European Union of Medical Specialists

November 18, 2011 Conference

John McLoughlinChairman, European Medical Technology

Industry Association (EUCOMED)Compliance Panel

What is Eucomed?

• Eucomed represents the medical technology industry in Europe. Its mission is to make modern, innovative and reliable medical technology available to more people.

• Based in Brussels, Belgium• 25 staff

• Members:

– 25 national industry associations

– 3 associate Members

– 61 direct corporate members

– Over 4,000 local association members

* OECD 2010; European Patent Office 2006

• In September 2008 EUCOMED issued an updated code of ethics called the EUCOMED CODE OF BUSINESS PRACTICE (the “EUCOMED Code”).

• EUCOMED also has a Guidance Document which is updated periodically and which explains the Code in more detail through a series of Questions and Answers.

Purpose of the EUCOMED Code• The purpose of the EUCOMED Code is to regulate

interactions between EUCOMED members and healthcare professionals.

• The EUCOMED Code covers all types of interactions, including research and consulting agreements, gifts and the sponsoring of healthcare professionals to attend company events and third party professional congresses.

• EUCOMED supports self regulation of HCP interactions. The trend today is toward government regulation.

• In 2010 the EUCOMED Board created a compliance panel to enforce the EUCOMED Code. The Panel is made up of three independent persons:– John McLoughlin – A US and French Lawyer– Bernard Maillet – UEMS– Nancy Russotto – A Consultant and Former

Secretary General of the European Plastics Manufacturers Association

• Resolve complaints filed against EUCOMED members which are referred to the Panel.

• Issue opinions and interpretations relating to the EUCOMED Code.

• Impose sanctions on members for violations.• Manage the new EUCOMED Congress vetting

system.

• The EUCOMED Code places restrictions on what companies can and cannot do regarding:

• Consulting agreements• Royalties• Gifts• Sponsoring physicians and other healthcare

professionals to attend company sponsored events and third party congresses (including those organized by medical societies)

COMPANY SPONSORED EVENTSWhat is allowed

What is not allowed

What Companies Can Do

EUCOMED member companies may organize product and educational training for physicians and other healthcare professionals:

BUTThese events must be at appropriate locations

and in appropriate settings.Companies may provide reasonable travel and

meals for these events and, if allowed by law, reasonable lodging expenses.

What Companies Cannot Do

• Companies may not pay for lavish meals, travel, lodging at luxury sites.

• Companies may not pay for meals, travel, lodging or other expenses of spouses or guests.

• Companies may not finance leisure, sports, or inappropriate entertainment activities.

What Companies Must Do

• Inform the HCP’s superiors or organization which employ the physician or healthcare professional about the financial support to attend training and congresses.

• Avoid any conduct which gives the appearance of being inappropriate.

• Comply with local laws.

Third Party or Professional Society Congresses

• The same rules which apply to company organized events also apply to congresses organized by third parties, such as professional medical societies.

• However, additional rules apply.

Additional Rules

• Sponsorship restrictions apply to not only to healthcare professionals, but also to the congress organizers. In other words, if it is not permitted under the EUCOMED Code for a company to provide financial support directly to the congress organizers (for example through advertising) if the congress is inappropriate.

New EUCOMED Congress Vetting System

• The new system will be run by a Compliance Officer who will report to the Compliance Panel.

• The new system will be compulsory. Members must comply with rulings issued by the Compliance Officer. If a congress is found to be inappropriate, companies may not sponsor either HCPs to attend or the congress itself.

• There will be a six month trial period before the system becomes fully operational.

Congresses Which Present Problems

• Inappropriate location “in season”• Luxury accommodations• Weak scientific content• Gaps in the program• Programs with sports or entertainment (other

than opening cocktail and or program dinner)• Congresses which encourage spouses or

partners to attend