COMPLIANCE: The Corporate Perspective
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The International Pharmaceutical Congress Advisory Association (IPCAA) aims to enhance medical congress outcomes through consistent policies and partnerships, responding to a changing landscape of tightened budgets and increased scrutiny. Established in 1989, it represents healthcare industry interests and facilitates discussions on compliance and transparency in medical congresses. Recent trends indicate a shift towards scientific engagement, reduced industry support for healthcare professionals, and increased geographical and cost considerations in congress planning.
COMPLIANCE: The Corporate Perspective
- 1. HOST SPONSORS #ACIE15 ORGANISED BY Co-President COMPLIANCE: The Corporate Perspective CHRISTIAN-CLAUS ROTH International Pharmaceutical Congress Advisory Association © Associations Network 2015
- 2. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S Christian-C. Roth IPCAA Co-President Head Global Event Governance – Novartis Pharma AG Compliance – the Corporate Perspective 2
- 3. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S An Overview The International Pharmaceutical Congress Advisory Association IPCAA
- 4. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S IPCAA mission statement "To ensure the most beneficial outcome for all parties involved in medical congresses, through the development of common and consistent congress policies and through recognised partnerships with medical societies."
- 5. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S History • Formed in 1989 as the European Pharmaceutical Congress Advisory Association (EPCAA), in 1991 change into International Pharmaceutical Congress Advisory Association (IPCAA) • First active members were Astra, Bayer, Ciba-Geigy, Glaxo, Hoechst, ICI, Janssen, Organon, Roche, Sandoz, Schering and SmithKline Beecham Reasons for formation: • „mushrooming“ of congresses • new and emerging regulations • sponsor contracts Note - The IPCAA and its members are aware of competition and anti-trust aspects. Vigilance is exercised, to avoid any discussion of topics that could raise anti-trust concerns.
- 6. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S IPCAA objectives • Act and be regarded as the voice of healthcare industry with leading policy-making healthcare organisations internationally • Facilitate and organise platforms for discussion of topics amongst relevant meetings industry stakeholders to contribute to improve understanding of congress-related issues such as compliance and transparency • Continue to offer high level education and information exchange in congress related matters. • Partner with medical societies and congress organisers on innovation, e.g. new technologies to enhance medical education dissemination of high level science. • Facilitate interactions within industry in order to play an instrumental role to determine the future of congress formats, policies etc.
- 7. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S Why are we doing all of this?
- 8. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S Changing Landscape Changing landscape with • tightened budgets • rising costs of healthcare • public scrutiny • reinforcement of laws and codices (FCPA, UK Bribery Act) • industry‟s reputational challenges • lack of transparency have led to a significant review of certain activities General financial situation in many countries has triggered a new view on well known practices
- 9. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S Changing Landscape in the medical congress world • Over the last couple of years a strong review and implementation of compliance programs within the Industry • Extension of scope and reach of various codes (“crossboarder”) • Multi layer approach, take into consideration -where company is based -where it operates and -with whom it interacts What used to be a logistical task developed into a complex challenge requiring a different approach and skill set
- 11. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S Laws International Reach (e.g. FCPA, UK Bribery Act) International (e.g. IFPMA, EFPIA) National National Self Regulation (Industry Codes) Company regulations Might impose more stringent requirements
- 12. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S • International Federation of Pharmaceutical Manufacturers & Associations • Represents the research-based pharmaceutical industry and the biotechnology and vaccine sectors • Scope of the 2012 revision of the IFPMA Code has expanded beyond marketing practices to cover interactions with healthcare professionals, medical institutions and patient organizations. • Launched in March 2015 the «Note for Guidance on Sponsorship of Events and Meetings» IFPMA
