Billy Kelleher (Cork North Central, Fianna Fail)
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224. To ask the Minister for Health his views on the delay in drafting regulations to enable the introduction of Suboxone (an alternative to methadone), bearing in mind that they were expected at the end of Q1 2016, and there is need for a notification period of three months under the European technical standards directive once the regulations have been published; his further views that these delays are unacceptable, as there is an urgent need for the availability of Suboxone to cater for persons with opioid dependency; and if he will make a statement on the matter. [17675/16]

Catherine Byrne (Dublin South Central, Fine Gael)
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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.

Billy Kelleher (Cork North Central, Fianna Fail)
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225. To ask the Minister for Health his views on the fact that according to recent research published by Health Research Board, there has been an increase in the number of persons dying from methadone overdoses, with the number of deaths due to methadone overdoses, the largest cause of deaths by poisoning in Ireland, ahead of even heroin overdoses; if, based on this data on methadone overdoses, he will fast-track the availability of Suboxone, to provide an alternative to methadone, as a way to reduce such overdose risks, given the much lower risk of overdose from Suboxone; and if he will make a statement on the matter. [17676/16]

Catherine Byrne (Dublin South Central, Fine Gael)
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According to a Health Research Board report on drug-related deaths for 2013, the latest year for which data is available, the total number of drug-related poisoning deaths increased from 361 in 2012 to 387 in 2013. Methadone was implicated in 93 poisoning deaths in 2013, compared with 86 in 2012. However, the majority of poisoning deaths where methadone was implicated, involved other drugs. There is clear evidence to indicate that having access to drug treatment is one of the major factors in reducing drug-related deaths.

Suboxone is a medicinal product comprising 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 determine the conditions to govern the wider availability of buprenorphine/naloxone products for opioid substitution therapy. In January 2016, the HSE submitted its report to the Department. The report recommends the phased increased access to buprenorphine/naloxone for a cohort of patients in specific circumstances, including the resources required, subject to the required legislation being enacted to provide buprenorphine/naloxone on the same statutory basis as methadone. If the provision of Suboxone is to be made on this basis, any regulations made in relation to Suboxone will need to be drafted subsequent to the legislative agenda associated with the Misuse of Drugs (Amendment) Bill 2016.

Methadone maintenance treatment is a critical stabilising treatment, which is the most appropriate substitution treatment for the majority of patients. Naloxone is an opioid antagonist which is used to reverse the effects of overdose of opioids such as heroin, morphine and methadone and has been proven to be an effective way of reducing the number of opioid overdose deaths. In May 2015, the HSE undertook a demonstration project to assess and evaluate the suitability and impact of using a pre-filled Naloxone injection which is designed for non-medical administration in Ireland. The project involved 600 opiate users receiving take-home naloxone on prescription. It also included those recently released from custody who have been identified as at high risk of opioid overdose. These drug users and those close to them have been trained on how to administer naloxone and to recognise the signs of an overdose. The HSE has advised that an evaluation of the demonstration project has been completed and a national implementation plan is currently being developed.