Recommendations1. The following changes should be made to the wording of the MAIF Agreement to ensure it reflects current legislation, standards, marketing practices and modern health terminology:
a. The preamble to the MAIF Agreement should clearly identify the relationship between the MAIF Agreement and the WHO Code and identify any relevant legislation operating in parallel
b. Clause 4 should be amended to change the term 'superiority' with wording that focuses on the benefits, importance and biological norm of breastfeeding
c. Clause 4(a) should be amended to include reference to 'electronic media and social marketing'
d. Clause 6 should be amended to replace the term 'mothercraft nurse' with 'child and family nurse'
e. Clause 7(c) should be amended to provide clear guidance around what constitutes an 'inducement'
f. Clause 7 (d) should be amended to provide clear guidance around what is considered a 'sample' and what constitutes 'professional evaluation'
g. Clause 9 should be amended to replace the reference to 'Australian Food Standard R7' with 'Australian Food Standard 2.9.1'
h. Clause 9(b) should be amended to replace the phrase 'should not discourage breastfeeding' with a statement about the importance of breastfeeding.
2. The voluntary, self-regulatory nature of the MAIF Agreement is the most cost effective regulatory mechanism and should continue, providing:
a. it continues to promote the achievement of the aim of the MAIF Agreement
b. industry coverage levels remain high. New entrants (manufacturers and importers of infant formula) should be encouraged to sign the MAIF Agreement.
3. The coverage of the MAIF Agreement should not be extended to cover:
- any food described or sold as an alternative for human milk for the feeding of infants beyond the age of twelve months;
- retailers and pharmacies;
- other infant feeding products such as bottles, teats and complementary foods.
Aim of the MAIF Agreement (Clause 1):“The aim is to contribute to the provision of safe and adequate nutrition for infants, by the protection and promotion of breastfeeding and by ensuring the proper use of breast milk substitutes, when they are necessary, on the basis of adequate information and through appropriate marketing and distribution”.
5.1.1 Existence of a formal agreement to regulate infant formula is a key strength, however there are a number of areas for improvement
|What are stakeholder views on the effectiveness of the MAIF Agreement, including perceived strengths and weaknesses?||
Many stakeholders (both targeted and wider respondents) indicated that a key strength of the MAIF Agreement was that it was a formal agreement for regulating the marketing of infant formula in Australia. Through the MAIF Agreement, Australia has adopted a number of the recommendations stipulated under the WHO Code and taken positive steps to increase the recognition and awareness of infant health and nutrition.
Stakeholders identified a range of key strengths of the MAIF Agreement. The five key strengths identified by targeted stakeholders through interviews and surveys are outlined in Table 6 (see Appendix F for a comprehensive table of identified strengths).
Table 6: Key strengths of the MAIF Agreement identified by targeted stakeholders
|Strengths identified by targeted stakeholders||APMAIF members||Government organisations||Industry signatories||Non-signatories||Health professionals/ organisations||Consumer groups|
|Existence of the MAIF Agreement: Australia has developed and implemented a formal Agreement that is signed by manufacturers of infant formula and implements elements of the WHO Code.|
|Self-regulation: Regulation through consensus by industry partners creates a stronger sense of ownership, engagement and responsibility amongst manufacturers for the MAIF Agreement. Co-regulation between government and industry also supports cooperation and consultation between stakeholders.|
|Adaptable to environment: The MAIF Agreement has been developed separately to the WHO Code and tailored appropriately to the Australian context. It has been demonstrated that the MAIF Agreement is robust enough to adapt to environmental changes.|
|Aim of the MAIF Agreement: The aim of the MAIF Agreement is clear and provides an effective framework for monitoring marketing in Australia. The two parts of the aim - promotion of breastfeeding and ensuring proper use of breast-milk substitutes - ensure the MAIF Agreement is well-balanced.|
|Complaints process: Current arrangements include an effective complaints process. The process is clear.|
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Table 7: Key weaknesses of the MAIF Agreement identified by targeted stakeholders
|Weaknesses identified by targeted stakeholders||APMAIF members||Government organisations||Industry signatories||Non-signatories||Health professionals/ organisations||Consumer groups|
