Pharmaceutical and Health Care Association of the Philippines vs. Health Secretary Francisco T. Duque III et al.

Facts of the case/Chronology of events  1986 – Philippines adopts Milk Code to implement the International Code.  1986 – 2006: marketing of BMS becomes more aggressive, revealing weaknesses in implementing rules  May 2006, Revised Implementing Rules and Regulations (RIRR) issued by DOH - 'delegated' legislation  27 June Petition to Supreme Court by Pharmaceutical and Health Care Association of the Philippines (PHAP), disputing authority of DOH to issue RIRR and validity of a number of provisions. Also applied for Temporary Restraining Order (TRO)  11 July 2006 – the Supreme Court said no to TRO

 15 August 2006 – PHAP applies for review and Supreme Court grants TRO.  9 June 2007 – the Supreme Court hears oral arguments  9 October 2007 – Decision delivered. Supreme Court:  a) Agreed partially with PHAP in relation to – i) total ban on advertising of all products under scope of Milk Code and i) total ban on advertising of all products under scope of Milk Code and ii) administrative sanctions exceeding the power conferred upon DOH by the Milk Code. ii) administrative sanctions exceeding the power conferred upon DOH by the Milk Code.  Such measures could only be implemented if a law is passed to amend the Milk Code.  b) Ruled in favour of DOH and lifted TRO because other parts of RIRR consistent with objective, purpose and intent of Milk Code and constituted reasonable regulation of an industry whose activities affect public health.

Where DOH won: rulings relevant to Code implementation  a. Code is not limited to products for infants (i.e. no 12 month limit)  Definition of “breastmilk substitutes” (BMS) in the Milk Code (in pari materia with definition of BMS in the International Code) lacks reference to any particular age group. Since BMS may also be intended for children >12 months of age, the Milk Code, intends to protect and promote the nutrition of young children over the age of 12 months.  b. Labelling requirements were ruled valid, specifically: i) that there be a statement that there is no substitute for breastmilk; i) that there be a statement that there is no substitute for breastmilk; ii) that there be a statement that infant formula may contain pathogenic microorganisms and must be prepared and used appropriately; and ii) that there be a statement that infant formula may contain pathogenic microorganisms and must be prepared and used appropriately; and iii) that all health and nutrition claims be prohibited. iii) that all health and nutrition claims be prohibited.

 C. Ban on company involvement in promotion, education and production of IEC materials.  Milk Code allows for dissemination of scientific and factual information to health workers and ban in the RIRR cannot be understood or interpreted to encompass the dissemination of information to the public.  d. Ban on participating in policy making body.  DOH is responsible for implementation of the Milk Code, so up to DOH to decide which entities can be part of policy making in relation to promotion of breastfeeding.  e. Ban on sponsorship for training of health workers.  DOH can ban such sponsorship as Section 8(e) of the Milk Code only says that industry may assist in research, scholarships and education of health professionals in accordance with existing rules and regulations.

 f. Restrictions on research assistance for health workers and researchers.  Court held that limitations imposed by the RIRR for research assistance such as approval by an ethics committee and disclosure on the parts of sponsors and recipients are completely in accord with the Milk Code.  g. Ban on donations  Prohibition on donation of products and materials upheld. Although Section 6(f) of Milk Code says donations may be made by manufacturers and distributors upon request and approval of DOH, doesn’t proscribe refusal of donations. Court interpreted Milk Code as leaving matter to discretion of DOH whether to request or accept donations. By banning donations, DOH appropriately exercised its discretion and RIRR sets forth its policy not to request or approve donations.

 h. Restraint of Trade  PHAP claimed RIRR “is in restraint of trade".  Court relied on earlier case - although Philippine Constitution enshrines free enterprise, government has power to intervene to promote general welfare. Industry failed to prove how protective regulation would result in restraint of trade or unreasonably hamper trade of breastmilk substitutes.

Lessons Learned  Government has considerable discretion to regulate the harmful marketing activities of baby food industry  Regulating the marketing of BMS is not a restraint of trade and does not violate WTO agreements.  International Code is a MINIMUM standard – Philippines case shows that countries can and should adopt strong national legislation that addresses all areas of concern:

Resolution WHA (2005 ) Member States (are to): To ensure that financial support and other incentives for programmes and health professionals working in infant and young-child health do not create conflicts of interest. Inappropriate funding Strengthens and reiterates Resolution WHA (May 1996) *

 Philippines case shows that it is possible to ban industry sponsorship for training of health workers and restrict research assistance for health workers and researchers.

Company involvement in promotion, education and production of IEC materials.  Code allows this under certain conditions. Often used to undermine breastfeeding Philippines Regulations prohibit this practice

Lessons learned  National Code legislation should cover all breastmilk substitutes which include products for children up to the age of two years – it is not limited to infant formula.  Labelling requirements should take account of relevant WHA resolutions which recommend that: there be a statement that infant formula may contain pathogenic microorganisms and must be prepared and used appropriately; there be a statement that infant formula may contain pathogenic microorganisms and must be prepared and used appropriately; all health and nutrition claims be prohibited. all health and nutrition claims be prohibited.

Lessons Learned  It is possible and appropriate to ban participation of the infant food industry in policy making body.  This is consistent with the Global Strategy on IYCF which limits the role of commercial enterprises to: Ensuring products comply with Codex Alimentarius standards Ensuring products comply with Codex Alimentarius standards Ensuring marketing practices comply with the Code Ensuring marketing practices comply with the Code

Finally ….babies know best!