Dáil Éireann Debate, Wednesday - 18 January 2023
1272. Deputy Colm Burke asked the Minister for Health his views on whether clinical guidance and licensing guidance should be reviewed on oxycontin in the context of litigation in other countries; and if he will make a statement on the matter. [63637/22]
View answerThe Health Products Regultory Authority (HPRA) are responsible for the regulation of medicines, medical devices and other health products and does not provide clinical guidance concerning medicines.
Guidance on the licensing of medicines is harmonised across the EU. Licensing guidance for the medicines intended for the treatment of different types of pain outlines the clinical trials that should be conducted depending on the severity of pain, the efficacy and safety requirements that need to be met, and the need for long-term safety data (12 months). Licensing guidance is reviewed, updated and agreed by EU member states, depending on clinical circumstances.
Oxycodone-containing medicines authorised in Ireland are indicated for the treatment of severe pain, that is uncontrolled by other pain medicines. The lowest effective dose for pain-relief should be used, and should only be used for duration of time when they are considered necessary. Oxycodone-containing medicines are subject to non-renewable prescription, and are controlled drugs. Such medicines cannot be promoted to the public. Therefore, the regulation of oxycodone-containing medicines in Ireland, and across the EU, is strict. The conditions of authorisation in other jurisdictions may be different.
