The Irish Government has passed the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 (the 2019 Regulations) which allow for the use of cannabis for the treatment of persons with certain medical conditions, under the care of a medical consultant. As a result of this legislation, projected statistics indicate that up to 50,000 Irish patients could be prescribed cannabis within the next four years.
Development of legislation
HPRA 2017 Report & 2017 Regulations
The Health Products Regulatory Authority (HPRA) published an expert report in January 2017 which concluded that the available scientific advice found a moderate benefit for cannabis in a small number of medical conditions.
Following which, the Misuse of Drugs Regulations 2017 (the 2017 Regulations) were brought into force in May 2017. Under this legislation an Irish registered practitioner can apply for a licence from the Minister of Health to prescribe a cannabis product for medicinal purposes for a named patient. The 2017 Regulations apply controls to groups of drugs which, for medical purposes, include cannabis, cannabinol, cannabinol derivatives, cannabis resins and other cannabis-related substances are listed under Schedule 1 of this Act.
2019 Regulations and further amendments of the law
The 2019 Regulations now do away with the requirement of licences allowing a medical consultant to issue prescriptions for cannabis without applying for a licence from the Minister for Health. However, under Part 2 Section 4(2), the patient’s name must be entered onto the Cannabis for Medical Use Register (CMUR) and the CMUR number which they are assigned by the Health Service Executive (HSE) must be listed on their prescription by their medical consultant.
Medical Cannabis Access Programme
A further development following the HPRA 2017 Report was the announcement by the Department of Health that a Medical Cannabis Access Programme (MCAP) would be established (although this has been delayed due to issues in finding a quality assured supplier of cannabis who can export their products to Ireland).
The aim of the MCAP scheme is to facilitate access to cannabis – based products for medical use in accordance with the 2019 Regulations, by allowing medical consultants to prescribe listed cannabis – based treatments for patients under their care where they have failed to respond to standard treatments. The Department of Health has published Clinical Guidance which they state will form part of the MCAP scheme once fully operational.
In order to enrol their patients onto MCAP, consultants must, under Part 2 Section 4(6) of the 2019 Regulations, notify the HSE, but ultimately, the final decision of the suitability of a cannabis prescription will be made by medical consultants. The Minister for Health has indicated that he expects patients to be able to access the scheme from autumn 2019, however in the interim, consultants may still utilise the ministerial licensing route established under the 2017 Regulations.
MCAP will operate on a pilot basis for five years, and as per the 2019 Regulations will allow prescription of cannabis products only for the following conditions:[1]
- Spasticity associated with multiple sclerosis
- Intractable nausea and vomiting associated with chemotherapy, and
- Severe, refractory (treatment-resistant) epilepsy
Supply chain
At present, as there are no medical cannabis products available in Ireland patients are required to travel abroad to fill their prescriptions. The 2019 Regulations will allow commercial operators whose products meet the specifications outlined in the legislation and which have been listed under Schedule 1 of the Regulations to supply these products on the Irish market by making an application to the HPRA.
The difficulties in sourcing quality assured suppliers who can export their product to Ireland is expected to be a significant issue and already has led in part to the delayed establishment of the MCAP.
To address this, the Government confirmed in March 2019 that a medical cannabis product for Irish import had been identified and a licence granted for the importation of “specified cannabis containing products”. The Minister for Health has indicated that the option of growing and developing the State’s own supply of medicinal cannabis is being looked at. It remains to be seen if this will be viable solution.
Global approaches
In amending its laws on the prescription of medical cannabis the Government is aligning itself with the current global trend; currently there are approximately forty countries which have legalised medical cannabis. In 2018, the UK and Northern Ireland approved new laws allowing prescription of medical cannabis based products without a Government license. Canada also introduced laws in respect of both recreational and medicinal use of cannabis last year.
In the US, ten states have approved recreational usage, and medicinal cannabis is legal in thirty three states. The US medical cannabis industry shows no sign of slowing down with estimates of around $4.5billion at the end of 2018.
Conclusion
This legal development has been hailed by the Government as a “significant milestone” and given current global industry trends, the progress of this area in Ireland will be extremely interesting to watch, especially as regards supply of the product. Given the apparent profitability of the market, it seems probable that there may not be a supply issue for long as key players in the industry will likely be keen to establish themselves as suppliers in Ireland as soon as possible.
For more information, contact a member of our Life Sciences & Product Regulatory team.
[1] Schedule 2 of Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 (S.I. No. 262. 2019)
