sted: findings on the pharmaceuticals sector

STED: Findings on the Pharmaceuticals SectorWorkshop on Skills for Trade and Economic Diversification in Bangladesh

Dhaka, December 7, 2011

Erik von Uexkull

ILO Trade and Employment Programme

Outline – the STED approach

STAGE 1: Sector

Position and Outlook

STAGE 2: Business

Capability Implications

STAGE 3: What Type of

Skills?

STAGE 4: How many Workers by Skill Type?

STAGE 5: Skills Supply

Gap

STAGE 6: Proposed Responses

Skills for Trade and Economic Diversification

STAGE 1: Sector Position and

Outlook

STAGE 2: Business


STAGE 3: What Type of Skills?



Gap


GDP Contribution...Total GDP:

4.5 trln. Taka

Data Source: Bangladesh Bureau of Statistics, 2005/6

Structure and Employment• 2005/6 LFS

� Total Employment 64k, including 3k women

• ILO (2004) � In 2000, over 300 companies

� Only final production, using imported generic active ingredients� Only final production, using imported generic active ingredients

� Largest pharmaceutical sector of any LDC

• World Bank (2008) � Highly protected domestic market (only ~5% imports)

� Only final production, using imported generic APIs

� Largest pharmaceutical sector of any LDC

� Only very few companies licensed for high-end markets

• But seems to be changing� e.g. Some API production

� Significant employment growth

I1

I1 update based on data from Pharma AssociationIch, 11/29/2011

Pharma: Bang. Exports by Market

Data Source: COMTRADE, EPB

World Pharma Market vs. Bangladesh Exports


Competitors (all pharma products)


Pharma: India Exports by Market

Data Source: COMTRADE

Health

care

Delivery

Commer-

cial

Manufac

ture

Process

Develo-

pment

Pharma Value Chain*Large

Scale

Trials

Small

Scale

Trials

Investigative

Medicine

Pre-

Clinical

Drug

Discovery

Basic

Research

Active Pharmaceutical Ingredients (APIs)

Bulk Chemicals

Specialty Chemicals

Drug Formulation

Tableting/Packaging / Printing etc.

Drug Marketing

Automation

Etc.

* Based on version by Inland Revenue Authority of Singapore

Bangladesh

India

Firm level characteristics ...

Data source: World Bank Enterprise Survey Bangladesh 2007

I4

I4 show comparison with India. Can we look at exports by market?Ich, 11/29/2011

... Technology and Innovation ...

Data source: World Bank Enterprise Survey Bangladesh 2007

I5

I5 same as previousIch, 11/29/2011

Growth Scenario• Business as Usual

� Good market growth prospects

� Expiration of TRIPS exemption (2016)

� Competition (India, China)� Competition (India, China)

• More of the Same� Room for a bigger push?

� More exporting firms

• Upgrade� Access higher end markets (higher prices)

� Integrate upstream (APIs, R&D, trials) and downstream (distribution)

parts of the value chain

Growth Scenario: Pharma Vision 2015

• To safe-guard public health of 160 million people by providing

quality product to be produced by all companies

• To become a global hub for pharma industry • To become a global hub for pharma industry

• To export generic products worth USD 5 Billion

• To get approval for 30 companies by the regulatory bodies of

developed countries

• To get DMF/EDMF of API for 40 API producing companies

Source: Bangladesh Pharmaceutical Industry Association

STAGE 1: Sector


STAGE 2: Business





Gap


Business Capability ImplicationsCompliance with Good Manufacturing Practice

Other Regulatory Compliance

Government: Effective Regulation

API Process Development and Scale-up

Other capabilities?

Priorities?API Process Plant Design and Installation

API Process Operation

Biologics Production

Organization and Management of Clinical Trials

Export marketing: Product management

Export Marketing: Channel Management

Priorities?

STAGE 1: Sector


STAGE 2: Business





Gap


Business Capabilities Types of Skills / Workers

by Skill Type

Skills Supply Gap

Critical Gaps?

