National Medicines Policy 1

2. National Medicines Policy (1)?

Objectives: Ensure equitable availability and affordability of essential medicines, the quality, safety and efficacy of all medicines and the promotion of therapeutically sound and cost-effective use of medicines by health professionals and consumers. National supply system: based on a pyramid approach: Central Medical Stores (CMS) distribution to Health Facilities : Directly from the CMS or Through Regional/District Medical Stores

3. National Medicines Policy (2)?

Donors support: within the past decade, increased funds to countries for medicines especially for HIV/AIDS, Malaria and TB Multilateral : EU, WB, ADB, IDB, Global Fund, UNITAID,... Bilateral : USAID, PEPFAR, French cooperation, DFID, CTB, JICA, SIDA... Foundation : Clinton, Bill & Melinda Gates, Damien... UN Family : UNICEF, UNFPA, UNDP, UNAIDS... Faith based NGOs : MSF, MSH, FHI... In some cases with their own procurement and supply system.

4. Mapping/in-depth assessment of medicines procurement and supply systems (1)?

Objectives: Support the Ministry of Health to : Map out all partners involved in medicines procurement and distribution Carry-out an in-depth assessment of the national procurement and supply management system, including all components of the medicines supply management cycle Determine the strengths and weaknesses Develop strategies to strengthen the coordination and the national capacity. 10 countries : Cameroon, Senegal, Rwanda, Burundi, Mali, Congo-Brazzaville, Ghana, Nigeria, Tanzania and Zambia

5. Mapping/in-depth assessment of medicines procurement and supply systems (2)?

Methodology: 2 steps Step 1: Mapping: Identify all partners and structures involved (category of products supported, financial value of support…) Describe the procurement (procurement agents) and distribution channel Describe financial flows Category of products : Essential Medicines with a focus on: adult and pediatric ARVs, Malaria, TB, OI, HIV/AIDS Reagent, Vaccines, Condoms, Contraceptives and Medical devices Step 2: In-depth assessment: Procurement and supply systems (calculate performance indicators for all the components of the medicines supply management cycle)

6. Mapping/in-depth assessment of medicines procurement and supply systems (3)?

Medicines management cycle Selection Quantification/Forecasting Procurement Ordering Storage/Stock management Distribution Quality assurance system Rational use Financing Information management Monitoring and evaluation Human resources Policy framework

7. Mapping/in-depth assessment of medicines procurement and supply systems (4)?

Tools: For each step, the methodology and questionnaires used to collect the data have been developed by WHO/AFRO and HQ. 6 questionnaires : Partners, Ministry of Health, Programmes, Central Medical Stores, Regional/District Stores and Health Facilities. Assessment team: National coordinator (to manage the exercise and provide direction in the process of data collection, entry, analysis, report writing and presenting the findings) Trained data collectors EDM National Professional Officer (NPO)? External consultant (WHO/Geneva or AFRO)?

8. Mapping results (1)

Burundi Congo-Brazzaville Mali Rwanda Senegal Tanzania Zambia

9. Mapping results (2)Strengths

Additional funds available to strengthen the medicines financial system Technical support available to strengthen national capacities in medicines procurement and supply management Logistic support to improve distribution and geographical availability of medicines

10. Mapping results (2)Weaknesses (1)?

Supply system organigram: Complex and unknown by the actors Responsibilities and tasks of each of the actors are not clearly defined Lack of transparency from partners CMS is rarely involved in forecasting/procurement Selection: Supply outside the EML/STG still exists Procurement of non registered medicines in countries still exists Quantification: The lack of coordination between MoH and partners results in stock-outs, shortages, overstocking and expired products An adequate logistic information system is currently not in place (due to the complexity of the system?)

