STED: Findings on the Pharmaceuticals Sector Workshop on Skills for - - PowerPoint PPT Presentation

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STED: Findings on the Pharmaceuticals Sector Workshop on Skills for - - PowerPoint PPT Presentation

STED: Findings on the Pharmaceuticals Sector Workshop 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 Skills for Trade and


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STED: Findings on the Pharmaceuticals Sector

Workshop on Skills for Trade and Economic Diversification in Bangladesh Dhaka, December 7, 2011 Erik von Uexkull ILO Trade and Employment Programme

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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

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STAGE 1: Sector Position and Outlook

STAGE 2: Business Capability Implications STAGE 3: What Type

  • f Skills?

STAGE 4: How many Workers by Skill Type? STAGE 5: Skills Supply Gap STAGE 6: Proposed Responses

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GDP Contribution...

Total GDP: 4.5 trln. Taka

Data Source: Bangladesh Bureau of Statistics, 2005/6

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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

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Pharma: Bang. Exports by Market

Data Source: COMTRADE, EPB

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World Pharma Market vs. Bangladesh Exports

Data Source: COMTRADE, EPB

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Competitors (all pharma products)

Data Source: COMTRADE, EPB

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Pharma: India Exports by Market

Data Source: COMTRADE

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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

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Firm level characteristics ...

Data source: World Bank Enterprise Survey Bangladesh 2007

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  • !" #
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... Technology and Innovation ...

Data source: World Bank Enterprise Survey Bangladesh 2007

$

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  • %
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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

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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

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STAGE 1: Sector Position and Outlook

STAGE 2: Business Capability Implications

STAGE 3: What Type

  • f Skills?

STAGE 4: How many Workers by Skill Type? STAGE 5: Skills Supply Gap STAGE 6: Proposed Responses

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Business Capability Implications

Compliance 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?

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STAGE 1: Sector Position and Outlook STAGE 2: Business Capability Implications

STAGE 3: What Type

  • f Skills?

STAGE 4: How many Workers by Skill Type? STAGE 5: Skills Supply Gap STAGE 6: Proposed Responses

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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

  • f 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?

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Business Capabilities Types of Skills / Workers 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

  • perations (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

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Business Capabilities Types of Skills / Workers 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

regulators skills and cultural change required too regulators

  • Redesign of regulatory system

and training in redesigned system

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Business Capabilities Types of Skills / Workers 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

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Business Capabilities Types of Skills / Workers 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?

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Business Capabilities Types of Skills / Workers 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)

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Business Capabilities Types of Skills / Workers 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