EFPIA codex on transparency of value exchange more sunshine or rain?

Transcription

1 Automotive the way we see it EFPIA codex on transparency of value exchange more sunshine or rain? How the EFPIA codex wil create new challenges for the industry

2 Pharma needs to create transparency for value exchanges between Healthcare professionals and organizations on aggregate and individual basis Pharma has traditionally fostered relationships with Healthcare Professionals (HCP) with value exchanges that consumer advocates now consider conflicts of interest. The pharmaceutical industry has suffered from several law cases and thus has initiated a codex to create further transparency on aggregate and individual spending to Healthcare Professionals. Challenge I: Protection of data privacy How to match national data privacy laws with the EFPIA codex and ensure privacy of potential HCPs with deviating from the EFPIA code? On June 24, 2013 the General Assembly of EFPIA formally approved the EFPIA Disclosure Code on Transfers of Value to Healthcare Professionals and Organizations ( EFPIA HCP/HCO Disclosure Code ). This code aims at helping the pharmaceutical industry to support measures that will enhance relationships between industry, healthcare practitioners, patients and citizens at large and advance public health by creating further transparency on aggregate and individual spending to Healthcare professionals.with this code the industry recognizes its responsibility to show leadership in advancing responsibility and transparency. The code will require each member company to document and disclose on their websites, or common websites: 1. The names of healthcare professionals and associations that have received payments or other transfers of value. Challenge II: How to combine pan-european view on regulation and compliance of codex with the local national regulation? 2. The amounts or value transferred, and the type of relationship, such as consultancy fees, payment for travel or congress fees. These disclosures will be made for the first time in 2016 for 2015 transfers of value. Although this seems being far ahead EFPIA members and those adhering to the EFPIA codex need to take action now to get prepared for By the end of 2013 the codex needs to be translated into national requirements by the national associations of EFPIA which will create further complexity in dealing with a transparency framework from a pan-european level for you. 2

3 Challenges of EFPIA Codex and how to prepare your business in EU Challenge III: How to impact the code and ensure organization adherence? Challenge IV: Dealing with diverging data points in the organization. The Physician Payments Sunshine Act introduced in 2010 in the US prompted the implementation of Aggregate Spend by healthcare companies, a process used to comply with their obligation to aggregate and communicate the total amount spent on individual healthcare professionals and organizations. In Europe, the dynamic has just begun with laws against corruption and bribery like the GB Bribery Act in 2010 or the Anti-Gift law in France. Later on, the trend towards transparency emerged either through self regulation of industry associations (e.g., in the Netherlands and UK) or through laws similar to the Sunshine act (adopted in 2011 in both Slovakia and France). In that context, EFPIA recognized the need for harmonized disclosure requirements across Europe and adopted the EFPIA HCP/HCO disclosure code of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organizations (HCO). It has to be applied by all European members by the beginning of Despite similarities to the US Sunshine Act a key difference is the voluntary self-control of the EFPIA codex versus a mandatory law leaving leeway for various interpretation and actions. Capgemini Consulting investigated the main challenging factors in order to adapt to the EFPIA codex and the requirements needed for a successful European transformation. Fig. 1: Overview of existing laws regarding Transparency across Europe The Netherlands' Code of Conduct on Transparency of Financial Relations (2012) requires disclosure of aggregate information In Denmark, companies are required to declare their payments to doctor since 2008 The GB Bribery Act prevents bribery while associations like the ABPI and the ABHI set transparency requirements In Belgium, regulations ensure transparency (internal recordkeeping, Mdeon visa since 2007 etc.) France is leading the way toward legal regulations with the French Sunshine Act (FSA) enforced in May 2013 In Italy, there are general anti-bribery rules (interdiction of gifts, regulation of hospitality) In Spain, certain transparency regimes are imposed by the industry associations mostly regarding hospitality Slovakia has also been a leader in Transparency act by implementing the Slovakia Sunshine Act in September 2011 In Germany, the doctrine of employer consent and the German Pharmaceutical Act set light approaches Source: Capgemini Research 2013 Capgemini Consulting

