healthcare meetings: hot issues

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Session code:

53rd ICCA Congress

Healthcare Meetings: Hot Issues

TE08

2 #ICCAWorld | iccaworld.com

ICCA Healthcare Meetings

• Welcome

• Why we’re here

• Ask questions!

• Case studies/table discussions



• 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


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


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


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


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


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

9 9 #ICCAWorld | iccaworld.com

What legislative/regulatory changes do you expect will influence meeting attendance negatively for your organization?

USA

Survey of medical society managers


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?


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


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


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


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


EFPIA & IPCAA


MEDTECH EUROPE


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


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


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”


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


TRANSFER OF VALUE


COMPLEXITY?


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


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


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)


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)


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


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


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).


THE ASSESSMENT CRITERIA

Scientific Programme

Conference Venue &

Geographic Location

Hospitality Other

Activities Spouses

Programme


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


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


THANK YOU


Healthcare Meetings

• Discussion Topic 1: Legislative and regulatory landscape

• Ask questions!

• Case studies



• Table Discussions

• Case studies to discuss; 20 minutes until break; experts answer after break


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?


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


• 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?


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



• What solutions?

• Is this congress sustainable in the long run?


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



• What solutions?

• Is this congress sustainable in the long run?


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

###


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


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


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


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



• Poll audience on CME

• Ask questions!

• Topic 2: CME Supply and Demand



• Panel conversation

• Ask questions!

• Topic 3: Other factors influencing the evolution of healthcare meetings



• Discussion

• Ask questions!

• Topic #5: Implications for destinations and venues


Session code:

53rd ICCA Congress

Future of Medical Meetings

USA vs Asia: Which Is UP?

Lewis A. Miller MS, Principal WentzMiller Global Services

[email protected]

###

mailto:[email protected]


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


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


Will meetings continue as a primary method of delivery of CME/CPD in your organization over the next 5 years?

USA



How do you feel the future is for healthcare sector meetings?

Asia

Survey of healthcare managers


What has been the pattern of attendance at your annual meeting over the past 5 years?

USA



What do you expect the pattern of attendance at your annual meeting to be over the next 5 years?

USA



Do you think healthcare/lifescience sponsorship of HCP attendees to medical congresses is…? [Med society-Healthcare company-Agency]

Asia



What has been the pattern of commercial support (education + exhibits) for your annual meeting over the past 5 years?

USA



What do you expect the pattern of commercial support (education + exhibits) for your annual meeting to be over the next 5 years?

USA



To what extent will exhibit booths continue to be an important part of scientific exchange? [Med society-Healthcare company-Agency]

Asia



What has been the pattern of venue cost for your annual meeting over the past 5 years?

USA



What do you expect the pattern of venue cost for your annual meeting to be over the next 5 years?

USA



Where do you expect increases in delivery of CME/CPD in your organization over the next 5 years?

USA




• Discussion

• Ask questions!

• Topic #5: Implications for destinations and venues



• Topic #6: Your future relationships

• Each panelist give 2-3 takeaways


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THANK YOU FOR COMING!

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