ethical marketing leadership for health products

Frequently Asked Questions

Questions we are asked on a regular basis and some answers provided by the MCA team.


As suitable venues to host large cost-effective conferences are limited in South Africa, would Sun City be considered an appropriate venue?

CTAC member replies
Whilst the venue is a resort/casino – it is one of the very few cost effective venues in South Africa able to accommodate large Congresses – such as SA Heart with over 600 delegates. The number of venues able to accommodate larger meetings is restricted in SA.
The venue offers relatively inexpensive accommodation ( Cabanas & even the Cascades) for Conference delegates – not ALL accommodation is 5 star!
The options for such a large group is limited to certain venues in main cities which according to many organisers is more expensive that Sun City
The cost of transfers to Sun City average about R700 a delegate – offset against more costly accommodation options
The venue has been used as a suitable conference facility for over 20 years by Industry and denying the use thereof now will, in my opinion lead to higher cost options.
The Eucomed stance that it is not suitable has, as far as we know, not been officially decided. Should such a decision be made, it would put Eucomed members in conflict with our Pharma counterparts who would then be allowed to use it – precluding Devices/Diagnostics??
Security – it is a secure, safe venue
Captive audience – ensures delegates don’t leave the venue during the day or immediately after the educational component – allows suppliers greater opportunities to engage and interact with delegates
There is no logic in Eucomed approving a venue such as Nice for Cardiostim which is clearly a holiday resort destination and not approving Sun City simply because it has a casino and other resort facilities.


Can one sponsor an HCP to attend a site visit abroad? What about preceptorships abroad? Would the same rules apply with respect to travel, accommodation & hospitality as for HCPs who attend conferences?

CTAC member replies
Yes it is appropriate for members to invite Healthcare Professionals to plant or factory tours in countries outside their country of residence if there is a legitimate business purpose and the tour complies with the guidelines in all respects. Accordingly, members should ensure that appropriate documentation is put in place, hotel accommodation is not normally provided at top category or luxury hotels, air travel is economy and meals are of a standard that Healthcare Professionals would routinely expect if they were paying for them out of their own pocket.


Can our company sponsor a medical conference where an afternoon of golf is part of the agenda?

Abeda Williams replies
One needs to review the scientific / educational part of the agenda vs the time for other activities. The majority of the time should be on the educational aspects.
Have a transparent discussion with the organisers raising the concerns regards the golf and the optics thereof and request that they reconsider the agenda
Participants wanting to play golf – it should be at their expense and not part of the conference package
Should you consider sponsor of the medical conference, one needs to make it clear (preferably in writing) to the organisers / faculty that your sponsorship is only for the educational part and not for the social aspects.


What is ‘Fair market value’ for local HCP activities as we have detected inconsistent payments across industry for e.g. advisory board activity, consulting and delivery of speeches?

Nicole Edelstein replies
It would not be permissible for the MCA to publish what it considers/calculates to be ‘fair market value’ as this would be deemed anti-competitive in terms of SA legislation. Also, there are different valuation methods that may be used. In all instances, companies should use objective, verifiable criteria, for example, the level of expertise of the HCP, the type and length of service to be rendered, the preparation time required etc. The method or methods used should be documented. In all cases, a written contract or agreement must be put in place before commencement of the services which clearly specifies the nature and basis for payment of those services.


Can we pay travel time for a KOL to attend an international Ad Board? Can we sponsor a locum to cover the KOLs clinical practice, whist s/he is at the Ad Board?

Lynette Terblanche replies
Clause 18 of the Code deals with Interaction with Healthcare Professionals.
Clause 18.5 permits the use of HCPs as for services such as Advisory board meetings.
Reimbursement for travel, accommodation and modest hospitality for the Ad Board attendees is permitted. You may also pay an honorarium.
It is not deemed acceptable to pay for a locum or travel time for the attendees.
Note 3 of the Guideline states that Companies may sponsor travel for HCPs for:
b.HCPs attending advisory boards
Note 14: Scientific advisory boards
If companies have scientific or advisory board meetings, there shall be bona fide consulting services agreements with the HCPs.
A written agreement is encouraged.
It is important to note that Companies may not pay HCPs for their time whilst attending the CPD events under the guise that such events are scientific meetings or advisory board meetings. The general rules relating to spouses/partners, meals and refreshments and entertainment also apply in this context.


