2011 European Trends Compliance Report

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2011 European Trends inAggregate Spend, Transparency

and Disclosure

Results from an Industry Survey

February 2012


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Exclusive Survey Results FromLife Sciences Executives on

Regulatory Compliance Trendsin Europe...

COMPLY


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Reproduction and distribution of this report is allowed

only with the written authorisation of Cegedim.

A New Year for the European Life Sciences industry brings

a broader network of regulatory legislation that is being

stringently enforced at local, regional, and global levels. With

an endgame to further prevent corruption and bribery, new

laws and current regulatory agencies force pharmaceutical,

medical device, and biotech companies to assess their ability

to achieve better transparency reporting of aggregate

healthcare practitioner (HCP) payment data. While the US

model of operational compliance serves as the handwriting

on the wall, European organisations remain uncertain on how

exactly to approach their future of increased transparency.

European companies are acutely aware of

the increased diculty of satisfying new

regulations.

Cegedim Relationship Management delivers its secondannual survey of European Life Sciences executives who

provided insight on current compliance trends. The aim is to

continuously evaluate and interpret the progress of industry

trends and highlight best practises for operational

compliance.

The 2011 compliance survey illustrates that European

companies are acutely aware of the increased diculty of

satisfying new regulations. As a result, many organisationsare proactively working towards operational compliance by

initiating integral processes. And while Europes condence

in reporting abilities is at an all-time high, companies are still

unclear how to ease the administrative work involved with

maintaining consistent, cross-organisational transparency.

Life Sciences organisations are no stranger to the emerging

series of legislation, such as the US Foreign Corrupt Practices

Act (FCPA) and the UK Bribery Act, that impose criminal

charges and skyrocketing nes if breached. Therefore,

the industry must collectively and proactively address the

new era of global transparency in order to restore and

sustain vital connections with healthcare practitioners and

customers. If one company failed to commit fully to the

initiative and received widely publicized penalties, it would

mar the appearance of the entire industry. Consequently,

companies now promote drastic measures that aim to

holistically change customer interactions and the capture,

organisation, and storage of data related to payments or

transfers of value to HCPs.

Furthermore, exactly seven out of 10 respondents (70%)

feel that upcoming anti-corruption legislation will aect

an increased number of countries, requiring greater

transparency. And nearly 5 out of 10 respondents feel that

upcoming legislation will result in changes to current sales

and marketing practises (46%) and increased resources to

manage transparency (45%).

Increased number of countries requiring

greater transparency

Changes to current sales and marketing

practices

Increased resources required to manage

transparency

Commercial advantage of improved

reputation

Benet the business through reduced cost

due to greater measurement and visibility

70%

46%

45%

29%

26%0% 20% 40% 60% 80%

Figure 1: Index - pg.17Impact of Anti-Corruption Legislation

Europe defers to the mature US enforcement model for

insights into their regulatory future, with nearly two-thirds

(64%) of respondents anticipating that promotional spend

tracking in Europe will reach US levels in one to three years.

But in keeping with the sea of cultural dierences that

separate Europe from the US, respondents hint that they will

most likely not follow the US model entirely, but rather pave

their own way to operational compliance.

The onset of 2012 marks great change in the US, as the

sunshine provision of the Patient Protection and Aordable

Health Care Act (PPACA), known as the Sunshine Act, will

Executive Summary


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require in-depth reporting on payments and transfers of value

to physicians and teaching hospitals for a portion of 2012

in the spring of 2013. The federal US agency responsible for

implementing the regulations of the Sunshine Act, Centers

for Medicare & Medicaid Services (CMS), is anticipated to

publish nal regulations during the rst half of 2012, with

the expectation that data would be required to be collected

during the second half of 2012.

87%of respondents ratetheir companies ability to comply with

transparency requirements is either

Good or Excellent.

In essence, these new federal obligations add to a complex

network of existing state laws that already regulate

pharmaceutical, biotech, and medical device organisations

marketing, sales, employee, and R&D expenditures.

Thus, companies have already made systemic alterations

in response to the federal law, according to Cegedim

Relationship Managements recent US survey. Of those

respondents who reported using spreadsheets, 77% plan to

move to an automated solution.

