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Editor's Notes

• #1: Your Excellencies, honorable delegates, colleagues, ladies and gentlemen, It is my pleasure to present you today a subject that is of a high priority for our Regional Director Dr Hanan Balkhy and for our region. It is about Expanding equitable access to medical products. This is a continuation of RD's briefing with you in Geneva last May.
• #2: There are some significant issues that I want to bring to your attention. Indeed, over these years and more and more, several countries from the region have difficulties to access to various medical products due to Limited Capacity to Produce Regional Needs of Medicines and Vaccines. Two third of medicines are imported . 10/22 countries import ≥90% of the medicines needs and 18/22 countries fully import their EPI vaccines), Sub-optimal quality issues and increased circulation of substandard and falsified products in the region. This is due to the weak regulatory systems in most of the countries. Currently only 2 countries have their National Regulatory Authorities internationally recognized as they achieved at minimum the maturity level 3 for medicines and/or vaccines Significant variations of prices among countries and nearly 50% of out-of-pocket spending in the LMIC in the region is going to medical products. Inefficient procurement and supply chain management that results to frequent shortage and stock-outs, particularly in LMICs and in countries that are facing multiple humanitarian crises.
• #3: Saying that, this flagship initiative aims to ensure equitable access to quality assured and safe medical products in timely manner in order to build regional resilient and efficient supply chain that will help contribute to the national economic growth as well as to prioritize impact on high burden of diseases towards achieving SDGs . The flagship initiative will mainly focus on some medical products that have been selected with the following criteria: high burden of disease , health security and cost-effectiveness evidence. The flagship initiative will address medical products under various categories of medications, vaccines, blood products, biosimilars such as insulin and certain health commodities.
• #4: This initiative will focus on three pillars: that are procurement and supply systems Production and Regulation . �� We will work with you to support For the procurement and supply system To improve the Country procurement systems through modernizing the central warehouses and distribution networks to ensure an efficient traceability and management of the medical products. As well as Establish a regional Pooled Procurement mechanism �� For the production we will collaborate with you to enhance the local production to Develop national policies, Improve infrastructure to be in compliance with the good manufacturing practices as well as buildworkforce capacities and facilitate technology transfers when needed. �� While for the regulation, which is the most difficult one, we will work with you to support the strengthening of the national regulatory systems and build the regulatory capacities using WHO global benchmarking tools to reach at least ML-3/ ML-4 and be listed in the WHO listed authorities. This will contribute improving the safety and market control systems and mitigate the circulation of substandard and falsified products as well as harmonize regulatory system and reliance which will help implement the regional pooled procurement as regional initiative
• #6: As you know the establishment of a regional procurement system will require a well-coordinated approach, strong governance and effective management. There are some pre-requisites that need to be met and some components and steps to be implemented for the establishment of the regional pooled procurement. We started working through expert consultations to define the pooled procurement model and the types of the medical products to be considered. ��
• #7: We need your engagement to achieve as targets by 2029 For the procurement and supply: - The implementation of the regional pooled procurement At minimum having 5 countries with modernized central warehouses modernization of For the production: Ensuring that we have minimum 7 countries producing quality assured medical products And for the regulation: Having 13 autonomous and independent countries And at minimum 6 National regulatory Authorities with at minimum reaching Maturity level -3 And at minimum 1 NRA listed in WHO listed Authority.
• #8: We will report to you on the progress of the implementation of this flagship as illustrated in this roadmap
• #9: Your Excellencies, Ladies and Gentlemen and Honorable Guests, Therefore, for achieving our targets to secure Equitable Access to Medical Products, we have a lot of work and we will need to work together to strengthen regulatory systems and local production of medical product Improve National procurement and Supply systems to be in line with the regional pooled procurement mechanism which will also require a regional collaboration and partnerships . ��