Automotive the way we see it
EFPIA codex on transparency of value
exchange – more sunshine or rain?
How the EFPIA codex wil create new challenges for the industry
Pharma needs to create transparency for “value
exchanges” between Healthcare professionals and
organizations on aggregate and individual basis
Pharma has traditionally fostered relationships with Healthcare Professionals (HCP)
with “value exchanges” that consumer advocates now consider conflicts of interest.
The pharmaceutical industry has suffered from several law cases and thus has
initiated a codex to create further transparency on aggregate and individual spending
to Healthcare Professionals.
Challenge I: Protection of data
privacy
How to match national data privacy
laws with the EFPIA codex and
ensure privacy of potential HCPs
with deviating from the
EFPIA code?
On June 24, 2013 the General Assembly of EFPIA formally approved the „EFPIA
Disclosure Code on Transfers of Value to Healthcare Professionals and Organizations”
( “EFPIA HCP/HCO Disclosure Code”). This code aims at helping the pharmaceutical
industry to support measures that will enhance relationships between industry, healthcare
practitioners, patients and citizens at large and advance public health by creating further
transparency on aggregate and individual spending to Healthcare professionals.With
this code the industry recognizes its responsibility to show leadership in advancing
responsibility and transparency. The code will require each member company to
document and disclose on their websites, or common websites:
1. The names of healthcare professionals and associations that have received
payments or other transfers of value.
Challenge II: How to combine
pan-European view on regulation
and compliance of codex with the
local national regulation?
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2. The amounts or value transferred, and the type of relationship, such as
consultancy fees, payment for travel or congress fees.
These disclosures will be made for the first time in 2016 for 2015 transfers of
value. Although this seems being far ahead EFPIA members and those adhering
to the EFPIA codex need to take action now to get prepared for 2015. By the
end of 2013 the codex needs to be translated into national requirements by the
national associations of EFPIA which will create further complexity in dealing with a
transparency framework from a pan-European level for you.
Challenges of EFPIA Codex and how to prepare your business
in EU
Challenge III: How to impact the
code and ensure organization
adherence?
Challenge IV: Dealing with diverging
data points in the organization.
The “Physician Payments Sunshine Act” introduced in 2010 in the US prompted the
implementation of “Aggregate Spend” by healthcare companies, a process used to
comply with their obligation to aggregate and communicate the total amount spent on
individual healthcare professionals and organizations. In Europe, the dynamic has just
begun with laws against corruption and bribery like the “GB Bribery Act” in 2010
or the “Anti-Gift law” in France. Later on, the trend towards transparency emerged
either through self regulation of industry associations (e.g., in the Netherlands and
UK) or through laws similar to the Sunshine act (adopted in 2011 in both Slovakia
and France). In that context, EFPIA recognized the need for harmonized disclosure
requirements across Europe and adopted the EFPIA HCP/HCO disclosure code of
transfers of value from pharmaceutical companies to healthcare professionals and
healthcare organizations (HCO). It has to be applied by all European members by the
beginning of 2015. Despite similarities to the US Sunshine Act a key difference is the
voluntary self-control of the EFPIA codex versus a mandatory law leaving leeway
for various interpretation and actions. Capgemini Consulting investigated the main
challenging factors in order to adapt to the EFPIA codex and the requirements needed
for a successful European transformation.
Fig. 1: Overview of existing laws regarding Transparency across Europe
The Netherlands' Code of Conduct
on Transparency of Financial
Relations (2012) requires disclosure
of aggregate information
In Denmark, companies are required to
declare their payments to doctor
since 2008
The GB Bribery Act prevents bribery
while associations like the ABPI and
the ABHI set transparency
requirements
In Belgium, regulations ensure
transparency (internal recordkeeping,
Mdeon visa since 2007 etc.)
France is leading the way toward
legal regulations with the
French Sunshine Act (FSA) enforced
in May 2013
In Italy, there are general anti-bribery
rules (interdiction of gifts, regulation
of hospitality)
In Spain, certain transparency
regimes are imposed by the industry
associations mostly regarding
hospitality
Slovakia has also been a leader in
Transparency act by implementing
the Slovakia Sunshine Act in
September 2011
In Germany, the doctrine of “employer
consent” and the German
Pharmaceutical Act set light approaches
Source: Capgemini Research 2013
© Capgemini Consulting 2013
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Key questions to address challenges
• National legislation and EFPIA codex leave leeway for interpretation - How to
interpret the industry code?
To operationalize an aggregate spend solution, your company will need to interpret
legislation and business rules around these requirements. Companies implementing
processes and tools to fulfill the code requirements must take into account actions
that have already been taken in those countries where laws or local codices pre-exist.
Compliance to all regulations needs to be considered in a specific framework in order
to fully comply on a pan-European level. In addition the different local requirements and
EU countries have differing definitions on data to be reported leading to a more complex
reporting requirement
• Ensure efficient data collection and reporting - How to collect, aggregate and
report data to fulfill all requirements?
Currently, most companies operating on a pan-European level collect spend data
on a national level, sometimes with different systems and processes due to local
requirements The practices of manual spend aggregation and reporting are not
scalable and may require increasing time or support as requirements expand with the
introduction of EFPIA codex leading to a risk of data inaccuracy and mishandling of
data. It is therefore crucial to establish processes and systems to allow for an efficient
data collection, aggregation and reporting.
• Changing the way you operate - How to create organizational awareness in
the organization and train on codex adherence?
