Leo Varadkar (Dublin West, Fine Gael) | Oireachtas source

I thank the Deputy for raising this matter. Benzodiazepines are a class of medicine available on prescription which are commonly used to treat anxiety, sleep disturbance and insomnia. They are known to be associated with dependence and withdrawal symptoms and consequently are primarily recommended for short-term treatment only. They are a very valuable treatment option when used correctly. However, there is increasing evidence of the inappropriate use of benzodiazepines in Europe, a problem which is not particular to Ireland.

Under the Medicinal Products (Prescription and Control of Supply) Regulations, it is an offence for a person, except where the person is a pharmacist or working under the personal supervision of a pharmacist, to supply a prescription medicine. These regulations also make it illegal for prescription medicines to be supplied by mail order or over the Internet. Additional levels of control are applied to medicines which have a high potential to be misused by means of regulations made under the Misuse of Drugs Acts. These regulations impose restrictions on the production, supply, importation and exportation of controlled drugs, such as morphine, methadone, amphetamines and benzodiazepines. A person who has in his possession a prescription medicine containing a drug controlled under the misuse of drugs legislation for unauthorised sale or supply is guilty of an offence under that legislation. Different levels of control apply to drugs controlled under the misuse of drugs legislation, dependent on their therapeutic value and potential for abuse.

The Department has been reviewing the misuse of drugs regulations to introduce stricter controls on benzodiazepines. In particular, it is proposed to apply formal import and export controls on benzodiazepines, thereby making it an offence for a person to import or export these drugs without a licence. The introduction of these controls will also provide comprehensive national information on the level of use of benzodiazepines and trade in benzodiazepines. It is also proposed to introduce stricter prescribing and dispensing controls for benzodiazepines, as well as an offence for a person to possess benzodiazepines without entitlement - for example, a prescription - thereby assisting the Garda and customs service in enforcing the law on the illicit importation of and dealing in benzodiazepines.

Following a consultation process, a draft amendment regulation was prepared and made available for further consultation on the Department's website. Submissions were received from a wide range of organisations and individuals, including doctors, pharmacists, the Pharmaceutical Society of Ireland, the Irish Pharmacy Union, private and public hospitals - both from medical practitioners and pharmacists - nursing homes, drug treatment centres and experts in addiction services.

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These submissions raised a number of legislative issues which require further consideration before finalising the amendments. The process is taking longer than anticipated because it is a complex and technical body of work. Some further work is required and the objective is to finalise the text of the draft regulations early next year.

Once the draft regulations are ready, they will be subject to a three month EU notification period under the Technical Standards Directive before they can be signed into law. This is because of the implications of the proposed regulatory changes on trade in pharmaceutical products.

No doubt the scale and nature of the drug problem in Ireland is constantly evolving. The emergence of new psychoactive substances, the increased strength of cannabis and the prevalence of poly-drug use represent serious challenges for our services in responding to the needs of vulnerable groups. The response of the HSE has involved the re-orientation of its addiction services in order to develop a comprehensive integrated addiction treatment service capable of dealing with all substances. The HSE continues to co-operate with local community representatives, particularly in the Dublin city centre area, and liaise with local gardaí to minimise any negative public order issues that may arise.

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