The Marketing Code

1
The Marketing Code

• February 2009

2
Note

• All healthcare professionals and their staff (
  including front shop assistants) non pharmacists
  who own pharmacies retail wholesalers other
  wholesalers retailers forecourt owners etc etc
  who sell or distribute or market medicines
  (including S0s) are bound by The Medicines Act
  and the Marketing Code in terms of the sale and
  marketing of these medicines
• This also applies to all manufactures of ALL
  medicines

3
Disclaimer

• Whilst this is an extensive summary of the
  Marketing Code and parts of The Medicines Act
  it remains your and your companies
  responsibility to familiarise yourself with the
  entire content of The Medicines Act and of The
  Marketing Code
• And to ensure that all relevant personnel of your
  company are up to speed with the Act and Code
  ( including third parties, agents, etc)

4
Note

• Whilst the Marketing Code is yet to be
  promulgated - all industry bodies have agreed to
  abide by it and to self regulate until
  promulgation this year
• BUT The Medicines Act is already law

5
The
Marketing Code covers
ethical practices of ALL marketers of ALL
medicines Is aligned with the International
Codes and the Perverse Incentives Policy of the
HPCSA which is endorsed by SAMA SAPC and
supported by the Associations below
6
Bonusing 18A. (1) No person shall supply any
product, medical device or IVD according to a
bonus system, rebate system or any other
incentive scheme. (2) Notwithstanding subsection
(1), the Minister may prescribe acceptable and
prohibited acts in relation to subsection (1).
Marketing of products, medical devices or
IVDs 18C. The Minister shall, after consultation
with the relevant industries and other
stakeholders, make regulations relating to the
marketing of products, medical devices or IVDs
and such regulations shall also provide for Codes
of Practice for relevant industries..
7
The Code is divided into 3 parts

• To Healthcare Professionals / Other Sellers of
  Medicines
• To Consumers
• Enforcement of the Code
• ( All based on Section 18C of Act 101)

8
Some important points from the Code

• All drugs can be advertised to the healthcare
  professional
• But only S0 and S1 can be advertised to the
  consumer
• But you may inform the general public of the name
  of the product, the pack size and the price of an
  S2 and above product

9
45 (2)   (a)  Medicines which do not contain a
scheduled substance and medicines which contain a
substance appearing in Schedule 0 or Schedule 1
may be advertised to the public. (b)  Medicines
which contain a substance appearing in Schedule
2, Schedule 3, Schedule 4, Schedule 5 or Schedule
6 may be advertised only for the information of
medical practitioners, dentists, veterinarians,
pharmacists and other persons authorised to
prescribe or in a publication which is normally
or only made available to persons referred to
therein. (c)  Paragraph (b) shall not be so
construed as to prohibit informing the public of
the prices, names, pack sizes and strengths of
medicines which contain a substance appearing in
Schedule 2, Schedule 3, Schedule 4, Schedule 5 or
Schedule 6.
10
What does inform mean?

• The intention of inform is for the consumer to
  make price comparisons
• All that is permitted is
• Name of product
• Pack size / strength
• Price
• It does not mean advertise
• If your intention is to advertise then you are
  breaking the law irrespective of how you go about
  it

11
Some important points from the Code

• All advertising should state for full
  prescribing information refer to the package
  insert as approved by the MCC
• Any loose insert in a journal may NOT be larger
  than the journal / magazine
• No disparaging advertising is allowed- directly
  or by implication
• One cannot advertise or promote a medicine prior
  to registration
• You cannot promote a medicine for anything other
  than what is in the package insert

12
Some important points from the Code

• Advertisements in journals may not resemble
  editorials
• All claims or comparisons must be accurate,
  balanced, fair, objective and unambiguous
• All comparative advertising must be substantiated
  and trade names are forbidden
• To use a registered trademark or other protected
  IP without permission is prohibited

13
Some important points from the Code

• The word NEW can only be used on brands that have
  been on the market for less than 12 months
• Cannot use a dummy box of a S2 product (without
  indications/ claims) as part of a window display
  in pharmacy or as a gondola end, behind or on the
  counter or in any other place or in any
  advertisement
• this is being currently challenged by SMASA with
  MCC

14
Continued

• Advertisements may not be exaggerated and
  superlatives are not permitted
• e.g. powerful, best , fast, etc
• All references must be supported by proven
  clinical data
• Data on File must be made available on request
• and may be evaluated by a independent third party
  

