PRESENTATION TO PORTFOLIO COMMITTEE [AGRICULTURE AND LAND AFFAIRS]

1. REGULATION AND CONTROL OF VETERINARY PHARMACEUTICALS IN SOUTH AFRICATHE ROLE OF THE NATIONAL DEPARTMENT OF HEALTH PRESENTATION TO PORTFOLIO COMMITTEE [AGRICULTURE AND LAND AFFAIRS] Mandisa Hela 19 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

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

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

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

6. MEDICINES CONTROL COUNCIL Pharmaceutical & Analytical Clinical Committee Clinical Trials Biologicals PEER REVIEW MECHANISM Complementary Medicines Scheduling African Traditional Medicines Pharmacovigilance HIV Vaccine Trials Veterinary Clinical HOW MCC FUNCTIONS Registrar

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.

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

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.

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)

11. 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)

12. Antimicrobial resistance, S. Typhimurium, England & Wales 2000- Tranfer of zonotic bacteria

13. Resistance in E.coli from healthy pigsand overall use of tetracyclines for animals (France 2000, Denmark and Sweden 2002)

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

15. SCHEDULING cont.

16. QUALITY EFFICACY SAFETY Pharmaceutical dosage formulation Process development for manufacturing Stability & other quality parameters In-vitro & animal studies Pharmacology Toxicology Chemical, pharmaceutical & biological tests Clinical studies Phase I,II,III Pharmacology REGISTRATION REQUIREMENTS IN TERMS OF ACT 101

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)

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

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

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

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