|Scope: The scope of the MAIF Agreement is too narrow and should be expanded to include some or all of the following:
||High Priority||High Priority||Low Priority||Low Priority||High Priority|
|Powers of enforcement: The ‘name and shame’ approach is not a strong enough disincentive, particularly since manufacturers operate as commercial entities and will try and exploit loopholes and push the boundaries. Some suggested the MAIF Agreement should be legally enforceable.||Low Priority||High Priority||Low Priority||High Priority|
|Disparity with WHO Code: The MAIF Agreement does not cover all aspects under the WHO Code and there is confusion about the alignment of the two documents. (see Section 5.1.7).||Low Priority||Low Priority||High Priority|
|Non-signatories: Not all industry members are signatories to the MAIF Agreement.||Low Priority||High Priority|
|Interpretation / guidelines: The broad nature of the MAIF Agreement means interpretations are difficult and may vary depending on the situation. Clearer guidelines of appropriate interpretations are required.||Low Priority||Low Priority||High Priority|
|Awareness: There is a lack of consistency in the understanding of the MAIF Agreement by healthcare professionals.||Low Priority||Low Priority||Low Priority|
- Cover the provision of sample bags to parents bearing the logo of infant formula brands.
- Contain provisions to regulate health or functional claims by manufacturers on product packaging (e.g. support for healthy immune functions, promotion of nerve development).
- Actively provide information, instead adopting a preventative approach. One suggestion is the provision of standardised information comparing different elements of products.
- Include the requirement for companies to identify the potential risks of using infant formula on package labelling.
5.1.2 The effectiveness of the MAIF Agreement may be impacted by limited community awareness
|Review question||Key insights|
|What are stakeholder views on the effectiveness of the MAIF Agreement, including levels of awareness and understanding of the WHO Code and the MAIF Agreement?||
Several interviewed stakeholders – particularly APMAIF members and industry representatives – indicated that greater awareness and understanding about the intent of the MAIF Agreement is required. It was suggested that the MAIF Agreement needs to be more widely disseminated and information provided to health professionals and industry members about their relevant responsibilities and compliance requirements.
This finding was supported through survey results. 82% of targeted stakeholders (n=17) and 75% of respondents from each stakeholder group represented in the general survey (n=516) disagreed or strongly disagreed that there is a good level of awareness and understanding of the WHO Code and the MAIF Agreement in the community.
The perceived effectiveness, or otherwise, of the MAIF Agreement may be due to low levels of awareness and / or understanding amongst the community. The effectiveness of the MAIF Agreement could be improved through the following:
- Increased awareness about the roles and responsibilities of signatories to the MAIF Agreement would potentially increase the pressure on signatories to comply with the MAIF Agreement and provide a stronger incentive for other manufacturers to become signatories.
- Stronger awareness and understanding of the scope and operation of the MAIF Agreement would potentially increase the identification of breaches (as this process currently relies on complaints being raised by community members).
5.1.3 More can be done to address community concerns
Review findings indicate that the MAIF Agreement may not be completely aligned with the needs of the community. 59% of targeted stakeholders (n=17) and over 75% of respondents from each stakeholder group represented in the general survey (n=517) disagreed or strongly disagreed with the statement ‘the MAIF Agreement responds to the needs of the community appropriately’.
Since 2007-08, the number of complaints submitted to the APMAIF has decreased year-on-year. There are several possible explanations for this decrease in complaints, including:
- stronger levels of compliance with the MAIF Agreement by industry
- higher levels of community satisfaction with current marketing practices
- lower levels of community awareness and / or decreased willingness to use the complaints process.
Table 8: APMAIF complaints data
(number and %)
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In 2010-11, the majority of out-of-scope complaints were related to retail activity in stores, followed by retail activity in pharmacies, and toddler milk drinks. All complaints regarding retail activity were related specifically to price promotion. Table 9 provides details of out-of-scope complaints submitted between 2004 and 2011.
