Pharmaceutical procurement and supply systems within national pharmaceutical policies: regulations, roles, responsibilities and challenges

Transcription

1 harmaceutical procurement and supply systems within national pharmaceutical policies: regulations, roles, responsibilities and challenges écile acé / Workshop on trenghtening Logistic anagement nformation ystems, Ouagadougou, 6 ay RB Workshop 6-8 ay 2014

2 2 ational harmaceutical olicy ommon framework to solve problems in pharmaceuticals within which the activities of the pharmaceutical sector can be coordinated commitment to a goal and a guide for action he Goal: o ensure equitable access to qualityassured, safe and efficacious essential medicines and health products and to promote rational use. o achieve this goal one of the component of the policy will describe the policy options chosen for the national supply system RB Workshop, 6-8 ay 2014

3 harmaceutical system ational olicy anufacturers R & anufacturers ublic sector ational procurement agency/department ational edicines Regulatory uthority edicines authorized for use Quality ontrol laboratory rivate sector istributors/wholesalers upply chain, R,, H harmaceutical inspection harmacovigilance upply chain H, rivate harmacies atients atients

4 ublic supply chain anufacturer anufacturer anufacturer ational rocurement gency/epartment Regional stores istrict stores eaching Hospital Regional Hospital istrict Hospital Health entre

5 rivate supply chain rivate wholesalers/distributors harmacies rivate health facilities (linics ) on-profit private health facilities

6 ational rocurement and upply ystem he structure, regulatory framework, norms and standards, roles and responsibilities for the rocurement and upply ystem should be defined at national level and should be described in a document his document should be validated at national level and implemented (e.g: procurement strategy, regulation ) Based on the structure of the national procurement and supply system, this document or an annex should describe the data to be collected at each level, where the data should be used for further decisions and clarify responsibilities 6 RB Workshop 6-8 ay 2014

7 Roles and responsibilities for public sector ational Regulatory uthority: to guarantee the quality, efficacy and safety of products procured, to license the pharmaceutical establishments, to inspect the establishments and facilities, to monitor the quality of medicines and health products within the distribution chain ational rocurement gency: to procure, stock and supply medicines until a certain level in the national system (often regional), to keep track of quantities dispatched in some countries functions done by two separate entities (national procurement department and central medical store) inistry of Health: management of districts and health facilities including distribution, stock and order management at peripheral level, responsible for providing tools and capacity building on drug management (existing tools available in many countries) 7 RB Workshop 6-8 ay 2014

8 orms and tandards hould be agreed at national level based on existing WHO Guidelines (Operational principles for good procurement practices, Q, G, G, Guidelines for medicine donations ) 8 RB Workshop 6-8 ay 2014

9 Role of artners in systems lignment with national policies and plans aris eclaration upport the development of national systems and the reinforcement of capacities 9 RB Workshop 6-8 ay 2014

10 n reality Results of the studies on apping and in depth assessment of medicines supply systems carried out in 17 countries and ongoing in 2 countries: oordination/en/index.html o document "Who does what, how and with which funds", to compare the situation with existing policies, legislation and regulation, norms and standards, best pharmaceutical practices and to use evidence for strengthening strategies, coordination and capacity building 10 RB Workshop 6-8 ay 2014

11 Results of mapping of supply systems ational rocurement systems exist and in most of the countries the distribution of pharmaceutical products (public and private) is well defined and functional artners are bringing important additional financial resources necessary to support purchase of pharmaceutical products (an average of 17 financial partners per country) ountries are having a national quality assurance policy in place ome partners are providing technical support to reinforce national capacities (but not always well coordinated) ome partners are providing logistic support to improve distribution and geographical availability of some specific products 11 RB Workshop 6-8 ay 2014

12 ystèmes d'approvisionnement des produits pharmaceutiques au BRK O, ept 2010 inistère de la anté u Burkina G RVs RVs B O R V ed utres ntipaludique ontraceptifs ispositifs édicaux tat onds commun Bailleurs bilatéraux Bailleurs multilatéraux OG/rivé ources de inancement G (opulation) / onds ondial R6 (/L- ) : B, onds ondial R8 Bill et elinda Gates ays-bas,,, tat O L BRK G G V R O O tructure d'approvisionnement G ournisseurs privés O G H G eliver 1er point de stockage G GL L central V central Burkina central 2ème point de stockage G gences régionales R R épôts district 3ème point de stockage épôts district (R) tructure dispensatrice tructures privées H HR / H HR OG/ssociation HR H

