2010 European Trendsin Aggregate Spend,Transparency, and Disclo-sure
2010 European Trendsin Aggregate Spend,
Transparency, and Disclosure
November 2010
Exclusive Survey Results on Life Sciences Industry Regulatory ComplianceTrends...
COMPLY
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Life Sciences companies across Europe are facing a
series of emerging global legislation and increased
regulatory enforcement, designed to prevent
corruption and bribery. But how well placed are these
organisations to comply with the need for improved
information transparency and aggregated healthcare
practitioner spend data? And how will the European
regulatory climate compare to the more mature U.S.
regulatory model?
Cegedim Relationship Management has undertaken
its first annual survey into pharmaceutical compliance
activity across Europe. The objective is to continuously
evaluate industry trends and best practices for
operational compliance.
The 2010 regulatory compliance survey reveals Life
Sciences companies across Europe are now very
aware that regulatory compliance and compliance
management is a challenge – a challenge that will
drastically change the way companies behave and
they way they interact with healthcare providers
and customers.
These organisations are also very aware that
compliance with new regulations, such as the UK
Anti-Bribery Act, will have a significant impact
on the industry’s image. Done well, regulatory
compliance should have a very positive effect on
image. However, if one company fails to step up
to the mark and receives high-profile fines, the
industry impact will be very detrimental. As a result,
organisations across the Life Sciences industry are
cooperating and collaborating to determine and
define the standards required.
These companies are certainly looking at the U.S.
regulatory market, with three quarters (75%) of the
respondents believing methods of tracking promotional
spending currently used in the U.S. will be deployed
in Europe. But while European regulators are closely
following the more mature U.S. model, the clear
cultural differences between Europe and the U.S. will
undoubtedly have an impact on the future regulations.
In the U.S., organisations must proactively disclose a
large amount of information; from violations to every
aspect of healthcare practitioner spend, under the
Sunshine Act that comes into effect in 2013, specific
to 2012 interactions with healthcare practitioners
and organizations.
This enforcement model reflects the high levels of
regulation and enforcement applied across every U.S.
industry, from finance to utilities. In Europe, however,
there is a far greater emphasis on self-policing. Life
Sciences companies are being asked by the authorities
to improve information transparency and provide
aggregated spend information. But, at the moment, the
final concept of transparency – and whether it will be
enforced – is still to be determined. However, there is no
doubt that the new regulatory requirements, at global,
regional and local levels will affect the way Life Sciences
companies do business; with 93% of respondents
agreeing that regulatory compliance will be a major
challenge in Europe.
Executive Summary
93% agree that regulatory
compliance will be a major challenge
in Europe
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7%
6%
8%
83%Pharmaceutical Company
Medical Device Company
Biotechnology Company
Other, Please Specify
There is little doubt that companies in the U.S. are
ahead of the regulatory curve – perhaps three to five
years ahead of their European counterparts. This
market has been highly regulated for several years, and
the forthcoming Sunshine Act includes even greater
demands for spend transparency. As a result, U.S. Life
Sciences companies are heavily focused on operational
compliance, working hard on the key issues of improving
data quality, meeting regulatory reporting requirements
and vendor management. As this data is compiled,
many are starting to leverage the insights from this
information to share across their organisations to
achieve productivity gains.
By contrast, in Europe, compliance officers are still
determining policy, assessing the implications of global,
regional and local regulatory requirements. Indeed, for
many companies, the process of creating a regulatory
compliance team is still in its infancy.
There are lessons that European companies can learn
from the U.S. that should streamline the regulatory
compliance process and drive down the cost of this
essential but non-core activity. Issues of data quality
remain a massive problem for U.S. Life Sciences
companies, despite the huge investment already made.
It is also important to gain business-wide involvement
in compliance activity – from senior management
commitment, to the IT team that must be involved in
executing the regulatory compliance programme and the
business people who own the data. Indeed, in the U.S.,
after several false starts, it has become apparent that
the most successful regulatory compliance programmes
are owned and driven by business people. Following this
model will help European Life Sciences companies reduce
time to market and the cost of regulatory compliance.
