Tuesday, 26 February 2019
Department of Health
Cannabis for Medicinal Use
390. To ask the Minister for Health the progress made to date on the proposed cannabis access programme; if potential suppliers have been identified; and the timeframe for the implementation of the programme. [9540/19]
I propose to take Questions Nos. 390 to 392, inclusive, together.
Quality Standards for medical cannabis products
The Medical Cannabis Access Programme aims to facilitate access to certain cannabis-based products which have not been authorised as medicines by a statutory Medicines Competent Authority. This means that the product manufacturers have not applied for an authorisation to market their products as medicinal products. This is because these products are unlikely to meet the same rigorous safety, quality and efficacy standards that authorised medicines must meet before being placed on the market, nor are the production processes likely to meet the same level of regulatory requirements as the marketing authorisation holders for authorised medicines.
However, whilst efficacy and safety data are not available for these products, it is crucially important that patients and prescribers can be assured, as far as possible, of the quality of these products. Department officials are working to ensure that appropriate procedures are put in place to facilitate this requirement in relation to cannabis-based products that will be permitted for medical use in Ireland.
Access to Medical Cannabis
Availability of cannabis products that are of an appropriate quality standard and are affordable to patients is clearly critical in establishing the access programme. To the Department’s knowledge only two countries, Canada and the Netherlands, currently permit export of such cannabis products, which meet acceptable quality control standards, beyond their borders. The Netherlands permits exports of cannabis dried herb, but does not permit commercial export of their oil-based cannabis formulations, which is the formulation preferred by the clinical community.
Department officials are working intensively on finding solutions to the supply of appropriate quality assured products for Irish patients, in parallel to their ongoing work on other significant projects. Department of Health officials are in regular contact with their counterparts in other countries, including Denmark, UK and Canada.
However, the Department of Health has no control in relation to business decisions taken by commercial product manufacturers and has no powers to compel companies to supply their products to the Irish market.
Pending full operation of the Access Programme, doctors may continue to utilise the Ministerial licensing route to prescribe medical cannabis for their patients. Thirty-two licences have now been granted in respect of sixteen individual patients.
As the Deputy has stated, until suitable medical cannabis products are made available in Ireland, prescribers and their patients are sourcing the prescribed product from a pharmacy in The Netherlands, on foot of their medical prescription.
It is intended that the Ministerial licence application scheme will continue to operate in parallel with the Cannabis for Medical Use Access Programme, after the programme becomes operational, for exceptional cases only where there is an unmet clinical need.
One licence has been granted to an entity for the importation of products containing medical cannabis.
Department of Health website:
Information on the situation regarding medical cannabis is available on the Department of Health website. The medical cannabis section is continually updated.