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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