Policy Unit

Legal and Regulatory Review and Analysis of Laws and Policies Related to Family Planning and Other Health Services
Deliverable No. 16
June 30, 2004

This report was made possible through support provided by the U.S. Agency for International Development, under the terms of Contract No. 492-C-00-03-00024-00. The opinions expressed herein are those of the author(s) and do not necessarily reflect the views of the U.S. Agency for International Development.

Table of Contents I. Overview II. Study Objectives and Approach III. Findings and Analysis IV. Recommendations Annexes 1 1 3 11

Legal and Regulatory Review and Analysis of Laws and Policies Related to Family Planning and Other Health Services I. OVERVIEW

The LEAD for Health Project aims to strengthen local government unit (LGU) provision and management of family planning (FP) and selected health services like tuberculosis (TB), HIV/AIDS and Vitamin A supplementation. In particular, Component C of the Project is concerned with creating and promoting a policy environment and obtaining a level of financing that would favor the sustained provision of quality FP and the identified health services. A major task of this Component involves Improving Legal and Regulatory Policies for Health Services Delivery. As a first step to accomplishing this task, Management Sciences for Health (MSH) engaged the services of a local team of experts from the Center for Economic Policy Research (CEPR), supported by a team from the Harvard School of Public Health (HSPH), in a short-term technical assistance (STTA) to carry out a legal and regulatory review of laws and policies relating to quality FP and other health services. This report is the culmination of that effort. II. STUDY OBJECTIVES AND APPROACH

Specifically, the STTA set out to: 1. Develop a framework for the review and analysis of laws and regulations that will be utilized for the conduct of the study; 2. Conduct an inventory of laws and regulations that serve to constrain the provision of quality FP services, TB-DOTS, and HIV/AIDS; 3. Describe the process of formulating and revising laws and regulations in the Philippines; 4. Review and analyze these laws and how they may serve to deter the provision of FP, TB-DOTS, and HIV/AIDS services; 5. Conduct a comparative analysis of how other countries dealt with these legal and regulatory constraints and with what level of success; 6. Make recommendations on how these legal and regulatory constraints may be removed; and, 7. On the basis of these recommendations, draft specific policy proposals that may be introduced to minimize constraints. The study commenced with a compilation and review of laws and regulations that either directly or indirectly impact on the delivery of the selected health services. This was followed by a series of interviews with 70 key informants from the national and local

governments, non-governmental organizations, the private sector and partner institutions. Through these consultations, the joint team of CEPR and Harvard consultants endeavored to identify (1) laws, regulations, and policies that serve as a barrier to effective service provision; and (2) new ways in which the law could potentially be used to improve the latter. Below are the institutions and bodies, as well as the specific organizational units within them, that participated in the consultations: National Government 1. Department of Health (Central Office): Health Policy Development and Planning Bureau (HPDPB); Procurement and Logistics Service (PLS); Family Planning Program 2. Bureau of Food and Drugs 3. Philippine Health Insurance Corporation 4. Commission on Audit 5. Professional Regulatory Commission 6. Population Commission Local Government 1. League of Provinces 2. League of Cities 3. League of Municipalities 4. Province of Pangasinan Population Office, Legal Office, Urdaneta Hospital, Malasiqui Rural Health Units (RHUs) 1 and 2, Mangaldan RHU Non-Government Organizations 1. Reproductive Health Rights and Ethics Center For Trainings and Outreach Network (REPROCEN) 2. Philippine Legislators Committee on Population and Development Foundation, Inc. (PLCPD) Private Sector 1. Organon Philippines, Inc.

Partner Institutions 1. The Futures Group Subsequent desk research and follow-up consultations also uncovered the various processes for formulating and revising laws at the national, local, and agency levels. These are described in Annexes 1, 2, and 3, respectively. III. FINDINGS AND ANALYSIS

