ast November, Simon Harris the Irish Minister for Health asked the Health Product Regulatory Authority (HPRA) to carry out a review of the Republic’s policy on medicinal cannabis. The review was requested following the introduction of the Cannabis for Medicinal Use Regulation Bill 2016 Bill before the Irish parliament last July by Gino Kenny and Brid Smith, members of the extreme left People Before Profit party.
Perhaps the most startling thing about the Cannabis for Medicinal Use Regulation Bill other than the fact it was very poorly drafted (and largely lifted from the earlier Cannabis Regulation Bill 2013) is that it managed to survive the second stage of the Irish parliamentary process to reach the Select Committee on Health. How precisely this happened can be attributed in part to the fact that Ireland currently has a minority government, which is dependent upon support from the largest opposition party to pass legislation. It was into this ‘parliamentary gap’ that Kenny took a punt with the poorly drafted medical cannabis bill.
Few observers familiar with the Irish parliamentary process believed it had a chance. But this bill has not only managed to survive but actually gain traction
Kenny who was only elected to the parliament for the first time last year, is genuinely pleased with his good fortune, however if it were not for the tenacious campaigning of Vera Twomey whose daughter Ava Barry suffers from Dravet syndrome, the bill would probably have fallen at the first hurdle.
Twomey more than anyone has managed to capture the public’s imagination with her ‘never-say-die-attitude’ and in a short period of time has employed the same tactics which the civil rights movement used back in the 60’s to bring an end to segregation. People Before Profit were quick to jump on Twomey’s bandwagon, which recently included a high profile walk from Cork to Dublin to highlight her daughter’s continuing struggle to access medicinal cannabis in the Republic.
But some credit must also be given to Simon Harris, who at 30 is Ireland’s youngest Minister for Health. Harris who suffers from Chron’s disease, has kept his door open to Twomey when many of his predecessors would have slammed the door firmly in her face. Of course, behind the Minister is Ireland’s notoriously conservative and duplicitous Department of Health known for its sleight of hand tactics and who have a penchant for dampening down progressive initiatives when it doesn’t suit their routine. One of it’s emanations the Health Service Executive (HSE) is currently at the centre of yet another scandal involving the sexual abuse of an incapacitated girl while she was in foster care.
The report from the HPRA, the government quango whose function is to regulate medicines is conservative and selective in its approach to medicinal cannabis. Conservative because it recommends that treatment with medicinal cannabis should only be permitted under a controlled access programme for the treatment of patients with;
a. Spasticity associated with multiple sclerosis resistant to all standard therapies and interventions whilst under expert medical supervision;
b. Intractable nausea and vomiting associated with chemotherapy, despite the use of standard anti-emetic regimes whilst under expert medical supervision;
c. Severe, refractory (treatment-resistant) epilepsy that has failed to respond to standard anticonvulsant medications whilst under expert medical supervision.
The document goes onto say that ‘patients accessing cannabis through the programme should be under the care of a medical consultant and medical information and utilisation data should be kept on a central register. This will ensure accountability and will inform the future direction of access to cannabis for medical purposes. Clinical (patient) research should be facilitated.
Researchers who are familiar with the benefits of medicinal cannabis would immediately see through the conservative ‘jig’ the HPRA are engaging in. The document is also selective in terms of the research which the HPRA focused on
“evidence finds, 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.”
Critics of the HPRA have been quick to point out, that the HPRA have relied too heavily on questionable research which has already been challenged successfully in other jurisdictions. Moreover the finger has been pointed at the HPRA for choosing to ignore research findings from Canada and Germany in particular.
The HPRA conducted a survey of 40 countries, 29 of which were its regulatory counterparts in the European Union (EMACOLEX) and globally through members of the International Coalition of Medicines Regulatory Authorities (ICMRA) to determine policies on access to cannabis for medical use. In total 40 countries were contacted, from which 28 responses from EU Member Countries and 7 outside the EU were received. Israel was included as a supplementary country which does not participate in either of the two groups mentioned above but which does have a large medical.cannabis programme.
It’s not clear who were the five countries that didn’t respond, but most likely Russia and Indonesia were among them. Curiously, the HPRA contacted China and Singapore two countries known for their hostility towards liberalisation of cannabis use. Under Section Seven of the Criminal Law of the People’s Republic of China, Article 345, individuals who smuggle, traffic, transport or manufacture narcotic drugs are sentenced to either 15 years of prison, life imprisonment or death, and suffer confiscation of property. Most people would know that Singapore has some of the most draconian laws in the world for dealing with drug offenders. Anyone who has ever read Singapore’s Misuse of Drugs Act would be under no illusions. Furthermore, in last year’s UNGASS conference Singapore restated its vehement opposition to any reforms to the Single Narcotic Drugs Conventions. Quite precisely, why the HPRA contacted two counties who have executed people for being found in possession of cannabis is anyone’s guess. At best you would it was stupid, but one cannot rule out that it was deliberate.
