corporate responsibility and third party relationships gsk and contract manufacturers
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Corporate Responsibility and Third Party Relationships GSK and Contract Manufacturers. James Hagan Vice President Corporate Environment, Health & Safety. GSK and Contract Manufacturing. Overview of GlaxoSmithKline Scope Business/CR/EHS drivers CR / EHS process - PowerPoint PPT PresentationTRANSCRIPT
Corporate Responsibility and
Third Party Relationships
GSK and Contract Manufacturers
James Hagan Vice President
Corporate Environment, Health & Safety
GSK and Contract Manufacturing
Overview of GlaxoSmithKline Scope Business/CR/EHS drivers CR / EHS process EHS management and audit EHS data reporting for CM Summary
Overview of GlaxoSmithKline - Who are we?
7% of total global pharmaceutical sales Total company sales: £21.2 bn / $31.8 bn
World leading research-based pharmaceuticalcompany.
GSK’s mission is “to improve the quality of human life by enabling people to do more, feel better and live longer”
GSK - Where are we?
Our International Region covers80% of the world’s population
GSK - Where are we?
100,000 employees worldwide– R&D
16,000 employees at 24 sites in 7 countries
– Manufacturing 42,000 employees at 91 sites in 38 countries
– Sales & Marketing 40,000 employees 191 countries
Our Flagship Products
Our Flagship Products
GlaxoSmithKline develops, manufacturers and markets:– pharmaceuticals, vaccines, over-the-counter
medicines and health related consumer products
Our broad pharmaceutical product line includes:– antibiotic, antidepressant, gastrointestinal,
dermatological, respiratory, cancer and cardiovascular medications
In 4 of the 5 largest therapeutic areas worldwide, we are world leaders:– anti-infectives, CNS, respiratory and metabolic
Our Flagship Products
We supply products to 191 global markets Produce over 1,200 different brands Manufacture 4 billion packs per year Produce over 28,000 different finished packs
per year Supply 6,900 tonnes of bulk active each
year Manage 2,000 new product launches
globally each year
Scope of Contract Manufacturing
GSK has strategic alliances and partnerships with over 400 Contract Manufacturers (many long term)
Across all the products in our portfolio For all the stages of product life cycles: GSK Spends over £800m per annum
Contract Manufacturers are integral to GSK’s supply chain
Business drivers for Contract Manufacturing
GSK has strategic alliances & partnerships with Contract Manufacturers:– To optimise supply chains & costs– To provide a ‘best in class’ supply base– To partner with companies on specialist
processes or technologies
GSK has a regional approach to supply local markets
Corporate Responsibility drivers for Contract Manufacturers
Committed to doing business with integrity Protect our Corporate Reputation Ensure compliance with EHS regulatory
requirements Protect CM employees, local communities, and
the environment Minimise business interruption and ensure
continuity of supply of medicines Minimise risk to GSK Foster sustainability Provide for competitive advantage
How do we manage the EHS / CR component?
Structure our approach within a comprehensive framework of Standards
Integrate EHS/ CR considerations in sourcing decisions and Contract Manufacturer selection
Incorporate EHS / CR requirements in contracts Conduct EHS audits to assess conformance with
GSK requirements and highlight areas for improvement
Monitor progress with audit follow-up
Work in partnership with Contract Manufacturersto prevent adverse events and ensure continuityof product supply:
Policy
Standards
Guidelines
Tools & Best Practices
GSK - EHS Framework
What the Global EHS Standards Do
• Establish a management system approach
• Outline minimum requirements
• Drive towards excellence
• Apply to everyone
• Effective from 2001
CR/EHS Requirements for Contract Manufacturers
Two specific Standards on CM Distilled set of Standards for CM Utilised in selection process Incorporated in contracts Requires
– compliance with laws & regulations– compliance with GSK Standards– report adverse events– report EHS performance
Corporate Responsibility issues beyond EHS
Comply with local employment legislation. Do not discriminate against sex, race,
religion or disability. Do not use child (< 16 years) or bonded
labour
CR requirements are included in contractlanguage and audit teams assess ContractManufacturers to ensure that they:
Scope of the EHS Audit Programme
Conduct over 40 audits per annum globally Selection for audit:
– where there is a significant spend / revenue / gross profit dependency
– serving multiple key markets or essential supply chains or supplying WHO products
– where significant hazards are presented by GSK technologies / products / processes e.g. cytotoxics
Contract Manufacturers have rated from 30% to 86% (out of 100%) on an EHS Audit scheme
Equivalent to ‘Poor’ - ‘Excellent’ on qualitative ratings or bandings
Audit process
Provides a governance review
Provides for working in partnership
Improves EHS performance of Contract Manufacturers through continuous review
Audit process
No progress = 2nd ‘exit’ opportunity
Example - EHS Audit Rating / Banding
6467
56
92
58
50
64
74
53
Overall EHS Audit % ratings by topic
Excellent
Good
Average
Poor
Unacceptable
Audit Experience Summary 2002-2003
Downsides– Some lack of investment / limited resources
(chiefly in the containment of APIs)– Occasionally poor Chemical Agents assessments– Occasional high incidence of EHS adverse events
Positives – Commitment to progress actions rapidly– Willingness to learn from the audit experience – Growing proportion of companies with ISO14001
– Best practices GSK could learn from…...
Annual Report Information
2002: Collected EHS data from key Contract Manufacturers
2003: Verifying the data collection process 2004 and beyond:
– Expand the number of CMs reporting results
– Incorporate collective results as part of GSK’s annual report
– Include Contract Manufacturers as part of GSK EHS footprint
Summary
The emphasis on partnership and continuous improvement
EHS / CR considerations are integrated in the business process
Audit teams conduct EHS audits to assess conformance with GSK requirements
EHS performance is generally good Future annual reporting to include EHS
performance results