Medical Innovation Bill Briefing to the Portfolio Committee 12 th August 2015 CENTRAL DRUG AUTHORITY 1
Purpose To provide the Central Drug Authority (CDA) opinion on the Medical Innovation Bill ( PMB 1 - 2014) 2
The mandate of the CDA The Central Drug Authority must: • Develop, oversee and monitor the implementation of the National Drug Master Plan • Facilitate and encourage the coordination of strategic projects • Ensure the development of effective strategies on prevention, early intervention, reintegration and aftercare services • Advise Government on policies and programmes in the field of substance abuse and drug trafficking • Recommend to Cabinet the review of the National Drug Master Plan every five years 3
The Purpose of Medical Innovation Bill The Medical Innovation Bill, 2014 must: • Make Provision for innovation in medical treatment • To legalise the use of cannabinoids for medical purposes and beneficial commercial and industrial uses 4
Objective of the Roundtable • Allow broad representation and generate robust debate on safety and dangers of Cannabis use in South Africa • Address medicinal use of Cannabis and recreational use separately • An evidence based and research supported debate on Medicinal Use of Cannabis to shed light on properties of chemicals residing in Cannabis (THC v CBD) • To inform the South African Position Paper on Cannabis 5
Summary of Roundtable • Generally, cannabis is a gateway drug for many countries • Section 21 applications can be made on behalf of patients to access cannabis for medicinal purposes • Cannabis can be used for research and medicinal purposes • There is a need to strengthen community education and awareness on cannabis for medicinal use • Parenting is key for modeling and shaping behaviour of young people who are vulnerable to cannabis use and/or abuse • Scientific investigation needs to be conducted to develop medication using cannabis without THC • Cannabis is an integral part of some religious, cultural and traditional practices 6
Summary cont. • Currently there is no comprehensive cost analysis conducted in South Africa on the economic implications of cannabis use • It is critical to measure the effectiveness of existing cannabis related treatment programs • Consider alternative use of cannabis and how this can contribute to the economy • Accurate information about medicinal use of cannabis should be disseminated through various media platforms • Currently there are well articulated and divergent views on criminalisation, decriminalisation and legalisation of cannabis 7
Summary in general • A need for more conversations and understanding of the divergent views is required. • The commission of the position paper for the country on the cannabis use and or abuse is required- informed international, national and regional developments. All these should be evidence-based. • The National Drug Master Plan which guides the country on the use and abuse of substances should be the basis for the way in which the position paper is premised. • There are strong views around the medicinal use and the legalization of cannabis for recreational/cultural and religious use. • The roundtable discussions has provided a platform for engagement among different stake holders on cannabis, further engagement with various stakeholders is critical for the finalisation of the position paper on cannabis in South Africa 8
• In South Africa Cannabis is most common illicit substance among young people and children Siphokazi et al. SACENDU REPORT June 2013 • THC potency in South African plant higher than in other parts of the world • On average 6. 3% of South African population use Cannabis (highest use 9. 1%) • World average is 3. 8% of population UNODC World Drug Report 2014 9
Current position • Dronabinol when intended for therapeutic purposes available as Schedule 7 medicine – Used for appetite loss, nausea and vomiting caused by AIDS or chemotherapy – 60 peer-reviewed studies on medical marijuana (http: //medicalmarijuana. prcon. org/view. resource. php? reso urce. ID=000884) reveals in about one third of these studies, no benefit or even harm was observed. • Nabilone listed as Schedule 7 medicine – Synthetic cannabinoid with antiemetic and anxiolytic properties • Required regulatory route protects the public from potential abuses. • “He who asserts, must prove” 10
Impact on Health • Global Burden of Disease Study 2010: Estimating the burden of disease from drug dependence – “the far higher number of cannabis-dependent users results in the greater global burden of disease overall”. • Dependence, lung problems, memory impairment, psychosocial development problems, mental health problems, poorer cognitive performance associated with early initiation • Primary effect (first decade) may differ from longer-term impacts. • Increased potency leads to increased health consequences E. L. Sevigny and others, “The effects of medical marijuana laws on potency”, International Journal of Drug Policy, vol. 25, No. 2 (18 January 2014), pp. 308 -319. 11
