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Business Learning Forum on
      Anti-Corruption

    25 September 2012
April 2011
   The Case for a Marketing Code of Practice

   The Marketing Code of Practice Journey

   Code Training

   The Parts to the Code

   Next Steps
SA Code of
 Practice for
the Marketing
   of Health
   Products
Tanya vogt  developing anti corruption best practice, applying incentives and enforcing  25 sept 2012
Tanya vogt  developing anti corruption best practice, applying incentives and enforcing  25 sept 2012
Tanya vogt  developing anti corruption best practice, applying incentives and enforcing  25 sept 2012
Tanya vogt  developing anti corruption best practice, applying incentives and enforcing  25 sept 2012
   Ethical promotion of health products
     To ensure that health care professionals and the
      public have access to the information they need
     That patients have access to the health products
      they need
     That health products are prescribed and used in a
      manner that provides the maximum healthcare
      benefit to patients


   Promotional activities that comply with
    applicable legal, regulatory and professional
    requirements
   To enhance the rational use of health products
    and fair competition in the marketing thereof
   To establish a clear understanding of the
    appropriate use of health products
   Accurate information about health products is
    integral to providing quality healthcare services
    to patients
   Preserve the independence of the decisions
    taken by healthcare professionals
   Enhanced confidence of the general public in the
    Pharmaceutical industry in general and in
    pharmaceutical products specifically
SA Code of
 Practice for
the Marketing
   of Health
   Products
• Marketing & promotion of
Part A     medicines to healthcare
           professionals

                                      - Replace ASA appendix
         • Marketing & promotion of     A&H
Part B     medicines to consumers     - Guidelines



Part C   • Devices



                                        - MoU
Part D   • Enforcement                  - Constitution
                                        -Sanctions
                                        -SLA with ASA
                                        -Guideline
Interim
                                                                    Phase

                                                  May 2011 – Agreed MoU



                                  Oct 2010 – Agreed version of the Code


                     Feb 2010 – Interim Board of the MCA


         2009 – SAMED & SALDA join



July 2007 – Marketing Steering Committee
   INNOVATIVE MEDICINES SA (IMSA)
   NATIONAL ASSOCIATION OF PHARMACEUTICAL MANUFACTURERS
    (NAPM)
   PHARMACEUTICALS MADE IN SA (PHARMISA)
   PHARMACEUTICAL INDUSTRY ASSOCIATION OF SA (PIASA)
   SELF-MEDICATION MANUFACTURERS ASSOCIATION OF SA
    (SMASA)
   THE SOUTH AFRICAN ANIMAL HEALTH ASSOCIATION (SAAHA)
   SOUTH AFRICAN MEDICAL DEVICE INDUSTRY ASSOCIATION
    (SAMED)
   SOUTHERN AFRICAN LABORATORY DIAGNOSTICS ASSOCIATION
    (SALDA)

Support for the initiative and enforcement
  PHARMACEUTICAL WHOLESALERS AND DISTRIBUTORS
  PHARMACEUTICAL SOCIETY OF SOUTHERN AFRICA (PSSA)
   The interim period will be between 6 – 12 months
    unless preceded by legislation and consists of.
    • 4 months of training and awareness by all companies
    • 2 months of self regulation whereby complaints will be
      managed company to company
    • EO notified of complaints and the outcome to allow for
      monitoring the robustness of the Code and its principles.
    • The Code will not be enforced i.e. no sanctions until MCA
      is formalised and members have signed the Constitution
      unless legislation intervenes.

•   Trade associations that form MCA are those that
    represent manufacturers of health products.
•   The Marketing Code Authority will be funded by
    these associations on a “market share” basis.
Market Share Determinations for Participating Associations
                                           Calculation and Logic                            Final Determination

                                     Deloitte study
                                                                     Intra-pharma % split    % figure used to determine
                     No of Members    Actual, total   Total market
                                                                       by private market         contribution to MCA
                                        market
Association
IMSA                      12                                                 26                       19.28%
NAPM                      24                                                 12                       8.90%
PHARMISA                   6             26.7            74%                 19                       14.09%
PIASA                     16                                                 32                       23.73%
SMASA                     20                                                 11                       8.16%

SAAHA                     ?               0.3           0.83%                                          0.83%

SALDA                     33              2.0           5.55%                                          5.55%

SAMED                     ?               7.0           19.47%                                        19.47%

Total Market                             36.0                                                        100.00%
Prepare
                  Appoint
                                    Member
Associations     Executive                        Regulations for
                                  Companies for
 sign MoU      Officer for the                     enforcement
                                      Code
                    MCA
                                 Implementation
Sign MoU
(before 1 May
    2011)


