PHARMACEUTICAL

SPOTLIGHT
EHS Compliance
Landscape and
Effects on Products
and Intermediates

Enablon 2015/2016
2016 - Confidential
- Confidential
 Today’s Guests

James Lee Peter Franke Pam Bobbitt

Senior Senior Partner Director of Sales EMEA
Regulatory Analyst at ERM at Enablon
at 3E Company

Enablon 2015/2016
2016 - Confidential
- Confidential
 Our Agenda Today

Hot Regulatory Developments in Pharma Regulations

around the World
Business Trends & Challenges affecting the
pharmaceutical industry
Benefits of a single, centralized, and integrated system
for product stewardship and chemical compliance
Questions and Answers

Enablon 2015/2016
2016 - Confidential
- Confidential
 25 Years of Pharmaceutical Industry Criminal & Civil Penalties:
1991 Through 2015

$35.7 BILLION

Enablon 2016 - Confidential

Hot Regulatory Developments
in Pharma Regulations around
the World

James Lee
Sr. Regulatory Analyst
3E Company
U.S.A.
Drug Supply Chain Security Act

Justice Department to make $40 million available for victims of 2012 deadly meningitis outbreak

76 Dead, 770 Infected

Drug Supply Chain Security Act
• DSCSA (effective Nov. 27, 2013)
• 2013 Drug Quality & Security Act
• Build an electronic, interoperable system
• Identify and trace certain prescription drugs in U.S.
commerce
• Verify the legitimacy
• Enhance detection and notification of illegitimate
drugs
Drug Supply Chain Security Act
• Product identification
• Product tracing
• Product verification
• Detection and response
• Notification
• Wholesaler licensing
• 3rd-party logistics provider licensing
U.S. TSCA Reform
• Revised Toxic Substances Control Act (effective June
22, 2016)
• Subjects all new and existing chemicals to an EPA
review
• Prioritization of chemicals
• Aggressive timelines for risk evaluations
U.S. TSCA Reform
• Less obstacle to ban or restrict chemicals
• Expands EPA authority to require reporting and testing
• Federal preemption
• Substantiation of Confidential Business Information
(CBI)
E.U.
BREXIT
• Will UK be subject to all tariffs and other EU import
requirements for drugs?
• UK to develop new drug laws?
• UK may negotiate to be part of European Economic
Area (e.g. Iceland, Liechtenstein, Norway)
• UK may develop a bilateral agreement with EU (e.g.
Switzerland)
• Alternative agreements?
EU New Pharma Packaging
• EU Delegated Regulation 61/2016
• Safety features on packaging of medicinal products
(MP)
• Eliminate falsified medicinal products
• Unique identifier
• Technical specifications: product code, serial number,
national reimbursement number, batch number and
expiration date
• Two-dimensional barcode
EU New Pharma Packaging
• Repository system
• Retain information on safety features of MP
• Managed by a non-profit legal entity
• Enforceable on February 9, 2019
• Belgium, Greece and Italy – an option to defer for 6
years
Latin America
Registry of Pharmaceuticals
• Drug registry is mandatory in Latin America
- Mercosur
- Central American Economic Integration (SIECA)
- Andean Community (CAN)
- Mexico
Regulation of Pharmaceuticals
Inefficient Regulatory Enforcement
• Inspection of facilities: manufacturing and distributing
pharmaceuticals
• Control on marketing and claims of pharmaceuticals
• Surveillance and control to enforce the current pharma
legislation
China and South Korea
Counterfeit Drugs in China
Counterfeit Drugs
• China’s State Food & Drug Administration implemented
new rules (Jan. 2013)
• Good Supply Practice for Pharmaceutical Products
• Requiring companies to use bar codes, electronic
monitoring, and standardized documentation to trace
drugs
• Other social issues
Children’s Deaths by Disinfectants
• Toxic disinfectant (e.g. PHMG (polyhexamethylene guanidine))
for humidifiers produced by Oxy, subsidiary of Reckitt Benckiser
• 96 confirmed deaths in South Korea (mostly children and
pregnant women); 400+ victims
• Boycott of all Reckitt Benckiser products in Korea
Remarks

 System for chemical/product regulatory data (e.g. TSCA

compliance, labeling, and pharma registry)
 For substance data (e.g. safety data to prevent disasters)
 For supply chain management (e.g. DSCSA, recalls, and
counterfeit drugs)
How 3E Can Help
 3E Tools and Services for Pharma Compliance

 Ariel WebInsight™ and PCTEC Plus enable you to search

and identify chemical substances
 Ariel WebInsight™ and Regulatory Monitoring have the
latest regulatory news on drug laws; WebInsight has full
texts of regulations and guidance documents
 Regulatory Consulting Services can assist you with
pharmaceutical compliance
 3E Supply Chain Solutions™ can help with all other supply
chain needs
 ERM