The responsibility of the Sunshine Act has undoubtedly set

the US apart in terms of regulatory compliance. And in a

market that has been sharply regulated for nearly a decade,

companies long ago committed to achieving operational

compliance. This involves implementing transparency

initiatives at all levels of the business structure and ensuring

compliance by monitoring each possible aspect of reportable

spend data.

Moreover, the solutions required to meet these strict

standards are creating valuable synergies in the US through

increased collaboration and communication and, in turn,

enable companies to achieve inherently better commercial

productivity.

Responses from Europes 2011 survey reveal wholehearted

condence in their ability to prosper in the new regulatory

landscape. But condence alone does not guaranteeresults, as many companies continue to struggle with

data discrepancies and inecient reporting methods. As

current policies take shape and new policies emerge, it is

imperative that companies act quickly to implement and

deploy solutions that streamline processes and reduce the

administrative burden of compliance reporting.

Many companies continue to struggle

with data discrepancies and inecient

reporting models..

As a result of the immense pressure from their strict

enforcement model, US Life Sciences companies have

outsourced internal spend tracking to leading third-party

providers. These solutions manage the impact of legislation

by consolidating disparate data into a single, convenient

source that relieves internal resources in order to maximize

commercial eciency. Presently, third-party providersenable companies to more easily track HCP spend data

and quickly pinpoint irregular nancial activity allowing

companies to devote more time to develop relationships

with invaluable stakeholders.

Cegedim Relationship Managements newest compliance

survey nds that Europe is inarguably making measurable

strides to enforce compliance internally. In direct comparison

with Cegedim Relationship Managements 2010 survey,

Europe is signicantly improving their cross-organisational

involvement in marketing and promotional spend compliance.

For Europe, its no longer a question of when increased

enforcement models will arrive, but how quickly companies

can adapt their systems and innovate processes to transform

the duty of compliance into a competitive business strategy.


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Pharma, medical device, and biotech companies are

rounding the corner to better compliance by increasing

cross-organisational involvement and are fully

committed to enforcing corporate standards.

Involvement in ensuring compliance has increased

signicantly over the past year for all activities

with the exception of data processing.

More than 9 out of 10 respondents (94%) say that

their company enforces corporate standards for

spending on HCPs.

Over one-half (53%) indicated that their company

already has a project team in place to address

compliance issues.

Manually / with spreadsheets

Internal software system

Third party solution

We are not satisfying them

Other, please specify

44%

0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%

43%

7%

4%

1%

Figure 2: Index - pg.17

Satisfying Reporting and Disclosure Requirements

A valuable dierence in the second annual survey is the

momentum gained through strong senior management

support and the added condence required for long-

term growth through current compliance initiatives.

Nearly 9 out of 10 respondents (87%) reportthat their senior management understands and

supports their eorts in transparency reporting.

Almost 9 out of 10 respondents (87%) feel condent

that their company is either excellently (30%)

or well (57%) capable of meeting transparency

requirements.

Three-quarters of respondents (73%) are very or

somewhat condent in their companies ability

to implement and build rules for transparent

processes.

As with all sizeable industry transitions, there are

signicant shortcomings particularly with data

management and a heavy reliance on inecient

reporting mechanisms.

The most signicant process challenge for

respondents is matching and establishing unique

identication of a healthcare practitioner from

expense data sources.

2011 saw a signicant increase in the use of

manual and Excel spreadsheet reporting methods.

Respondents anticipate increased regulatory

legislation in Europes near future, and a majority plan

to devote resources and implement reporting solutions

accordingly.

Slightly less than two-thirds (64%) of the

respondents surveyed expect promotional spend

tracking in Europe to reach US levels in one to three

years.More than one-half of the respondents (52%)

anticipate that investments in solutions and

resources that account for aggregate spend

transparency will increase over the next year.

Almost two-thirds of respondents (64%) feel that

implementing a unique spend data reporting and

disclosure solution is an absolute requirement.

