Dáil Éireann Debate, Tuesday - 13 July 2021
92. Deputy Mick Barry asked the Minister for Health if it will be ensured that a drug manufactured by a company (details supplied) will be included in the cannabis access programme; if he will report on the operation of this programme; and if he will make a statement on the matter. [37664/21]
View answerMedical Cannabis Access Programme
The provision of the Medical Cannabis Access Programme as a result of recommendations by the Health Products Regulatory Authority in their “Cannabis for Medical User – A Scientific Review”.
The review stated that if the policy decision is to make cannabis available for medical purposes, the HPRA advised that it should recognise patient need, but be evidence based. It was advised, that treatment with cannabis be only permitted under a controlled access programme for the treatment of patients with the following medical conditions which have failed to respond to standard treatments;
spasticity associated with multiple sclerosis;
intractable nausea and vomiting associated with chemotherapy;
severe, refractory (treatment-resistant) epilepsy.
Subsequently the Minister for Health established an Expert Reference Group to advise on the development of a Medical Cannabis Access Programme. This Group developed detailed Clinical Guidelines for the MCAP to be followed by clinicians, which contained inter alia guidance on ingredient combinations that are recommended for each of the three indications included in the MCAP
The Medicinal Cannabis Access programme (MCAP) is a 5-year pilot programme. The purpose of the programme is to facilitate access to acceptable cannabis-based products for medical use that are of a standardised quality and which meet the requirements outlined in the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 (as amended).
There are currently 4 products assessed by the HPRA for inclusion in Schedule 1 of the Regulations, more products are currently being assessed by the HPRA.
Reimbursement of the products, prescribed by approved medical consultants and supplied through community pharmacies for a specified therapeutic indication in line with Schedule 2 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019 (as amended) will be on an individual named patient basis aligned to the patient’s eligibility under the community drug schemes (Medical Card, Long Term Illness Scheme and Drugs Payment Scheme). It cannot be assumed that reimbursement approval will be forthcoming on submission of applications. A reimbursement decision will be communicated with the prescribing consultant in writing.
The HSE have indicated that the MCAP will be operational this month.
Bedrocan
The products you refer to are manufactured by the dispensing pharmacy in the Netherlands. Owing to Dutch government restrictions cannabis-based oils may not be commercially exported to pharmacies or wholesalers however they will allow the filling of individual prescriptions for collection by the patient, the patient’s family or a representative.
Representations were made to the Dutch authorities about having the products exported to Ireland to facilitate their inclusion in the Access Programme if the producers wished to do so. The Dutch authorities replied that magistral preparations may only be provided directly to patients or their representative on the basis of a prescription, presented for dispensing.
Since April 2020, owing to the pandemic the Department has been collecting patient’s prescriptions from the Netherlands and delivering them to patient’s homes. These collections approximately every four weeks and will continue post-pandemic.
As a result of the prohibition of commercial export of the cannabis-based products the manufacturers cannot apply to the Health Products Regulatory Authority to have the products included in the Medical Cannabis Access Programme. However patient's can continue be treated with these products if their clinicians have a Ministerial licence issued under the Misuse of Drugs Act to do so.
