Access to Medicines
Outline Availability and distribution: UNITAID, patent pool In country drug registration: PaATH, NEPAD Procurement/stock‐outs: PEPFAR, Global Fund
Availability & Distribution: UNITAID Established in 2006 as a new form of financing for public health using
innovative tools such as an airline tax. UNITAID works to impact the health commodities market by working to
reduce prices, improve quality and accessibility to quality treatments and reduce the length of time at which medicines are available. UNITAID’s model is based on long‐term funding commitments and the
purchase of high volumes of medicines and diagnostics. This helps stimulate increased production, which creates economies of scale that drive prices down.
UNITAID cont. UNITAID strives to drive the development of new medicines and
diagnostics UNITAID is not an implementing agency and does not give money or
medicines directly to countries. UNITAID does not take the place of any existing organizations that help
facilitate access to drugs in low‐income countries.
UNITAID Medicines Patent Pool Initiative In July 2008 the UNITAID Board gave the Secretariat the go‐ahead to establish
a patent pool on medicines for HIV/AIDS. The aim is to improve access to patents and foster development and
production of life‐saving, more affordable and suitable medicines. Currently, UNITAID is in the pre‐patent pool phase: determining the priority
products and missing ARVs. UNITAID worked closely with WHO to identify the medicines to be included
in the initial pool.
The Patent Pool It will be a voluntary mechanism Its geographical target will be low‐income/developing countries Initial focus on HIV/AIDS medicines It will aim to ensure producers make use of patents to meet agreed quality
standards There will be collective management of patents The pool will stimulate innovation
Global patent pool campaign Current campaigning on patent pool has mainly been in Europe; in the UK
spear‐headed by Stop AIDS Campaign, led to high level support from the UK Govt, which recently called on pharmaceutical companies to join the patent pool. http://edmi.parliament.uk/EDMi/EDMDetails.aspx?EDMID=38730&SESSION=899 http://www.stopaidscampaign.org.uk/PushForPool.asp
Groups working to support the patent pool are strategizing on how to roll out
the campaign to strategic global regions including Sub‐Saharan Africa Health Action International(HAI)‐Africa and Oxfam GB Kenya are taking the
lead in rolling our the campaign in Africa and soliciting high level support from African govts.
Patent pool and pediatric medicines Even if the patent pool is established this would not solve the problem of
there not being enough pediatric formulations. It is a necessary BUT not sufficient precondition for ensuring the development of new pediatric formulations. The second and very important issue is who will fund the clinical trials for
pediatric medicines? Currently no one is willing to do this. The EU’s Director‐ General of Research has indicated that if patent barriers are removed then they would seriously investigate funding clinical trials for pediatrics.
In‐country drug registration: PaATH Its intended to assure undisrupted product supply It is a dossier with technical and administrative information on the product It includes a commitment to pursue registration in‐country PaATH applicant is a manufacturer or their representative only It was developed based on awareness of limitations of in‐country import
waiver processes, which vary by country and permit import of only limited supply of drugs
PaATH Pilot? Tentatively approved pediatric dosage forms of single or combination ARVs Lamivudine, Stavudine and Nevirapine Lamivudine and Stavudine Lamivudine and Abacavir Abacavir Efavirenz
Harmonization of In‐country drug registration: NEPAD Workshop in February 24‐26 in South Africa Purpose: build on countries’ efforts to harmonize medicines regulation by
sharing regional experiences, models of successful harmonization efforts from other parts of world, and discussion of next steps Agreed that harmonization of approval procedures would improve access to quality medicines Challenges: funding, limited skilled human resources, inadequate implementation of existing harmonization plans and policies Next steps: RECs encouraged to develop an outline of their proposal; RECs will be invited to develop a detailed project proposal for consideration once donor support is identified
Harmonization of In‐country drug registration: NEPAD timeline
March – May 2009: RECs are invited to submit a proposal in support of harmonization. NEPAD and WHO are willing to give technical support to the development of these proposals, and they must be received by May 31, 2009.
June 2009: Review of proposals. The project consortium will identify those proposals to be developed into full project proposals by June 30, 2009.
July – October 2009: Selected RECs will be invited to develop their summary proposals into full proposals. NEPAD and WHO are willing to give technical support to the development of these proposals, and they must be received by October 31, 2009.
November – December 2009: The project consortium will review the full proposals. Those which are judged as sound and promising will be submitted to interested donors both within and outside of the consortium.
January – June 2010: Start of the first approved projects. Regular reviews will be reinforced with a full mid‐term review two years after the start of implementation.
Procurement/Stock‐outs: PEPFAR SCMS steps in to address urgent/emergency requirements on ad‐hoc basis SCMS supports countries to develop forecasts for the ARV medications
including pediatric formulations: CHAI prime supplier of pediatric formulations in most countries Coordinated Procurement Planning Initiative: to improve coordination on HIV/AIDS among donors including procurement planning and implementation Pilot in 6 initial countries focused on ARVs: Ethiopia, Mozambique BUT rolled out initiative to 3 other countries including Zambia Coordinated Procurement Planning process: framework for coordination and consists of 6 elements that culminate in a coordinated procurement plan Progress: extend initiative to OIs, lab commodities; agreed to use initiative as platform to support transition of UNITAID funded 2nd line and pediatric ARVs
Procurement/Stock‐outs: Global Fund Current procurement situation: Procurement is fragmented at country‐level Lack of concerted approach to influence market sustainability Multiple steps in funds flow process Voluntary Pooled Procurement: Influence market dynamics; consistent access to products, lower prices, and sustainability of market Address procurement bottlenecks; reduce lead time in procurement process, reduce episodes of stock‐outs due to delays in procurement Improve grant management and performance;
Procurement/Stock‐outs: Global Fund cont. VPP model: 1. Price negotiation agent Partner engaged to negotiate prices and determine approach to markets Negotiate prices where none exists, facilitate access to other globally negotiated/competitive prices Set price ceilings and negotiate terms and conditions 2. Procurement services agent Manage operational process of VPP Contract suppliers, aggregate demand, process orders/deliveries Process payments to manufacturers/suppliers through direct payment mechanism 3. Core products 1st & 2nd line ARVs, ACTs, LLINs