15
Continued

• You may not use a doctor or any personality of
  any nature to endorse any medicine
• The use of SMS, e-mail, fax or telephone etc may
  not be used to promote a medicine unless written
  permission is granted by the recipient
• Any promotional activity may not be disguised
• e.g. A promotion for a weight loss product cannot
  be disguised as a symposia on weight loss
• Post cards, mailings etc may not be disguised in
  a way to force the recipient to open the letter

16
OTC Medicines S1 and S0Consumer Marketing

• Whilst all parts of Section A B of the Code
  apply to OTC Medicines there are certain elements
  that should be highlighted
• Repeat Can only advertise S0 and S1 directly to
  the consumer
• Generally aimed at self limiting / self
  diagnosable conditions
• May encourage responsible self-medication
• But may not encourage consumers to exclusively
  self-medicate

17
OTC Medicines S1 and S0Consumer Marketing

• Must be in line with the package insert
• Advertisements must take into account the
  vulnerability of the consumer
• Do not use language to confuse, alert or panic
  and do not use scare tactics
• Do not exploit the consumer, do not offer to
  diagnose, advise, prescribe or treat personally
  by correspondence
• Do not target advertising at children (under 12)
  
• Cannot advertise showing children using or within
  reach of a medicine without adult supervision

18
OTC Medicines S1 and S0Consumer Marketing

• May not suggest that normal health is improved or
  make recovery claims
• No prohibited claims i.e. treatment, cure or
  prevention
• Vitamin supplements - should not imply that
  vitamins are a substitute for good nutrition, are
  superior to normal dietary nutrients or that
  normal health will be affected by not taking
  vitamin supplements
• Weight management Have to state only effective
  when used in conjunction with a kilojoule
  controlled balanced diet

19
OTC Medicines S1 and S0Consumer Marketing

• No exaggerated or flippant claims
• May not claim enhance life
• You may not use the word safe
• You may not use the word natural
• May not claim guarantees

20
OTC Medicines S1 and S0Consumer Marketing

• Cannot use trade names of other competitors
• No superlatives may be used e.g. unique
• Cannot state that the product has been available
  on Rx
• Cannot use a real doctor to endorse a product
  (can use an actor)
• BUT you must use a real pharmacist and not a
  actor should you have a pharmacist in your
  advertisement
• Reason Pharmacists and doctors are governed by
  different bodies and have different laws /
  regulations

21
OTC Medicines S1 and S0Consumer Marketing

• Cannot use a personality to endorse a product
• Cannot encourage directly or indirectly for a
  consumer to discontinue the use of prescribed
  medication
• May not state that a product does not contain a
  particular ingredient
• e.g. codeine free or aspirin free
• May not suggest that a products effects are
  equal to or better than another

22
OTC Medicines S1 and S0Consumer Marketing

• Consumer promoters / agents etc selling or
  promoting S0 medicines remain the responsibility
  of the company whose products are being promoted
  /sold
• These people must be adequately trained and
  offer accurate, balanced and fair information

23
What about - Schedule 0 ?

• S0 products are medicines and are therefore
  governed by both The Medicines Act and the Code
• The ONLY deviation is that S0 medicines are
  exempt until 2011 from only sections 18A and 22G
  of the Act in so far as the matter relates to a
  Single Exit Price

24
(No Transcript)
25
Interpretation of the Exemption

• The exemption relates to issues of price and
  practices associated with what price one charges
• Price is something which has to do with what you
  charge, how that charge is reflected etc
• The phrase bonus, rebate or other incentive
  scheme has to be interpreted within that
  context
• It cannot be regarded as a loophole for practices
  that are not honestly related to the price and
  any bonuses etc that go with it
• To prevent charges of corruption and fraud one
  must be able to reflect bonuses, rebates and
  incentives schemes on lawful invoices and
  financial accounting mechanisms
• Giving gift vouchers, credit card refunds, entry
  into a competition, presents, tickets to sports
  games etc in return for a sale constitutes quid
  pro quos and not conditions of sale quid pro
  quo is not an incentive, it is a kickback!

