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Medicinal Products Regulation

Dáil Éireann Debate, Tuesday - 31 May 2016

Tuesday, 31 May 2016

Questions (708)

Billy Kelleher

Question:

708. Deputy Billy Kelleher asked the Minister for Health when he intends to update and amend the Misuse of Drugs Act to deal with prescription drugs. [13208/16]

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Written answers

Under the Medicinal Products (Prescription and Control of Supply) Regulations, it is prohibited for a person to supply prescription medicines except in accordance with a prescription, and the supply must be made from a registered pharmacy by or under the personal supervision of a registered pharmacist. A person who contravenes these Regulations is guilty of an offence.

Medicines which have a high potential to be misused are subject to additional and stricter controls under the Misuse of Drugs Acts. These medicines include benzodiazepines and certain z-drugs. The Misuse of Drugs Acts and Regulations impose restrictions on the production, supply, importation and exportation of controlled drugs. A person who has in his possession a prescription medicine containing a controlled drug for the purpose of selling or supplying it in contravention of the Misuse of Drugs legislation, is guilty of an offence under that legislation.

Following a Court of Appeal decision on 10 March 2015 which declared unconstitutional the section of the Misuse of Drugs Act empowering the Government to declare substances to be controlled under the Act, the Misuse of Drugs (Amendment) Act 2015 was urgently enacted to recontrol all substances which had previously been declared controlled by Government order. A further Bill to amend the Misuse of Drugs Act so as to allow the Government to declare substances to be controlled, including prescription medicines, is currently being drafted and is intended to be published as soon as possible. This will bring under the scope of the Act new substances, and allow the introduction of stricter controls on substances such as benzodiazepines, which are already covered under the legislation.

It is important to note that the problem of abuse of prescription medicines will not be solved by Regulations alone, and that prescribers need to ensure that these substances are only prescribed as appropriate. The Health Product Regulatory Authority which is the competent authority for human medicines, Revenue’s Customs service and an Garda Síochána work closely to prevent the unauthorised flow of illegal medicinal products into and out of the State. The enforcement of the law relating to the sale of drugs, including prescription drugs, continues to be a priority in the Government’s commitment to tackling the issue of drug misuse.

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