WIXLIB

PANEL DISCUSSIONSeminar – 28 May 2015

Question 1 Pre-licenceactivity - Advertisement andpromotion are subject to domesticlegislation, i.e. if a product is notregistered in South Africa, it cannot bepromoted, even if the congress isinternational in nature, unless exemptionhas been granted in terms of applicablelegislation. Who grants that exemption?

Q1 – Bernice Grusd PART A CLAUSE 4Promotion of a medicine must be in accordancewith the registration & consistent with the PIA medicine must not be advertised or promoted: prior to registrationException - application has been submitted in terms ofSection 14(3) of the Medicines Act (“old medicine”),which permits its sale, supply and use in South Africa.The legitimate exchange of medical and scientificinformation during the development of a medicine isnot prohibited provided that this does not constitutepromotion.The MCC grants that exemption

Question 2 Wewould like to find out if we are allowedto invite staff (Clinical and TechnicalEngineers) from Government Hospitals fora Product Launch on new technology forOperating Rooms?

Q2 – Tanya Vogt Differentrules apply depending on theprimary mode of action of a device orcombination device Audience must comprise of persons whorequire specific information on the devicein order to deliver a service to the patienti.e. you must be able to justify why aparticular category of person was invited

Question 3 Reimbursement - Please can you assist me. I wouldlike to make use of the services of XXX through anumber of CME meetings around the country on thetopic of reimbursement and the changing climatebut my US colleague says its not Code compliant.The reason given was that depending on the contentof the talk, it can be seen as offsetting a business costfor the surgeons (it's not really an "educational" talkbut more helping surgeons manage his part of theirbusiness). Second, sometimes these talks help guidesurgeons to submit for higher reimbursement in aninappropriate manner. But in SA, what about patientaccess?

Q3 – Nicole Edelstein Rationale for any meeting or sponsorship to attenda meeting is to be transparent, valid and cogentThe Code aims to ensure - maximum healthcarebenefit to patientsNo mention of product specificsProviding the required information needed for thefunder to make an appropriate decisionReimbursement assists patients more than doctorsEvidence-based choicesFinances cannot be ignored in healthcaredecisions

Question 4 Reply paid cards - We have a pharmaceutical client whosends out a postcard – DL Size with their new productinformation that is addressed to either a doctor – by name –followed by a postal address or pharmacy – by name andmailed as a first port of call to the healthcare provider.This means that the address label which is affixed to thepostcard will be sent out from our mail house directly to thedoctor or pharmacist in question. I wish to point out that it isaddressed to a person and therefore it is for the intendedrecipient.The recipient does NOT HAVE TO RETURN THE POSTCARD VIAPOST TO THE SENDER and this must be stressed. I have beenasked by my client to clear the confusion around thedifference between a direct mail shot and a response mailmechanism.

Q4 – Nicole Edelstein Clause 9.8 HIGH STANDARDS, FORMAT, SUITABILITYAND ENDORSEMENT BY HCPS Clause 9: Note 2: Reply paid cards “Reply paid cards which are intended to bereturned to companies through the post must notinclude matters which relates to a health productwhich may not be legally advertised to the public.Reply cards may only bear the name of theproduct. The inclusion of information wouldconstitute advertising to the public. “

Q4 – Nicole Edelstein Whatrestrictions apply if a postcard isaddressed by name to a doctor orpharmacy? Do these restrictions differ depending onwhether a direct mail shot or a responsemail mechanism is employed?

Q4 – Nicole Edelstein Differencebetween a direct mail shotand a response mail mechanism Medicine scheduled 2 or higher, thiswould be in contravention of Regulation45 The guideline explains this further byadvising that reply cards may only bearthe name of the product

Question 5 Itemsat conferences and exhibitionstands - Can a pharmaceutical companyput an interactive programme on anexhibition stand that requires an attendeeto make a series of judgements andchoices regarding a treatment pathway? When would such a programme becomea quiz, if it was not one already?

Q5 – Bernice Grusd May be regarded as simply educational material,depending on its content it could also beconsidered to be a quiz and thus subject to therequirements relating to quizzes in Clause 19.4.Any assessment or evaluation of the delegates’decisions may mean that the interactiveprogramme is a quiz.A quiz would be acceptable if it related to thesubject matter of the meeting and formed part ofthe meeting’s formal proceedings.Exhibition stands are not considered to be aformal part of a meeting’s proceedings.