Its absolutely a requirement32%

64%2%

It would be nice but its not necessary


Importance of Implementing a Unique Spend DataReporting and Disclosure Solution

Key Findings


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In combination with government initiatives aimed at

cutting healthcare costs, the increased enforcement of

anti-corruption and anti-bribery regulations comes at an

inconvenient time for the European Life Sciences industry.

Since doctors throughout Europe are nding nearly all their

prescribing power usurped, pharmaceutical organisations

must recruit all available help to address the increasingly

complex regulatory landscape.

The UK Bribery Act and the Foreign Corrupt Practices

Act (FCPA) are not the only strict regulations facing

the pharmaceutical industry in Europe. Following the

amendment of the Association of the British Pharmaceutical

Industry (ABPI) Code of Practises in 2010, France adopted

a new transparency law very similar to the US Sunshine Act

in December 2011 broadening the category of covered

recipients that must report. Further, the Netherlands is in

the process of enacting new transparency rules that arelikely to arrive this year. And the European Federation of

Pharmaceutical Industries and Associations (EFPIA) is

working to update its Codes of Practises, calling for greater

transparency at all levels of the Pharmaceutical business

structure in Europe. This multi-national shift towards

improved reporting clarity raises the bar even higher for

organisations and, in turn, increases the potential for a

breach in compliance.

These acts have grim implications: pharmaceutical, medical

device and biotech companies can face unlimited nes and,

for an individual who is convicted, up to 10 years in prison.

In recent history, one of the top-10 biopharmaceutical

companies was ned over 1 billion dollars for failing to

maintain an accurate book of records.

Yet, how exactly are senior industry executives interpreting

this eventual shift into a stricter enforcement model? In the

second annual Cegedim Relationship Management report,

the results reveal senior managements overwhelming

support and understanding (87%) of their companys eorts

in transparency reporting.

Understand the issues and support

my eects

Aware of issues but dont support

Unaware of issues


9%

87%

1%

3%


Senior Management Attitudes toward Transparency

Reporting

The windfall of insight from the extensive US gift laws

which require tracking on nearly any marketing spend over

10 dollars is most likely accountable for the evolving

perceptions of European respondents. Over one-half of the

respondents (52%) anticipate increasing investments in

solutions and resources over the next year, while one-third(34%) believe that investments will remain the same. Nearly

two-thirds (64%) of the respondents surveyed expect

promotional spend tracking in Europe to reach US levels in

one to three years.

It is apparent that these responses do not add up. There

exists an evident disjoint between the healthy majority

that fully anticipate increased regulation and the one-third

of respondents that believe investments in solutions andresources will stay the same despite the shift toward

greater transparency. The discrepancy between companies

committed to investment and those unprepared to address

the reality of increased regulation reveals an alarming

trend. The Life Sciences industry must collectively embark

on solutions that seamlessly incorporate compliance into

the business model before the issue becomes a legal and

nancial liability.

Introduction


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With the recent strides to increase transparency and

prepare for upcoming regulations, are respondents

feeling condent in their companys ability to face the

future? When asked about their companys ability to meet

current transparency requirements, an overwhelming

majority of respondents (87%) selected either good or

excellent a signicant increase from last years results.

Excellent

Good

Fair

Poor

30%

57%

11%

3%

Figure 6: Index - pg.19Companys Ability to Meet Transparency Requirements

Today

The question that Life Sciences organisations should be

asking themselves is, Is this a positive trend? Notnecessarily. Specically, when respondents were asked

to address their current state of readiness for the

upcoming compliance legislation, the majority of

respondents selected either analysing needs (39%) or

waiting for more European laws (16%).

With the pharmaceutical regulatory structure being

newly built in Europe, companies are showing high levels

of condence in systems that are not translating intoactual readiness for Europes foreseeable future.

Collecting required compliance data

Analysing needs

Waiting for more European laws

41%34%

39%36%

16%16%

0% 10% 20% 30% 40% 50%

Country Head Oce Corporate / Regional Headquarter


Current State of Readiness for Transparency

Requirements

Critically, European companies are showing condence

in a currently under-regulated market that is quickly set

to change. This condence in existing internal reporting

systems and methods will wane as evolving regulations

demand more from pharmaceutical organisations.

