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On 26 June, the Minister for Health, Simon Harris, signed the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 (the “2019 Regulations”).
The 2019 Regulations establish the Medical Cannabis Access Programme (“MCAP”), allowing certain patients to be treated with cannabis products (as distinct from authorised medicinal products containing cannabis such as Sativex) and commercial operators to supply these products to the Irish market. The Misuse of Drugs (Designation) (Amendment) Order 2019 and the Misuse of Drugs (Amendment) Regulations 2019, both of which amend existing secondary legislation to facilitate the use of certain cannabis product for medical purposes, were signed into law on the same date.
The MCAP mirrors Denmark’s Medicinal Cannabis Pilot Programme, but stops short of permitting the cultivation of cannabis products in Ireland.
Although the MCAP is now operational, there are currently no medical cannabis products authorised for supply in Ireland. Medical Cannabis product manufacturers and suppliers must now apply to the Health Products Regulatory Authority (“HPRA”) for the necessary authorisation to make their products available in Ireland. Pending the availability of these products, it is envisaged that health care professionals will continue to use the Ministerial licensing route to access medical cannabis treatments for their patients.
Summary of the MCAP:
|MCAP Regime||Further Details|
|Type of drug available under the MCAP?||A “Specified Controlled Drug” (medical cannabis product meeting the requirements under the 2019 Regulations, and listed in Schedule 1 of these Regulations).||Content and strength requirements.
Not an authorised medicine.
Must be permitted to be sold or supplied to patients in another EU Member State, and must be currently supplied to patients in that Member State.
Must be packaged and labelled in English.
|Who can prescribe?||A registered “Medical Consultant” with specialist training in a specified medical condition.||Registered on the Specialist Division of the register of medical practitioners.
Recognised by the Medical Council by reason of his/her training, skill and experience in a medical specialty related to a specified therapeutic indication.
Is a consultant.
Has a continuing clinical and professional responsibility for the patient’s treatment/care.
|Who can benefit?||A person diagnosed with a “Specified Medical Condition”.|
The MCAP is aimed at those who have failed to respond to standard medical treatment.
|Spasticity associated with multiple sclerosis.
Nausea and vomiting associated with chemotherapy.
Severe refractory epilepsy.
|How to avail of the MCAP?||A Medical Consultant must notify the HSE for inclusion of his/her patient on the “Cannabis for Medical Use Register” before issuing a prescription for a medical cannabis product.||The HSE assigns a “CMUR Number” to each person whose name is entered on the Register. A patient’s CMUR Number must be included in his/her prescription.|
|Cost of product?||The HSE will meet the cost of medical cannabis products prescribed under the MCAP.||Reimbursement will be on a named-patient basis and according to the patient’s eligibility under the community drug schemes, with the following conditions:
treatment is consultant initiated;
online reimbursement approval is required for each patient;
all standard approved treatment have been exhausted for that patient; and
new patients are initiated on Irish pharmacy-supplied medical cannabis products
|Who can supply?||A pharmacist or a person carrying on a retail pharmacy business, where the medical cannabis product is supplied for the purposes of his/her profession or business.||The supplier must apply to the HPRA to have the product considered for inclusion on Schedule 1 of the 2019 Regulations.(1) An application fee of €63.50 is payable to the Department of Health.
Additional requirements are imposed where specified controlled drugs are supplied in a hospital.
Suppliers cannot advertise a specified controlled drug to the general public.
|Import licences||A controlled drug annual licence will be required to import the medical cannabis products included in the MCAP.(2) |
A controlled drug import licence will be required to accompany each import consignment.
|The import of specified controlled drugs is subject to rigorous packaging and labelling requirements (see the HPRA’s guide(3) for further detail).
An import licence may be refused if the Department of Health or the HPRA becomes aware of any safety or quality issues associated with the medical cannabis product.
A medical cannabis product imported for the purpose of the MCAP cannot subsequently be exported outside of the State.
|Record-keeping obligations||The 2019 Regulations impose record-keeping obligations on the HSE, suppliers and importers.||The HSE must record all particulars of the supply of medical cannabis products for a period of at least 5 years.
A person receiving or supplying a consignment of medical cannabis products must record (for at least 5 years) certain information such as the name of the drug, its dosage form, quantity and batch number. S/he must also record the name and address of the producer or the person to whom the product was supplied.
|Reporting obligations||A person must report any suspected adverse reaction or quality defect.||A person shall report to the HPRA any suspected adverse reaction within 15 days of receipt of this information.
A similar report to the HPRA must be made within 15 days of learning of any critical or serious quality defect.
Knowledge of any other quality defect must be reported to the HPRA within 90 days of receipt of the information concerned.
(1) The application forms can be found on the ‘Publications and Forms’ section of www.hpra.ie or by contacting email@example.com.
(2) Once a product is listed by the HPRA in Schedule 1 of the 2019 Regulations, it will automatically be included under Schedule 2 of the Misuse of Drugs Regulations 2017. The 2017 Regulations govern the type of licence required for the import or export of various controlled drugs (now including medical cannabis products).
(3) https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0127-guide-to-import-and-export-licences-and-letters-of-no-objection-for-controlled-drugs-v7.pdf?sfvrsn=50 (page 13)Download PDF