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
5.
6.
7.
8.
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
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
29.
30.
31.
32.
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
40.
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