Overwhelming condence will not drive companies

to reinvent their technology in the face of increased

transparency acts but will encourage them to remain

complacent until ineective internal reporting becomes

a systemic issue. And as can be seen by their current

state of readiness, respondents internal systems have

not yet proved themselves. Thus, companies will soon

start experiencing a certain apprehension, comparable

to their US counterparts, which could prove to be a

valuable driver for change if Europes condence levels

respectively decrease.

For example, in the US, less than one-third (31%) ofrespondents were very condent that their transparency

reporting is fully compliant, according to Cegedim

Relationship Managements recent US aggregate spend

survey. The US operates under increasing pressure to

demonstrate high levels of compliance, especially since

2012 will be the rst year for which all marketing spend

will be reported to the US Department of Health and

Human Services (in early 2013). And as a result, 64%

of US respondents in the recent survey expected toincrease investments in solutions and resources devoted

to aggregate spend reporting and compliance over the

upcoming year.

US companies are in an analytical stage to discover

best practises through the use of the latest technology.

Due to this pivotal transition period, they cannot yet

develop condence in systems that are perpetually

being optimized to provide better compliance outcomes

in a heavy-handed regulatory enforcement landscape.

Europe cannot yet compare to the mature US

enforcement model, where companies are constantly

On the Road to Compliance


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With companies condence, involvement, and internal

enforcement on a signicant rise, does this trend

correlate with a willingness to commit to the suite of

available compliance solutions that are providing real

results in the US and globally?

The answer to this question uncovers a particularly

unusual trend. When asked to predict new investments in

solutions and resources for the upcoming calendar year,

over half (52%) of respondents believe that investments

will increase. On a more specic question about the

importance of implementing a spend data reporting

solution, a large majority (64%) of those surveyed

believe it to be an absolute requirement to their current

business. This suggests that a signicant number of

companies are either operating on integrative compliance

solutions or are in the process of implementing them.

Stay the same

Increase

Decrease

34%

52%

12%0% 10% 20% 30% 40% 50% 60%


Anticipated Investments in Solutions & Resources over

the Next Year

Surprisingly, nearly all companies surveyed are satisfying

reporting and disclosure requirements manually or

through the use of Excel spreadsheets (44%) or through

internal software reporting systems (43%). Less than

one-tenth (7%) of respondents are using a third-party

solution to full reporting requirements. And although

the use of internal reporting is down from last year, that

gain went directly back to the exhaustive practise of

both manual and Excel spreadsheet reporting.

So what exactly can be taken away from this increasingly

internalized trend in compliance? Could companies be

resting on the old laurels of reporting methods that

have proved successful in the past? Are they exercising

excessive caution in a cost-contained economy that

impedes their ability to invest in third-party provider

solutions?

This disconcerting shift to traditional mechanisms may

jeopardize the investments and resource allocation

that Europe has already made. Over one-half (53%)

of surveyed organisations have proactively instituted

project teams to internally manage compliance. Further,

as mentioned, respondent companies have recently

invested in the labour-intensive task of redistributing

the responsibility of compliance throughout their entire

business structure.

At a time when the industry must reconcile every

promotional expense, companies must not misuse

precious internal resources on time-consuming reporting

practises that are antiquated and unsustainable. If

companies continue down this path in the face of

current and upcoming regulations, vital resources

will be consumed by the manual tracking of all types

of customer interactions from everyday sampling,

to implementing patient co-pay assistance programs,to oering continuous medical education (CME) to a

physician.

So just how long does Europe have to reverse this trend?

Looking to the US model, it is evident that companies

have already made this transition, with less than one-

third of respondents (28%) still using manual reporting

systems to satisfy transparency requirements, according

to the Cegedim Relationship Management 2011 survey.

And with European respondents in agreement that

promotional spend tracking will reach US levels in as

little as 12 months, there exists a brief timeframe to

Attaining Operational Compliance


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streamline processes by leveraging the proven benets

of deploying advanced technology and outsourcing

compliance to best-in-class solution providers.