4 Key questions to address challenges National legislation and EFPIA codex leave leeway for interpretation - How to interpret the industry code? To operationalize an aggregate spend solution, your company will need to interpret legislation and business rules around these requirements. Companies implementing processes and tools to fulfill the code requirements must take into account actions that have already been taken in those countries where laws or local codices pre-exist. Compliance to all regulations needs to be considered in a specific framework in order to fully comply on a pan-european level. In addition the different local requirements and EU countries have differing definitions on data to be reported leading to a more complex reporting requirement Ensure efficient data collection and reporting - How to collect, aggregate and report data to fulfill all requirements? Currently, most companies operating on a pan-european level collect spend data on a national level, sometimes with different systems and processes due to local requirements The practices of manual spend aggregation and reporting are not scalable and may require increasing time or support as requirements expand with the introduction of EFPIA codex leading to a risk of data inaccuracy and mishandling of data. It is therefore crucial to establish processes and systems to allow for an efficient data collection, aggregation and reporting. Changing the way you operate - How to create organizational awareness in the organization and train on codex adherence? HCP spending occurs in various departments throughout your organization. Creating the awareness for the EFPIA codex is key for the effective implementation of this regulation. It is thus important to develop a communication across various functions to ensure full employee participation. We suggest ongoing educational programs and change management measures to ensure a company transformation, mindset change and acceptance throughout the whole organization. Mastering data, system and business complexity - How to intersect business processes and individual data in numerous systems? Within your company various systems are used in order to track, measure or plan interactions with HCPs or HCOs used by multiple departments in various business processes. These systems include billing, travelling, event planning, CRM systems and other types of databases to plan, analyze and review transactions. Expenses and spend information often are linked to specific events, processes or interactions and are tracked in these different systems. For an effective and transparent reporting of spend data companies need to consolidate these information and adhere to standards to meet the codex requirements. As a result traditional business process and technology need to be adjusted alongside compliance requirements. The transformation is often regarded as additional burden to the running business leading to development cost and further challenges in timing. Accurate data collection and analysis is critical - How to avoid duplicates of HCPs tracked data and misreporting to safe standing of HCP? Accurate identification of HCPs is critical for accurate data collection and analysis. Duplicate HCP records occur when an HCP is called on by different parts of the business and interaction information is stored in different systems. These duplicates need to be reconciled to accurately report spending. 4

5 How to prepare for 2016 Given our experience in projects with leading global pharmaceutical companies we suggest to take a few steps forward in planning EFPIA codex compliance to get prepared for Fig. 2: Our assessment approach to codex integration Spend Discovery Assessment Step 1 What is needed to comply with the EFPIA codex? Step 2 Step 3 What is the current local situation and what effect will compliance have? What are valid alternative solutions to comply and how would it be done? Scoping / Situation analysis Country analysis Wave 1 1 Roadmap Precise definition of data required to be disclosed by law & legislation by country / EU Map out legislative requirements by country to show minimum requirements and full obligation of requirements Prioritize countries with biggest variations from legislation as well as process perspective Set the internal ambition by discussing and aligning scope of disclosure obligation Review individual countries in scope and assess country vs. EFPIA codex Scenario development In parallel see different country scenarios and evaluate compliance change Technology, Process and Ressource Assesment to estimate impact of codex Development of country specific and EU specific roadmap for implementation Risk analysis incl. soft factors for each country if not compliant Cost / Benefit calculation per compliant / non-compliant country Capgemini Consulting

6 Define the degree of compliance for your organization The EFPIA codex is a voluntary codex to adhere to. Consider the actions that you want to take and evaluate the additional business burden to comply to the codex and your specific business requirements. Review your current local / national situation Review the actual compliance codices relevant to you on national / regional level. What will be the effect for your current business situation? Define compliance framework Set-up measures for compliance to EFPIA codex including business processes, data requirements and technology used. Review the potential of aligning business processes and technology to meet data requirements. Your Benefits of EFPIA adherence A well designed EFPIA compliance solution provides efficiency and time savings from automating tracking, reporting and risk mitigation through robust data-driven reporting and audit readiness. Furthermore it can create potential insights in: Better customer insight, customer segmentation, business analytics and targeting through a transparent view of enterprise-wide HCP activities Greater clarity of spending enables control of activities Identification of non-value adding activities leading to better spend allocation in the future Next steps The Capgemini Consulting Life Science Practice has worked with leading pharmaceutical companies to implement the Transparency of Value codices and is a leading global provider of management consulting, technology and outsourcing services to the pharmaceutical, biotechnology and medical devices industry. We have specific expertise in: Support of other pharmaceutical clients in similar transparency projects so that we can draw from past experience projects for an audit proof transparency compliance framework Establishing efficient processes in order to quickly scan needed requirements and set-up a compliance framework for your needs Describe and analyze complex processes and provide end-to-end process definitions to support a transparency of value project Deep technological understanding of typical systems involved to track, analyze and report value exchanges Ability to evaluate savings potential and technology set-up for a transparency project Please contact us for further assistance. 6

7 7

8 Automotive the way we see it Contact: Sebastian von Strachwitz Head of Life Sciences Tel.: Tim Fischer Managing Consultant About Capgemini Consulting Capgemini Consulting is the global strategy and transformation consulting organization of the Capgemini Group, specializing in advising and supporting enterprises in significant transformation, from innovative strategy to execution and with an unstinting focus on results. With the new digital economy creating significant disruptions and opportunities, our global team of over 3,600 talented individuals work with leading companies and governments to master Digital Transformation, drawing on our understanding of the digital economy and our leadership in business transformation and organizational change. Find out more at: About Capgemini With more than 125,000 people in 44 countries, Capgemini is one of the world s foremost providers of consulting, technology and outsourcing services. The Group reported 2012 global revenues of EUR 10.3 billion. Together with its clients, Capgemini creates and delivers business and technology solutions that fit their needs and drive the results they want. A deeply multicultural organization, Capgemini has developed its own way of working, the Collaborative Business Experience TM, and draws on Rightshore, its worldwide delivery model. Find out more at: Capgemini. No part of this document may be modified, deleted or expanded by any process or means without prior written permission from Capgemini. Rightshore is a trademark belonging to Capgemini..