MCA
South African Health Products Industry

Issued by the MCA Board in terms of clauses 5.11 and 9.6 of the MCA Constitution and aligned with clauses 51.7 and 56.6.3 of the Code of Marketing Practice

The sanctions have been approved by the board on 21st September 2010. At the Special general meeting with members on the 13th March 2013, these sanctions were revisited and adopted by the Board of the MCA


Principles for determining sanctions

1.1 Subject to the Constitution and the Code, companies should provide evidence that they have exhausted all reasonable options to resolve complaint at company level, as per Part D of the Marketing Code.
1.2 The reasoning behind the imposition of a sanction should be transparent to both the complainant and respondent company.
1.3 Such imposition of a sanction must be aligned with the sanctions document and policy as set by the Board of the MCA from time to time.

It must be acknowledged that sanctions are not static. The upper limits of monetary sanctions will be reviewed as part of the periodic review of the Code. However, within the limits identified in the Code, the MCA has the discretion to apply a range of monetary fines and other sanctions based on consideration of these principles.

The following includes some of the principles which will be taken into consideration by the MCA in determining an appropriate sanction following a finding of breach/es of the Code.


1.4 Principal factors in determining a sanction:

1.4.1   The nature and extent of the activity/material, including its impact on the market and the reputation of the industry;
1.4.2   whether the breach should have been clearly evident to the Company;
1.4.3   breadth of activity or campaign, including its impact on the market;
1.4.4   length of time that the materials have been in use;
1.4.5   the number and type of alleged breach/es;
1.4.6   previous similar breaches, including but not limited to:

1.4.6.1   history of previous breaches of the Code in relation to a specific therapeutic area;
1.4.6.2    sanctions previously imposed on the company by the MCA in relation to the same or similar types of breach/es or in comparable circumstances;
1.4.6.3    repeated or multiple breaches;
1.4.6.4 any evidence that previous breaches or sanctions have not successfully encouraged improved compliance within the company (not necessarily within the same therapeutic area);
1.4.6.5    any evidence that the breach related to an activity that was not sanctioned by the company’s operating procedures or training of personnel; and
1.4.6.6    Cooperation/acknowledgement of offence and evidence of internal procedures implemented to avoid similar breaches in future.

1.4.7   impact on patients, providers and/or healthcare service provision;
1.4.8   harm to competitors, patients, providers and/or healthcare service provision;
1.4.9   non-implementation of previously imposed sanctions and/or corrective action and/or failure to implement undertakings previously made;
1.4.10   circumstances i.e. the environment in which the activity took place; and
1.4.11   the potential costs to be incurred by a company for corrective action – the MCA will consider the overall monetary cost of the package of sanctions, for example the cost of issuing a corrective letter in combination with a fine.

1.5    Double Jeopardy
The MCA will not rehear a complaint against a particular section or sections of the Code in relation to the same activity or same material irrespective of whether there was a finding of a breach of the Code, unless there is an allegation that the material has not been withdrawn or the activity has not ceased. If a complaint is received in relation to an activity or material already considered by the MCA the complainant will be referred to the outcome of the previous complaint.

1.6    Guidelines in relation to specific sanctions:

1.6.1   In the case of a corrective letter the specific Committee of the MCA who heard the matter will specify to whom the letter must be sent. This will reflect the audience who may have received the material found in breach of the Code.

1.6.2   Where the sanction includes a corrective advertisement the placement must be in the same journal as that of the advertisement found in breach of the Code. The corrective advertisement must be of the same size and prominence as the original advertisement.

1.6.3   A copy of the distributed corrective letter (on company letterhead bearing the signature of the company Chief Executive Officer or Code Compliance Officer) and published corrective advertisement should be provided to MCA for the file records. (Refer to Section 24.2 of Code).

1.6.4   The number, format, size, wording, mode of publication, prominence, timing (including duration of publication) and method of distribution of corrective statements must be approved by the MCA prior to release.

 

The Adjudicating- or Appeals Committee will make a decision regarding the fines. Refer to Sanctions attached.

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
Additional Sanctions/Fines
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
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
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