2010 european trends in aggregate spend, transparency and disclosure

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2010 european trends in aggregate spend, transparency and disclosure

  1. 1. 2010 European Trends in Aggregate Spend, Transparency, and Disclo- sure 2010 European Trends in Aggregate Spend, Transparency, and Disclosure November 2010
  2. 2. Exclusive Survey Results on Life Sciences Industry Regulatory Compliance Trends... COMPLY
  3. 3. 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
  4. 4. 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
  5. 5. e White Paper 5 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
  6. 6. 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
  7. 7. 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
  8. 8. White Paper8 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
  9. 9. 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
  10. 10. White Paper10 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
  11. 11. 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
  12. 12. White Paper12 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
  13. 13. 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 external and internal data Yes, but applies only to external partners and internal systems No, we do not have standards No, but we are in the process of defining one 0% No, looking for a vendor to provide a solution 31% 32% 35% 37%Managing disparate formats and standards Matching and establishing unique identification of a Healtcare Professional from all the expense data sources Identifying all data sources Managing incomplete spend and customer information
  14. 14. White Paper14 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
  15. 15. 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 william.buzzeo@cegedim.com Guillaume Roussel VP Compliance Solutions EMEA Cegedim Relationship Management guillaume.roussel@cegedim.com Exclusive Survey Results on Life Sciences Industry Regulatory Compliance Trends... COMPLY Reproduction and distribution of this report is allowed only with the written authorisation from Cegedim.
  16. 16. White Paper16 2010 European Trends in Aggregate Spend, Transparency, and Disclosure For more information, please contact compliance@cegedim.com www.cegedim.com/eucompliance 2010 Cegedim, Inc. All Rights Reserved Reproduction and distribution of this report is allowed only with the written authorisation from Cegedim.White Paper16 2010 European Trends in Aggregate Spend, Transparency, and Disclosure For more information, please contact compliance@cegedim.com www.cegedim.com/eucompliance 2010 Cegedim, Inc. All Rights Reserved Reproduction and distribution of this report is allowed only with the written authorisation from Cegedim.

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