discussion item # 3: people strategy

29
ETHIOPIA AN EMERGING MANUFACTURING HUB IN AFRICA Tilahun E. Kassahun Senior Policy Advisor, Ethiopian Investment Commission

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Page 1: Discussion item # 3: People Strategy

ETHIOPIA AN EMERGING

MANUFACTURING

HUB IN AFRICA

Tilahun E. Kassahun

Senior Policy Advisor, Ethiopian Investment Commission

Page 2: Discussion item # 3: People Strategy

2

Pharmaceutical manufacturing is a nascent industry in Ethiopia but has the potential

to promote import substitution, grow exports, and improve health through access to

medicines

100+ million Population

Total GDP : $74.bn

GDP/capita : $740

Gini coefficient : 0.3

Economics

Literacy 49% of total population

Pharmaceutical manufacturing market

▪ Ethiopia has a sizable and growing domestic pharmaceutical market

($684M in 2018), ~85% of which is met by imports

▪ Pharma manufacturing is a nascent industry:

– 9 local pharma manufacturers in Ethiopia

▫ Only few are GMP-certified

▫ Out of 380 essential medicines, less than 90 are produced locally

– 200+ importers

▪ Nonetheless, there are significant opportunities to grow the sector to:

– Promote import substitution

– Grow or diversify exports

– Improve access to essential medicines

▪ The Ethiopian government is keen to establish a pharma manufacturing hub

and plans to launch an industrial park for pharmaceuticals (Kilinto)

– In July 2015, the government put forth an ambitious 'National Strategy

for Pharma Mfg Development (2015-25)’

Health spend : $2.7bn

Health spend/capita : $27

Health spend/GDP : 5%

Availability of EDMs* : ~70%

Health

450 518 595 684

2015E 2016F 2017F 2018F

Pharmaceutical market in Ethiopia (2015-18F, $M)

Note: *Essential drugs and medicines

Source: World Bank, IMF, WHO, National Strategy and Plan of Action for Pharmaceutical Manufacturing

Page 3: Discussion item # 3: People Strategy

3

The key drivers of demand are increasing disease burden, rising healthcare coverage,

and progressive growth of the Ethiopian population and economy

• Awareness, diagnosis and treatment of diseases are increasing for both communicable

and non-communicable diseases in Ethiopia

– Ethiopia is affected by the burden of communicable diseases; the country is

among the highest burden countries for Malaria, HIV/AIDS and TB

– In addition, prevalence of non-communicable diseases, such as diabetes, cancer,

and hypertension has also increased.

Rising healthcare

coverage

Progressive growth of

the Ethiopian

population and

economy

Increased

determination to

address disease

burden

• The Ethiopian government is increasing healthcare coverage to its large rural

population, thus promoting the need for increased access to pharma

– Ethiopia has a Health Extension Programme (HEP), which is a community based

strategy to deliver health promotion and awareness creation among the public

– The overall primary health care service coverage has reached 100% in 2015 and a

social health insurance scheme has been introduced to the public aiming to

increase access to health services

• With a population size of > 100M, Ethiopia has the second-largest population in Africa

• Ethiopia is expected to become a middle income country by 2025 with an average

economic growth of 10% per year resulting in an increase in the disposable income

of the population; the increase in disposable income will influence spending on

healthcare pharma products

Key drivers of pharmaceutical demand in Ethiopia

Source: Interviews, market research, AGI analysis

Page 4: Discussion item # 3: People Strategy

4

Strategic objectives

1.Improve access to medicines through quality local production

2.Strengthen the national medicine regulatory system

3.Create incentives designed to move along the value chain

4.Develop HR through relevant education and training

5.Encourage cluster development & API production

6.Create a R&D platform

7.Attract FDI in the pharmaceutical sector

8.Exploit the LDC status to locally produce patented products

The Ethiopian government has put forth an ambitious national strategy to

develop the pharmaceutical manufacturing industry

Indicators 2015 2020

target

2025

target

Pharmaceutical manufacturers with

international GMP compliance (n)