What should we consider if we plan to give a grant to a government institution/hospital? In return we would like the hospital to train certain staff members in our company on disease entities, attend ward rounds etc?

Abeda Williams replies
The two issues / activities should be separate and not linked i.e. the grant is not given on condition staff are trained on company related disease entities
A grant – should be clearly documented in an agreement specifying the amount, what the intended purpose is and that it is not based on the institution supporting/ prescribing your company products. For US and UK based companies – need to include clauses relating to FCPA.
The training – need to seek the HoD or senior hospital official permission to do training. Same applies to ward rounds and patients written consent that you are allowed to be part of the ward around even if you are a HCP. The consent should clearly explain the purpose of you attending the ward round.


In a large radiology practice with a number of HCPs, could one give an international book as a gift if it costs > R2500 as it would be used by a number of HCPs?

Nicole Edelstein replies
For scientific medical reference books, the maximum value permitted for an individual practicing HCP or for a practice (irrespective of the number of HCPs in the practice) is R2500 (incl. VAT) per year. Only for training or academic institutions may this value be exceeded to a maximum of R10000 (incl. VAT) per year.


Can we give HCPs mugs, cell phone holders (for their desk), car cellphone charger, IPad covers? Would these be acceptable gifts in terms of the value & intent? What about gifts to staff of an HCP who are not themselves HPCs?

Nicola Brink replies
Clause 19 Note 7: Gifts -items of general utility
Items of general utility which have been held to be acceptable gifts to doctors as being inexpensive and of relevance to their work include but are not limited to pens, pads, diaries, nail brushes, desk trays, calendars, and desk clocks.
Names of health products should not be used on promotional aids when it would be inappropriate to do so, for example, when it might mislead as to the nature of the item.
The value of gifts should not exceed R300 inclusive of VAT.
Gifts given to the staff of a Healthcare Professional should be treated as though they were given to the Healthcare Professional and accordingly must comply with the provisions of the guidelines in all respects.


Can we brand a gift to a patient who is already on our product? What gifts are permitted to patients e.g. Could we give earphones to patients to listen to music whilst they are on dialysis or receiving chemo?

Lynette Terblanche replies
Clause 19.2 and 19.3 of the Code address Gifts and Promotional Aids respectively.
Clause 19.2 of the Code deals with Gifts
19.2 Gifts
19.2.1 Occasional gifts to healthcare professionals, appropriate administrative staff, sales and other staff are acceptable provided that they are:
19.2.2 Inexpensive and of modest intrinsic value i.e. within the cost limit set from time to time per annum by the MCA.
19.2.3 Not for personal use e.g. no entertainment CD‟s/DVD‟s, electronic items for entertainment, tickets to attend sporting events or other forms of entertainment.
19.2.4 Educational and/or of scientific value, benefit the patient and/or be relevant to the practice.
19.2.5 No cash or cash equivalents are allowed.
Items intended for the benefit of patients could include educational brochures, for example.
However, “scrubs” and office supplies would not be considered an item for the benefit of patients. These are not offered as an unlawful inducement to the practice or HCP.
The Guideline states:
Note 10 :
Some items distributed as promotional aids are intended for use by patients and these are acceptable provided that they meet the requirements of Clause 19.2 and 19.3 i.e. modest (not more than R50 including VAT).
Note 11:
Items for patients
Other items that may be made available to patients should meet the relevant principles set out in Clause 19.2, that is they should be inexpensive and be related to either the condition under treatment or general health. Care must be taken that any such activity meets all the requirements of Medicines Act (Act 101) as well as the Code and in particular Clause 20 i.e. . No advertising of Schedule 2 – 6 medicines is permitted to the public.
No gift or promotional item for use by patients must be given for the purpose of encouraging patients to request a particular health product.
Reminder: The regulations pertaining to advertising in Act 101 (Reg 45) should be adhered to in terms of branding such gift.
Tip: Consider corporate branding as an alternative to product labeling.


Can my company give a charitable donation by buying tickets for HCPs to a Sports and Cultural day? The proceeds will go towards the Nelson Mandela Children’s Hospital?

