Healthcare Meetings: Hot Issues
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Transcript of Healthcare Meetings: Hot Issues
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#ICCAWorld iccaworld.com
Session code:
53rd ICCA Congress
Healthcare Meetings: Hot Issues
TE08
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ICCA Healthcare Meetings
• Welcome
• Why we’re here
• Ask questions!
• Case studies/table discussions
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ICCA Healthcare Meetings
• Our format today, a discussion + interaction: • regulatory/legislative
• CME landscape
• other factors affecting medical meetings
• medical association funding
• implications for venues
• implications for the future
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Our Experts
Dr. Edwin Borman, Associate, WentzMiller Global Services Alessandro Cortese, CEO, European Society for Radiology and Oncology Martin Jensen, Senior Manager & Head of Global Congress and Event Mgmt Global Product Strategy - Portfolio Development, H. Lundbeck Lewis Miller, Principal, WentzMiller Global Services LLC, Consultants in Health Education Worldwide, USA
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Our Experts
• Christian Mutschlechner, Director of the Vienna Convention Bureau
• Christine Sainvil, Compliance Officer, Eucomed
• Daniel Waigl, Executive Director, CIRSE: The Cardiovascular & Interventional Radiology Society of Europe
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#ICCAWorld iccaworld.com
Session code:
53rd ICCA Congress
Legislative/Regulatory Landscape: The Americas, Asia/Pacific
Lewis A. Miller MS, Principal WentzMiller Global Services Dr. Edwin Borman, Associate WentzMiller Global Services
TE08
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Open Payment rules go global
Transparency Required
•USA
•Europe
•Australia
•Japan
•Colombia (draft)
Considered
•India
•Pakistan
• Issues
• Law vs voluntary code
• Only 15% of companies who report in USA have global system in place
• Differing codes in different countries
• Cultural resistance
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U.S.: A complicated morass
The Sunshine law calls for disclosure of payments of $10 or more from industry to HCPs, except …
Payments made to 3d parties for accredited continuing medical education – now under challenge as discriminatory
First-year reporting a mess – not linking 40% of payments to individual doctors, wrong data, etc.
Thanks to Tom Sullivan, Policy and Medicine, for his contributions
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What legislative/regulatory changes do you expect will influence meeting attendance negatively for your organization?
USA
Survey of medical society managers
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U.S.: Transparency’s effect on meetings
Speaking payments by 4 major companies declined by more than 50% from 2011 to 2012 – in anticipation of Sunshine Act?
If payments made to speakers through 3rd parties for accredited CME must be reported, risk of further declines
Fewer EU docs coming to meetings in US as EU disclosures come in 2015?
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Transparency: rest of Americas
Canada •Encouraged by professors and press but no action yet
Colombia
•Draft law, if adopted, starts January 2015, mandatory in 2016
Comment
•Companies and physicians are happy with status quo: travel funded to medical meetings
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Transparency in Asia/Pacific
Australia Medicines Australia code goes into effect in 2015, less restrictive re meals
Japan
Pharma code adopted last year but reporting not implemented yet
India Indian Medical Council restricts industry sponsorship of travel, lodging for conference attendees – but no reporting
Pakistan
Drug Regulatory Authority seeks to increase industry-HCP transparency
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The Data Disparity Dilemma
Aggregate Spend
Reporting
Expense system-HCPs
Trial payment system-trial
mgrs
Purchasing system-vendors
Third parties-hotels,
airlines…
Manual entries-other
Trouble is – in most companies the processes and systems used in different countries do not always look the same nor have the same data dictionary
From Rhys Tee, Biogen Idec, March 2013
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#ICCAWorld iccaworld.com
Session code:
53rd ICCA Congress
HEALTHCARE MEETINGS/Europe
TBC
4 November 2014
Christine M. Sainvil Compliance Officer, EthicalMedTech
Martin N. Jensen Senior Manager & Head of Global Congress and Event Management, Lundbeck Global Product Strategy - Portfolio Development
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EFPIA & IPCAA
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MEDTECH EUROPE
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Acceptable Questionable Beyond
Adapted from Van Aelst, Roeland, April 2013
WHY COMPLIANCE?