2 5 20

WHO prequalified products produced

locally (n)

0 4 15

New manufacturing companies and

local capital invested (n)

0 5 11

Joint ventures with international GMP

compliant companies (n)

3 8 15

API manufacturers (n) 0 1 3

Export of locally produced meds by

GMP-complaint producers (USDmn)

2 30 80

Selected targets

Source: National Strategy and Plan of Action for Pharmaceutical Manufacturing Development in Ethiopia (2015-2025)

The study also incorporated other reports from the MOI, e.g. proposed incentive package, implementation plan for national

strategy, policy advisory report on intellectual property and local pharma manufacturing in FDR Ethiopia

Page 5: Discussion item # 3: People Strategy

5

Pharmaceutical

Industrial

Park

• Power consumption is dependent on the pharmaceutical product line, although it is not different from other

industries

- Power reliability is as important as availability in the pharmaceutical sector, as interruptions highly affect

the production process and quality of the end products

• Water supply is vital for pharmaceutical production. Depending on the product, different grades of water purity

are required (potable, bulk purified water, bulk highly purified water, water for injections, etc.)

- Input water treatment is typically done individually by investors, but GoE can provide the standards for

potable water. It can also be provided at different purity levels (Potable water < cleaning water < water for

syrups & suspension < water for injections)

• Waste Management: Pollution prevention, reduction, and/or treatment is required for air emissions, liquid

effluents and solid wastes. The toxic concentration depends on the type of product. Pre-treatment at the

facility / cluster before joining the CETP is most often required. Zero-liquid discharge is also a possible

(but quite expensive) technology. HVAC for air emissions should be chosen and justified by companies

• Warehouse: Storage area should be of sufficient capacity to allow orderly storage of the various categories of

materials and products (raw materials, intermediaries, packaging, finished, quarantined, released & rejected

products). Segregation and labelling is required to prevent errors/mix-ups

- Warehouses should be designed to ensure good storage conditions (clean & dry, maintained within

acceptable temperature/humidity limits). Highly active products stored in a secure area

Clustering, infrastructure and exports: Pharmaceutical industrial parks have

unique infrastructure requirements from ones focused on other sectors

Source: EFMHACA, Arvind, WHO

Infrastructural requirements for a pharmaceutical industrial park

• Others: transportation facilities and one stop shop services should be included

- Ideal if the one-stop-shop include customs, FMHACA, environmental protection and other government

offices for ease of operation

Notes: in manufacturing Finished products, the loss is projected to be 2-3%

Page 6: Discussion item # 3: People Strategy

6

Hawassa Eco-Industrial Park

The strategy of attracting a high-profile company to serve as an ‘anchor’ for

pharmaceutical cluster development can work, but needs to be nuanced

Page 7: Discussion item # 3: People Strategy

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Page 8: Discussion item # 3: People Strategy

8

Kilinto industrial park - dedicated to pharmaceuticals

Source: Kilinto design report, IPDC

Page 9: Discussion item # 3: People Strategy

9

The goal is to attract investment from leading pharmaceutical manufacturers so that

Ethiopia can become an export hub and top API manufacturer in Africa

Criteria for targeting foreign

companies for investment promotion

Technological

capability

Export

experience

Financial

resources

Companies should have strong technological capability

that they will bring to Ethiopia through investment

Companies should have proven track record of

exporting pharmaceuticals, and should have the

intention of exporting pharmaceuticals from Ethiopia

Companies should bring their own financial resources

(debt and/or equity) to finance their investment in

Ethiopia

Goal: To become an export hub and leading API manufacturer in Africa

EIC will:

• Lead targeted recruitment of anchor investors

• Conduct due diligence on potential investors

• Cooperate with relevant GoE agencies (MoI, FBPIDI, MoH, FMHACA, PFSA, MoFA)

Page 10: Discussion item # 3: People Strategy

10

Market access 1:

