Juanita Folmsbee, Country Project Director, SIAPS program Feedback related to Pharmaceutical Sector

General Remarks on the Strategy We support the proposed overall SAG strategy with minor amendments There is a need to review and revise the current Concept for Development of the Pharmaceutical Sector ( ) and link to health sector reform. Statements on price setting mechanisms (line 812) in this overarching policy document is premature – until overarching pharmaceutical policy objectives have been established – It reduces future policy flexibility

General Remarks on the Strategy (2) There is a focus on tasks and mechanisms in the area of pharmaceutical management We would like to see a clear focus of what the final expected outcome is rather than leaving it at the detailed implementation plan phase (page 24, line 900)

Suggestions to the Strategy (1) The term “National EML” is mentioned the first time in line 810 without emphasizing the importance of updating the current EML to address the needs of the health system at various levels. SAG needs to recommend legislation to mandate use of the EML/harmonized list of medicines as the basis for public procurement and/or reimbursement. – This harmonized list of medicines should clearly designate/authorize the use of the medicines at various levels of the health system. – This is critical to meet health sector reform goals

Suggestions to the Strategy (2) Pharmaceutical regulation is fragmented across the SAUMP and the SEC – leading to lack of clarity for manufacturers, importers, etc. The SAG should make a strong recommendation to – Streamline and simplify the two different entities to better rationalize their roles and responsibilities – Then the stated goal of pharmaceutical reform in line 780 can be achieved

Suggestions to the Strategy (3) Rational use of resources is mentioned several times in relation to services, infrastructure, funding, etc. There is however, no statement on rational use of medicines* – RUM is critical to improving efficiency – and essential to the long term sustainability of the system, given resource limitations * Prescribing, dispensing, use, pharmacovigilance, quality, etc