26
Schedule 0

• If we abuse the exemption we face losing it at
  any time or not having it renewed
• What does this mean?
• S0 medicine e.g. Grand-pa will be subject to
• Single Exit Pricing
• Benchmarking
• A prescribed maximum annual price increase
• No bonusing, rebates, discount or incentives
  Therefore the implications are HUGE
• NOTE Even if your company is primarily an FMCG
  company but you are the MANUFACUTER and SELLER of
  medicines (S0 included), you are required to be
  registered as a pharmaceutical company and you
  are by implication further required to abide by
  the law and by the conditions of your license

27
Schedule 0

• You may sell S0 products at different prices to
  different customers
• SEP is not applicable
• You may bonus a S0 medicine (only if reflected on
  an invoice in relation to price)
• Can offer - buy one get one free ( only if
  reflected on an invoice in relation to price)
• Cannot give vouchers / gifts / entry into a
  competition etc as an incentive to purchase a
  particular deal
• You may discount a S0 medicine
• Off the price only (only if reflected on an
  invoice in relation to price)

28
Schedule 0

• You may rebate a S0 medicine ( only if reflected
  on an invoice in relation to price)
• S0 products are not subject to a logistic fee
• S0 are not subject to benchmarking
• You may pay for shelf space for a S0 product
  (only if reflected on an invoice in relation to
  price)
• You cannot offer incentives of any description to
  anyone to sell, recommend or prescribe a S0
  product

29
Schedule 0

• S0 medicines may be sold according to an
  incentive scheme based on price and is reflected
  on an invoice
• The incentive cannot be in the form of a
  competition, nor in the form of a prize, gift,
  give-away etc (violates the Act under Section 18C
  )
• NOTE ALL SALES AND MARKETING ACTVITIES,
  IRRESPECTIVE OF THE CHANNEL, OF A S0 PRODUCT ARE
  REQUIRED TO BE SIGNED OFF BY YOUR REGULATORY
  DEPARTMENT - GMP /CODE GUIDELINES
• You may not sample a S0 product to a healthcare
  professional or to a wholesaler, retailer, agent,
  spaza shop, forecourt owner or to any other
  person

30
Schedule 0

• You may not donate S0 medicines to any cause
  without the prior consent of the DoH ( violation
  of Section 18B)
• You may not tamper or change the appearance of a
  S0 medicines e.g. placing stickers onto the pack
  ( refer to Regulations)
• The S0 medicine is to be sold in its original
  registered format

31
Schedule 0

• You may not swap damaged S0 stock with sample /
  or boot stock
• You may not sweeten a deal by offering
  boot/sample stock
• Any piece of promotional material ( including
  sales promotions) that contains a pack shot (s)
  of a product (s) MUST contain the full product
  legals

32
Schedule 0

• You may band a S0 medicine with a gift that is
  modest and has a direct correlation to the
  product e.g. a water bottle for a tonic, teaspoon
  for a liquid NO free binoculars, golf balls,
  calculators, iPods etc
• NB You may not deface any of the panels of the
  unit carton when banding the pack of the primary
  or the secondary packaging
• You may put a give-away relating to the product
  e.g. a spoon inside the secondary packaging of a
  product e.g. a syrup
• Once again
• No defacing of the packaging in any way
• The gift must be modest and have a direct
  correlation to the product

33
Schedule 0

• You may bind 2 packs of the same product (
  identical name) but of different strengths e.g. a
  50ml and a 100m
• BUT without defacing either pack
• You may not bind 2 packs of different products
  together e.g. an analgesic with a cold and flu
  product or a cold and flu product with a lozenges
  or a chest rub etc

34
Schedule 0

• You may offer competitions to healthcare
  professionals, wholesalers and retailers etc
• Please note that retailers ( who are not
  healthcare professionals), retail wholesalers,
  other wholesalers, forecourt owners etc ARE
  subject to the law as they are sellers of
  medicines
• But The prize for a healthcare professional and
  other staff ( this includes an owner of a
  pharmacy who is not a healthcare professional)
  and for retailers, retail wholesalers, other
  wholesalers, spaza store owners, forecourt owners
  etc must be no more than R1000 inc VAT in value
  
• Note this value will be reevaluated and
  determined by the code authority from time to
  time

35
Schedule 0

• The prize must be of value or applicable to the
  practice / pharmacy/ wholesaler etc
• The competition must have a scientific or product
  related question ( some skill involved)
• For all stakeholders
• Entry into the competition must not be linked to
  purchase of a medicine or be conditional to the
  purchase or sale or prescription of a medicine IN
  ANY WAY

