WHO Essential Medicines and Health Products. Update at IPC Washington DC, Dec 11-12, 2012
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1 WHO Essential Medicines and Health Products Update at IPC Washington DC, Dec 11-12, 2012 Kees de Joncheere Essential Medicines and Health products November 2012
2 Health Systems and Innovation Cluster Health Systems and Innovation (HIS) Office of the ADG Marie-Paule Kieny Enabling Functions (Management and External Relations) Secretariat Independent Expert Review Group (ierg) Technology Transfer Initiative (TTi) Core Departments Partnerships Essential Medicines and Health Products (EMP) Cornelis De Joncheere Ethics and Social Determinants (ESD) Ruediger Krech Global Health Workforce Alliance (HWA) Mubbashar Sheikh Health Statistics and Information Systems (HSI) Ties Borema Health Systems Policies and Workforce (HPW) Wim Van Lerberghe Health Metrics Network (HMN) Marie-Paule Kieny a.i Health Systems Financing (HSF) David Evans Knowledge Management and Sharing (KMS) Najeeb Al Shorbaji Alliance for Health Policy and Systems Research (HSR) Abdul Ghaffar Public Health, Innovation and Intellectual Property (PHI) Zafar Mirza Patient Safety Programme (PSP) Ed Kelley WHO Centre for Health Development (Kobe) (WKC) Alex Ross 2 WHO Essential Medicines
3 Essential Medicines and Health Products Department (EMP) Office of the Director MPC Medicines Policy, Governance & Country Collaboration Medicines policy; regional & country collaboration & support Indicators and tools for pharmaceutical sector monitoring & assessment Transparency & good governance in medicines Publications & website MAR Medicines Access and Rational Use Rational use and anti-microbial resistance Selection of essential medicines, HTA Supply management systems Pricing policies Psychotropics & narcotics, including substance evaluation Access to controlled medicines QSM Quality Assurance and Safety: Medicines Norms/standards (including nomenclature INN) Quality assurance and Int. Pharmacopeia (including blood products) Safety /pharmacovigilance Prequalification of medicines; Strenghtening NRAs SSFFC MDD Medical Devices & Diagnostics Policies, norms/standards Prequalification, quality and safety Management; Access & use; Regulation QSS Quality, Safety & Standards: Vaccines Regulatory norms & standards Vaccine quality & regulation : Prequalification NRA systems strengthening Global vaccine safety 3 WHO Essential Medicines
4 2012 developments Development of new WHO Global Programme of Work Development of Action plan on Access to Medical products Universal health coverage Working towards global regulatory convergence 4 WHO Essential Medicines
5 Access to medical products Expert Committee on Selection and Use of Essential Medicines will meet April 2013 WHO Guideline / Policy options for Medicines Pricing Policies to be published early 2013 Ministerial summit Amsterdam Oct highlighted the cost of inappropriate medicines use, and the need to improve the prescribing and use of medicines New partnership with EU to strengthen pharmaceutical policies in 15 African countries Continued focus on Good governance + transparency in pharmaceutical policies 5 WHO Essential Medicines
6 Regulation and quality ICDRA October 2012 and Manaus November 2012 : discussions on new global collaboration, convergence, networking African Medicines Regional Harmonization initiative with WB, NEPAD, BMGF Expert Committee on Specifications on Pharmaceutical Preparations, and Expert Committee on Biologicals, oct International Pharmacopeia meeting India, March 2013 : working towards Good Pharmacopeias practices and global quality standards Pharmacovigilance and global vaccine safety initiatives 6 WHO Essential Medicines
7 Prequalification Synergies and efficiencies in the approaches of the three PQ streams of work Common IT platform Quality management systems Common tool for NRA assessment Networking with NRAs PQ currently critical for ensuring access to quality medical products, long term approach to be worked out with partners 7 WHO Essential Medicines
8 SSFFC medical products WHA established a new Member State mechanism to combat SSFFC Meeting of Member States in Argentina in Nov agreed on : Structure and governance of MSMech Workplan including Strengthening NRAs Enhance exchange information, experience Communication, information awareness raising 8 WHO Essential Medicines
9 Open-ended meeting of Member States on the follow-up of the report of the CEWG Report and draft resolution to be submitted to World Health Assembly: Member States to establish or strengthen national health R&D observatories for tracking and monitoring of relevant information on health R&D contribute to coordinated and sustainable financing mechanisms for health R&D, through voluntary contributions The Director-General to establish a global health R&D observatory within WHO s Secretariat in order to monitor and analyse relevant information on health R&D to identify the gaps and opportunities for health R&D and to define priorities in consultation with Member States and other stakeholders implement a few health R&D demonstration projects to address identified gaps for which immediate action can be taken explore and evaluate existing mechanisms for contributions to health R&D and, if there is no suitable mechanism, to develop a proposal for effective mechanisms, including pooling resources and voluntary contributions 9 WHO Essential Medicines IPC meeting December 2012
10 Local production and transfer of technology phase II of the project Policy analysis for policy coherence industry, trade and health policies will be mapped and analysed to promote policy coherence for local production and access to medical products. Situational analysis for Africa plus 4 African countries. Global resources on local production, technology transfer and access to medical products A web-based global repository of technical materials. A global advisory committee. Case study of Brazil how it produced coherence across industry and public health. Advocacy for the policy framework Briefing papers, journal articles and workshops will be used to advocate the framework approach to promote local production for improving access to medical products. Capacity building and technical assistance for local production of selected essential medical products 10 IPC meeting December WHO Essential 2012 Medicines
11 Ongoing work on IP with relevance to the IPC Trilateral WHO, WIPO, WTO study Promoting Access to Medical Technologies and Innovation: Intersections Between Public Health, Intellectual Property and Trade will be launched by the three DGs in the first quarter of 2013 covers access and innovation related topics, including IP, FTAs, regulatory issues, tariffs and taxes WIPO, WHO WEB-BASED GATEWAY TO PATENT INFORMATION ON MEDICINES AND OTHER MEDICAL TECHNOLOGIES is under way pilot searches have been carried out IPC member can file requests for patent information on specific products WIPO essential platform on patent information relating to products on the Model List of Essential Medicines work is ongoing difficulties were encountered regarding information: what patents are relevant? what patents should be included? 11 IPC meeting December WHO Essential 2012 Medicines
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