Action points and notes. UNFPA, UN House, Copenhagen Denmark

Transcription

1 Action points and notes IPC Meeting 30 th November 02 nd December 2011 UNFPA, UN House, Copenhagen Denmark Action points - Share draft documents on diagnostics to be shared with IPC members for review (WHO) - Share information of technical specifications for medical devices among agencies (WHO, UNICEF, WB, UNFPA etc) - Follow up on existence of evidence of efficacy of patient packages (UNICEF); - Follow up on finalization of 2011 Interagency Emergency Health Kit; (WHO) - Explore how WHO National Regulatory Authorities assessment tool could consider medical devices (WHO); - Explore feasibility for WHO to host a World Bank portal for publications; (WHO & WB) - Revive global database on IPC documents and training resources (WHO); - Explore feasibility for a joint inter-agency interaction with the pharmaceutical industry (All); Discussions on the future of IPC - WHO EMP is committed to continue being the Secretariat of IPC, though currently in transition waiting for a new Director; - IPC objective is to share information on current and ongoing initiatives on medicines and health products policies among the UN family and other international agencies e.g. the Global Fund and on guidelines, practices and other reference policy documents; - IPC should remain an informal group that aim at identifying synergies among agencies and at shaping global agenda and activities for improving access to quality medicines. - The group is happy with the current IPC model and membership: UN agencies, International agencies, NGOs and would like this to be pursued; - Communication material to make IPC more visible should be developed and disseminated. Next meeting in 6 months: - 25 (pre-meeting), 26/27 April in WHO in Geneva Issues to be considered for next IPC: o minimum shelf life of small volume orders and what to do in emergencies and for donations; o Early warning systems for stock-outs in programmes and at local level; o Emergency Reproductive Health (ERH) Kits prequalification of suppliers for ERH Kits; o Work for improving Quality Assurance of medicines that are on the EML and that are not WHO Pre-Qualified. 1

2 Notes of the meeting Pre-meeting: 30 Nov 2011 Medical Devices and Diagnostics - WHO started prequalification of male circumcision devices to assist in the procurement of male circumcision kits; - WHO supports post market surveillance in 5 selected countries and the focus is on strengthening regulatory authorities and reference laboratories; - A WHO team is working on harmonization of technical specifications for medical devices. - A working group to define a template and content of technical specifications of medical devices is meeting in December 2011; - Update the 2011 global survey on medical devices - WHO to start work on essential medical devices for NCDs - Carry out work on harmonization of regulations of medical devices - Develop a template for countries requests for technical support on medical devices from WHO Supply Chain Management - There is a need to focus on strengthening the supply chain management system and utilize lessons learnt from the private sector (e.g. Coca Cola); - Learn the lessons from the AMDS stock out review carried out in Zimbabwe and using 12 indicators; - Need for a UN strategy to support Supply Chain Management (SCM), new technologies for SCM that will address challenges, taking into account the enabling factors for implementation; the capacity required and the incentives for the stakeholders involved. Day 1 of IPC: 01 December UNFPA presentation Limited pool of prequalified manufacturers thereby reduced options for quality assured products; QA policy under implementation and Influencing Market forces by encouraging prequalification. Questions and comments: - Need to publish inspection reports, transparency and harmonization; - Need more information on what are the challenges for manufacturers to meet quality standards; - Promote Incentives for manufacturers and the price to pay for quality; 2

3 WHO presentation Focus is currently mainly on normative work for quality assurance and on support to countries including for the development of country profiles, transparency and good governance; New monographs that have just been approved QA guidelines : 46 th WHO Expert Committee on specifications WHO Network for Pharmacovigilance has expanded. UNICEF presentation Working closely with UNDP on price analysis, UNITAID on PMTCT project, GDF to support TB programmes; Country programmes: o Zimbabwe: Health system strengthening: shortage of staff, training on drug management and use at district/provincial levels; Malawi; Sierra Leone; Demand for emergency response has heightened attention on emergency response kits; Questions/Comments: - WHO, UNICEF no compromise on quality with components in the kits. Though kits are meant for emergencies, they are not used only for emergencies - Identifying sources and suppliers that meet quality - Identify Issues with emergency kits - Analysis of the demand for kits: volumes of kits supplied in the past, survey with manufacturers; UNDP update Risk management plan has been developed; PSM tool available online on UNDP website. WHO AMFM There have been discussions on packaging and more attention on counterfeit products; Evaluation of AMFM in progress and will advise the future of AMFM; Questions/discussions - Market motivation and the approach by manufacturers has changed for ACTs - Lessons from AMFM will be key as they can help advise on supply for other medicines; World Bank Support harmonization of QA for other products that are outside the WHO PQP; Split the Essential Medicines by risk: stringent requirements for high risk; low risk products align with local regulators decisions; 3

