Prospective Models for Vaccine Procurement and Security in National Immunization Programmes;

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1 Prospective Models for Vaccine Procurement and Security in National Immunization Programmes; Sri Lankan Experience Dr. Sudath Peiris, Immuinization Programme Manager, Sri Lanka

2 Achievements and strengths of EPI Sri Lanka One of the strong performer in the region Diseases under cover (11) have been controlled and reached elimination levels Maintenance of potency of vaccines is ensured by well managed cold chain system Made access to known good quality vaccine to the total population with lowest possible cost through matured procumbent system Well functional NITAG, NRA and NCL Sensitive AEFI surveillance system Secured financial allocation by a separate vote in the national budget

3 Rate per 100,000 population Incidence of Measles and MCV1/MCV2 Immunization Coverage, Year Coverage(%) Rate per 100,000 population Incidence of Poliomyelitis and OPV 3 immunization Coverage, Year Incidence rate Coverage(%) Incidence rate MCV1 Rate per 100,000 population Incidence of whooping cough and DPT3 immunization coverage, Year Incidence rate Coverage(%) Rate per 100,000 population Incidence of tetanus and DPT 3 immunization coverage, Year Incidence rate Coverage(%)

4 Evolution of vaccine procurement system in Sri Lanka : UNICEF donation (BCG, OPV, DPT, Measles) : Sri Lanakan government took over self procurement vaccines over five years : Sri Lankan government procured all vaccines directly from global market through competitive bidding except HBV ( GAVI donation UNICEF SD) Sri Lankan government procured all vaccines directly from global market through competitive annual bidding except Penta Vaccine ( GAVI co-finance UNICEF SD) Sri Lankan government procured all vaccines directly from global market through competitive annual bidding including cofinancing component of the Penta Vaccine 2013 Commenced three year international competitive bidding ( )

5 Vaccine procurement. Objective.. Ensure uninterrupted supply of potent known good quality vaccines at competitive cost while maintaining adequate stocks of vaccines at every level at all times keeping the vaccine wastage minimum.

6 Vaccine procurement. Main Tasks.. Forecasting demand Request for budgetary allocations Preparation of specifications Preparing and issuing tender Tender opening and evaluation Awarding contract Payment Receipts and clearance Performance and quality monitoring Litigation?

7 Vaccine Procurement. Main tasks, agencies involved & time line Tasks Agency Time Line Licensing DRA On submission Forecasting/Planning Specifications Request for budget EPI EPI/NCL EPI 1 year ahead Evaluation MSD/EPI/NCL 9 Months ahead Confirmation MSD/EPI 6 Months ahead Tender/Contracts SPC 3 Months ahead Payments SPC At the time of establishment of L/C Receipt/Delivery SPC According to delivery schedule Quality Assurance/Lot Release NCL/DRA/SPC On receipt of each lot Distribution EPI Every two months Immunization EPI Through the year Cold Chain/Monitoring EPI Through the year AEFI/Safety Monitoring EPI/DRA Through the year

8 Vaccine procurement. Forecasting demand. Objective.. To make sure uninterrupted adequate supply of total vaccine requirements of the country by predicting the needs early.

9 Vaccine Procurement. Forecasting. Factors considered.. Projected target population Estimated coverage Average past consumption Vaccine wastage rates Stocks in hand Buffer stock

10 Vaccine Procurement. Forecasting Estimated vaccine Requirements for 2013 ( Done in early 2012) OPV DPT DT TT BCG atd HBV Penta JE Live MMR Typhoid 1 Balance as of 2012/01/01 1,150, , , , , ,320 3, , , , On order year ,500, , , ,000 1,000, ,000 5,000 1,200, , ,000 10,000 Total(1+2) 2,650, , , ,590 1,725, ,320 8,040 1,698, ,105 1,200,540 10,286 3 Use during year ,800, , , ,000 1,100, ,000 5,000 1,200, , ,000 10,000 4 (same as 2011 use) Balance as of 2013/01/01 (Actual) 850, , , , , ,320 3, ,733 72, , Expected use for ,800, , , ,000 1,100, ,000 5,000 1,200, , ,000 10,000 6 Deficit for 2013 (5-4) 949,360 14,220 86, , ,940 44,680 1, , , ,460 9, months buffer (50% of 5) 900, , , , , ,000 2, , , ,000 5,000 8 Total Requrment for 2013 (6+7) 1,849, , , ,410 1,024, ,680 4,460 1,301,267 1,127,895 1,049,460 14,714 9 To be ordered for ,600, , , ,000 1,000, ,000 2,000 1,200, , ,000 10,000

