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Presentation re promotion 8 june 2011(2)

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Erik Vollebregt
Erik Vollebregt

The document provides an overview of regulations and guidelines around the promotion of medical devices in Germany, the Netherlands and the UK. It discusses regulatory requirements, misleading and comparative advertising laws, industry codes of practice, and alternatives to legal action such as making complaints to regulatory or advertising standards authorities. Key points covered include the need for CE marking, restrictions on claims, guidelines around providing information versus promotional materials, and dealing with competitors' advertising claims.

Health & MedicineBusiness
1 of 57
Life Sciences Seminar Germany, the Netherlands and the UK Alex Denoon, Mathias Klümper & Erik Vollebregt ©2009, Greenberg Traurig, LLP. Attorneys at Law. All rights reserved. GREENBERG TRAURIG, LLP ▪ ATTORNEYS AT LAW ▪ WWW.GTLAW.COM [ June 8, 2011 ] A Guide to Promotion of Medical Devices
Program: 4:00 – 4:45 Part I 5:15 – 5:30 Break 5:30 – 6:30 Part II 6:30 – Drinks & snacks
Slide Overview 3 Regulatory Framework 5 Misleading Advertising and Comparative Claims (and TM Infringement) 10 Alternatives: Complaint to Advertising Standards Authority or Malicious Falsehood 20 Industry Codes of Practice 26 Cases and Examples 32 Unsolicited Emails and Other Considerations 43 Resources and Definitions 49
Medical Device Promotion ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Information vs Advertising ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]
Regulatory Requirements ,[object Object],[object Object],[object Object],[object Object],[object Object],Restriction Article Devices may only be placed on the market (or put into service ) if they are CE marked 2 Devices may only be placed on the market for their intended purpose (IFU & marketing) 1(2) ,[object Object],[object Object],4(3)
Regulatory Enforcement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Regulatory Enforcement (2) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Exceptional Uses: Extra Care ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]
Misleading Advertising ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Misleading Advertising ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Misleading Advertising – Target Audience ,[object Object],[object Object],[object Object]
Misleading Advertising – Target Audience & Facts ,[object Object],[object Object]
Comparative Advertising ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Misleading and Comparative Claims ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Burden of Proof ,[object Object],[object Object],[object Object],[object Object]
National Differences ,[object Object],[object Object],[object Object],[object Object],Germany & The Netherlands UK Enforcement of MCAD? Competitor can bring action directly against a competitor ,[object Object],[object Object],[object Object],[object Object],Injunctive Relief ,[object Object],[object Object],[object Object],[object Object],Challenging
[object Object],[object Object]
Trade Mark Infringement ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ASA – Committee of Advertising Practice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ASA – Committee of Advertising Practice ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ASA Sanctions and Examples ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Malicious Falsehood ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Malicious Falsehood - Case ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]
Codes of Practice (UK) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ABPI Code ,[object Object],[object Object],[object Object],[object Object],[object Object]
ABPI Code (continued) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Industry Codes in Germany ,[object Object],[object Object],[object Object]
Therapeutic Goods Advertising Code ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]
GP v Boehringer Ingelheim ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Result of Case Claim regarding Misleading Conduct Result ,[object Object],No breach. While non-inferiority studies do not establish comparability and one product may not be as good as another, the differences are not clinically significant. ,[object Object],Breach. The claims together with the perfectly balanced scales implied that the products had been shown to be unequivocally equivalent. ,[object Object],No breach. As the RE-MOBILIZE study related to a lower dose than the approved indication, the omission was not misleading.
More Claims and Cases Promotional Claim Result ,[object Object],Breach. Denigrating comparative statement. Suggestion of superior efficacy and suggestion that other product is not effective at all. Not supported by proof. ,[object Object],No breach. Claimant s glucose meter is auto-coding and therefore not in the same market. ,[object Object],Breach. Readers were unable to understand the clinical relevance of the data presented as the dose ranges were not like for like (there were issues with maintenance dose and maximum dose). The report cited was out of date and did not reflect the current balance of evidence or support the claim
“ Substitutable” Example ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Claims – Avoid Absolutes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Specific Comparison Claims ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Claims re Company, not Product ,[object Object],[object Object],[object Object],[object Object],[object Object]
Animal Data ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Animal Data (2) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
General Suggestions re Slides ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]
Unsolicited Emails ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Unsolicited Email – Case ABPI Code ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Other Considerations ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Acknowledgement This presentation is based on an article written by the presenters that was published in Regulatory Affairs Journal – MedTech in March 2011.
Thank You ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Some Definitions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Some Definitions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
German Healthcare Advertising Law (I) ,[object Object],[object Object],[object Object]
German Healthcare Advertising Law (II) ,[object Object],[object Object],[object Object],[object Object]
German Healthcare Advertising Law (III) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
German Healthcare Advertising Law (IV) ,[object Object],[object Object],[object Object],[object Object]
Resources Eucomed Code http://www.eucomed.org/~/media/pdf/tl/2008/portal/abouteucomed/ethics/eucomedcodeofbusinesspractice.ashx ABHI Code http://www.abhi.org.uk/multimedia/docs/code-of-practice/abhi-cobp-december-2009.pdf Eucomed Q&A http://www.eucomed.org/~/media/C751B58FE49D4163B507007EF2F4A3F3.ashx ABPI Code http://www.pmcpa.org.uk/files/ABPI Code 2011.pdf Aust Code http://www.comlaw.gov.au/Details/F2007L00576 The Blue Guide (re advertising of medicines in the UK) http://www.mhra.gov.uk/home/groups/pl-a/documents/publication/con2022589.pdf The Business Protection from Misleading Marketing Regulations 2008 http://www.legislation.gov.uk/uksi/2008/1276/contents/made
Resources Nefemed code http://www.nefemed.nl/attachments/007_Nefemed%20gedragscode%202009.pdf Nefemed code Q&A http://www.nefemed.nl/attachments/007_Gedragscode%20Begeleidingsdocument%20Q&A.pdf Nefemed flyer http://www.nefemed.nl/attachments/007_Nefemed%20Flyer%20Gedragscode.pdf

