1. Towards Universal Health Coverage (UHC)-
Implementation of the Pharmaceutical
Manufacturing Plan for Africa (PMPA)
Business Plan
Paul K. Tanui
NEPAD Agency
AWA Consultative Experts’ Committee Meeting
04-05 May 2015 Victoria Falls, Zimbabwe

2. Outline of Presentation
• PMPA Background
• Principles underpinning the promotion of Africa’s
Pharmaceutical Manufacturing Agenda
• PMPA: Challenges in Pharma Value Chain
• NEPAD Agency’s Interventions in implementing
PMPA-BP
• AMRH Initiative Strategic Directions & Progress
• Vision for AMRH Programme: AMA
• Conclusion

3. PMPA Background
• Medicines & the Healthcare system: One of the
core functions of an effective health system is to
ensuring reliable access to, and appropriate use
of safe, effective, and affordable medicines
• Medicines are important beyond their
therapeutic utility: they are often seen by the
public as the most tangible representation of
health care
• Availability of medicines is a critical indicator of
the quality and accessibility of healthcare
services

4. PMPA Background..
• Recognition by African Heads of state of the
tremendous challenges facing African healthcare
systems
• The Pharmaceutical Manufacturing Plan for Africa
(PMPA) framework endorsed by the AU Conference
of Ministers of Health in Accra in 2007 in
response to call by the African Heads of States
in 2005 (Abuja)
• Endorsement of the PMPA Business Plan – 2012
(AUC, UNIDO & partners)

5. PMPA Background..
• Some of the key issues identified by the PMPA
Framework and BP
– Ineffective regulatory systems in Africa
– Technical barriers to the free movement of
products within and across regions
– Local production policy priorities
– Sound medicines regulatory systems
– Intra regional and intra continental trade
– Creation of a viable market size

6. Principles underpinning the promotion of Africa’s
Pharmaceutical Manufacturing Agenda
1. Quality and affordability of medical products is
essential for promoting public health and for
viability and sustainability of the local industry
2. Expansion of the local industry will trigger
strengthening of regulatory systems to promote
safety, efficacy and curtail counterfeit products
3. Competitiveness driven by enhancing skills,
innovation & technology base will bring the
industry closer to the consumer market

7. Principles underpinning the promotion of Africa’s
Pharmaceutical Manufacturing Agenda..
4. Self reliance will emanate from optimizing
the global pharmaceutical value chains as
opposed to dependence on imported
finished products
5. Development and enforcement of coherent
policies across supporting sectors will create
enabling environment for sustainability of
robust healthcare delivery systems

8. 8
PMPA-BP: Challenges in the Pharma Value Chain

9. Optimizing the global
pharmaceutical value chain for
improved health and development

10. Collaborative efforts for implementation of the PMPA-
BP
Current members of the PMPA Consortium of Partners convened by
AUC and contributing at various levels implementing PMPA-BP:
• United Nations Industrial Development Organization (UNIDO),
• Joint United Nations Programme on HIV/AIDS (UNAIDS),
• World Health Organization (WHO),
• United Nations Population Fund (UNFPA),
• United Nations Development Program (UNDP),
• United Nations Economic Commission for Africa (UNECA),
• New Partnership for Africa’s Development (NEPAD) planning and coordinating
Agency,
• African Development Bank (AfDB),
• United States Pharmacopoeial Convention (USP),
• African Network for Drugs and Diagnostics Innovation (ANDI),
• Federation of Pharmaceutical Manufacturers’ Association (FAPMA)- Rep. over 230
companies
Others: RECs, International 0rganizations, MS initiatives etc also have programmes
aligned to PMPA-BP

11. PMPA Consortium of Partners Initiatives
• Consortium Collaborative Framework: Roles and
responsibilities of partners, PMPA-Technical
Committee: to augment efforts and avoid duplication
• Annual PMPA Stakeholders Meetings
• Proposed Joint Consortium 3 year Workplan
• Selection criteria for country or REC technical
support in implementation of PMPA-PB
• High Level pan-African dialogue on pharmaceutical
manufacturing in Africa: AUC, UNAIDS, Government
of South Africa & consortium partners to be held on
sidelines of AU Summit in June 2015

