- Mots-clés > accountability - pharmaceutical sector
- Mots-clés > corruption
- Mots-clés > ethical practices and standards
- Mots-clés > good governance
- Mots-clés > Good Governance for Medicines (GGM)
- Mots-clés > monitoring and evaluation
- Mots-clés > pharmaceutical sector - individual and institutional integrity
- Mots-clés > pharmaceutical systems - effective management
- Mots-clés > transparency
(2018; 43 pages)
The Pharmaceutical system transparency and assessment tool is based on the WHO Assessment Instrument for measuring transparency in the public pharmaceutical sector published in 2009.
WHO has developed the Pharmaceutical System Transparency and Accountability Assessment Tool (hereafter referred to as ‘the assessment tool’) to assist countries with the assessment of the public availability of key documentation that facilitates accountability of the pharmaceutical system. This document is intended for policy makers and concerned stakeholders with an interest in improving governance in the pharmaceutical system as well as for those who will carry out an assessment.
The assessment results are intended to be used in the policy cycle to:
- Identify strengths and weaknesses with regards to transparency of pharmaceutical information
- Inform priority setting
- Develop targeted policy interventions
- Periodically to monitor progress
The main focus of the assessment is on transparency and accountability in the public sector. Other sectors are included in the assessment when relevant for accountability.
Transparency of processes and decisions is assessed rather than the performance of those processes and decisions. As such, this this tool complements other tools that assess operational capacity of the pharmaceutical system such as the WHO Regulatory System Strengthening Benchmarking Tool ( See Annex 1 for synergies and differences with other available tools).
The following cross-cutting areas and eight core functional areas of the pharmaceutical system are included in the assessment:
Access to information
Code of conduct an anti-corruption
Managing conflict of interest
I. Registration and marketing authorization of pharmaceutical products
II. Licensing premises of manufacturers, wholesalers and retailers
III. Regulatory inspections of manufacturers, wholesalers, retailers and CROs
IV. Pharmaceutical promotion and independent information
V. Clinical trials oversight
VI. Medicine selection and reimbursement lists
VII. Public procurement