Events

Friends of ALMA Manufacturers' Forum

You can find the final Forum report here.

Presentations

Manufacture of pharmceuticals and other malaria technologies in Africa: Overview of current situation and challenges (presented by Dr. Raquel Child, UNITAID)

The Kenya Experience with WHO Prequalification (presented by Dr. Sarah Vugigi, M. Pharm)

Challenges: Regulation, Quality Standards, and Material Sourcing (presented by Mr. Ian Boulton, TropMedPharma Consulting)

Economic and Finance Issues Associated with the Local Pharmaceutical Industry, and Strategies for the Sector's Development (presented by Mr. Alastair West, UNIDO)

Quality Standards and Economics of Production for Mosquito Bednet Manufacturing (presented by Kalpesh Shah, A to Z Textile Mills Ltd)

Rapid Diagnostics Tests Manufacturing (presented by Mr. Deepak Tripathi, Tulip Group)

Intellectual Property Rights and How They Impact the Pharmaceutical Industry in Africa (presented by Dr. Konji Sebati, WIPO)

Challenges and Experiences of Africa-based Manufacturers of Generic Medicines and Other Malaria Technologies (presented by Dr. William Mwatu, FEAPM)

Challenges and Experiences of Africa-based Pharmaceutical Manufacturers in West Africa (presented by Dr. Joseph Odumodu, WAPMA)

The Challenges of Vaccine Manufacture: An African Vaccine Manufacturer's Experience (presented by Mr. Patrick Tippoo, The Biovac Institute)

Breakout Session: Regulation, Quality Standards and Materials Sourcing (faciliated by Mr. Ian Boulton, TropMedPharma Consulting)

WHO Prequalification of Medicines Program (presented by Milan Smid, WHO Prequalification of Medicines Program)

Objectives

The Friends of ALMA Manufacturers’ Forum will bring together key stakeholders interested in the future of the pharmaceutical industry in Africa and the business economics of malaria control technologies including artemisinin-based combination therapies (ACTs), long-lasting insecticide-treated nets (LLINs), insecticides for indoor residual spraying (IRS), and vaccines. Participants will consider how to address current bottlenecks to the supply of these technologies by Africa-based manufacturers. Regarding the pharmaceutical industry, the Forum will address three specific areas currently identified as hampering the development of an Africa-based pharmaceutical manufacturing capacity:

1. Regulation, quality standards and material sourcing;
2. Market and economic issues; and
3. Challenges specific to generic manufacturers.

The Forum will conclude by making recommendations to African Heads of State on:

1. Opportunities to create a conducive investment climate for the continued development of the Africa-based pharmaceutical industry.
2. Follow-up actions that are relevant to the production of malaria control technologies.

The meeting will be co-convened by the African Leaders Malaria Alliance (ALMA), Roll Back Malaria Partnership (RBM), the Office of the UN Secretary-General's Special Envoy for Malaria (UNSEO), the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria (the Global Fund), Medicines for Malaria Venture (MMV) and the United Nations Industrial Development Organization (UNIDO). The meeting will be hosted by the Government of Kenya in Nairobi from 30-31 May 2011.

Background

Africa bears a disproportionate share of the suffering and deaths from many diseases, including malaria. ALMA was launched in September 2009 to serve as a unique forum through which African leaders work together to combat malaria in Africa. ALMA aims to contribute to the achievement of African Union, RBM and UN targets including the aggressive pursuit of universal coverage with effective malaria interventions and the attainment of zero deaths from malaria by 2015. A major priority in ALMA's mission is to foster manufacturing of high-quality anti-malarial medicines (such as the WHO-recommended first-line treatment course of ACTs and their active pharmaceutical ingredients), and malaria commodities such as LLINs and appropriate insecticides to support IRS. The full achievement of an internationally competitive pharmaceutical industry requires that ACTs meet specific challenges, such as the achievement of WHO prequalification standards. However, it also requires addressing a number of crosscutting issues, such as the business environment, economic and regulatory challenges and constraints on access to qualified staff or raw materials. These aspects are essential not only to the pharmaceutical industry, but are also key requirements for the development of other malaria and essential health commodities, such as LLINS, which have been the subject of some highly successful national investment and technology transfer strategies. Despite the success of individual companies or sub-sectors, local pharmaceutical manufacturing in Africa's developing and Low Income Countries (LICs) has been hampered over the years by several impediments including issues around market size and prequalification. Against these challenging realities, support for local pharmaceutical manufacturing of commodities for malaria control has increased in recent years as evidenced by initiatives of the Africa Union and the East African Community, among others. In this newly positive environment, there is an opportunity for all stakeholders and Africa-based pharmaceutical manufacturers to:

