A CAMPAIGNING MOTHER has helped to propel the debate around medicinal cannabis to the top of the national agenda.
Vera Twomey’s march to Dublin from Cork was the latest in a string of ways she has tried to raise awareness of the problem and secure access to medicinal cannabis for her daughter Ava, who suffers from a rare form of epilepsy that can cause multiple seizures a day.
Solidarity-PBP TD Gino Kenny brought the matter to the Dáil chamber, and his medicinal cannabis bill passed its first hurdle in sailing through a Dáil vote in December.
But, Twomey’s efforts to secure her daughter’s access to cannabis-based treatments goes on and Kenny’s medicinal cannabis bill has not come into effect.
So, what’s going on? Why is Ava Twomey unable to access her medicine? What needs to happen for that to happen? And what will Gino Kenny’s bill do once enacted?
Here’s what you need to know on the medicinal cannabis debate in Ireland.
1. Is cannabis a medicine?*
It is not.
That is, at least according to the Health Products Regulatory Authority (HPRA) of Ireland.
In effect, they decide what is, and what is not, a medicine in Ireland. To date, they have not deemed that cannabis, in any form, can be classed as a medicine in Ireland.
For a person to be prescribed something by their doctor, in most circumstances, that product must be classified as a medicine for the specific ailment by the HPRA.
As such, unless given under special dispensation, no cannabis product can be described by a doctor in Ireland because it is not considered a medicine.
Simon Harris commissioned a report from the HPRA to examine the scientific evidence in relation to medicinal cannabis and, while tentatively recommending medicinal cannabis for certain conditions, the report was clear in how it viewed cannabis.
It said: “To date, there is an absence of scientific data demonstrating the effectiveness of cannabis products. The safety of cannabis as a medical treatment is not well characterised.
In particular, there is insufficient information on its safety during long-term use for the treatment of chronic medical conditions, such as those for which there is a public interest.
For these reasons, and because most cannabis products available under international access schemes do not meet pharmaceutical quality requirements, they are not capable of being authorised as medicinal products.
The HPRA added that there appeared to be a “significant gap between the public perception of effectiveness and safety, and the regulatory requirement for scientific data which is mandatory to determine the role of cannabis as medicine”.
Here, the HPRA is pointing out that despite public calls for its introduction, cannabis does not meet its criteria to be deemed a medicine, regardless of whether that product contained cannabidiol (CBD), or the stronger tetrahydrocannabinol (THC).
Despite this, products containing just CBD are technically legal as they don’t fall under the Misuse of Drugs Act, although they can’t be prescribed by a doctor, and Vera Twomey says that giving Ava CBD has greatly helped in reducing her seizures.
Even the Food and Drug Administration (FDA) in the US hasn’t approved cannabis as a “safe and effective drug” for any medical indication. In other words, it doesn’t consider cannabis a medicine either.
The FDA may be the federal body in charge of drugs in America, but that hasn’t stopped some States going ahead and legalising it anyway.
In some 28 states in the US, the use of cannabis for medical purposes is legal.
While steps were taken at federal level to attempt to limit states’ access to medicinal cannabis, a 2014 amendment was signed into law, prohibiting the Justice Department from trying to prevent the implementation of state medical cannabis laws.
2. But anecdotal evidence on the medicinal effects of cannabis appears to be very strong, right?
Tetrahydrocannabinol, or THC, is the substance in cannabis which gives the high.
Vera Twomey has been campaigning for her daughter to access products with THC in them. Ava’s condition has improved vastly when treated with CBD, but she still suffers from seizures
TheJournal.ie spoke to a cancer sufferer in December, who detailed how they’d been self-medicating with cannabis since their diagnosis and how they’d found it to be effective.
I started taking it and immediately felt relief from the side effects of chemotherapy. I haven’t looked back since.
Using it daily, he said he’s even felt more active since he began taking cannabis.
“My son plays sports and my daughter is involved with clubs. I can follow them anywhere now,” he added.
Despite being the principal psychoactive substance in cannabis, Stephen was keen to stress that the presence of THC in the cannabis he has taken has greatly benefitted him.
“There’s ways of counteracting the psychoactive elements,” Stephen said. The presence of THC in what he’s been taking has been key, he added.
There have been studies published reporting that THC can assist in the treatment of conditions such as Alzheimer’s and autoimmune disease, but these are countered by reports of the negative effects of THC.
When appearing before an Oireachtas Committee, Vera Twomey was clear that she wanted access to stronger, THC-based medication for her daughter Ava.
”We want to be in a position where a doctor could prescribe THC,” she said.
3. So is the lack of a large body of clear, scientific proof holding it back?
Cannabis can contain many different ingredients but a central part of the debate on its use for medicinal purposes rests on the presence, or lack thereof, of tetrahydrocannabinol (THC).
