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Government Affairs & Public Policy
Excellence: Optimizing Group Structure &
              Operations




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              Copyright © Best Practices®, LLC   BEST PRACTICES,
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Table of Contents

               Table of Contents                                                    TOC Continued
                                                                    •Government Affairs & Policy Funding Levels & Sources:
•Project Blueprint – pg. 3
                                                                    Examining the Resources Invested for Success – pg. 43
•Executive Summary: Benchmark Insights and Research
                                                                    •Government Affairs & Policy Group Services: Trends in
Group– pg. 4
                                                                    Service Levels & Key Priorities – pg. 49
•Government Affairs Group Structures: Key Trends &
                                                                    •Government Affairs & Policy Responsibilities: Trends in
Drivers of Sub-group Evolution – pg. 11
                                                                    Forging Accountability & Clear Roles – pg. 60
•Government Affairs Group Models and Structures – pg.
                                                                    •Communicating the Value of Government Affairs &
28
                                                                    Policy In a Global Bio-Pharma Company – pg. 67
•Government Affairs & Policy Groups Staffing
                                                                    •Contact Information – pg. 72
Benchmarks: Key Trends in Resourcing Government
Affairs Groups – pg. 37




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                                               Copyright © Best Practices®, LLC                     BEST PRACTICES,       ®
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Universe of Learning: Government Affairs & Public
Policy Benchmark Research Participants
 Participants in this benchmarking research included 16 Government Affairs and Public
 Policy executives and managers at 15 leading bio-pharmaceutical, healthcare and
 medical device companies.




                                           Page - 3
                               Copyright © Best Practices®, LLC   BEST PRACTICES,
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Most Participants Hold Job Title of Director or Above
 Research participants included a Vice President, Executive Directors, Medical
 Executives, Directors and Managers. More than 44% of benchmark partners were
 directors or above, 38% were managers and 19% were vice presidents – all of whom
 worked directly or indirectly in Government Affairs and Policy functions.



                                     JOB TITLE
                Vice President                                       Director
              Executive Director                                     Director
                Senior Director                                   Senior Manager
                Senior Director                                   Senior Manager
              Medical Executive                                      Manager
                    Director                                         Manager
                    Director                                         Manager
                    Director                                         Manager


                                           Page - 4
                               Copyright © Best Practices®, LLC          BEST PRACTICES,
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Key Functional Perspectives Inform the Benchmarks
 Benchmark partners reflect functional experience that interacts directly or indirectly
 with the Government Affairs function. Because Government Affairs resides in different
 places across different companies, diverse functions from Government Affairs, Federal
 Affairs, Communications, Medical Affairs and Public Policy participated in this study.




                                 GROUP OR FUNCTION
          State Government Affairs                              Government Affairs
        Public Policy and Advocacy                         Global Regulatory Affairs
               Medical Affairs                                 Global Public Policy
               Medical Affairs                                       Federal Affairs
      Government Strategy & Relations                                Federal Affairs
       Government Affairs Operations                                Corporate Affairs
             Government Affairs                                     Corporate Affairs
                                                      Communications & Government
             Government Affairs                                 Affairs


                                             Page - 5
                                 Copyright © Best Practices®, LLC                BEST PRACTICES,
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Key Insights & Observations from Analysis – 1
 Field interviews and study analysis produced many observations and benchmark
 findings. Key study insights reflect the inter-related evolution of a company’s
 commercial structure and how Government Affairs is organized to serve internal and
 external customers.


