new EU legislation continues to be felt across the HPRA. For example, the Falsified Medicines Directive will commence in February 2019, the Medical Devices Regulations will commence in May 2020, the Clinical Trials Regulation is scheduled to be implemented in 2020 and the In Vitro Diagnostic Medical Devices Regulations will commence in 2022. The regulatory model for medicines is becoming more complex, and EU pharmacovigilance legislation has led to an increase in the number of referrals and regulatory actions arising from the outcome of these referrals. Public scrutiny and the role of the regulator in relation to medical devices and medicines such as the HPV vaccine has increased, while compliance activity is also increasing.

Over the last several years, the HPRA has continued to enhance services to support the pharmaceutical industry in Ireland. The development of an innovation office and an international platform has brought greater oversight and global co-operation to the benefit of all stakeholders and of public health. The development of the agency has ensured that the HPRA is well placed to negotiate the impact of Brexit and continual changes in the regulatory environment.

It is acknowledged that Brexit and the Falsified Medicines Directive will also present significant challenges to the pharmaceutical industry. However, the HPRA plays a vital role in supporting this industry, and this fee increase is considered necessary in order to enable the Authority to continue to fulfil its public health remit.