11 Vaccine Procurement. Specifications.. shaumi/c/mydoc/vaccine requirements 2001 EPI VACCINE REQUIREMENTS, SPECIFICATIONS AND SCHEDULE OF DELIVERY 2005 DESCRIPTION OF ITEM WITH SPECIFICATIONS PACKAGING QUANTITY REQUIRED Bacillus Calmette-Guerin Vaccine (BCG). 10 or 20 dose vial. 1,500,000 (based on cost per vial) doses DELIVERY SCHEDULE 500,000 doses in 1 st week of Feb 2005 Bacillus Calmette- Guerin Vaccine BP (BCG Vaccine) Each infant (< 1 year old) dose should contain mg of live Bacillus Calmette- Guerin and when reconstituted, the dose should be 0.05 ml. (1) Offers should be only from vaccine suppliers recommended by World Health Organization (WHO) for bulk purchase for the U.N. Agencies. (2) The product should be from fresh stocks and each consignment should be prepared preferably from a single batch. Each batch should accompany a certificate of analysis (lot release certificate) issued by a laboratory accredited by National Control Authority and Summary Protocol of vaccine blending should be submitted for protocol review. (3) Each consignment should have a minimum shelf life of 2 years at the time of dispatch. (4) The vaccine should also comply with the general requirements for vaccines in the BP or USP (5) The vaccine should meet the most recent requirements of WHO when tested by the methods outlined by WHO. (6) Cold Chain Monitors should be included for each 3000 doses and the Cold Chain should be maintained according to the Manufacturer s instructions during storage, transport and delivery of vaccines. (7) The vaccine should be protected from light and should be stored at a temperature - 20 o C. (8) Each vial should be labeled accordingly. (9) Each vial to be provided with a suitable sterile diluent 50 vials per box. Vaccine should be packed according to the WHO guidelines on international packaging and shipping of vaccines for EPI WHO/EPI/ CCIS/81.04/Rev.5,(1093) 500,000 doses in 1 st week of June ,000 doses in 1 st week of September 2005

12 Approval of the specifications, tender documents & fixing dates to publish the tender Vaccine Procurement. Preparing and issuing tender Receipt of requirements, schedule of delivery and specifications from the EPI to the Medical Supplies Division Appointment of Technical Evaluation Committee (Secretary to Ministry of health) Approval of the specifications & the tender documents by the TEC Submissions of the approved specifications, tender documents to Ministry Tender Board/Cabinet Approved Tender Board

13 Vaccine Procurement. Tender opening and evaluation. Receipts of bids by State Pharmaceutical Cooperation (SPC) Scheduling of bids Evaluation of the bids by the technical evaluation committee (TEC) TEC recommends lowest acceptable/responsive bidder to the tender Board

14 Vaccine Procurement. Awarding contract.. Tender board receives TEC recommendations Award of the tender by the Tender Board Inform the selected bidder to accept the tender Release of the indent to the accepted bidder Signing of the contract & providing of the performance bond by the supplier

15 Vaccine Procurement. Payment & Receipt of goods.. Establishing the LC All indent conditions are included in the LC Arrival of goods at airport Scrutinizing the documents Physical verification of goods Custom clearance Transport of vaccines to central cold rooms of EPI

16 Vaccine Procurement. Performance and quality monitoring Lot release using summery lot protocol AEFI surveillance Monitoring of cold chain

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23 Unit Cost Vaccines Procured for EPI, Sri Lanka Sri Lankan Rupies VACCINE (Per dose) (Per dose) (Per dose) (Per dose) (Per dose) (Per dose) (Per dose) (Per dose) (Per dose) (Per dose) (Per dose) BCG DPT DT TT OPV Measles Rubella MR MMR atd Hep-b JE PENTA AD Syrin.0.5ml AD Syrin.0.05ml 8 8 AD Syrin..2ml AD Syrin. 5ml Safety Box

24 Comparison of vaccine prices quoted by manufacturer to UNICEF* and Sri Lanka VACCINE UNICEF* Sri Lanka** Per dose US $ BCG DPT DT TT OPV MMR atd Hep-b JE PENTA *Lowest price as per UNICEF vaccine price data ** CIF price Sri Lanka

25 Advantages and possible Challenges FORECASTING Stable birth cohort and immunization coverage Vaccine wastage, cold chain failures, expiry Outbreaks PLANNING & BUDGETING Need good coordination between EPI, MSD, SPC, Finance, NRA Unbelievable reduction in administrative work PRICES? Current experience is cost reduction New producers, pre-qualifications after multiyear contract REGULATION Quality issues and revoking of WHO prequalification AEFI issues Non renewal of license with DRA

26 Thank You