Impact on Health cont • “legalisation or medical use of smoked cannabis is likely to impose significant public health risks including an increased risk of schizophrenia, psychosis, and other forms of substance use disorders” Svrakic. DM, Legalisation, Decriminalisation & Medical Use of Cannabis: A Scientific and Public Health Perspective, Missouri Medicine, March/April 2012, pp 90 -98 • All botanically-based medication must have; – – Standardised identity, purity, potency and quality Adequate directions for use Well controlled risk/benefit profiles Non-smoked, reliable delivery systems 12
Impact on Health cont • Increased cannabis potency heightens risk of adverse events in cannabis-naive patients (youth) • Can physicians base judgement on non-evidence based information? No information regarding composition, dose, side effects, therapeutic targets • Is it fair to impose ethical and professional responsibility on practitioner as gatekeeper? • Increased potency heightens risk of addiction as inhalation raises plasma and brain levels • Dose-response exhibits biphasic effect – lower dose relieves symptoms but higher dose exacerbate it 13
Impact on Health cont • The Global Burden of Disease Study 2010: – Cannabis is higher than cocaine due to the higher number of users • There is an absence of CBD reported in Cannabis from South Africa and three regions in Mexico • “the results also indicate that illicit substances such as cannabis have a manifold increased risk of psychopathology with adjustments for age and gender” The association between substance use and common mental disorders in young adults: results from South African Stress and Health Survey 14
J Clin Psychiatry. 67 Suppl 7: 18 -23. Adolescent substance abuse and psychiatric comorbidities. Deas, 2006 Psychiatric disorders in adolescents often predate the substance use disorder. Once the substance use disorder develops, the psychiatric disorder may be further exacerbated.
J Clin Psychiatry Adolescent substance abuse and psychiatric comorbidities. Deas and Brown, 2006 Concomitant psychiatric disorders depression anxiety bipolar disorder conduct disorder attention-deficit/hyperactivity disorder
Biol Psychiatry. Moderation of the effect of adolescent-onset cannabis use on adult psychosis by a functional polymorphism in the catechol-O-methyltransferase gene: longitudinal evidence of a gene X environment interaction. Caspi et al. , 2005 A functional polymorphism in the catechol-O-methyltransferase (COMT) gene moderated the influence of adolescent cannabis use on developing adult psychosis COMT valine 158 allele psychotic symptoms if they used cannabis COMT methionine allele no such adverse influence
Schizophr Bull. Gene-environment interplay between cannabis and psychosis. Henquet et al. , 2008
Lancet Adverse health effects of non-medical cannabis use. The health effects most likely to occur and to affect a large number of cannabis users: a dependence syndrome increased risk of motor vehicle crashes impaired respiratory function cardiovascular disease adverse effects on adolescent psychosocial development and mental health disorders Hall and Degenhardt, 2009
Allostatic View of Neurotransmitter Adaptation During the Transition from Drug Use to Addiction Koob, 2012
Impact on Health cont • Concomitant mental health disorders cannot be ignored • Pre-existing parallel consequent • Large rate, not a minority • They influence negatively treatment outcomes • Integrated therapy • Psychiatrist in the team • A component of relapse prevention
Impact on Economy • Legislation reduces price over time • Cannabis consumption responds to price leading to higher consumption • Estimated 10% drop in price = 3 -5% increase in youth initiation Rosalie Liccardo Pacula, “Examining the impact of marijuana legalization on marijuana consumption: insights from the economics literature” (RAND Corporation, Working Papers, July 2010). 23
• Requires careful monitoring to measure effect • Poly drug use occurs both recreationally and regularly (EMCDDA), “Polydrug use: patterns and responses”, Selected issue 2009 (Lisbon, November 2009). • Tax reviews from retail Cannabis sales weighted against cost of prevention and health care • World wide markets continue to expand increase in the abuse will lead to increase in related public health United States, Department of Justice, Drug Enforcement Administration, National Drug Threat Assessment Summary 2013 (November 2013), p. 12. 24