Priorities?

Possible Responses

Compliance with Good

Manufacturing Practice

Knowledge of GMP on all levels

of manufacturing operations:

• Operatives & technicians

• Production managers

• Chemists / pharmacists

GMP change programmes in

each firm, supported by

training, update training, and

training for new hires at firm

level•• Engineers • Industry standard training

materials?

• Shared training provision?

Qualified GMP trainers • Development of domestic

training suppliers?

• Development of shared

training unit?

• Attract international

consultants to establish BD

units?


by Skill Type

Skills Supply Gap

Critical Gaps?

Priorities?

Possible Responses

Other Regulatory

Compliance

Awareness of importance of

strict compliance across all

levels of manufacturing

operations (see GMP)

Awareness raising at firm level

• Industry training materials /

provision?

Regulatory affairs professionals

– especially for main target

markets

Multiple strands, eg.

• International regulatory

affairs professional societies

• Use of professional services

providers specialised in main

markets

• Local regulatory affairs

network

• Possibly, Masters in RA

Regulatory affairs skills for

managers, scientists, engineers


by Skill Type

Skills Supply Gap

Critical Gaps?

Priorities?

Possible Responses

Government: Effective

Regulation

primarily a matter of upgrading

regulation, but complementary

skills and cultural change

Understaffing of NRA

– supply problem?

• PhD and higher education

• Placements with other

regulatorsskills and cultural change

required too

regulators

• Redesign of regulatory system

and training in redesigned

system


by Skill Type

Skills Supply Gap

Critical Gaps?

Priorities?

Possible Responses

API Process Development

and Scale-up

High level chemistry, pharmacy,

chemical engineering

• Local graduates: Collaborate

with universities to anticipate and Scale-up chemical engineering with universities to anticipate

required numbers and enhance

relevance of curricula

• Attract return of highly skilled

diaspora

• Training programme to raise

skills of operatives to junior

technician level (industry

materials / programmes)

• Initiative to develop local

process engineering services

sector (API park)

• start / support technical

networking / professional

societies

API Process Plant Design and

Installation

Specialist engineers and

technicians (chemical/process)

API Process Operation Skilled operatives, technicians

(operations and laboratory),

chemists, pharmacists,

production managers


by Skill Type

Skills Supply Gap

Critical Gaps?

Priorities?

Possible Responses

Biologics Production Biosciences skills (mix of

disciplines – Biotechnology,

microbiology, biochemistry,

genetics ...) at degree to PhD

level to develop generic versions

• Biosciences courses from

degree level up (work with

universities)

• Attract return of highly skilled

diaspora

and processes

Bio-processing technicians (for

production, once developed)

•Courses for bio-processing

technicians (eventually)

• Bio-processing training

center?


by Skill Type

Skills Supply Gap

Critical Gaps?

Priorities?

Possible Responses

Organization and

Management of Clinical Trials

• Clinical trials managers

• Statisticians

• Medical practitioners (and

support staff)

• Regulatory affairs professionals

Possible centre of expertise in

clinical trials based at a

university medical school, with

courses for clinical trials

managers, statisticians, medical •professionals

Initiative to develop local

clinical trials sector, focused

initially on bioequivalence trials

(work with hospital operators)


by Skill Type

Skills Supply Gap

Critical Gaps?

Priorities?

Possible Responses

Export marketing: Product

management

• Marketing managers and staff

• Sales staff

• High level international

business development staff

• Executive education for

managers (collaboration with

Int. Business School?)

• Attract diaspora

• Consider hiring internationally •to get people with existing

expertise in international sales

and marketing of generics for

key positions

• Possible placement of BD staff

downstream in distribution

channels to gain experience

• Languages

• ‘Call centre skills’

• Alliance-based marketing

networks?

Export Marketing: Channel

Management

sted: findings on the pharmaceuticals sector

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