12. NEPAD Agency Contribution to PMPA-BP
implementation
• NEPAD Agency’s Focus in Supporting the
implementation of the PMPA since 2009
–Building a conducive policy and regulatory
environment for pharmaceutical sector
development
• Through AMRH: Policy and regulatory reforms,
regulatory capacity development and knowledge
generation and leveraging

13. Background…
2005-2007: AU Pharmaceutical
Manufacturing Plan for Africa (PMPA)
PMPA
2012: AU-Roadmap on Shared
Responsibility & Global Solidarity for
ATM response in Africa
Creating an Enabling
Regulatory Environment
Pharmaceutical sector development
(Optimizing the African Market for
new medical products and
technologies)
Increased access
to medical
products and
technologies
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14. AU Roadmap: Action Pillar Two- Access to affordable
and quality-assured medicines
The Roadmap outlines a suite of high priority actions to ensure
accelerated access to affordable and quality-assured medicines
and health-related commodities as enshrined in the
• Pharmaceutical Manufacturing Plan in Africa (PMPA). These
four priority actions can be summarized as:
• 1. Promote and facilitate investing in leading medicines hub
manufacturers in Africa –focusing initially on AIDS, TB and malaria
medicines;
• 2. Accelerate and strengthen regional medicines regulatory harmonization
initiatives and lay foundations for a single African regulatory agency;
• 3….

15. The African Medicines Regulatory Harmonization Initiative
The African Medicine Regulatory
Harmonization (AMRH) initiative aims to
accelerate the access to products by
improving the fragmented system of product
registration in Africa
Main focus
• Develop common requirements / guidelines /
format
• Work sharing among countries
• Streamlined regional decision making at the
regional level
• Gradual expansion of scope to other
regulatory functions (e.g. PhV, CT Oversight)
and products
Expanded Partnership
RECs, AUC, PAP, NEPAD, WHO, World Bank,
DfID, BMGF, US-PEPFAR, UNAIDS, USP, EDCTP
• Initial stakeholder
engagement (NEPAD)
• Situation Analysis &
Regional proposals
developed
• Multi-donor trust-fund
established
• EAC MRH Project launched
30 March 2012; EOI for
joint assessment
• WAHO/UEMOA Project
Launched 2 Feb 2015
• NPCA/WB/SADC MoU
Signed
• Central Africa consultation
& projects consolidation
2009
2010/
2011
2011
2012
2015
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16. Policy & Regulatory Reforms
Regulatory Capacity Development
Knowledge Management
Enabling environment for Effective
Coordination & Accountability
AMRH Strategic Directions & Progress..
EAC, West Africa Launch of AMRH
Central & Southern Africa plans
AU Model Law on Medical Prd Regn
AfricanMedicinesRegulatoryHarmonizationInitiative
10 Regional Centers of Regulatory
Excellence Designated
80 Regulatory pool of Experts
Biennial Scientific and
Medicines Regulators
Conferences; RF
AMRH Secretariat
AMRH Governance structure:
TWG/EWG, Steering & Advisory
Committees
AMRH M&E Framework,
AMRH Partnership Framework

17. 17
Roughly 85% of Sub-Saharan Africa covered with medicines
registration harmonization (MRH) Projects at different levels
Completed or in-process RECs
Countries
covered
Total
members*
% pop
covered
EAC & OCEAC
EAC, OCEAC, ECOWAS
EAC, OCEAC, ECOWAS, SADC
12 (20%)
26 (46%)
41 (74%)
11
26
41
17%
45%
72%
REC progress
SADC
We are pushing forward those RECs that are ready while
continuing to work with the remaining regions
•REC
• EAC
• OCEAC/ECCAS
• WAHO/UEMOA
• SADC
• North/Northeast
Africa
•Status •Comments
•Implementation
•In progress
•In progress
•In progress
•Ongoing discussions
•Launched 2012
•Consultations ongoing
•Launch of Steering
Committees 2015
17
EAC
ECCAS/OCEAC
CEN-SAD/UMA/COMESA
IGAD