Nicole Edelstein replies
Companies may support charitable events by making a donation to the sponsoring organisation but may not pay for individual HCPs to attend or participate in the charitable event. Furthermore, companies are not permitted to suggest to the sponsoring organisation the names of HCPs who could be invited to attend the event. The company may use some or all of its ticket allotment for its own employees and return any unused portion to the sponsoring organisation for use as the sponsoring organisation sees fit.
Charitable donations should also not be considered in response to requests by HCPs unless the HCP is an employee or officer of the charitable organisation and submits the request on behalf of the organisation.


Consumer Competitions –what is the maximum prize value & would this be construed as promotion to the public?

Nicola Brink replies
Clause 20.6 Note 1: Advertising of health products to the general public.
The advertising of S2 and above health products to the general public is prohibited by regulations under the Act. The promotion of health products in S0 or S1 to the general public for self-medication purposes is permitted.
Invitations to the public to participate in competitions or quizzes which are linked directly or indirectly to a S 2 and prescription-only health product are promotional in nature and are unacceptable. Competitions for S0 and S1 should not be linked to the purchase or sale of the product in any manner or form.
Clause 36 Note 2: Value of competition prizes
The total value of the prizes for a consumer competition must not exceed R100 000 (including VAT); and each individual prize may not exceed R5 000 (including VAT). A donation of any nature linked to the competition needs to be included in the total prize money.
37.1 No company shall be involved in promotional schemes which are hazardous to the public or which bring the industry into disrepute.
37.2 Entry into consumer competitions shall not be dependent on the conditional purchase of a health product nor shall a health product be offered as a prize. The value of the prize shall not exceed the limits set by the Marketing Code Authority from time to time.


What are some of the aspects to consider for product evaluations for medical devices given to HCPs? What about product evaluations to patients e.g. an IVD analyser?
Can one sample medical devices to HCPs?

Doreen Howard replies
Explanation of the difference between sampling and product evaluation.
Product evaluations are comprehensively explained in the Code.
Chemistry analyzers are worth millions of rands, however there is tremendous growth in point of care testing (POCT) – need to address this in the Code and Guidelines.


Pre-licence activity - Advertisement and promotion are subject to domestic legislation, i.e. if a product is not registered in South Africa, it cannot be promoted, even if the congress is international in nature, unless exemption has been granted in terms of applicable legislation. Who grants that exemption?

Bernice Grusd replies
•Promotion of a medicine must be in accordance with the registration &consistent with the PI
•A medicine must not be advertised or promoted:
• Prior to registration
•Exception – application has been submitted in terms of Section 14(3) ofthe Medicines Act (“old medicine”), which permits its sale, supply anduse in South Africa.
•The legitimate exchange of medical and scientific information during thedevelopment of a medicine is not prohibited provided that this does notconstitute promotion.
•The MCC grants that exemption


We would like to find out if we are allowed to invite staff (Clinical and Technical Engineers) from Government Hospitals for a Product Launch on new technology for Operating Rooms?

CTAC member replies
• Different rules apply depending on the primary mode of action of a device or combination device
• Audience must comprise of persons who require specific information on the device in order to deliver a service to the patient i.e. you must be able to justify why a particular category of person was invited


Reimbursement - Please can you assist me. I would like to make use of the services of XXX through a number of CME meetings around the country on the topic of reimbursement and the changing climate but my US colleague says it’s not Code compliant.
The reason given was that depending on the content of the talk, it can be seen as offsetting a business cost for the surgeons (it's not really an "educational" talk but more helping surgeons manage his part of their business). Second, sometimes these talks help guide surgeons to submit for higher reimbursement in an inappropriate manner. But in SA, what about patient access

Nicole Edelstein replies
• Rationale for any meeting or sponsorship to attend a meeting is to be transparent, valid and cogent
• The Code aims to ensure – maximum healthcare benefit to patients
• No mention of product specifics
• Providing the required information needed for the funder to make an appropriate decision
• Reimbursement assists patients more than doctors
• Evidence-based choices
• Finances cannot be ignored in healthcare decisions


a) What restrictions apply if a postcard is addressed by name to a doctor or pharmacy?

b) Do these restrictions differ depending on whether a direct mail shot or a response mail mechanism is employed?

a) Nicole Edelstein replies
Reply paid cards – We have a pharmaceutical client who sends out a postcard – DL Size with their new product information that is addressed to either a doctor – by name – followed by a postal address or pharmacy – by name and mailed as a first port of call to the healthcare provider.
This means that the address label which is affixed to the postcard will be sent out from our mail house directly to the doctor or pharmacist in question. I wish to point out that it is addressed to a person and therefore it is for the intended recipient.
The recipient does NOT HAVE TO RETURN THE POSTCARD VIA POST TO THE SENDER and this must be stressed. I have been asked by my client to clear the confusion around the difference between a direct mail shot and a response mail mechanism.