During the desk research and subsequent confirmatory consultations, the team identified more than 50 issues that may be addressed by law or regulations. These issues were subsequently reduced to a more manageable number based on: (i) the importance of the issue as a barrier to the effective provision of services; (ii) their relevance to the LGUs; (iii) the political and economic feasibility of the proposed reform intervention; and (iv) the capacity of MSH and the LGUs to effect the proposed reform measures. The HSPH and CEPR consultants together identified the relevant issues and the corresponding potential reform measures based on the first two criteria. The local consultants of CEPR subsequently evaluated the feasibility of the proposed measures using the last two criteria. The issues and potential reform measures identified by the combined teams of HSPH and CEPR consultants are summarized below. It must be noted, however, that responsibility for determining which interventions are feasible and deserve to be pursued lies solely with the local consultants. 1. Adopt regulatory reforms to spur the development of a private market for contraceptives. - At present, the private market is small and unattractive for new commercial entrants. Although the private market is not expected to service many contraceptive users who currently obtain their supply for free from the government, the development of the private market is still critical for it not only ensures constant supply for those who have the resources to buy contraceptives but could also help increase public awareness about family planning. Private market development may be bolstered through the following regulatory measures: a. Make the pill an over-the-counter (OTC) product1. Contraceptive pills are currently classified by the Bureau of Food and Drugs (BFAD) as ethical products. As such, they can be sold only in BFAD-licensed drug outlets under the supervision of a registered and licensed pharmacist. There is the view that this restriction has made access to such pills difficult for women as they would have to obtain prescriptions from a licensed physician before they could purchase them in the drugstores. Obtaining a prescription is not only cumbersome and costly, but could also be difficult in areas where there are no
OTC drugs are drug products that can be dispensed even without the written order or prescription of a licensed physician . . . for human use, for the symptomatic relief of minor or self-limiting ailments. DOHA.O. No. 23-C, s. 2000, Sec. 1.
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licensed physicians or the available physicians are unwilling to prescribe any form of contraceptives. DOH-A.O. No. 23-C, s. 2000 lists down the following criteria before any drug product is reclassified from ethical to OTC: (i) the drug product is time-tested and has undergone thorough investigation and extensive clinical use; (ii) the drug product is recognized to contain active ingredient(s) with proven safety and efficacy even without professional supervision as proven by adverse drug reaction monitoring; and (iii) the drug product is neither with bioequivalence problem nor classified as prohibited or regulated by the Dangerous Drugs Board or as an internationally controlled drug product by the International Narcotics Control Board.2 To establish compliance with these criteria, DOH-A.O. No. 23-C requires submission of documents proving that: (i) under recommended conditions of use, the product is safe and effective; (ii) the concentration(s) of the active ingredient(s) have been found to be clinically safe and effective and does not exceed the maximum limit imposed by the Secretary of Health for symptomatic relief of minor or self-limiting ailments; (iii) the worldwide incidence of reported adverse drug reactions (ADRs) and interactions of the drug is low and clinically insignificant; (iv) the number of years the drug product has been released in the international market and the sale of the originally registered strength and form is at least 20 years and in the Philippine market for at least 10 years; and (v) the drug product, if imported, is classified as an OTC or nonprescription drug in the country of origin and marketed in at least two of the following countries: Canada, United Kingdom, U.S.A. , Japan, Australia and Sweden.3 Any application to shift a drug product from ethical to OTC will be referred by the BFAD Director to the Technical Advisory Committee of BFAD (ACB) for evaluation and corresponding recommendation.4 Experience shows that it would be difficult for BFAD to agree to any ethical-to-OTC shift unless it receives the endorsement of the ACB. Hence, any move to shift contraceptive pills must get the support of the ACB to succeed. The ACB is a technical body, and must therefore be convinced of the technical merits of the proposal
2 3

Ibid. Sec. 2-A. Ibid. Sec. 2-B. 4 Ibid, Sec. 3(1).

to shift selected contraceptive pills to OTC. The messenger, or the person who will argue in favor of the OTC shift before the ACB, is therefore as important as the message. The biggest hurdle is expected to be the fifth requirement as we are not aware that any of the countries listed above have classified contraceptive pills as OTC or non-prescription product. The fourth requirement could also be a problem as it prevents any new contraceptive formulation from being introduced into the country as OTC despite its extensive use abroad. Assuming there is enough data to prove safety and efficacy of contraceptive pills as OTC, there are three options in dealing with requirements (iv) and (v). First is to work for the amendment of DOH-A.O. No. 23-C, specifically for the deletion of these two requirements. However, BFAD is unlikely to agree to such proposal as it could open the floodgate to the reclassification of many pharmaceutical products to OTC.5 The second option is to seek an explicit exception to A.O. 23-C for contraceptive pills on the ground that it is not therapeutic in nature, unlike the drug products covered in the Order. Any explicit exception, however, could be a lightning rod for those against any form of contraceptives and thus could be politically non-viable. The third option, which we believe to be most feasible, is to seek the issuance of another A.O. The new A.O. would be specific to contraceptive pills and would implicitly set aside the last two requirements in Sec. 2-B of A.O. No. 23-C. However, before taking any further step to make contraceptive pills OTC, it is best to consult again with potential private market players as they may not consider the shift to OTC critical, or even desirable. Organon, for instance, expressed opposition to any proposal to make their contraceptive products OTC. This is not surprising. Ethical marketing is focused on a limited number of doctors, while OTC marketing targets the more dispersed end-users. Most pharmaceutical companies in the Philippines, especially the small- to mediumsized ones, currently do not have the expertise and resources for the latter. A product that has been shifted to OTC loses a significant portion of its prescription base and eventually becomes a consumer item that is heavily dependent on costly multi-media advertising and promotions. Thus, even if regulations were to be amended to facilitate the OTC shift, it is conceivable that some private players will not avail themselves of its benefits, more so if there is no significant competitive threat to their existing prescription products. There is likewise the view that there is no need to shift contraceptive pills to OTC as many drugstores do not require prescriptions anyway. Any advocacy to change the regulations could unnecessarily call attention to current practices and disrupt the modus vivendi that exists in the field.

