Breast or bottle: The final showdown

THE battle between breast and bottle saw its final showdown at the Supreme Court Tuesday, when the court en banc heard the oral arguments presented by the Department of Health (DOH) through Solicitor General Agnes Devanadera, against the Pharmaceutical and Healthcare Association of the Philippines (PHAP), a group of pharmaceutical and milk companies.

The High Court has ordered both sides to submit their written comments on the oral arguments within 30 days. Chief Justice Reynato Puno has said that because of its “far-reaching implications” the issue will be resolved as soon as the parties have submitted their comments.

Earlier, trade and industry secretary Peter Favila reportedly sent a letter to Devanadera to caution her about the negative implications on investments in the event that the revised Implementing Rules and Regulations (RIRR) take effect.

The controversy stemmed from the implementation of the RIRR of Executive Order 51, or the Milk Code. The RIRR prohibits the promotion of breastmilk substitutes for children up to two years of age; disallows breastmilk substitutes from making any health and nutrition claims; and, requires breastmilk substitute containers to be labeled with a warning that inappropriate preparation and improper use may have health hazards.

The DOH has blamed the milk companies for the decline in breastfeeding rates, specifically, the aggressive and unethical marketing of breast milk substitutes. For 2006, milk companies have spent P2.5 billion in advertising for the first half alone, according to AC Nielsen Media Research. A small amount compared to the P21 billion annual profit of the milk companies, which, according to the DOH, is a conservative estimate. (Read the PCIJ report on breastfeeding.)

The health department has been advocating for tighter regulation against breast milk substitutes. They have good reason for doing so. In 2003, results of the National Demographic and Health Survey (NDHS) showed that:

• Only 16.1 percent of infants are exclusively breastfed up to four to five months of age;

• 13 percent of infants were never breastfed, making the Philippines the lowest in ever breastfed rates among 56 countries that have conducted a DHS in the past ten years;

• 39 percent of infants are using infant formula in their first 12 months of life;

• Half stopped exclusively breastfeeding by the third week of life;

• Infants delivered in a health facility or by a health professional are less likely to breastfeed.

This decline in breastfeeding rates in the country has resulted in death and malnutrition of children under 5 years of age. In 2004, there was a reported 82,000 under 5 deaths in the Philippines, making the Philippines one of the 42 countries that account for 90 percent of under 5 deaths.

The World Health Organization (WHO) has also reported that at least 16,000 infants die in the Philippines annually, deaths that could have been prevented had there been exclusive breastfeeding in the first hour; exclusive breastfeeding for the first six months; and continued breastfeeding and appropriate complementary feeding to at least two years.

Aside from the deaths that could have been prevented, Unicef has enumerated the costs of inappropriate infant feeding practices:

• 1.2 million more illness episodes;
• 10 million more days ill;
• 450,000 more health facility visits;
• 36,000 more infants hospitalized.

Economically, this translates to:

• P320 million in funeral expenses;
• P1 billion in lost wages caring for sick infants;
• P100 million on out of pocket expenditure for health facility visits and basic drugs;
• P50 million out of pocket for hospitalizing their infants;
• P230 million government expenditure on hospitalization;
• P21.3 billion to purchase formula.

In the National Nutrition Survey conducted by the Food and Nutrition Research Institute (FNRI) in 2003, it was found that 27.6 percent of Filipino children below the age of five were underweight and 30.4 percent were stunted.

Alarmed by these statistics, the DOH, through then Health Secretary Francisco Duque III, signed the revised IRR.
PHAP filed a temporary restraining order (TRO) against the enforcement of the RIRR, arguing that the rules went beyond the powers of EO 51.

PHAP contended that:

• While the Milk Code limits its coverage to infants, defined under EO 51 as “a person falling within the age bracket of 0-12 months,” the RIRR extended its coverage to young children.

• The Milk Code recognizes that milk formula may be a proper and possible substitute for breast milk in certain instances, showing that EO 51 only provides for the regulation of the use of formulas, not its outright prohibition.

• While EO 51 merely regulates advertising and promotional activities and materials for milk formula, the RIRR imposes an absolute ban on advertising, promotions or sponsorships of milk formula.

• The Milk Code allows the dissemination of scientific information and factual matters regarding the products to health professionals.

• While the Milk Code permits the manufacturers and distributors to extend assistance in the research, scholarships, and continuing educations of health professionals, the RIRR unqualifiedly prohibits being involved in policy-making entities concerned with the advancement of the government’s breastfeeding program.

• The RIRR imposes additional labeling requirements not found in the Milk Code and forbids the use of health and nutrition claims in advertisements.

• While EO 51 merely regulates the donations of sample products and give-aways, the RIRR prohibits the same.

• The RIRR provides administrative sanctions for violations, these are not provided in the Milk Code.

• The RIRR provides for the repeal of existing laws, which could only be done by an act of Congress.

The milk companies further claim that the implementation of the new rules will cost them nearly P10 billion and that consumers’ right to information will be violated.

The Supreme Court initially denied PHAP’s TRO on August 11, 2006. Four days later, on appeal, the high court overturned its earlier decision and granted the TRO.

Observers have noted that the turnaround coincided with the letter from the president of the US Chamber of Commerce to President Arroyo saying that the implementation of the RIRR would have “negative consequences for investors’ confidence in the predictability of business law in the Philippines.”

See a copy of the letter here.

The DOH filed a petition seeking to lift the TRO, arguing that the TRO has “tied the hands of government in solving the worsening problem of infant mortality and malnutrition which is attributable to the unregulated and unchecked advertising of infant milk formula and breast milk substitutes that convey messages that undermine breastfeeding and glamorizes infant formula.”