On June 26th, 2019, the Health Minister gave the green light to a new law allowing the Medical Cannabis Access Programme (MCAP) to kick off as a trial run for five years – we are currently heading towards the end of that period and we have been asked to have a look at the relevant legislation that grounds the whole scheme.
This Programme is all about making it easier for people to get their hands on cannabis-based products for medical use. They’ll follow the rules and guidance set by the law and medical experts and will only get access of they suffer from any of the following very limited complaints (1) Spasticity associated with multiple sclerosis, (2) Intractable nausea and vomiting associated with chemotherapy and (3) Severe, refractory (treatment-resistant) epilepsy.
Only after careful evaluation and approval within the Medical Cannabis Access Programme, cannabis products will be added to the official list in Schedule 1 of the Regulations.
Basically, this Programme lets doctors prescribe cannabis treatments to patients dealing with the above medical conditions, but only if standard treatments didn’t work. Remember, the Medical Cannabis Access Programme follows strict rules to make sure cannabis treatments are used safely and appropriately for eligible patients.
Remember, the Medical Cannabis Access Programme follows strict rules to make sure cannabis treatments are used safely and appropriately for eligible patients.
A review of the actual Statutory Instrument (Misuse of Drugs (Prescription and Control of Supply of Cannabis for Medical Use) Regulations 2019) mostly deals with the application to the scheme and the controls in place – in summary, the main points are as follows:
- Definitions: The passage defines various terms related to the regulations, such as “adverse reaction,” “Authority,” “CMUR number,” “Cannabis for Medical Use Register,” “Directive 2001/83/EC,” “Executive,” “medical consultant,” “medicinal product,” “Member State,” “person carrying on a retail pharmacy business,” and others.
- Restrictions on issuing prescriptions: The regulations state that a practitioner can only issue a prescription for a specified controlled drug if they are a medical consultant, the prescription includes their name and address, and the treatment remains under their supervision. Additionally, the prescription can only be issued to a person registered in the Cannabis for Medical Use Register and with a CMUR number.
- Cannabis for Medical Use Register: The Executive is responsible for establishing and maintaining a register called the “Cannabis for Medical Use Register,” which contains information about patients, medical consultants, and their prescribed treatments.
- Supply of specified controlled drugs: Only pharmacists, persons carrying on a retail pharmacy business, or hospitals can supply specified controlled drugs. The supply must be for professional or business purposes and made under certain conditions, including prescription by a practitioner.
- Record-keeping: Persons carrying on a retail pharmacy business must keep records of each supply of specified controlled drugs, including the prescription details, drug information, and relevant parties’ names and addresses.
- Reporting adverse reactions and quality defects: Anyone involved in prescribing, supplying, or importing specified controlled drugs must report any suspected adverse reactions or quality defects to the appropriate authority within specified time frames.
From a business perspective (and we are experts in advising Cannabis Companies in this jurisdiction who have made applications under the MCAP as well as negotiating Supply Contracts with EU Medical Cannabis Producers), the main issue is the restriction on advertising.
Our suggestions on approaches to advertise in line with the regulations are as follows:
- Advertising specified controlled drugs:
- Restrict advertisements or representations relating to specified controlled drugs from being seen by the general public in the State. This would involve targeting specific audiences or ensuring that the advertisement is only accessible to individuals who meet the appropriate criteria (e.g., medical professionals, authorised personnel, or registered users).
- Use targeted advertising methods that reach specific groups, such as healthcare professionals or individuals with valid prescriptions for specified controlled drugs.
- Supplying information about specified controlled drugs:
- Only provide information about specified controlled drugs in response to a bona fide unsolicited order. This means that you should refrain from actively promoting or initiating discussions about these drugs unless explicitly requested by a qualified individual.
- Ensure that any information provided is accurate, unbiased, and complies with relevant regulations and guidelines. It should be based on reliable sources and supported by scientific evidence, focusing on the appropriate and approved use of the drugs.
If you have any further questions on the MCAP, the Medical Cannabis Industry or the negotiation of supply Contracts with international Cannabis growers, please contact us at firstname.lastname@example.org or via our contact details here.