Transcript Schedule 7 - Amazon Web Services

Medical Innovation Bill
Comment by the Department of Health
Briefing to the Portfolio Committee
11th March 2015
Medicines Control Council
Legal Framework:
The sale, supply and use of a medicine or scheduled substance
in South Africa is governed by section 22A of the Medicines and
Related Substances Act, 1965 (Act 101 of 1965 as amended),
and supporting Regulations.
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Public Health Regulatory Mandate
Two distinct objectives:
• Protect patients against harmful or ineffective medicines
– Gatekeeper function with obligation to apply stringent
standards of assessment and to restrict availability where
deemed necessary.
• Protect patients against the consequences of untreated disease
– Enabling drug development to ensure that patients have
access as early as possible to safe and effective drugs.
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Legal Framework for Scheduling and Control
• 'Scheduled substance': defined as “any medicine or substance
prescribed by the Minister under Section 22A”.
• All medicines are subject to a scheduling process on the basis
of the substances they contain (active pharmaceutical
ingredients - APIs).
• Section 22A(2) – Schedules approved by the Minister, on the
recommendation of the MCC.
• Section 37A – provides for amendments to the Schedules.
• Schedules are published in the Gazette or amended by
subsequent notice in the Gazette.
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Principles of Scheduling
• Allows for different levels of regulatory control over substances,
whether in the form of naturally-occurring products, APIs, or
finished pharmaceutical products (medicines).
• Ensures compliance with Single Convention on Narcotic Drugs
(1961), Convention on Psychotropic Substances (1971) and
Convention against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances (1988).
• Primary consideration is safety in relation to therapeutic indications
for its use. Substances may be listed one of eight Schedules.
• Substances may also be listed in more than one Schedule, based on
indication, dosage form, route of administration, strength, dose,
duration, or a combination of these factors.
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Scheduling and Control of Medicines
With regard to substances which may be abused or misused:
• Ensure appropriate levels of control consistent with international
drug control conventions.
• Ensure timely implementation of policies and resolutions of the
International Narcotics Control Board (INCB).
• Ensure that scheduling in terms of the Drugs and Drug
Trafficking Act (Act No. 140 of 1992) and the Prevention and
Treatment of Drug Dependency Act (Act No. 20 of 1992) are
based on the Schedules to the Medicines and Related
Substances Act (Act 101 of 1965).
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Criteria for Scheduling
• Primary emphasis is on evidence of safety and requirements
for professional intervention and/or supervision of use.
• Requirements for control, in international agreements, are
considered where appropriate.
• Scheduling decisions involve the consideration of a number
of factors, including:
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evidence for the toxicity of the substance and the safety in use
the proposed indication for the substance
the need for medical diagnosis
the potential for dependence, abuse and misuse
the need for access to the substance.
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Framework for Scheduling
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Schedule 0:
Schedule 1:
Schedule 2:
Schedules 3-6:
Schedule 7:
Schedule 8:
Available through general sales outlets
Pharmacy OTC products
Pharmacist-prescription products
Prescription-only medicines; authorised prescribers
Prohibited substances
Limited use; special permits issued by DG
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Schedule 7 (Banned substances)
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Substances not recognised for routine clinical use.
Extremely high potential for abuse and dependence.
Possession and use prohibited.
Restricted to scientific and clinical research use only.
Special permits issued by the DG on the recommendation
of the MCC.
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Schedule 8
(Limited use of habit forming drugs)
• Limited medical use of substances listed in Schedule 7.
• Extremely high potential for abuse and dependence.
• Specific medical conditions requiring approval by the
MCC.
• Special permits for medical use issued by the DG.
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The Legal Status of Cannabis
• Cannabis is classified under Schedules I and IV of the 1961 United
Nations (UN) Single Convention on Narcotic Drugs, making it
subject to special restrictions.
• In SA, cannabis is controlled in line with the 1961 Single
Convention and is listed as a banned substance in Schedule 7.
• Section 22A (9)(a)(i) of the Medicines and Related Substances Act
provides that no person may acquire, use, possess, manufacture
or supply cannabis as the whole plant or any portion or product
thereof, and includes synthetic derivatives.