Ethiopia is highly dependent on imports; local production contributes only ~15-20%

of domestic demand

324 338 352 364 374 383

2015E 2016E 2017F 2018F 2019F 2020F

Ethiopia pharmaceutical imports (2015E-20F)*

$US million

0.2123.69.5

878.5

74.7Ethiopia

Glands and organ, dried and extracts, for

therapeutic use

Blood, antisera, vaccines, toxins and cultures

Pharmaceuticals in bulk form

Pharmaceuticals in finished dose form

Special pharmaceutical goods

Note: Forecast based on external market research report

Source: BMI Research, AGI analysis

Page 11: Discussion item # 3: People Strategy

11

While there are 200+ importers, there are only 9 local manufacturers of

human medicines in Ethiopia

Level 1

Import

Level2

Packaging and

labeling

Level 3

Product

manufacturing

Level 4

API

manufacturing

Level 5

Research and

development

>200

importers,

wholesalers

and

distributors

0 company 0 companies 0 companies • 9 manufacturers of

human medicines or

gelatin capsules

− 4 GMP-certified

companies

− 0 WHO prequalified

products

Source: The National Strategic Plan of Action for Pharmaceutical manufacturing development in Ethiopia (2015-2020)

Description

Domestic

companies

Mapping of the Ethiopian Pharmaceutical sector in the value chain

Distribution of

finished

pharmaceutical

products

Packaging and

labelling of imported

bulk finished

pharmaceutical

products following

national or

international GMP

standards

Formulation of

finished products

from imported Active

Pharmaceutical

Ingredient(API) and

excipients by

following national or

international GMP

standards and WHO

prequalification

standard for products

Production of Active

Pharmaceutical

Ingredient (API) and

excipients by

following national or

international GMP

standards and WHO

prequalification for

APIs

Research and

development for new

formulations,

processes and new

chemical entities

following national or

international

GLP/GCP and

ethical standards

Page 12: Discussion item # 3: People Strategy

12

0.6 0.6 0.8 0.9 1.0 1.1 1.2 1.3 1.4 1.5 1.6 1.8 1.9 2.0 2.1 2.20.7 1.0 1.2 1.4 1.5 1.6 1.7 1.8 2.0 2.1 2.3 2.4 2.5 2.6 2.8 2.9

2010 2011 2012 2013 2014 2015E 2016F 2017F 2018F 2019F 2020F 2021F 2022F 2023F 2024F 2025F

Public Private1.3

1.6

2.0

2.3 2.5

2.5 2.9

3.1 3.4

3.6

3.9

4.2 4.4

4.6

4.9

5.1

Government is the largest customer; 75% of all medicines consumed in

Ethiopia is procured through the public sector

Ethiopia: Public and private heath spend (2010-25F)

($US billion)

Note: *Based on National Strategy and Plan of Action for Pharmaceutical Manufacturing Development

Source: BMI, AGI analysis, Interviews

• Government contributes ~60%

of total healthcare spend in

Ethiopia

• For pharmaceuticals, the share

of the public market is even

higher

– ~75% of all medicines

consumed in Ethiopia is

procured through the public

sector*

• The public sector procures

products largely based on price,

favoring generics medicines

• ~90% of branded products are

sold through the private

pharmaceutical market

Page 13: Discussion item # 3: People Strategy

13

The majority of drugs are procured through the public sector

Ethiopian Pharmaceutical market (2015)

Pharmaceutical market in Ethiopia (2015)

Public market*

Government purchases

(Revolving drug fund)**

Program purchase

(donor funded)

Purchase from local

manufacturers International tenders

1 company: direct

negotiation 2 or more companies:

Closed bid

In-kind donations Private market**

Note: *Public sector includes RDF and Program Purchases (in-kind donations are not included). **private sector share was estimated at 25% of the total domestic market size

Source: PFSA, Interviews, NS-POA, AGI analysis

~75% of value

~30%

~25% of value*

Public market

~70%

Page 14: Discussion item # 3: People Strategy

14

Market access and other incentives

Key incentive categories

Market Access (Revenue

enhancing)

Incentives that directly impact

the revenue of the company

(e.g., price and/or volume)

