The new rules will make access more systematic by putting the decision in the hands of medical consultants.
Minister for Health Simon Harris TD today signed legislation which will allow for the operation of the Medical Cannabis Access Programme on a pilot basis for five years. The Programme will facilitate access to cannabis-based products for medical use in line with legislation.
Minister Harris said:
Today is a significant milestone. For years, families have fought for this programme to be established and for years, we have faced many challenges, obstacles and hurdles. I am so pleased to be here today to advance this Programme and help the lives of many families across the country.
The purpose of this Programme is to facilitate compassionate access to cannabis for medical reasons, where conventional treatment has failed. It follows the clear pathway laid out by the Health Products Regulatory Authority in their expert report ‘Cannabis for Medical Use – A Scientific Review’.
Ultimately it will be the decision of the medical consultant, in consultation with their patient, to prescribe a particular treatment, including a cannabis-based treatment, for a patient under their care. It is important to state that there are no plans to legalise cannabis in this country.
Minister of State for Health Promotion and the National Drugs Strategy Catherine Byrne also welcomed the secondary legislation that will underpin the Medical Cannabis Access Programme.
Minister Byrne commented: This is an important and positive step forward for those individuals who are suffering serious ill health but for whom conventional medicines are not working.
The signing of the legislation underpinning the Access Programme allows for commencement of the operation of the Access Programme, for first stage of which is for potential suppliers to apply to have their medical cannabis products assessed for suitability for medical use.
Currently no medical cannabis products are available in Ireland, however, this legislation now means that commercial operators whose cannabis products meet the specified requirements set out in the legislation and which have been listed in Schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations will be able to supply these products to the Irish market.
Once suitable medical cannabis products are made available by suppliers, the Access Programme will make it possible for a medical consultant to prescribe a listed cannabis-based treatment for a patient under his or her care for the following medical conditions, where the patient has failed to respond to standard treatments:
- spasticity associated with multiple sclerosis;
- intractable nausea and vomiting associated with chemotherapy;
- severe, refractory (treatment-resistant) epilepsy.
In thanking the Expert Reference Group, chaired by Dr Máirín Ryan, Deputy Chief Executive of HIQA, which drafted the detailed Clinical Guidelines for the Access Programme, Minister Harris commented that the important work carried out by the Expert Reference Group in producing these clear and concise clinical guidelines, informed the development, direction and ultimate delivery of the Access Programme.
Work on the establishment of Programme began in March 2017, on foot of the conclusions from the Health Products Regulatory Authority’s (HPRA) expert report Cannabis for Medical Use – A Scientific Review, which was prepared at the request of the Minister for Health.
The Minister for Health extends his sincere thanks to Dr Lorraine Nolan and the staff of the HPRA and to the Expert Working Group for providing the foundation block for the development of this Programme and for assisting in making the Access Programme a reality for patients. Further information on the Medical Cannabis Access Programme:
- Suppliers / Importers: A prospective supplier can apply to the Health Products Regulatory Authority (HPRA), on behalf of the Minister, to have a product considered for inclusion in the Schedule of ‘specified controlled drugs’ in this new piece of legislation (see also below under ‘Additional Information – Guidance for Suppliers/Importers’). As specified controlled drugs will fall under schedule 2 to the Misuse of Drugs Regulations 2017, a controlled drugs licence, processed by the HPRA, on behalf of the Minister, is also required for possession, supply or import of such cannabis products.
- Patients with a specified medical condition should see their medical consultant for advice. It is important to understand that it will only be possible for specialist consultants to prescribe a specified controlled drug (medical cannabis products) under the Access Programme, once suppliers make these products available on the Irish market.
- Prescribers (medical consultants on the specialist register) will be able to prescribe cannabis for medical use to patients as set out in the legislation. It is important to understand that it will only be possible for specialist consultants to prescribe a specified controlled drug (medical cannabis products) under the Access Programme, once suppliers make these products available on the Irish market. Prescribers should also refer to the clinical guidelines prepared by the Expert Reference Group, available on the Department of Health Website.