36
Schedule 0

• You may run a consumer competition for a S0
  medicine
• But
• Entry into the competition must not be linked to
  purchase of a medicine or be conditional to the
  purchase of a medicine IN ANY WAY
• The value of the consumer competition prize may
  not exceed R100 000 inc VAT in value in totality
  and each individual prize may not exceed R5000
  inc VAT in value
• A corporate social investment component to the
  competition needs to be included in this amount
  - any amount above this should be done through
  your CSR department and not as part of a
  competition

37
Schedule 0

• To repeat
• Any medicine that has a Scheduling of S0, and
  that is sold in the open market such as spaza
  shops, forecourts, through agents, wholesalers,
  retailers or anywhere else are subject to the
  Code of Marketing Practice plus the Medicines Act
  
• except for limited circumstances pertaining to
  Sections18A and 22G of the Act as so far as it
  pertains to the Single Exit Price

38
Wholesalers

• No wholesaler shall purchase products from any
  other source other than from the original
  manufacturer or from the primary importer of the
  finished product. A wholesaler shall sell
  products only into the retail sector
• Notwithstanding the above , provision has been
  made by the Portfolio Committee of Health for
  SOs
• The below has been added ( yet to be promulgated
  ) to Section 22H(c) of the Bill
• A wholesaler may purchase from or sell to, other
  wholesalers or the public Schedule 0 substances'

39
Link between the ACT and Policy
on Perverse Incentives

• No Professional e.g. doctor or pharmacist may
• Pay commission for recommending patients
• Charge fees for seeing medical representatives
• Request samples, bonuses, gifts and other
  incentives
• NB The Corruption Act clearly defines that
  anyone e.g. pharmacist, retailer, wholesaler MAY
  NOT direct customers to purchase a particular
  brand

40
Samples, Gifts Inducements

• No gift, benefit in kind, rebate, discount,
  kickback or any other pecuniary advantage may be
  offered or given to healthcare professionals,
  administrative staff, government employees,
  wholesalers, retailers, spaza store owners,
  forecourt owners etc or the general public as an
  inducement to prescribe, supply, stock, dispense,
  administer or buy any medicine

41
Samples, Gifts Inducements

• Gifts in the form of promotional aids and prizes
  may be distributed provided that the gift or
  prize is inexpensive and of relevance to the
  practice of the recipients profession or
  employment
• Gifts may not be for personal use e.g. DVDs,
  binoculars etc
• Repeat The maximum acceptable value of a prize
  in a promotional competition is R 1000 (incl.
  VAT)
• Give-aways may not exceed R 200 (incl. VAT)
• Under review, and to be determined by the code
  authority from time to time

42
Hospitality and Meetings

• No payment for a person accompanying a delegates
  is allowed
• Costs for travel within S.A. may only be made to
  professional bodies organising the meeting
• Payment of reasonable honoraria and actual travel
  costs for speakers is permitted

43
Hospitality and Meetings

• Declaration of sponsorship must be prominent
• Meetings of a mainly social, leisure or sporting
  nature are not acceptable!
• Any sort of hospitality must be secondary to the
  educational aspect of the meeting

44
Practical Applications CPDs Dinners

• Must be non-promotional - no product
  advertising
• May only use generic names and not product names
• Can serve appropriate refreshments (not
  extravagant)

45
Practical Applications CPDs Dinners

• No spouses allowed to attend ( unless also a
  healthcare professional)
• No transport or accommodation costs to be paid
  for delegates
• Must be overseen by organization e.g. APC, SAMA,
  PSSA
• Invitations - can have product branding ( in
  dispute)

46
Practical Applications Branding

• No product branding during CPD event itself
• Pads and pens used in the CPD room can have
  corporate branding
• Product branded items including stand may be
  displayed outside CPD room
• No product posters or banners inside room
• Any form of hospitality MUST be secondary to the
  educational element

47
Some questions asked..

• Can reps still take pizzas etc to pharmacies?
• Yes, but take appropriate precautions in your
  company SOP for approval of the reps activities
  and expenses claims It is not appropriate for
  professionals to demand anything in response for
  granting an interview
• 2. Can a rep invite OVER a weekend pharmacists /
  wholesalers, retailers to a game of golf or to a
  rugby match?
• A qualified yes, i.e. If they are personal
  friends and if he/she does not claim the expense
  from the company. Your company SOP should make it
  clear that such an expense will not be approved