Political observers of the HPRA and the Department of Health, know that the former largely does the bidding of the later, and the Minister’s views are generally known when there is a ‘hot topic’ before them. And so the case is this, the Minister has a report, the report suggests making medicinal cannabis available to a limited category of patients, whilst ruling it out for people suffering from chronic pain and a variety of other conditions.
the report concludes by making the following observations
If a policy decision (Minister Harris and his special advisors decide) is made to facilitate access to cannabis for medical use, the following recommendations could be considered:
1. A five-year pilot programme that permits patients with the defined medical conditions (outlined above) to be treated with cannabis or cannabinoids prescribed by their doctors, under current legislation, should be conducted. Under the cannabis treatment programme:
– A registry of patients, prescribers, and pharmacists should be established (a registry may be necessary to provide legal protection for possession).
Information on the product prescribed, the medical condition treated, adverse events and the outcome of treatment should be collected.
- The registry should be subject to medical oversight, and report provided to the Department of Health on the numbers of patients, patterns of prescribing, and supply needs. A report at the end of the period would permit decisions to be made on future direction of access to cannabis for medical purposes.
- The annual national reports to the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) will facilitate the tracking of problem drug use.
2. The pilot programme would allow patients to be treated legally with cannabis products within the healthcare system, and avoid the use of cannabis products that are subject to no regulation.
3. Legislation to support the cannabis treatment programme should specify the medical conditions identified above where cannabis can be used as a medical treatment, the doctors that can prescribe treatment (consultants with expertise in the relevant medical condition), and the permissions necessary to allow doctors to prescribe, pharmacists dispense, and patient possession. The legislation should identify the routes of supply and the required quality controls. It should also address labelling requirements and appropriate categorisation of cannabis products. It should outline the records that are required to be kept and the necessity for a patient register.
4. Dronabinol is an authorised medicine in other countries and is currently controlled in Ireland by the provisions of Schedule 1 of the Misuse of Drugs Regulations. To facilitate patient access, it is recommended that dronabinol is included in Schedule 2, this would place the medicine in a similar category to other authorised medicines including nabiximols and nabilone.
5. The defined medical conditions that could be treated with cannabis should be presented to the medical professional bodies, such as the Royal College of Physicians (RCPI) or societies, for review. The development of prescribing guidelines or training could be considered by the professional bodies. These guidelines could address the patient population suitable for treatment, taking into account:
- the age of the patient and their medical history (including active substance use, concomitant medical or psychotic disorder, cardiovascular or respiratory disease, whether they are pregnant or breast-feeding); and
- the type of cannabis product suitable for treatment (THC and CBD content).
The elements to be included in an education programme for patients could also be considered, such as the correct use of the cannabis for medical purposes, the benefits and risks involved, how to report side-effects, and the care and safe disposal of cannabis products.
6. A confidential survey should be conducted across patient’s organisations to determine the use of cannabis-based medicines with this information providing an estimate of the supplies required.
7. Clinical research into the safety, in particular the long-term safety and the effectiveness of cannabis for medical use, should be encouraged through facilitated access under the legislation, and targeted funding. The HPRA fully endorses clinical research with cannabis products to characterise their therapeutic promise, and will provide the necessary supports.
8. The HPRA working group should continue to review scientific developments in this area, and report to the Minister, as required.
Conservative though the recommendations may be, it is start. But elsewhere things have moved on with Germany’s doctors being allowed to prescribe medicinal cannabis (without resort to a consultant!) since the beginning of March 2017. Before the German parliament (Bundestag) passed the new legislation in January, the only way for patients to use cannabis as a treatment was to apply and wait for special, individual approval – and the bar was set fairly high for those seriously ill. It seems that in Ireland, the conservative Department of Health, the HPRA and the medical consultants who have a strong vested interest in restricting access, are quite happy to play the game of ‘Paddy-Go-Slow’ much to the annoyance of Vera Twomey and other campaigners who favour a more progressive approach towards the medicinal use of cannabis. They seem to be ignoring developments in Canada, and Germany two more scientifically advanced countries that are even more rigorous when it comes to the licensing of medications than Ireland.
Minister Harris should make note that perhaps the Canadians and the Germans know better than the HPRA when it comes to regulating medicinal cannabis.