Furthermore, growing numbers of U.S. companies are
turning to dedicated third party solutions for support in
the compliance activity – with around 44% either already
using or planning to take this approach. This survey
reveals that European companies are beginning to follow
suit, although in much smaller numbers.
As the U.S. forges ahead with operational regulatory
compliance projects, it has become apparent that managing
the volume of regulatory change and reconciling diverse
data sources to deliver transparency, is too challenging
to handle internally. The use of third party providers is
becoming key in adhering to policies and procedures while
effectively tracking aggregate spend, identifying suspicious
financial transactions and streamlining regulatory
compliance monitoring.
But there is one area where Europe is already ahead of
the game, at a planning level at least, namely, leveraging
transparency and aggregate spend information to derive
benefits above and beyond compliance. 83% agree the
implementation of transparency guidelines will lead to
better resource allocation; whilst almost two thirds (62%)
agree implementation of transparency guidelines will
generate promotional spend decreases.
This first annual survey provides a fascinating insight into
the nascent regulatory landscape in Europe. It reveals
that Life Sciences companies are investing in regulatory
compliance and assessing policies and procedures. But
it also raises concerns about timing and the need to
extend monitoring beyond traditional sales and marketing
functions. With demands for information transparency
looming, Life Sciences organisations must now move
beyond the planning stage, consider every aspect of spend
and embark upon operational compliance programmes.
Figure 1 - Awareness of Regulatory Compliance Requirements
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Figure 1 - Awareness of Regulatory Compliance Requirements
Regulatory compliance will grow as a strategic
challenge for the Life Sciences industry within the
next three years with the growing implementation
of new regulatory legislation and compliance
requirements:
93% of respondents agree that regulatory
compliance will be a major challenge in Europe.
Specifically, 82% believe that anti-corruption
regulation (Foreign Corrupt Practices Act, UK
Anti-Bribery Law) will impact the regulatory
environment and global transparency
requirements.
Almost two thirds (62%) agree that the
implementation of transparency guidelines will
generate promotional spend decreases.
The European compliance function is mostly
focused on high-level compliance governance
design and validation – as opposed to the U.S.,
where compliance is being implemented at an
operational level, with an emphasis on data,
reporting and vendor management
The U.S. transparency and aggregate spend model
is likely to spread across Europe, leading to an
increase in companies’ investments
Over half (53%) of respondents anticipate their
investment in aggregate spend transparency to
grow.
Data identification, consistency and quality are
the major challenges in project implementation and
compliance governance processes
22% of companies in Europe are using Excel
today to monitor expenditure. This is set to
drop to 10% as organisations increase their
dependency on third party solutions to meet
compliance requirements.
Organisations in Europe are looking to exploit
greater information transparency to derive further
benefits beyond compliance:
83% agree the implementation of transparency
guidelines will lead to better resource allocation
Key Findings
6%
73%
22%
5%
Somewhat informed
Not at all informed
Very well informed
40%
38%
49%
36%26%
53%
47%
44%
Implementation of transparency guidelines will lead to a better resource allocation.
Regulatory compliance will be a major challenge in Europe.
Completely Agree Mostly Agree
Implementation of transparency guidelines will generate promotional spend decreases.
Regulatory compliance environment will have a major impact on the Life Science industry image.
Figure 2 - Awareness of Regulatory Compliance Requirements Figure 3 - Regulatory Compliance Outlook
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Whether or not it was merited, there can be no
argument that Life Sciences organisations are now
firmly in the spotlight of anti-corruption and anti-
bribery officials. Global polices regulating promotional
expenditure and sample distributions are being
reinforced, whilst in the U.S. Life Sciences companies
have experienced both dawn raids and serious
investigations by the Department of Justice.
And the implications are significant; pharmaceutical
and medical device companies can face both civil
and criminal sanctions. Siemens was recently fined
more than $1 billion for not maintaining accurate
books of records, while individual executives from
well-established international companies are being
prosecuted for not having implemented enough internal
control and validation measures.
Furthermore, the series of legislation facing Life
Sciences companies continues to grow. The recently
revisited UK Anti Bribery Act comes into force in April
2011 and adds even more complexity to the existing
Foreign Corrupt Practices Act (FCPA), the Organisation
for Economic Co-operation and Development (OECD)
Convention and the Sunshine Act due to come into
force in the U.S. in 2013.
