REGULATION AND CONTROL OF VETERINARY PHARMACEUTICALS IN SOUTH AFRICA THE ROLE OF THE NATIONAL DEPARTMENT OF HEALTH

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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
  19 September 2006

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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

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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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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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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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HOW MCC FUNCTIONS
Registrar
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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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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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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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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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ANTIMICROBIAL RESISTANCECONCERNS

• 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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Antimicrobial resistance, S. Typhimurium,
England Wales 2000- Tranfer of zonotic
bacteria
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Resistance in E.coli from healthy pigsand
overall use of tetracyclines for animals (France
2000, Denmark and Sweden 2002)
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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
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SCHEDULING cont.
CURRENT SCHEDULES CURRENT SCHEDULES CURRENT SCHEDULES CURRENT SCHEDULES
0 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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REGISTRATION REQUIREMENTS IN TERMS OF ACT 101
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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)
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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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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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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

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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