Arguably, there is no need for requirements (iv) and (v) if the other three requirements to show safety and efficacy are met. The last two requirements may have been inserted simply to facilitate evaluation by, and as added legal protection to, the ACB and BFAD.

b. Include additional pill brands in the Philippine National Drug Formulary (PNDF). In at least one interview, the limited number of pills in the PNDF was cited as a stumbling block to the development of the private market. Government agencies, including the LGUs, cannot purchase medicines outside of those listed in the PNDF. The same is true as regards issuance of prescriptions by doctors in government hospitals. Increasing the number of contraceptive products and brands in the PNDF could provide additional sales opportunities for some private companies and thus make the private market more attractive. The DOH is responsible for the PNDF but relies heavily on the opinion of its technical consultants. Hence, it would have to be convinced of the technical merits of expanding the PNDF to include more contraceptive products and brands. We see no legal or regulatory hurdles that would prevent the DOH from expanding the PNDF if there are strong policy and technical justifications for doing so. c. Reduce the review period for BFAD product registration. It takes more or less one year for BFAD to evaluate the registration dossier of any drug product, including contraceptive pills. Although companies already factor in the BFAD application period when planning their product launches, a quicker review process would enable the private players to recoup their investment faster. BFAD has previously provided an express lane for pharmaceutical products which are priced at least 50% lower than those available in the market. A similar scheme could be implemented for contraceptive products except that instead of simply complying with the lower-price condition a company could be granted express lane status in exchange for certain undertakings that would help boost the demand for family planning services or provide subsidized contraceptives to certain segments of the population. d. Adopt measures to improve public awareness of modern-method contraceptives. These include: (i) making counseling on modern methods of family planning a requirement of the Philippine Health Insurance Corporation (PhilHealth) accreditation or PhilHealth reimbursement for certain services such as delivery of babies. This may be achieved by a simple resolution from the PhilHealth Board and embodied in a circular distributed to the concerned hospitals. However, the mechanism for monitoring implementation would have to be carefully crafted to minimize administrative burden while ensuring compliance; (ii) requiring that family planning be part of the public high school and medical curricula. As a first step, a Memorandum of Agreement could be executed between the Department of Health and the Department of Education (for the high school curricula) and the Commission on Higher Education (for the medical curricula) to design the course and train teachers to handle it; and (iii) imposing a family planning course as one of the requirements for continuing professional education for physicians, nurses, midwives, and pharmacists. There was previously a requirement that doctors participate in continuing education, but it is no longer in place. An administrative issuance by the Professional Regulations Commission (PRC) requiring continuing education as a condition for renewal of license would

suffice. However, it would be difficult to persuade PRC to reimpose the requirement unless previous problems in implementation are first addressed. e. Use public service announcements to boost demand. - To make commercial advertising of prescription products legal would require changing the current regulations prohibiting the advertisement of prescription drugs, specifically BFAD Regulation No. 5, s.1987. However, the same regulation allows press releases, editorials, health columns and features, and public service announcements, provided that no brand/trade names are specified and that they clearly state that prescription products can be bought only with a prescription and upon the advice of a doctor. The so-called advertorials are now commonplace and private companies can take advantage of them to promote contraceptive products. Pharmaceutical companies are engaged in a constant tug-of-war with BFAD as regards the scope of the prohibition, and in many instances, BFAD has been reasonable in its decisions. An ingenious way of side stepping the prohibition is the use of the company name in promotional campaigns, which company name is also used to identify a line of contraceptive products. BFAD has thus far been tolerant of such a scheme. Hence, we see no need to amend the regulations to enable companies to use public service announcement in fostering demand for contraceptive products. Revising BFAD Regulation No. 5, s. 1987 to allow direct-to-consumer advertising of pharmaceutical brands, including contraceptives, is not feasible at the moment as there is no significant constituency to push for it. Moreover, physicians and pharmacists, both organized and articulate segments of the population, would likely mount a vigorous opposition to the proposal. 2. Address misconceptions about the legal and regulatory regime relating to modern methods of family planning. The following misconceptions can easily be addressed by orders or circulars from relevant government agencies: a. Ensure that pre-marriage counseling on family planning is provided to all couples by LGUs rather than only by churches. - At present, pre-marriage family planning counseling is required in order for couples to obtain a marriage license, but some LGUs have apparently delegated responsibility for actually providing the counseling to representatives of religious institutions, particularly the parish priests. As a result, some couples do not receive counseling on modern-method contraception. The Department of Interior and Local Government (DILG) could be requested to issue an administrative order reiterating the role of LGUs in pre-marriage counseling. If a DILG order cannot be obtained, LGUs may be encouraged to assert their authority over pre-marriage counseling by requiring all couples to attend a family planning (natural and modern methods) seminar, whether or not such couples also attend a church-sponsored program. b. Rebut the widespread misconception that the law requires spousal consent for tubal ligations. - Some providers fear that they will be sued if they provide tubal ligations without the husbands consent. An advisory opinion from the