But just how geared up are European Life Sciences
companies for this new regulatory intensity? In the
first annual compliance survey conducted by Cegedim
Relationship Management, the results revealed
some awareness (95%) of the growing regulatory
compliance requirement and the majority (73%) are
very well informed.
Meanwhile, over eight out of ten respondents (82%)
believe the coming anti-corruption regulations, such
as the FCPA and UK Anti-Bribery Law will highly (38%)
or somewhat (44%) impact the regulatory environment.
Less than two out of ten (16%) feel that there will be
low or no impact.
But understanding the extent of that impact remains
a challenge. European Life Sciences companies do
not necessarily want to follow the U.S. route which
will require companies to publish online all spend to
healthcare professionals - both direct and indirect.
This highly-enforced regulatory environment does
not fit comfortably with the European culture of
self-regulation.
However, European regulators are currently looking
closely at the U.S. model to determine the right route
forward and three quarters (75%) of the respondents
believe that methods of tracking promotional
spending currently used in the U.S. will eventually
be deployed across Europe. Approximately one-half
(47%) believe that they will probably come; around
one-quarter (28%) believe that they are likely to
come. And just one in ten (10%) believe that they are
not coming.
Certainly organisations are aware of the implications
of escalating compliance demands. 93% of respondents
agreed that regulatory compliance will be a major
challenge in Europe; and 93% also say the regulatory
Introduction
82% believe the coming
corruption regulations will impact the
regulatory environment
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compliance environment will have a major impact on
the Life Sciences industry image.
However, it is apparent that despite well-publicised
regulatory compliance recruitment programmes, the
responsibility for compliance in Europe still rests
primarily with sales and marketing teams. 117
individuals contributed to the research; 83% of these
were from pharmaceutical, 8% medical device and 6%
biotechnology companies.
Just 26% of respondents, however, have a
dedicated regulatory compliance role; while 29%
are in marketing and 18% in sales. In contrast in
the U.S., 32% of respondents were in compliance
and 21% in operations; just 14% were in marketing
and 13% in sales.
However, it is good to note that in the European
research, 7% are in general management; 5% in
finance/audit; 4% in public/government affairs
and 4% in medical, demonstrating the growing
realisation that compliance must become a part
of the daily business life across every part of the
pharmaceutical organisation.
The emphasis on sales and marketing personnel
taking control of regulatory compliance requirements
also reflects the fact that the European marketplace
is still focused heavily on tracking sales and
marketing spend to healthcare professionals rather
than every aspect of spend, such as support for
clinical trials which also will demand input from R&D
and public affairs.
Furthermore, while the majority (88%) of these
individuals have a direct involvement in mandate
marketing and promotional spend laws, only 51% are
very involved in healthcare professionals
spend tracking and monitoring process based
on existing laws and legislations. In the U.S., by
comparison, 69% of respondents were very involved
in spend tracking and monitoring. No doubt the
level of European involvement will increase as the
compliance function in Europe becomes more mature.
29%
26%
18%
7%
5%
4%
4%
3%
2%
2%
10%
Marketing
Compliance
Sales
Management (General)
Finance/Audit
Public/Government Affairs
Medical
Legal
Technical Operations (IS)
R&D
Other
Figure 4 - Report Participant Demographics
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Understanding Compliance
So how confident are these organisations in achieving
fast emerging regulatory compliance demands?
According to the research, almost three-quarters
(73%) of the respondents say that their company is
either excellently (31%) or well equipped (42%) to
comply with transparency regulations as they exist
today. Just one quarter (25%) feels that their company
is fairly (22%) or poorly (3%) equipped to deal with
transparency regulations.
This compares with just 29% of companies in the U.S.
believing the organisation is either excellently or well
equipped to comply. This clearly reflects the different
levels of maturity in the U.S. and the very strong culture
of enforcement: in the U.S., organisations have to
demonstrate regulatory compliance to what are far more
stringent regulations that span the entire organisation,
not just the sales and marketing role; whilst in Europe
there are, as yet, no best practice guidelines or
benchmarks for regulatory compliance activity.
