Medical Innovation Bill
Briefing to the Portfolio Committee
12th August 2015
CENTRAL DRUG AUTHORITY
1
Purpose
To provide the Central Drug Authority (CDA)
opinion on the Medical Innovation Bill ( PMB 12014)
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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
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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
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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
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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
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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
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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
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• 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
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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
urceID=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”
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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.
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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”
SvrakicDM, Legalisation, Decriminalisation & Medical Use of
Cannabis: A Scientific and Public Health Perspective, Missouri
Medicine, March/April 2012, pp90-98
• 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
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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
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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
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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 valine158 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).
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• 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 and 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.
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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
University, 24
revenues” (Colorado, Colorado State
April 2013).
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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.
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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
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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
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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.
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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.
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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.
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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
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