Medical Cannabis

02 June 2017
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Frequently asked questions

Last updated: June 2nd 2017

Medicinal Cannabis has consistently been featured in the news in recent months with impassioned debates for its use for certain types of epilepsy and other medical conditions.

In this article, we will answer a number of the most frequently asked questions in what has become a complex and evolving issue. Links are given throughout to further information and a list of further reading, as well as some pdf documents are available at the end.

Does medicinal cannabis work?

Anecdotal evidence suggests that treatment with medicinal cannabis may reduce seizures in some individual patients, particularly those with severe forms of paediatric epilepsy. However, as with any potential treatment, anecdotal evidence is not sufficient to establish whether or not a treatment has a proven efficacy and safety that would justify its widespread use.

A report by the Health Protection Regulatory Authority (HPRA) in February found a lack of scientific data to demonstrate the robust effectiveness of medicinal cannabis. It stated that there was "At best, a moderate benefit for cannabis in a small number of conditions and conflicting evidence, or no evidence at all, in a large number of other medical conditions. The effectiveness and safety of cannabis in large numbers of medical conditions is simply not proven." In addition, "The HPRA considers that there is not currently evidence that cannabinoids are an effective treatment in epilepsy".

In the UK, a recent All Party Parliamentary Group report by Professor Michael Barnes of Newcastle University found that there is a reasonable evidence base for the management of chronic pain, spasticity and nausea/vomiting in the context of chemotherapy. However, his detailed report also concluded that cannabis has limited effectiveness in relation to epilepsy.

"Whilst there is a theoretical basis and animal model studies and early human studies are promising, at the moment robust trials are lacking but further results are awaited. There is only limited evidence at the moment", he said.

Are there side-effects?

All medicines can potentially have side effects and a significant amount of caution is needed regardless of the drug. Medical supervision is also essential. 

According to the HPRA report: "The medical treatment of children and adolescents with cannabis requires careful consideration due to the potential impact on the developing brain. In addition, there is compelling evidence linking cannabis use in adolescence with the development of psychosis in later life."

Are any cannabis drugs already legal?

If a substance contains THC (the psychoactive element), then it is illegal under the Misuse of Drugs Acts. The exception to this is Sativex, a licenced medication that is used to treat spasticity in MS. A cannabis-based product that does not contain THC is legal in Ireland. Therefore, CBD substances such as Charlotte's Web are available in Ireland, marketed as food supplements. For any of these products, no scientific efficacy or safety data exists, and in many cases, there are significant concerns over the composition and quality control of the products.

What about the Medicinal cannabis bill that was discussed in the Dail?

Gino Kenny TD introduced the Medicinal Cannabis Bill to the Dail in 2016 and it passed the 2nd Stage with cross-party support earlier this year. However, most parties acknowledged that significant changes are required and the Bill has since been debated at committee stage where significant opposition was expressed. The future of the Bill is unclear due to numerous concerns including references to recreational use, the proposed role of medical professionals, the setting up of two new 'quangos' and the separation or medicinal cannabis regulation from the regulation of all other medicines.

Can the Minister for Health authorise a cannabis product?

It is currently within the Minister for Health's powers to issue a licence for medicinal cannabis if a formal request is made for a particular patient by a specialist. To date, one such licence has been approved. As has been reported n the media, at least one other application was denied because it did not have the support of a specialist. However it remains open for any neurologist to request for their patient a licence for a cannabis-based product that would otherwise be illegal. The Minister does not have any other powers to intervene in the doctor-patient relationship. 

Is there going to be some kind of Compassionate Access Programme?

The HPRA report was clear that any decision to permit access to cannabis for medical use would be a societal and policy decision rather than a scientific one. It recommended that if treatment with cannabis is permitted it should be under tight control and in limited circumstances. Three conditions were highlighted including "Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications whilst under expert medical supervision".

Following this, the Minister established an Expert Reference Group to recommend guidelines on how an access programme could be established; in what circumstances medicinal cannabis could be supplied and what form this might take. The group has met three times (at the date of writing) and may complete its work later in the summer. It is likely that new legislation would then be needed to give effect to an access programme.

How does it work in other countries?

Medicinal cannabis laws have been introduced in a number of countries. In the EU, this includes Netherlands, Italy and Czech Republic. Other programmes exist in Canada, Israel, Australia and in many US states. Other countries, including in the EU have programmes for 'exceptional use' or are in the process of revising laws. There is no uniform system and access programmes differ substantially across the world. There is more on this in the HPRA Report.

Is there any licenced cannabis-based medication available for epilepsy?

Not at the moment. A UK company, GW Pharmaceuticals are the leaders in the pharmaceutical application of cannabis. Their drug Sativex has been licenced for treating spasticity in MS. Sativex contains THC and needed a statutory instrument to be exempt from the Misuse of Drugs act. HSE have yet to agree a price with GW, so the drug is still not reimbursed in Ireland.

GW has also developed a drug called Epidiolex which is currently undergoing clinical trials in rare types of paediatric epilepsy. Emerging data from the trials has been positive. Last month, data was published in the NEJM which found that Epidiolex reduced the number of seizures by 39% in children with Dravet syndrome over a 14-week period, compared to 13% taking placebo. 43% of patients experienced a 50% or greater reduction in seizures compared to 27% taking placebo. It is hoped that an application will be made to authorities like the US FDA and the European Medicines Agency in the coming months. It is important to note that these findings cannot be applied to other cannabis-containing products.

What is the Medical Professionals position?

The National Epilepsy Clinical Care Programme (NECCP) has issued a statement highlighting the lack of scientific evidence for all cannabis products other than Epidiolex. They state: "No other cannabis derivatives or products have been adequately studied to a level that they are proven to be effective and safe to use in clinical practice. Specifically, products containing THC remain inadequately tested."

What is Epilepsy Ireland's stance on medicinal cannabis?

Given the devastating impact of rare epilepsies like Dravet Syndrome and the limited success of existing drugs in treating these conditions, it is understandable that many affected families are reaching out for the potential benefits provided by medical cannabis. 

Epilepsy Ireland has long held an evidence-based position on medical cannabis and we agree with the path recommended by the HPRA in February's Report. We also fully support the position of the NECCP and with the need for further research. In recent months, we have discussed these issues with Minister Harris and with Minister for Drugs Strategy, Catherine Byrne, and we engaged with the HPRA's consultation process in developing their report.

More Information

  • See a selection of papers published in the world's leading epilepsy journal, Epilepsia.
  • Watch below the discussion at our 2016 National Epilepsy Conference.
  • Read Dr Colin Doherty's article on medical cannabis published in Epilepsy News

Attached Documents

PDF icon HPRA Report on Medicinal Cannabis (HPRA_Report_on_medicinal_cannabis.pdf | 1.01 MB)
PDF icon The Barnes Report (UK) (Barnes_Report.pdf | 798 kB)
PDF icon Cannabis for Medicinal Use Bill (b7616d.pdf | 491 kB)

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