Amendments to the Drug Dependency (treatment not imprisonment) Bill which would allow medical practitioners to prescribe medicinal marijuana show that authorities propose to ban medicinal preparations intended for smoking. This means that medicinal cannabis would be legally prescribed in the form of edibles – oil or other non-smoking methods of consumption.
Health Minister Chris Fearne will start the debate on the amendments, which is in its second reading, tomorrow evening in Parliament. The Bill, which was presented for its first reading on 27 November, permits registered medical practitioners to prescribe medicinal cannabis if “no viable alternative” exists.
Contents of the proposed amendments seen by The Malta Independent on Sunday, state: “A licensed medical practitioner who is duly registered in accordance with the Health Care Professions Act, shall be entitled to prescribe to patients medicinal preparations of the plant cannabis and synthetic cannabinoid products licensed under the Medicines Act or manufactured under good manufacturing practice, if it is considered that there is no viable alternative to such prescription due account being taken of any protocols which may be in force from time to time in respect of the prescription of medicines, of the interests of the patient and of the costs.
“None of the preparations referred to in sub-article 1 may be indicated for smoking or in any form meant for smoking.”
As per directions by the Superintendent of Public Health, medicinal cannabis preparations are only to be prescribed on a named-patient basis.
The standard operating procedure to authorise cannabis preparations are to observe the following conditions: All preparations requested by medical practitioners are “to comply with the Medicines Act or manufactured under Good Manufacturing Practice”.
All licensed medical practitioners are entitled to prescribe medical cannabis; they must send an application for its use to a generic e-mail at the office of the Superintendent of Public Health. The application is then processed and if accepted, the “prescriber, pharmaceutical wholesale dealer and the pharmacist receive a copy of the application endorsed by the Superintendent for Public Health”.
Should the application be rejected, the above parties would be notified with the reason for the rejection listed.
Time-line of events
The subject of legislating cannabis for medicinal purposes was first broached in Parliament by former Labour and now Partit Demokratiku MP Godfrey Farrugia back in June 2014. He called for the legalisation of medicinal cannabis for non-smoking purposes to improve the patients’ quality of life where no other alternative exists. He also called on lawmakers to listen to the needs of patients.
The following month, Justice Minister Owen Bonnici issued a white paper for what would be the Drug Dependency Act. This Act, approved in 2015, gave softer penalties to those caught with specified quantities of marijuana, ecstasy and cocaine. It also enabled medical practitioners to prescribe medicinal cannabis.
The latter part encountered difficulties however and because of inconsistencies with the law, medical practitioners were not in fact allowed to prescribe medicinal cannabis product derivatives. The only instance where, on a name basis, patients could access one type of cannabis derivative product was for those suffering from Multiple Sclerosis.
In August of this year, synthetic CBD oil (CBD being one type of cannabinoid found in the cannabis plant) became legal; however, because it is extremely expensive price, many patients could not benefit from this product.
While the battle raged on, many patients turned to black-market products in order to get access.
At this stage, the amendments to allow medical practitioners to prescribe medicinal cannabis were drafted, with the first reading presented on 27 November and a debate on the issue to take place tomorrow evening in Parliament.
Farrugia insists patients must be registered with family doctor ahead of medical cannabis debate
PD MP Godfrey Farrugia believes that patients must be registered by their family doctor for a Medical Cannabis Control Cards, when providing suggestions for patient-centric implementation process of the legal amendments due to be debated in Parliament tomorrow.
He said that this would be issued for one year and may be renewed by a fresh application, although it might also be withdrawn for a valid reason by the Superintendent of Public Health.
Urgent Prescriptions, he says, should not be permitted during the interim period from application to the issue of the control card.
The prescriber should also follow a number of obligations, Farrugia explained.
“To qualify for such a card, a qualifying patient must be at least 18 years of age; have a medically indicated debilitating medical condition; have no medical contraindication such as mental disorders; cautions must be indicated to patients to abstain from drinking alcohol among others; the family doctor prescribing the medication must have a sound doctor-patient relationship.”
The Medical Superintendent of Health would also need to follow certain obligations.
Within 15 days of a family doctor’s submission to the Drug Control Regulatory Unit on behalf of a patient a cannabis control card has to be issued.
However, prior to the issue of the control card, the Health Depart in co-ordination with other government entities has to ensure that the patient has never been convicted of a drug offence; is not under Seqda or Caritas or psychiatric management for substance misuse; does not hold a public bus/school van or commercial driver’s licence; and is not a soldier, a policeman, a correctional officer or a civil service officer.
Farrugia said that medical cannabis should be dispensed from a pharmacy against a doctor’s monthly prescription, not a repeat prescription, and on the presentation of a control card.
This control card has to be duly filled in and signed by the family doctor and community pharmacist.
Synthetic and product derivatives of medical cannabis
Referring to a parliamentary question concerning GMP (good manufacturing practice) products, Farrugia said that synthetic and product derivatives of medical cannabis, even when GMP manufactured, have different ratios of THC / CBD for different therapeutic effects.
“CBD products do not have psychotropic effects and as such should be a prescription medicine only, and hence should not have a drug control card application,” he said.
“I presume that it is being suggested by authorities that CBD products are included to ensure that it is not used in synergy with recreational drugs.”