• Clause 9: Note 2: Reply paid cards
• “Reply paid cards which are intended to be returned to companies through the post must not include matters which relates to a health product which may not be legally advertised to the public. Reply cards may only bear the name of the product. The inclusion of information would constitute advertising to the public.”

b) Nicole Edelstein replies
• Difference between a direct mail shot and a response mail mechanism
• Medicine scheduled 2 or higher, this would be in contravention of Regulation 45
• The guideline explains this further by advising that reply cards may only bear the name of the product


Items at conferences and exhibition stands - Can a pharmaceutical company put an interactive programme on an exhibition stand that requires an attendee to make a series of judgements and choices regarding a treatment pathway?
When would such a programme become a quiz, if it was not one already?

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


I have been asked to sponsor a Specialist Forum meeting. The committee consists of 4 specialists (surgeon, oncologist, radiologist and pathologist) meeting once every 4 months to plan the meetings. I attend this planning meeting to facilitate logistics and have no input into the topic selection. Once the date and topic is selected, I source the venue, catering.
The Committee sources the speakers. (No honorarium is paid to these speakers)
I print the invitation on the Pharma Company X letter head. This invitation is distributed via two laboratories, to all doctors in the area. I am listed as RSVP, thus I manage RSVPs for catering numbers.
XX sponsor and apply for CPD accreditation.
On the evening of the meeting, I ensure the attendance register is completed and that CPD certificates are distributed.
• Can the rep sit in the planning meeting?
• Can the rep print the invites on Pharm Company X letterhead?
• Can the rep be responsible for the RSVPs?
• Can the rep attend the meeting?
• Can Pharma Company X pay for the venue and catering (sponsorship/grant)?

Bernice Grusd replies
• The following documentation is advisable
• A letter of request from the Specialist Committee
• Signed contract of engagement between the Specialist Committee and the Pharma company
• Can 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 Pharma Company X letterhead?
Yes, provided there is full disclosure
18.3 Transparency
• Can the Sales Representative be responsible for the RSVPs?
Yes, there is no unfair or improper advantage to be gained, they are providing reasonable support
• Can the Sales Representative attend the meeting?
Yes, but only as a silent observer
• Can Pharma Company X pay for the venue and catering (sponsorship/grant)?
Clause 15.4 – Organising meetings
Clause 18.1 – Hospitality/venues of meetings and events
Hospitality costs and provision of alcohol – What is a reasonable cost of a meal and drinks for an HCP for hospitality at a meeting?
Bernice Grusd replies
• Clause 19.1 of the Code requires that the costs of subsistence must not exceed that level which the recipients would normally adopt when paying for themselves.
• Standard operating procedure (SOP) – maximum amounts, quantity, costs and for which type of meals


Meeting venues – follow up on the MCA stance with respect to casino venues to host sizeable HCP meetings

CTAC member replies
• Template letter – shared with EUCOMED available on the MCA website library


Representatives paying for access to HCPs

Suzette Bezuidenhout replies
• 18.7.1 No direct payments may be made to Healthcare Professionals for any other services
• 15.3 Gaining interviews No fee / inducement / donation to gain an interview


In light of recent amendments to the General regulations published under the Medicines Act (which have introduced CAMs as a Category D medicine which are subject to full product registration), please confirm whether the Marketing Code is applicable to CAMs?

Nicola Brink replies
• 18C provides for a Code but does not mandate at this stage membership to the MCA
• Industry self-regulates
• 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 the Code as is OTCs, devices etc. It is at the discretion of the MCA board to bring the HPA on board or not.
• So for now – CAMs are not included. They are however subject to 18A, 18B and 22G where applicable.