• Reevaluate the quantitative and qualitative deterrents and determine whether such entry barriers could be revised.
• Determine what solutions may help manufacturers achieve competitive economies of scale.
• Determine, with respect to the qualitative deterrents:
  • How best to comply with the requirements of WHO and/or stringent drug authorities.
  • How best to become eligible to participate in the co-pay subsidy mechanism of the Affordable Medicines Facility-malaria (AMFm), currently being piloted with the support of the Global Fund in eight African countries.
• Learn how to best comply with regulatory standards and develop the most efficient pharmaceutical industry.
• Access funding sources to enable Africa-based manufacturers to obtain WHO prequalification and WHOPES certification, Good Manufacturing Practices certification, and to attain and sustain financial viability.

Platform

The Africa-based Manufacturers Forum will provide a neutral platform for stakeholders to present their respective issues and positions, and to exchange views with other stakeholders, authoritative speakers, government representatives, regulatory and NGO officials and potential investors. Discussion papers will be delivered to compliment the presentations. The Forum will focus on the following:

• A realistic market analysis of future needs for ACTs and LLINs.
• Issues relating to market and economic factors for the quantitative deterrents (such as minimum market size and the possibility of aggregated markets via Regional Economic Communities (RECs); competitiveness; economies of scale; management.
• Issues relating to perceived qualitative hurdles (such as quality assurance; access to raw materials and APIs; eligibility for the AMFm (including meeting the Global Fund's Quality Assurance Policy requirements).
• Challenges specific to generic drug manufacturers.
• Challenges specific to emerging LLIN manufacturing.
• Challenges specific to vaccines.
• Challenges specific to insecticides for indoor residual spraying.
• Funding needs.

Process

Parallel discussion sessions will follow the general addresses and presentations. Participants may choose to discuss either: 1) regulation, quality standards and material sourcing (presented and chaired by Ian Boulton), or 2) market and economic issues for local manufacturing of LLINs and ACTs (presented and chaired by Ambassador John Simon). In preparation, confirmed stakeholders and registered participants will receive copies of the two background papers on the topics approximately four weeks in advance of the Forum. Responses and recommendations from recipients will be solicited so that they might be assessed by the respective preparers of the Discussion Papers and made part of the presentations at the Forum. It is hoped that this will help the attendees in focusing on the matters most important to them as well as facilitate the identification of follow on actions relevant to the pharmaceutical industry and malaria technologies.

Outputs

The principal conclusions and consensus reached at the Forum will be summarized into a Forum Findings Report, including a draft action plan, which will be presented to the heads of state of the ALMA member nations at its annual meeting the following month in Tanzania.

Participants

It is estimated that there will be approximately 80 attendees participating in the proceedings at the Forum. In an effort to provide a stimulating and productive mix of participants, ALMA has notified 30 local manufacturers, 10 private investors, 10 government representatives, 10 representatives from technical and economic bodies, 10 persons from the convening organizations, and six speakers.

Registration Contacts

Travel subsidies will be available for participants from malaria endemic countries. For inquiries, please e-mail Esther.otieno@theglobalfund.org and Saleemah@amelior.org. The registration deadline is 17:00pm CET, 11 April 2011. To register, please download the Registration Form available on this web page and e-mail it to both:

1. Esther Otieno
   Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria
   Esther.otieno@theglobalfund.org
2. Saleemah Abdul-Ghafur
   African Leaders Malaria Alliance
   +917-838-1822
   Saleemah@amelior.org