UNFPA Because everyone counts UNFPA Update IPC meeting December 2015, Geneva Procurement Services Branch, Copenhagen

UNFPA Because everyone counts UNFPA Update 1. ERP 2. Training of National Procurement Agencies 3. Thermal cycling study - Oxytocin 4. Contraceptive devices and lubricants 5. Generic Hormonal Medicines uptake 6. Eco Requirements for UNFPA Supplies

1. UNFPA ERP for RH Pharmaceutical Products Products Since 2011 – 8 EOIs published Challenges For some product categories: still not enough that are WHO PQed Injectable hormonal contraceptives – DMPA Oxytocin Mifepristone For some product categories: none WHO PQed Magnesium sulphate Uptake of Generic RH medicines – Hormones

2. Training of National Procurement Agencies E-learning Modules Good Governance of Medicines – in collaboration with WHO Introduction to Quality Assurance of Reproductive Health Medicines English/French/Spanish In-country procurement trainings 2 weeks training 1-2 days dedicated to QA Institutionalisation of the training

3. Thermal Cycling Study - Oxytocin Study Objectives Primary aim simulate interruptions in cold-chain storage of oxytocin by cycling storage temperatures of ampoules to various levels and for varying durations, and determine the effects of these excursions on the active content of oxytocin 10 IU/mL ampoules. Secondary aim a qualitative analysis of possible known degradants will be undertaken further qualitative investigations using a separate assay may be performed on any samples that fall below 90% of expected oxytocin levels during the study, in order to investigate possible degradation pathways that have resulted from temperature excursions. UNFPA Because everyone counts

3. Thermal Cycling Study - Oxytocin Study Objectives Primary aim simulate interruptions in cold-chain storage of oxytocin by  cycling storage temperatures of ampoules to various levels  for varying durations, and determine the effects of these excursions on the active content of oxytocin 10 IU/mL ampoules. Secondary aim a qualitative analysis of possible known degradants will be undertaken qualitative investigations using a separate assay may be performed on any samples that fall below 90% of expected oxytocin levels during the study, in order to investigate possible degradation pathways that have resulted from temperature excursions. UNFPA Because everyone counts

3. Thermal Cycling Study - Oxytocin TempStorage period and conditions 30°C Day 1 – 30 Storage at Elevated Temperat ure Day 31 – 45 Storage at 2-8°C Day 46 – 75 Storage at Elevated Temperat ure Day 76 – 90 Storage at 2-8°C Day Storage at Elevated Temperat ure 40°C 50°C Analy sis day Day 30Day 45Day 75Day 90Day 120 UNFPA Because everyone counts

3. Thermal Cycling Study - Oxytocin Samples Three manufacturers – three batches each Transported under cold-chain from supplier to Monash University Analysis LC-MS-MS Partnership Facilitated by FIP UNFPA Because everyone counts

4. Contraceptive devices Review and update of TCu380A IUD Specification and Prequalification Guidelines: on-going Specification update d and usability enhanced Additional guidance on stability studies, sterility assurance, and QA monitoring by procurers added Review and update of WHO/UNFPA Male Latex Condom Specification and Prequalification Guideline initiated Updated list of WHO/UNFPA Prequalified contraceptive devices available on line (m ale condoms, female condoms, IUDs) Lubricants – completed systematic review completed which will feed into development of technical specifications - Urgently needed to support sex workers

5. Generic uptake: AccessRH online catalogue Procurement planning tool - Now gives prominence to INNs Progress: procurement value of generic Gain value for money: The significant volume of contraceptives and related items procured by UNFPA allows for competitive pricing. UNFPA passes these savings on to partners via AccessRH UNFPA Because everyone counts

5. Generic uptake UNFPA Because everyone counts

6. New eco-requirements for UNFPA/WHO supplies Beginning in 2015, UNFPA tenders will require potential suppliers to comply with 5 eco-requirements: ISO certified – If a factory does not have ISO certification, it must agree to work on obtaining it within the next 36 months. Wastewater treatment plan – The factory must comply with local laws regarding wastewater treatment and discharge. It must also demonstrate that any resulting sludge or solid waste is disposed of according to local regulations. The factory should analyse its wastewater handling system and prioritize and create a plan for improving the treatment of wastewater where practicable.

7. New eco-requirements for UNFPA/WHO supplies contd. Air pollution reduction plan – The factory must comply with local laws regarding air pollution. Plan for saving energy and using renewable energy – The factory must document a long-term plan for saving energy and using renewable energy, and demonstrate any recent energy-saving developments. Some bonus points will be awarded to factories using renewable energy. Packaging: – All cardboard and outer boxes must be FSC or equivalent (sustainable forestry) – The outer box and shipping box must be made of minimum 40% by – The gross box should only contain paper/cardboard. – The plastic carton liner should be made from recycled material/plastic by 2015 and biodegradable plastic by UNFPA Because everyone counts

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