Department of Justice in response to a request of the DOH or Population Commission (POPCOM) would suffice to address this concern. c. Clarify and possibly ease legal requirements concerning who may prescribe and dispense oral contraceptives and Depo-Provera. - Whether nurses and midwives can legally dispense a womans initial supply of oral contraceptives and injectables without a doctors prescription is not totally clear. Most people we talked to had the impression that they could. Although Presidential Decree No. 79 arguably provides legal authority for this proposition, the law is certainly not as clear as it might be because of the subsequent passage of laws governing the nursing and midwifery professions6. However, necessity rather than legal formalism seems to be dictating practice at the moment, and thus further consideration of the need for regulatory clarification is warranted. In addition, there is at present no legal authority allowing nurses to write prescriptions. The issue of nurses prescribing may well become an important issue as the supply of free contraceptives is reduced and a greater proportion of contraceptives are obtained through private pharmacies. Since this will require the amendment of Republic Act No. 9173, or the Philippine Nursing Act of 2002, and will necessarily have to include other prescription products, further consultation is necessary to assess the benefits of granting nurses the prescribing authority vis--vis the expected resistance from stakeholders, particularly the physicians. 3. Explore policy measures to decrease the price of contraceptives, TB, and HIV drugs in Philippines. - This is an important and complex area involving broad policy considerations. Issues involved are diverse and range from efficiency of the procurement process to a consideration of supply side regulations. Among the potential policy options are reviving parallel importation in conjunction with expanded bulk purchasing; improving the market for generics; removing the valueadded tax and tariffs; applying direct price controls for drugs; reviving the DOH practice of accrediting certain drug companies and either encouraging LGUs to buy from them or having the Commission on Audit (COA) disallow purchases from other companies; ensuring faster payment of suppliers by DOH by improving cash flow processes, thereby giving DOH leverage to negotiate for discounts from suppliers; instituting an "expanded discount" program through which government contracts for drugs are awarded contingent upon the supplier's agreement to sell to indigent private patients at the same price; and creating public-private partnership with drug companies to create programs to stimulate demand for drugs on the private market.
Presidential Decree No. 79 [1971], as amended by Presidential Decree No. 1204 [1977], lists as one of the duties and functions of POPCOM to employ or authorize the employment by participating agencies in the national family planning, health and welfare programs of physicians, nurses and midwives and other persons to provide, dispense and administer all acceptable methods of contraception to all citizens of the Philippines desirous of spacing, limiting, or preventing pregnancies: Provided, That the above mentioned persons except physicians, for the purpose of contraception, have been trained and duly certified by the POPCOM. [Sec. 5(a), emphasis supplied]. However, there is no similar function of nurses and midwives mentioned in R.A. No. 9173 (Philippine Nursing Act of 2002) and R.A. No. 7392 (Philippine Midwifery Act of 1992), respectively.
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Of these options, there are three which are feasible and immediately actionable, namely: (i) parallel importation in conjunction with expanded bulk purchasing; (ii) reviving the DOH practice of accrediting certain drug companies and either encouraging LGUs to buy from them or having COA disallow purchases from other companies; (iii) ensuring faster payment of suppliers by DOH by improving cash flow processes, thereby giving DOH leverage to negotiate for discounts from suppliers. No legislative intervention is necessary to implement these options as the DOH already has the legal authority to implement them.7 4. Improve LGUs ability to participate in inter-zone cooperative arrangements and bulk purchasing programs for prescription drugs and contraceptives. Presumably facilitating bulk purchasing would allow LGUs to benefit from the resultant economies of scale. There are a number of ways that this could be done, including use of Inter-local Health Zones, allowing LGUs to procure through the DOH, or routing LGU procurement through the Philippine International Trading Corporation (PITC) or the Department of Budget and Management (DBM). 5. Fully implement the AIDS Prevention and Control Act of 1998. - At present, implementation is incomplete due to a combination of funding shortfalls and absence of implementing rules and regulations (for example, on the procedures through which victims of HIV discrimination can obtain legal redress). Since these are implementation issues, there is at the moment no need for additional legislation. Other interventions were suggested to address various perceived legal and regulatory hurdles to the provision of the four program areas covered by the study but which were set aside for being outside the mandates of MSH or the LGUs. They include the following: 1. Using public interest litigation to: (a) Challenge unconstitutional local ordinances that restrict access to modernmethod contraceptives. - Several LGUs have passed ordinances prohibiting or restricting access to oral contraceptives and other modern-method contraceptives. One LGU has gone so far as to announce its intent to burn stockpiles of contraceptives. Such ordinances arguably violate various provisions of the Philippine Constitution. Public-interest litigation could be brought to challenge such ordinances. (b) Address non-enforcement of constitutional rights to health and family planning. A number of provisions in the Constitution relate to health care and/or contraception. Article II, Section 6 states that separation of the Church and State shall be inviolable. Despite such provisions, anti-family
The Department of Trade and Industry has taken the lead in implementing the government parallel import scheme for pharmaceutical products. Parallel importation is particularly critical for HIV-AIDS drugs. However, most of these drugs are patented and the parallel importation scheme of the government is limited to off-patent, branded drugs, or the so-called branded generics. To enable the government or any private entity to parallel import patented products, the Intellectual Property Code of the Philippines will have to be amended either to adopt the international exhaustion principle or create an exception for lifesaving medicines.
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planning ordinances such as those mentioned above go unchallenged. The case of Oposa v. Factoran, et al., G.R. No. 101083 (July 30, 1993) has acknowledged the right to health in Article II, Sec. 15 as an actionable right, yet unfettered information on and access to family planning services which is an integral part of such right continues to be denied to women. 2. Impose restrictions on distribution of TB drugs in the private sector. Despite the fact that the DOH Directly Observed Treatment Short Course (DOTS) program provides free drugs, private doctors continue to prescribe TB medications. Follow-up for private patients appears to be inadequate in many cases, leading to high rates of default which in turn lead to an increase in drug resistance. Some pharmacists are also dispensing Isoniazid for weak lung, again potentially promoting the emergence of drug resistance. Restrictions on the private sale of TB medications were proposed by many informants working in the public sector. 3. Use the Quarantine Law to deal with noncompliant TB patients. Some officials in the DOH expressed interest in how the law can be used in order to require recalcitrant TB patients to undergo treatment. The Department of Labor and Employment and the Civil Service Commission could be persuaded to issue regulations to require employers to compel TB-positive employees to undergo treatment. The quarantine issue, however, will have to be studied further in the light of the SARS experience and of concerns such as compensation and benefits of patients during the quarantine period and socially acceptable mechanisms to implement the quarantine. 4. Expand COAs use of safe harbors, advisory opinions, and guidance to address LGU fears concerning audits. - Fear of COA audit has a chilling effect on LGUs willingness to innovate. COA has provisions for safe harbors, advisory opinions, and regulatory guidance, but they may be underutilized. Such measures are a means of reassuring LGUs that contemplate innovative financing or procurement policies that they will not incur audit liability. 5. Permit multiyear budgets for DOH and LGUs. - Fluctuations in national health care budgets and delays in mobilizing funds were frequently cited as a major impediment to the delivery of health care services. The DOH was interested in multiyear budgets as a legislative solution to this problem. However, the DOHs previous attempt to pass such legislation was unsuccessful. Given the current fiscal crisis, it is extremely unlikely that the DBM would allow any government agency multiyear budgets unless it is expressly required by the funding source. 6. Ease the requirements of the Magna Carta for Health Workers. This was one of the most frequently mentioned legal impediments to health care delivery at the LGU level. However, any attempt to change the Magna Carta would likely be vigorously opposed by covered health workers, not to mention by the DOH. 7. Expand COAs use of performance audit to monitor LGU provision of services in the four program areas. The COA currently performs such audits, albeit infrequently. This would seem a ready means for monitoring the extent to which LGUs are actually providing the services specified in the DOH national programs. COA budgetary restrictions may be the primary obstacle here.

