A QUESTION OF BALANCE: DEALING FAIRLY WITH CLAIMS FOR MEDICINES

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
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

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