While regulatory approval has been recommended for around two years, legal changes are needed to allow its use as a treatment for muscle spasms suffered by patients with MS. The progressive, neurological condition affects 8,000 people in Ireland.
The Department of Health said it will introduce regulations in the coming weeks which would enable authorised, cannabis-based medical products such as Sativex to be legally prescribed by medical practitioners and used by patients.
Sativex is already in use for the relief of spasm symptoms by MS patients in a number of EU countries, including the UK. The availability of this and other cannabis-based treatments have long been sought by support organisation MS Ireland, which welcomed the prospect of revised legislation to allow their use.
“Ongoing research into the benefits of medicinal cannabis and cannabis-based medication extract for the symptoms of MS has shown the efficacy of such treatments to alleviate spasticity, sleep disorders, pain and other symptoms associated with MS,” said chief executive Ava Battles.
“MS Ireland believes people with MS should have access to all and any appropriate and licensed treatments that would improve or assist in the management of their condition,” she said.
More than two-thirds of MS patients who took part in 2010 research by University of Limerick reported spasticity, and one-in-six said it was a main symptom.
Pat O’Mahony, chief executive of the Health Products Regulatory Authority, formerly the Irish Medicines Board, said he understands the department’s move follows the resolution of a High Court appeal relating to the 2010 restrictions on head-shop sales of legal highs. “This is a very important step forward, this is being proposed now for about four years.”
The board recommended approval in 2012. “This will be a prescription product, so MS sufferers will have the prescription written by their GP and then dispensed by the pharmacist,” he said on Today with Sean O’Rourke on RTÉ radio.
In a consultation on wider changes last August, the department proposed excluding medicinal products containing cannabis extract from the list of controlled drugs in regulations governing misuse of drugs.
But the use of cannabis would remain firmly banned as a result of any legal change. Last November, the Dáil rejected a bill from Independent Roscommon TD Luke ‘Ming’ Flanagan that would have regulated the sale and marketing of the drug, and allowed licensed growers cultivate up to six cannabis plants.
Meanwhile, the authority is to increase the number of products which will no longer be dispensed on a prescription-only basis by pharmacists. Mr O’Mahony said it will publish a list of 12 products next week for which it will approve over-the-counter sales in pharmacies, to include some steroid-based skin creams and a migraine drug.