• 5,000 employees
• 150 offices in 40 countries
• 40 years of experience
• Projects in more than 170 countries
• Worked for 50% of the global Fortune
500 companies in the past five years
• Annual revenue (FY ‘15) of $945M

Enablon 2016 - Confidential

 ERM – Our Uniqueness in the Market

High

System Integrators
ERM
(EMIS experience, IT skills)
Technology

Sustainability/EHS Consultants

Low Subject Matter High

•Combined Sustainability / EHS and Information Technology Professionals
•Global Reach with a Local Presence

Enablon 2016 - Confidential

 Pressure on Pharma Market

Water
GxP Standards from Scarcity Increasing
FDA, EMA, ANSM… Pharma B Pharma A
number of
Regulations

Applicability
End of “High-Value”
Blockbuster drug Energy Pharmaceutical Kingdom
model” REACh

Minimizing
Waste Seveso 3

Pharma C
Chemical Risk &
Inspection
Industrial Hygiene Pharma D Pharma E

Enablon 2016 - Confidential

 Growing Pressure on Pharma Market

Water
GxP Standards from Scarcity Increasing
FDA, EMA, ANSM… Pharma B Pharma A
number of
Regulations

Applicability
End of “High-Value”
Blockbuster drug Energy Pharmaceutical Kingdom
model” REACh

Minimizing
Waste Seveso 3

Pharma C
Chemical Risk &
Inspection
Industrial Hygiene Pharma D Pharma E

Enablon 2016 - Confidential

 More & More

Water
GxP Standards from Scarcity Increasing
Pharma B Pharma A
FDA, EMA, ANSM… number of
Regulations

Applicability
End of “High-Value”
Blockbuster drug Pharmaceutical Kingdom
model” Energy REACh

Minimizing
Waste Seveso 3

Pharma C
Chemical Risk &
Inspection
Industrial Hygiene Pharma D Pharma E

Enablon 2016 - Confidential

 Headlines

Enablon 2016 - Confidential

 Mega Trends -> Pharma Trends/Challenges
Growing Population

Rise of the middle class and an ageing External Operational Profit/Loss

population
Staying on top of Need for Decreasing Costs
Image & Brand Reputation
regulation & Increasing efficiency
Water/food/energy/

Stakeholder Pressure Supply Chain Rising Energy costs

Rapidly emerging technologies

Backlash Differentiation Payer Pressure
Increased transparency, additional
regulation, and declining trust Environmental & Social
Big Data High M&A Activity
Stewardship

Global supply chains

Climate change : adaptation and

mitigation

Enablon 2016 - Confidential

 ERM Subject Matter Expertise
Transaction Performance & Contaminated Site
Services Assurance Management
Mega Trends,
Pharmaceutical
Trends &
Challenges …
GRC Investigation
…can be Post Merger Integration
Reporting Risk Assessment
supported by ERM Environmental Social
Governance PS&S Remediation
SME practices & Auditing
ERM-IS EHS Incidents
Information Solutions

Enablon 2016 - Confidential

 Communication Challenges

Legal Procurement Maintenance

HSE
Regulatory Update ERP ERP
Service Maintenance
Excel Operations

E
Homegrown Solution
SharePoint
Marketing Production Customer Access Databases
Excel

CMO ERP CMO

Niche Solution

Enablon 2016 - Confidential

 TECHNOLOGY

SERVICES
CONTENT

Enablon 2016 - Confidential

 Software
SOLUTIONS

Enablon 2016 - Confidential

 Value

• Single Version of the Truth

• Transparency
• Risk Reduction
• Revenue Recognition
 IT Optimization
 Resource Allocation

Enablon 2016 - Confidential

 TOP Product Stewardship Challenges &
Opportunities

CHALLENGES OPPORTUNITIES

• Regulatory Changes • Increase visibility to Regulatory

• Internal Communication Changes

• Material Compliance Link • Single Version of the Truth

• True BOM/BOS • Forecasting Volumes

• Diverse Supply Chain • Increase visibility to Supply Chain

Enablon 2016 - Confidential

 VALUE DRIVEN SOLUTION
Output to
Regulatory
Authority Portals
Chemical
Mgmt. Software ECHA: IUCLID5,
Solution REACH-IT,
Compliance Chesar
Mgmt.

Product Level
Global PS Solution Optional Content
Regulations Partners
Content
Providers
Supplier Mgmt.

Audit, Waste, &

Integration
Event Mgmt.

ERP Third Party Data

Systems

Enablon 2016 - Confidential

 THANK YOU
erm.com 3ecompany.com enablon.com
Peter.Franke@erm.com ajohnson@3ecompany.com pbobbitt@enablon.net

Enablon 2016 - Confidential