Home fortification, using Multiple Micronutrient Powders Products, Procurement and Supply Jan Komrska & Alison Fleet UNICEF Supply Division Medicines and Nutrition Center, Nutrition Unit Outline • Key product characteristics • How MNP products could be purchased/ordered? • Product Price • Manufacturing Process Objective of the Supply • To deliver right quantities of right product, to the right locations and at the right time. • To minimize costs and to satisfy quality requirements. Supply Process Plan Expression of need for a product Procure Produce Deliver Product arrives to the port of entry Plan • • • • • Definition of requirements What? How many? Where? When? How much? • • • • • Specification Quantity Delivery address Delivery date Available budget Plan Vitamin and Mineral Powder (MNP) Product Plan Specifications (HF TAG) • Name of the product – VITAMIN and MINERAL POWDER • Composition – 15 components • Label language – English x local language • Instructions for use – Text x Pictograms Plan Standard Product(1) Plan Standard Product(2) Plan Standard Product(3) • Available through UNICEF Supply Division • Suitable for pilot projects or small orders Plan Customised Products Haiti Yemen Nepal Rwanda Kyrgyzstan Plan Product characteristics Product shelf life – 2 years Under storage conditions indicated by the manufacturer Plan Quantification of needs • Good forecast and higher volumes result in: – Cost saving (obtaining better price from the supplier) – Better lead time – Less stock in warehouse – Uninterrupted supply Plan Timelines Standard product 3 – 4 weeks Confirmation of Layouts Warehouse Processing 4 weeks 8 – 12 weeks Production Shipment by Sea Clearance at the port TOTAL Customised product 4 – 6 weeks 4 – 6 weeks 2 weeks 2 weeks 10 – 12 weeks 17 – 24 weeks Plan Lessons Learnt • Product specification - refer to HF TAG Programmatic Note • Customisation of the product layouts possible but allow enough time • Product shelf life is short – plan for continuous orders to avoid long storage time • Storage conditions need to be adhered to keep the product fresh • Forecasting product quantities is very important Procure Regulatory environment(1) • Principles of public procurement: – Fairness – Transparency – Equal treatment • Registration of the product: – Law on medicinal product for human use • Import/VAT regulations Procure Regulatory environment(2) • Why MNP should not be registered as medicine? – Product does not claim to treat a specific disease – Product is not usually manufactured by pharmaceutical companies – Premix components comply with the Food Chemical Code (FCC) not Pharmacopoeias – Product is not distributed exclusively through pharmacies • MNP should be registered as food supplement however country specific constrains may require other registration avenues Supplies of MNP Procure Number of countries ordering MNPs 45 40 2011: 4 million monthly doses purchased 35 30 2014: 11 million monthly doses purchased 25 20 15 2012: 9 million monthly doses purchased 10 5 0 2007 2008 2009 2010 2011 Total number of countries 2012 2013 2014 MNP Prices Procure Price of 15 component standard layout product (USD/sachet) 0.026 0.025 0.025 USD/sachet ~ 0.75 USD/PAC-30 0.024 0.023 0.022 Additional costs: - Shipping cost - Clearance - Customs duties 0.021 Programming costs 0.020 0.019 2008 2009 2010 2011 USD/sachet 2012 2013 2014 Procure HF Products Prices Daily Dose Cost (USD ex Factory basis) 0.10 0.09 0.08 0.07 0.06 0.05 0.04 0.03 0.02 0.01 MNP LNS Small Quantity Procure How could home-fortification products be ordered/ procured? • Through Agencies (UNICEF country programme / WFP / NGOs) • Through Procurement Agents (UNICEF Procurement Services or GAIN Premix Facility) • Direct procurement by the governments from manufactures or appointed traders Procure Procurement through UN Agencies UNICEF country programme / WFP / NGOs • Advantage: – Funding is secured outside government (initial phases) – Good product quality and good price • Disadvantage: – Product is imported, cleared under Agencies' name – Capacity of the government is not built – Capacity of the local industry is not built • Suitable for initial stages of programs/pilots and in emergency response phase Procure Through Procurement Agents Through UNICEF Procurement services (PS) or GAIN Premix Facility (GPF) • Advantage: – Government is securing funds (through own resources or donors) – Good product quality and good price – GAIN provides credit arrangement – Product is imported, cleared under Governments' name • Disadvantage: – – – – Advance payment is required by UNICEF Capacity of the government is not built Capacity of the local industry is not built Often conditioned by Donors • Suitable for nationwide distribution Procure Government direct procurement From the manufacturer or appointed traders • Advantage: – Government is securing funds – Ownership – Capacity building for local industry • Disadvantage: – Prone to irregularities during the procurement process – Technical capacity to evaluate product quality might be a challenge – Product quality may become less important in selection process – Challenge when no local suppliers/agents available • Suitable for nationwide distribution Procure Lessons Learnt • International purchase: – Results in better price compared to local purchase – Quality of product is easier to assure – Conducting open international bidding might be difficult to implement for national authorities • Challenges in technical evaluation: – Limited data on product provided by supplier – Stability study to confirm product shelf life is not available Produce Manufacturing process(1) Requirements for food manufacturers: 1. Licence for food manufacturing 2. Hazard Analysis and Critical Control Points (HACCP) 3. Recommended International Code of Practice - General Principles of Food Hygiene of Codex Alimentarius 4. ISO 22000:2005 (Food Safety Management System) Produce Manufacturing process(2) • Requirements for the product: – Safety, Efficacy, Quality – Stability Data – Certificates of Analysis (CoA) Finished product Premix CoA CoA CoA Produce Manufacturing process(3) Blending Packaging Premix Finished product Produce Manufacturing process(4) “Local” production of MNP requires • • • Investment in 1 gram sachet filling machine Compliance to strict hygiene and quality rules Import of pre-mix and foil It is not cheaper compared to international procurement Produce Packaging of sachets Produce Finished product Produce UNICEF Approved Suppliers • DSM France/Bulgaria • DSM South Africa • DSM/Fortitech Malaysia • Renata, Bangladesh • Piramal Healthcare, India Potential suppliers: • Stern Vitamins, Germany • Glanbia, Germany Consult HF TAG website Produce Lessons learnt • Limiting points in manufacturing process – Capacity of the blender – Capacity of the packaging machine – Customized foil production time • Manufacturers understanding of quality requirements varies – Finished product analysis are not carried out systematically Deliver Product Receipt About 100,000 packs in one 20’’ container Deliver Product Storage • Product must be stored as per product label (dry, clean storage below 25 C) • Good distribution practice (batch management and tractability • Product expiry date Deliver • • • • Complaints Color Odor Layouts Not possible to open sachets Deliver Lessons learnt • Respect supplier’s instruction on how to store HF products (even though these products are not classified as pharmaceuticals) • Allow sufficient time for stock replenishment/reordering to avoid stock outs • Provide feedback to purchaser/person who drafted specification to implement improvements Plan Procure Thank you ! Produce Deliver