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 Economic Diversification STAGE 1: STAGE 2: STAGE 4: STAGE 3: STAGE 5: STAGE 6: Sector Business How many What Type of Skills Supply Proposed Position and Capability Workers by Skills? Gap Responses Outlook Implications Skill Type?
STAGE 1: Sector STAGE 2: STAGE 4: Position and STAGE 3: STAGE 5: STAGE 6: Business How many What Type Skills Supply Proposed Outlook Capability Workers by of Skills? Gap Responses Implications Skill Type?
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
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Pharma: Bang. Exports by Market Data Source: COMTRADE, EPB
World Pharma Market vs. Bangladesh Exports Data Source: COMTRADE, EPB
Competitors (all pharma products) Data Source: COMTRADE, EPB
Pharma: India Exports by Market Data Source: COMTRADE
Pharma Value Chain* Commer- Small Large Health Process Basic Pre- Drug cial Investigative Scale Scale care Develo- Medicine Manufac Research Clinical Discovery Delivery Trials Trials pment ture India Active Pharmaceutical Ingredients (APIs) Bulk Chemicals Specialty Chemicals Drug Formulation Bangladesh Tableting/Packaging / Printing etc. Drug Marketing Automation Etc. * Based on version by Inland Revenue Authority of Singapore
�� Firm level characteristics ... Data source: World Bank Enterprise Survey Bangladesh 2007
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�$ ... Technology and Innovation ... Data source: World Bank Enterprise Survey Bangladesh 2007
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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
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 2: Business STAGE 1: STAGE 4: STAGE 3: STAGE 5: STAGE 6: Sector How many Capability What Type Skills Supply Proposed Position and Workers by of Skills? Gap Responses Outlook Skill Type? Implications
Business Capability Implications Compliance with Good Manufacturing Practice Other Other Regulatory Compliance capabilities? Government: Effective Regulation API Process Development and Scale-up Priorities? 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
STAGE 3: STAGE 4: How STAGE 5: STAGE 6: STAGE 1: STAGE 2: Sector Business What Type many Workers Skills Supply Proposed Position and Capability of Skills? by Skill Type? Gap Responses Outlook Implications
Business Capabilities Types of Skills / Workers Skills Supply Gap Possible Responses by Skill Type Critical Gaps? Priorities? Compliance with Good Knowledge of GMP on all levels GMP change programmes in Manufacturing Practice of manufacturing operations: each firm, supported by • Operatives & technicians training, update training, and • Production managers training for new hires at firm • Chemists / pharmacists • 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?
Business Capabilities Types of Skills / Workers Skills Supply Gap Possible Responses by Skill Type Critical Gaps? Priorities? Other Regulatory Awareness of importance of Awareness raising at firm level Compliance strict compliance across all • Industry training materials / levels of manufacturing provision? operations (see GMP) Regulatory affairs professionals Multiple strands, eg. – especially for main target • International regulatory markets affairs professional societies • Use of professional services Regulatory affairs skills for providers specialised in main managers, scientists, engineers markets • Local regulatory affairs network • Possibly, Masters in RA
Business Capabilities Types of Skills / Workers Skills Supply Gap Possible Responses by Skill Type Critical Gaps? Priorities? Government: Effective primarily a matter of upgrading Understaffing of NRA • PhD and higher education Regulation regulation, but complementary – supply problem? • Placements with other skills and cultural change skills and cultural change regulators regulators required too • Redesign of regulatory system and training in redesigned system
Business Capabilities Types of Skills / Workers Skills Supply Gap Possible Responses by Skill Type Critical Gaps? Priorities? API Process Development High level chemistry, pharmacy, • Local graduates: Collaborate and Scale-up and Scale-up chemical engineering chemical engineering with universities to anticipate with universities to anticipate required numbers and enhance relevance of curricula • Attract return of highly skilled diaspora API Process Plant Design and Specialist engineers and • Training programme to raise Installation technicians (chemical/process) skills of operatives to junior API Process Operation Skilled operatives, technicians technician level (industry (operations and laboratory), materials / programmes) chemists, pharmacists, • Initiative to develop local production managers process engineering services sector (API park) • start / support technical networking / professional societies
Business Capabilities Types of Skills / Workers Skills Supply Gap Possible Responses by Skill Type Critical Gaps? Priorities? Biologics Production Biosciences skills (mix of • Biosciences courses from disciplines – Biotechnology, degree level up (work with microbiology, biochemistry, universities) genetics ...) at degree to PhD • Attract return of highly skilled level to develop generic versions diaspora and processes Bio-processing technicians (for • Courses for bio-processing production, once developed) technicians (eventually) • Bio-processing training center?
Business Capabilities Types of Skills / Workers Skills Supply Gap Possible Responses by Skill Type Critical Gaps? Priorities? Organization and • Clinical trials managers Possible centre of expertise in Management of Clinical Trials • Statisticians clinical trials based at a • Medical practitioners (and university medical school, with support staff) courses for clinical trials • Regulatory affairs professionals • managers, statisticians, medical professionals Initiative to develop local clinical trials sector, focused initially on bioequivalence trials (work with hospital operators)
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