Pharmaceutical and Health CarePharmaceutical and Health CareAssociation of the Philippines vs. HealthAssociation of the Philippines vs. Health

Secretary Francisco T. Duque III et al.Secretary Francisco T. Duque III et al.

Facts of the case/Chronology of eventsFacts of the case/Chronology of events 1986 – Philippines adopts Milk Code to implement the 1986 – Philippines adopts Milk Code to implement the

International Code. International Code.

1986 – 2006: marketing of BMS becomes more 1986 – 2006: marketing of BMS becomes more aggressive, revealing weaknesses in implementing rulesaggressive, revealing weaknesses in implementing rules

May 2006, Revised Implementing Rules and Regulations May 2006, Revised Implementing Rules and Regulations (RIRR) issued by DOH - 'delegated' legislation(RIRR) issued by DOH - 'delegated' legislation

27 June 2006 - Petition to Supreme Court by 27 June 2006 - Petition to Supreme Court by Pharmaceutical and Health Care Association of the Pharmaceutical and Health Care Association of the Philippines (PHAP), disputing authority of DOH to issue Philippines (PHAP), disputing authority of DOH to issue RIRR and validity of a number of provisions. Also applied RIRR and validity of a number of provisions. Also applied for Temporary Restraining Order (TRO)for Temporary Restraining Order (TRO)

11 July 2006 – the Supreme Court said no to TRO11 July 2006 – the Supreme Court said no to TRO

15 August 2006 – PHAP applies for review and Supreme 15 August 2006 – PHAP applies for review and Supreme Court grants TRO.Court grants TRO.

9 June 2007 – the Supreme Court hears oral arguments 9 June 2007 – the Supreme Court hears oral arguments

9 October 2007 – Decision delivered. Supreme Court:9 October 2007 – Decision delivered. Supreme Court: a) Agreed partially with PHAP in relation to –a) Agreed partially with PHAP in relation to –

i) total ban on advertising of all products under scope of Milk i) total ban on advertising of all products under scope of Milk Code andCode and

ii) administrative sanctions exceeding the power conferred upon ii) administrative sanctions exceeding the power conferred upon DOH by the Milk Code. DOH by the Milk Code.

Such measures could only be implemented if a law is Such measures could only be implemented if a law is passed to amend the Milk Code.passed to amend the Milk Code.

b) Ruled in favour of DOH and lifted TRO because other b) Ruled in favour of DOH and lifted TRO because other parts of RIRR consistent with objective, purpose and parts of RIRR consistent with objective, purpose and intent of Milk Code and constituted reasonable regulation intent of Milk Code and constituted reasonable regulation of an industry whose activities affect public health.of an industry whose activities affect public health.

Where DOH won: Where DOH won: rulings relevant rulings relevant to Code implementationto Code implementation

a. Code is not limited to products for infants (i.e. no a. Code is not limited to products for infants (i.e. no 12 month limit)12 month limit)

Definition of “breastmilk substitutes” (BMS) in the Milk Code (in Definition of “breastmilk substitutes” (BMS) in the Milk Code (in pari pari materiamateria with definition of BMS in the International Code) lacks with definition of BMS in the International Code) lacks reference to any particular age group. Since BMS may also be reference to any particular age group. Since BMS may also be intended for children >12 months of age, the Milk Code, intends to intended for children >12 months of age, the Milk Code, intends to protect and promote the nutrition of young children over the age of protect and promote the nutrition of young children over the age of 12 months.12 months.

b. Labelling requirements were ruled valid, b. Labelling requirements were ruled valid, specifically: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 ii) that there be a statement that infant formula may contain pathogenic

microorganisms and must be prepared and used appropriately; andmicroorganisms 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, C. Ban on company involvement in promotion, education and production of IEC materials.education and production of IEC materials.

Milk Code allows for dissemination of scientific and Milk Code allows for dissemination of scientific and factual information to health workers and ban in the factual information to health workers and ban in the RIRR cannot be understood or interpreted to encompass RIRR cannot be understood or interpreted to encompass the dissemination of information to the public.the dissemination of information to the public.

d. Ban on participating in policy making body.d. Ban on participating in policy making body. DOH is responsible for implementation of the Milk Code, DOH is responsible for implementation of the Milk Code,

so up to DOH to decide which entities can be part of so up to DOH to decide which entities can be part of policy making in relation to promotion of breastfeeding.policy making in relation to promotion of breastfeeding.

e. Ban on sponsorship for training of health workers.e. Ban on sponsorship for training of health workers. DOH can ban such sponsorship as Section 8(e) of the DOH can ban such sponsorship as Section 8(e) of the

Milk Code only says that industry may assist in research, Milk Code only says that industry may assist in research, scholarships and education of health professionals in scholarships and education of health professionals in accordance with existing rules and regulations.accordance with existing rules and regulations.

f. Restrictions on research assistance for health f. Restrictions on research assistance for health workers and researchers.workers and researchers.