It is interesting to note that this organisation HH is advertising 23 CPD points and cash and getaway prizes. Surely this is contrary to the Marketing Code? A discount for early registration is also advertised? And as a health care event it is certainly not in the spirit thereof?

Suzette Bezuidenhout replies
• Offering a differential rate for early registration is acceptable however the prizes offered are not aligned to the Code. A complaint can be lodged to address this matter.
• In the case of the organiser being a non-member, MCA may consider highlighting the requirements of the Code in writing on behalf of its members
• Companies should establish the compliance to the Code of an event before sponsoring / aligning with any such events.


How do we address a concern if the company perpetuating the problem is not a member of the MCA?

Suzette Bezuidenhout replies
• MCA is self- regulating to the members that belong. Only other recourse is MCC or legal.


MCA do’s and don’ts for events
•   Ask yourself – can I substantiate this should it appear in the media? Is it justifiable, fair,
transparent, balanced and in the interest of the patient?
•   Remember that this applies to both online and offline advertising (including social media)
•   Consider how you interact with HCP’s and how this can be perceived by patient
•   Is it reasonable, fair and modest?
•    Remember to recertify your promotional material at least every two years
•    Remember you need to recertify by taking the assessment every two years to be code compliant
•   Occasional gifts to healthcare professionals, appropriate administrative staff, sales and
other staff are acceptable provided that they are: Inexpensive and of modest intrinsic value.
•   The value of gifts should not exceed R300 (inclusive of VAT)
•   The main focus of CPD meetings and conferences must be clearly scientific and/or
•   The venue must be appropriate
•   The meeting and event must be appropriate to all delegates’ scope of practice
•   Do NOT advertise scheduled medications directly to consumers (with the exception on
S0 and S1 medications)
•   Do NOT have sales and marketing personnel disseminate off-label information
•   NO celebrity endorsements are allowed for promotion of medicine directly to consumers
•   Professional endorsement of medicine by a HCP shall be within the scope of their respective professional Codes
•   Do NOT use promotional material without credible referencing
•   References must be made available on request from a HCP
•   NO stand-alone entertainment or other leisure, social or sporting activities may be
planned, arranged or funded by companies


Is premium economy travel acceptable considering that business class travel for HCPs is generally not acceptable?

Robyn Howes replies
•The Guideline to the Code States
“Companies may sponsor Business class travel for HCPs only for:
a.Faculty members presenting at a congress irrespective of day of arrival
b.HCPs attending advisory boards and clinical investigations irrespective of day ofarrival
•Business class airfares may not be exchanged for two Economy tickets so thata companion/spouse may accompany the HCP.
•For any other travel, economy class travel is the standard class travel thatcompanies may offer HCPs to attend both local and international events,including congress attendance and site visits.
•It is not appropriate to pay for travel expenses for guests or spouses/partnersof HCPs or for any other person who does not form part of the trainees orinvited attendees at such a meeting.
•Travel should be arranged by the sponsoring company (or their designatedtravel agent), and should be restricted to the designated meeting dates(dependent on the travelling time involved, this may include arriving 48 hoursbefore the meeting, and departing soon thereafter).”
•Developments in recent times had led to classes of travel being offered whichincluded ‘economy’ in their title such as premium economy and were partway between economy and business class.
•The CTAC noted that airlines’ offerings differed. Some airlines offeredeconomy, premium economy and upper-class flights and therefore premiumeconomy might be considered a version of business class. Other airlinesoffered economy, world traveller plus, business and first-class flights so worldtraveller plus might be considered to be part way between economy andbusiness class. The matter was further complicated as airlines used differentterms to describe similar levels of service.
•Delegates could of course organise and pay at their own expense thegenuine difference between economy travel and business class or first class.
• It was unlikely that the payment of a significantly more expensive fare than economy would ever be acceptable under the Code. The MCA’s view is that the use of economy tickets put companies beyond reproach.
• The CTAC thus considered that perception and cost are important factors when deciding whether premium economy flights were acceptable. There is no mention in either the Code or the published advice that the length of travel is a relevant factor. Thus the MCA stance is that a premium economy flight may be considered in the class of economy travel, but this remains at the discretion of the member company.


Are we allowed to sponsor a retirement event / Christmas party for HCPs?

