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A QUESTION OF BALANCE: DEALING FAIRLY WITH CLAIMS FOR MEDICINES
Peter Folb
Treatment Action Campaign26 September 2006
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CONSIDERING CLAIMS
Quality
Efficacy
Safety
- In the public interest
Note: Need clause
National Regulatory Authority (NRA)
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EXPERTISE REQUIRED BY NRA
Clinical medicinePaediatricsToxicologyClinical pharmacologyPharmacologyPharmacy and industrial pharmaceuticsStatistics and epidemiologyPublic health
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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
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SPECIAL ISSUES
• locus standi• audi alteram partem• subject to appeal• mandamus
NOTES: SA ADMINISTRATIVE LAW CONFIDENTIALITY
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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 publicself-
sufficiency
Encouraging publicself-
sufficiency
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TRADITIONAL MEDICINES – SPECIAL ISSUES
Empirical nature of practice
International pharmacopoeias
Quality – Good Manufacturing Practice
Safety – normal standards
Efficacy – no misleading claims
SETTING SCIENTIFIC STANDARDS
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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
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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