4 Questions/discussions - focus of harmonisation is currently on medicines and will expand to other health products - Build mechanisms for enforcement of procurement policies for medicines - a lot of progress has been made for sharing information between regulatory bodies WHO AMDS Monitor procurement of ARV drugs and diagnostics annual survey focusing on drug use Issues with Quality of the data and in some cases the inco-terms were not very clear Reviewing regulatory status of ARVs as a lot of regulatory hurdles Indicators have been developed to prevent stock-outs Global Fund update During 2011 bid, price increase due to increase in price of API especially for rifampicin Monitoring missions and workshops on supply chain management in 52 countries in 2010 and executive summary of the reports will be posted on the website Gaps in PSM staff capacity, training required New proposal for consolidated stock pile procurement Early warning systems at country level to prevent stock outs WHO Procurement update Procurement of USD million/yr Most procurement functions will be moving to Kuala Lumpur UN Initiative on Non Communicable Diseases An integrated approach required to strengthen national policies, health system structure Access to these essential medicines is inadequate Questions/Discussions: - Not enough clinical guidelines on chronic diseases e.g. diabetes, cancer etc WHO and TGF Country Profiles project Questionnaires were sent to countries and cover the whole pharmaceutical sector profile of the country; Questionnaire also asks for the key source of the information and to attach the source documents and for official endorsement; Initiative aims to improve the quality of the information available for countries using the same tool and to reduce burden of data collected in countries 4

5 This will enable international agencies to use this data instead of asking for this information from countries again causing duplication in data requests which increase the workload on the countries Questions/discussions - In addition, TGF looks at more parameters on procurement and supply management. - World Bank: useful to have a standardized tool to create profiles and will reduce duplication. - Suggestion: involve UNDP as they have many recipients as they will increase dissemination Heath Technologies Country Profiles - Prior to the 2011 survey, no information on medical devices was available - Information is now available on the Global Health Observatory, by type of medical devices DAY 2: 02 December UNFPA Initiative on Essential Lifesaving Maternal Health Medicines Global Programme funded by the EU, working in 45 countries that are divided into Stream 1, 2, 3 countries; Provision of contraceptive commodities and 10 Priority Lifesaving medicines developed together with WHO, USAID and other partners Monitoring framework which monitors stock out of contraceptives and the 10 Priority Medicines Objective and goals: o Identify bottlenecks of these EM in selected countries(west East Africa, Southern Africa and Asia), using WHO assessment tool o Initially study done in 7 countries with WHO o Technical assistance in supply chain management and monitoring to track results o Expected outcome: improved availability of selected EM o selected countries: criteria high MMR o Implementation dependent on country acceptance to participate Questions/discussions: - Comment to use Country Profiles developed by WHO to prevent repetitions - Formulate policy for waste management of combined products that have medicines and packaged with devices: ampoules, syringes, uniject - Inter-agency collaboration on essential equipment and hospital furniture: joint bid done with UNICEF and UNFPA - Oxytocin: 5

6 o o o on PQP and there are serious quality issues with the manufacturer, WHO providing technical assistance to manufacturers Need for coordination within the UN to improve availability of heat-stable oxytocin Inter-agency ERH Kits are also affected as they contain this product UN Commission on access to commodities for maternal and child health UNICEF working jointly with UNFPA and WHO on maternal and child health High level focus as children are a vulnerable overlooked group Questions and Comments: - Suggestions for nominations to be part of the Commission and Working Groups are welcome - Identifying manufacturers in Africa for the essential medicines - It will be good to learn from UNDP work on social marketing of condoms, bed nets UNIDO Update The objective is to develop pharmaceutical industry in Africa: accompanied by a technical assistance programme through the African Union Working with generic manufacturers and training on GMP Questions and comments: o Working at 3 levels: policies, strategies and dialogue between private sector and the ministries of health o Targeted training to manufacturers on GMP. WHO willing to collaborate with UNIDO and work in improving GMP - There is need for input on resources to support the infrastructure as the training alone will not solve the problems - Need to strengthen the regulatory environement and leverage interest at the local level - The price of quality products, but support for investments is critical as agencies are always looking for the lowest possible price - Important to have procurement policies that encourage competition WHO PQP update The International Pharmacists Group (IPG) is meeting next week. Exchange information among members on GMP status of manufacturing sites Quality Control on same batch could be very duplicative: study done and found countries testing same batch repeatedly 6

7 PQP suggests a risk management/analysis process for Non ATM medicines that are on the EML and that categorize them by risk Study on failure of batches, recall: very little available information as manufacturers and regulators do not consistently capture or release information Quality Assurance of Medicines (TGF) Interest to define quality assurance measures for EM that are not under WHO PQP Worked with WHO and other organizations and partners to improve the quality of the EM Category based approach o WHO PQP o ERP o SRA o NMRA approval o Procurement as per WHO MQAS Harmonized risk based approach for essential medicines will save resources and focus on systems using following categorization o High risk: o Medium risk: o Low risk: Qualification of Procurement agencies o Common tool for assessment of procurement agencies based on the WHO MQAS o WHO will now publish on website completed and planned manufacturing site inspections, affiliation of lead inspectors to the IPG World Bank on registration processes of EM in Africa (EAC) Focus is on registration of generic products Harmonization of registration processes of medicines UNFPA Current Initiatives in procurement AccessRH presentation Questions and Comments - UNFPA acts as intermediary as manufacturers didn t want to deal directly with governments - Payment mechanisms slightly problematic but Pledge Guarantee Mechanism allows for some ease in the funding process to allow procurement process to start. This works by reducing the lead times. o Pledge Guarantee mechanism has worked very well for UNICEF with bed nets procurement in Zambia when funding was going to delay procurement 7

8 - Studies done in 2005 looked at small volume procurement and if countries could benefit from this Other UNFPA initiatives - ECO friendly condoms: treatment of water, packaging materials - Waste management guidance proposal - QA project with Concept Foundation and WHO to improve number of prequalified products. 8