• In line with your values • Legal • Legitimate business need • Modest • Appropriate • Fair market value • Patient benefit • Perceived to be acceptable
• What you can’t explain • What you can’t defend • What is not or poorly
regulated • Common practice, not in
line with values or codes • Common practice due to
lack of enforcement • Complex activity with all of
the above
• What puts the patient at risk
• Wrong intent • Illegal • Against your values • Not in line with industry
code or regulations • Extravagant
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EFPIA LEADERSHIP STATEMENT
General statements of industry leaders
- CEOs of 23 global companies
– Full respect for the role that EU legislation plays in regulating interactions between pharmaceutical companies and healthcare professionals
– Commitment to working towards greater transparency, accountability and ethical behaviour within an industry framework of self-regulation
– Adherence to EFPIA Codes establishing standards for appropriate behavior in companies relations with healthcare professionals and patient organisations is essential – breaches should not be tolerated
19
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DISCLOSURE CODE
EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals
and Healthcare Organisations the “EFPIA HCP/HCO Disclosure Code”
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DISCLOSURE CODE
This Code sets out the minimum standards which EFPIA considers must apply to all EFPIA Member Associations in all member states.
All EFPIA Member Associations are required to transpose this Code into their national codes in full by 31 December 2013, except where its provisions are in conflict with applicable national laws or regulations, in which case deviations are allowed, but only to the extent necessary to comply with such national law or regulation.
Member Companies shall be bound by the relevant EFPIA Member Association’s code in each country in Europe in which they operate (whether directly or through its relevant subsidiary).
Starting from 1 January 2015 - first Reporting/Disclosure early 2016
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TRANSFER OF VALUE
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COMPLEXITY?
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Article 17 PROHIBITION OF GIFTS New article clarifying that no gifts or pecuniary advantage (in cash or benefit in kind) may be supplied, offered or promised to an HCP Examples This includes brand reminders such as pens, binders, briefcases, bags etc. that could include product or company brand Impact Hıgher degree of scıentıfıc communıcatıon and delıverıng of key messages and promotıon through other channels
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PHARMA vs MEDTECH
Similarities Differences
• Promotion to and interactions with HCPs
• Medical and Professional Education support (CME)
• Attendance to congresses
• Research and innovation through collaboration with HCPs
• Advisory board
• Consulting arrangements
• High variety of products
– Development process
– Distribution channels
– Distribution/ purchase models
– Equipment-consumable relation
• High variety of companies
– Large multinationals
– SME
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EUCOMED CODE OF ETHICS
1. Eucomed Guidelines on Interactions with Healthcare Professionals (2008)
Statement of purpose and values (the spirit of the law vs. the letter of the law)
Specific rules of conduct
2. Q&A on the Eucomed Guidelines On Interactions with Healthcare Professionals (updated regularly)
3. Eucomed Compliance & Competition Law Guidelines (2012)
Statement of purpose and values
Specific rules of conduct
4. Procedural Framework (2012)
Implementation of the code, handling of code violations & sanctions
5. Opinions and advisory interpretations of the Eucomed Compliance Panel (ref. Conference Vetting System)
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MEDTECH – PRIOR NOTIFICATION REQUIREMENTS
Level 1:
Simple prior notification (Eucomed rules)
Direct Sponsorship of HCPs
Czech Republic, Denmark, Finland, Hungary, Ireland, the
Middle East, Poland, Portugal, Romania, Slovakia, Spain, UK
Contracts with HCPs
Belgium, Czech Republic, Finland, Greece, Hungary, Ireland,
Italy, the Middle East, Poland, Portugal, Romania, Slovakia,
Spain, Switzerland, UK
Level 2:
Specific prior notification
(national rules)
Direct Sponsorship of HCPs France, Italy (if passive attendance), The Netherlands
Contracts with HCPs Denmark (requirement on HCPs), France
Level 3:
Prior approval
(national rules)
Direct Sponsorship of HCPs
Austria, Belgium, Germany, Greece (if outside the country),
Italy (if active attendance), Switzerland, Turkey
Contracts with HCPs
Austria, Belgium (requirement of HCPs, Denmark (requirement
on HCPs), France (in certain cases), Germany, The Netherlands,
Norway, Russia, Sweden
Level 4:
Forbidden
Direct Sponsorship of HCPs Norway, Russia, Sweden (as of Jan 2015)
Contracts with HCPs Turkey (if public HCPs)
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MEDTECH FINANCIAL DISCLOSURE
Red: Legislation applicable to medical
technology industry.