- 13. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S • European Federation of Pharmaceutical Industries and Associatiosn • EFPIA represents the pharmaceutical industry operating in Europe, direct membership 33 national associations and 38 leading companies (plus Vaccines Europe), with 9 member companies and emerging bio-pharmaceutical companies – EBE with approx. 65 member companies.) • EFPIA‟s members are bound by a code of practice governing these exchanges with those who prescribe, dispense and use medicines. • e4ethics Assessment Platform • EFPIA Disclosure Code launched in 2014, Data Collection in 2015, Reporting of HCP and HCP Spend in 2016. 33 Different Reporting requirements. EFPIA
- 14. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S The local Codes and regulations • Significant increase of local codes and regulations based on IFPMA and EFPIA standards with additional national requirements • Constant changes and interpretation standards • Local mandatory review or approval bodies (e.g Mdeon, Farmaindustria) • At the end every company must interpret external codes, set own standards and roll out their own compliance program
- 15. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S Medical Congresses • Pharmaceuticals Industry Focus is on Scientific, Medical Education • Main Focus at a congress is on the Scientific Program and the Symposia - Scientific Education & Exchange • Congress Exhibition is a mixture of commercial and medical activities which should be distinct. These two areas of activities require different review and approval forms. • Two different and distinct levels: • Company Activities at congress - e.g exhibition, symposia • Support of HCPs to attend
- 16. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S Key Stakeholders to consider... Medical Congress / Medical Associaton CME Provider Medical Society / PCO Delegations Origin & HCP in general IFPMA EFPIA e4ethics Suppliers / 3rd parties Speakers / Experts Company Standards Host Country Regulations EUCOMED et al
- 17. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S What should be done? • Collaboration internally with Congress Managers & Logistics Function • Collaboration of all involved internal & external parties. Use Industry Bodies like IPCAA Forums to address common issues and raise awareness and provide training • «Destination» is part of the Industry‟s assessment, very often the reputational aspect is a key criteria, how the destination and infrastructure is positioned. Raise awareness! • Co-promotion partner could influence the perception. Avoid that touristical attractiveness overshadows the business view. Address this with Congress Organizer and third party suppliers. • Infrastructure criteria, security considerations and access from countries & continents in relation to the event must be given. Share this with Organizer • Understand that «social part» of a congress can create huge issues for Pharma Companies.
- 18. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S What should be done? • Certain words (e.g. Gala Dinner) and activities (e.g. shows of local culture) are not in line with Industry's standards, they should not be proposed • Focus on “science” results in increase need for symposia halls, poster areas and meeting rooms etc. The exhibition part is decreasing. The selection of a destination or center must be due to the respective infrastructure, not the attractiveness. • Be aware that many Compliance Officers are searching the Internet for «publicly available information», if the destination and congress is promoted as touristic overall this could be challenging.
- 19. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S What should be done? • Understand that there might different interpretations of codes or regional differences (e.g. «Middle Eastern Medical Congress of XYW» in Dubai might allow different activities as the «International Medical Congress of ABC» in Dubai) • Medical Societies can arrange congresses and meetings up to their own standards, the support of Pharma Industry or the support of delegates to attend might not be possible. Lets work together. • Ensure that all company affiliates and regions are trained to the same standards. Raise awareness that Country delegations and HCP support are in focus, if not done right huge risk
- 20. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S “Please note that the following slides „Trends and Outlook‟ are the personal opinion of the speaker basing on his observation and experience as professional and IPCAA Co-President. Since they look into the future, no certain outcome can be guaranteed.”
- 21. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S Potential Trends and Outlook – to name a few... • Pharmaceutical Companies will act differently on the mentioned codes • Less direct Industry support to HCPs, Shift to co-payment arrangements • Shift from Marketing to Science - new and different ways of supporting scientific interactions • Increased geographical reach. LatCan and AsiaPac will come more into consideration • Prices & cost will become a new criteria in public reporting • New generation & expectations to have access to information at any time, everywhere and for free... • Increased awareness of Environmental issues
- 22. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S
- 23. E X C E L L E N C E I N G L O B A L H E A L T H C A R E C O N G R E S S E S www.associationscongress.com www.associationsnetwork.org