Written answers

Tuesday, 18 December 2007

Department of Health and Children

Pharmacy Regulations

11:00 pm

Photo of Jim O'KeeffeJim O'Keeffe (Cork South West, Fine Gael)
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Question 237: To ask the Minister for Health and Children if a drug (details supplied), available under special licence in the UK and elsewhere, for pain relief for those suffering from multiple sclerosis will be made available on prescription here; and if not, the reason for same. [35508/07]

Photo of Mary HarneyMary Harney (Dublin Mid West, Progressive Democrats)
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My Department is aware that Sativex is a cannabis based product and that claims have been made in respect of cannabis based products and their possible benefits for patients suffering from certain conditions such as Multiple Sclerosis.

Applications for Marketing Authorisations for medicinal products are made to the Irish Medicines Board (IMB). On receipt of an application, the IMB assesses the quality, safety and efficacy data submitted and judges if the benefits of the product outweigh the risk for the proposed indication. If the benefits are deemed to outweigh the risks then the product is normally granted an authorisation.

The current legal position in relation to cannabis is that it is a Schedule 1 controlled drug under the Misuse of Drugs Act 1977 which means that it has no recognised medical use under the law. Under Section 13(1) of the MDA 1977, the manufacture, production, preparation, sale, supply (including administration), distribution and possession of cannabis is unlawful except for the purposes of research. Licences may only be granted for the purposes of research, forensic analysis or as an essential intermediate or starting material in an industrial manufacturing process. Licences may also be granted in the case of certain low Tetrahydrocannabinol plant varieties of Cannabis for the growing of hemp.

Approval was granted a number of years ago for a clinical trial into the use of a cannabis based medicinal extract in controlling cancer related pain but the trial never took place. As the law currently stands, it would not be possible for a cannabis extract to be licensed here for medical use or for a General Practitioner to prescribe it. There are currently no plans to change the law in this regard. The IMB has confirmed that no application for a Marketing Authorisation has been made in respect of Sativex.

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