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Presentation re promotion 8 june 2011(2)

  • 1. Life Sciences Seminar Germany, the Netherlands and the UK Alex Denoon, Mathias Klümper & Erik Vollebregt ©2009, Greenberg Traurig, LLP. Attorneys at Law. All rights reserved. GREENBERG TRAURIG, LLP ▪ ATTORNEYS AT LAW ▪ WWW.GTLAW.COM [ June 8, 2011 ] A Guide to Promotion of Medical Devices
  • 2. Program: 4:00 – 4:45 Part I 5:15 – 5:30 Break 5:30 – 6:30 Part II 6:30 – Drinks & snacks
  • 3. Slide Overview 3 Regulatory Framework 5 Misleading Advertising and Comparative Claims (and TM Infringement) 10 Alternatives: Complaint to Advertising Standards Authority or Malicious Falsehood 20 Industry Codes of Practice 26 Cases and Examples 32 Unsolicited Emails and Other Considerations 43 Resources and Definitions 49
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  • 48. Acknowledgement This presentation is based on an article written by the presenters that was published in Regulatory Affairs Journal – MedTech in March 2011.
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  • 56. Resources Eucomed Code http://www.eucomed.org/~/media/pdf/tl/2008/portal/abouteucomed/ethics/eucomedcodeofbusinesspractice.ashx ABHI Code http://www.abhi.org.uk/multimedia/docs/code-of-practice/abhi-cobp-december-2009.pdf Eucomed Q&A http://www.eucomed.org/~/media/C751B58FE49D4163B507007EF2F4A3F3.ashx ABPI Code http://www.pmcpa.org.uk/files/ABPI Code 2011.pdf Aust Code http://www.comlaw.gov.au/Details/F2007L00576 The Blue Guide (re advertising of medicines in the UK) http://www.mhra.gov.uk/home/groups/pl-a/documents/publication/con2022589.pdf The Business Protection from Misleading Marketing Regulations 2008 http://www.legislation.gov.uk/uksi/2008/1276/contents/made
  • 57. Resources Nefemed code http://www.nefemed.nl/attachments/007_Nefemed%20gedragscode%202009.pdf Nefemed code Q&A http://www.nefemed.nl/attachments/007_Gedragscode%20Begeleidingsdocument%20Q&A.pdf Nefemed flyer http://www.nefemed.nl/attachments/007_Nefemed%20Flyer%20Gedragscode.pdf