Review of the effectiveness and validity of operations of the MAIF Agreement:Research Paper

4.1 What are the approaches to the regulation of infant formula in other countries?

Page last updated: 18 June 2012

In 2011, the University of Sydney NHMRC Clinical Trials Centre was contracted by DoHA to complete an international comparison study into the implementation of the WHO Code and other breastfeeding initiatives (University of Sydney 2011). The study gathered data on nine developed countries to assist in the assessment of the relative success of measures implemented in Australia. The study was divided into two parts: (i) a rapid, systematic review of the evidence base to identify key global interventions which influence breastfeeding practice; and (ii) a review of websites and databases to retrieve other necessary information to assess the implementation of the WHO Code in each country.

Table 3 outlines the extent and form of regulation used to implement the WHO Code across the nine countries covered in the study.

Table 3: International approaches to the implementation of the WHO Code


International approaches to the implementation of the WHO Code. For detailed description please refer to the descriptive link next to the image. Description of the Image

There are differences in the mechanisms used and the degree to which the nine countries have implemented the WHO Code:
  • The European Union (EU) countries studied have all partially adopted the WHO Code in legislation (in line with the EU Directives that cover Articles 2-6 and Article 9). None of the European countries included in the study have regulations or codes covering Articles 7 and 8, and there is limited coverage of Article 11.
  • Both Australia and New Zealand have voluntary, industry codes in place that cover all articles of the WHO Code (Articles 9 and 10 are covered by the Food Standards Code).
  • Canada and the United States of America (USA) have taken little or no action to implement the WHO Code
  • Australia regulates both infant formula (0-6 months) and follow-up formula (6-12 months), a range of other approaches have been taken in the other countries studied (see Table 2 below).
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Table 4: International approaches to product coverage


 International approaches to product coverage. For detailed description please refer to the descriptive link next to the image. Description of the Image

The International Baby Food Action Network (IBFAN) conducts monitoring of international efforts to implement the WHO Code and categorises countries on a scale of one (law) to eight (no action). Under this system, Australia was most recently assigned to category three, indicating government adoption of a policy or voluntary measure encompassing all or nearly all provisions of the WHO Code.

4.1.1 The MAIF Agreement is most similar to the approach taken in New Zealand

Review questionInsights:
To what degree is the MAIF Agreement consistent with regulatory approaches to infant formula in other countries?
  • The MAIF Agreement is similar to New Zealand’s voluntary code. Most other countries that have implemented the WHO Code have done so via legislation.
  • The scope of the MAIF Agreement (e.g. it only covers infant formula to 12 months) is similar to many countries.
  • The extent to which the WHO Code has been implemented varies across countries from low (e.g. USA, Canada) to high (e.g. Ireland, New Zealand).

The international comparison of WHO Code implementation (University of Sydney 2011) demonstrated that Australia is situated approximately in the middle of the international spectrum in terms of the scope and enforceability of its implementation. The study identifies the following similarities and differences in WHO Code implementation:
  • Many countries have limited their regulation to infant formula, including Australia, New Zealand and EU countries.
  • There is a high degree of consistency in relation to food standards (MAIF Article 9: labelling and Article 10: quality).
  • Both Australia and New Zealand have adopted a voluntary, industry self-regulatory system with self-regulated enforcement. However one of the key differences is that New Zealand’s system enables complaints to be lodged against the Code of Practice for Health Workers and includes an appeals process.
  • The Australian MAIF Agreement has a more transparent reporting process than the approaches taken in several other countries.
  • The UK has implemented stronger regulatory mechanisms by giving legal effect to the WHO Code. The UK system includes both enforcement of regulations and a timely and transparent process for adjudicating advertising breaches.

4.1.2 Several lessons can be learnt from how other countries have implemented the WHO Code

Review questionInsights:
What lessons can be derived from the success or otherwise of the approaches adopted in other countries?The findings from the 2011 review of the New Zealand regulation suggest strengths in maintaining the independence of the regulatory body and demonstrate the importance of a robust complaints handling process.

There does not appear to be a causal relationship between the level of regulation of infant formula (or implementation of the WHO Code) and the level of breastfeeding in a country.

