As provided by the 1987 Constitution, it is the State's policy to protect and promote the right to health of the people and instill health consciousness among them (Sec. 15, Art. II). This includes the adoption of an integrated and comprehensive approach to health development which shall endeavor to make essential goods, health and other social services available to all the people at affordable cost (Sec. 11, Art. XIID, as well as the establishment and maintenance of an effective food and drug regulatory system (Sec. 12, 4rt. XIII), among others.
Article 108 of the Consumer Act of the Philippines (R.A. No. 7394) also declared as a policy of the State to protect the consumer from misleading advertisements and fraudulent sales promotion practices. The Food, Dnrg, Cosmetic and Medical Device Act (R.A. 3720 as amended by EO 175 and further amended by R.A. No. 9711) provides that it is State policy to ensure safe and good quality supply of food, drugs, and cosmetics, and to regulate the production, sale, and traffic of the same to protect the health of the people (Sec 2, Chapter II). The Generics Act of 1988 required all health professionals practicing both in public and private institutions, to write prescriptions using the generic name. The law further requires that any organization or company involved in the manufacture, importation, repacking, marketing andlor distribution of drugs and
medicines shall indicate prominently the generic name of the product. Towards this end, Section 5 (o) of R.A. No. 97ll mandated the Food and Drug Administration (FDA), under the Office of the Secretary Department of Health (DOH), to prescribe standards, guidelines, and regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities about health products. Section 4, Anicle V, Book II of the Implementing Rules and Regulation of R.A. No. 9711 likewise empowers the FDA to promulgate policies and directives that would rationalize promotional and marketing practices subject to existing laws on consumer protection.
To protect patient and consumers from the high out-of-pocket spending for medicines, Republic Act 9502, otherwise known as the Universally Accessible and Affordable Quality of Medicines Act of 2008, also authorized the Secretary of Health to promulgate policies and directives to rationalize promotional and marketing practices on medicinal products and prohibit healthcare professionals from engaging in the promotion, advertisement or endorsement of drugs and medicines through all possible modes of communication.
The Philippines, as a member of the Asia-Pacific Economic Cooperation (APEC), supports APEC's thrust to promote the growth of small and medium enterprise (SME) which has been hampered by inappropriate business practices. These unethical business practices, especially in the area of product promotion imposed a significant market access barrier and high costs for SMEs in the health products sector. To address these problems, APEC has endorsed certain principles for codes of business ethics for players in the medical device and biopharmaceutical sectors, among others. These principles are specifically contained in two documents, to which the Philippine government is a signatory, namely: (a) The Kuala Lumpur Principles (KLP) Medical Device Sector Codes of Ethics; and (b) The Mexico City Principles (MCP) for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector. The FDA has earlier issued Memorandum Circular 024 s. 2AI3 and Memorandum Circular 007 s. 2014 for Mexico City and Kuala Lumpur Principles, adopting both Codes for local application. To further strengthen the adoption of the Codes, Department Circular 0389 s. 2014 created an lnter-agency Committee to develop the Implementing Rules and Regulations on the Promotion and Marketing of Pharmaceutical Products and Medical Devices. The Codes, being consistent with the current thrust of the Administration to uphold the values of integrity, accountability, transparency and good governance, affest the government's commitment to a sustainable implementation of anti-comrption measures and to exact the highest standards of integrity and professionalism in government processes and transactions as contained in the existing laws on graft and comrption, Anti-Graft and Comrpt Practices Act (RA 3019), and Code of Conduct and Ethical Standards for Public Officials and Employees (RA6713). To provide effective, safe and good quality drugs and medical devices, as well as to protect the people's rights to health, it is essential to maintain professionalism and high ethical standards in the interactions among the stakeholders in the pharmaceutical industry including manufacturers, distributors, traders, health care professionals, health care related institutions and patients' organizations. Thus, consistent with the foregoing policies and pursuant to paragraphs (4), (9) and (10) of Section 3, Chapter 1, Title IX, Book IV of the Administrative Code of 1987 (EO No. 292), this Administrative Order is hereby promulgated.