1. Procurement: Closed bids

• Price advantages in tenders

• Export incentives and facilitation

Reduced import competition

1. Regulation

2. Talent development & facilitation

3. Availability of infrastructure

4. Access to R&D

5. Access to foreign exchange

6. One-stop-shop services

1. Custom duty exemptions

2. Corporate income tax

3. VAT exemption

4. Access to finance

Incentive types

1

2

3

5

6

7

8

9

10

11

13

4

12

Tax and Finance (Profit

enhancing)

Incentives that directly impact

costs, and consequently the

company’s profit margin

Operational efficiency Incentives that facilitate setting

up and running a business in the

sector

Ethiopia

14

Page 15: Discussion item # 3: People Strategy

15

According to manufacturers, 6 out of the 14 incentives are critical

Importance to manufacturers

Procurement: Closed bids 1

2

3

5

6

4

Price advantages in tenders

Export incentives and facilitation

Reduced import

competition

Custom duty exemptions

Corporate income tax exemption

VAT taxes

Access to finance

7

8

Regulation 9

Talent development & facilitation

10

Availability of infrastructure

11

Access to R&D 12

Access to foreign exchange 13

One-stop-shop services 14

Feedback from manufacturers

Market

Access

(Revenue

enhancing)

Tax and

Finance

(Profit

enhancing)

Operational

efficiency

• Manufacturers indicated that closed bid RDF procurements by

PFSA and protection of the domestic market through import

tariffs are the most important market access incentives

• Existing domestic manufacturers indicate that the 25% price

premium offered by PFSA in international tenders is less

important, as they are seldom competitive even with the price

advantage

• As a majority of inputs to pharmaceutical production are

imported, e.g. APIs, excipients, and primary packaging, custom

duty exemptions are one of the most important incentives to

maintain

• Regulatory challenges and access to foreign exchange are

among the most significant challenges to pharmaceutical

manufacturing in Ethiopia, and incentives aimed at facilitating

these processes are important

• As pharmaceuticals is a knowledge-intensive industry, talent

development and facilitation was similarly rated as an

important incentive to offer

• Access to finance is less important for large MNCs, but a

significant challenge among existing domestic manufacturers

Sub-category Category Critical Important

Moderate Low

Page 16: Discussion item # 3: People Strategy

16

Public procurement can be more attractive to investors with proper legal

framework for closed bids and longer-term supply contracts

Note: Closed/restricted bid: a bid restricted to participants selected based on a specified criteria by the procuring body. In Ethiopia, closed-bid tenders are allowed only to local manufacturers.

Source: Interviews, EIC & AGI analysis

Closed tender

for local

manufacturers

Long term

market

guarantee

(volume or

price)

• Local closed-bid tenders are currently offered for products being produced in

sufficient quantity by two or more domestic manufacturers;

• Hence, the exercise of closed-bid tenders to encourage local manufacturers is

available

• A number of improvements have been recently be introduced

• A significant trade-off with public health must be considered

• Long-term purchase contracts are attractive for MNCs looking to invest in Ethiopia

• The experience of Anti-retroviral (ARV) production in South Africa and Uganda

• South Africa: Central Procurement Authority has a long-term contact with a local

manufacturer, Aspen, to supply ARVs

• Uganda attracted Cipla to manufacture ARVs locally by signing MOU, providing 20%

price preference for local production and guaranteed volumes

Increase transparency of the tender system • Review procurement/tender management system: Manufacturers associations/private sector should be

engaged • Procurement results should be made public so that local manufacturers and/or other suppliers can submit

objections • Enhance PFSA laboratory and technical evaluation capacity to ensure quality of procurement

Page 17: Discussion item # 3: People Strategy

17

Market access 2: While the Ethiopian market ~$684 M – 1billion, the African pharmaceutical market is

valued at >$25B and is growing at a rate of ~13% per annum

Note: * 2013 numbers are approximate; 2020 numbers are estimates; ** CAGR is for the top seven countries in Africa (Algeria, Egypt, Ghana, Kenya,

Morocco, Nigeria, and South Africa)