A country’s breastfeeding rate is contingent on many factors, including3

  • level of support available
  • education
  • training of health care professionals
  • the Baby-Friendly Hospital Initiative (BFHI)
  • parental leave, childcare and other government initiatives
  • social and cultural norms, which have a significant influence on breastfeeding practice
  • demographics
  • supplemental foods.
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The Review derived important insights from two sources. The first is a review that was conducted in 2011 of the WHO Code implementation in New Zealand (Burgess & Quigley 2011). This review is particularly useful given that New Zealand has used a similar regulatory mechanism to implement the WHO Code. Insights can also be gathered from the international comparison study identified in Section 4.1 (University of Sydney 2011). Both are discussed in turn below.

Implementation of the WHO Code in New Zealand

The 2011 review of the implementation of the WHO Code in New Zealand (Burgess and Quigley, 2011) identified several areas for improvements to New Zealand’s implementation of the WHO Code.The Review recommended:
  • increased independence of the code monitoring and compliance body to ensure appropriate, non-biased investigation of complaints
  • strengthened complaints handling procedures to increase confidence in the system.
The report also recommended that the Minister for Health should table final decisions on complaints in parliament to name and shame signatories who have breached the codes. Burgess and Quigley also stress the importance of assessing whether a complaint falls in-scope prior to commencing an investigation.

Burgess and Quigley also conducted a literature review on the market characteristics necessary for an industry self-regulatory model to be successful. They recognised that, if certain characteristics are present in the industry, self-regulation can be a cost effective regulatory mechanism. They concluded that the market for infant formula is a strong candidate for self-regulation.

International comparisons of breastfeeding rates

The aim of the MAIF Agreement 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. Consistent with this aim, one measure of regulatory success is the relative breastfeeding rates across different countries.

The University of Sydney study showed a high degree of variability in breastfeeding rates across the countries examined (see Figure 3 below).

Noting the different approaches taken by comparable countries (see Table 3 above), there appears to be no correlation between the degree and type of implementation of the WHO Code and increased breastfeeding rates.

Figure 3: Comparison of breastfeeding rates in comparable countries (University of Sydney 2011) 4 5

Figure 3: Comparison of breastfeeding rates in comparable countries (University of Sydney 2011). For detailed description of the image please refer to the descriptive link next to the image. Description of the Image

The study found that:
  • There is a high level of initial breastfeeding in seven of the nine countries studied. Only two countries have less than 75% of mothers that initiate breastfeeding (including France at 63% and Ireland at 50%).
  • The percentage exclusively breastfeeding at six months significantly reduces across all countries. Canada and New Zealand are the only countries (of those included in the study) whose rate remains above 20%.
  • Several of the countries have relatively high rates of partial breastfeeding at six months, headed by Norway at 81 per cent, with Australia, Canada and Germany all recording above 50 per cent.
  • France and Ireland have notably lower breastfeeding rates than the other countries across all comparable measures.
  • Despite limited implementation of the WHO Code in formal regulations, the USA has higher initial breastfeeding rates than both France and Ireland. Similarly, Canada, with its limited implementation of the WHO Code, has relatively high breastfeeding rates across all three measures.
The study found6 that no one key factor or intervention was responsible for determining the breastfeeding rate in any given country. Rather, it identified several influencing factors that may explain the variations in breastfeeding rates, including:
  • Level of support available – whether from a partner, lay person, peer, or professional, the level of support has an impact on breastfeeding rates.
  • Education – particularly important for low-income families.
  • Training of health care professionals – the NHMRC Report commented that there is a positive correlation between the level of training of health care professionals and breastfeeding rates.
  • The Baby-Friendly Hospital Initiative (BFHI) – there is a high implementation of BHFI in Norway and NZ.
  • Parental leave, childcare and other government initiatives – Norway has the most generous leave provisions and the lowest use of childcare. There is some evidence that increasing paid parental leave only leads to a small increase in rates of breastfeeding.
  • Social and cultural norms have a significant influence on breastfeeding practice – societal barriers to breastfeeding in public were experienced by women in several countries. Societal influence was not identified as a barrier to breastfeeding in Norway.
  • Demographics – older women, more highly educated women, and women with a higher socio economic status have higher rates of breastfeeding across most countries surveyed.
  • Supplemental foods – the study found that the effect of formula feeding on breastfeeding rates was inconclusive.
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3 University of Sydney 2011 (pp100-103)
4 NB: ‘6 month rate (any breastfeeding)’ data not available for France and New Zealand
5 NB: ‘6 month rate (exclusive or fully breastfeeding)’ not available for France
6 University of Sydney 2011 - p100 ‘Findings and conclusions’.