Denmark, France, Italy, Ukraine
Blue: Self-regulation in discussion to be
applicable to medical technology industry.
Belgium, Netherlands
Green: Legislation applicable to pharma and/or
HCPs but not medical technology industry.
Portugal, Czech Republic, Slovakia
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THE CONFERENCE VETTING SYSTEM (CVS)
Objective CVS reviews the compliance of third-party educational conferences with the Eucomed Code of Ethical Business Practice (the “Code”) to determine the appropriateness for companies which are members of Eucomed and members of the national associations affiliated with Eucomed to sponsor Healthcare Professionals to participate in such conferences. Decisions Are binding on Eucomed members
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THE CONFERENCE VETTING SYSTEM
Scope Third party educational conferences in: European Economic Area Agreement + Switzerland + Russia + Turkey.
Eligibility •Eucomed members, including corporate members, national associations and associate members. •Conference Organisers (PCOs), •Medical Societies (MS).
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THE ASSESSMENT CRITERIA
Scientific Programme
Conference Venue &
Geographic Location
Hospitality Other
Activities Spouses
Programme
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e4ETHICS
• European Healthcare Congresses pre-assessment tool
• Three levels (orange, blue and green)
• The pre-assessment of events provided on e4ethics cannot, under any
circumstance, be interpreted as a judgement on the quality or content of
the scientific programme, or on the quality of the speakers.
• It is the company’s individual decision to decide to sponsor / participate in
the event.
• Companies belonging to the EFPIA membership should be mindful of the
rules and provisions that apply when deciding to sponsor, participate or
collaborate in an event
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Similarities
•HCP interaction
•Applies to direct sponsoring of delegates
• Although EFPIA relates to all of article 9 of it
guidelines including sponsorship activities
•EU (33 membership states) only
•Review programs, venues, destinations,
hospitality & accompanying persons
Differences
•Spouse programme
•Decision vs must follow Review process:
• EUCOMED done by conference owners
• e4Ethics done by EFPIA
CVS vs e4THICS
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THANK YOU
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Healthcare Meetings
• Discussion Topic 1: Legislative and regulatory landscape
• Ask questions!
• Case studies
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ICCA Healthcare Meetings
• Table Discussions
• Case studies to discuss; 20 minutes until break; experts answer after break
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A Large European Oncology Congress
Scenario
• 18.000 pax
• Registrants are oncologists, diagnosticians, nurses, patients
• Congress takes place in Amsterdam
• Exhibition over 20.000 m2: pharma, medical devices, publishers
• Over 2600 abstracts selected and presented
Questions to Address
• What are the compliance implications involved?
• What are solutions?
• What is the liability of the organizers? The association and the PCO (if involved)?
• Who is liable in case of infringement of local compliance policies?
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A Global Meeting to Untangle
Scenario
• American Heart Assn. annual meeting in 2016 in major convention center in Dallas
• Attendees include physicians from around the world
• AHA has its own meeting managers
• 40 pharma/device companies are exhibitors or sponsors – some international, some national
Questions to Address
• Whose responsibility is it to determine which doctors are being paid, how much and by whom?
• If a doctor from Japan is paid by the Japanese subsidiary of a US-based company, how is reporting handled?
• Do venue managers have any responsibility?
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Educational Master Class on Research
Scenario
• 80 pax
• Clinical oncologists with an interest on research
• Selected based on CV, sponsored by the inviting scientific society
• 5* resort in the Swiss Mountains, June
• Presentation of educational tools from the industry
• Corporate support possible
Questions to Address
• What are the compliance implications involved?
• What solutions?
• Is this congress sustainable in the long run?
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A Smaller Congress: Networking and Science
Scenario
• 100 pax
• Registrants are doctors, medical physicists, biologists and researchers
• Congress takes place in a French sky resort in January
• By invitation only
• Sessions between 8-10 am and between 17-19 pm
• All-inclusive rate
Questions to Address
• What are the compliance implications involved?
• What solutions?
• Is this congress sustainable in the long run?