Table 9: Out-of-scope complaints 2004-2011
|Retail – store|
|Retail – pharmacy|
|Bottles, teats and dummies|
^ Includes Retail Activity – Other
Findings that the MAIF Agreement does not adequately respond to the needs of the community may, in part, be due to the scope of the MAIF Agreement. Some respondents from all stakeholder groups represented in the general survey indicated that coverage of the MAIF Agreement is too narrow. Some consumer respondents commented that the narrow scope of the MAIF Agreement results in many complaints being considered out-of-scope and a few indicated that they had stopped submitting complaints to the APMAIF as a result of their complaints repeatedly being deemed to be out-of-scope. The appropriateness of the scope of the MAIF Agreement is discussed in Section 5.1.7.
5.1.4 The MAIF Agreement covers the majority of the infant formula market
|Review question||Key insights|
|What is the percentage of the infant formula supply market (including manufacture and retail) covered by the MAIF Agreement?||The MAIF Agreement covers the majority of the infant formula market in Australia.|
Limited public information about the market share for infant formula in Australia makes it difficult to determine the exact coverage of the MAIF Agreement in Australia. In 2009, it was estimated that the value of domestic infant formula sales in Australia was $132 million (FSANZ 2010). There are two primary distribution channels for infant formula in Australia – supermarkets and pharmacies. Across both of these channels, the six signatories account for the majority of market sales. Some interviewed stakeholders suggested that signatories account for up to 95% of the total infant formula market in Australia.
All six signatories to the MAIF Agreement are members of the Infant Nutrition Council (INC). Established in 2009, the INC aims to represent the infant formula industry in Australia and New Zealand and to improve infant nutrition by supporting the public health goals for the protection and promotion of breastfeeding and, when needed, infant formula as the only suitable alternative.
The Australian market is also comprised of a number of non-signatories, many of which predominately manufacture and supply infant formula to Asian and Middle Eastern markets. Only two non-signatories appear to have a significant presence in the Australian infant formula market – Bellamy’s Organic and Amcal.
A table of manufacturers and importers of infant formula in Australia can be found in Appendix G.
5.1.5 Self-regulation remains appropriate for the MAIF AgreementReview question
What is the extent to which the voluntary, self‐regulatory nature of the MAIF Agreement affects its effectiveness (including the relative values of self‐ and co‐regulation, and the case for legislation)?
- Self-regulation is most effective when the Code is industry ‘owned’.
- Self-regulation encourages high levels of consultation between government and industry and creates a sense of ownership.
- Stronger consequences for breaches may be required to ensure the voluntary, self-regulated model remains effective.
Voluntary industry codes
The ACCC has identified several benefits of a voluntary industry code (such as the MAIF Agreement), including (ACCC 2011):
- greater transparency of the industry to which signatories to the code belong
- greater stakeholder or investor confidence in the industry
- ensuring compliance with the Competition and Consumer Act 2010
- a competitive marketing advantage.
The self-regulatory model of the MAIF Agreement was identified by many APMAIF members and industry representatives as a key strength of the MAIF Agreement. This was supported by some representatives from government departments. It was suggested that self-regulation encourages higher levels of consultation between government and industry than would occur under a legislated model and creates a sense of ownership for the MAIF Agreement amongst industry members.
Consumer groups indicated that self-regulation has been unsuccessful in other areas of public health and is not suitable for the infant formula market. It was suggested that self-regulation by industry leads to a gradual narrowing of scope and as such it would be more appropriate to introduce a regulatory model similar to the pharmaceutical advertising laws in Australia and New Zealand.
There were mixed responses amongst interviewed stakeholders regarding voluntary participation in the MAIF Agreement. Whilst some government representatives and APMAIF members indicated that all industry members should be signatories to the MAIF Agreement, others identified that voluntary participation drives greater commitment and responsibility by manufacturers. It was noted that despite its voluntary nature, the MAIF Agreement covers the majority of the infant formula market. Several stakeholders suggested that greater efforts should be made to encourage participation by non-signatories.
