World Health Organization 8 November, 2018 IPC Action Points Update Jan. – June 2015 IPC Meeting UNICEF Supply Division Copenhagen June 18-19, 2015 Dr Kees de Joncheere

World Health Organization 1- Access to Essential Medicines and other Health Technologies Area 8 November, 2018 a) PSM Toolbox : Mapping Existing PSM tools Several “toolboxes” : AMDS has identified existing PSM tools developed by the different partners. A Working Group will be convened to review the list of the 420 PSM tools. Next steps: WHO will look at the PSM Tools proposed by the ISG and analyse them for further inclusion in the PSM toolbox if possible. At the same time an exercise will be initiated to map missing tools, based on information reported by the countries and/or partners in the field.

1- Access to Essential Medicines and other Health Technologies Area b) Access to malaria drugs and AMFm Initiative: Results of the formal Independent Evaluation (IE) of AMFm Phase 1 fed into the recommendations of the Global Fund Board in late 2012 for the 2013 transition phase and the Co-payment Mechanism, through which Global Fund grant funding could be used for ACT co-payments beginning in 2014. Continuation of HAI/WHO price and availability surveys that were initiated in August 2011 in AMFm Phase 1 countries - presentation at IPC meeting.

1- Access to Essential Medicines and other Health Technologies Area World Health Organization 1- Access to Essential Medicines and other Health Technologies Area 8 November, 2018 c) Model Quality Assurance System (MQAS) for the Assessment of procurement agencies: -The 48th Expert Committee for Specifications for Pharmaceutical Preparation adopted in 2014 the updated MQAS, (published in TRS 986 Annex 3. including a revised model inspection report and a revised interagency product questionnaire. -ECSPP adopted as well the Assessment tool based on the model quality assurance system for procurement agencies: aide-memoire for inspection , (published in TRS 986 Annex 4). -French translation of the main MQAS and the assessment tool available (e-publication) IPC/Agencies to agree / to adopt as Interagency guidelines publication to replace the 2007 version

1- Access to Essential Medicines and other Health Technologies Area d) Procurement 4 Impact initiative and market shaping: The Global Fund is conducting a market assessment that will help for the development of a long term procurement strategy, to better define manufacturers and partners’ engagement and improve the overall coordination. The Global Fund and the World Bank will report on progress.

1- Access to Essential Medicines and other Health Technologies Area e) Inter Agency Emergency Health Kit IEHK: - Survey of users of the IEHK Kits have been completed and meeting to confirm changes to PEP and malaria modules is scheduled end of June (WHO)

1- Access to Essential Medicines and other Health Technologies Area f) Safe disposal of Pharmaceuticals, waste management – WHO + GF Waste management guidelines: inventory of PSM related policy and guidance documents underway to ensure a logical update approach.

World Health Organization 2- Regulatory issues: Quality, Safety and Efficacy 8 November, 2018 g) Inter Agency Statement on value added of PQ: An Interagency Pre Qualification statement has been elaborated and submitted to IPC members for comments. Additional late contributions received will be reviewed by participants, in the perspective of a final endorsement of the statement by IPC Members;

World Health Organization 2- Regulatory issues: Quality, Safety and Efficacy 8 November, 2018 h) NRA Assessment Work: WHO International Consultation to develop the harmonized assessment Tool and discuss the assessment process (Oct 2014 – Nov 2015) - WHO joint working group established to coordinate the development of a concept paper and policy discussions regarding phase 1 and 2 (monthly meeting). Planning 2nd international consultation for Nov. 2015 -Consultation to finalize the model of assessment with focus on level 1 then on level 2. -Mapping of existing assessment in order to streamline the processes. -Discussions involving NRA to explore concept of NRA RR (eg.PAHO) to global concept.