            Appoint Executive
                 Officer
                (May 2011)


                       Prepare Industry for Code
                           Implementation
                      (Four months training / awareness and
                            two months self-regulation
                      without sanctions from May-Oct 2011)


                                   Launch of fully operational
                                    MCA & Code Enforcement
                                      (no later than 12 months from
                                    signing of MoU, unless preceded by
                                                legislation)
   Training providers and any other interested persons to
    download the interactive programme and roll out the
    training to their organisations.
   The training program consist of modules that unpack
    the code through explanations, definitions and
    examples that promote understanding.
   It also consists of an assessment portion that will later
    on be used for certification of employees of the
    member companies

   The programme can be down loaded from:

          http://www.jfmultimedia.co.za/health
Action                                        By When               Status
Arrange Signing of Master Copy of MoU         End of April


Finalise amendment of Association             End of April
Constitution or receive resolution to bind
members to the Code
Provide Numbers to Train per Association      21 April
to support budget finalisation

Share communication / presentation with       Early May
members

Provide input into annual certification fee   Next MCA IB Meeting
                                              (May 10th or 17th)
Provide input to proposed budget              Next MCA IB Meeting
                                              (May 10th or 17th)
Action                                             By When                  Status
Provide Numbers to Train to your                   18 April
association

Raise Awareness by sharing                         May
communication / presentation with your
company

Distribute training link / copy of CD to all       May
employees that will require certification
Ensure employees train themselves                  May-Aug
Apply self-regulation during pilot phase           Sep-Oct
and report examples to EO
(more details to follow in next industry update)

Await instruction from Executive Officer of        TBD, but certification
the MCA on formal certification process            to be completed by no
                                                   later than Oct
Distribute Quarterly Code of Practice              July
Updates
(next update in July)
SA Code of
 Practice for
the Marketing
   of Health
   Products
   PART A – Marketing and promotion of
    health products to healthcare
    professionals (19 clauses)
   PART B – Marketing and promotion of
    health products directly to the consumer
    (18 clauses)
   PART C – Medical Devices (7 clauses)
   PART D – Provision for enforcement of
    the Code (12 clauses)
    The Code is further supported by Guidelines to the
       Interpretation of the Code and a Sanction &
                Corrective Action Proposal
   PART A – Marketing and promotion of
    health products to healthcare
    professionals
   PART B – Marketing and promotion of
    health products directly to the consumer
   PART C – Medical Devices
   PART D – Provision for enforcement of
    the Code




                  SA Marketing
no resolution
       no resolution

Company to         Refer to                  Refer to
                              Sanction        DoH
 company            MCA




                                 Legal mechanisms
Tanya vogt  developing anti corruption best practice, applying incentives and enforcing  25 sept 2012
Tanya vogt  developing anti corruption best practice, applying incentives and enforcing  25 sept 2012
Tanya vogt  developing anti corruption best practice, applying incentives and enforcing  25 sept 2012
Tanya vogt  developing anti corruption best practice, applying incentives and enforcing  25 sept 2012
Breach           Expanded definition                    Corrective Action/Public Disclosure              Fine     Timelines
Classification
Minor            No safety implications for patients’   Immediate withdrawal of material/activity from   R6K-     30 days
                 well being                             market
                 No effect on how healthcare            Company to Issue a corrective statement, as      R100K
                 professionals will use product         determined by MCA, including target audience
                                                        Written reprimand to company by MCA
                                                        Notify HCP of breach, if relevant
Moderate         No safety implications to patients’    Immediate withdrawal of material/activity from   R100K-   30 days
                 wellbeing                              market
                 May have effect on how healthcare      Company to Issue a corrective statement, as      R200K
                 professionals will use product         determined by MCA, including target audience
                                                        Written reprimand to company by MCA
                                                        Notify HCP of breach, if relevant
                                                        Publication of corrective advertisement, as
                                                        determined by MCA, including target audience

Serious/Severe   Will have safety implications to       Immediate withdrawal of material/activity from   R200K–   30 days
                 patients’ wellbeing                    market
                 Will have effect on how healthcare     Written reprimand to company by MCA              R300K
                 professionals will use product         Publication of corrective advertisement, as
                 Commercial impact on relevant          determined by MCA, including target audience
                 market                                 Issue a corrective letter to healthcare
                 Activities that bring disrepute to     professionals/public, as determined by MCA
                 industry or reduce confidence in
                 the industry
Breach              Expanded definition                    Corrective Action/Public Disclosure          Fine             Timelines
Classification
Fines not paid      When a monetary fine is not paid                                                    Further          60 days
                    within the required time period
                    from receipt of the decisions and                                                   fine of
                    the reasons for the decisions of                                                    R50K
                    the MCA