 Differentiated Services Are the Norm for Government Affairs: Almost three-quarters of
Differentiated Services Are the Norm for Government Affairs: Almost three-quarters of
participants said they vary the level of services ––staffing, time, responsiveness ––across internal
 participants said they vary the level of services staffing, time, responsiveness across internal
 customers. The practice reflects the significant impact that Government Affairs can have on important
customers. The practice reflects the significant impact that Government Affairs can have on important
business issues such as reimbursement and regulatory. ItItfurther underscores how small expert staffs
 business issues such as reimbursement and regulatory. further underscores how small expert staffs
 provide services to diverse stakeholders while reflecting differences in stakeholder issues and impact.
provide services to diverse stakeholders while reflecting differences in stakeholder issues and impact.
 Government Affairs Groups Seek to Balance Centralized Focus with Decentralized
Government Affairs Groups Seek to Balance Centralized Focus with Decentralized
 Local Needs: Nearly half of all benchmark partners employ Regional Models and Hub-and-Spoke Models
Local Needs: Nearly half of all benchmark partners employ Regional Models and Hub-and-Spoke Models
 in designing their structural approach to serving diverse geographies. Both approaches seek to balance
in designing their structural approach to serving diverse geographies. Both approaches seek to balance
 centralized policy and GA perspectives while reflecting local needs across continents and country units.
centralized policy and GA perspectives while reflecting local needs across continents and country units.
Purely centralized or decentralized shaping factors are less commonly employed. A balanced approach ––
 Purely centralized or decentralized shaping factors are less commonly employed. A balanced approach
such as the Hub-and-Spoke model ––can be advantageous in dealing with reduced staff and growing
 such as the Hub-and-Spoke model can be advantageous in dealing with reduced staff and growing
 emerging markets.
emerging markets.



                                                  Page - 6
                                      Copyright © Best Practices®, LLC         BEST PRACTICES,    ®
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Government Affairs Structure Follows Business Lines
Business Units lead the functional design factors shaping Government Affairs Sub-Group
Structure – followed closely by matrix models whereby Government Affairs staff serve more
than one internal customer group or unit. About one-quarter of the companies employ
product-focus, project-focus or therapeutic-area-focus in designing the GA structure.

       Q2. Government Affairs Sub-Group Structure: Note all functional factors describing how your
                              Government Affairs organization is designed.



                        Business Unit
                                                                             75%
                           Focus


                         Matrix Model                                      69%


                       Product Focus                25%


                        Project Focus               25%


                     Therapeutic Area
                                                 19%
                          Focus

                                    % of Companies
    (n=16)

                                                    Page - 7
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                                                                                                         LLC
One Big Pharma’s Government Affairs Serves Across
 BUs
A Top 20 Pharma company divided its company into four Business Units: Pharmaceuticals,
Devices, Diagnostics and Nutrition. The company’s Government Affairs group consists of
four teams: State, Federal, Global and Reimbursement. The State team serves as generalists
while the others are specialists. While Government Affairs serves each of the four BUs, the
level of service varies by the units’ economic impact for the company.



                Pharma-
                                   Devices                        Diagnostics          Nutrition
                ceuticals
  Generalists




                                                       State


                    Federal           Federal                         Federal           Federal
  Specialists




                     Global            Global                          Global           Global

                  Reimbursement     Reimbursement                 Reimbursement      Reimbursement



                  Government Affairs = State, Federal, Global and Reimbursement teams
                                                     Page - 8
                                         Copyright © Best Practices®, LLC         BEST PRACTICES,    ®
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Government Affairs Group Models
        & Structures




                      Page - 9
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POV: Leveraging Resources - Merging Federal-State Roles
Requires Clear Objectives, Overlapping Visits in Critical States
One Government Affairs veteran said it’s possible for one person to be effective in a dual
federal-state role, but it will require clear goals and priority-setting. While the GA staffer
can focus on Congress all year, for most of the states that staffer can limit herself/himself
just on the state government sessions, and work with the state representatives then.


            To Merge Federal and State Roles
            In Government Affairs:

    Target your issues and prioritize them.

    Identify states where you need to be aggressive
    and pinpoint critical states where you need
    to be more active.

    Create relationships with Congressional
    delegation while in critical states.


