1. PRESENTATION TO PORTFOLIO COMMITTEE [AGRICULTURE AND LAND AFFAIRS]
REGULATION AND CONTROL OF VETERINARY PHARMACEUTICALS IN SOUTH AFRICA THE ROLE OF THE NATIONAL DEPARTMENT OF HEALTH
PRESENTATION TO PORTFOLIO COMMITTEE
[AGRICULTURE AND LAND AFFAIRS]
Mandisa Hela September 2006

2. OVERVIEW MANDATE OF NDoH POLICY AND LEGISLATIVE FRAMEWORK
ROLE OF THE MEDICINES CONTROL COUNCIL (MCC)
REGULATION OF ANIMAL PHARMACEUTICALS
CHALLENGES
RESPONSE TO SOME OF SAAHAs CONCERNS
WAY FORWARD
11/15/2018

3. MANDATE OF NDoH Safeguard national health interests
To improve the health status of all citizens through prevention, treatment and rehabilitation strategies
To continuously monitor and evaluate strategies. This implies surveillance of emerging and existing health problems
Ensure access to medicines that meet approved standards of safety, quality, and efficacy in the most cost-effective and sustainable manner
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4. MEDICINES POLICY AND LEGISLATIVE FRAMEWORK
National Drug Policy aims to ensure access to efficacious, safe, quality medicines
Through strengthening the MCC, rationalising drug registration, controlling the registration of practitioners and licensing premises, enhancing the inspectorate and laboratory functions and promoting other quality measures e.g. GCP, GMP, GWP, GLP, GDP
Mainly Act 101 of 1965 as amended, Pharmacy Act
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5. MANDATE OF THE MCC
Registration of medicines based on safety, quality and efficacy
Approval of clinical trials
Inspection of manufacturing premises to ensure GMP
Control of access to medicines
Licensing of manufacturers, wholesalers and distributors of medicines
Pharmacovigilance
Provision of information
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6. MEDICINES CONTROL COUNCIL
HOW MCC FUNCTIONS
Registrar
MEDICINES CONTROL COUNCIL
Clinical Committee
Clinical Trials
Scheduling
Pharmacovigilance
HIV Vaccine Trials
Veterinary Clinical
African Traditional Medicines
Complementary Medicines
Biologicals
Pharmaceutical & Analytical
PEER REVIEW MECHANISM
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7. PILLARS OF MEDICINE REGULATION
Existence of an Independent Regulatory authority
Transparency and Accountability
Registration of medicines: Quality, efficacy, and safety
Licensing: Manufactures, wholesalers
Control aspects: who may manufacture, import, export, distribute, prescribe, dispense, etc.
Compliance with requirements: Reporting Adverse Drug Reactions, Medicines Recalls etc.
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8. WHO-ELEMENTS OF EFFECTIVE REGULATION
Decisions should be based on scientific evidence and data
Practicable enforcement capacity
Accountability and public interest/public good
Safeguard against conflict of interest
Limit discretionary powers
Good regulatory practices and standards
Independence from public, commercial, and public pressure
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9. VETERINARY PHARMACEUTICALS IN S.A
Regulated since 1947 under Act 36 (stock remedies) with the intention of giving farmers access to medicines for livestock conditions they can readily diagnose and treat
Between 1965 and 1977, the number of “new” veterinary medicines & their sophistication increased with years. They were not regulated under Act 36 of 1947as most were indicated for complicated conditions that could not be readily diagnosed by farmers and needed the services of a veterinarian
Safety concerns were raised as they were also not regulated under the Medicines and Related Substances Act 101 of 1965.
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10. VETERINARY MEDICINES cont.
