Richard O'Donoghue (Limerick County, Independent)
Link to this: Individually | In context | Oireachtas source

986. To ask the Minister for Health if his attention has been drawn to the number of persons in Ireland that need to take PCBD 110 oil prescribed by their consultants for their illness (details supplied); and if he will make a statement on the matter. [52774/21]

Stephen Donnelly (Wicklow, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

The Health Service Executive (HSE) has statutory responsibility for decisions on pricing and reimbursement of medicines under the community drugs schemes, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. Reimbursement for medicines under the community drugs schemes is for licensed indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact. The Minister for health has no role in these decisions. The HSE have advised that PCBD110 is not reimbursable under the community drugs schemes.

The Medical Cannabis Access Programme (MCAP) is a 5-year pilot programme. The MCAP allows medical consultants to prescribe specified cannabis-based products for patients with certain medical conditions who have exhausted all other available medical treatment options. Those conditions are:

- Spasticity associated with multiple sclerosis

- Intractable nausea and vomiting associated with chemotherapy

- Severe, refractory (treatment-resistant) epilepsy

The MCAP is now open for medical consultants to make an application for themselves and their patients to be registered on the Cannabis for Medical Use Register, operated by the HSE.

Prospective suppliers of products to the MCAP can apply to the Health Products Regulatory Authority (HPRA), acting on behalf of the Minister for Health, to have a cannabis product considered for inclusion in the schedule to the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019. The onus is on prospective suppliers to submit applications to the HPRA.

For medical indications not included in the MCAP, doctors may continue to utilise the Ministerial licensing route to prescribe medical cannabis for their patients. In line with the Chief Medical Officer's advice, the granting of a licence for cannabis for medical purposes must be premised on an appropriate application being submitted to the Department of Health, which is endorsed by a consultant who is responsible for the management of the patient and who is prepared to monitor the effects of the treatment over time.

It is important to note that the medical decision to prescribe or not prescribe any treatment, including cannabis treatment, for an individual patient is strictly a decision for the treating clinician, in consultation with their patient. The Minister for Health has no role in this clinical decision-making process.