Corrective Action Where corrective action has not The matter will be raised by MCA with the             Further          60 days
not implemented   been actioned within required subject company and may be taken to MCA
                  timelines                       for consideration                                     fine of
                  Any other sanction including                                                          R100K
                  orders as to cost and fees

Repeated Breaches   >3 infringements in 1 year             The MCA may publish the decision in a        First:R10K +     60 days
                    When a company repeats any             newspaper with national circulation along    original fine;
                    breach, as classified by MCA, in the   with the name of the offending company.      Second: R15K
                    promotion/activity of any of the       Publication of the infraction on MCA         + original
                    company’s products/activity            website                                      fine; Third:
                                                           All postings will remain on website for 12   R25K +
                                                           months.                                      original fine
                                                           Inform the MCC of infringement and           R200K max
                                                           recommend cancellation of registration of    MCC can
                                                           product                                      cancel
                                                                                                        product
                                                                                                        registration
Breach Classification   Expanded definition                   Corrective Action/Public Disclosure              Fine           Timelines

Multiple breaches       Where the MCA, through monitoring,    The MCA may publish the decision in a            MCC can        60 days
                        finds a number of breaches of the     newspaper with national circulation along with
                        Code by a company:                    the name of the offending company.               cancel
                        MCA will usually consider the         Publication of the infraction on MCA website     product
                        aggregate of the breaches to          Inform the MCC of infringement and               registration
                        determine whether a sanction should   recommend cancellation of registration of
                        be imposed                            product/s involved MCA may impose a sanction
                                                              in respect of each breach of the Code, but may
                                                              choose to impose an additional financial
                                                              sanction



Invalid / unjustified / Does not comply with requirement of MCA informs complainant in writing                 R10K           60 days
vexatious complaints complaint as defined in Code



Bringing the Code When a company brings the Code The MCA may publish the decision in a                         R200K max      60 days
into disrepute    into disrepute or misrepresents the newspaper with national circulation along with
                  Code                                the name of the offending company.
                                                      Publication of infraction on MCA website
   Ultimate goal – Regulation to S18A
    enabling enforcement of the code across
    the entire industry
   Recognition of the MCA as the industry’s
    self-regulatory body
   Co-operation between the MCC/DoH and
    industry in ensuring ethical marketing of
    health products
   Ultimate sanction – non-compliance
                Product deregistration
SA Code of
 Practice for
the Marketing
   of Health
   Products
SA Code of
 Practice for
the Marketing
   of Health
   Products
   Code of Marketing Practice: exemption
    required
       Part B:
         S 11: Right to restrict unwanted direct marketing
         S 22: Plain Language: Guideline needed
       Part E:
         S 29: General standard in marketing
         S 30: Bait marketing
         S 31: Negative option marketing
         S 34: Promotional offers
         S 36: Competition
Tanya vogt  developing anti corruption best practice, applying incentives and enforcing  25 sept 2012
SA Code of
 Practice for
the Marketing
   of Health
   Products
For more information contact:
Achieng Ojwang, Manager: Business in Society
+27(0)11 544 6000; ojwang.achieng@nbi.org.za

           www.nbi.org.za

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Tanya vogt developing anti corruption best practice, applying incentives and enforcing 25 sept 2012

