Applying to the Minister for Health for a medical cannabis licence
Where an Irish-registered medical practitioner wishes to consider using cannabis as a treatment for their patient, a licence can be requested from the Minister for Health. In all cases, certain strict conditions must be met in order for such a request to be considered valid.
Medical cannabis products that meet accepted quality standards have not, as yet, been made available by producers directly to the Irish marketplace. Until these products are available in Ireland, it will be a matter for the prescriber and their patient to source the prescribed medical cannabis-based product. It is understood that patients who have been prescribed such products
have sourced it from the following Pharmacy in the Netherlands: Transvaal Pharmacy, Kempstraat 113, 2572 GC The Hague. Tel: 070-3469314.
This pharmacy is supplied with the active ingredients for their CBD and THC-based oils by BEDROCAN International, Postbus 2009 9640CA Veendam, the Netherlands, who are licenced by the Dutch Office of Medicinal Cannabis.
Who can apply for a medical cannabis licence
It is important to note that cannabis for medical use licence applications can only be accepted by the Minister for Health from:
- an individual patient’s medical consultant, where evidence of an established doctor-patient relationship exists, or
- from the individual patient’s General Practitioner (GP) where the GP’s licence application is accompanied by a written endorsement for the cannabis treatment from the patient’s medical consultant.
To see the requirements for the granting of a Ministerial licence and information on how to apply please see the Ministerial Licence Application Process section below.
Medical Cannabis Access Programme
The Minister intends to introduce a Cannabis for Medical Use Access Programme. This programme is under development and it will facilitate access to cannabis products, which are not authorised as medicines, for patients suffering from a limited number of medical conditions. Until such time as producers of medical cannabis products that meet accepted quality standards and make their products available directly to the Irish marketplace, the access programme cannot be fully operationalised.
Difference between (i) (authorised) cannabis-based medicines, (ii) cannabis-based products and (iii) investigational cannabis-based products
This section explains the difference between an authorised cannabis-based medicine and a product derived from cannabis which is not authorised but which may be considered for inclusion as part of a patient’s medical treatment.
A Ministerial licence is not required for a clinician to prescribe an authorised medicine containing cannabis, as these medicines are not normally listed in Schedule 1 of the Misuse of Drugs Regulations 2017. As such, authorised medicines containing cannabis can be prescribed and procured in the usual manner in line with controlled drugs prescribing and supply rules. Authorisations are issued by either a national competent authority such as the HPRA or by the European Medicines Agency. Authorised medicines have a positive benefit/risk profile and are subject to on-going monitoring by regulatory authorities
Neither the Ministerial licence route nor the Cannabis Access Programme (once it is up and running) are intended to facilitate access to authorised medicines containing cannabis. Both routes of access are intended to allow access to cannabis-based products which are not authorised as medicines. However, it is intended that such unauthorised cannabis-based products must be of a standardised quality and must meet an acceptable level of quality assurance during their manufacturing process.
Medicines, authorised in Ireland or elsewhere, including authorised cannabis-based medicines, should always be considered for use in the first instance. However, if an authorised medicine is not available or is not suitable for the patient, cannabis-based products that do not have a marketing authorising may be considered as a treatment option, via the Ministerial licence application process, or eventually through the Medical Cannabis Access Programme, once it is established.
(i) Cannabis-based medicines
There are a number of cannabis-based products which have been authorised as medicinal products in some countries, including Sativex®, nabilone, and dronabinol (please note that dronabinol is currently classified as a Schedule 1 Controlled Drug and therefore does require a Ministerial Licence). These are therefore referred to as cannabis-based medicines. Authorisations are issued by either a national competent authority such as the HPRA or by the European Medicines Agency. Authorised medicines have a positive benefit/risk profile and are subject to on-going monitoring by regulatory authorities.
(ii) Cannabis-based products
Cannabis-based products that do not have a marketing authorisation are not medicines as defined under national and European legislation. As such, they are not subject to the same rigorous safety, quality and efficacy standards that are in place for medicines, nor are the producers subject to the same responsibilities as the marketing authorisation holders for authorised medicines.
Whilst efficacy and safety data are not available for these products, it is important to be assured, as far as possible, of the quality of the products. These products will be required to be made to specified laboratory and manufacturing standards and are often supplied in the form of processed oils or sprays with identified levels of the cannabinoids required.
(iii) Investigational cannabis-based products
A product called Epidiolex has recently been approved by the United States Food and Drug Administration (FDA) for the treatment of two forms of Epilepsy: Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older.
Epidiolex is a liquid formulation of purified, plant-derived CBD. It has investigational medicine status in Europe, and as such, if a patient’s medical consultant is considering prescribing it, he or she may apply directly to the manufacturers – GW Pharma (www.gwpharm.com) for further information on access arrangements.
Medical cannabis products that meet accepted quality standards have not, as yet, been made available by producers directly to the Irish marketplace. This is a critical aspect of facilitating access to medical cannabis for Irish-based patients. Department of Health officials are working intensively to ensure a supply of appropriate cannabis-based medical products to meet the needs of Irish patients. Until these products are available in Ireland, it will be a matter for the prescriber and their patient to source the prescribed medical cannabis-based product. It is understood that patients who have been prescribed such products have sourced it from the following Pharmacy in the Netherlands: Transvaal Pharmacy, Kempstraat 113, 2572 GC The Hague. Tel: 070-3469314.
This pharmacy is supplied with the active ingredients for their CBD and THC-based oils by BEDROCAN International, Postbus 2009 9640CA Veendam, the Netherlands, who are licenced by the Dutch Office of Medicinal Cannabis.’
Glossary of terms
- Cannabinoid – any of a group of closely related compounds which include cannabinol and the active constituents of cannabis.
- Tetrahydrocannabinol – also known as THC – A psychoactive cannabinoid which is strictly controlled under the Misuse of Drugs Act.
- Cannabidiol – also known as CBD – A non-psychoactive cannabinoid which is not subject to control under the Misuse of Drugs Act and which is sometimes sold as a food supplement.
- Health Products Regulatory Authority (HPRA) – the Competent Authority for the implementation of EU and national legislation relating to medicines in Ireland. The HPRA’s role includes monitoring and inspecting health products on the market to ensure their safety, efficacy and legality.
- Psychoactive Substance – a substance having a profound or significant effect on mental processes.
- Misuse of Drugs Acts and Regulations – The Misuse of Drugs Acts and the Regulations made thereunder are the main laws regulating controlled drugs in Ireland. They include controls relating to cultivation, licensing, possession, administration, supply, record-keeping, prescription-writing, destruction, storage and safe custody, import and export. They also establish the offences and penalties under the Act.