Dáil Éireann Debate, Thursday - 21 July 2016
663. Deputy Billy Kelleher asked the Minister for Health if the HSE plan for phased increased access to buprenorphine/naloxone and buprenorphine products within the context of available resources has been commenced; and the resources required for commencement. [24091/16]
View answerBuprenorphine-naloxone is a medicinal product, authorised as a substitution treatment for opioid drug dependence within a framework of medical, social and psychological treatment. It is currently being provided to a cohort of patients involved in a piloting and feasibility study.
The report of an implementation group established by the HSE to determine the conditions to govern the wider availability of buprenorphine-naloxone recommends the phased increased access to the product for a cohort of patients in specific circumstances, subject to the required legislation being enacted to provide the product on the same statutory basis as methadone.
If the provision of buprenorphine-naloxone is to be given the same statutory basis as methadone, in order to ensure its safe appropriate and cost-effective use, an amendment to the Misuse of Drugs (Supervision of Prescription and Supply of Methadone) regulations 1998 will be required.
The Misuse of Drugs (Amendment) Bill 2016 is currently making its way through the Houses of the Oireachtas and will allow for the revocation of the previously confirmed regulations. It is hoped that this Bill can be enacted before the summer recess. New regulations will then be required to allow legitimate users, such as patients with a prescription and healthcare professionals, to possess the newly controlled substances. Work is underway on drafting these regulations as a matter of priority.
Any regulations made in relation to buprenorphine-naloxone will be drafted subsequent to this legislative agenda and will then be subject to the 3-month EU notification under the EU Technical Standards Directive.
The resource requirements for making buprenorphine-naloxone more widely available following the enactment of the required legislation will be examined in the context of the estimates process for 2017.
