Two medicinal cannabis products approved for use in Ireland
TWO MEDICINAL CANNABIS products have been approved and registered for use in Ireland under the new Medical Cannabis Access Programme.
The two products are Aurora High CBD Oil Drops and CannEpil.
The two companies approved to supply the products are Aurora Cannabis Enterprises Inc and MGC Pharmaceuticals, which have both been recommended as being suitable for use under programme.
Health Minister Simon Harris signed legislation in June to allow for the operation of the programme on a pilot basis for five years.
The medicinal cannabis access scheme now makes it possible for a medical consultant to prescribe a cannabis-based treatment for a patient under his or her care, but only for patients with specific medical conditions, where the patient has failed to respond to standard treatments.
These conditions are:
spasticity associated with multiple sclerosis
intractable nausea and vomiting associated with chemotherapy
severe, refractory (treatment-resistant) epilepsy
Following the signature of the legislation, work got underway to find appropriate and approved suppliers of cannabis products for use in Ireland.
Commercial medicinal cannabis suppliers had to meet specified requirements set out in the legislation in order to be able to supply these products into Ireland.
The companies cannabis products will now be listed on Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019.
While the approval of the products has been described as an important step in the process, these products are still subject to international controlled drug import and export licensing requirements.
Under the programme, when a consultant prescribes the medicinal cannabis for use, the companies will apply for a licence to bring the product into Ireland for distribution. Such requirements are outside the Department of Health’s control.
However it is understood it will only take a matter of weeks before patients get to use the products.
CannEpil is a product that “has been years in the making”, according to Roby Zomer, Executive Director and CEO at MGC Pharmaceuticals. CannEpil was released to the market in 2017, and is a CBD-based medication that is used as a treatment for people with refractory epilepsy.
Aurora CBD drops are extracted from the company’s “non-psychoactive CBD strains”, it states on its website.
In a statement today about its cannabis products being approved for distribution in Ireland, Canadian company, Aurora confirmed that its CBD oil drops will now be added to the regulatory schedule enabling importation, prescribing and supply under the scheme.
Dr Shane Morris, Chief Product Officer at Aurora said the company is pleased to be able to assist patients who are seeking treatment with high quality EU-GMP (good manufacturing practice) certified pharmaceutical-grade medical cannabis in Ireland.
We are very proud to be one of the first approved suppliers of medical cannabis under the MCAP. We want to acknowledge the efforts made by many people, especially the patients and doctors who have campaigned for access to these medicines.
“We look forward to more of Aurora’s high-quality medicines being approved, so that more patients can benefit from the MCAP in Ireland. We will continue to work closely with all parties and state agencies to facilitate further availability.”
People Before Profit TD for Dublin Mid-West, Gino Kenny, who has been a long-time campaigner for medicinal cannabis use, has said that the news that medicinal cannabis products are available now to be prescribed is “a step in the right direction”.
“This represents a step in the right direction for those that have been campaigning for the past four years on getting legal and medical access to cannabis-based products in Ireland…
“Though welcome the programme needs to include other conditions where these products could be beneficial for a stated condition- such as pain relief for chronic pain,” he said.
Kenny said it has been a “very protracted number of years for campaigners, but this could be the beginning of something much bigger in the future”.