This document provides a summary of code awareness and case studies handled by the MCA. It discusses issues around misleading claims, inadequate substantiation, and improper links from pharmaceutical websites. Three case studies are examined: 1) Bayer vs PD regarding links from a patient website to Bayer's product page; 2) Boehringer Ingelheim vs Servier around off-label claims and claim substantiation; 3) PD vs Bayer where Bayer's global website allowed consumer access in violation of local regulations. The document stresses ensuring proper claim substantiation, separating consumer and HCP sections of websites, and being aware of how global company links can affect local operations.

1. Code Awareness
SESSION 1

2. Introduction
Are you aware of the current complaints being handled and adjudicated by the MCA? Being
aware of current issues ensures your marketing and signatory teams are up to date with code
awareness protecting your company from competitor complaint and raising your ethical
standard among your pharma friends and ‘frenemies’!
Use this code update as a short training session; email with your colleagues or as a sales
meeting slot for Code Awareness.

3. Case Study 1
Bayer vs PD
Misleading and exaggerated claims and Patient Organisations and The Internet
Clause 7.3 and 20.8 Links from www.philthelegend.com had a direct link to product
Dynafil® on PD website
Clause 22.1 The Internet: www.edu-cate.co.za for use by HCPs but not password
protected therefore public could access
Outcome: link and password protection rectified and PD to pay all lodging and adjudication fees
to Bayer R22500! First transgression so no additional fine imposed by MCA.

4. Case Study 2
Boehringer Ingelheim vs Servier
Claimed off label claims and inadequate claim substantiation
A 4.2/5.2.5 “With proven mortality benefits”…Found to be consistent with PI
therefore no break in code found
A 7.2 “introducing the only RAASi/CCB combination with proven mortality benefits”
This has not been substantiated – guilty
A7.2 “5mg perindopril arginine is equivalent to 4mg perindopril terbutylamine”
..equivalence between the 2 salts is inferred but not substantiated – even
though bioequivalence data was submitted to MCC and was the basis of
approval! Withdraw all promotional material using this statement without
substantiation!
Outcome – no fine but Servier had to pay 50% of Ingelheim’s lodging/adjudication fee

5. Case Study 3
PD vs Bayer:
Advertising of products by parent global company, utilizing the internet, was within spirit of the Code?
2.1 Failed to maintain high ethical standards whilst conducting promotional activities because of
the below transgressions
2.3.5 Likely that a consumer would not distinguish between local bayer.co.za and parent
Bayer.com
2.5 Consumer able to access product information via links from www.bayer.co.za
5.2.1 Medicines Act/Section 5.2.1 of Code says cannot advertise S2-6 medicines to consumer –
website aided this
20.8 Links from site encouraged consumers to request doctors for specific medicines
22.1 Bayer does not require HCPs to enter a password before accessing educational information
and this contravenes this clause.

6. Case Study 3
Actions
 Remove all links from bayer.co.za constituting direct consumer marketing
 Any information intended for HCPs must be password protected
 MCA ongoing monitoring of Bayer's advertising
References
Code of Marketing Practice; 13 September 2013
http://www.marketingcode.co.za Last accessed Feb 2015

7. Learning Points
Websites for patient organisations/disease related/intending to be non promotional cannot
link to a product on a company website
Sections on websites for HCPs must be password protected to avoid promotion of products to
members of public
Inadequate claim substantiation is a risk! Use of the term “proven” is unlikely to be accepted
and use of bioequivalence data does not infer equivalence between products when using this in
comparative claims.
Global parent companies links to your company page can come under scrutiny especially with
regards to access by a consumer leading to product information and promotion.
If you complain against a competitor, expect to receive a complaint in return as ‘pharma
frenemie pay-back’! IOW ensure your own house is in order before you criticise another,
however inter-company dialogue is always encouraged to keep a competitive spirit alive.

8. In Conclusion
Does this make you think about your claims, interactions with patient organisations and more
importantly how these claims are portrayed on the internet and access to this information?
Makes you think….Who in your department or multifunctional team is reviewing your material
online?
A regular review is essential to keep your material current, up to date and at less risk of
complaint.

9. Thank you
I hope you enjoyed Session 1 of Code
Awareness. Follow me next week for more on
the Code and Pharmaceutical Marketing.
Yours in Pharma
Jessica
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BPHARM RHODES UNIVERSITY
jessica@iwrite-consulting.co.za
4 Sandberry Avenue
Tokai,Cape Town, 7945
www.iwrite-consulting.co.za
Tel 0837458240
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