Less than 1 year

1 to 3 years

3 to 5 years

Dont know

7%

64%

16%

14%


Expected Timeline for Promotional Spend Tracking in

Europe to Reach US Levels

The most recent innovations in solving compliance

reporting challenges are perfectly suited to address

European organisations aggregate spend tracking

across complex multi-national business models. And

with native integration into regional and global businessstructures, the most groundbreaking solutions alert

users of suspicious nancial transactions, specic to

each countrys standards, to streamline the monitoring

process and reduce the administrative burden of tracking

new legislation.

Furthermore, the leading providers of breakthrough

compliance systems deliver unparalleled exibility to

capture, control, and share databases. Todays third-

party providers feature compliance functionalities

that are fully compatible with Customer Relationship

Management (CRM) solutions to promote optimal data

accuracy and feature continuous updates from global

healthcare reference databases.

These innovative solutions feature intuitive interfaces

that allow end users to adjust and edit databases with

unparalleled ease. The import of data is now simpler

and allows for multiple entry points, such as through

integration with other business applications. Any new

data entered is fully controlled through detailed audit

trails and monitored by automated quality control

reporting.

These solutions have been created and rened with the

expertise of providers that are already accustomed to a

heavily regulated environment. As increased regulation

becomes a reality and compliance risks mount in themonths ahead, Europe can transform the current liability

of manual reporting into a valuable growth opportunity.


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What facets of compliance are respondents pointing out

as the most pressing drivers for change and the biggest

pain points? The majority of respondents perceive

system and process shortcoming as well as errors

in internal healthcare databases to be the greatest

obstacles for this year.

Systems / Process shortcoming

Lack of understanding policy

Poor record keeping or data entry errors

Not a current priority

No Issues Complying

42%

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

25%

21%

17%

7%

Other, please specify 1%


Issues Aecting Promotional Spend Compliance

Ineciencies with processes comes as little surprise in

the second annual compliance report. The increase ofmanual reporting systems and the use of Excel

spreadsheets to manage requirements, both from the

UK Bribery Act and the FCPA, directly correlate to 42%

of respondents feeling unsatised with their current

reporting method. Those surveyed cite a lack of policy

understanding (25%) and poor record keeping or data

entry errors (21%) as their second and third largest pain

points aecting promotional spend compliance.

With two of the top three concerns regarding inabilities

to manage data eectively, organisations must urgently

consider enhancing and upgrading their existing

aggregate spend reporting systems. Presently, European

companies are adding an unnecessary level of complexity

to the already taxing process of compliance.

According to the US compliance survey, many

respondents currently derive game-changing benets

from aggregate spend and disclosure reporting solutions

that leverage superior technology. Todays innovative

solutions seamlessly integrate promotional expenses,

such as marketing, research, salaries, and honoraria

data, which are then consolidated into a single customer

view. To alleviate the uncertainty in achieving cross-

enterprise transparency, US companies have invested

in next-generation solutions to automatically generate

reports, deliver due-date reminders, and continually

update regulations and report requirements.

Matching and establising unique

identication of a Healthcare Professional

Managing incomplete spend and customer

information

Identifying all data sources

Reporting and disclosure management

Regulatory analysis and monitoring

37%

0% 10% 20% 30% 40% 50% 60%

33%

29%

28%

24%

15%

10%

12%

11%

11%

Challenging Very Challenging

Figure 13: Index - pg.23Extent of Challenges for Processes

Persistent issues with reconciling databases have

continued since the rst annual compliance report in

Europe. Specically, respondents nd it dicult to

match and establish unique identication of healthcare

practitioners from an increasing multitude of expense

data sources with over one-half of respondents (52%)

considering this process to be either very challenging or

challenging.

When collating spend information from diverse and

numerous sources from across a companys structure,

one of the biggest challenges is incomplete data. A

company that cannot pinpoint a healthcare practitioner

from a group of expense data sources will be hindered

by inaccurate monitoring and reporting running the

risk of a compliance breach.

The survey reveals that data challenges extend beyond

establishing unique customer identications, as just

under one-half (43%) of respondents view managing

Drivers for Change


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incomplete spend and customer information, identifying

all data sources (41%) and reporting/disclosure to

management (39%) as either very challenging or

challenging.