  • 1. Business Learning Forum on Anti-Corruption 25 September 2012
  • 3. The Case for a Marketing Code of Practice  The Marketing Code of Practice Journey  Code Training  The Parts to the Code  Next Steps
  • 4. SA Code of Practice for the Marketing of Health Products
  • 9. Ethical promotion of health products  To ensure that health care professionals and the public have access to the information they need  That patients have access to the health products they need  That health products are prescribed and used in a manner that provides the maximum healthcare benefit to patients  Promotional activities that comply with applicable legal, regulatory and professional requirements
  • 10. To enhance the rational use of health products and fair competition in the marketing thereof  To establish a clear understanding of the appropriate use of health products  Accurate information about health products is integral to providing quality healthcare services to patients  Preserve the independence of the decisions taken by healthcare professionals  Enhanced confidence of the general public in the Pharmaceutical industry in general and in pharmaceutical products specifically
  • 11. SA Code of Practice for the Marketing of Health Products
  • 12. • Marketing & promotion of Part A medicines to healthcare professionals - Replace ASA appendix • Marketing & promotion of A&H Part B medicines to consumers - Guidelines Part C • Devices - MoU Part D • Enforcement - Constitution -Sanctions -SLA with ASA -Guideline
  • 13. Interim Phase May 2011 – Agreed MoU Oct 2010 – Agreed version of the Code Feb 2010 – Interim Board of the MCA 2009 – SAMED & SALDA join July 2007 – Marketing Steering Committee
  • 14. INNOVATIVE MEDICINES SA (IMSA)  NATIONAL ASSOCIATION OF PHARMACEUTICAL MANUFACTURERS (NAPM)  PHARMACEUTICALS MADE IN SA (PHARMISA)  PHARMACEUTICAL INDUSTRY ASSOCIATION OF SA (PIASA)  SELF-MEDICATION MANUFACTURERS ASSOCIATION OF SA (SMASA)  THE SOUTH AFRICAN ANIMAL HEALTH ASSOCIATION (SAAHA)  SOUTH AFRICAN MEDICAL DEVICE INDUSTRY ASSOCIATION (SAMED)  SOUTHERN AFRICAN LABORATORY DIAGNOSTICS ASSOCIATION (SALDA) Support for the initiative and enforcement  PHARMACEUTICAL WHOLESALERS AND DISTRIBUTORS  PHARMACEUTICAL SOCIETY OF SOUTHERN AFRICA (PSSA)
  • 15. The interim period will be between 6 – 12 months unless preceded by legislation and consists of. • 4 months of training and awareness by all companies • 2 months of self regulation whereby complaints will be managed company to company • EO notified of complaints and the outcome to allow for monitoring the robustness of the Code and its principles. • The Code will not be enforced i.e. no sanctions until MCA is formalised and members have signed the Constitution unless legislation intervenes. • Trade associations that form MCA are those that represent manufacturers of health products. • The Marketing Code Authority will be funded by these associations on a “market share” basis.
  • 16. Market Share Determinations for Participating Associations Calculation and Logic Final Determination Deloitte study Intra-pharma % split % figure used to determine No of Members Actual, total Total market by private market contribution to MCA market Association IMSA 12 26 19.28% NAPM 24 12 8.90% PHARMISA 6 26.7 74% 19 14.09% PIASA 16 32 23.73% SMASA 20 11 8.16% SAAHA ? 0.3 0.83% 0.83% SALDA 33 2.0 5.55% 5.55% SAMED ? 7.0 19.47% 19.47% Total Market 36.0 100.00%
  • 17. Prepare Appoint Member Associations Executive Regulations for Companies for sign MoU Officer for the enforcement Code MCA Implementation
  • 18. Sign MoU (before 1 May 2011) Appoint Executive Officer (May 2011) Prepare Industry for Code Implementation (Four months training / awareness and two months self-regulation without sanctions from May-Oct 2011) Launch of fully operational MCA & Code Enforcement (no later than 12 months from signing of MoU, unless preceded by legislation)
  • 19. Training providers and any other interested persons to download the interactive programme and roll out the training to their organisations.  The training program consist of modules that unpack the code through explanations, definitions and examples that promote understanding.  It also consists of an assessment portion that will later on be used for certification of employees of the member companies  The programme can be down loaded from:  http://www.jfmultimedia.co.za/health
  • 20. Action By When Status Arrange Signing of Master Copy of MoU End of April Finalise amendment of Association End of April Constitution or receive resolution to bind members to the Code Provide Numbers to Train per Association 21 April to support budget finalisation Share communication / presentation with Early May members Provide input into annual certification fee Next MCA IB Meeting (May 10th or 17th) Provide input to proposed budget Next MCA IB Meeting (May 10th or 17th)
  • 21. Action By When Status Provide Numbers to Train to your 18 April association Raise Awareness by sharing May communication / presentation with your company Distribute training link / copy of CD to all May employees that will require certification Ensure employees train themselves May-Aug Apply self-regulation during pilot phase Sep-Oct and report examples to EO (more details to follow in next industry update) Await instruction from Executive Officer of TBD, but certification the MCA on formal certification process to be completed by no later than Oct Distribute Quarterly Code of Practice July Updates (next update in July)
  • 22. SA Code of Practice for the Marketing of Health Products