When asked whether they agreed that the voluntary self-regulatory arrangement does not affect the effectiveness of the MAIF Agreement, 42% of targeted stakeholders agreed or strongly agreed and 53% disagreed or strongly disagreed. In comparison, more than 80% of respondents from each stakeholder group represented in the general survey (n=516) disagreed or strongly disagreed. Some stakeholders noted that stronger consequences for breaches may make the current arrangement more effective.
Results from targeted stakeholders are shown in Figure 5 below.
Figure 5: Survey statement: “The voluntary, self-regulatory nature of the MAIF Agreement does not affect its effectiveness” – responses from the targeted survey (n=17)
When asked whether the MAIF Agreement is effective in meeting its stated aim, there were mixed responses amongst stakeholders. Whilst the majority of targeted stakeholders (n=17) agreed (47%) or strongly agreed (18%) that the MAIF Agreement is effective in meeting its stated aim, more than 70% of respondents from each respective stakeholder group represented in the general survey (n=516) disagreed or strongly disagreed.
The voluntary nature of the MAIF Agreement has led to strong industry buy-in, with all major manufacturers and importers of infant formula being signatories to the MAIF Agreement. There is no evidence that voluntary participation has impacted market coverage of the MAIF Agreement. Self regulation enables a higher level of industry engagement than would be achieved under a legislated model and encourages a cooperative and consultative arrangement between government and industry. This model of voluntary, self-regulation remains the most appropriate arrangement for the MAIF Agreement and should continue provided it continues to promote the aim of the MAIF Agreement and industry coverage remains high.
5.1.6 The MAIF Agreement is adaptable to environmental changes, however clearer guidance on interpretations is required
|What is the extent to which any ambiguous, inconsistent, unclear or out of date wording in the MAIF Agreement affects the APMAIF’s ability to interpret and apply the MAIF Agreement to modern marketing activities?||Stakeholders indicated that the MAIF Agreement is robust enough to accommodate environmental changes, however it needs to be:
Stakeholders identified that the MAIF Agreement contains, in a number of areas, ambiguous wording or out of date terminology. Amongst survey respondents, 71% of targeted stakeholders (n=17) and between 50-60% of respondents from each stakeholder group represented in the general survey (n=516) indicated that the wording of the MAIF Agreement is ambiguous, inconsistent or requires updating.
Some interviewed stakeholders identified that the nature of the MAIF Agreement lends itself to very general wording and that the overall language of the MAIF Agreement needs to be updated to reflect changes in legislation and standards, to ensure that definitions remain accurate and that terminology is consistent with that commonly used in the health sector.
Table 10 outlines the key stakeholder suggestions for improvements to specific clauses of the MAIF Agreement and provides an assessment of how difficult implementing the proposed changes might be.
Table 10: Key stakeholder suggestions to improve the wording of the MAIF Agreement
Difficulty of implementation
|Clause 3||Definition of ‘health care system’ should be updated to include pharmacies since the definition of ‘health care professional’ includes pharmacists.||Difficult – inclusion of pharmacies requires expansion of the current scope|
|Clause 3||Definition of ‘healthcare professional’ requires greater clarification as many parents receive advice from part-time pharmacy assistants who are not currently covered under the MAIF Agreement.||Difficult – inclusion of part-time retail staff in pharmacies may have wider implications for the inclusion of all retail staff under the MAIF Agreement|
|Clause 4||Clause 4(a) should be updated to include electronic media and social marketing||Straightforward|
|Clause 4||Term ‘superiority’ should be changed to focus on the benefits, importance and biological norm of breastfeeding.||Straightforward|
|Clause 5||Clause 5(a) should provide a clear definition of ‘promote’ and could be updated to include online advertising (including mothers / parents clubs and online advice services).