Court held that limitations imposed by the RIRR for Court held that limitations imposed by the RIRR for research assistance such as approval by an ethics research assistance such as approval by an ethics committee and disclosure on the parts of sponsors and committee and disclosure on the parts of sponsors and recipients are completely in accord with the Milk Code.recipients are completely in accord with the Milk Code.

g. Ban on donationsg. Ban on donations Prohibition on donation of products and materials upheld. Prohibition on donation of products and materials upheld.

Although Section 6(f) of Milk Code says donations may Although Section 6(f) of Milk Code says donations may be made by manufacturers and distributors upon request be made by manufacturers and distributors upon request and approval of DOH, doesn’t proscribe refusal of and approval of DOH, doesn’t proscribe refusal of donations. Court interpreted Milk Code as leaving matter donations. Court interpreted Milk Code as leaving matter to discretion of DOH whether to request or accept to discretion of DOH whether to request or accept donations. By banning donations, DOH appropriately donations. By banning donations, DOH appropriately exercised its discretion and RIRR sets forth its policy not exercised its discretion and RIRR sets forth its policy not to request or approve donations.to request or approve donations.

h. Restraint of Tradeh. Restraint of Trade PHAP claimed RIRR “is in restraint of PHAP claimed RIRR “is in restraint of

trade".trade". Court relied on earlier case - although Court relied on earlier case - although

Philippine Constitution enshrines free Philippine Constitution enshrines free enterprise, government has power to enterprise, government has power to intervene to promote general welfare. intervene to promote general welfare. Industry failed to prove how protective Industry failed to prove how protective regulation would result in restraint of trade regulation would result in restraint of trade or unreasonably hamper trade of or unreasonably hamper trade of breastmilk substitutes.breastmilk substitutes.

Lessons LearnedLessons Learned Government has considerable discretion to Government has considerable discretion to

regulate the harmful marketing activities of baby regulate the harmful marketing activities of baby food industryfood industry

Regulating the marketing of BMS is not a Regulating the marketing of BMS is not a restraint of trade and does not violate WTO restraint of trade and does not violate WTO agreements.agreements.

International Code is a MINIMUM standard – International Code is a MINIMUM standard – Philippines case shows that countries can and Philippines case shows that countries can and should adopt strong national legislation that should adopt strong national legislation that addresses all areas of concern:addresses all areas of concern:

Resolution WHA 58.32 (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 fundingInappropriate funding

Strengthens and reiterates Resolution WHA 49.15 (May 1996) *

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

Company involvement in promotion, Company involvement in promotion, education and production of IEC materials.education and production of IEC materials. Code allows this under certain conditions. Code allows this under certain conditions.

Often used to undermine breastfeedingOften used to undermine breastfeeding

Philippines Regulations prohibit this practice

Lessons learnedLessons learned

National Code legislation should cover all National Code legislation should cover all breastmilk substitutes which include breastmilk substitutes which include products for children up to the age of two products for children up to the age of two years – it is not limited to infant formula.years – it is not limited to infant formula.

Labelling requirements should take account Labelling requirements should take account of relevant WHA resolutions which of relevant WHA resolutions which recommend that:recommend that:

there be a statement that infant formula may contain pathogenic there be a statement that infant formula may contain pathogenic microorganisms and must be prepared and used appropriately; microorganisms and must be prepared and used appropriately;

all health and nutrition claims be prohibited.all health and nutrition claims be prohibited.

Lessons LearnedLessons Learned It is possible and appropriate to ban It is possible and appropriate to ban

participation of the infant food industry in participation of the infant food industry in policy making body. policy making body.

This is consistent with the Global Strategy This is consistent with the Global Strategy on IYCF which limits the role of on IYCF which limits the role of commercial enterprises to:commercial enterprises to: Ensuring products comply with Codex Ensuring products comply with Codex

Alimentarius standardsAlimentarius standards Ensuring marketing practices comply with the Ensuring marketing practices comply with the

CodeCode

Finally ….babies know best!Finally ….babies know best!