48
Note

• You may not take a pharmacist / wholesaler,
  retailer etc to a game of golf or a rugby match
  etc under the guise of e.g. an energy drink,
  toothpaste or deodorant that you might sell. If
  you sell S0s and above medicines you are
  registered with the MCC as a healthcare company
  and you must act accordingly

49
Some questions asked..

• Can we still take customers to rugby IF we have
  a 1 hour educational workshop beforehand ?
• No because
• The venue is not suitable for a scientific or
  educational meeting
• 75 of the time spent at the venue must be for
  education not entertainment
• The entertainment part of the meeting must not be
  the main part of the educational meeting
• A singer or band etc during dinner following a 6
  hour educational meeting is allowed provided it
  is not at a separate venue

50
Note

• No stand-alone entertainment of any description
  by a pharmaceutical company or consumer
  healthcare company is permitted for ANY seller of
  medicines i.e. for healthcare professionals,
  their staff, retail wholesalers, other
  wholesalers, retailers, pharmacy owners etc

51
Some fraudulent, perverse and prohibited
practicesMany of these violate Section 18A, as
well as the Marketing Code AND The Corruption
Act!

• Swiping of credit cards in pharmacies by reps
• Passing credits for stock, but failing to uplift
  the stock
• Discounting off invoice for S1 and above
  products
• Paying money into pharmacists private bank
  accounts
• Paying for holidays, trips, hunting, fishing,
  nights away etc
• Paying for licenses of software, for stationery
  etc

52
Some fraudulent, perverse and prohibited
practices

• Paying for golf lodge and other accommodation,
  world cup tickets, invites to Super 14 , cricket
  tests, theater, shows, etc
• Rewarding front shop assistants or others to
  promote your brand ( S0 and above) or bundling a
  S0 and above drug with a unscheduled product
• Note incentives allowed for a S0 product is off
  price ONLY
• Offering incentives for support e.g. gifts,
  money, vouchers, fridge, for the pharmacy /
  practice,air conditioners etc

53
Some fraudulent, perverse and prohibited
practices

• Using stickers linked to the sale of the product
  placed in a book to earn points or discounts
• Use of free or reduced cost of any product for
  achieving overall sales targets
• Payment for shelf space for S1 and above
  (Violation of section 18A)
• Payment for use of electronic order systems to
  switch one brand for another or using this
  mechanism to disguise a promotion /competition (
  with elaborate prizes such as overseas trips
  World Cup Rugby, Grand Prix etc)

54
Some fraudulent, perverse and prohibited
practices

• Using vouchers for pharmacists/ front shop
  assistants to reward or encourage the sale of
  selected brands
• Temporary price reductions to disguise a push for
  sales in pretence that there is excess stock when
  there is not
• Giving any one in the Healthcare chain voyager
  miles, e-bucks, extended credit terms etc
• Paying excessive co marketing fees, data fees,
  special fees etc
• Data fees can be paid but they must be a fee
  for a legitimate, required and used service, be
  transparent and be reasonable

55
Some fraudulent, perverse and prohibited
practices

• Misguided promotions through a 3rd party
• Formulary listing payments
• Paying kickbacks
• Excessive logistic fees ( up to 50)
• Contractual agreements with healthcare
  professionals to dispense brands in exchange for
  data fees

56
Some fraudulent, perverse and prohibited
practices

• Taking doctors or other healthcare professionals
  to dinner under the guise of getting information
  on for e.g. how to market to them

57
Sales Representatives - including those calling
on retailers,wholesalers, spaza stores etc

• Must be adequately trained
• On product
• On the Marketing Code
• On The Medicines Act
• Must comply with The Medicines Act and the
  Marketing Code
• All briefing, promotional material, trade
  presenters etc must comply with the Medicine Act
  and the Marketing Code
• Note This also applies to third parties and
  agents

58
Mechanism for Complaints

• Until such time as the Code Authority is set up -
  should you wish to alert us as to a violation of
  the code by a competitor company please email
  Allison Vienings on smasa_at_telkomsa.net and
  outline the complaint together with proof thereof
  and the necessary action will be taken
• Please make an effort to clean up our industry
• Should you have a complaint re a pharmacy,
  pharmacist doctor or any other healthcare
  professional please report this to the HPCA or to
  Pharmacy Council and not to SMASA

59
For any questions regarding this presentation
please contact the SMASA office on
smasa_at_telkomsa.net or on 27 (0)12 803-4444
/-6223 /-5955 /-1039
60
Thank you