Medical Cannabis

In November 2012, the NSW Parliament launched a public inquiry into the medical use of cannabis. The final report was released in May 2013 and is located here. The government’s response to this report was issued on November 15, 2013. A line-by-line critique of the NSW Government response has been prepared by the ADLRF and can be found below. The ADLRF critique appears in bold font alongside the government’s original text which has been italicized. It is as follows:

Comment

The NSW Government acknowledges the work of the Legislative Council Committee in considering the issues surrounding the use of cannabis for medical purposes, including their implications for health and legal policy.

# The eight members of the Legislative Council Committee read the submissions, listened to the evidence, wrote the report and made the recommendations unanimously. More than two thirds of the community also want to see medicinal cannabis used compassionately and legally. The NSW government has not given plausible reasons for rejecting almost all of the recommendations.

The NSW Government is compassionate to the suffering of patients with a terminal illness, chronic pain and AIDS. The Government supports the use of prescription pharmaceutical cannabis products that are approved and regulated by the Therapeutic Goods Administration (TGA) as these products have been assessed for quality, safety and clinical efficacy.

# If the government were acting on compassionate grounds they would make the necessary amendments to permit the lawful use of medicinal cannabis by sick and dying people. The older pharmaceutical cannabis agents are not sufficiently effective, while the newest pharmaceutical cannabis agent is too expensive for elderly sick people who have used up their meagre savings.

The Government does not support the use of unregulated crude cannabis products for medical purposes as the potency and safety of these products cannot be guaranteed. The NSW Government believes this will not prevent access to appropriate medical treatment for any patient in NSW, given the availability of safe and effective alternative medications.

# There are many plant derived pharmaceutical products in use, and regulation and control of the active ingredient content is routine technology. The Netherlands manages to regulate botanical cannabis to very high standards of quality control. If the Netherlands can do this, then NSW could purchase this high quality product from the Netherlands if it wanted to. However, it could also be produced within NSW.

High quality regulated botanical cannabis is sold by a number of companies including:

– The Dutch agricultural company Bedrocan BV,
– The Canadian biotech company CanniMed® and;
– The Israeli company Tikam-Olam

The cannabis sold by these companies conforms to strict regulatory standards. Potency and safety is guaranteed. The stringent product standards of Bedrocan BV can be observed in this 3 minute video produced by the Dutch Ministry of Health. The following is a direct quote from the CanniMed® website:

The cannabis plant material is milled to create a homogenous product for consistency of dosage. Dose consistency is required for research and therapeutic purposes, allowing the overseeing healthcare practitioner to be confident in the level of THC (delta-9-tetrahydrocannabinol) and/or CBD (cannabidiol) the patient is receiving. CanniMed® pharmaceutical-grade cannabis products are packaged in child-proof, tamper evident containers compliant with the Canadian Standards Association (CSA) and the Food and Drugs Act (FDA). CanniMed® product labels indicate the THC and CBD content for the product type, the packaging date and storage instructions.

The Government notes the limited evidence on the clinical efficacy of cannabis for medicinal purposes, and that based on the limited evidence currently available cannabis use for pain relief is not currently supported as a priority by pain and palliative care specialists.

# The evidence is certainly not “limited” and is based on both the underlying neuropharmacological science and the observed medical application. A vast array of evidence of clinical efficacy has accumulated during the past 15 or so years, with the majority of evidence based on “pharmaceutical grade” cannabis, of known strength, in institutionally approved trials, and published in the peer-reviewed scientific/medical literature. Such evidence has been further distilled into comprehensive reviews and commentaries, many of which were included in the evidence considered by the Legislative Council Committee for the preparation of their report.

One such recent review of the controlled clinical trials of medicinal cannabis found 82 favourable and 9 unfavourable controlled trials for six medical conditions. Major reviews by prestigious, independent scientific bodies (1999, 2001, 2001, 2009) concluded that medicinal cannabis used for these conditions is effective and acceptably safe.

Professor Michael Cousins, a leading Sydney-based pain specialist, was quoted frequently in the Legislative Council report: he gave evidence to the committee supporting the medically supervised use of medicinal cannabis for pain relief. Moreover, a recent US review of the place of cannabis pharmacotherapy in the palliative care setting concluded that potentially thousands of lives lost to opioid toxicity could have been prevented had cannabis remained available to treat chronic pain.

To more broadly address the issue of pain relief, the NSW Government has developed the NSW Pain Management Plan 2012-2016. This plan aims to improve services to consumers across NSW by increasing capacity and access to service options within existing pain management services in tertiary hospitals. It involves increasing access to expertise in pain management in rural NSW through the opening of five new clinics. It also aims to increase support for primary care through the development of resources and provision of training and education through Local Health Districts and the Agency of Clinic Innovation.

The NSW Government also has a comprehensive approach to palliative care. The NSW Palliative Care Network has over 350 clinicians, carers, health managers and researchers and is currently developing a Statewide Model of Palliative and End of LIfe Care Service Provision. The model aims to ensure all NSW residents have access to quality care based on assessed needs as they approach and reach the end of their life.

# Medicinal cannabis has been shown, repeatedly, to be a useful drug for relieving distressing symptoms in various cases when conventional medicines have been ineffective or produced unacceptable side effects. Even with an excellent NSW Pain Management Plan 2012-2016 and a high quality NSW Palliative Care Network, there will still be many cases where conventional medicines are inadequate. A compassionate government would allow medicinal cannabis to be used in these cases as recommended unanimously by the Legislative Council committee.

Recommendation 1

The Government supports this recommendation and will write to the Commonwealth Minister for Health expressing in principle support as described.