11. Mapping results (3)Weaknesses (2)?

Procurement: Difficult to manage due to the number of different procurement and financial procedures they have to deal with (specific for each partner). Stock management: Most of the time separate for each partner therefore increasing the burden of work for personnel and adding to the complexity of stock management. Storage capacity exceeded due to lack of coordination. Distribution: Lack of coordination between the different programmes leads to high operational costs for all programmes. Financing: Financial figures not always available. Some programmes may be under-supported while others are over-supported due to insufficient information and/or coordination. Logistic support is under- funded. Monitoring-Evaluation: Difficult to manage due to the number of different reporting tools therefore increasing the burden of work for personnel.

12. Relevance to MoH

Evidence-based to: Develop transparency Create with partners a coordination mechanism for a coordinated, harmonized, coherent and efficient national medicines supply system Mobilize resources for under-served programme areas within the macro frame of sector needs Organize and plan capacity building at each level Monitor the performance of the system

13. Relevance to partners

Evidence-based to: Prioritize investments in medicines procurement Target support to address gaps identified in the procurement and supply management system Provide information to monitor progress and plan for future support Have a platform to share information and coordinate procurement and distribution of medicines among partners

14. Guidelines for drugs donations

Guideline no. 12: "Costs of international and local transport, warehousing, port clearance and appropriate storage and handling should be paid by the donor agency, unless specifically agreed otherwise with the recipient in advance." Additional guidelines for drug donations as part of development aid: "It should be recognized that drugs do not arrive in an administrative vacuum. Drug donations should not create an abnormal situation which may obstruct or delay national capacity building in selection, procurement, storage, distribution and rational use of drugs." "Administratively, the drugs should be treated as if they were procured. This means that they should be registered or authorized for use in the country through the same procedure that is used for government tenders. They should be entered into the inventory, distributed through the existing distribution channels and be subject to the same quality assurance procedures. If cost-sharing procedures are operational in the recipient country, the donated drugs should not automatically be distributed free of charge."

15. Paris Declaration

Ownership Alignment: Donors align with partners’ strategies Donors use strengthened country systems Partner countries strengthen development capacity with support from donors Strengthen public financial management capacity Strengthen national procurement systems Harmonization: Donors implement common arrangements and simplify procedures Complementarity: more effective division of labour Incentives for collaborative behaviour Delivering effective aid in fragile states Promoting a harmonized approach to environmental assessments Managing for results Mutual accountability: Donors and partners are accountable for development results

16. DAKAR Declaration 8 December 2006ACAME (African Central Medical Stores Association)www.acame.org

Article 1: ACAME recommends that the implementation of any essential drugs supply program in Africa, including programs related to the provision of drugs used for the treatment of the priority diseases mentioned in the preamble, be part of the concerted approach leading to the strengthening and sustainability of national supply systems. Article 2 : The decision to substitute national Purchasing Centres by United Nations Agencies or Western Non Governmental Organizations, regarding priority programs' essential drugs management and/or supply, is considered to be contrary to: the basic principles relating to national capacity building of developing countries the rationalization of existing supply systems the pharmaceutical requirements Article 3 : This decision shall be only provisional and shall be replaced as soon as possible by a strategy for use and national Purchasing Centres capacity building. Article 4 : ACAME recommends that national Purchasing Centres assessment be made within a concerted framework, which further comprehensively mainstreams drug and environment context within which the Purchasing Centres evolve, and be documented in a detailed report, providing accompanying measures in case possible failures have been recorded. Article 5 : In the light of the outcomes of the Purchasing Centres assessments made by health development partners, ACAME has decided to develop a strategic plan for Purchasing Centres development.

18. The role of WHO (1)

In collaboration with partners, regional blocks, collaborating centres etc… to ensure effectiveness, accountability and transparency of procurement and supply management system Develop and implement strategies to increase the alignment of aid Support the implementation of a national coordination mechanism in-country (planning, financing, disbursement, monitoring-evaluation, training…) Support the harmonization and the improvement of the technical and financial procedures for procurement (ACAME) Develop norms, standards and good practices, using a harmonized approach, to support and monitor capacity building and increase transparency

19. The role of WHO (2)

Support the implementation of efficient and sustainable medicines financing systems Reinforce collaboration and joint initiatives with our partners Thank you