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Medical Innovation Bill

Medical Innovation Bill. Comment by the Department of Health. Briefing to the Portfolio Committee 11 th March 2015. Legal Framework:

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Medical Innovation Bill

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  1. Medical Innovation Bill Comment by the Department of Health Briefing to the Portfolio Committee 11th March 2015

  2. 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. Medicines Control Council

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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: • 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.

  8. Schedule 0: Available through general sales outlets Schedule 1: Pharmacy OTC products Schedule 2: Pharmacist-prescription products Schedules 3-6: Prescription-only medicines; authorised prescribers Schedule 7: Prohibited substances Schedule 8: Limited use; special permits issued by DG Framework for Scheduling

  9. 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. Schedule 7 (Banned substances)

  10. 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. Schedule 8 (Limited use of habit forming drugs)

  11. 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.

  12. 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 47497-C8; CP 47497-C9; HU-210”

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. 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.

  21. THANK YOU

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