Given that far more stringent regulations are expected
in Europe shortly, the results suggest a worrying level
of complacency amongst organisations. And those
that only rate their ability to comply as ‘fair’ today, in
what is a relatively unregulated environment, should
be particularly concerned about how they will address
compliance at global, regional and local levels over the
coming 12-18 months.
The research also revealed that organisations are
still developing strategies to deliver effective
transparency projects. Indeed, when asked to
describe their role in the company’s involvement with
locally-mandated marketing and promotional spend
compliance, the majority of respondents (60%) said
they were directly involved with process design and
implementation.
Approximately four out of ten are involved with data
analysis (44%) and report review and approval (39%);
approximately three out of ten are involved with
tracking legislative updates (30%) and gathering and/
or entering of data (25%); while approximately two in
ten are involved in report generation (19%), processing
data (18%), vendor selection (16%) and vendor
management (15%).
In contrast, U.S. Life Sciences companies are three
to five years ahead with the implementation of
operational-based compliance solutions, with a far
higher emphasis on areas such as data processing,
report generation and vendor selection.
It is understandable that these European organisations
are focusing attention on understanding the regulatory
compliance requirements, particularly since local
and regional interpretations of regulations vary. The
differences can range from not bribing “public officials”
– a term that itself can be interpreted differently
across the globe depending on the way health services
are delivered; to the new Anti-Bribery Law that
includes both private and public Healthcare sectors in
the UK. This law also has far tougher sanctions than
other legislation: an individual convicted for failing
to implement adequate measures now faces up to 10
years in prison and unlimited fines.
U.S. Life Sciences companies are
three to five years ahead with the
implementation of operational-base
compliance solutions
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Furthermore, each country has a different limit for the
amount of promotional spend allowed per official – for
example, small gifts cannot exceed £6 in the UK, but
€30 in Spain or 100 zloty in Poland. And even the use
of samples is significantly reduced, with organisations
now complying with the ‘four times two’ standards
– no more than four samples per physician for two
years after the product’s launch – laid down by the
European Federation of Pharmaceutical Industries and
Associations (EFPIA).
Despite this complexity, the survey highlighted
opportunities associated with compliance activity
– most notably the value of creating and providing
aggregated spend information to the business as
a whole. Some 83% agree the implementation of
transparency guidelines will lead to better resource
allocation; while almost two thirds (62%) agree
implementation of transparency guidelines will
generate promotional spend decreases.
These figures make it clear that organisations
across Europe are already looking to derive benefits
beyond compliance from this investment by better
understanding the deployment of resources in terms of
both people and investment. This contrasts heavily to
the U.S. where there has traditionally been a clear line
between compliance and the business: organisations
in the U.S. are only now beginning to look at attaining
possible business benefits from regulatory compliance
data. The business-based attitude of the European
market should enable companies not only to embed
compliance activity in every part of the organisation
but also derive additional benefits faster.
3%
22%
42%
31%Excellent
Good
Fair
Poor
Figure 5. Ability for Company to Comply with Transparency Regulations Today
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Given the awareness of the importance of regulatory
compliance activity to the Life Sciences industry, just
how committed are these organisations to investing in
the right people, processes and technologies to drive
successful compliance programmes?
Over half (53%) of respondents anticipate their investment
in solution and resources to provide aggregate spend
transparency to grow, reflecting the growing awareness of
the compliance risk across both the industry and Europe.
And of the 40% that expect investment to stay the same,
the majority of respondents are in country-based, rather
than regional roles revealing a gap between local and
regional compliance understanding.
So how will this investment be made? Today over half
(56%) are using internal software systems to monitor
company expenditure in Europe; and 22% are reliant
on manual processes and Excel spreadsheets; with just
10% using a dedicated third party solution. When asked
how the company planned to satisfy spend transparency
requirements tomorrow, there is a significant shift away
from manual processes. Indeed, just 10% plan to use
Excel in the future. Instead, 56% will use internal software
systems; and 19% will use third party solutions.