Source: McKinsey (2015) Africa: A continent of Opportunity for Pharma

The growth of pharmaceutical sales in Africa*

(2013-20E), $US billion

6%

9% 6%

10% 13%

17%

Pharma segment growth in Africa

(2013-20E), $US billion

As developed markets stagnate, Africa represents a promising source of growth for multinational pharmaceutical

companies

CAGR%

CAGR**

Page 18: Discussion item # 3: People Strategy

18

Pharmaceutical market in Africa, however, is led by seven countries, which

constituted ~70% of the total market in 2015

Pharmaceutical sales in Africa (2010-20F)

US$ billion

Note: The order of the countries is based on their Pharmaceutical sales in 2020F

Source: BMI, AGI analysis

Ethiopia represented

only ~2% of the African

pharma market in 2015

CAGR CAGR

2010-15 2015-20F Top 7 in Africa

Sub-Saharan

Africa

3.9% 4.4%

Total Africa 5.1% 6.8%

17.1

18.9

20.8

22.7

23.8

21.8 22.3

23.6

25.5

27.8

30

9.5% Algeria 9.2%

Egypt 9.5% 5.3%

Tunisia 5.4% 6.7%

Morocco 3.0% 8.6%

Nigeria 1.4% 0.4%

South Africa 0.2% 2.5%

8.0% 3.6% Rest of Africa

Kenya 12.3% 9.7%

Page 19: Discussion item # 3: People Strategy

19

400

141

39 35 25 19 12 6 5 4 4 2 2 2 2 2 1 1 1 0

50

100

150

200

250

300

350

400

450

South Africa, Egypt, and Kenya are the largest exporters of pharmaceuticals

in Africa; top 5 countries represent 90% of the continent’s exports

Top African countries that export pharmaceuticals

Export value of pharmaceutical products (2015), $US million

Note: *While UN COMTRADE states that Ethiopian pharmaceutical exports was only $998K in 2015, the Ethiopian government in its GTP-II states that

the actual figure was $2.7M. For consistency, the data in this graph is from UN COMTRADE.

Source: Calculations based on UN COMTRADE statistics, AGI analysis

Top 5 countries in

Africa represent 90%

of continent’s exports

($640M)

Ethiopia exported only

~0.14% of the continent’s

pharmaceutical exports in

2015*

Exports in India and China, in

comparison, are ~$12.5B and

~$6.9B respectively

Page 20: Discussion item # 3: People Strategy

20

0

2000

4000

6000

8000

0 0.1 0.2 0.3 0.4 0.5 0.6

Ave

rag

e d

ista

nc

e w

ith

de

sti

na

tio

n c

ou

ntr

ies

(k

m)

Concentration of exporting countries**

Egypt

Kenya

Mauritius

Tunisia

Uganda Tanzania

Morocco

Senegal Ghana

Botswana

Cameroon

Togo

Zimbabwe

Swaziland

Algeria Ethiopia

Benin

South Africa

Concentration of exporting countries in Africa and average distance to importing partners*

Pharmaceutical products (2015)

Across the continent, pharmaceuticals produced locally are typically

consumed domestically or traded regionally

Note: *Size of bubble is proportional to the export value. **The concentration is based on the Herfindahl index. Indices between 0.10 and 0.18 is considered

to be moderately concentrated and indices above 0.18 to be concentrated. This indicator is a measure of the dispersion of trade value across an

exporter’s partners.

Source: Calculations based on UN COMTRADE statistics

Long-distance

exporters with many

importing partners

Page 21: Discussion item # 3: People Strategy

21

Manufacturers indicate that the key criteria when selecting export destinations are

market size, registration requirements, trade agreements, distance and competition

Criteria for choosing export destinations

Average ratings by companies (N=9)

On a scale of 1 to 7; where 1 is not important criteria and 7

is most important criteria

4

5

5

5

5

6

6

6

Existing business relationswith vendors/distributors

Drug pricing in destinationcountry

Import tariff

Competition in destinationcountry

Distance (cost oftransportation)

