Transcript Corporate Design PowerPoint-Basis

Current Developments in
International Marketing Regulations
Pre-sales Challenges
Presentation by RA Dr. Ted Ganten,
Siemens Healthcare Sector, General Counsel Clinical Products Division
Head of Regulatory and Legal Compliance
Copyright © Siemens
Schutzvermerk
AG 2010. Alle Rechte
/ Copyright-Vermerk
vorbehalten.
Introduction 1/2
What is a pre-sales challenge?
 Marketing efforts that relate to specific
uncleared features or systems.
 Any contractual obligations/promises to
deliver an uncleared feature or system.
 Any import or exhibition of uncleared
features or systems.
Seite 2
14.09.2011
RA Dr. Ted Ganten
Copyright © Siemens AG 2011. All rights reserved.
Siemens Healthcare Sector / Clinical Products
Introduction 2/2
What is wrong with pre-selling?


 If a company is facing loss of reputation
or contractual liablities, it might not
validate new features or systems
unbiased.
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RA Dr. Ted Ganten
Copyright © Siemens AG 2011. All rights reserved.
Siemens Healthcare Sector / Clinical Products
Consequences 1/2
Violation against the country specific legal requirements could lead to…
 disciplinary sanctions against employees incl. termination,
 fines,
 import restrictions/detentions,
 debarment from public bidding procedures,
 administrative sanctions and
 criminal sanctions against Siemens, employees and management.
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RA Dr. Ted Ganten
Copyright © Siemens AG 2011. All rights reserved.
Siemens Healthcare Sector / Clinical Products
Consequences 2/2
The aforementioned legal requirements are mandatory law.
To start marketing uncleared medical devices poses
many other risks, such as:
 Early fixation of development roadmap;
 Likelihood of contract breaches resulting in
 damages;
 termination/recession
 Potential of „Fraudulent Inducement“ claims.
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RA Dr. Ted Ganten
Copyright © Siemens AG 2011. All rights reserved.
Siemens Healthcare Sector / Clinical Products
Executive Summary for Key Markets
Country
Advertisement
Quotations
Orders
Exhibitions
USA
No. Limited after
510k submittal.
No.
No.
Only after 510k
submittal.
Canada
Yes. Disclaimer
needed.
No.
No.
Disclaimer and info
of RAQA.
Brazil
No. Exceptions
possible*.
No.
No.
Authorization of
ANVISA required.
China
Not in public
media.
After start of
registration.
Yes
Import permission
required.
Japan
No
No
No
Import limited.
Russia
Yes
Not to gov.
customers
Not with gov.
customers
Max. 6 months
temp. import.
EU+Switzerland
Yes
Yes
Yes
Disclaimer
required.
There are separate rules for the use of investigational devices. Please contact the local Regulatory Affairs Manager.
*Case specific decision by ANVISA needed.
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RA Dr. Ted Ganten
Copyright © Siemens AG 2011. All rights reserved.
Siemens Healthcare Sector / Clinical Products
Pre-Sales Trouble
What are the alarm signals for pre-sales trouble?
 Sales Revenue is decreasing.
 Development of features/systems delayed.
 Competitor has released new important features.
 Customer dissatisfaction due to quality challenges.
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RA Dr. Ted Ganten
Copyright © Siemens AG 2011. All rights reserved.
Siemens Healthcare Sector / Clinical Products
Pre-Sales Issues
What do we do to avoid pre-sales issues?
 Regular in person training of the Management Teams by Legal.
 Web Based Training for Headquarter employees.
 Obligation of Country organizations to do regular trainings.
 Limits of authority process requires escalation in case of pre-sales.
 Software based global review and approval process for marketing material.
 Global set of disclaimers to be applied in specific situations (see next page).
 Strict disciplinary measures in case of misbehaviour.
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RA Dr. Ted Ganten
Copyright © Siemens AG 2011. All rights reserved.
Siemens Healthcare Sector / Clinical Products
Communication Control
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RA Dr. Ted Ganten
Copyright © Siemens AG 2011. All rights reserved.
Siemens Healthcare Sector / Clinical Products
Content
1.
Australia
10. Saudi Arabia
2.
Brazil
11. South Korea
3.
Canada
4.
China
5.
European Union + Switzerland
6.
Japan
14. Mexico
7.
Mexico
15. Saudi Arabia
8.
Malaysia
16. India
9.
Russia
17. Thailand
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12. Taiwan
RA Dr. Ted Ganten
13. United States of America
Copyright © Siemens AG 2011. All rights reserved.
Siemens Healthcare Sector / Clinical Products
Seite 11
14.09.2011
RA Dr. Ted Ganten
Copyright © Siemens AG 2011. All rights reserved.
Siemens Healthcare Sector / Clinical Products