Given the comparative sophistication of the U.S.
marketplace, it is interesting to see how attitudes to
monitoring aggregate spend compare. Today in the
U.S., some 40% are still reliant on Excel, 32% use
internal software systems, 24% third party solutions
and 4% do not monitor at all. In the future, the
majority (44%) plan to adopt dedicated third party
software; 31% will use internal software systems, while
17% plan to remain with Excel.
Certainly this shift away from manual processes is
critical. The new regulatory implications extend far
beyond traditional detailing activity and embrace
every part of the organisation that has any kind of
customer interaction, from engaging with customers
in clinical trials, to providing grants to physicians or
simply inviting a Key Opinion Leader to a progress
meeting. Also companies will have to include all
payments made on their behalf by external partners
and third parties companies.
Therefore, pharmaceutical companies now need to
track every interaction and financial transaction,
monitor both direct and indirect payments undertaken
on behalf of the organisation, and then reconcile the
expenses to each physician or official.
This process becomes even more complex when
considering the multi-national nature of most Life
Achieving Compliance
Figure 6. Anticipation of Level of Investment on
Aggregate Spend Level for Next Year
3%
11%
40%
42%Increase
Stay the same
Significant increase
Decrease
83% Agree the
implementation of transparency guidelines will lead to better resource allocation
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Sciences company operations: organisations have to
put in place global guidelines and consistent standards
to monitor closely all interactions with healthcare
professionals. They have to be able to reflect the
different regulations in each country; and they need
to achieve this without incurring an unmanageable,
expensive overhead.
This huge shift towards third party software, especially
in the U.S., is a clear indication of the need for support
in designing and implementing robust processes for
creating aggregated spend data that encompasses more
than just sales and marketing expenditures.
In Europe, Customer Relationship Management (CRM)
provides companies with an easy route to collate the
sales and marketing aspect of spend information.
The significant numbers of organisations looking to
adopt third party solutions in the U.S. demonstrates
recognition that when organisations have to include
information from R&D, medical affairs and third party
vendors, there is a need for external support in areas
such as data management and aggregation. As the
compliance model in Europe becomes more mature,
it is very likely the same patterns of third party
software adoption will be followed.
And a fundamental component of this process is the
creation of a unique customer record – a problem that
has been extremely understated, even in the mature
U.S. market. Pulling information from multiple, diverse
systems - from ERP to third party vendors - and
ensuring spend is reconciled to a single, accurately
identified customer, is a significant challenge. Customer
data will be often incomplete and recorded differently
in each system. How can an organisation ensure that
Dr. Brown is the same Dr. Patrick Brown, or hospital
consultant Pat Brown in Manchester?
U.S. companies are investing heavily in creating
excellent customer Master Data Management (MDM)
systems, the core component of the transparency
process. Yet just 15% of U.S. companies are very
confident in the ability of the internal customer MDM
system to define the unique recipient records across all
spend sources; with 31% somewhat confident.
In Europe, by contrast, where organisations have yet
to embark upon the creation of MDM, one quarter
(25%) of respondents are very confident in the ability
of internal systems to define the unique recipient
record across spend sources or across countries;
while 37% are only somewhat confident. Again, this
difference reflects the sales and marketing emphasis
of the European compliance activity to date, with
companies reliant upon and confident in the quality
of their CRM systems.
However, true transparency will require cross-system
information provision and failure to define the unique
recipient (customer) record across all spend sources or
across countries will lead to the failure of the entire
compliance project.
Figure 7. Functions to Ensure Compliance with Local Mandated Marketing and Promotional Spend Regulation
60%
44%
39%
30%
25%
19%
18%
16%
15%
13%
Process design and implementation
Data Analysis
Report review and approval
Tracking legislative updates
Gathering and/or entry of data
Report generation
Processing data
Vendor selection
Vendor management
Other, please specify
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Data Challenge
This issue is reflected in the concerns raised in
response to complying with FCPA and regulations
such as the OECD convention and UK Anti-Bribery.
The greatest concern is collecting all relevant spend
data (39%), followed by data integrity (36%) and
identification of spend recipients (36%) and preparing
reports for data disclosure (34%).
Given that Life Sciences companies in Europe will
have to report accurately on this data within the
next 12-18 months notably in the U.S. and UK, it
is clear that organisations must focus hard up-
front on enhancing data management governance
before embarking upon any further regulatory
compliance activity.
