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

Dr. Paul A. Lartey
Chairman
Federation of African Pharmaceutical Manufacturers Associations
CEO
LaGray Chemical Company
FEDERATION OF AFRICAN PHARMACEUTICAL
MANUFACTURERS ASSOCIATIONS

Launched, Addis Ababa, Jan 25,2013
Currently 3 regional associations
• Federation of East African
Pharmaceutical Manufacturers

• Southern African Generic Medicines
Association
• West African Pharmaceutical
Manufacturers Association

2
FAPMA

FAPMA
231 manufacturers

3
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.

4
PHARMACEUTICAL MANUFACTURING PLAN FOR
AFRICA
• 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

5
VISION OF THE PMPA

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.

6
CORE OBJECTIVES OF THE PMPA
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

7
OBJECTIVES FAPMA
Promote 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, selfsufficient and viable pharmaceutical
industry in Africa

8
FAPMA AND PMPA
• 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

9
KEY CHALLENGES OF THE INDUSTRY IN
SUB SAHARAN AFRICA

 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

10
Generic Solutions










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

11
Enhancing market data
collection and facilitating
market access

Partnerships, collaboratns
and fostering business
linkages

Regulatory systems
Strengthening and
enforcement

Access to affordable finance
and time limited incentives

Access to products
and technology

HR development

BASIC FOUNDATION
Quality
Access  Availability
Affordability  Competitiveness
Sustainability  Self-reliance

Sound sector strategy
Policy coherence
12
ROLE OF FAPMA IN IMPLEMENTATION OF PMPA
 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

13
SYNERGY THROUGH PARTNERSHIP

Development
Partners

Financial
institutions
AUC
NEPAD

AFRICA
BASED
OPEN FOR
Private PHARMACEUTICAL
MANUFACTURING
BUSINESS
Sector

Regulators

African
Governments

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

  • 1. The AU Pharmaceutical Manufacturing Plan for Africa (PMPA) Business Plan – Role of the Africa-based Industry Dr. Paul A. Lartey Chairman Federation of African Pharmaceutical Manufacturers Associations CEO LaGray Chemical Company
  • 2. FEDERATION OF AFRICAN PHARMACEUTICAL MANUFACTURERS ASSOCIATIONS Launched, Addis Ababa, Jan 25,2013 Currently 3 regional associations • Federation of East African Pharmaceutical Manufacturers • Southern African Generic Medicines Association • West African Pharmaceutical Manufacturers Association 2
  • 4. 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. 4
  • 5. PHARMACEUTICAL MANUFACTURING PLAN FOR AFRICA • 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 5
  • 6. VISION OF THE PMPA 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. 6
  • 7. CORE OBJECTIVES OF THE PMPA 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 7
  • 8. OBJECTIVES FAPMA Promote 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, selfsufficient and viable pharmaceutical industry in Africa 8
  • 9. FAPMA AND PMPA • 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 9
  • 10. KEY CHALLENGES OF THE INDUSTRY IN SUB SAHARAN AFRICA  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 10
  • 11. Generic Solutions          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 11
  • 12. Enhancing market data collection and facilitating market access Partnerships, collaboratns and fostering business linkages Regulatory systems Strengthening and enforcement Access to affordable finance and time limited incentives Access to products and technology HR development BASIC FOUNDATION Quality Access  Availability Affordability  Competitiveness Sustainability  Self-reliance Sound sector strategy Policy coherence 12
  • 13. ROLE OF FAPMA IN IMPLEMENTATION OF PMPA  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 13
  • 14. SYNERGY THROUGH PARTNERSHIP Development Partners Financial institutions AUC NEPAD AFRICA BASED OPEN FOR Private PHARMACEUTICAL MANUFACTURING BUSINESS Sector Regulators African Governments