1 A QUESTION OF BALANCE: DEALING FAIRLY WITH CLAIMS FOR MEDICINES Peter Folb Treatment Action Campaign 26 September 2006

2 CONSIDERING CLAIMS Quality Efficacy Safety - In the public interest Note: Need clause National Regulatory Authority (NRA)

3 EXPERTISE REQUIRED BY NRA Clinical medicine Paediatrics Toxicology Clinical pharmacology Pharmacology Pharmacy and industrial pharmaceutics Statistics and epidemiology Public health

4 ALL DECISIONS OF THE NRA MUST BE in the public interest free of external influence without fear or favour based on strict scientific and clinical evidence explicable to applicant and public

5 SPECIAL ISSUES locus standi audi alteram partem subject to appeal mandamus NOTES: SA ADMINISTRATIVE LAW CONFIDENTIALITY

6 INVOLVEMENT OF THE PUBLIC Risk – benefit assessment Conferring with the public Accounting to the public Rules for limiting advertisement NB: Government is an ordinary client – manufacture; advocacy role Encouraging public self- sufficiency Encouraging public self- sufficiency

7 TRADITIONAL MEDICINES – SPECIAL ISSUES Empirical nature of practice International pharmacopoeias Quality – Good Manufacturing Practice Safety – normal standards Efficacy – no misleading claims SETTING SCIENTIFIC STANDARDS

8 WORKING WITH THE HEALERS SA Novel Drugs Development Programme TB; malaria; diabetes; immune modulation Innovation Fund award Clinical trials (Note: ethics) Agricultural processing SETTING NEW STANDARDS OF COLLABORATION

9 WHO EVALUATION OF NRA Statutory basis for evaluation Quality systems for each NRA function Independence in decision-making Effective recall system Appropriate expertise and qualification of staff NRA institutional development plan Transparency and public accountability