IPC 11 th Dec 2015 Geneva National Strategy for Pharmaceutical Manufacturing Development in Ethiopia developing industry to improve access P eople everywhere have access to the essential medicines they need that the medicines are safe effective and of good quality and that the m ID: 581483
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Slide1
Zafar Mirza
IPC
11th Dec 2015, Geneva
National Strategy for Pharmaceutical Manufacturing Development in Ethiopia
developing industry to improve accessSlide2
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 authoritiesSlide3
"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 2014Slide4
"We will support local production"12
th 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?Slide5
Political commitment of government to develop local industry
Clear vision, coherent policy framework, action plan
"Health-industry complex" : explicitly linking local industry with local needsDevelopment of industry overtime along the value chain: from imports to local R&DZero-tolerance on qualityCorresponding investment in strengthening NRAsDevelopment of national GMP road map and its honest and forceful implementationTime-bound government incentive packagePreferential support to local industry in short to medium term Fiscal and non-fiscal incentivesWHO's Approach to Supporting
Local Production improving quality & access Slide6
Facilitating technology transfer
North-south and south-south cooperationStrategic joint venturesbetter
licensing arrangementsBuilding human resourceEducation, training, retentionAttracting expertise from diasporaSupporting management of IP to support local production Use of transitional period under WTO/TRIPSbenefitting from flexibilitiesWHO'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 partnersAUC
UNIDO, UNAIDS, UNFPA10. One WHO approachHQ, ROs, Country offices working togetherSlide7
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National Strategy for Pharmaceutical Manufacturing Development in Ethiopia
developing industry to improve accessSlide8
This Presentation is aboutSlide9
Middle Income Country
by 2025. the economy has been growing at > 10% for > 10 years
Investing economic growth in human developmentUniversal healthcare and universal access to medicines enhancing local manufacturing is to achieve this visionLeading nation in light manufacturing in Africaindustrial Development Roadmap (2013-2025)
9
Ethiopia Vision - 2025
developing local pharmaceutical industry to improve accessSlide10
G T P – I (2010-15)
Targeted 50% of demand for essential medicines
through locally produced medicines, only 20% could be managedOnly $ 2million exports; only 50% production capacity utilization; limited product portfolioKey lesson learnt: There was no specific sector strategyG T P – II (2015-20)National Strategy and Action Plan for Pharmaceutical Manufacturing Development in Ethiopia part of GTP-II
10
Growth Transformation Plan (GTP)5 Y
ear National Development Plan
developing local pharmaceutical industry to improve accessSlide11
Government considers pharmaceuticals as strategic
commodities in line with AU’s Pharmaceutical Manufacturing Plan for Africa
Sizeable internal market (93 million) and expanding economy pharmaceutical sector growth rate 25%, market $ 1 billion by 2018Huge investment in health sector by the government introduction of social health insuranceGovernment has created attractive investment environment
11
Conducive Factors for the Strategy
developing local pharmaceutical industry to improve accessSlide12
“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 approach12National Strategy & Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia(2015-25)developing local pharmaceutical industry to improve accessSlide13
13
developing local pharmaceutical industry to improve accessPharmaceutical Value ChainSlide14
Improving access to medicines through quality local production – implementing GMP roadmap
14
Strategic Objectivesdeveloping local pharmaceutical industry to improve access1
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
4Slide15
Encouraging cluster development and production of active pharmaceutical ingredients (APIs)
Strategic Objectives
developing local pharmaceutical industry to improve access5
Creating a research and development platform
6
Attracting foreign direct investments (FDIs) in the pharmaceutical sector
7
Exploiting the LDC Status to locally produce patented products
8Slide16
Currently 9 pharmaceutical manufacturers
only 2 are GMP certified
By 2018 all manufacturers have to be GMP-complaint4 WHO prequalified products by 2020Implementing GMP Road Mapdeveloping local pharmaceutical industry to improve accessSlide17
C
urrent 2020 2025Public procurement of locally produced EMs (%) 20 50 60
Joint ventures with int. GMP compliant companies 3 8 15API manufacturers 0 1 3Bioequivalence studies at local bioequivalence center 0 10 25Locally developed traditional medicines 0 5 20No. of graduates in industrial pharmacy and 0 200 1500 regulatory sciences
Selected targets
2020 & 2025
developing local pharmaceutical industry to improve accessSlide18
70 % loan for GMP set-up costs for FFP, packaging
and API production
25% preference and 30% pre-payment by public sector procurement agency5 year contract to local producers by public procurement agencyFacility for pooled procurement of APIs by a government agencyTechnology acquisition grant3 years income tax exemptionZero tax from export income for 5 years
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
developing local pharmaceutical industry to improve accessSlide19
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developing local pharmaceutical industry to improve accessSlide20
f
or
more information and accessing publications:http://www.who.int/phi/publications/local_production/en
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nk you