Pharmaceutical System Transparency and Accountability Assessment Tool. Good Governance for Medicines: Progressing access in the SDG era. Geneva: World Health Organization; 2018
(2018; 43 pages)

Abrégé

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:

Cross-cutting areas
Access to information
Public participation
Medicines policy
Code of conduct an anti-corruption
Managing conflict of interest

Functional areas
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
VIII. Distribution

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Le Portail d'information - Médicaments essentiels et produits de santé a été conçu et est maintenu par l'ONG Human Info. Dernière mise à jour: le 29 octobre 2018