Simon Harris (Wicklow, Fine Gael)
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Tetrahydrocannabinol (THC) is the principal psychoactive constituent of cannabis. Under the Misuse of Drugs Acts 1977 to 2016 and the Regulations made thereunder, the manufacture, production, preparation, sale, supply, distribution and possession of cannabis and certain cannabis-related compounds is currently unlawful except under licence. However, the scope for such licences to be issued is restricted to a limited number of specific circumstances. This is in line with the international controls on cannabis as prescribed under the United Nations Single Convention on Narcotic Drugs 1961. It is open for an Irish registered doctor to apply for a licence for such preparations for an individual, named-patient under their care. Such applications will be considered on a case by case basis. The appropriateness of any particular treatment is a matter between the patient and their doctor. It would be entirely inappropriate for me, as Minister for Health, to involve myself in this process. My understanding is that many doctors would be quite cautious about recommending a cannabis-based treatment for a patient, in the absence of the robust clinical evidence which underpins authorised medicines.

Under European and Irish legislation, before a medicine can be placed on the Irish market the manufacturer has to 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.

In July 2014, the Misuse of Drugs Regulations 1988, were amended to allow for a specific cannabis-based medicinal product to be used in Ireland. This derogation was facilitated based on evidence from scientific data submitted by a company to demonstrate the quality, safety and efficacy of this specific medicine and its ability to provide a clear medical benefit for patients with multiple sclerosis. Subsequently the HPRA granted a marketing authorisation for Sativex Oromucosal Spray to be marketed in the State for the relief of symptoms of spasticity for people with multiple sclerosis where other conservative treatments have failed to provide adequate benefits. To date, the HPRA has not received any applications for authorisation for any further cannabis-based products, but remains open to doing so.

I have committed to urgently reviewing policy on medicinal cannabis. I have asked the HPRA for advice on emerging research and international developments in the use of medicinal cannabis. I hope to receive a report from the HPRA early in the new year. I will then be in a position to consider and progress any legislative changes that may be recommended.