Ireland is embarking on a five-year medical cannabis pilot program, opening up commercial opportunities for companies to supply the Irish market once their products have met approval requirements set out in legislation.
The cannabis products will be dispensed from pharmacies – a common trait in federally regulated European medical marijuana markets.
The country’s Health Service Executive will cover the cost of prescriptions for patients with qualifying medical conditions, so long as treatment is consultant-initiated, online reimbursement approval is accepted and all standard approved treatments have been exhausted.
However, patient enrollment in the program does not automatically mean approval for reimbursement.
The new rules will make access more systematic by putting the decision in the hands of medical consultants.
“Today is a significant milestone,” Health Minister Simon Harris said in a statement. “The purpose of this program is to facilitate compassionate access to cannabis for medical reasons, where conventional treatment has failed.”
Ireland’s medical cannabis program is similar to ones already underway or in the works in countries such as Denmark and France in that it will run for a predetermined amount of time.
Ireland’s health department issued the following guidance for potential suppliers and importers of cannabis-based medical products:
- Appropriate medical marijuana products are defined as “specified controlled drugs” in the legislation.
- Only products that make the list of “specified controlled drugs” can be prescribed by medical consultants.
Details on how to apply for a licence to supply or import medical cannabis products – including packaging and labeling requirements – can be found here.
Companies must complete an application form for their products to be considered for approval. The application form from the Health Products Regulatory Authority can be found here.
Medical consultants will be able to prescribe a cannabis-based treatments when “standard” treatments have failed for:
- Spasticity associated with multiple sclerosis.
- Intractable nausea and vomiting associated with chemotherapy.
- Severe, refractory (treatment-resistant) epilepsy.
For more information, contact the Compliance Department at the Controlled Drugs, Licensing Section of the Health Products Regulatory Authority, at [email protected].
The clinical guidelines can be found here.