 “Well I think it’s doable if you have the targeted selection of what you’re trying to do. So work
 those Congressional delegations, either within the domestic offices in the states or actually
 go to the Hill and try to create a relationship there as well. I mean it’s going to take time, but
 if you schedule your itinerary properly, you could probably work that.”
                                                      – Interviewed Director, Government Affairs
                                                  Page - 10
                                      Copyright © Best Practices®, LLC         BEST PRACTICES,        ®
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Differentiated Services Are the Norm for Government
  Affairs
About three-quarters of participants said they vary the level of services – staffing, time,
responsiveness – across internal customers. The practice reflects the significant impact that
Government Affairs can have on important business issues such as reimbursement and
regulatory. It further underscores how small expert staffs provide services to diverse
stakeholders while reflecting differences in stakeholder issues and impact.
            Q21. Differentiating Services: Does your Government Affairs & Public Policy group
            differentiate its service levels (i.e. amount of staff support, time invested, speed of
                                response, etc.) to different internal customers?




                                    No, 27%


                                                 Yes, 73%




   (n=11)                                     % of Companies
                                                     Page - 11
                                         Copyright © Best Practices®, LLC             BEST PRACTICES, ®
                                                                                                          LLC
Communications & Goal Setting Best for Building Bridges With
Other Corporate Affairs Functions & Internal Customers
 Intensive communication was chosen as the most highly effective way of forging close
 ties with other Corporate Affairs teams and internal customers. Goal setting/alignment
 activities also ranked high in importance for building bridges with colleagues and
 stakeholders.

Q26. Forging Close Working Ties: Rate the effectiveness of various approaches to build bridges and forge
   close ties among Government Affairs and Policy group members, other Corporate Affairs function
                                  colleagues and internal customers.
                                                       Highly        Somewhat              Somewhat      Total
                                                                                 Neutral
                                                       Effective     Effective             Ineffective   Effective
    Intensive Communications                              55%           27%        9%          9%          82%
    Corporate Goal Setting                                27%           55%        9%          9%          82%
    Cascading Goal Alignment                              18%           55%        18%         9%          73%
    Planning Alignment                                    27%           36%        36%         0%          64%
    Budget Setting Linkages                               18%           45%        36%         0%          64%
    Embed function / structure optimization updates
                                                          10%           50%        30%        10%          60%
    on staff meeting agenda's
    Collaboration Events                                   9%           45%        36%         9%          55%
    Monthly Staff Meetings                                 9%           45%        36%         9%          55%
    Interlinking goals among groups                       18%           27%        36%        18%          45%
    Co-location                                            0%           40%        50%        10%          40%




                                                       Page - 12
        (n=11)                             Copyright © Best Practices®, LLC                BEST PRACTICES,           ®
                                                                                                                         LLC
Contact Information



 Best Practices, LLC is a research and consulting firm that conducts work
 based on the simple yet profound principle that organizations can chart a
 course to superior economic performance by studying the best business
    practices, operating tactics and winning strategies of world-class
                                companies.

                 Best Practices, LLC
 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
                     919-403-0251
           bestpractices@best-in-class.com
                www.best-in-class.com

                                       Page - 13
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Government Affairs and Public Policy Excellence Report Summary