Nicole Edelstein replies
The Code prohibits healthcare companies from sponsoring / funding events that are not bona fide medical educational events. Thus, year-end functions, Christmas parties, retirement events or any standalone entertainment events cannot be sponsored by member companies.
I refer you to clause 18.4 of the Code on Stand-alone entertainment, leisure, social or cultural events with healthcare professionals that states:
• “Meetings organised for patients, general public, individual or groups of doctors, other healthcare professionals and/or for administrative staff that are wholly or mainly of an entertainment, leisure, social or sporting nature are not permitted.
• No stand-alone entertainment or other leisure, social or sporting activities may be planned, arranged or funded by companies as these are unrelated to the promotion of scientific or educational objectives.”


Is one allowed to put a sticker on the box of an S0 product advertising the promotional leaflet inside? The reason for my question is that it alters the design that is registered with the MCC (albeit a temporary sticker for a limited duration)

Nicola Brink replies
• A S0 product is a registered medicine with an MCC prescribed label
• You are not permitted to deface a medicine in any manner
• Putting a sticker on the product would deface it
• You are also not permitted to put a promotional leaflet inside the box of any medicine albeit in this instance you may advertise a S0 DTC


What kind of gifts can one give to HCPs, i.e. hand wash and hands lotion, will this be deemed of a personal nature?

Rene Richards replies
• Let’s use the gift table to evaluate:

Hygienic items (hand
Tickets to sport game? Popular magazines for
HCP waiting
Occasional 4 / year (what about every
yes every month acceptable?
Inexpensive /
yes no yes
Educational /
scientific value
no no no
Benefit patient /
practice related
yes no no
Meet limit
yes probably not yes
No entertainment /
personal use
no yes yes
Cash / equivalent no no no

• Which criteria in the gift table have the casting vote?
• To recap:
• Note 7 in the guidelines references gifts as items of general utility:
“Items of general utility which have been held to be acceptable gifts to doctors as being inexpensive and of relevance to their work include but are not limited to pens, pads, diaries, nail brushes, desk trays, calendars, and desk clocks.”
• This could depend. The risk with a hand soap would be that it is taken home and not utilized in the practice. Therefore, if the hand soap was from a high end brand (Charlotte Rhys / Body Shop / Crabtree and Evelynn) it would likely be raise eyebrows, but if it is a no name brand of anti-septic hand wash to be used in a practice the possibly yes. The CCO should apply some level of discretion at passing the red face test.


Social Events in aid of a registered charity
a) May a company representative participate in the social event with a HCP which is organised by a third party entity?
b) May a company participate in the sponsorship of a registered charity social / golf event?
c) May company staff members participate?
d) Can we do product promotion and have a stand at the charity social event?
e) May we sponsor gifts and prizes?

CTAC member replies
a) Yes any company representative may participate in the social event with an HCP; however, the company representative may NOT pay for the HCP to participate in such an event.
The guideline is not absolute but states the following: Charitable donations to a bona fide organisation should not be made in response to requests made by healthcare professionals unless the healthcare professional is an employee or officer of the organisation and submits the request on behalf of the organisation. It would not be appropriate for a member to support the favourite charity of a Healthcare Professional in response to a request by that healthcare professional.” The should is not an absolute. Rather quote the guidelines and suggest that charitable donations should go through a corporate charity committee to ensure that the support is based on the strength of a charity and not as an indirect reward to an HCP.
b) May a company participate in the sponsorship of a registered charity social / golf event?
Yes, a company may participate in the sponsorship of a charity social event, provided that the sponsorship is paid directly to the registered charity concerned and not to the organizers of the event. For multinationals bound by the Foreign Corrupt Practices Act (FCPA), this type of sponsorship at the request of an HCP or Government Official (GO) may be interpreted as an indirect benefit to the HCP / GO which is a contravention of the law.
c) May company staff members participate?
Staff members’ participation in the social event may be at the company’s discretion and in accordance with the company policy.
d) Can we do product promotion and have a stand at the charity social event?
No product promotion may take place at any social event. A company may however display their company logo at such an event. E.g. banner with Company logo at a sponsored hole at a charity golf day.


MCA Ex-Parte Process – how does this work?