Regulation under Act 101 was only promulgated in 1979 after amendment of the definition of a medicine to include veterinary medicine as a result of safety concerns
Act 101 describes through scheduling, various limits of control, to ensure access, distribution and use of medicines (including veterinary medicines)
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11. ANTIMICROBIAL RESISTANCE CONCERNS
Use of antimicrobial drugs particularly in food producing animals may contribute to emergence of resistant strains in animals & humans
Transfer of antibiotic-resistant bacteria from animals to humans is well documented for salmonella infections and other zoonotic infections
Use of antimicrobials as feed additive for growth promotion in animals (banned in EU 1999)
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12. Antimicrobial resistance, S
Antimicrobial resistance, S. Typhimurium, England & Wales Tranfer of zonotic bacteria
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13. Resistance in E.coli from healthy pigs and overall use of tetracyclines for animals (France 2000, Denmark and Sweden 2002)
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14. SCHEDULING OF MEDICINES IN S.A
General Considerations:
- Safety: Inherent characteristics of a medicine/ substance
- Professional advice/supervision: The complexity or severity of the condition for which the medicine is indicated
- Control: Requirements in terms of International conventions
- Public health considerations: Essential needs, etc
- Usage: Safety to the handler of the medicine
- International drug regulation: Scheduling status in other countries
General Considerations
- Safety: Inherent characteristics of a medicine/ substance
- Professional advice/supervision: The complexity or severity of the condition for which the medicine is indicated
- Control: Requirements in terms on International conventions
- Public health considerations: Essential needs, etc
- Usage: Safety to the handler of the medicine
- International drug regulation: Scheduling status in other countries
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15. SCHEDULING cont. CURRENT SCHEDULES 1 – 5 Specified 5 & 6 – 8 ACCESS
1 – 5
Specified 5 & 6 – 8
ACCESS
OTC/Open shop
Professional advice [veterinarian, pharmacist, nurse etc]
International conventions [ potentially dependence producing dependence producing & Banned]
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16. REGISTRATION REQUIREMENTS IN TERMS OF ACT 101
SAFETY
EFFICACY
QUALITY
In-vitro & animal studies
Pharmacology
Toxicology
Chemical, pharmaceutical & biological tests
Pharmaceutical dosage formulation
Process development for manufacturing
Stability & other quality parameters
Clinical studies
Phase I,II,III
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17. CHALLENGES
The apparent overlap in the definition of veterinary medicine/ stock remedy in terms of the two acts:
Veterinary medicine: any substance or mixture of substances, other than a stock remedy or farm feed to be registered in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947), used or purporting to be suitable for use or manufactured or sold for use in connection with vertebrates, for the treatment, diagnosis, prevention or cure of any disease, infection or other unhealthy condition, or for the maintenance or improvement of health, growth, production or working capacity, or for curing, correcting or modifying any somatic or organic function, or for correcting or modifying behaviour. (As defined in Act 101 of 1965 as amended)
Stock remedy: a substance intended or offered to be used in connection with domestic animals, livestock, poultry, fish or wild animals (including wild birds), for the diagnosis, prevention, treatment or cure of any disease, infection or other unhealthy condition, or for the maintenance or improvement of health, growth, production or working capacity, but excluding any substance in so far as it is controlled under the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965) (as defined in Act 36 of 1947)
The apparent overlap in the definition of veterinarymedicine/stock remedy in terms of the two acts: the two acts uses the “exception rule” in defining what falls within their scope and no other clear criterion exists
Veterinary medicine: any substance or mixture of substances, other than a stock remedy or farm feed to be registered in terms of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947), used or purporting to be suitable for use or manufactured or sold for use in connection with vertebrates, for the treatment, diagnosis, prevention or cure of any disease, infection or other unhealthy condition, or for the maintenance or improvement of health, growth, production or working capacity, or for curing, correcting or modifying any somatic or organic function, or for correcting or modifying behaviour.
a substance intended or offered to be used in connection with domestic animals, livestock, poultry, fish or wild animals (including wild birds), for the diagnosis, prevention, treatment or cure of any disease, infection or other unhealthy condition, or for the maintenance or improvement of health, growth, production or working capacity, but excluding any substance in so far as it is controlled under the Medicines and Related Substances Control Act, 1965 (Act 101 of 1965)
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18. CHALLENGES cont… Registration of the same substance with both acts;
Scheduling of medicines is on the basis of risk under Act 101
International conventions (INCB) mandates
Regulation and control of the use of unregistered medicines
Pharmacovigilance implications
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19. CHALLENGES cont…
All animal medicines have potential safety concerns in humans; some are direct whilst others are indirect.
-   - Drug residues in food producing animals
-   - Handler/operator (contact with medicines)
- Environment
Antimicrobial resistance from inappropriate use of antibiotics in animals
Economic implications of having two regulatory bodies
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20. SAAHA CONCERNS
Dichotomy in terms of how animal medicines are registered in S.A
Changes in health policies have an impact on animal health industry (Single exit price & marketing codes)
Act 101 focus on human beings and thus inappropriate standards are applied to animal pharmaceuticals
Lack of registration of new drugs by Act 101
Evaluation of drug residue studies (capacity?)
Harmonization implications within SADC
- Inappropriate standards applied to animal pharmaceuticals () -
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21. CONCLUSION
Human safety risk-assessment should form the basis of approval of veterinary antimicrobials
The risk-benefit of the use of antimicrobials as growth promoters needs to be evaluated
Resistance containment strategies needed
Better communication with all stakeholders involved required maybe a structure similar to the WHO/FAO one
Pharmacovigilance vital element
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