Substitution effect learnt from Portugal • Referrals from 47% in 2001 to 65% in 2005. • Heroin decreased from 33% to 15% over same period. • Tax revenue from retail cannabis sales may provide revenue offset by need to regulate new industry “The fiscal impact of Amendment 64 on state revenues” (Colorado, Colorado State University, 24 April 2013). 25
Impact on Criminal justice • Possession charges can be expected to decrease but controls of cultivation, sale and distribution will require routine monitoring • Convicted users are more likely to experience adverse employment consequences, relapse, relationship problems, accommodation difficulties. S. Lenton and others, “Laws applying to minor cannabis offences in Australia and their evaluation”, International Journal of Drug Policy, vol. 10, No. 4 (1999), pp. 299 -303. 26
Decriminalisation or Legalisation affect • Public budgets need to be balanced against cost of prevention and health, security, family problems, low performance, absenteeism, car and workplace accidents. • Annals of Epidemiology: “ among youths age 12 to 17, cannabis usage rates were higher in states with medical cannabis laws (8. 6%) compared with those without such laws (6. 9%) Annals of Epidemiology, Vol 21 issue 9 pages 714 -716 • Colorado Department of Health: “ only 2% of users reported cancer and less than 1% reported HIV/AIDS as reason for use. 94% reported “severe pain” http: //www. cdphe. state. co. us/hs/medicalcannabis/statistics. html 27
Current CDA Position First • data on smoking Cannabis indicates that this practice is unhealthy; it is linked to cardiovascular and respiratory disorders, as well as to cognitive impairment and mental disorders. Second • given the significant public health problem represented by Cannabis, particularly highly potent cannabis, its use should be prevented, and its continued use treated, using evidence-based approaches. Third • components of Cannabis have been suggested effective in a few medical conditions such as refractory seizures, and access to medical marijuana may therefore be needed. Fourth • Cannabis is safer than alcohol and many other substances (but does not have as many recognisable immediate affects) and policy regarding cannabis should reflect this key point 28
Recommendations Harms of Marijuana: • Significant scientific research has established beyond doubt that marijuana is associated with a range of potential harms • Smoking cannabis linked to cardiovascular and respiratory disorders, cognitive impairment, mental disorders, and associated neural spasticity. • In adolescence associated with a higher risk for psychosis in later life, and risk is dose-related. • High potent cannabis, represents a significant public health problem. • Acute marijuana use, associated with increased motor vehicle accidents and fatal crashes. • Marijuana use should therefore be prevented, and its continued use treated, using evidence-based approaches. 29
Recommendations Potential Benefits of Marijuana : • Dorabinol and Nabilone, is available • Ongoing research on the use of psychoactive ingredients in various medical conditions, including seizure disorders, pain control, and wasting continued. • Establish data about safe dose limits. • There is a need for greater medical research including work on marijuana, balanced against the national health research priorities, which focus on the largest contributions to medical mortality and medical morbidity. 30
Recommendations • The National Drug Master Plan emphasizes the importance of supply reduction, demand reduction, and harm reduction strategies for combating tobacco, alcohol, and substance use disorders in South Africa. For any particular substance, the balance between these 3 strategies, and the precise nature of the approach taken, should be evidence-based. On balance, for example, alcohol is the substance that causes the most individual and societal harm, and it is therefore key to implement the most evidence-based policies for combating such harm; thus focus on alcohol demand reduction and harm reduction. School survey data suggests high rates of experimentation with marijuana during early adolescence, hence evidence-based interventions that prevent and/or delay the initiation of cannabis use are needed for this population. The continued and chronic use of marijuana (particularly among vulnerable groups such as adolescents and people who are at risk for mental disorders) should be treated. 31
Conclusion • More research in the field is required, before concluding resolutions can be taken – Research into physiological effects and plantderived cannabinoids – Research into symptom management for rapidonset, reliable and safe delivery systems – Evaluate anxiety reduction and sedation which can influence medical benefits using clinical trials – Define health risks of smoking cannabis particularly among populations in which cannabis use is prevalent 32
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