The AU Pharmaceutical Manufacturing Plan for Africa (PMPA) Business Plan – Role of the Africa-based Industry

Dr. Paul A. Lartey

ChairmanFederation of African Pharmaceutical Manufacturers Associations

CEOLaGray Chemical Company

FEDERATION OF AFRICAN PHARMACEUTICAL MANUFACTURERS ASSOCIATIONS

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Launched, Addis Ababa, Jan 25,2013Currently 3 regional associations

• Federation of East African Pharmaceutical Manufacturers

• Southern African Generic Medicines Association

• West African Pharmaceutical Manufacturers Association

FAPMA

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FAPMA231 manufacturers

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FAPMA – VISION:

To be a vibrant and self-sustaining pharmaceutical manufacturing industry in Africa by providing quality and affordable medicines so as to contribute to the reduction of disease burden and promote economic development of the continent.

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• African Union Heads of State mandate Abuja July 2005

• Initial plan endorsed by Heads of State, Accra July 2007

• Conf. of African Ministers of Industry accepts sector in Accelerated Industrial Development plan for Africa, Algiers March 2011

• Plan endorsed by Conf. of African Ministers of Health, May 2012

• Submission to Heads of State, Addis Ababa, July 2012

PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA

VISION OF THE PMPA

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To develop a competitive and enduring integrated pharmaceutical manufacturing industry in Africa, able to respond to the continent’s need for a secure and reliable supply of quality, affordable, accessible, safe and efficacious medicines.

CORE OBJECTIVES OF THE PMPA

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Support local pharmaceutical manufacturing in Africa to:

increase access to affordable quality medicines

ensure sustainable supply of essential medicines

improve public health outcomes

promote industrial and economic development

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OBJECTIVES FAPMAPromote excellence, facilitate networking, disseminate information and raise awareness on matters relating to the pharmaceutical industry

Promote access to safe, quality, efficacious medicines in Africa

Strengthen the local production of medicines in Africa

Facilitate economic growth through development of a sustainable, self-sufficient and viable pharmaceutical industry in Africa

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• Alignment of objectives

• Participated in evolving the PMPA

• Participated in development of the Business Plan for implementation

• Will be a strong partner in its implementation

FAPMA AND PMPA

KEY CHALLENGES OF THE INDUSTRY IN SUB SAHARAN AFRICA

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Capacity and skills shortages Poor quality and counterfeit drugs Facilities are not compliant with

international standards of GMP Weak regulatory framework Lack of technology or absence of

technology No market data Lack of partnership or linkages

Generic Solutions

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Human capital development Development of a GMP road map Time limited incentives and other government support Facilitation of access to affordable financing Legislation and policy at regional and national levels Technical assistance to MRAs Establishment of business linkages platform Assistance with formulations for TRIPs as incentive Support for national regional and pan-African

manufacturers associations Developing options for market data collection

BASIC FOUNDATION

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QualityAccess Availability

Affordability CompetitivenessSustainability Self-reliance

Sound sector strategyPolicy coherence

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ROLE OF FAPMA IN IMPLEMENTATION OF PMPA

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Support efforts of our members in:−Step up facilities upgrading and staff development

for GMP compliance−Developing capacity and technology to take

advantage of TRIPS flexibilities Advocate for support and incentives – governments to

honor commitments Support strengthening of MRAs and advocate for

harmonization Partner and collaborate with other stakeholders

AUCNEPAD

Private Sector

African Governments

SYNERGY THROUGH PARTNERSHIP

DevelopmentPartners

Financial institutions

Regulators

OPEN FOR BUSINESS

AFRICABASED

PHARMACEUTICALMANUFACTURING