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 Pharmaceutical Industry’s view of congresses, trends & developments Christian-C

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

Pharmaceutical Industry’s view of congresses, trends & developments

Christian-C. RothIPCAA Co-PresidentGlobal Head Congresses & Conventions – Novartis Pharma AG

A new urgency for Compliance: Recent Legal Developments and their Implications for Conferences and Exhibitions

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 S2

Agenda

• IPCAA – An overview• General View on Congresses• Evolution of compliance programs • US Foreign Corrupt Practices Act and Sunshine Act • UK Bribery Act and ABPI Code • EFPIA e4ethics and Transparency Initiative• Standardization of Codes• What we all should do?• Outlook


An Overview

The International Pharmaceutical Congress Advisory Association IPCAA


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."


History

• Formed in 1989, originally as the European Pharmaceutical Congress Advisory Association (EPCAA)

• 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 • 1991 – became the International Pharmaceutical Congress Advisory

Association

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.


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 CPD/CME, 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.

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Interaction with Stakeholders

• Representatives of the Association meet regularly with leading meetings industry partners

• IPCAA is a frequent contributor to educational / information events arranged by other bodies within the meetings industry

• Coordinate with regulatory bodies – IFPMA, EFPIA, EUCOMED, etc

• Contributes to improved understanding of compliance within Medical Congresses and Conventions

► Compliance Ambassadors


Changing Landscape

Changing landscape with • tightened budgets• rising costs of healthcare• public scrutiny• reinforcement of laws and codices• 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


A general Pharma view on Congresses...Healthcare Industry remains committed to support scientific exchange and education

What is a medical congress for the Pharma Industry....

a sales Platform? ...a networking Platform?...an education Platform?....a Platform to mingle, wine and dine?...a bit of an incentive?.....

Or a bit of all of the above?


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


Laws

International (e.g. FCPA)

International (e.g. IFPMA, EFPIA)

National National

Self Regulation

(Industry Codes)

Company regulation

s

Might impose more stringentrequirements


Evolution of Compliance Programs

• Especially over the last couple of years a strong review and implementation of compliance programs across the Industry.

• Extension of scope and reach • Multi layer approach, take into consideration where

company is based, where it operates and with whom it interacts

• Increase of Industry led Codes, especially on a national level


“The following summaries of US Foreign Corrupt Practices Act, UK Bribery Act, UK ABPI Code and US Sunshine Act are compiled by the speaker to his best

knowledge and ability. However, these summaries do not claim to be complete nor shall they render any legal advice”


U.S. Foreign Corrupt Practices Act (FCPA)

• Applies to - companies listed on the U.S. stock exchange or - required to file disclosures under the U.S. Securities

and Exchange Act and- individuals acting on behalf of such companies


US Foreign Corrupt Practices Act – The Guide... • For example, the Guide contains detailed hypotheticals

addressing questions regarding jurisdiction under the FCPA;

- the treatment of gifts- travel and entertainment expenses- facilitating payments- successor liability involving acquired companies (previously not subject to the FCPA)- and third-party vetting

Will only cover selected topics on the following slides


US Foreign Corrupt Practices Act – The Guide... • The Guide includes, among other things:

An extensive discussion regarding the provision of gifts, travel and entertainment, including a hypothetical addressing the issue. This discussion includes the fact that DOJ and SEC have not focused enforcement efforts on the payment of reasonable travel and entertainment expenses, instead bringing cases where the corrupt payment of travel and entertainment expenses occurred in conjunction with other conduct reflecting systemic bribery or other clear indications of corrupt intent.


US Sunshine Act

• Under Obama called “Physician Payments Sunshine Act”, instigated in 2009 by Grassley / Kohl, adopted by Obama in 2010 to reduce healthcare costs through greater transparency

• All Transfer of Value from Industry to an HCP or HCP above USD 10 / transaction or above USD 100 aggregated per calendar year must be publicly available

• Penalties apply in case of failure• Various States in the US have additional reporting requirements,

e.g. D.C., West Virginia, California• Companies have started to self-report as part of CIA (Corporate

Integrity Agreements) on their websites• Official Reporting will start in August 2013


UK Bribery Act

• Applies to companies incorporated under the UK law irrespective of where they operate

• Corporate offence applies to any company “carrying on business in the UK” regardless of where the bribe is paid

• The other offences apply if the bribe is paid in the UK or if the person giving/receiving the bribe has a “close connection” to the UK (i.e. British citizen or resident, or company incorporated in UK)

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General Bribery Defintion

What is bribery? It is not just money – bribery has many forms

• Bribery is any gift, favor, or any other benefit given, offered or promised with the intention of influencing someone’s behavior for commercial advantage

• Even common business practices can constitute bribes in some circumstances

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UK Bribery Act

Risky areas:

• Cooperation with HCPs as prescribers but as well as researchers• Health officials and their influence to put particular products on

formularies as well their work as consultants• Health regulators can have dual functions as HCPs and decision

makers relating to approval of products• Hospitals, many of which are publicly owned (in the context of

purchasing decisions)• Hospitals or laboratories (in the context of new product testing)


UK Bribery Act

What can be classified as a payment or advantage?• Monetary payments• Invitations to congresses, workshops and events• Contractual payments for studies / clinical trials• Honoraria for speeches and articles• Honoraria for advisory boards and consulting• Gifts• Charitable donations• “Favours” (e.g., employing public official’s relative)