As the HPRA puts it, THC is the “main psychotogenic component of cannabis”. In other words, it gives the “high” associated with smoking cannabis.
Products containing CBD, or cannabidiol, however do not contain these psychoactive elements. As such they can be acquired under existing legislation, although not under a regular prescription as cannabis “is not a medicine”.
Doctors can be granted special dispensation to give products to their patients, but the lack of long-term data on its effectiveness and fears over the safety of such products, prevent many physicians seeking to acquire it for their patients.
Responding to a parliamentary question in recent weeks, Simon Harris indicated that, to date, he has received just two applications for a licence for a product containing THC.
Since THC contains psychoactive elements, it falls under the Misuse of Drugs Act and is therefore, illegal.
Under that Act, the Minister for Health can, if it is in “the public interest”, allow products containing THC to be prescribed by doctors, subject to license.
While the HPRA welcomed reports of “effectiveness for a medicine containing only CBD” in epilepsies such as Dravet Syndrome, which is the condition Ava Twomey suffers from, they said that THC has appeared to act as an “anti-convulsant in some circumstances but as a pro-convulsant in others”.
The authority concluded that “the data available are not sufficient to support their authorisation as medicines”.
In fact, THC has only ever actually been approved as a medicine in Ireland in one specific instance.
In 2014, a medicine containing both THC and CBD, called Sativex, was authorised as a prescription-only medicine as treatment for adult patients with moderate to severe spasticity due to multiple sclerosis, where these patients have not responded well to anti-spasticity medication.
As this drug cleared all the hurdles of scientific rigour, peer review, and analysis for safety and efficacy, it was deemed a medicine for patients with that specific condition.
Any potential drug containing THC for other illnesses would appear to be quite far away.
4. Can Simon Harris grant special dispensation for the likes of Ava Twomey?
The Minister can grant a licence for access to cannabis for medical purposes in individual cases when an application is endorsed by a consultant “who is responsible for the management of the patient”.
The problem in the specific case of Ava Twomey is that her consultant has so far not sought this licence from Harris.
In an interview with Ray D’Arcy on RTÉ radio before she set off on her trek to Dublin, the mother described her current predicament regarding getting Ava access to stronger cannabis-based treatments.
Twomey said that she had been told in a meeting with Harris that they needed a consultant neurologist, not just an “Irish registered doctor” to apply for this licence and that, without that, they had no other option.
I’m done for, because I don’t have that and I can’t get that for Ava. This isn’t fair.
People elsewhere can get this for their children. If I don’t get some kind of answer for Ava, she’s not going to be around… I’ve done everything I can, and I don’t know what more I can do.
In effect, Simon Harris could grant a special dispensation for Ava to access her treatment if her neurologist makes an application.
Because that hasn’t happened, Twomey has repeatedly petitioned Harris to take further action and explore different measures to allow Ava access this medication.
5. The proposed medicinal cannabis bill would change this… do we have a timeframe for this yet?
Gino Kenny raised the issue of a timeframe for this bill to be enacted last week in the Dáil.
He urged the Taoiseach to commit to a comment he said Simon Harris had made during the meeting with Vera Twomey following her march from Cork to Dublin.
The Solidarity-PBP TD said he wanted a commitment that “the medicinal cannabis Bill [be] introduced plus any relevant statutory instrument will be legislated for in a 12-week timeframe”.
Enda Kenny, however, was offering no guarantees. He replied:
I can never give a commitment on the timescale for any legislation because, first, the Business Committee of the Dáil dictates when any legislation comes before the House and, second, one has no idea how many Deputies might wish to contribute to debate on a Bill.
6. What happens next?
Since the publication of the report, Simon Harris has been clear in his support for the HPRA’s recommendations.
These recommendations clearly say that it will not classify cannabis as a medicine until an application is made from a pharmaceutical company, proving its long-term efficacy and safety, and fulfilling the required criteria to be classed as such.
However, it does say it will comply with a “policy decision to permit access” and that cannabis will be available made on a medical basis when a) other treatments have failed and b) when the patient is under the care of a medical consultant with expertise in the relevant medical condition, who will be responsible for monitoring the patient, and for follow-up.
No cannabis-based product – and certainly not one containing THC – is going to be approved in the usual channels by the HPRA any time soon.
The case of Ava Twomey may not be the only case of a person seeking medicinal cannabis but it has certainly captured the nation’s attention.
As Twomey still waits for Ava to access the treatment, and the legislation on medicinal cannabis still works its way around Leinster House, people seeking to access it as a treatment may have to wait a little longer.
Read: ‘It’s not a done deal by any means but it’s positive’: Ava Barry edges closer to cannabis medication