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IV.

RECOMMENDATIONS

In general, many of the concerns raised in the four program areas relate to the interpretation and implementation of existing laws and regulations. Hence, there may be no immediate need to advocate for any changes in existing laws and regulations. Attention may be better focused on improving implementation and clarifying misconceptions about the legal and regulatory systems. As to family planning, current challenges seem to lie in the national government policy of de-emphasizing modern-method contraception in favor of natural methods. Existing laws already provide sufficient anchor for a vigorous and effective family planning program. Whatever gaps there may be in the legal and regulatory regime can be addressed by administrative issuances from relevant government agencies, including LGUs, or by pragmatic and creative solutions in the field. In any case, it may be worth extending technical assistance to LGUs in the form of templates or guidelines to assist them in drafting local health ordinances. The DOH, LGUs, and Leagues of Cities and Municipalities all seem receptive to using this as a way of encouraging action at the LGU level. We believe, however, that this is not a precondition to implementing effective programs in the four program areas, particularly family planning, as existing laws and regulations are already in place. Moreover, care must be taken to avoid the experience with child protection ordinances where a number of LGUs passed ordinances based on templates without a clear understanding of the specific problems affecting their constituencies.

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ANNEX 1

ANNEX 1 THE NATIONAL LEGISLATIVE PROCESS HOW A BILL BECOMES A LAW 1. Preparation of the Bill 2. First Reading 3. Committee Consideration/Action 4. Second Reading 5. Third Reading 6. Transmittal of the Approved Bill to the Senate 7. Senate Action on Approved Bill of the House 8. Conference Committee 9. Transmittal of the Bill to the President 10. Presidential Action on the Bill 11. Action on Approved Bill 12. Action on Vetoed Bill Note: A joint resolution having the force and effect of a law goes through the same process. PREPARATION OF THE BILL The bill is prepared by the Member or by the Bill Drafting Division of the Reference and Research Bureau upon his request. FIRST READING 1. The bill is filed with the Plenary Affairs Bureau and the same is labeled "HB/HR", numbered and reproduced. 2. Three days after its filing, the same is included in the Order of Business for First Reading. 3. On First Reading, the Secretary General reads the Title and Number of the bill. The Speaker refers the bills to the appropriate Committee/s.

