Róisín Shortall (Dublin North West, Social Democrats)
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268. To ask the Minister for Health whether all sections of the Misuse of Drugs Act 2016 have been commenced; if so, the date on which they commenced; and the impact to date of this legislation [5170/17]

Catherine Byrne (Dublin South Central, Fine Gael)
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The Misuse of Drugs (Amendment) Act 2016 was passed by the Oireachtas on the 27 July 2016. Controlling the substances in the Act was part one of a two-step process and Regulations and various Orders are also required to allow legitimate users (e.g. patients with a prescription, health professionals) to possess the substances. It is expected that various sections of the 2016 Act can be commenced in the coming weeks when the drafting of the various Regulations and Orders is complete.

Once the Regulations are finalised, under the Technical Standards Directive, Member States are required to inform the Commission of any new regulations or standards which may create a barrier to the free movement of goods. Since these draft Regulations have the potential to affect trade, in particular because of the introduction of a requirement for import licences, they must be notified to the EU whilst they are in draft and before they are adopted in national law.

Notified regulations are usually subject to a 3-month standstill period - to enable the Commission and the other Member States to examine the notified text and to respond appropriately. The Department intends to invoke an urgency procedure which can shorten the notification period to 10 days if the matter is considered to be related to the protection of public health or safety. If the Commission does not raise any objections the Regulations will be in order to be signed.

The primary purpose of the 2016 Act 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. These include so-called z-drug sedatives - zopiclone and zaleplon.

The Act also controls the benzodiazepine phenazepam and a number of new psychoactive substances which Ireland is required to control under our EU and UN obligations, as well as two substances found in the headshop drug ‘Clockwork Orange’.

The new Regulations will apply import and export controls, tighter prescribing and dispensing controls as well as an offence of possession, thereby assisting the Customs and An Garda Síochána in protecting public health and local communities. Benzodiazepines, such as diazepam, will also be subject to these additional controls.

Whilst the imperative to bring these medicines under the control of the Misuse of Drugs Acts is understood, many of these medicines are used by tens of thousands of legitimate patients. Updating the regulations from 1988, imposing additional prescription and dispensing controls on many of the legitimate medicines has had to be undertaken whilst ensuring that there are no significant unintended consequences on those legitimate patients and ensuring healthcare professionals are enabled to continue to prescribe and dispense these medicines, as appropriate.