Cannabis remains a controlled substance in most jurisdictions, but demand for medicinal and wellbeing cannabis products and their derivatives is growing fast. While Ireland was once considered a conservative market when it comes to cannabis and CBD, in line with other European jurisdictions, there has been a recent focus on modernising the legislative framework surrounding cannabis. This is a rapidly changing industry, subject to significant controls, with a lack of regulatory harmonisation internationally. At DLA Piper Dublin, we are currently helping clients plan for developments, working with our global cannabis practice to anticipate likely changes and provide strategic insights. As local cultural attitudes evolve and further scientific developments are made, we are advising in every segment of the pharmaceutical, biopharmaceutical, wellness and medicinal sectors around the world.
Globally there has been a renewed interest in this area, in recognition of the importance of the developments around medicinal and wellbeing products deriving from cannabis. However, given the heavy regulatory burden and criminal sanctions around these products, there has been limited scope to access the medicinal benefits of the products. This is now set to change and open up a new pathway for medical access in Ireland.
As matters stand, cannabis and cannabidiol derivatives containing THC are controlled substances under the Misuse of Drugs Act. While we do not anticipate there being significant changes to this position in the near future, the Government has identified the review of the regulatory framework regarding cannabis as a strategic aim. The 2020 Programme for Government included two strategic aims in this respect:
- to examine the regulations and legislation that apply to cannabis for medical conditions, having regard to the position in the UK; and
- to re-examine alternative approaches to possession of drugs for personal use.
To this end, on 21 January 2021 the Minister for Health announced provision for the delivery and funding of the Medicinal Cannabis Access Programme. Once suitable medical cannabis products are made available by suppliers, the Access Programme makes it possible for a medical consultant to prescribe a listed cannabis-based treatment for a patient under their care. The Access Programme is limited to certain conditions, and only in circumstances where the patient has failed to respond to standard treatments for:
- spasticity associated with multiple sclerosis;
- intractable nausea and vomiting associated with chemotherapy; or
- severe, refractory (treatment-resistant) epilepsy.
Currently, there is no provision in Irish legislation for the approval of compassionate use programmes for specific groups of patients with an unmet medical need, and instead the Misuse of Drugs (Prescription and control of supply of cannabis for medical use) Regulations 2019 provides a legal framework for the Access Programme.
To access the Programme, potential suppliers apply to the Irish regulator, the Health Products Regulatory Authority (HPRA), to have their cannabis-based products assessed for suitability for medical use. Currently four products have been successfully assessed by the HPRA, and further products are under active review. Only products which have been assessed and included in the schedule of specified controlled drugs can be prescribed.
Ultimately it will be for the medical practitioners to determine the appropriateness of treatment for patients, and there may be uncertainties of re-imbursements where there is reliance on private medical insurance. However this is an important step in creating an accessible medical cannabis regime, and will be welcomed by patients, and across the wider industry.