UK Bribery Act

• Unlawful? Intention Matters• Giving an advantage for improper

performance e.g.: • Rewards for high prescribers (Travel to meetings in

desirable locations, Advisory board contracts with minimal duties)

• Sending nurses to conferences to induce favorable placement of products

• Benefits to HCPs to create sales


UK ABPI Code

Association of British Pharmaceutical Industry (ABPI) Code of Practice Clause 18:• Only gifts that HCPs may keep are pens, pencils and notebooks at bona fide

meetings not exceeding £6 in total per person• Joint work with health authorities must be made by formal written agreements

which are publicly available

Clause 19:• Restrictions on meetings, hospitality and sponsorship• Sponsorship of meetings must be disclosed prominently on all related

materials• Financial details of sponsorship of HCPs to attend meetings must be

publicly available

Note: This is stricter than requirements of the Bribery Act


UK ABPI Code

ABPI Code of Practice Clause 19

• “Payment of travel expenses and the like for persons accompanying the delegate is not permitted”

• “Should only offer or provide economy air travel to delegates sponsored to attend meetings”

• “Lavish, extravagant or deluxe venues must not be used”

• “Companies must not sponsor or organise entertainment”

• “Companies should avoid using venues that are renowned for their entertainment”

• Meetings “which are wholly or mainly of a social or sporting nature are unacceptable”


• EFPIA represents the pharmaceutical industry operating in Europe. Its direct membership includes 33 national associations and 38 leading companies (plus Vaccines Europe (previously EVM), with 9 member companies and emerging bio-pharmaceutical companies – EBE with approx. 65 member companies.)

• The aim of the European Federation of Pharmaceutical Industries & Associations, which has no profit-making purpose, is to promote pharmaceutical discovery and development in Europe and to bring to the market medicinal products in order to improve human health worldwide.

• EFPIA pursues a mainly scientific aim, ensuring and promoting the technological and economic development of the pharmaceutical industry in Europe.

EFPIA Overview


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 behaviour in companies relations with healthcare professionals and patient organisations is essential – breaches should not be tolerated


EFPIA Position

• Establishment of National Ethics Groups in EFPIA’s member associations

• Inviting non-member companies to adhere to self-regulatory rules and guidance adopted by the R&D-based pharmaceutical industry

• Developing additional guidance around 5 areas to ensure that EFPIA membership continues to uphold the highest standards, including: (1) provision of information, (2) medical sales representatives,(3) medical samples, (4) events & congresses (including exhibitions), and (5) relationships with patient organisations

• Any practice that might create confusion about the real (scientific and educational) purpose of interactions between healthcare professionals and pharmaceutical companies shall not be tolerated.

• Corporations have a responsibility towards the communities in countries where they operate, and recognise that society has particularly high expectations of our industry.


EFPIA e4ethics

• An EFPIA website• www.efpia-e4ethics.eu

• A dedicated mail-box

• [email protected]• 5 Review areas – Scientific program, location and venue,

hospitality provided, other activities, accompanying people

• Three levels (orange, blue and green)

http://www.efpia-e4ethics.eu/

http://www.efpia-e4ethics.eu/


Real Life EFPIA Congress Assessment Example

http://www.efpia-e4ethics.eu/Farma_EFPIA/index.htm


EFPIA’s “Transparency” Project

• Increased external scrutiny of interactions between pharmaceutical companies and HCPs at national level:

Legal provisions: Denmark, France, Slovakia

Self-regulatory provisions: Netherlands, UK

Disclosure activities outside Europe: Japan, US

• EFPIA will soon disclose a European Initiative to manage Transparency Reporting within the Pharmaceutical Industry on EU Level


Standardization

• Lots of evolution and development in the compliance world

• The National Aspect will always be part of any program• General Principles will mostly be the same• At the end every company must interpret and roll out

their program


What we all should do?

• Be aware of the ongoing changes within Pharma Industry’s guidelines

• «Destination» is part of the Industry’s assessment, very often the reputational aspect is a key criteria, how the destination and infrastructure is positioned

• Co-promotion partner could influence the perception. Avoid that touristical attractiveness overshadows the business view

• Infrastructure, security, access from countries & continents in relation to the event must be given

• Understand that «social part» of a congress can create huge issues for Pharma Companies.



• Certain words (e.g. Gala Dinner) and activities (e.g. shows of local culture) are not in line with Industrys 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



• 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.


“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.”


Trends and Outlook – to name a few...• Pharmaceutical Companies will act differently on the

mentioned codes, e.g. e4ethics, total ban of congress delegations

• Less direct Industry support to HCPs• Shift from Marketing to Science - new and different ways

of supporting scientific interactions• Shift to co-payment arrangements• Increased geographical reach. LatCan and AsiaPac will

come more into consideration


Trends and Outlook – to name a few...• Prices and cost will become an even bigger criteria

within public reporting• Under the EFPIA Code national associations are

required to put in place national spent caps, e.g. for accommodation, F&B, etc

• Industry Partners are part of the regulations, we all need to be aware of it....

• New generation and their expectations to have access to information at any time, everywhere and for free...

• Increased awareness of Environmental issues



Many thanks!

Documents

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 Pharmaceutical Industry’s view of congresses, trends & developments Christian-C