Clause 5(d) should address the issue of helplines and baby / mother clubs. However, consideration should be given to the ability of consumers to interpret information.
|Best addressed in MAIF guidelines. This approach will support APMAIF’s interpretation of the MAIF Agreement and allow flexibility to address future changes and potential applications of technology|
|Clause 6||Term ‘mothercraft nurse’ is out-dated and should be replaced with ‘child and family nurses’.||Straightforward|
|Clause 6||Clause 6(c) should provide clarification of the term ‘use’.||Straightforward|
|Clause 7||Clause 7(c) should provide greater clarity around what constitutes an ‘inducement’.||Difficult – a definition will provide some clarity however this area will be subject to the APMAIF’s interpretation.|
|Clause 7||Clause 7 (d) should clearly define what is considered a ‘sample’ and what constitutes ‘professional evaluation’.||Straightforward|
|Clause 9||Australian Food Standard R7 – Infant Formula is out-dated and should be replaced with Standard 2.9.1.||Straightforward|
|Clause 9||Clause 9(b) should replace ‘should not discourage breastfeeding’ with a statement about the importance of breastfeeding.||Straightforward|
Several interviewed stakeholders indicated that interpretations of the MAIF Agreement are ambiguous and require review and clarification (e.g. distinction between information and promotion). When asked about the impact of the wording of the MAIF Agreement on APMAIF interpretations, survey results demonstrated:
- 53% of targeted stakeholders (n=17) thought that the current wording of the MAIF Agreement affects the APMAIF’s ability to interpret and apply the MAIF Agreement to modern marketing activities
- Between 50-55% of consumer (n=326), consumer group (n=28) and health professional (n=148) respondents from the general survey indicated that wording of the MAIF Agreement has an impact on APMAIF operations. (NB: a significant proportion of respondents from each stakeholder group (>20%) were unsure of the response to this question).
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5.1.7 Inclusion of toddler milk drinks and retailers in the scope of the MAIF Agreement is not warranted
|What changes should be made to the scope of the MAIF Agreement including coverage of the infant formula market?
What are stakeholder views on improvements to the effectiveness of the MAIF Agreement in achieving its stated aim?
|Many stakeholders were concerned about the use of similar product identifiers on toddler milk drinks and infant formula.
The review found insufficient evidence to support expanding the MAIF Agreement scope to cover retailers and pharmacies.
Stakeholders identified that non-signatories and new market entrants should be encouraged to sign the MAIF Agreement.
Stakeholders supported expanding the MAIF Agreement to cover electronic marketing.
Scope of the MAIF Agreement (Clause 2):“This document applies to the marketing in Australia of infant formulas when such products are marketed or otherwise represented to be suitable, with or without modification, for use as a partial or total replacement of breast milk. It also applies to their quality and availability, and to information concerning their use”.
Complaints considered outside the scope of the MAIF Agreement may include the following (but not limited to):a
- An Infant Formula Manufacturer or Importer (Company) that is not a current signatory to the MAIF Agreement or was not a signatory at the time the complaint was made
- Some retailer activity (e.g. price promotions in retail catalogues)
- Infant merchandise (e.g. infant feeding bottles, teats, dummies, etc.); and / or
- Infant foods, including milk products formulated for children over 12 months of age.
Many stakeholders (both targeted and general survey respondents) expressed concern about the current scope of the MAIF Agreement. 59% of targeted stakeholders (n=17) and approximately 75% of consumer, consumer group and health professional / organisation respondents from the general survey (n=516) disagreed or strongly disagreed that the scope of the MAIF Agreement is appropriate.
Some stakeholders (both targeted and general survey respondents) suggested that the MAIF Agreement should better align with the WHO Code and that more information should be provided on the differences and relationship between the two documents.
The WHO Code notes that governments should give effect to the principles and aims of the Code as appropriate to their own social and legislative framework (WHO 1981). Many of the WHO Code recommendations are of particular relevance to developing countries, where issues such as poverty, illiteracy and hygiene present specific challenges to infant feeding. As such, Australia need not implement the WHO Code in its entirety, nor does the wording of the MAIF Agreement need to be completely aligned for it to be successful.
