Zafar Mirza IPC 11 th Dec 2015, Geneva National Strategy for Pharmaceutical Manufacturing...

Zafar Mirza

IPC

11th Dec 2015, Geneva

National Strategy for Pharmaceutical Manufacturing Development in

Ethiopia

developing industry to improve access

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.

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.

WHO Vision about Access to Medicines

What will we do? We will continue to improve access to safe, quality, affordable and effective medicines . We will support innovation for affordable health technology, local production and national regulatory authorities

• "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."

• "Africa’s development partners, especially the BRICS countries (Brazil, the Russian Federation, India, China and South Africa), have a special role in supporting this critical phase of African development."

WHO Bulletin, June 2014

"We will support local production"12th General Program of work

Local production: geography and/or ownership – we use jurisdiction

as a basis for defining local production rather than ownership

Transfer of technology: broadly defined to include education, training,

licensing, know- how, movement of persons, supply of materials and equipment, through various mechanisms

…but what is local production?

1. Political commitment of government to develop local industry

2. Clear vision, coherent policy framework, action plan "Health-industry complex" : explicitly linking local industry with local needs Development of industry overtime along the value chain: from imports to local R&D

3. Zero-tolerance on quality Corresponding investment in strengthening NRAs Development of national GMP road map and its honest and forceful implementation

4. Time-bound government incentive package Preferential support to local industry in short to medium term Fiscal and non-fiscal incentives

WHO's Approach to Supporting Local Production

improving quality & access

5. Facilitating technology transfer North-south and south-south cooperation Strategic joint ventures better licensing arrangements

6. Building human resource Education, training, retention Attracting expertise from diaspora

7. Supporting management of IP to support local production Use of transitional period under WTO/TRIPS benefitting from flexibilities

WHO's Approach to Supporting Local Production

improving quality & access

8. Ongoing monitoring and evaluation

Reliable and sustainable market data gathering system

Regular reports

9. Working with partners AUC UNIDO, UNAIDS, UNFPA

10. One WHO approach HQ, ROs, Country offices

working together

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National Strategy for Pharmaceutical Manufacturing Development in

Ethiopiadeveloping industry to improve access

This Presentation is about

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 Africaindustrial Development Roadmap (2013-2025)

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Ethiopia Vision - 2025

developing local pharmaceutical industry to improve access

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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Growth Transformation Plan (GTP)5 Year National Development Plan


Government considers pharmaceuticals as strategic commoditiesin line with AU’s Pharmaceutical Manufacturing Plan for Africa

Sizeable internal market (93 million) and expanding economypharmaceutical sector growth rate 25%, market $ 1 billion by 2018

Huge investment in health sector by the government introduction of social health insurance

Government has created attractive investment environment

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Conducive Factors for the Strategy


“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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National Strategy & Plan of Action for Pharmaceutical Manufacturing Development in

Ethiopia(2015-25)


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Pharmaceutical Value Chain

Improving access to medicines through quality local production – implementing GMP roadmap

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Strategic Objectives


1

Strengthening the national medicine regulatory system 2

Creating incentives designed to move companies along the value chain

3

Developing human resources through relevant education and training

4

Encouraging cluster development and production of active pharmaceutical ingredients (APIs)

Strategic Objectives


5

Creating a research and development platform6

Attracting foreign direct investments (FDIs) in the pharmaceutical sector

7

Exploiting the LDC Status to locally produce patented products

8

Currently 9 pharmaceutical manufacturersonly 2 are GMP certified

By 2018 all manufacturers have to be GMP-complaint

4 WHO prequalified products by 2020

Implementing GMP Road Map


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 1500regulatory sciences

Selected targets2020 & 2025


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

Incentives to move companies along the value chain – some examplesTime-bound incentives to help industry stand on its own feet and compete in the market place


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for more information and accessing publications:

http://www.who.int/phi/publications/local_production/en/

THANK YOU



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