- Pharmacists will be able to dispense Cannabis for Medical Use to patients as set out in the legislation, on foot of a valid prescription, once suppliers make the specified controlled drugs available on the Irish market. Pharmacists should also refer to the Clinical Guidelines prepared by the Expert Reference Group, available on the Department of Health website.
The offences and penalties for unauthorised supply and possession of controlled substances remain unchanged. It is important to note that where a cannabis product is a specified controlled drug legally permitted for medical use, in connection with the MCAP, this does not signify any endorsement whatsoever of the safety, quality or efficacy of the specified controlled drug for the indication prescribed and the Minister for Health will have no liability in respect of the use of such products by a person issued with a prescription by their clinician under this Regulation. The use of a cannabis product for the purposes of the MCAP is a matter for the patient and their medical advisor.
Additional Background Information
The Medical Cannabis Access Programme was initiated on foot of the Health Products Regulatory Authority’s (HPRA) expert report Cannabis for Medical Use – A Scientific Review, which was prepared at the request of the Minister in 2016. Following publication of the report, Minister Harris established an Expert Reference Group to advise on the development of a Medical Cannabis Access Programme. The Group developed detailed clinical guidelines for the Programme, which are available on the Department of Health website. The HSE will establish and maintain a Register for the Medical Cannabis Access Programme to facilitate the enrolment and recording of certain data including patient identifiers (in anonymised format), prescribers enrolled in the programme, as well as prescribed / supplied medical cannabis products. The underpinning secondary legislation for the Programme includes:
- The Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 set out the legal provisions for the operation of the Medical Cannabis Access Programme and the legal obligations for healthcare professionals and commercial operators;
- The Misuse of Drugs (Designation) (Amendment) Order 2019 amends S.I. No. 533 of 2017, Misuse of Drugs (Designation) Order 2017 by removing from the scope of the Order certain cannabis-based products that will be permitted for use under the Medical Cannabis Access Programme;
- The Misuse of Drugs (Amendment) Regulations 2019 amends S.I. No. 173 of 2017 – Misuse of Drugs Regulations 2017 to reschedule certain acceptable cannabis-based products for medical use under the Medical Cannabis Access Programme from Schedule 1 to Schedule 2.
Guidance for Suppliers / Importers of cannabis-based products
- Cannabis products that can be used in the Medical Cannabis Access Programme are defined as ‘specified controlled drugs’ in legislation and the definition outlines the specific requirements for those products.
- Only products included in the schedule of specified controlled drugs can be prescribed by medical consultants under the Medical Cannabis Access Programme.
- The criteria cannabis products must meet in order to be considered by the Minister for inclusion on the schedule are set out in the legislation and can be found in the operator guidance issued by the HPRA
- Details on how to apply for a licence to possess, supply or import medical cannabis products for use under the Medical Cannabis Access Programme in accordance with the requirements for schedule 2 products in the Misuse of Drugs Regulations 2017 can be found in the operator guidance issued by the HPRA
For further information operators should contact the HPRA at [email protected]
The HSE will meet the cost of cannabis products listed in Schedule 1 of the Misuse of Drugs Prescription and Control of Supply of Cannabis for Medical Use, under the Medical Cannabis Access Programme and supplied through community pharmacies for patients with a qualifying medical condition, in line with the existing support schemes for medicines dispensed through community pharmacy, namely the Long-Term Illness Scheme, GMS (Medical Card) Scheme and the Drug Payment Scheme. Products will only be listed in Schedule 1 of the Misuse of Drugs Prescription and Control of Supply of Cannabis for Medical Use once they have been assessed as suitable for medical use under the Medical Cannabis Access Programme. Authorisation will be on a named-patient arrangement and subject to the following conditions:
- Treatment is consultant-initiated
- Online reimbursement approval is required for each patient
- All standard approved treatments have been exhausted for that patient
- New patients are initiated on Irish pharmacy-supplied products
Enrolment on the Medical Cannabis Access Programme does not automatically mean approval for reimbursement of cannabis-based products.
Source – Irish Government News Service
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