African Medicines Regulatory Harmonisation (AMRH) Initiative:

Presentation by Margareth Ndomondo-SigondaPharmaceutical Coordinator

NEPAD Agency26 March, 2013

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Presentation Outline1. Background

2. AMRH Vision, Mission, SD & Partners

3. AMRH achievements

4. Pharma Industry participation• Perceptions by local manufacturers• Opportunities for local manufacturers• Market Viability

5. Conclusion & Way Forward

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1. AMRH Initiative Background

New Partnership for Africa’s Development (NEPAD)

• 2001: A Programme of the African Union (AU) adopted in Lusaka, Zambia

• February 2010: Integration of NEPAD under the AU structures• Re-newed mandate as a technical body of the African Union

to:• Facilitate and coordinate the implementation of the

continental and regional programmes and projects;• Mobilize resources and partners in support of the

implementation of Africa’s priority programmes and projects;

• Conduct and coordinate research and knowledge management;

• Coordinate the implementation of programmes and projects, &

• Advocate on the AU and NEPAD vision, mission and core principles/values

Est.: OAU – May 1963 AU – July 2002Tel: +251-11 551 77 00 Fax: +251-11 551 78 44 Website: www.africa-union.org

Head Office Address: P.O. Box 3243, Roosevelt Street (Old Airport Area), W21K19, Addis Ababa, Ethiopia

Algeria

Angola

Benin

Botswana

Burkina Faso

Burundi

Cameroon

Cape Verde

C/African Rep.

Chad

Comoros

DRC

Congo

Côte d’Ivoire

Djibouti

Egypt

Equatorial Guinea

Eritrea

Ethiopia

Gabon

Gambia

Ghana

Guinea

Guinea-Bissau

Kenya

Lesotho

Liberia

Libya

Madagascar

Malawi

Mali

Mauritania

Mauritius

Mozambique

Namibia

Niger

Nigeria

Rwanda

Sharawi Arab DR

São Tomé & Prínc.

Senegal

Seychelles

Sierra Leone

Somalia

South Africa

Sudan

Swaziland

Tanzania

Togo

Tunisia

Uganda

Zambia

Zimbabwe

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African Union

• 54 member states of the African Union– fifty two republics, and two kingdoms– South Sudan is the newest member state, joining on 2011

July 27

• Total population: ~ 1 billion• 8 Regional Economic Communities:

– Arab Maghreb Union (UMA), Common Market for Eastern and Southern Africa (COMESA), Community of Sahel Saharan States (CEN-SAD), East African Community (EAC), Economic Community of Central African States (ECCAS), Economic Community of West African States (ECOWAS), Intergovernmental Authority on Development (IGAD) and Southern Africa development Community (SADC)

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PMPA-AMRH GenesisAfrican Union Assembly Decision 55 of 2005 - Abuja Summit: African Union Commission (AUC) to develop a Pharmaceutical

Manufacturing Plan for Africa (PMPA) within the NEPAD Framework Aim: to contribute to a sustainable supply of quality essential medicines

to improve public health and promote industrial and economic development on the continent

Critical elements for successful implementation of PMPA : Legislative framework: Sound regulatory systems e.g. GMP, GDP, GCP

e.t.c. Full use of TRIPS and related flexibilities Appraisal of technical feasibility and financial viability A market size to ensure sustainability Technology transfer Human resource Duties and taxes

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2. AMRH Vision, Mission, Strategic Directions & Partners

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AMRH VISION & MISSION

VISION:African people have access to essential medical products and technologies

MISSION:Provide leadership in creating an enabling regulatory environment for pharmaceutical sector development in Africa

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AMRH Strategic Directions• Policy and Regulatory Reforms

– Increased use of harmonized policies and regulatory frameworks by member states

• Regulatory capacity Development – Increased human and institutional capacity for regulation of

medical products and technologies– Use of existing structures & institutions to ensure sustainability

• Knowledge Management– Knowledge assets on medicines regulation at country, regional

and continental levels created

• Enabling environment for AMRH– Governance & coordination– Partnership Platform Accountability Framework– M&E and impact assessment framework04/12/2023 10

Consortium of key partners established to accelerate and ensure African Medicines Regulatory Harmonization

(AMRH)

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Consortium and majorstakeholders convened inFebruary and November

2009

Consortium Partners

Other Stakeholders NMRA Representatives

Regional Economic Communities and Organizations (RECs)

COHRED

• Unanimous consensus emerged: now is the right time to push for regulatory harmonization in Africa

• Global Medicines Regulatory Harmonization - Multi-Donor Trust Fund established under the World Bank

AMRH Partners….

