2010 european trends in aggregate spend, transparency and disclosure

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2010 European Trends in Aggregate Spend, Transparency, and Disclosure November 2010

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Page 1: 2010 european trends in aggregate spend, transparency and disclosure

2010 European Trendsin Aggregate Spend,Transparency, and Disclo-sure

2010 European Trendsin Aggregate Spend,

Transparency, and Disclosure

November 2010

Page 2: 2010 european trends in aggregate spend, transparency and disclosure

Exclusive Survey Results on Life Sciences Industry Regulatory ComplianceTrends...

COMPLY

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e White Paper 3

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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White Paper4

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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White Paper6

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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e White Paper 7

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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e White Paper 9

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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e White Paper 11

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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e White Paper 13

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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e White Paper 15

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

[email protected]

Guillaume Roussel

VP Compliance Solutions EMEA

Cegedim Relationship Management

[email protected]

Exclusive Survey Results on Life Sciences Industry Regulatory ComplianceTrends...

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White Paper16

White Paper16

2010 European Trendsin Aggregate Spend,

Transparency, and Disclosure

For more information, please contact

[email protected]

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

[email protected]

www.cegedim.com/eucompliance

2010 Cegedim, Inc. All Rights ReservedReproduction and distribution of this report is allowed only with the written authorisation from Cegedim.