Trade agreements

Registration requirements formarketing approval

Market size in export country

• Addressable market size

and regulatory

requirements for drug

approval are the two most

important criteria

• Membership in Regional

Economic Communities

(RECs) is also considered an

important criteria, as it can

facilitate easier market

access

• Inland transport

considered cost effective

for export to neighbouring

countries due to

inaccessibility of many

African markets by sea and

high cost of air transport

Source: AGI survey of Ethiopian pharma manufacturers (2016)

Page 22: Discussion item # 3: People Strategy

22

Source: AGI analysis

Target regions with high export

potential and pursue RECs-based

regulatory harmonization, which is likely to

be achieved in the medium to long-term

This may be a necessary pre-condition

for the GoE to realize its vision to become

the leading regional hub for

pharmaceutical production and export

Prioritize countries with high export

potential in Africa and pursue bilateral

harmonization / mutual recognition of

regulatory frameworks

− FMHACA is pursing this approach with

countries like Jordan

− Recommend initiating the same with

prioritized export destinations

… while pursuing country-specific bilateral regulatory agreements over short-term

REC-based regulatory harmonization is important; but also bilateral

agreements can be solutions in the short run

Harmonize regulations through RECs as a

medium to long-term strategy…

2 1

Page 23: Discussion item # 3: People Strategy

23

Regulatory harmonization is crucial for reasons of regulatory efficiency and

market access

Benefits of harmonization

1. Differences in regulation across countries constitute trade restrictions

(non tariff barriers) - Standards convergence or harmonization

facilitates market access

- assessment of dossiers and registration takes 1- 3 years in African

countries. In the absence of joint assessment or mutual recognition

system, companies face lengthy time and complex country-specific

procedures in each importing country.

- country specific requirements (labeling, fees etc.) form NTBs

2. Many African MRAs do not have the required capacity – less than 30%

of African MRAs are considered competent by WHO – reduces burden

on national MRAs by pooling resources, reducing duplication, and

adopting best practice

• Driven by AMRHI (African Medicines Registration Harmonization

Initiative) which is led by consortium of regional organizations and

development partners

• RECs-based harmonization – all RECs invited to submit

proposal

• Piloting and sequenced approach – level of harmonization and

choice of RECs

Source: Accelerating regulatory approval through WHO (2016), Impact of regulatory requirements on medicine registration in Africa (2012)

Level 1 – Information sharing: common data/ regulation repository - easy access to countries and companies

Level 4 – Joint registration: regional level /central assessment and registration – zero country-specific procedure

Level 2 - harmonization of technical and scientific materials: harmonized guidelines for registration and GMP inspection (country level assessment and decision)- streamlined procedure and requirements

Level 3 - Joint assessment and inspection: simultaneous submission to NMRAs => REC Secretariat/lead country coordinates joint assessment sessions => joint dossier assessment => Country level registration subject to administrative requirements - reduced time for national registration (3-6 months Vs 1-3 years)

4 levels of harmonization identified Harmonization overview

Page 24: Discussion item # 3: People Strategy

24

Harmonization is occurring through RECs; EAC is the furthest along, while

IGAD and COMESA are lagging behind

Source: Accelerating regulatory approval through WHO (2016), Impact of regulatory requirements on medicine registration in Africa (2012)

IGAD

EAC

SADC/

COMESA

ECCAS

ECOWAS/

UEMOA

RECs Current level of harmonization

EAC

Level 3 – Joint assessment

•3 rounds, over 8 products approved, largely essential

generic drugs, registration within 3 months

SADC

Level 3 – Joint assessment

•125 generic products and one innovative medical

product assessed so far

•Focus on regional priority drugs – anti-infectives, anti-

hypertensive, anti-diabetics, registration within 11

months

ECOWAS

Level 2 - harmonization of technical and scientific

materials

•Developing regional “centres of excellence” on

bioequivalence centre & quality control labs

•Regionalization is championed by Nigeria

ECCAS

Level 2 - harmonization of technical and scientific

materials

•At initial stages

IGAD

Level 1 – Information sharing

•Regional harmonization program launched in 2015, yet

to establish a regional regulatory unit, preparing a

proposal for participation in AMRH

COMESA

Not actively engaged so far

•60% countries in EAC and SADC

Page 25: Discussion item # 3: People Strategy

25

6.2B

4.3B

2.8B

2.2B

1.4B

COMESA SDAC ECOWAS IGAD EAC

Addressable market size by region ($B, 2015 pharmaceutical imports)