AMRH Partners Roles• Mobilising political support, and

financial and technical resources for AMRH programme

• Promoting and facilitating inter-REC communication, coordination, technical consistency and shared learning

• Building a continental initiative, assisting in priority setting and plans for regulatory harmonization

Political/Technical/Operational• New Partnership for Africa’s

Development (NEPAD Agency)• African Union Commission

(AUC)• Pan African Parliament (PAP)• World Health Organization

(WHO)• The World Bank

Donors & NGOs• Bill & Melinda Gates

Foundation• UK Department for

International Development (DFID)

• Clinton Health Access Initiative (CHAI) 12

AMRH…• Overall Objective

– To improve public health by increasing access to quality, safe and efficacious essential medicines for the treatment of priority diseases

– Contribute to socio-economic development agenda for Africa

• Specific Objective– To reduce the time taken to register priority medicines

– Registration as pathfinder to a broader harmonization of other regulatory functions and products

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AMRH Approach…

Building on the existing regional efforts, political mandates and plan

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AMRH …

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Earlier approvalof more

medicines & vaccines

Today

~ 54 National Medicines Regulatory Authorities (NMRAs) governing medicines regulation across Africa

Lack/inadequate medicines policies and laws

Regulators' capacity highly variable: Financial, HR, Institutional

Different requirements and formats, lack of clear guidelines

Minimal transparency, No clear timelines

Reference evaluations1 underleveraged

Streamlined (harmonized)

future

Between 5-7 regional economic communities (RECs)

covering the entire African continent1

Harmonized medicines policies and Laws

Stronger, institutionalized regulatory capacity & systems

strengthening programmes

Single set of requirements, Clear guidelines, Fewer

dossiers to prepare

Transparent regulatory processes with clear timelines

Resource pooling and information sharing1. WHO prequalification, Article 58 positive opinions, stringent regulatory approval, certificate of pharmaceutical product (CPP) 15

Critical Milestones

Member States Operating independently

Member States Collaborate on selected topics

Harmonised standards and broad collaboration

Centralized Procedure

• each country has its own technical requirements and format for registration applications

Regional harmonised guidelines & procedures: • Guidelines for

registration of medicines

• Procedures for evaluation of medicines

• GMP guidelines & Inspection procedures

• Joint evaluations and inspections

• Sharing assessment and inspection reports

• Quality Management Systems

• Information Management Systems

Centralized registration on behalf of participating member states

Regional Medicines Agencies e.g. EAC-MFSA

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1. Harmonised requirements and standards

Not Harmonised Fully Harmonised

National sovereignty is respected: Medicines registration decisions remaining firmly that of sovereign nations

Robust & transparent regulatory processes

Critical Milestones

Working independently

Member States Collaborate on training programmes

Harmonised training standards and broad collaboration

Utilise Existing Regional structures & expertise: NMRAs & Academic institutions

Existing training programmes for NMRA staff based on donor funding

• Evaluation & registration of medicines

• GMP Inspections

• Quality Management Systems

• Management Information Systems

• Harmonised training curriculum

• Certification • Evaluation of

training programmes

• Potential partners: WHO, US-FDA, PQM, AfDB, EDCTP, ANDi, PDPs, SIAPS

Short Term:• Twinning/Exchange

programmes among NMRAs within & outside the continent

• Regional Centres of Regulatory Excellence (RCORE)

Long-Term:• Engagement of academic

institutions to offer post graduate courses in Regulatory Science

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2. Regulatory capacity development

Ad-hoc training programmes Institutionalised training programmes

• Increased regulatory workforce in Africa

Critical Milestones

Current status Country level Regional level Continental level

• Lack/Weak medicines laws

• Medicines regulated within territories

• Varying comprehensiveness of laws

• No sanctions on non compliance to regional treaties

• Adoption and domestication of model law on medicines regulation

• Mutual recognition agreements

• Binding regional legal instruments

• At least 5 regions have adopted regionally harmonized policies and legislative frameworks

• At least 20 countries implementing the regionally harmonized policies and legislative frameworks

• At least 2 regional medicines agencies established

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3. Policy and Regulatory Reforms

Inadequate policies & laws Harmonised policies & Laws

• Increased adoption of regionally agreed standards• Mutual recognition of regulatory decisions

• Establishment of regional medicines agencies

3. AMRH Achievements

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1. GMRH Multi-Donor Trust Fund

• The World Bank administration of a Global Medicines Regulatory Harmonization Multi-Donor Trust Fund (GMRH-MDTF)

• Initial funds to cover EAC Medicines Registration Harmonization Project and AMRH Partners

• US$ 12.5 million• Bill & Melinda Gates Foundation provided initial start-up

grant while other interested donors are engaged

• Strategically mobilize resources to cover other RECs• Sustainable domestic financing options

2020

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2. CONTINENTAL PROGRESS

• AMRH Advisory Committee established – NEPAD Agency Secretariat: Coordination and Political advocacy– Provides strategic and policy advise on AMRH programme

implementation– Composed of representatives from RECs, NMRAs, AUC, PAP,

NEPAD, WHO, World Bank, industry associations, civil society

• Technical Working Groups– Regulatory Capacity Development– Medicines Policies & Regulatory Reforms

• Draft Model Law for Medicines Regulation Harmonization in Africa developed– Stakeholders consultations planned for 2013

CONTINENTAL PROGRESS…

Related Continental Frameworks• July 2012: 19th AU Assembly decision on Roadmap for

Shared Responsibility and Global solidarity for the AIDS, TB and Malaria response in Africa

