By Dr.Marie-Goretti HARAKEYE, Head of Division-HIV/AIDS, TB, Malaria & OID Department of Social Affairs

1. CONTEXT 2. Mandate AUC/DSA 3. Abuja Declaration-Translating commitments into actions 4. AWA and the AU Roadmap 5. AU Roadmap: Three Actions Pillars 6. PMPA: Pharmaceutical Manufacturing Plan for Africa

In fact while Africa accounts for only 13% of the global population it is home to 57% of global maternal and 50% of child deaths respectively. AIDS and malaria are the greatest contributors to the disease burden in Africa with 70% HIV cases and 90% of the deaths due to malaria. It is noteworthy that AIDS has been the fastest growing cause of disease burden globally in the last 20 years. Communicable and non-communicable diseases including neglected tropical diseases are also increasingly becoming prominent across the continent.

 Coordinate and Ensure Coherence of Heath related policies and programmes in the continent;  To work with relevant international partners in the eradication of preventable diseases and the promotion of good health on the continent. ◦ The continental response is targeting: the health system strengthening, scaling up Health interventions with'a ccélération of access to Health services especially those aiming to control HIV and AIDS, TB and Malaria

 The last decade :moment for health and development, with compelling vision for the future and strong political commitment to control the three diseases.  Recognising that the successes of the last decade, a decision was taken by the 18th Session of the African Union assembly in January 2012 to revitalise and in July 2012:. and endorsment of the AU Raodmap.  The mandate of AWA was broadened to cover the three diseases Building on the experience in responding to the AIDS epidemic with mobilisation of substantial global resources flowing in rapid scale from contributions by donors.

 African High Level Advocacy and accountability Platform to combat HIV/AIDS, TB and Malaria  The roadmap provides a blueprint for fast tracking implementation of the priority areas of the “Abuja Declarations and Abuja Call” following three action pillars which are health governance, diversified financing and access to medicines. The roadmap  2013: Special Summit AIDS TB and Malaria in Abuja

5. The Roadmap: three action pillars 1 More diversified, balanced and sustainable financing models  Develop financial sustainability plans with clear targets  Ensure development partners meet commitments and align with Africa’s priorities  Maximise opportunities to diversify funding sources and increase domestic resource allocation  Invest in leading medicines manufacturers – focusing on AIDS, TB and malaria  Lay foundations for a single African regulatory agency  Acquire essential skills through technology transfers and south-south cooperation  Incorporate TRIPS flexibilities and avoid "TRIPS-plus" measures in trade agreements  Use strategic investment approaches for scale-up of basic programmes  Support communities to claim their rights and participate in governance of the responses  Ensure investments contribute to health system strengthening  Mobilise leadership at all levels to implement the Roadmap 3 Leadership, governance and oversight for sustainability 2 Access to medicines – local production and regulatory harmonisation Priority actions 8

9 6. Pharmaceutical Manufacturing Plan for Africa

 Africa = 54 countries, >1 billion people (about 14% of the global population)  60 million people with hypertension by 2020  1 million cases of cancer annually  18.6 million people with diabetes by 2020  Other CVS, chronic respiratory diseases (COPD / asthma) and neuro-psychiatric conditions  NCD’s will have surpassed infectious diseases as the leading cause of death in Africa by  Source: WHO, WHO AFRO, Frost & Sullivan analysis 10

African Pharma expected to grow dramatically in the next decade

 PMPA: Borne out of the recognition by African Heads of state of the tremendous challenges facing African healthcare systems  AU Heads of State recognized the need for a sustainable strategy with treatment as central point  This in turn implies the need for readily available efficacious, high quality and affordable medicines  Original decision to develop a PMPA – Abuja 2005  Initial Plan – Accra 2007  Series of technical workshops and political dialogues undertaken  Development and adoption of Business plan – 2012

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.

Key PMPA Success Factors

 Progress has been made to enable countries to scale up pharmaceutical manufacturing, especially in ARVs and ACTs, as well as other malaria commodities (e.g. ITNs).  Pharmaceutical Manufacturing Plan for Africa (PMPA) Business Plan, an African-wide framework supported through a PMPA Business Plan Consortium.  At least two PMPA Business Plan pilots  Other countries, including South Africa, Kenya, Uganda, Nigeria, Tanzania and Tunisia, have negotiated public- private partnerships that will allow for more rapid pre- qualification for manufacturing of essential drugs by WHO as well as other, Bednets and other commodities 15

Progress is also being made in improving regulatory harmonisation across the continent:  The NEPAD Planning and Coordination Agency began work in 2012 on the development of a Model Law for Medicines Regulation Harmonisation in Africa. The Model Law aims to address legislative gaps that hamper medicines and commodities regulatory harmonization  African Medicines Regulation Harmonisation (AMRH) Initiative is promoting the establishment of Regional Centres of Regulatory Excellence to strengthen and harmonise their medical products regulatory systems through the existing REC structures, supported by the NEPAD Agency  African Medicine Agency (AMA) Project 16

 Implementation of TRIPS flexibilities within national legislation, focused intellectual property management and licensing training, as well as relevant workshops on the implementation of an integrated industrial, public health and innovation policy framework.  We need to ensure appropriate synergies with the initiatives of the National, Regional Pharmaceutical Manufacturing Plan of Action (EAC-ECOWAS, SADC) and the African Union’s Pharmaceutical Manufacturing Plan (AU PMPA)and AMA project 17

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“ Pharma is amongst the best performing sectors in Africa; the industry has been growing at a steady rate over the past few years and this momentum is expected to continue in tandem with overall economic growth being witnessed in Africa” Ahmed Badreldin, Partner and Head of MENA at The Abraaj Group

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