• This section also provides for the Director-General to issue a
permit authorising a medical practitioner, analyst, researcher or
veterinarian to use cannabis, on the prescribed conditions, for the
treatment or prevention of a medical condition in a particular
patient, or for the purposes of education, analysis or research.
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Cannabis Inscription in Schedule 7
”Cannabis (dagga), the whole plant or any portion or product thereof, except:
• when separately specified in the Schedules; (S6); or
• processed hemp fibre containing 0.1 percent or less of tetrahydrocannabinol and
products manufactured from such fibre, provided that the product does not
contain whole cannabis seeds and is in a form not suitable for ingestion, smoking
or inhaling purposes; or
• processed product made from cannabis seeds containing not more than 10
milligram per kilogram (0,001 percent) of tetrahydrocannabinol and does not
contain whole cannabis seeds.”
“Synthetic cannabis substances (synthetic cannabinoids) included but not limited to:
• cannabicyclohexanol;
• JWH-018; JWH-073; JWH-200; CP-47497; CP 47497-C6; CP 47497-C7; CP 47497C8; CP 47497-C9; HU-210”
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Registered Products in SA and other Countries
• Dronabinol is registered in some jurisdictions, including
RSA, for nausea and loss of appetite in cancer and AIDS
patients respectively.
• Nabilone is registered for nausea in other countries.
• Sativex is registered for multiple sclerosis in other
countries (also Phase III trials for pain management).
• Ongoing R&D for use in glaucoma, pain management
and some forms of childhood epilepsy.
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Mechanisms for Legal Access
• Section 22A(9)(a)(i) of the Medicines and Related
Substances Act, enables acquisition, possession,
manufacture and use of a schedule 7 substance if
the Director General has issued a permit for that
substance under specified conditions.
• Section 21 of this Act also enables the use of an
unregistered drug under specified conditions.
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Section 21 Access
Specified conditions include:
• Patients suffering from a serious illness where a
clinical need can be demonstrated and where
evidence exists to support the request.
• Mechanism for continued access to medicines
provided to patients following completion of a clinical
trial.
• Clinical need exists for a medicine available in other
countries, but not registered in South Africa.
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Section 21 Access (cont.)
• Objective evidence to support the proposed use must
be provided.
• The dosage, route of administration and duration of
treatment must be provided.
• Appropriate monitoring of the patient during and after
treatment must be in place in order to assess efficacy
and adverse events.
• Reports on treatment outcomes must be provided.
• Treating physician must be a specialist in the field.
• Informed consent by the patient or legal representative
is required.
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Adverse effects of Cannabis Use
Short term use:
• Impaired short–term memory and attention.
• Impaired motor co-ordination and reaction times.
• Altered skilled activities.
• Anxiety and panic reactions.
• Acute psychosis, auditory and/or visual illusions, and
pseudo-hallucinatory responses.
• Ataxia from selective impairment of reflexes.
• Dissociative states such as depersonalization and
derealization.
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Adverse effects of Cannabis Use (cont.)
Long term use:
• Addiction particularly in those who begin use in
adolescence.
• Poor educational outcomes.
• Cognitive impairment.
• Respiratory and reproductive system effects.
• Increased risk of schizophrenia, depersonalization
disorder, bipolar disorders, and major depression.
• Possible role as a gateway drug.
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Potential Therapeutic Uses
• Glaucoma
• Chemotherapy-induced nausea and vomiting
• HIV/AIDS-associated loss of appetite and weight
loss
• Chronic pain syndromes
• Multiple sclerosis
• Epilepsy in children
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Conclusions
• Mechanisms to enable controlled access to cannabis for
medical use does exist within the current legal framework.
• More work is needed on causality and strength of
association of some adverse effects.
• More research is needed on age-related cognitive decline.
• More research is also needed on THC-related effects based
on emerging evidence that the THC content or potency of
marijuana has been steadily increasing.
• A better understanding needs to be gained of the
benefit/risk ratio of cannabis for each indication considered.
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THANK YOU
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