Towards Universal Health Coverage (UHC)-Implementation of the Pharmaceutical Manufacturing Plan for Africa (PMPA)

Business PlanPaul K. TanuiNEPAD AgencyAWA Consultative Experts’ Committee Meeting04-05 May 2015 Victoria Falls, Zimbabwe

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

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 healthcareservices

PMPA Background..

• Recognition by African Heads of state of thetremendous challenges facing African healthcaresystems

• The Pharmaceutical Manufacturing Plan for Africa(PMPA) framework endorsed by the AU Conferenceof Ministers of Health in Accra in 2007 inresponse to call by the African Heads of Statesin 2005 (Abuja)

• Endorsement of the PMPA Business Plan – 2012(AUC, UNIDO & partners)

PMPA Background..

• Some of the key issues identified by the PMPAFramework and BP

– Ineffective regulatory systems in Africa

– Technical barriers to the free movement ofproducts within and across regions

– Local production policy priorities

– Sound medicines regulatory systems

– Intra regional and intra continental trade

– Creation of a viable market size

Principles underpinning the promotion of Africa’s Pharmaceutical Manufacturing Agenda

1. Quality and affordability of medical products isessential for promoting public health and forviability and sustainability of the local industry

2. Expansion of the local industry will triggerstrengthening of regulatory systems to promotesafety, efficacy and curtail counterfeit products

3. Competitiveness driven by enhancing skills,innovation & technology base will bring theindustry closer to the consumer market

Principles underpinning the promotion of Africa’s Pharmaceutical Manufacturing Agenda..

4. Self reliance will emanate from optimizingthe global pharmaceutical value chains asopposed to dependence on importedfinished products

5. Development and enforcement of coherentpolicies across supporting sectors will createenabling environment for sustainability ofrobust healthcare delivery systems

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PMPA-BP: Challenges in the Pharma Value Chain

Optimizing the global pharmaceutical value chain for

improved health and development

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

PMPA Consortium of Partners Initiatives• Consortium Collaborative Framework: Roles and

responsibilities of partners, PMPA-TechnicalCommittee: to augment efforts and avoid duplication

• Annual PMPA Stakeholders Meetings

• Proposed Joint Consortium 3 year Workplan

• Selection criteria for country or REC technicalsupport in implementation of PMPA-PB

• High Level pan-African dialogue on pharmaceuticalmanufacturing in Africa: AUC, UNAIDS, Governmentof South Africa & consortium partners to be held onsidelines of AU Summit in June 2015

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

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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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….

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 PartnershipRECs, 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 MoUSigned

• Central Africa consultation & projects consolidation

2009

2010/ 2011

2011

2012

2015

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Policy & Regulatory Reforms

Regulatory Capacity Development

Knowledge Management

Enabling environment for Effective Coordination & Accountability

AMRH Strategic Directions & Progress..

EAC, West Africa Launch of AMRHCentral & Southern Africa plans AU Model Law on Medical Prd Regn

Afr

ican M

edic

ines R

egula

tory

Harm

oniz

ation Initia

tive

10 Regional Centers of Regulatory Excellence Designated80 Regulatory pool of Experts

Biennial Scientific and Medicines Regulators Conferences; RFAMRH SecretariatAMRH Governance structure: TWG/EWG, Steering & Advisory CommitteesAMRH M&E Framework,AMRH Partnership Framework

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Roughly 85% of Sub-Saharan Africa covered with medicines registration harmonization (MRH) Projects at different levels

Completed or in-process RECsCountries covered

Totalmembers*

% 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/NortheastAfrica

•Status •Comments•Implementation

•In progress

•In progress

•In progress

•Ongoing discussions

•Launched 2012

•Consultations ongoing

•Launch of Steering Committees 2015

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EAC

ECCAS/OCEAC

CEN-SAD/UMA/COMESA

IGAD

Vision for AMRH Programme

55 countries 1 continent

African Medicines Agency

5regions

IGAD / AMU/ CEN-SAD

EAC

SADC/COMESA

ECCAS/OCEAC

WAHO / UEMOA

Vision: East African Community Medicines and Food Safety Commission

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 legaland institutional framework including financial implications for its establishment

AMA Milestones and corresponding timelines

Milestone Timeline

Adoption of proposal for the establishment of the AMA by the AU

Conference of African Ministers of Health2014

Establishment of Task Team/Project Unit for operationalization of

the objectives of the AMA by Ministers of Health2014

Decision/endorsement in principle by the AU Summit of Heads of

State and Government2015

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

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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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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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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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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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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Recommendations

• MS to utilize the AU Model Law on MedicinesRegulation and Harmonization as a reference guidefor their regulatory reforms

• AU, RECS, MS and partners to participate inconsultation processes for elaboration of thestructure and functions of the African MedicinesAgency

• MS and RECs to review their PharmaceuticalManufacturing Policies and Plans in alignment withthe PMPA and PMPA-BP

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 theharmonization effort: process is slow, requiresconsultation; harmonization models exist; regulationbased on science is key for harmonization; importance ofeffective regulatory management systems cannot beoveremphasized; regulation to take into account issuesof globalisation, cross-border trade and cross-bordermanufacturing

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Thank You

Merci

Obrigado

شكرا

paul@nepadst.org

www.amrh.org

www.nepad.org

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