Dáil Éireann Debate, Tuesday - 21 March 2017
991. Deputy Richard Boyd Barrett asked the Minister for Health the way the HPRA is funded; the proportion of that funding which is from pharmaceutical companies; the measures taken by his Department to prevent undue influence by the pharmaceutical industry on HPRA decisions on drug policy and appointments to the HPRA; and if he will make a statement on the matter. [14076/17]
Amharc ar fhreagraThe Health Products Regulatory Authority (HPRA) has confirmed that in 2016, 77% of the Authority's total income was obtained via regulatory fees charged to the pharmaceutical industry. These fees reflect the costs associated with regulatory activities such as the assessment of medicinal products and the inspection of manufacturing and distribution sites. These regulatory activities are critical to ensuring the quality, safety and efficacy of medicinal products on the Irish market. Such fees ensure that the industry (and not the public) covers the majority of the costs related to the regulation of their activities. My Department provided 15% of the HPRA’s total income for 2016.
Competent Authorities in other European countries and in other countries such as the USA, Canada and Australia also charge fees to pharmaceutical companies to reflect the costs associated with the regulation of medicines. Similarly, other Irish regulatory authorities also charge fees to the industries that they regulate.
The HPRA fully complies with the Ethics in Public Office Acts, 1995 and 2011. In addition, the Irish Medicines Board Acts 1995 and 2006 have specific provisions in relation to the disclosure of interests by HPRA Board members, employees and members of advisory committees. The HPRA also operates in accordance with the Code of Practice for the Governance of State Bodies.
The HPRA’s Code of Conduct and Conflicts of Interest Policy reflect the above requirements. All Authority/Committee members, external experts and HPRA staff are required to provide declarations of interests at the time of their initial appointment (and subsequently on an annual basis), not just in relation to their personal interests but also interests related to close family members and any other matters or personal connections which could represent a conflict of interest. Any declared interests are systematically evaluated and appropriate restrictions are put in place to avoid any potential conflicts.
All Authority / Committee members, external experts and HPRA staff must also comply with specific provisions in relation to gifts, hospitality, invitations to speak, fees, external activities and employment as outlined in the HPRA’s Conflicts of Interest Policy.