HCP spending occurs in various departments throughout your organization. Creating
the awareness for the EFPIA codex is key for the effective implementation of this
regulation. It is thus important to develop a communication across various functions
to ensure full employee participation. We suggest ongoing educational programs and
change management measures to ensure a company transformation, mindset change
and acceptance throughout the whole organization.
• Mastering data, system and business complexity - How to intersect business
processes and individual data in numerous systems?
Within your company various systems are used in order to track, measure or plan
interactions with HCPs or HCOs used by multiple departments in various business
processes. These systems include billing, travelling, event planning, CRM systems and
other types of databases to plan, analyze and review transactions. Expenses and spend
information often are linked to specific events, processes or interactions and are tracked
in these different systems. For an effective and transparent reporting of spend data
companies need to consolidate these information and adhere to standards to meet
the codex requirements. As a result traditional business process and technology need
to be adjusted alongside compliance requirements. The transformation is often
regarded as additional burden to the running business leading to development cost and
further challenges in timing.
• Accurate data collection and analysis is critical - How to avoid duplicates of
HCPs tracked data and misreporting to safe standing of HCP?
Accurate identification of HCPs is critical for accurate data collection and analysis.
Duplicate HCP records occur when an HCP is called on by different parts of the
business and interaction information is stored in different systems. These duplicates
need to be reconciled to accurately report spending.
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How to prepare for 2016
Given our experience in projects with leading global pharmaceutical companies we suggest to take a few steps forward in
planning EFPIA codex compliance to get prepared for 2016.
Fig. 2: Our assessment approach to codex integration
Spend Discovery Assessment
Step 1
„What is needed to comply with
the EFPIA codex?“
Scoping / Situation analysis
• Precise definition of data required
to be disclosed by law & legislation
by country / EU
• Map out legislative requirements by
country to show minimum
requirements and full‐obligation of
requirements
• Prioritize countries with biggest
variations from legislation as well as
process perspective
• Set the internal ambition by discussing
and aligning scope of disclosure
obligation
Step 2
Step 3
„What is the current local situation and
what effect will compliance have?“
„What are valid alternative solutions to
comply and how would it be done?“
Country analysis Wave 11
• Review individual countries
in scope and assess country
vs. EFPIA codex
Roadmap
• Development of country specific and
EU specific roadmap for
implementation
• Risk analysis incl. soft factors
for each country if not compliant
• Cost / Benefit calculation per
compliant / non-compliant country
Scenario development
• In parallel see different country
scenarios and evaluate
compliance change
• Technology, Process and
Ressource Assesment to
estimate impact of codex
© Capgemini Consulting 2013
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• Define the degree of compliance for your organization
The EFPIA codex is a voluntary codex to adhere to. Consider the actions that you want
to take and evaluate the additional business burden to comply to the codex and your
specific business requirements.
• Review your current local / national situation
Review the actual compliance codices relevant to you on national / regional level. What
will be the effect for your current business situation?
• Define compliance framework
Set-up measures for compliance to EFPIA codex including business processes, data
requirements and technology used. Review the potential of aligning business processes
and technology to meet data requirements.
Your Benefits of EFPIA adherence
A well designed EFPIA compliance solution provides efficiency and time savings
from automating tracking, reporting and risk mitigation through robust data-driven
reporting and audit readiness. Furthermore it can create potential insights in:
–– Better customer insight, customer segmentation, business analytics and
targeting through a transparent view of enterprise-wide HCP activities
–– Greater clarity of spending enables control of activities
–– Identification of non-value adding activities leading to better spend allocation in
the future
Next steps
The Capgemini Consulting Life Science Practice has worked with leading pharmaceutical
companies to implement the Transparency of Value codices and is a leading global
provider of management consulting, technology and outsourcing services to
the pharmaceutical, biotechnology and medical devices industry. We have specific
expertise in:
–– Support of other pharmaceutical clients in similar transparency projects so that
we can draw from past experience projects for an audit proof transparency
compliance framework
–– Establishing efficient processes in order to quickly scan needed requirements and
set-up a compliance framework for your needs
–– Describe and analyze complex processes and provide end-to-end process
definitions to support a transparency of value project
–– Deep technological understanding of typical systems involved to track, analyze
and report value exchanges
–– Ability to evaluate savings potential and technology set-up for a transparency project
Please contact us for further assistance.
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Automotive the way we see it
Contact:
Sebastian von Strachwitz
Head of Life Sciences
Tel.: +49 151 4025 1999
[email protected]
Tim Fischer
Managing Consultant
+49 151 4025 0232
[email protected]
About Capgemini Consulting
Capgemini Consulting is the global strategy and transformation consulting
organization of the Capgemini Group, specializing in advising and supporting
enterprises in significant transformation, from innovative strategy to execution
and with an unstinting focus on results. With the new digital economy creating
significant disruptions and opportunities, our global team of over 3,600 talented
individuals work with leading companies and governments to master Digital
Transformation, drawing on our understanding of the digital economy and our
leadership in business transformation and organizational change.
Find out more at:
www.de.capgemini-consulting.com
About Capgemini
With more than 125,000 people in 44 countries, Capgemini is one of the
world’s foremost providers of consulting, technology and outsourcing
services. The Group reported 2012 global revenues of EUR 10.3 billion.
Together with its clients, Capgemini creates and delivers business and
technology solutions that fit their needs and drive the results they want.
A deeply multicultural organization, Capgemini has developed its own
way of working, the Collaborative Business ExperienceTM, and draws on
Rightshore®, its worldwide delivery model.
Find out more at:
www.de.capgemini.com
©2013 Capgemini. No part of this document may be modified, deleted or expanded by any process or means without prior written permission from Capgemini.
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