COMMITTEE CONSIDERATION/ACTION 1. The Committee concerned evaluates the bill to determine the necessity of conducting public hearings. If the Committee finds it necessary to conduct public hearings, it schedules the time thereof, issues public notice and invites resource persons from the public and private sectors, the academe, and experts on the proposed legislation. If the Committee finds that no public hearing is needed, it schedules the bill for Committee discussion/s. 2. Based on the result of the public hearings or Committee discussions, the Committee may introduce amendments, consolidate bills on the same subject matter, or propose a substitute bill. It then prepares the corresponding committee report. 3. The Committee approves the Committee report and formally transmits the same to the Plenary Affairs Bureau. SECOND READING 1. The Committee report is registered and numbered by the Plenary Affairs Bureau, and included in the Calendar of Unassigned Business. 2. Upon motion of any Member, the bill is calendared for consideration. 3. On Second Reading, the Secretary General reads the number, title and text of the bill, and the following takes place: a. Period of Debate Sponsorship Speech Interpellation Turno en Contra b. Period of Amendments Committee Amendments Individual Amendments c. Voting - which may be by i. viva voce ii. raising of hand iii. division of the House; or iv. nominal or roll call

THIRD READING 1. The amendments, if any, are engrossed and printed copies of the bill are reproduced by the Plenary Affairs Bureau for third reading. 2. The engrossed bill is included in the Calendar of Bills for Third Reading and copies of the same are distributed to all the Members three days before the Third Reading. 3. On Third Reading, the Secretary General reads only the number and title of the bill. 4. A roll call is called and a Member, if he so desires, is given three (3) minutes to explain his vote. No amendment on the bill is allowed at this stage. a. The bill is approved by an affirmative vote of a majority of the Members present. b. If the bill is disapproved, the same is transmitted to the Archives. TRANSMITTAL OF THE APPROVED BILL TO THE SENATE The approved bill is transmitted to the Senate for its concurrence. SENATE ACTION ON APPROVED BILL OF THE HOUSE The Senate considers the bill in the same manner as bills filed by the Senators. CONFERENCE COMMITTEE 1. A Conference Committee composed of Members from each House of Congress meets to settle or reconcile different versions or disagreements in any provision of the bill. 2. The conferees are not limited to reconciling the differences in the bill but may introduce new provisions germane to the subject-matter or may report out an entirely new bill on the subject. 3. The Conference Committee prepares a report which is signed by all the conferees in each and every page thereof. 4. The Conference Committee Report is submitted for consideration/approval of both Houses. New amendment is allowed.

TRANSMITTAL OF THE BILL TO THE PRESIDENT Copies of the bill, signed by the President of the Senate and the Speaker of the House of Representatives, and certified by both the Secretary of the Senate and the Secretary General of the House, are transmitted to the President. PRESIDENTIAL ACTION ON THE BILL 1. If the bill is approved the President, the same is assigned a Republic Act (RA) number and transmitted to the House where it originated. 2. If the bill is vetoed, the same together with a message, citing the reason for the veto is transmitted to the House where the bill originated.

ACTION ON APPROVED BILL The bill is reproduced and copies are sent to the Official Gazette and distributed to the implementing agencies and thereafter included in the Annual compilation of Acts and Resolutions. ACTION ON VETOED BILL The message is included in the Order of Business. If the Congress decides to override the veto, the House and the Senate shall proceed separately to reconsider the bill or the vetoed items of the bill. If the bill or its vetoed items is passed by a vote of third-thirds of all Members of each house, such bill or items shall become a law.

ANNEX 2

ANNEX 2 THE LOCAL LEGISLATIVE PROCESS ORDINANCE AND RESOLUTION DEFINED An ordinance is a local law, a regulation of a general, permanent nature, and a rule established by authority. It prescribes some permanent rules of conduct of government which have the force and effect of law, to continue in force until repealed or superseded by subsequent enactment. A resolution is merely for the translation of the current business of the local government unit and has no permanent value, for it deals only with matters of special or temporary character. It is a mere expression of the opinion or mind of the sanggunian concerning some matters of administration coming within its official cognizance and provides for the disposition of a particular item of the administrative business of a local government unit. CARDINAL RULES THAT SHOULD BE OBSERVED BY THE SANGGUNIAN IN ENACTING AN ORDINANCE AND/OR A RESOLUTION Must be in harmony with the Constitution, laws or statutes as well as general principles of law and equity; in a sense must be consistent with public policy and must not contravene human rights Must be enacted in good faith, in the public interest, and designed to enable the local government unit to perform its functions Must extend only to subjects or matters which are within the powers of the sanggunian to enact Must be reasonable in its terms Must not be partial or discriminatory Must not restraint, but may regulate trade Must be adopted by an authorized sanggunian, legally convened

STEPS IN ENACTING AN ORDINANCE OR A RESOLUTION Sponsorship of an Ordinance or a Resolution Sanggunian member(s) files with the secretary to the sanggunian two (2) or three (3) copies of the draft ordinance or resolution.