However, when asked ‘what are the key issues that
impact the level of regulatory compliance,’ organisations
cited lack of understanding of policy (62%) as the
primary impact. Lack of policy knowledge leads to errors
in data, therefore organisations need to embark upon
company-wide education and training programmes to
reinforce the importance of compliance and FCPA to the
pharmaceutical business – and the market as a whole.
It is no surprise that poor record keeping or data entry
errors is the next most significant impact (54%), given
the need for high quality data to achieve compliance;
if individuals do not understand the policies and
procedures, or recognise the need for ethical
behaviour, poor record keeping and data errors will be
inevitable. Improving education should, by default, lead
to better information.
The third most important impact is system process
shortcomings (52%). But as the need for a unified,
strategic global compliance strategy and view becomes
more important, the shortcomings of existing systems
for monitoring and reporting aggregate spend will
become even more evident.
The way in which information is captured is just half
the problem. In the U.S. just 37% of respondents
indicate that their company enforces corporate
standards for healthcare professional and spend data
capture which applies to all suppliers and staff. The
remaining respondents either do not have standards or
have standards which are not used universally.
In Europe, however, where the market is significantly
less regulated, some 83% of organisations enforce
corporate standards for healthcare professionals and
Figure 8. Areas of Concern Complying with the FCPA and Anti-Corruption Regulations
36%
39%
36%
34%
30%Handling inquiries after spend is posted
Prepare reports and analysis for potential data disclosure
Proper identification of spend recipients
Data Integrity - having accurate, certified, complete, and timely data
Collecting all relevant spend data
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spend data capture. The majority (62%) have standards
that apply to all external parties and internal data;
whilst only 21% have standards that only apply to
some external parties and internal data. Just 7% of
organisations currently have no standards and are not
in the process of defining any.
Where enforced, these standards apply to
honorarium fees (71%); promotional spend (75%) and
consultancy fees (68%). Third party data (38%) is
less commonly covered.
These figures are very revealing. The strong
emphasis on sales and marketing related spend
underlines the relative immaturity of the European
market when compared to the U.S. – and reflects the
very different enforcement models applied in these
markets.
The challenges associated with collecting and collating
this data reflect the problems already encountered in
the U.S.; issues include managing disparate formats
and standards (37% challenging) and establishing
unique identification of healthcare professional from all
the expense data sources (35% challenging), identifying
all data sources (32%) and managing incomplete spend
information (31%).
The implications of these problems are significant.
A lack of consolidated customer view created by the
inability to uniquely identify a healthcare professional
from diverse expense data sources will lead to
inaccurate monitoring and reporting, and a risk
of compliance breach. But with multiple source
systems and owners, file format differences and
numerous third party sources, even identifying all
the sources before creating the unique customer
number is a massive challenge. Add in global
regulatory compliance needs and the complexity
increases significantly
Figure 9. Does your Company Enforce Corporate Standards for Healthcare Professionals and Spend Data Capture
Figure 10. How Challenging are the Following Processes?
3%
7%
21%
62%Yes, applies to all the externaland internal data
Yes, but applies only to external partners and
internal systems
No, we do not have standards
No, but we are in the processof defining one
0%No, looking for a vendorto provide a solution
31%
32%
35%
37%Managing disparate formatsand standards
Matching and establishingunique identification of a
Healtcare Professional from all the expense data sources
Identifying all data sources
Managing incomplete spendand customer information
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Robust Model
If organisations are to achieve a consistent, global
model for regulatory compliance, it is essential to
create a standard data capture model that also
supports local rules to ensure every market is managed
consistently and effectively. As a dire imperative,
organisations need to consider not only spend
aggregation but also robust and thorough customer
data management.
One option is to put in place an aggregate spend
solution that builds on existing Key Account
Management (KAM) information to automate and
streamline regulatory compliance monitoring and
reporting. It is by leveraging this strong, accurate
data source and integrating a wide range of
enterprise applications for Sales Force Automation,
ERP, Finance and HR, that organisations can
streamline and automate the process of highlighting
suspicious transactions.