Lizel Jacobs replies
• MCA Constitution 11.13.1 The Executive Officer shall after receiving an ex-parte request, and disposing of all criteria and processes set by the Code, appoint from amongst the members of the Adjudicating committee, an Ex-Parte Committee consisting of at least three persons (or any odd number of persons) and shall document the substantiation for the selection, provided that at least 50% or more of the committee members thus appointed are au faît with the specific industry to which the specific ex-parte request relates.
• Code clause 57. Be limited to the question posed by the Ex-Parte applicant, i.e. whether a particular activity would be in line with the Marketing Code and/or Guidelines, within the circumstances as outlined by the applicant; – Pay ex-parte fee R5000 +VAT, complete he application form, send all relevant information & supporting documentation. The adjudicating committee will review the information and provide an ex-parte (non-binding) opinion within the timelines as set out for an adjudication.
• Remember that an ex-parte opinion is not a means to avoid the complaints’ process – An Adjudication Committee may refuse to admit a matter on the basis that the applicant is attempting to address a dispute with another member of the MCA and/or on the basis that a member is using the Adjudication Committee in its Ex-Parte role to avoid lodging an appeal.


• We have received a query from one of our business units regarding an online subscription for an HCP who is part of a hospital group
• The current limit is set at R 10 000 (inclusive of VAT) which is quite low. We were wondering if and when the limits will be revised to include subscriptions which is a bit higher than the set limit?
• In the alternative, may we apply for an exception because the subscription value exceeds the current limit

Annelie de Klerk replies
• Guidelines Appendix 1 Values / Limits:
“Items of medical utilities:
For scientific medical reference books / journal and periodical
– individual practicing HCP or practices, the value should not exceed R 2 500 (inclusive of VAT)/year
– training or academic institutions, the value should not exceed R 10 000 (inclusive of VAT)/year
The value of medical devices should not exceed R300 (inclusive of VAT) / per item with a cap of R 2500 (inclusive of VAT)/ practice or institution.”
• The MCA revises these values annually and a Guideline review is currently underway. Proposals representing the majority opinion of your industry association may be submitted via your CTAC representatives. All proposals will be evaluated by the CTAC and the Guidelines will be updated if deemed reasonable and appropriate.


Is MCA endorsement via lapels and high visibility on promo material permitted?

Nicole Edelstein replies
• Yes – MCA member companies may make use of the MCA logo by including it on their promotional material or items should they so choose, as a benefit of membership.
• However, it goes without saying that the promotional material or items on which the logo is used must be Code compliant, and that inclusion of the logo should not be used to sanction any material or item that would not be acceptable in terms of the Code.


Can a company advertise a vaccine to the general public?

Nicola Brink replies
Vaccines are scheduled medicines. Vaccines are schedule 2 and therefore need to comply with the laws on advertising regarding S2 and above medications. One can provide information on disease types/ states directly to the public as well as immunisation awareness posters in conjunction with the DoH and this is line with the MCA Code.
In terms of Guidelines to the Code of Marketing Practice February 2015 Clause 20.9 Relations with the General Public and Media page 24 – it says the following:
•Note 2: Information to the public.
This clause allows for the provision of non-promotional information about S2 and above to the general public either in response to a direct inquiry from an individual, including inquiries from journalists, or by dissemination of such information via press conferences, press announcements, television and radio reports, public relations activities and the like. It also includes information provided by means of posters distributed for display in surgery waiting rooms.
This prohibition does not apply to vaccination campaigns or other public health campaigns carried out by companies and approved by the Department of Health and/or Medicines Regulatory Authority. Any information so provided must observe the principles set out in this clause, that is, it should be factual, balanced and must not encourage members of the public, to ask their doctors to prescribe a specific health product.


Has the South African MCA Code been amended to include the changes which will be implemented in the IFPMA Code in January 2018?

EO replies
The MCA Code and the Guidelines were updated in June 2018 following a protracted consultative process with our partner associations and independent members. As a result, our final Code is well, although not completely, aligned with pending changes to the IFPMA Code. We have engaged with the IFPMA roll out process and IFPMA have been diligent in keeping us appraised of developments. There is, however, no mandate for the MCA to follow the IFPMA code precisely.

Our local MCA process for Code revision is to take input from member companies through their Trade Associations via their representatives on our Code Technical Advisory Committee (CTAC). I believe it is correct to state that no changes recommended by associations were denied in our recent revision process. Some of the changes in the IFPMA Code however were not raised and do not currently reflect e.g. in respect of gifting.