Ensuring that customers are accurately identied is a

signicant challenge faced by both European and US

companies. As todays companies manage global customer

databases that draw from multiple sources, the task

of creating a unique identication for each healthcare

practitioner becomes increasingly challenging. Customer

data will often be incomplete and recorded dierently in

each business unit. As a result, US companies are relying

more on Customer Relationship Management (CRM)

solutions powered by comprehensive HCP databases to

help collect and verify complex, multi-source customer

data.

The creation of a Master Data

Management (MDM) system increases

accessibility across the enterprise and

minimizes bad data in order to mitigate

the risk of compliance breach.

Maintaining intelligent databases continues to be a

pressing challenge for the global Life Sciences market.

A key investment for US companies in recent years has

been Master Data Management (MDM) systems, which

improve transparency by providing a single master view

of databases for enhanced analysis and reporting. The

creation of MDM increases accessibility across the

enterprise and minimizes bad data in order to mitigate

the risk of a compliance breach.

With MDM yet to be optimized in the US business

model, the adoption of this solution could provide a

distinctive opportunity for Europe to further its self-

enforcing strategies. In combination with Aggregate

Spend Transparency and CRM solutions, MDM creation

would fully optimized their databases while helping to

leverage the sum of Europes nancial commitments that

have been made to improve transparency.


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Restoring the perception of the Life Sciences industry

will be no simple task. Companies have taken the

essential steps to re-establish partnerships with

healthcare providers and foster new trust in patients.

Yet 2012 nds legislators throughout Europe forging

ahead with transparency laws that impose criminal

charges and unlimited nes while many organisations

are still developing their strategies.

2012 represents a call to action for the

Life Sciences industry in Europe now is

the time to commit to transparency by

investing in solutions that will streamline

the compliance process.

But most of the groundwork for operational compliancepractises has already been done. The second annual

survey reveals that a majority of European companies

have very quickly enacted cross-organisational

corporate standards.

2012 represents a call to action for the Life Sciences

industry in Europe now is the time to commit to

transparency by investing in solutions that will

streamline the compliance process. Leveraging best-in-class Aggregate Spend Transparency technology

will not only provide competitive commercial gains but

also mitigate the dire risk of negative publicity that a

violation would produce.

Since Europe has one to possibly three years to

prepare, the upcoming year may bring about holistic

changes to their business structure. One can draw

endless comparisons to the US enforcement model,

but those companies exist in a separate market in

the throes of heavy regulation. Europe has the brief

advantage of strategizing for the future. When all is

said and done, European companies will create their

own path to integrate more stringent regulations into

their business model.

Another benecial path that Europe may advance

toward is employing breakthrough Life Sciences-

specic, Customer Relationship Management (CRM)

solutions. These IT solutions, when combined with

Aggregate Spend Transparency solutions, feature

actionable alerts that notify end users when a certain

HCP is reaching a proposed payment threshold

depending on the myriad of compliance standards

within Europe. And with many companies in Europe

already operating on CRM solutions, adopting new

functionalities geared toward compliance will help

automate the process of searching for suspect

nancial records.

Furthermore, the creation of MDM will provide

an accurate master view of customers in order to

organise sales and marketing initiatives and lay the

foundation for operational compliance. Especially as

many companies must consolidate data from multiple

customer sources, MDM systems serve as a centralized

source that veries data quality to promote holistic

accuracy.

Europe must quickly engage a combination of new

technologies and improved organisation at all levels

of promotional and marketing spending. As the cost

of sustaining manual reporting has become even

higher, it is imperative for companies to nd the

right solution to automate data capture and ensure

compliance at all levels of their business structure.

With increased tracking of aggregate spend data

already becoming an everyday function of Europes

Life Sciences industry, it is time to align with business

intelligence solutions that have a proven track record

of success in furthering global compliance.