Interviewed stakeholders and survey respondents (both targeted and general) suggested expanding the scope of the MAIF Agreement to cover the following issues: Toddler milk drinks; retailers and pharmacies; electronic marketing; non-signatories and infant feeding products. These issues are discussed in more detail below.
Toddler milk drinksThe most commonly identified weakness by both targeted stakeholders and general survey respondents was the exclusion of toddler milk drinks from the MAIF Agreement. This was primarily identified as a key concern due to the ability of manufacturers to use similar product identifiers on both toddler milk drinks and infant formula products.
Advertising toddler milk drinks can potentially provide de facto marketing for infant formula, hindering the ability of consumers to distinguish between the two products. Some countries have raised the issue of whether follow-up formula is covered under the WHO Code , with some countries (e.g. Australia, Netherlands and UK), seeking specific guidance. WHO has previously observed that assuming follow-up formula is not marketed or otherwise represented to be suitable as a breast-milk substitute, strictly speaking it does not fall within the scope of the WHO Code (WHO 2001).
Placing restrictions on the marketing of toddler milk drinks may be costly to implement. An alternative mechanism to prevent toddler milk drinks being used as de-facto advertising for infant formula would be to restrict the ability of industry to market and label both toddler milk drinks and infant formulas in a similar manner.
Retailers and pharmaciesMany stakeholders suggested that the scope of the MAIF Agreement should be expanded to cover the role of pharmacies and retailers in the sale and marketing of infant formula.
Expanding the MAIF Agreement to cover all areas of the supply chain presents a number of potential issues. Expansion of the MAIF Agreement to include retailers would require a major change to the MAIF Agreement and may involve significant costs. It would also pose a number of practical issues – e.g. whether both major as well as smaller retailers should be covered under the MAIF Agreement. Although pharmacists are not covered under the MAIF Agreement, the Pharmaceutical Society of Australia (PSA) has a Position Statement on Infant feeding which outlines the role of pharmacists in encouraging breastfeeding and the position of PSA in supporting the WHO Code. The Statement clearly states that pharmacists should not promote breast-milk substitute products to the general public in a manner that discourages breastfeeding and encourages pharmacists to monitor marketing practices in their pharmacies (PSA 2004).
The Review did not identify sufficient evidence to warrant a regulatory change of this nature.
Non-signatoriesWhen asked whether all companies involved in the infant formula supply market (including manufacturers and retailers) should be signatories to the MAIF Agreement:
- the majority of targeted stakeholders (n=17) indicated they agree (29%) or strongly agree (53%)
- more than 75% of respondents from the general survey from each respective stakeholder group of the general survey agreed or strongly agreed.
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Electronic marketingA number of new marketing practices have emerged since the introduction of the MAIF Agreement, including online forums, digital marketing and use of social media (see Appendix D). Several interviewed stakeholders (across all stakeholder groups) suggested the scope of the MAIF Agreement needs to be revised to address changes in the marketing environment. Specifically, changes have been identified for Clause 4(a) and Clause 5(a) of the MAIF Agreement (see Section 5.1.6).
Infant feeding productsSome stakeholders suggested that the scope of the MAIF Agreement should be expanded to prevent the advertising of any infant feeding products, including bottles, teats and complementary foods. Bottles and teats are used by both formula-feeding and breastfeeding parents (e.g. for expressed breast milk). Restrictions on these products would be inappropriate and there is insufficient evidence to warrant a regulatory change of this nature.
1 In-scope’ and ‘out-of–scope’ columns will not sum to total complaints for 2004-05, 2005-06, 2006-07 because the ‘In-scope’ data is based on actual APMAIF decisions and excludes complaints carried forward to the next year. The APMAIF complaints reporting template was amended for the 2007-08 Annual Report.
2 In 2004-05, three breaches were found, however these were reconsidered in 2005-06 due to natural justice issues.