In the light of the recent IFPMA code revisions, the members of the Code Technical Advisory Committee (CTAC) have been invited to engage with their stakeholders on recommendations for potential amendments to the MCA Code.  Input will be debated by the CTAC committee and recommendations made to the Board.

Some companies have/will probably voluntarily adopt principles enforced globally – this is normal practice. Should individual companies wish to recommend changes to the SA MCA Code or Guidelines it should be initiated through their association and agreement reached first at that level. This is necessary as our Code has been adopted by multiple trade associations representing different sectors.
Date: February 2019


What is principle-based approval of promotional items or events?

EO replies
The Code provides rules and guidance on what constitutes ethical marketing practices. In some situations, no applicable rule can be found in the Code, the situation where the Code is so-called “silent” on a matter.
A decision nonetheless needs to be made and the compliance officer and the commercial team are encouraged to ask questions to determine if the activity is ethically “right” to approve.
In some cases, as in the case of the determination of Fair Market Value (FMV), competition law prevents the Code from prescribing a value. Companies must therefore have their own an internal system to determine FMV.


1. The patient must be at the heart or centre of everything you do.
i. Is the patient at the centre/heart of this activity?
ii. Would the patient’s interests (such as the need to receive the best care for their needs) or rights (such as right to accurate, scientific information on a product) be negatively impacted by the activity?

2. Activities must not compromise HCP independence in making treatment decisions.
i. Does the activity incentivise or intend to incentivise the HCP to recommend/prescribe/use a particular product and hence compromise independent judgement?
ii. Does the HCP stand to receive direct financial gain from the activity?

3. Promote the approved, appropriate and rational use of your product
i. Is the material or activity in line with the relevant approved/registered professional information or instructions for use? (e.g. no claims made that are not in the professional information or instructions for use).
ii. Is the activity in line with the Medicines and Related Substances Act? (e.g. is the audience appropriate with regard to the scheduling or the category of the product.)
iii. Does this activity respect the independent decision making of the relevant stakeholders?

4. Act lawfully, ethically and with integrity
a. Is the material or activity legal / legitimate?
b. Is the material or activity factual, accurate, and balanced? Check that material does not mislead.
c. What is the actual intent of the activity? Is the intent clear or designed to mislead? Examples:
i. Market research (ad boards/phase 4 studies etc.). Is the intent to promote a particular product or is it legitimate research?
ii. Is the intent of a CPD meeting to educate HCPs or to promote a product? (Note: Different approaches apply but both are permissible).
d. Is there any active or passive participation e.g. by staff or consultants, to hide or misrepresent the true intent of the activity?

5. Be transparent
a. Are you willing to disclose all the information that leads to the approval and execution of this activity? This will involve at least (ref chapter 6 of the Code);
i. documenting all transactions and information related to the activity such as invitations, payments, instructions.
ii. Recording all financial transactions in an agreement signed by the company and the recipient and kept on file in the company for 5 years.
b. Will the activity appear as ethical/acceptable when viewed by patients / public / regulator / competitors?
c. Can you substantiate how you determined the FMV? (See separate guidance on determination of FMV).
d. Will this activity strengthen confidence and trust in the pharmaceutical industry?
e. Have you considered what could go wrong and put measures in place t ensure correct procedures are followed.


How is Fair Market Value (FMV) determined?

EO replies
The Code provides for the contracting of HCPs for certain activities. The MCA cannot prescribe an amount for FMV (due to competition law). Companies must therefore determine and substantiate the FMV for reimbursing an HCP. HCPs may not be reimbursed for time out of their practice, (Refer to the Code Chapter 12 for guidelines on contracting with HCPs).


How does one determine if reimbursement of HCPs complies with the Code?

EO replies
1. Does the Code allow the engagement with HCPs that is intended in the activity?
2. Does the activity require special experience or qualifications of the HCP?
3. How many similarly competent HCPs would be available to do the presentation?
4. Is the HCP from an international jurisdiction?
5. How influential is the HCP?
6. What is the “value” to the company of the audience being addressed?
7. What amount of time would be involved in preparation or research by the HCP?
8. How much time will be spent on the actual activity?

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