– Emphasis - accelerate and strengthen regional medicines regulatory harmonization initiatives

– Establishment of regional medicines agencies– Foundation for a single African Regulatory Agency– Lead Partners: AUC, UNAIDS & NEPAD Agency

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3. REGIONAL PROGRESSEast African Community• Launch & subsequent implementation of EAC Medicines Registration

Harmonization (MRH) Project since March 2012

• 5 EAC Partner States (6 NMRAs) participating in the AMRH Initiative: Burundi, Kenya, Rwanda, Tanzania, Uganda

• MRH Project Steering Committee Established

• Technical Working Groups (TWG) established to develop registration and GMP guidelines and procedures in line with internationally acceptable standards

• Partner States NMRAs taking lead• Tanzania: TWG on medicines evaluation & registration• Uganda: TWG on good manufacturing inspection• Kenya: TWG on quality management systems

• Rwanda: TWG on Information Management System (IMS) 2323

REGIONAL PROGRESS…

West African region:• 15 participating member states• 2011: Development of MRH Project framework in

consultation with industry• August – Nov 2012:

– WAHO, UEMOA, WHO & NEPAD Agency High Level consultation meetings

– Experts consultation meetings– WAHO engagement of 7 countries (5 Anglophone & 2 Lusophone)– UEMOA engagement of 8 Francophone countries

• 2013: WAHO/UEMOA Regional coordination framework, plan of action and Memorandum of Understanding

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REGIONAL PROGRESS…

Central African region• 10 participating member states

• 2009-11: Situation analysis and development of a project framework for OCEAC/ECCAS

• 2012: Consultation with OCEAC and ECCAS

• 2013: Consultation on OCEAC/ECCAS Regional coordination framework, plan of action and memorandum of understanding

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4. PHARMA INDUSTRY PARTICIPATION• 2010-2012: NEPAD commissioned situation

analysis of medicines regulation & harmonization across African RECs and countries– National & regional policy & legislative frameworks– NMRAs assessment

• 3 categories based on agreed criteria; i) Existing NMRA; ii) Existing legal framework; iii) performance of full regulatory functions (registration, GMP); iv) Existing Management Information System; v) Available HR

– Industry perception on AMRH• Consultation through National & regional industry associations• General agreement

• EAC, SADC, ECOWAS consultation meetings– Development of regional MRH Frameworks

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AMRH Coverage Roughly 85% of Sub-Saharan Africa

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RECsCountries covered

Population(Mill)

Pharma market

(US$ Bill p.a.)

EAC ECCAS/OCEACECOWAS-WAHO/UEMOASADCUMA/CEN-SADC/COMESA/IGAD

51015159

133.1120~300267.58N/A

N/AN/A3.5 (2010)3 (2006)N/A

Total: 54

REC Status/Progress

Source: BCG analysis

SADC

• We are pushing forward with RECs that are willing

• Industry participation in stakeholders consultation is key

• National & regional industry association a good platform for engagement

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WAHO/UEMOAEAC

ECCAS/OCEAC

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AMRH contribution to Pharma Industry Development dev

Intermediateterm

Long term

Increased access to generics treating many

important diseases

Broader, more rapid access to vaccines and

other therapies

Extension to all regulatory functions

More efficient launches for vaccines and

other PDP products

Greater impact of new life-saving technologies

Foundation for African pharma industry

(PMPA)

• Benefit to Regional Economic & Trade Treaties

• Increased market access

Healthier, more productive workforce

Short term

Prevention and treatment of infections diseases (overall)

Broad economic development in the

regionEnhanced access to

new health technologies

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5. WAY FORWARD• Regional Stakeholders consultation

– EAC harmonised guidelines & procedures– AMRH Model Law

• Institutionalization of the regulatory training programmes in the continent– Establishment of Regional centres of regulatory Excellence

(RCOREs)– Training for regulators & industry– Key for sustainability

• Expanding the scope for harmonization to clinical trials oversight and safety monitoring

• Governance and effective coordination regionally & continentally– Establishment of Partnership Platform Accountability Framework– Impact assessment of policy & regulatory reforms in Africa

• Continued political advocacy

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WAY FORWARD…• 1st Scientific conference for medicines regulation in

Africa– Theme:

“Building Partnerships for Sustainable Capacity Development in Medicines Regulation in Africa”

– Target group: African regulatory authorities, researchers, academic institutions and industry

• Necessity of working together to address socio-economic issues affecting the African populace

– Call for Abstracts

• Read: AMRH-PMPA Policy Brief• Visit: www.amrh.org

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CONCLUSION• AMRH is a strategic initiative for pharmaceutical sector

development in Africa

• Strong political constituency and partnerships built– AU organs (AUC, NEPAD Agency, PAP), RECs, NMRAs,

pharmaceutical industry & Civil Society– Donors, development partners & international agencies

• Cooperation, collaboration and commitment by all stakeholders is key for success– Need practical alignments & engagement between African

NMRAs, industry, academia and researchers

• EAC MRH Project provides a Model for replication to other RECs

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Thank You!

Merci!

Obrigado!

Ahsanteni Sana!

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