Michael Creed (Cork North West, Fine Gael)
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459. To ask the Minister for Health the status of legalisation concerning a drug (details supplied) for medical uses; the experience in this regard of clinical trials being held in other jurisdictions that he is aware of; the process involved in approving new drug treatments; and if he will make a statement on the matter. [5554/16]

Leo Varadkar (Dublin West, Fine Gael)
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Cannabis oil is not a definitive term and could contain cannabis or any number of cannabis-related compounds. Cannabis and certain cannabis-related compounds are controlled under the Misuse of Drugs Acts 1977 to 2015 and are listed in schedule 1 of the Misuse of Drugs Regulations 1988, as amended.

Cannabidiol, the substance referred to as CBD by the Deputy, is not subject to control under these Acts. However, CBD is derived from cannabis which is a controlled drug. Due to the manufacturing processes, CBD extracts may contain a number of other ingredients, some of which may be controlled. In order to elucidate and define the ingredients of a CBD oil product, a full certificate of analysis would be required for that product. If a CBD oil product does not contain an ingredient which is a controlled substance, it may be feasible to have that product imported and used in Ireland, in accordance with specific conditions.

Cannabis oil or CBD oil are not an authorised medicinal products in Ireland. Products for which medicinal claims are made, or which contain certain substances likely to have pharmacological actions on the body are considered as medicinal products. Under European and Irish legislation, before a medicine can be placed on the Irish market, the manufacturer must seek an authorisation from the Health Products Regulatory Authority (HPRA) or, in the case of certain medicinal products, the European Medicines Agency (EMA). A determination on an application for authorisation of a medicine is based on a rigorous scientific assessment of the application against the criteria of safety, quality, efficacy, legal and regulatory requirements. I have no role in the process of authorising medicinal products.

The HPRA is responsible for the assessment of clinical trials with medicinal products conducted in Ireland. Before a medicinal product can be authorised for use, it must go through the clinical trials process to ensure that it is safe and effective, and also that the quality of the product is sufficient. The publicly-accessible EU Clinical Trials Register of trials being conducted in the EU and European Economic Area currently lists 38 trials authorised using cannabis. These trials are mainly investigating the safety and efficacy of cannabis in neurological and psychiatric conditions. There are currently no clinical trials using cannabis taking place in Ireland.