13 ystèmes d'approvisionnement des produits pharmaceutiques en R ai 2009 République de R inistère de la santé L RVs L Y compris B O RVs ed R sécurité du sang (+ test HV) V réservatifs ontraceptifs ispositifs édicaux tat Bailleurs bilatéraux Bailleurs multilatéraux OG/rivé ources de inancement R (15) R (7) HGR R O OL O B L O B O B G V G Grossistes privés (G) tructure d'approvisionnement B Kin. R (15) RR R L O R LO BO G G 1er point de stockage R (15) R (ctb) R (ue) R GR épôt épôt O BO G kin. V 2ème point de stockage BZ R OGs épôts V R HGR BO O (ue) rov. nud B rov. rov. (15) OG rov. rov. G 3ème point de stockage ntennes V BZ G tructure dispensatrice O BZ HGR obi. H H O

14 ystèmes d'approvisionnement des produits pharmaceutiques au L. Janvier 2008 République du ali inistère de la santé L RVs L Y compris B O RVs ed R sécurité du sang (+ test HV) V réservatifs ontraceptifs aladies tropicales négligées ispositifs édicaux tat Bailleurs bilatéraux Bailleurs multilatéraux OG/rivé ources de inancement O OL G O Z R alaria o ore H R G V K W Grossistes privés / opulation tructure d'approvisionnement G O LO L J BOL ite Z Grossistes privés 1er point de stockage R L O G Grossistes privés 2ème point de stockage Ref L agasin régional R G Grossistes privés 3ème point de stockage R Ref R Grossistes privés tructure dispensatrice Ref O H V Ref V O ite prise en charge ite de dépistage O /Vacc

15 edicines supply systems in GH 2007 Republic of Ghana ategory of roducts color code L RVs LR B O RVs ed RG Blood safety (+ test HV) V OO ontraceptives L L Government Bilateral onor ultilateral onor GO/ rivate ource Of unds GOVR WB GLOBL GV GOV Of J rocurement gent/body ROR OH (ROW G) GLOBL WHO GOV Of J oint of first warehousing RL L OR oint of 2 nd warehousing RGOL L OR/ RGOL L OR G R R oint of 3th warehousing R L OR (RV LVRY O

16 hallenges Very complex procurement and supply systems in countries with many technical and financial partners involved, lack of harmonization and alignment Responsibilities and tasks of each actor not clearly defined and not always in compliance with their mandate Lack or ineffective national coordination mechanism particularly in quantification and procurement between oh,, ational rograms and artners ultitude of procurement agencies in countries with specific procurement procedure not in accordance with the national policy to use ational rocurement gency/epartment Lack of coordination of technical assistance and lack of technical assistance for strengthening the national system 16 RB Workshop 6-8 ay 2014

17 hallenges High risk of stock-outs and overstocks due to the complexity of the system High risk of financial loss and waste High risk of obtaining unreliable logistic data for quantification due to the fragmentation of the system and the lack of a clearly defined L (existence of parallel systems with non-harmonised data to be recorded and various tools) Lack of computerization and use of new technology 17 RB Workshop 6-8 ay 2014

18 edicines supply systems in country: proposed model and strategy H/ L RVs LR B O RVs ed edicines for eglected. iseases edicines for oncommunicable & ental Health RG Blood safety (+ HV test) V OO ontraceptives L V GOVR BLRL OOR ut in place a ational oordination mechanism LLRL OOR GO/RV ource of unds R L L O R B O L B implify, harmonize and align technical and financial procedures R B G Z G V G rivate wholesalers Basket funds : upply driven financing or emand driven financing rocurement agent/body RL L OR rivate wholesalers trengthen and use existing system oint of 1er warehousing oint of 2nd warehousing RL L OR RGOL OR rivate wholesalers oint of 3th warehousing R OR oint of dispensation istrict hospital rimary health centre Regional hospital eaching hospital rivate clinic harmacy easure the results : access to quality edicines

19 roposed solutions and Role of WHO upport the establishment of a coordination mechanism between the oh, ational rograms, key actors of the pharmaceutical system and partners to support the oh in the establishment/development of the national system (including L and tools) and to clarify responsibilities and for the coordination of funding, technical assistance, capacity building and training. ncourage technical and financial partners to respect their commitment on the alignment to national systems and to contribute to the development and reinforcement of national systems mprove dissemination of WHO norms and standards, good practices and of best practices in countries in the development/improvement of their national system 19 RB Workshop 6-8 ay 2014

20 roposed solutions and Role of WHO upport the mobilization of resources for activities (including development of national L) upport countries to prioritize investments for strengthening national systems and to take the best benefit of support given by partners in a coordinated way upport countries to monitor and evaluate system performance and take corrective action accordingly 20 RB Workshop 6-8 ay 2014