Tanya vogt developing anti corruption best practice, applying incentives and enforcing 25 sept...
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Business Learning Forum on Anti-Corruption 25 September 2012
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Transcript of Tanya vogt developing anti corruption best practice, applying incentives and enforcing 25 sept...
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
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 medicines to healthcare professionals
Part A
• Marketing & promotion of medicines to consumers Part B
• Devices Part C
• Enforcement Part D
- Replace ASA appendix A & H
- Guidelines
- MoU - Constitution -Sanctions -SLA with ASA -Guideline
July 2007 – Marketing Steering Committee
2009 – SAMED & SALDA join
Feb 2010 – Interim Board of the MCA
Oct 2010 – Agreed version of the Code
May 2011 – Agreed MoU
Interim Phase
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
Association
No of Members Deloitte study Actual, total
market Total market
Intra-pharma % split by private market
% figure used to determine contribution to MCA
IMSA 12
26.7 74%
26 19.28%
NAPM 24 12 8.90%
PHARMISA 6 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%
Associations sign MoU
Appoint Executive
Officer for the MCA
Prepare Member
Companies for Code
Implementation
Regulations for enforcement
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 Constitution or receive resolution to bind members to the Code
End of April
Provide Numbers to Train per Association to support budget finalisation
21 April
Share communication / presentation with members
Early May
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 association
18 April
Raise Awareness by sharing communication / presentation with your company
May
Distribute training link / copy of CD to all employees that will require certification
May
Ensure employees train themselves May-Aug
Apply self-regulation during pilot phase and report examples to EO (more details to follow in next industry update)
Sep-Oct
Await instruction from Executive Officer of the MCA on formal certification process
TBD, but certification to be completed by no later than Oct
Distribute Quarterly Code of Practice Updates (next update in July)
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
Company to company
Refer to MCA
Refer to DoH Sanction
no resolution no resolution
Legal mechanisms
Breach Classification
Expanded definition Corrective Action/Public Disclosure Fine Timelines
Minor No safety implications for patients’ well being No effect on how healthcare professionals will use product
Immediate withdrawal of material/activity from market Company to Issue a corrective statement, as determined by MCA, including target audience Written reprimand to company by MCA Notify HCP of breach, if relevant
R6K-R100K
30 days
Moderate No safety implications to patients’ wellbeing May have effect on how healthcare professionals will use product
Immediate withdrawal of material/activity from market Company to Issue a corrective statement, as 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
R100K-R200K
30 days
Serious/Severe Will have safety implications to patients’ wellbeing Will have effect on how healthcare professionals will use product Commercial impact on relevant market Activities that bring disrepute to industry or reduce confidence in the industry
Immediate withdrawal of material/activity from market Written reprimand to company by MCA Publication of corrective advertisement, as determined by MCA, including target audience Issue a corrective letter to healthcare professionals/public, as determined by MCA
R200K–
R300K
30 days
Breach Classification
Expanded definition Corrective Action/Public Disclosure Fine Timelines
Fines not paid When a monetary fine is not paid within the required time period from receipt of the decisions and the reasons for the decisions of the MCA
Further fine of R50K
60 days
Corrective Action not implemented
Where corrective action has not been actioned within required timelines Any other sanction including orders as to cost and fees
The matter will be raised by MCA with the subject company and may be taken to MCA for consideration
Further fine of R100K
60 days
Repeated Breaches >3 infringements in 1 year When a company repeats any breach, as classified by MCA, in the promotion/activity of any of the company’s products/activity
The MCA may publish the decision in a newspaper with national circulation along with the name of the offending company. Publication of the infraction on MCA website All postings will remain on website for 12 months. Inform the MCC of infringement and recommend cancellation of registration of product
First:R10K + original fine; Second: R15K + original fine; Third: R25K + original fine R200K max MCC can cancel product registration
60 days
Breach Classification Expanded definition Corrective Action/Public Disclosure Fine Timelines
Multiple breaches Where the MCA, through monitoring, finds a number of breaches of the Code by a company: MCA will usually consider the aggregate of the breaches to determine whether a sanction should be imposed
The MCA may publish the decision in a newspaper with national circulation along with the name of the offending company. Publication of the infraction on MCA website Inform the MCC of infringement and recommend cancellation of registration of 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
MCC can cancel product registration
60 days
Invalid / unjustified / vexatious complaints
Does not comply with requirement of complaint as defined in Code
MCA informs complainant in writing R10K 60 days
Bringing the Code into disrepute
When a company brings the Code into disrepute or misrepresents the Code
The MCA may publish the decision in a newspaper with national circulation along with the name of the offending company. Publication of infraction on MCA website
R200K max 60 days
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
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; [email protected]
www.nbi.org.za