  • 1. Government Affairs & Public Policy Excellence: Optimizing Group Structure & Operations 1 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 2. Table of Contents Table of Contents TOC Continued •Government Affairs & Policy Funding Levels & Sources: •Project Blueprint – pg. 3 Examining the Resources Invested for Success – pg. 43 •Executive Summary: Benchmark Insights and Research •Government Affairs & Policy Group Services: Trends in Group– pg. 4 Service Levels & Key Priorities – pg. 49 •Government Affairs Group Structures: Key Trends & •Government Affairs & Policy Responsibilities: Trends in Drivers of Sub-group Evolution – pg. 11 Forging Accountability & Clear Roles – pg. 60 •Government Affairs Group Models and Structures – pg. •Communicating the Value of Government Affairs & 28 Policy In a Global Bio-Pharma Company – pg. 67 •Government Affairs & Policy Groups Staffing •Contact Information – pg. 72 Benchmarks: Key Trends in Resourcing Government Affairs Groups – pg. 37 Page - 2 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 3. Universe of Learning: Government Affairs & Public Policy Benchmark Research Participants Participants in this benchmarking research included 16 Government Affairs and Public Policy executives and managers at 15 leading bio-pharmaceutical, healthcare and medical device companies. Page - 3 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 4. Most Participants Hold Job Title of Director or Above Research participants included a Vice President, Executive Directors, Medical Executives, Directors and Managers. More than 44% of benchmark partners were directors or above, 38% were managers and 19% were vice presidents – all of whom worked directly or indirectly in Government Affairs and Policy functions. JOB TITLE Vice President Director Executive Director Director Senior Director Senior Manager Senior Director Senior Manager Medical Executive Manager Director Manager Director Manager Director Manager Page - 4 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 5. Key Functional Perspectives Inform the Benchmarks Benchmark partners reflect functional experience that interacts directly or indirectly with the Government Affairs function. Because Government Affairs resides in different places across different companies, diverse functions from Government Affairs, Federal Affairs, Communications, Medical Affairs and Public Policy participated in this study. GROUP OR FUNCTION State Government Affairs Government Affairs Public Policy and Advocacy Global Regulatory Affairs Medical Affairs Global Public Policy Medical Affairs Federal Affairs Government Strategy & Relations Federal Affairs Government Affairs Operations Corporate Affairs Government Affairs Corporate Affairs Communications & Government Government Affairs Affairs Page - 5 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 6. Key Insights & Observations from Analysis – 1 Field interviews and study analysis produced many observations and benchmark findings. Key study insights reflect the inter-related evolution of a company’s commercial structure and how Government Affairs is organized to serve internal and external customers. Differentiated Services Are the Norm for Government Affairs: Almost three-quarters of Differentiated Services Are the Norm for Government Affairs: Almost three-quarters of participants said they vary the level of services ––staffing, time, responsiveness ––across internal participants said they vary the level of services staffing, time, responsiveness across internal customers. The practice reflects the significant impact that Government Affairs can have on important customers. The practice reflects the significant impact that Government Affairs can have on important business issues such as reimbursement and regulatory. ItItfurther underscores how small expert staffs business issues such as reimbursement and regulatory. further underscores how small expert staffs provide services to diverse stakeholders while reflecting differences in stakeholder issues and impact. provide services to diverse stakeholders while reflecting differences in stakeholder issues and impact. Government Affairs Groups Seek to Balance Centralized Focus with Decentralized Government Affairs Groups Seek to Balance Centralized Focus with Decentralized Local Needs: Nearly half of all benchmark partners employ Regional Models and Hub-and-Spoke Models Local Needs: Nearly half of all benchmark partners employ Regional Models and Hub-and-Spoke Models in designing their structural approach to serving diverse geographies. Both approaches seek to balance in designing their structural approach to serving diverse geographies. Both approaches seek to balance centralized policy and GA perspectives while reflecting local needs across continents and country units. centralized policy and GA perspectives while reflecting local needs across continents and country units. Purely centralized or decentralized shaping factors are less commonly employed. A balanced approach –– Purely centralized or decentralized shaping factors are less commonly employed. A balanced approach such as the Hub-and-Spoke model ––can be advantageous in dealing with reduced staff and growing such as the Hub-and-Spoke model can be advantageous in dealing with reduced staff and growing emerging markets. emerging