79. Deputy Jack Chambers asked the Minister for Health when regulations will be introduced to provide for the introduction of suboxone as an alternative to methadone. [20967/16]

Minister of State at the Department of Health (Deputy Catherine Byrne): Suboxone is 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 the pilot and feasibility study for Suboxone.

If the provision of Suboxone 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 necessary. The Misuse of Drugs (Amendment) Act 2015 was enacted as emergency legislation in March 2015 following a Court of Appeal decision on a constitutional challenge to section 2(2) of the Misuse of Drugs Act 1977. The 2015 Act reconfirmed the existing ministerial regulations and orders made under the 1977 Act, including the Misuse of Drugs Regulations 1988 and the 1998 Methadone Regulations. As a result, these Regulations may only now be amended by primary legislation.

As you know, on Tuesday 21 June the Misuse of Drugs (Amendment) Bill 2016 was published. The primary purpose of this Bill is to protect public health by bringing certain substances which are open to misuse and known to be traded on the illicit market under the scope of the misuse of drugs legislation, as well as aiding the law enforcement functions of An Garda Síochána and the Customs Service. The Bill also provides for the revocation of the previously confirmed regulations and ministerial orders. It is hoped that the Bill can be enacted before the summer recess.

New regulations will then be required to allow legitimate users (patients with a prescription, health 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 Suboxone will be drafted subsequent to this legislative agenda and will then be subject to the 3-month EU notification under the Technical Standards and Regulations Directive 2015/1535/EU.