Question 6 I have been asked to sponsor a Specialist Forum meeting. Thecommittee consists of 4 specialists (surgeon, oncologist,radiologist and pathologist) meeting once every 4 months toplan the meetings. I attend this planning meeting to facilitatelogistics and have no input into the topic selection. Once thedate and topic is selected, I source the venue, catering.The Committee sources the speakers. (No honorarium is paid tothese speakers)I print the invitation on the Pharma Company X letter head. Thisinvitation is distributed via two laboratories, to all doctors in thearea. I am listed as RSVP, thus I manage RSVPs for cateringnumbers.XX sponsor and apply for CPD accreditation.On the evening of the meeting, I ensure the attendanceregister is completed and that CPD certificates are distributed.

Question 6 Canthe rep sit in the planning meeting? Can the rep print the invites on PharmCompany X letterhead? Can the rep be responsible for the RSVPs? Can the rep attend the meeting? Can Pharma Company X pay for thevenue and catering (sponsorship/grant)?

Q6 – Bernice Grusd The following documentation is advisableA letter of request from the Specialist CommitteeSigned contract of engagement between the SpecialistCommittee and the Pharma companyCan the Sales Representative sit in the planning meeting?Yes, as they provide no input into the agenda.Can the Sales Representative print the invites on PharmaCompany X letterhead?Yes, provided there is full disclosure18.3Transparency

Q6 – Bernice Grusd Can the Sales Representative be responsible for the RSVPs?Yes, there is no unfair or improper advantage to be gained,they are providing reasonable supportCan the Sales Representative attend the meeting?Yes, but only as a silent observerCan Pharma Company X pay for the venue and catering(sponsorship/grant)?YesClause 15.4 – Organising meetingsClause 18.1 - Hospitality/venues of meetings and events

Question 6 Hospitalitycosts and provision of alcohol What is a reasonable cost of a meal anddrinks for an HCP for hospitality at ameeting

Q6 – Bernice Grusd Clause19.1 of the Code requires that thecosts of subsistence must not exceed thatlevel which the recipients would normallyadopt when paying for themselves. Standard operating procedure (SOP) –maximum amounts, quantity, costs andfor which type of meals

Question 7 Meetingvenues – follow up on the MCAstance with respect to casino venues tohost sizeable HCP meetings

Q7 – Tanya Vogt Templateletter – shared with EUCOMEDavailable on the MCA website library

Question 8 RepresentativesHCPspaying for access to

Q8 – Suzette Bezuidenhout 18.7.1No direct payments may be madeto Healthcare Professionals for any otherservices 15.3 Gaining interviews No fee / inducement / donation to gainan interview

Question 9 Inlight of recent amendments to theGeneral regulations published under theMedicines Act (which have introducedCAMs as a Category D medicine whichare subject to full product registration),please confirm whether the MarketingCode is applicable to CAMs?

Q9 – Nicola Brink 18C provides for a Code but does not mandate atthis stage membership to the MCAIndustry self-regulatesThis said the HPA have put forward a formalrequest to the MCA for CAMs to be included aspart of the MCA. They have put forward their ownCode but will be subject to the general part of theCode as is OTCs, devices etc. It is at the discretionof the MCA board to bring the HPA on board ornot.So for now – CAMs are not included. They arehowever subject to 18A, 18B and 22G whereapplicable.

Question 10 Itis interesting to note that thisorganisation HH is advertising 23 CPDpoints and cash and getaway prizes.Surely this is contrary to the MarketingCode? A discount for early registration isalso advertised? And as a health careevent it is certainly not in the spiritthereof?

Q10 – Suzette Bezuidenhout Offering a differential rate for early registrationis acceptable however the prizes offered arenot aligned to the Code. A complaint canbe lodged to address this matter.In the case of the organiser being a nonmember, MCA may consider highlighting therequirements of the Code in writing on behalfof its membersCompanies should establish the complianceto the Code of an event before sponsoring /aligning with any such events.

Question 11 Howdo we address a concern if thecompany perpetuating the problem is nota member of the MCA?

Q11 - Suzette Bezuidenhout MCAis self- regulating to the membersthat belong. Only other recourse is MCCor legal.

Thank Youinfo@marketingcode.co.za

sends out a postcard . please confirm whether the Marketing . This said the HPA have put forward a formal request to the MCA for CAMs to be included as part of the MCA. They have put forward their own Code but will be subject to the general part of