markets. Page - 6 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 7. Government Affairs Structure Follows Business Lines Business Units lead the functional design factors shaping Government Affairs Sub-Group Structure – followed closely by matrix models whereby Government Affairs staff serve more than one internal customer group or unit. About one-quarter of the companies employ product-focus, project-focus or therapeutic-area-focus in designing the GA structure. Q2. Government Affairs Sub-Group Structure: Note all functional factors describing how your Government Affairs organization is designed. Business Unit 75% Focus Matrix Model 69% Product Focus 25% Project Focus 25% Therapeutic Area 19% Focus % of Companies (n=16) Page - 7 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 8. One Big Pharma’s Government Affairs Serves Across BUs A Top 20 Pharma company divided its company into four Business Units: Pharmaceuticals, Devices, Diagnostics and Nutrition. The company’s Government Affairs group consists of four teams: State, Federal, Global and Reimbursement. The State team serves as generalists while the others are specialists. While Government Affairs serves each of the four BUs, the level of service varies by the units’ economic impact for the company. Pharma- Devices Diagnostics Nutrition ceuticals Generalists State Federal Federal Federal Federal Specialists Global Global Global Global Reimbursement Reimbursement Reimbursement Reimbursement Government Affairs = State, Federal, Global and Reimbursement teams Page - 8 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 9. Government Affairs Group Models & Structures Page - 9 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 10. POV: Leveraging Resources - Merging Federal-State Roles Requires Clear Objectives, Overlapping Visits in Critical States One Government Affairs veteran said it’s possible for one person to be effective in a dual federal-state role, but it will require clear goals and priority-setting. While the GA staffer can focus on Congress all year, for most of the states that staffer can limit herself/himself just on the state government sessions, and work with the state representatives then. To Merge Federal and State Roles In Government Affairs: Target your issues and prioritize them. Identify states where you need to be aggressive and pinpoint critical states where you need to be more active. Create relationships with Congressional delegation while in critical states. “Well I think it’s doable if you have the targeted selection of what you’re trying to do. So work those Congressional delegations, either within the domestic offices in the states or actually go to the Hill and try to create a relationship there as well. I mean it’s going to take time, but if you schedule your itinerary properly, you could probably work that.” – Interviewed Director, Government Affairs Page - 10 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 11. Differentiated Services Are the Norm for Government Affairs About three-quarters of participants said they vary the level of services – staffing, time, responsiveness – across internal customers. The practice reflects the significant impact that Government Affairs can have on important business issues such as reimbursement and regulatory. It further underscores how small expert staffs provide services to diverse stakeholders while reflecting differences in stakeholder issues and impact. Q21. Differentiating Services: Does your Government Affairs & Public Policy group differentiate its service levels (i.e. amount of staff support, time invested, speed of response, etc.) to different internal customers? No, 27% Yes, 73% (n=11) % of Companies Page - 11 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 12. Communications & Goal Setting Best for Building Bridges With Other Corporate Affairs Functions & Internal Customers Intensive communication was chosen as the most highly effective way of forging close ties with other Corporate Affairs teams and internal customers. Goal setting/alignment activities also ranked high in importance for building bridges with colleagues and stakeholders. Q26. Forging Close Working Ties: Rate the effectiveness of various approaches to build bridges and forge close ties among Government Affairs and Policy group members, other Corporate Affairs function colleagues and internal customers. Highly Somewhat Somewhat Total Neutral Effective Effective Ineffective Effective Intensive Communications 55% 27% 9% 9% 82% Corporate Goal Setting 27% 55% 9% 9% 82% Cascading Goal Alignment 18% 55% 18% 9% 73% Planning Alignment 27% 36% 36% 0% 64% Budget Setting Linkages 18% 45% 36% 0% 64% Embed function / structure optimization updates 10% 50% 30% 10% 60% on staff meeting agenda's Collaboration Events 9% 45% 36% 9% 55% Monthly Staff Meetings 9% 45% 36% 9% 55% Interlinking goals among groups 18% 27% 36% 18% 45% Co-location 0% 40% 50% 10% 40% Page - 12 (n=11) Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC
  • 13. Contact Information Best Practices, LLC is a research and consulting firm that conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies. Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 919-403-0251 bestpractices@best-in-class.com www.best-in-class.com Page - 13 Copyright © Best Practices®, LLC BEST PRACTICES, ® LLC