Secretary to the sanggunian records the draft ordinance or resolution in a logbook. On first reading, the secretary to the sanggunian reports all proposed ordinances or resolutions, then the Presiding Officer assigns same to appropriate committee(s) to study same, hold hearings and debates. Committee Deliberations If the committee concerned recommends action on the proposed ordinance or resolution, a report to the effect is submitted to the presiding officer through the chairman of the Committee on Rules who calendars the proposed ordinance or resolution for second reading. If the committee action on a proposed ordinance of resolution is unfavorable, it is laid on the table and, within ten (10) days, the author or authors concerned are given notice stating the reason(s) for such action. Second Reading and Floor Consideration On second reading, the secretary reads the proposed ordinance or resolution in its entirety, although this can be dispensed with since every sanggunian member is presumed to have a copy of the measure under consideration. The chairman of the committee recommending the ordinance or resolution, or someone designated for the purpose, explains briefly the nature of the ordinance or resolution and recommends its approval. Thereafter, the proposed ordinance or resolution is subject to debate, then to amendments, and other proper parliamentary motions. The secretary to the sanggunian prepares enough copies of the proposed ordinance or resolution in the form it was passed on second reading, and distributes them to each member at least three (3) days before final reading. Third Reading and Final Vote Upon third reading of the proposed ordinance or resolution, the presiding officer puts the question(s) to a vote, and directs the secretary to the sanggunian to call the roll to record each members vote. Approval of Ordinances and Resolutions Every ordinance or resolution enacted by the sanggunian is presented to the local chief executive (LCE) for approval.

If the LCE approves the same, he affixes his signature on each and every page thereof; otherwise, he vetoes it and returns the same with his objections to the sanggunian, which may proceed to consider the same. The sanggunian may override the veto of the LCE by a two-thirds (2/3) vote of all its members thereby making the ordinance or resolution effective for all legal intents and purposes. The veto shall be communicated by the LCE to the sangggunian within fifteen (15) days in the case of a province, and ten (10) days in case of a city or municipality; otherwise, the ordinance is deemed approved as if he had signed it. Review of Ordinances or Resolutions by the Sanggunian An ordinance or resolution of the sanggunian panlungsod of a component city and sanggunian bayan shall be submitted to the sangguniang panlalawigan for review, by the secretary within three (3) days after its approval. For sangguniang barangay, an ordinance or resolution shall be submitted to the sanggunian panlungsod or sangguniang bayan, as the case may be, for review within ten (10) days after its enactment. If no action has been taken by the sangguniang panlalawigan or sanggunian panlungsod or sanggunian bayan, as the case may be, within thirty (30) days after submission of an ordinance or resolution enacted by a lower level sanggunian, the same shall be presumed consistent with law and therefore, valid. Effectivity of Approved Ordinances and Resolutions Unless otherwise stated in the ordinance or the resolution approving the local development plan and public investment program, the same shall take effect after ten (10) days from the date a copy thereof is posted in a bulletin board at the entrance of the provincial capitol or city, municipal or barangay hall, as the case may be, and in at least two (2) other conspicuous places within the territorial jurisdiction of the local government unit concerned. Publication of Approved Legislative Action The secretary to the sanggunian concerned shall cause the posting of an ordinance or resolution in the bulletin board at the entrance of the provincial capitol or city, municipal or barangay hall, as the case may be, and in at least two (2) conspicuous places in the local government unit concerned not later than five (5) days after approval thereof.

The secretary to the sanggunian concerned shall transmit official copies of such ordinances to the chief executive officer of the Official Gazette with seven (7) days following the approval of the said ordinance for publication purposes.

SCHEMATIC PRESENTATION OF THE LOCAL LEGISLATIVE PROCESS

INTRODUCTION Sanggunian member(s) introduces an ordinance or resolution. Secretary to the sanggunian records the ordinance in a logbook. First Reading Secretary to the sanggunian reads the draft ordinance, then the Presiding Officer assigns same to appropriate committee(s) to study same, hold hearings and debates. COMMITTEE ACTION after favorable report of the committee is received, draft ordinance or resolution is included in the Calendar of Business no committee action is taken sanggunian ends further consideration of the measure

Second Reading for rule expediting floor action, settling conditions for debate and amendments.

Third Reading after amendments have been suitably incorporated; debate is often waived and amendments need unanimous consent at this stage; the vote following the reading is final.

if deleted, the ordinance is shelved in the sanggunian archives

if passed by the sanggunian, the ordinance is sent for approval of the

if ordinance is voted down, it is dead

Local Chief Executive PASSAGE INTO LAW Approval affixes his signature on each and every page of the ordinance Veto returns the ordinance with his objections to the sanggunian; ordinance becomes a law if sanggunian overrides LCEs veto by its two-thirds vote

