Public Health, Innovation and Intellectual Property

Improving access to medicines

through local production in Africa:
the case of Ethiopia
Zafar Mirza
PharmaAfrica Market Access Conference

23-25 September 2015, London

 WHO Bulletin, June 2014

• "We welcome the surge of interest in the manufacturing of essential health

technologies in Africa. "

• "UNAIDS, UNIDO and WHO are working closely with the AUC to better coordinate
inter-agency efforts to support African governments."
WHO vision about Access to Medicines

Public Health, Innovation and Intellectual Property

People everywhere have access to the
essential medicines they need; that
the medicines are safe, effective, and
of good quality; and that the
medicines are prescribed and used
rationally.
 INDUSTRIAL
POLICY
Framework for Local Production for
Improving Access
• Competitive
• Reliable
• Innovative
• Productive
• Responsible SHARED GOALS HEALTH +
• Strategic INDUSTRY
Government
• Strategic selection of
essential medical products Support
• Pricing of local products Direct support to
that governments & people reduce the cost of
can afford. manufacture
• Strict compliance to quality
standards Indirect support of
• Effective NRAs. local production for
HEALTH improving access
POLICY • Health security
• Innovation.
• Access
(Availability
Affordable)
• Quality
• Supply
• Rational Use
 National Strategy for Pharmaceutical
Manufacturing Development in Ethiopia
developing industry to improve access

5
 Public Health, Innovation and Intellectual Property
This Presentation is about
 developing local pharmaceutical industry to improve access

Ethiopia Vision - 2025

 Middle Income Country by 2025.
the economy has been growing at > 10% for > 10 years

 Investing economic growth in human development

 Universal healthcare and universal access to medicines

enhancing local manufacturing is to achieve this vision

 Leading nation in light manufacturing in Africa

industrial Development Roadmap (2013-2025)

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 developing local pharmaceutical industry to improve access

Growth Transformation Plan (GTP)

5 Year National Development Plan

G T P – I (2010-15)
 Targeted 50% of demand for essential medicines through locally
produced medicines, only 20% could be managed
 Only $ 2million exports; only 50% production capacity utilization;
limited product portfolio
 Key lesson learnt: There was no specific sector strategy

G T P – II (2015-20)
 National Strategy and Action Plan for Pharmaceutical
Manufacturing Development in Ethiopia part of GTP-II
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 developing local pharmaceutical industry to improve access

National Strategy & Plan of Action for Pharmaceutical

Manufacturing Development in Ethiopia
(2015-25)

“To transform the Ethiopian pharmaceutical

manufacturing sector into a fully GMP-compliant,
competitive and innovative industry that meets the
national needs of essential medicines through local
production by 2025”

A strategy based on the value chain approach

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 developing local pharmaceutical industry to improve access

Strategic Objectives

1 Improving access to medicines through quality local

production – implementing GMP roadmap

2 Strengthening the national medicine regulatory

system

3 Creating incentives designed to move companies

along the value chain

4 Developing human resources through relevant

education and training

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 developing local pharmaceutical industry to improve access

Strategic Objectives

5 Encouraging cluster development and production of

active pharmaceutical ingredients (APIs)

6 Creating a research and development platform

7 Attracting foreign direct investments (FDIs) in the

pharmaceutical sector
 developing local pharmaceutical industry to improve access

Incentives to move companies along the value

chain – some examples
Time-bound incentives to help industry stand on its own feet and compete in the
market place

 70 % loan for GMP set-up costs for FFP, packaging and API production

 25% preference and 30% pre-payment by public sector procurement agency

 5 year contract to local producers by public procurement agency

 Facility for pooled procurement of APIs by a government agency

 Technology acquisition grant

 3 years income tax exemption

 Zero tax from export income for 5 years

 developing local pharmaceutical industry to improve access

Selected targets
2020 & 2025
Current 2020 2025

 Public procurement of locally produced EMs (%) 20 50 60

 Joint ventures with int. GMP compliant companies 3 8 15

 API manufacturers 0 1 3

 Bioequivalence studies at local bioequivalence center 0 10 25

 Locally developed traditional medicines 0 5 20

 No. of graduates in industrial pharmacy and 0 200 1500

regulatory sciences
 developing local pharmaceutical industry to improve access

Projected positioning of Ethiopian companies

along the Value Chain by 2020 and 2025

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 developing local pharmaceutical industry to improve access

Success factors
 National policy coherence across ministries
Ministry of Health; Ministry of Industry; Ministry of S&T etc.

 Implementation of government incentives

preferential procurement; long term contracts; grants; loans etc.

 Local and foreign investments

 Strong national regulatory authority

 Effectively working Food, Beverages and Pharmaceuticals Industry

Development Institute
 Acquisition of expertise to build local capacity
 Regional and international cooperation
THANK YOU

Public Health, Innovation and Intellectual Property

For More Information and Accessing Publications:
http://www.who.int/phi/publications/local_production/en/
Thank you