18. Vision for AMRH Programme
55 countries 1 continent
African
Medicines
Agency
5regions
IGAD / AMU
/ CEN-SAD
EAC
SADC/CO
MESA
ECCAS/
OCEAC
WAHO /
UEMOA
Vision: East African
Community Medicines
and Food Safety
Commission

19. AU Decision on AMRH-AMA-PMPA
• January 2015: The 26th Ordinary Session of the Executive
Council in its decision EX.CL/Dec.857(XXVI)
– Recognizes the need to strengthen the capacity for regulation of
medical products in Africa, and the harmonization of medicines
regulatory systems as a foundation for the establishment of AMA
within the context of the AMRH
– Recognizes AMA-AMRH as part of the PMPA Framework
– Endorsed the milestones for the establishment of AMA
– Requested the AUC, the NEPAD Agency and the WHO in
collaboration with other stakeholders to elaborate AMA’s legal
and institutional framework including financial implications for
its establishment

20. AMA Milestones and corresponding timelines
Milestone Timeline
Adoption of proposal for the establishment of the AMA by the AU
Conference of African Ministers of Health
2014
Establishment of Task Team/Project Unit for operationalization of
the objectives of the AMA by Ministers of Health
2014
Decision/endorsement in principle by the AU Summit of Heads of
State and Government
2015
Designation of host institution/country 2016
Approval of the governing body of the AMA 2017
Appointment of staff and allocation of resources 2017
Launch of the AMA 2018

21. Rationale for Establishment of the African Medicines
Agency…
• The AMA is intended to be an organ of the AU, legally
mandated by Member States;
• AMA will serve as a platform for coordination and
strengthening of ongoing initiatives to harmonize
medicines regulation;
• AMA will also serve the purpose of pooling expertise and
capacities and strengthening networking for optimal use
of the limited resources available.
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22. Rationale for Establishment of the African Medicines
Agency…
• AMA will provide guidance, complement and enhance the
efforts of the RECs towards harmonization of medical
products regulation; and
• By enhancing the regulatory environment, AMA will
contribute to improving access of medical products.
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23. Opportunities for AMA Establishment
• African Medicines Regulatory Harmonization Initiative
• African Vaccines Regulators Forum (AVAREF)-WHO/AFRO
• Biennial African Medicines Regulators Conference (AMRC)
• Biennial Scientific Conference on Medicines Regulation in
Africa
– are opportunities to enhance regulatory convergence on the continental
level.
– These initiatives, which aim at enhancing the availability of medical products,
require proper and effective coordination
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24. Opportunities for AMA Establishment…
• African countries recognize the need for a coordination
mechanism for the regulation of medical products, and
AMA will fulfill that need;
• The time frame for establishment of AMA should take into
account the current opportunities and partnerships to
support global health initiatives and will require less
investment if established sooner rather than later;
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25. Opportunities for AMA Establishment…
• AMA will provide guidance, complement and enhance the
efforts of the RECs towards harmonization of medical
products regulation; and
• By enhancing the regulatory environment, AMA will
contribute to enhancing access to medical products.
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26. Recommendations
• MS to utilize the AU Model Law on Medicines
Regulation and Harmonization as a reference guide
for their regulatory reforms
• AU, RECS, MS and partners to participate in
consultation processes for elaboration of the
structure and functions of the African Medicines
Agency
• MS and RECs to review their Pharmaceutical
Manufacturing Policies and Plans in alignment with
the PMPA and PMPA-BP

27. Conclusion
• Progress on PMPA-BP implementation
• Progress in regulatory harmonization made in Africa
through RECs and process for establishing AMA
• Several lessons have been learnt in Africa in the
harmonization effort: process is slow, requires
consultation; harmonization models exist; regulation
based on science is key for harmonization; importance of
effective regulatory management systems cannot be
overemphasized; regulation to take into account issues
of globalisation, cross-border trade and cross-border
manufacturing
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28. Thank You
Merci
Obrigado
‫شكرا‬
paul@nepadst.org
www.amrh.org
www.nepad.org
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