The NSW Government strongly believes pharmaceutical cannabis products should only be approved for patient use base on robust peer reviewed scientific evidence, including clinical trials. The Government supports the currently national regulatory framework for the registration of medicines in Australia, which ensure the safety, quality and efficacy of prescription medicines.

The Government also supports pharmaceutical companies, universities and other scientific institutions conducting research and developing new pharmaceutical cannabis products within this existing regulatory framework. However, the Government notes there are a number of other products already listed on the Australian Register of Therapeutic Goods and subsidised by the Pharmaceutical Benefits Scheme for the treatment of chronic and acute pain, nausea and vomiting associated with cancer chemotherapy and the symptoms of multiple sclerosis and terminal illnesses. Furthermore patients with HIV/AIDS have access to the latest first line treatments to holt the progression of the disease and to treat secondary infections, either at a subsidized cost through the Pharmaceutical Benefits Scheme, or through the public hospital system.

The NSW Government currently provides significant assistance and funding for medical research through the Office for Health and Medical Research (OHMR). The OHMR works with the health and medical research sector to support greater collaboration between research organisations and encourage the development of a priority-driven approach to research and innovation. The OHMR focuses on the translation of research evidence into better patient care and health outcomes for NSW.

The Agency of Clinical Innovation works with clinicians, academics and the community to undertake or source scientifically robust research to establish a strong evidence base for the models of care and clinical practice guide the NSW Government develops.

Recommendations 2 to 5

The Government does not support these recommendations.

The NSW Government acknowledges the use and supply of crude cannabis for medical purposes is a complex issue. However, the Government does not support the medical use of crude cannabis products that fall outside existing regulatory and legal frameworks. The Government believes crude cannabis products are unlikely to be approved as medicines by the TGA while their quality and safety are uncontrolled.

# The use and supply of botanical cannabis for medical purposes is not really a complex issue. Other developed countries manage to provide high quality regulated botanical cannabis. Why can’t NSW?

Should it become available, nabiximols (Sativex) will be welcomed as it has been shown in many trials to be a useful preparation for cannabis pharmacotherapy. But it is necessary to have a less expensive option than nabiximols, and a more efficacious option than the older cannabis pharmaceutical agents. This is why a regulated pharmaceutical grade cannabis option also needs to be made available.

The issue of unregulated supply of crude cannabis is a major concern to the Government. In contrast to pharmaceutical cannabis products, the potency and safety of crude cannabis unknown, variable and unregulated. There is also the risk of illegal diversion of any medical authorised crude cannabis product to recreational users.

# Governments in a number of other countries have managed to ensure that regulated botanical cannabis is high quality. It is hard to envisage how illegal diversion of medicinal cannabis to recreational users will be necessary when, nationally, 93% of respondents to the 2013 IDRS reported that hydroponic cannabis was ‘easy’ or ‘very easy’ to obtain, while 74% reported that bush cannabis was ‘easy’ or ‘very easy’ to obtain. It is most unlikely that the availability of recreational cannabis will be increased by introducing medicinal cannabis. The recreational use of cannabis in the USA has not increased in the states where medicinal cannabis has been made available.

To realise these recommendations, decriminalisation of cannabis cultivation by patients may be needed or a market may need to be created, either through a government provider or via approved private providers. As noted in its report, the Committee found there are likely to be a range of complex administrative and legal challenges to be overcome for a crude medical cannabis market to operate. The Committee also noted it did not find a solution to these within the timeframe for the inquiry.

# These administrative and legal issues are not impossible to overcome. Many countries around the world, including Canada, the Netherlands and Israel have managed these issues without difficulty.

The NSW Government believes establishment of a register of authorised cannabis patients and carers raises a range of complex legal, administrative and regulatory issues.

# Several countries (e.g. Canada, the Netherlands and Israel) have established a working system for registering cannabis patients and carers.

Unregulated crude cannabis can be a harmful drug with a number of known negative mental health and physical health impacts, particularly when inhaled via smoking. It is important the Government does not undermine other initiatives being undertaken to reduce the incidence of tobacco smoking.

# Scientific studies of medicinal cannabis show that side effects are generally mild and non-serious. The side effects of medicinal cannabis should be compared to the side effects of the other drugs likely to be used in these patients or the nature and severity of the original symptoms. Medicinal cannabis can be inhaled as a vapour and does not have to be smoked. Medicinal cannabis should not be taken with tobacco.

The NSW Government is concerned about the harms associated with cannabis use. THe NSW Ministry of Health already funds seven Cannabis Clinics to assist patients to reduce or cease their cannabis use. In addition, the Mental Health Drug and Alcohol Office (MHDAO) of the Ministry of Health has published educational material regarding the potential mental and physical harms of smoking cannabis. MHDAO also funds the NSW Alcohol and Drug Information Service line.

# The NSW Government is right to be concerned about the harms of unregulated cannabis use, particularly in the young where the risks are serious and are most prevalent. However, the NSW Government should also be appreciative of the benefits of regulated cannabis use in people with distressing symptoms, often from a terminal illness, who are unresponsive to conventional medication and in whom the potential benefits outweigh the risks.

In conclusion, not supporting Recommendations 2 to 5 will not prevent access to appropriate medical treatment for any patient in NSW. THere are safe and effective medications currently available for the symptoms and conditions that medical cannabis is purported to be effective in treating.

# Unfortunately the failure of the NSW Government to accept the unanimous and compassionate recommendations of the Legislative Council committee guarantees that some people in NSW with severe symptoms not responsive to previous treatments, including those with chronic pain, cancer or HIV, and will continue to suffer.

This critique was prepared by Prof. Laurence Mather, Prof. Alex Wodak & Mr. Evert Rauwendaal on November 19, 2013.