Suboxone is a medicinal product comprising of the drugs buprenorphine and naloxone. It 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 piloting and feasibility study for Suboxone.
At the request of the Department of Health, the HSE set up an implementation group to introduce, supervise, monitor and review the wider availability and cost of buprenorphine/naloxone products for opioid substitution therapy. In January 2016 the Director General of the HSE submitted the report of this Opioid Substitution Implementation Group to my predecessor, the Minister of State with special responsibility for drugs strategy. No decision on the report was taken at that time. The report recommends the phased, increased access to buprenorphine/naloxone for a cohort of patients in specific circumstances, subject to required legislation being enacted and resourcing. It was noted in the report that additional funding would be required and that these additional resources for 2016 had not been allocated.
The mechanisms proposed in this report will require legislative changes to be made. 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 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 provides for a small number of other amendments of a technical nature including the ‘unlocking’ of the previously confirmed Regulations and Ministerial Orders.
It is hoped that this Bill can be enacted before the summer recess. Controlling the substances in the Bill is part one of a two-step process. Regulations are also 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 buprenorphine/naloxone 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.