COMESA represents a large export market with an addressable market size

of $6.2B; other neighbouring regions, IGAD and EAC, are considerable in

market size as well

Source: Calculations based on UN COMTRADE statistics, AGI analysis

Page 26: Discussion item # 3: People Strategy

26

Regional blocks

Member countries –

addressable market

size (2015)*

Note: * Import of pharmaceutical products was used as a proxy for addressable market size **local supply as % of market

Source: Calculations based on UN COMTRADE statistics and BMI, Interviews, AGI analysis

COMESA

IGAD

ECOWAS

EAC

SADC

6 countries – $1.4B

19 countries – $6.2B

8 countries – $2.2B

15 countries – $2.8B

Competition**

Level of

harmonization

(1-4)

Possibility for FMHACA to

harmonize (Medium-term)

High to Medium

▪ Member, but

harmonization not high

on the agenda

Medium to Low

▪ Not member, but more

than half are COMESA

members

No

Low

▪ Not member

Ethiopia

membership

High to Medium

▪ Member, harmonization on

the agenda only recently,

capacity limitations

YES

Yes

NO

NO

30%

25%

7%

20%

6%

Medium

▪ Not member, but

observer

3

0

1

3

2

15 countries – $4.3B

GoE should champion regulatory harmonization within IGAD, as it represents a favourable regional market

with relatively low competition; COMESA also represents a significant opportunity provided regularity

harmonization is pursued in the medium to long-term

Ethiopia can play a leadership role in achieving regulatory harmonization with

IGAD in the medium-term and COMESA in the longer-term

Page 27: Discussion item # 3: People Strategy

27

In the following prioritized countries, the GoE should seek to harmonize its regulatory

procedures, facilitate information exchange, and foster vendor/distributor relationships

Source: Interviews and survey

+Somaliland

Prioritized export markets

Average rating across key export challenges

faced as reported by 5 companies

On a scale of 1 to 7; where 1 is not challenging

and 7 is most challenging

4.8

4.8

5.6

6.2

6.8

Lack of competitiveness of locally produced products

in export markets

Access to forex

No vendors / distributor relationships

Limited knowledge of export markets

Regulatory procedures in export destinations / lack

of regulatory harmonization

Most challenging issues

10 prioritized export

markets

•7 in COMESA

•3 in ECOWAS

(see appendix for

detailed list) Sudan

Kenya Uganda

Congo

(DRC)

Zimbabwe

Senegal Mali

Burkina Faso

Zambia Malawi

Page 28: Discussion item # 3: People Strategy

28

The following interventions are also necessary to address other export-

related bottlenecks

Lack of competent Bioequivalence studies – key for export

competitiveness and has high cost implications

• The Bioequivalence Centre in Ethiopia (under School of

Pharmacy of AAU) lacks effective organizational structure,

adequate resources and is yet to be certified by the WHO

• Undertaking the test overseas has high cost implication – the

cost of testing in Kenya or South Africa is 2X that of Ethiopia’s

Lack of timely access to foreign exchange – key for optimal

production and export

Lack of (High cost) of special refrigerated trucks necessary for

some inland transportation – the preferred means for African

countries

Expensive outsourcing of pharmaceutical transports by ESLSE

due to lack of refrigerated containers

Source: Interview, AGI analysis

Capacitate Bioequivalence

center through diagnostics and

tackling of prevailing challenges

CBE to enhance bank to bank

transactions

Enhance the forex regime (see

incentive)

Incentivize duty free import of

specialized trucks as capital

goods

Enhance ESLSE’s care logistics

capacity

Recommended Interventions Export-related bottlenecks identified

Page 29: Discussion item # 3: People Strategy

29

Thank you!