Using Business Intelligence, Life Sciences companies
can not only conduct the required in-depth historic
analysis but also put in place proactive alerts both
for individuals identified as highly influential and also
if payments to specific practitioners are about to hit
the threshold (Fair Market Value); preventing both
intentional and accidental compliance breaches.
There is a further component to compliance activity,
namely transparency. In this global operating
environment organisations are increasingly looking
at opportunities to drive best practice, create global
policies with local implementation and improve
processes and key to this is to improve transparency.
This regulatory compliance drive is now enabling
organisations to collect and share information not only
with government and regulators but also internally.
Indeed, the wealth of financial information collected
to achieve compliance provides valuable insight into
cross-organisational spend with specific healthcare
providers. Adding customer data management to the
process provides a depth of information that can
be analysed to assess value, understand how much
is being spent at an individual level and improve
resource allocation.
This improved insight also has implications for Key
Account Managers. The aggregate spend information
can be analysed to provide a Key Account Manager
with insight into spend at a local level, such as
investment in training or continuous medical education
(CME) to a physician. With a complete picture of the
investment by organisation, a Key Account Manager
embarking upon negotiation for a new bid or new
customer is in a far stronger position to demonstrate
the value being provided by the Life Sciences company.
This is a powerful tool that, if used correctly, should
have a direct, bottom line impact on business.
Using Business Intelligence,
companies… can put in place
pro-active alerts. Preventing
both intentional and accidental
compliance breaches
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Conclusion
Transforming the image of the Life Sciences
industry will take time. But the commitment being
demonstrated today is extremely positive. And
whilst organisations are obviously keen to avoid the
negative publicity, fines and possible court cases
associated with bribery and corruption, there is no
doubt that organisations in Europe are also looking to
derive benefits from improved transparency, whether
for internal compliance reasons or external disclosure.
With a real opportunity for a Life Sciences company
to establish a good image to the healthcare market,
the industry is increasingly considering transparency
as a huge competitive advantage and benefit, and
an opportunity to improve resource utilisation,
rather than simply an expensive and time-consuming
overhead expense.
But, while the commitment is not in doubt,
organisations are still struggling to actually deliver
transparency, both from a technology and business
model perspective. This is a multi-disciplinary project
that is not just about exploiting technology but also
about driving new behaviour change and imposing
compliance as a change in ethical behaviour to the
customer.
Critically, global regulatory compliance and
transparency demands an automated and streamlined
solution: not only are the costs of a manual or
spreadsheet approach too high, but without some
kind of automation and built-in alerts that reflect the
different countries’ interpretations, organisations will
be exposed to a high risk of compliance breach.
Regulatory compliance is becoming a key function
within the Life Sciences business; indeed it is, in
some companies, becoming a cornerstone of how
business is conducted and is massively influencing
the commercial model. But for the industry to achieve
wholesale changes in attitude and perception, every
organisation needs to commit. Without that, European
Life Sciences companies will face the highly enforced
model being adopted in the U.S., rather than a self-
policing approach – a model that many fear will
significantly undermine customer relationships.
Now is the time to work with other organisations in
the field to develop best practices, to assess how
to best leverage existing spend capture sources
and resources, and to put in place procedures and
practices that will mitigate both the risk and cost
associated with global compliance.
Authored by;
Bill Buzzeo
VP and GM of Global Compliance Solutions
Cegedim Relationship Management
Guillaume Roussel
VP Compliance Solutions EMEA
Cegedim Relationship Management
Exclusive Survey Results on Life Sciences Industry Regulatory ComplianceTrends...
COMPLY
Reproduction and distribution of this report is allowed only with the written authorisation from Cegedim.
White Paper16
White Paper16
2010 European Trendsin Aggregate Spend,
Transparency, and Disclosure
For more information, please contact
www.cegedim.com/eucompliance
2010 Cegedim, Inc. All Rights ReservedReproduction and distribution of this report is allowed only with the written authorisation from Cegedim.White Paper16
2010 European Trendsin Aggregate Spend,
Transparency, and Disclosure
For more information, please contact
www.cegedim.com/eucompliance
2010 Cegedim, Inc. All Rights ReservedReproduction and distribution of this report is allowed only with the written authorisation from Cegedim.
