2. Introduction
My first code awareness session focussed on current complaints and case studies, making you
aware that it is important to regularly review your marketing material to ensure high standards
of promotion within the code limitations.
This second session will focus on the procedural process through the MCA when a complaint is
lodged against you. Typically when a complaint comes in against you, panic and pandemonium
sets in, your team is pulled away from busy campaigns to focus on a claim you may have
forgotten about - where do you start in putting a defence together? What processes or
procedures can you put in place proactively to help you defend claim or code related
complaints?
Use this code update as a short training session; email with your colleagues or as a team
meeting slot for Code Awareness.
3. A complaint….What now?
How can complaints be raised – how will you know about it?
Typically a complaint must be raised against you from your fellow competitors themselves
before they go to the MCA. Inter company dialogue is ENCOURAGED.
However a complaint can come directly from a HCP or member of public straight to the MCA..
Calls would typically come into your medical affairs/medical information department, not to
marketing. Who is equipped there to handle such calls? Do they know procedure?
What next?
4. A complaint….What next?
Steps to take:
Reporting line identified – product manager, marketing manager, medical affairs signatory i.e.
the signatory team for that product
Identify lead in complaint adjudication – often medical affairs manager
Procedure/SOP?
Identify material/staff involved – find signatory record and accompanying claim reference pack
Team meeting to identify strategy
Draw up response – verbal and written, fully substantiated and code referenced – code
compliance officer?
Enter into negotiation with complainant/MCA
5. Code requirements
PART D – PROVISION FOR ENFORCEMENT
The MCA adjudicates on complaints and disputes in terms of the Code which is based on the
principle of self-regulation in line with international standards and practice. Basic steps are as
follows:
1. Intercompany dialogue - A reasonable response time for the respondents is 7 working days.
2. If the above fails and a MCA complaint is lodged, the MCA contacts the Respondent and
requests formal response within 5 working days.
3. The MCA shall upon receipt of the response, send a copy of the response to the Complainant
and invite a reply to be submitted within 7 working days
4. A complaint may be withdrawn by the Complainant at any time in writing, addressed to the
Executive Officer, in which case the complaint fee will be forfeited.
6. How to make a complaint - Complainant
1. Intercompany dialogue - A reasonable response time for the respondents is 7 working days.
2. If the complainant still wishes to, they must lodge a formal written complaint with the Executive
Officer, clearly setting out details of the complainant and the complaint, and shall be
accompanied by:
• proof that the company and complainant have made all reasonable attempts to resolve the matter
between themselves
• supporting literature and any studies relied on
• copies of any advertisements and/or promotional material which may be relevant
• make reference to the sections of the Code which may have been contravened
• the prescribed complaint fee applicable at the time
• send seven copies of the pre-requisite documents to the MCA for distribution to the Respondent and the
committee members when appointed
7. How to respond to a complaint -
Respondent
1. Intercompany dialogue – You have 7 working days for this response! Take down the details
(telephonic/email) and gather your team. Try and get this resolved amicably before they
decide to take it to the MCA.
2. Prepare a full written response in case it is taken to MCA
3. Find your signatory record and supporting literature needed to substantiate your claim
4. It may involve a rep, get a record of what transpired ( * what briefing material do you have
on record)
5. Refer to the Code – everything needs to be supported by specific clauses – have you broken
any clauses?
8. Learning Points
It is best to have a procedure drawn up as to what steps to take if a complaint is lodged against
you
Identify who is responsible for each step
Ensure your claims and materials have sufficient and easily accessed reference packs to back
them up
Briefing material for reps on how to promote a product using specific promotional material
comes in handy when trying to defend alleged inappropriate promotion
Know your weak points that may draw attention and have a plan to defend these
Its more about being PROACTIVE rather than REACTIVE when it comes to protecting company
claims.
9. In Conclusion
You can see that it takes numerous steps and preparation for a company to make a formal
complaint against you. Do you really want to be on the back step when this happens?
Rather be prepared and fight fire with fire. It is good to have some competition but only to
defend your claims SUCCESSFULLY – be confident that you can do this.
10. Thank you
I hope you enjoyed Session 2 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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