  • 23. PART A – Marketing and promotion of health products to healthcare professionals (19 clauses)  PART B – Marketing and promotion of health products directly to the consumer (18 clauses)  PART C – Medical Devices (7 clauses)  PART D – Provision for enforcement of the Code (12 clauses) The Code is further supported by Guidelines to the Interpretation of the Code and a Sanction & Corrective Action Proposal
  • 24. PART A – Marketing and promotion of health products to healthcare professionals
  • 25. PART B – Marketing and promotion of health products directly to the consumer
  • 26. PART C – Medical Devices
  • 27. PART D – Provision for enforcement of the Code SA Marketing
  • 28. no resolution no resolution Company to Refer to Refer to Sanction DoH company MCA Legal mechanisms
  • 33. Breach Expanded definition Corrective Action/Public Disclosure Fine Timelines Classification Minor No safety implications for patients’ Immediate withdrawal of material/activity from R6K- 30 days well being market No effect on how healthcare Company to Issue a corrective statement, as R100K professionals will use product determined by MCA, including target audience Written reprimand to company by MCA Notify HCP of breach, if relevant Moderate No safety implications to patients’ Immediate withdrawal of material/activity from R100K- 30 days wellbeing market May have effect on how healthcare Company to Issue a corrective statement, as R200K professionals will use product determined by MCA, including target audience Written reprimand to company by MCA Notify HCP of breach, if relevant Publication of corrective advertisement, as determined by MCA, including target audience Serious/Severe Will have safety implications to Immediate withdrawal of material/activity from R200K– 30 days patients’ wellbeing market Will have effect on how healthcare Written reprimand to company by MCA R300K professionals will use product Publication of corrective advertisement, as Commercial impact on relevant determined by MCA, including target audience market Issue a corrective letter to healthcare Activities that bring disrepute to professionals/public, as determined by MCA industry or reduce confidence in the industry
  • 34. Breach Expanded definition Corrective Action/Public Disclosure Fine Timelines Classification Fines not paid When a monetary fine is not paid Further 60 days within the required time period from receipt of the decisions and fine of the reasons for the decisions of R50K the MCA Corrective Action Where corrective action has not The matter will be raised by MCA with the Further 60 days not implemented been actioned within required subject company and may be taken to MCA timelines for consideration fine of Any other sanction including R100K orders as to cost and fees Repeated Breaches >3 infringements in 1 year The MCA may publish the decision in a First:R10K + 60 days When a company repeats any newspaper with national circulation along original fine; breach, as classified by MCA, in the with the name of the offending company. Second: R15K promotion/activity of any of the Publication of the infraction on MCA + original company’s products/activity website fine; Third: All postings will remain on website for 12 R25K + months. original fine Inform the MCC of infringement and R200K max recommend cancellation of registration of MCC can product cancel product registration
  • 35. Breach Classification Expanded definition Corrective Action/Public Disclosure Fine Timelines Multiple breaches Where the MCA, through monitoring, The MCA may publish the decision in a MCC can 60 days finds a number of breaches of the newspaper with national circulation along with Code by a company: the name of the offending company. cancel MCA will usually consider the Publication of the infraction on MCA website product aggregate of the breaches to Inform the MCC of infringement and registration determine whether a sanction should recommend cancellation of registration of be imposed product/s involved MCA may impose a sanction in respect of each breach of the Code, but may choose to impose an additional financial sanction Invalid / unjustified / Does not comply with requirement of MCA informs complainant in writing R10K 60 days vexatious complaints complaint as defined in Code Bringing the Code When a company brings the Code The MCA may publish the decision in a R200K max 60 days into disrepute into disrepute or misrepresents the newspaper with national circulation along with Code the name of the offending company. Publication of infraction on MCA website
  • 36. Ultimate goal – Regulation to S18A enabling enforcement of the code across the entire industry  Recognition of the MCA as the industry’s self-regulatory body  Co-operation between the MCC/DoH and industry in ensuring ethical marketing of health products  Ultimate sanction – non-compliance Product deregistration
  • 37. SA Code of Practice for the Marketing of Health Products
  • 38. SA Code of Practice for the Marketing of Health Products
  • 39. Code of Marketing Practice: exemption required  Part B:  S 11: Right to restrict unwanted direct marketing  S 22: Plain Language: Guideline needed  Part E:  S 29: General standard in marketing  S 30: Bait marketing  S 31: Negative option marketing  S 34: Promotional offers  S 36: Competition
  • 41. SA Code of Practice for the Marketing of Health Products
  • 42. For more information contact: Achieng Ojwang, Manager: Business in Society +27(0)11 544 6000; ojwang.achieng@nbi.org.za www.nbi.org.za