This blog covers the legal commercial supply of medicinal cannabis (physical distribution of medicinal cannabis products) in Ireland by wholesalers.
With the introduction of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019, came the first legalised route for medicinal cannabis to be distributed in the Irish state. This legislative introduction came with stringent measures attached to ensure medicinal cannabis was not able to be distributed in a manner similar to other standard prescription or controlled drugs permitted within the state. Important to note that the information below relates to the physical distribution of medicinal cannabis products in Ireland. Use link here for access to the original 2019 legislation at the Irish Statute Book website, https://www.irishstatutebook.ie/eli/2019/si/262/made/en/print?q=Misuse+of+Drugs+Prescription+and+Control+of+Supply+of+Cannabis+for+Medical+Use+Regulations
The first aspect of these stringent measures is the referral of medicinal cannabis as not a “controlled drug” but a “specified controlled drug”. The definition of a specified controlled drug is defined within the Act itself but in essence it is medicinal cannabis produced from dried, ground or powdered cannabis and listed within schedule 1 of the Act, schedule 1 will be elaborated upon below. Defining medicinal cannabis as separate to standard controlled drugs allows the government to impose more stringent measures around its prescription and distribution.
Before a wholesaler decides they want to distribute medicinal cannabis they must understand the upcoming points, there is a reason the Act has made a distinction between medicinal cannabis and other controlled drugs. Medicinal cannabis can only be prescribed to patients with one of three specific conditions:
- spasticity associated with multiple sclerosis;
- intractable nausea and vomiting associated with chemotherapy;
- severe, refractory (treatment-resistant) epilepsy.
Only if a patient has one of these conditions can they apply for access to the Medicinal Cannabis Access Program (MCAP). MCAP is a system which permits the patient and their prescribing medical practitioner the right to access medicinal cannabis products. From a wholesaling perspective, this is a very small pool of patients who may access the medication.
A further caveat is listed within section 11 of the Act. This section puts restrictions on who can be supplied with a specified controlled drug. A wholesaler can only supply medicinal cannabis to a pharmacist or a hospital, no other customer type. This means wholesaler to wholesaler transactions in Ireland are not permitted. If you are physically distributing medicinal cannabis products, you are only permitted to supply them to pharmacists and hospitals.
Section 13 of the Act puts an added restriction on distribution, once a wholesaler imports a specified controlled drug into Ireland, the specified controlled drug cannot be then exported to another State. Our general understanding of export as wholesalers is with regards to exporting to a third country. Under this Act however, export means to export to any country outside Ireland. Since Brexit, Northern Ireland falls under EU law but do not confuse this here, this legislation is specifically referring to the state as in the Republic of Ireland. Once a wholesaler imports a medicinal cannabis product this product can only be supplied to pharmacies and hospitals within Ireland.
The final aspect within the legislation that affects wholesalers is which medicinal cannabis products can be distributed. A wholesaler cannot purchase any random medicinal cannabis product it wishes and supply it to a pharmacy or hospital. Schedule 1 is built into the Act and within here is listed the medicinal cannabis products that have successfully applied to the HPRA to be part of the Medicinal Cannabis Access Program. Only the products listed within this schedule are permitted to be distributed as specified controlled drugs. There have been 5 amendments to the Act since its inception in 2019, with each amendment a new schedule is 1 is produced listing more medicinal cannabis products. The most recent incarnation is the 2022 Amendment Act, Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) (Amendment) Regulations 2022, see link for access to the Act https://www.irishstatutebook.ie/eli/2022/si/237/made/en/print?q=Misuse+of+Drugs+Prescription+and+Control+of+Supply+of+Cannabis+for+Medical+Use+Regulations
To get a cannabis based medicinal product listed within this schedule is not as arduous as one might expect. An application is made to the HPRA using the “Application for products to be considered for inclusion in Schedule 1 of the Misuse of Drugs (Prescription and control of supply of cannabis for medical use) Regulations 2019” or AUT-F0824 for short, see link for access to the HPRA website with further information on the form, http://www.hpra.ie/homepage/controlled-substances/controlled-substances/medical-cannabis-access-programme. In order for a product to be listed on Schedule 1 certain information is required and the product concerned must already be supplied to patients for medical purposes in another EU state. This piece about supply to patients in another EU state requires a confirmation in the form of documentation from the specific EU states Competent Authority.
The wholesaler who does decide to follow through on distribution of medicinal cannabis also then has the normal licencing requirements from the HPRA to follow, such as the maintenance of an annual controlled drug licence, import licences for each batch of medicinal cannabis imported and updating the HPRA on product numbers imported each year. It is important to understand that medicinal cannabis products that can be distributed within Ireland are listed on schedule 1 of the Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019, but these medicinal cannabis products are further listed as schedule 2 controlled drugs under the Misuse of Drugs (Amendment) Regulations 2019. This means the wholesaler will require a controlled drug licence, not a registration. This licence will need to be re-applied for annually. See link for the Act, https://www.irishstatutebook.ie/eli/2019/si/282/made/en/print?q=Misuse+of+Drugs+Amendment+Regulations+2019
The conclusions from the current legislation are the following:
- the current patient pool that can access medicinal cannabis is small due to the specific conditions listed within the legislation that can access the MCAP;
- the distribution models a company can utilise are very limited, physical supply of medicinal cannabis products must be to pharmacies or hospitals;
- there is an export ban on medicinal cannabis products imported into the Republic of Ireland;
- there is a limited number of products that can be distributed as per schedule 1 of the Act, but the schedule can be updated.
References:
- Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) 2019 as amended.
- HPRA Guide to Good Distribution Practice of Medicinal Products for Human Use IA-G0046.
- HPRA Guide to Import and Export Licences and Letters of No Objection for Controlled Drugs (including the import of cannabis products for medical use) AUT-G0127.
By Ruairí Doyle, FQS GDP Manager and Compliance Lead.