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#ICCAWorld iccaworld.com
Session code:
53rd ICCA Congress
How Changes in CME/CPD May Affect
Medical Meetings
Lewis A. Miller MS, Principal WentzMiller Global Services Dr. Edwin Borman, Associate WentzMiller Global Services
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Non-regulatory Trends in CME/CPD
Accredited CME requirements are on the rise in emerging markets
India’s states are mandating CME
China may start penalties for non-compliance
Indonesia instituted a sophisticated CPD program
Asia Healthcare Meetings Forum calls for an improved focus on CME/CPD accreditation
Commercial support spending is down for CME as well as exhibits
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Non-regulatory Trends
More creativity needed from medical societies to maintain attendance and non-industry support
Millennials emphasize online, social media to learn and interact with patients
Maintenance of Certification emphasis in U.S. is on performance, not attendance
In UK, emphasis on revalidation through performance improvement
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Non-regulatory Trends in CME/CPD
EU legislation addresses the subject of CPD for the first time; UEMS welcomes the recognition by EU institutions of the importance of CPD
In EU, extending activities accepted for accreditation:
lectures, article reviews, enduring materials, examining, MCQ writing…
In Asia, pharma speaker predicts scaling back of large-scale meetings and sponsored convention activity in favor of small groups, tech-enabled
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Should venue managers worry?
Yes
Over time, doctors will migrate to more personalized learning, fewer large meetings
Possible changes
Look for flexible use of space or smaller sessions, workshops
Incorporate technology to personalize learning on site with social interaction
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ICCA Healthcare Meetings
• Poll audience on CME
• Ask questions!
• Topic 2: CME Supply and Demand
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ICCA Healthcare Meetings
• Panel conversation
• Ask questions!
• Topic 3: Other factors influencing the evolution of healthcare meetings
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ICCA Healthcare Meetings
• Discussion
• Ask questions!
• Topic #5: Implications for destinations and venues
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#ICCAWorld iccaworld.com
Session code:
53rd ICCA Congress
Future of Medical Meetings
USA vs Asia: Which Is UP?
Lewis A. Miller MS, Principal WentzMiller Global Services
###
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What we will cover
Attitudes toward medical meeting growth in USA and Asia
Commercial support spending patterns for medical meetings in USA and Asia
New growth areas and threats in USA Data sources: WentzMiller/ACEHP survey of medical meeting planners; Audience
response at Healthcare Meetings Forum Asia 2014
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Should venue managers worry?
USA
•Yes, if you are looking for growth in major medical meeting business
•No, unlikely to be major losses in next 5 years
Asia
•Yes, there is
– less optimism for the status quo
– more concern about declines in revenue sources
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Will meetings continue as a primary method of delivery of CME/CPD in your organization over the next 5 years?
USA
Survey of medical society managers
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How do you feel the future is for healthcare sector meetings?
Asia
Survey of healthcare managers
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What has been the pattern of attendance at your annual meeting over the past 5 years?
USA
Survey of medical society managers
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What do you expect the pattern of attendance at your annual meeting to be over the next 5 years?
USA
Survey of medical society managers
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58 58 #ICCAWorld | iccaworld.com
Do you think healthcare/lifescience sponsorship of HCP attendees to medical congresses is…? [Med society-Healthcare company-Agency]
Asia
Survey of healthcare managers
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59 59 #ICCAWorld | iccaworld.com
What has been the pattern of commercial support (education + exhibits) for your annual meeting over the past 5 years?
USA
Survey of medical society managers
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60 60 #ICCAWorld | iccaworld.com
What do you expect the pattern of commercial support (education + exhibits) for your annual meeting to be over the next 5 years?
USA
Survey of medical society managers
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61 61 #ICCAWorld | iccaworld.com
To what extent will exhibit booths continue to be an important part of scientific exchange? [Med society-Healthcare company-Agency]
Asia
Survey of healthcare managers
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62 62 #ICCAWorld | iccaworld.com
What has been the pattern of venue cost for your annual meeting over the past 5 years?
USA
Survey of medical society managers
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63 63 #ICCAWorld | iccaworld.com
What do you expect the pattern of venue cost for your annual meeting to be over the next 5 years?
USA
Survey of medical society managers
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64 64 #ICCAWorld | iccaworld.com
Where do you expect increases in delivery of CME/CPD in your organization over the next 5 years?
USA
Survey of medical society managers
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65 #ICCAWorld | iccaworld.com
ICCA Healthcare Meetings
• Discussion
• Ask questions!
• Topic #5: Implications for destinations and venues
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66 #ICCAWorld | iccaworld.com
ICCA Healthcare Meetings
• Topic #6: Your future relationships
• Each panelist give 2-3 takeaways
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67 #ICCAWorld | iccaworld.com
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