Conclusion


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Cegedim Relationship Management is the leading global provider of Regulatory Compliance solutions for the Life

Sciences industry. The company provides the most comprehensively packaged oering, enabling companies to

meet present and future business requirements and objectives, and to achieve rewarding and lasting relationships

with customers. Solutions include:

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Contact Cegedim Relationship Management today for more information.www.cegedim.com/rm

[email protected]

Authors:

Bill Buzzeo

Vice President & General Manager,

Global Compliance Solutions

Cegedim Relationship Management

[email protected]

1425 U.S. Highway 206,

Bedminster, NJ 07921, USA

Tel: +1 908.443.2000

Guillaume Roussel

Vice President,

Compliance Solutions EMEA

Cegedim Relationship Management

[email protected]

127-137 rue dAguesseau,

92100, Boulogne Billancourt, France

Tel :+33 1 49 09 22 00

KNOW PERFORM PROMOTE COMPLY EVALUATE SUPPORT


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only with the written authorisation of Cegedim. White Paper 17

Chart Index

Increased number of countries requiring

greater transparency

Changes to current sales and marketing

practices

Increased resources required to manage

transparency

Commercial advantage of improved

reputation

Benet the business through reduced cost

due to greater measurement and visibility

70%

46%

45%

29%

26%0% 20% 40% 60% 80%

Figure 1:Impact of Anti-Corruption Legislation

Manually / with spreadsheets

Internal software system

Third party solution

We are not satisfying them


44%

0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%

43%

7%

4%

1%

Figure 2:Satisfying Reporting and Disclosure Requirements.


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Chart Index



Its absolutely a requirement

32%

64%2%

It would be nice but its not necessary

Figure 3:Importance of Implementing a Unique Spend Data Reporting and Disclosure Solution.

Understand the issues and support

my eects

Aware of issues but dont support

Unaware of issues


9%

87%

1%

3%

Figure 4:Senior Management Attitudes toward Transparency Reporting


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Chart Index



Collecting required compliance data

Analysing needs

Waiting for more European laws

41%34%

39%36%

16%16%

0% 10% 20% 30% 40% 50%

Country Head Oce Corporate / Regional Headquarter

Figure 7:Current State of Readiness for Transparency Requirements

Yes, applies to all the external partners and

internal data

Yes, but applies only to some external

partners and internal systems

No, we do not have standards

No, but we are in the process of dening ore

No, looking for a vendor to provide a

solution

76%

0% 10% 20% 30% 40% 50% 60% 70% 80%

18%

3%

1%

1%

Figure 8:Enforcing of Company Spending for HC Professionals.


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Chart Index

All items listed

Speaker fees

Consultancy services

Continuing Medical Education

Promotional Meeting Costs

Clinical Trials

Participation in Advisory board


30%

0% 5% 10% 15% 20% 25% 30% 35%

22%

12%

12%

7%

6%

3%

3%

Figure 9:Types of Data that Standards Are Applied To

Stay the same

Increase

Decrease

34%

52%

12%0% 10% 20% 30% 40% 50% 60%

Figure 10:Anticipated Investments in Solutions & Resources over the Next Year.


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Chart Index



Less than 1 year

1 to 3 years

3 to 5 years

Dont know

7%

64%

16%

14%

Figure 11:Expected Timeline for Promotional Spend Tracking in Europe to Reach US Levels

Systems / Process shortcoming

Lack of understanding policy

Poor record keeping or data entry errors

Not a current priority

No Issues Complying

42%

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

25%

21%

17%

7%

Other, please specify 1%

Figure 12:Issues Aecting Promotional Spend Compliance.


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Chart Index

Matching and establising unique

identication of a Healthcare Professional

Managing incomplete spend and customer

information

Identifying all data sources

Reporting and disclosure management

Regulatory analysis and monitoring

37%

0% 10% 20% 30% 40% 50% 60%

33%

29%

28%

24%

15%

10%

12%

11%

11%

Challenging Very Challenging

Figure 13:Extent of Challenges for Processes


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-Cegedim

RelationshipManagementBusinessUnit-RCSNanterreB350422622-13

7ruedAguesseau-92100BoulogneBillancourt-France-WP-2012

-02-EUCOMP-GL-A

2011 European Trends in

Aggregate Spend, Transparency

and DisclosureFebruary 2012

For more information, please contact

[email protected]

www.cegedim.com/eucompliance

2011 European Trends Compliance Report

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