ANNEX 3

ANNEX 3 PROCESSES FOR FORMULATING AND REVISING LAWS AT THE AGENCY LEVEL THE DEPARTMENT OF HEALTH ADMINISTRATIVE ISSUANCE SYSTEM ADMINISTRATIVE ISSUANCE DEFINED An Administrative Issuance is an official document issued from time to time by higher authorities of government, e.g., the President of the Philippines, Department Secretaries, or other officials. It is intended to convey decisions, policy guidelines, procedural directions, standards, rules and regulations, information relating to the assignment, detail, or transfer of personnel, and other information of an administrative nature. TYPES OF ADMINISTRATIVE ISSUANCES OF THE DEPARTMENT OF HEALTH

Administrative Order Department Order Department Memorandum Department Circular

Administrative Order (A.O.) Provides policies, standards, rules and regulations or general instructions for the proper and efficient administration of all DOH units based on existing laws. More specifically:

It is confined to matters of a general and permanent nature and which fall under the jurisdiction of the Department; It may be initiated by the head of any bureau or office, but shall take effect only upon approval by the Secretary of Health and/or publication in the Official Gazette or in a newspaper of general circulation as may be required by existing laws, rules and regulations; It has the effect of the law for which it is issued until rescinded or amended; It shall not prescribe penalties for violation unless expressly provided by law.

Examples of the Subject Matter of an A.O. Rules and regulations governing the enforcement of food and drug laws; establishment of blood banks Policies and standards on the accreditation for government hospitals; Implementing rules to cover the reorganization of the DOH; Detailed functions of each office, bureau, service, and other major organizational unit affected by the reorganization Department Order (D.O.) Confined to a particular purpose, specific object, person, or class. It may consist of instructions given to specific personnel regarding permanent or temporary assignment, transfer and/or movement from one assignment to another, designations and other matters of administrative detail. Examples of the Subject Matter of a D.O. Assignment to perform field work Transfer and detail of personnel Designation of Officer-in-Charge of major units Designation of Special Disbursing Officer Attendance on official business Creation of Committees/Task Forces Department Memorandum (D.M.) Issued to remind heads of offices of Memorandum Circulars issued by the Department of Health or other Departments, e.g., Department of Budget and Management (DBM), Civil Service Commission (CSC), Commission on Audit (COA), which have specific time frames and require strict compliance Examples of the Subject Matter of a D.M. Budget estimates/proposals to be submitted with a specific deadline Financial work plans to be submitted to DBM Compliance with requirements of COA circulars within the specified time frame

Department Circular (D.C.) A general communication that refers to the internal administration of an office. They are advisory and informative in nature and less directional. Also disseminates circulars of other government offices whose functions relate with the DOH for the information of DOH personnel. Examples of the Subject Matter of a D.C. Memorandum Circular of the CSC for information/reference and compliance General Circular of the COA Requests of private medical societies/other professional organizations for attendance of DOH personnel in their official meetings OTHER TYPES OF ISSUANCES BY DOH OFFICIALS OTHER THAN THE SECRETARY OF HEALTH Per Administrative Order No. 32 s. 1994, the following issuances can be issued by other DOH officials who are heads of their respective major organizational units: Office Orders, Office Circulars, and Office Memoranda by the Undersecretaries Office Orders, Office Circulars, and Office Memoranda by the Assistant Secretary for Financial, Operations and Frontline Services Audit Office Orders, Office Circulars, and Office Memoranda by the Assistant Secretary for Legal Affairs

Example of the Office Order Designation of Officer-in-Charge for Hospital Operations and Management Service by the Undersecretary of Health Bureau Orders, Bureau Circulars, and Bureau Memoranda by the Bureau Directors

Example of the Bureau Circular Guidelines on the conduct of HIV-related examinations Regional Field Office Orders, Regional Field Office Circulars, and Regional Field Office Memoranda by the Regional Field Office Directors

Example of the Regional Field Office Memorandum Reminder on the submission of the annual report of various units Regional Health Office (RHO) X with deadline Service Orders, Service Circulars, and Service Memoranda by the Service Directors

Example of the Service Order Directing TB Control Service personnel to conduct monitoring of TB activities in Region IX Hospital Orders, Hospital Circulars and Hospital Memoranda by the Medical Center Chiefs of Specialty Hospitals, Medical Centers, Regional Medical Centers, Regional Hospitals and Sanitaria

Examples of the Hospital Order assignment of personnel detail of personnel designation creation of committees Examples of the Hospital Circular (advisory/informative/less directional in nature) operating procedures/regulations of hospitals instructions from other government agencies CSC/DBM/COA/Government Service Insurance System (GSIS) related to its functions/activities personnel for hospital personnel/patients/visitors Examples of the Hospital Memoranda (mandatory/directional/advisory/informative in nature) administrative/technical instructions to a particular division/department/medical center-wide reminder on regulations/instructions transmitted by other government agencies related to particular activities/personnel matters with time frame STEPS IN THE ISSUANCE OF DOH LEGISLATION Preparation/Drafting of the Issuance Any head of office, regional office, bureau, service, or medical center may initiate the preparation or drafting of issuances related to their respective areas of specialization and

which conform with existing Department policies. Upon instructions from the Head of Office (HO), the actual drafting of the issuance is usually carried out by the Administrative Officer or his designate, or any other key employee that the HO may assign. Initial Review of the Issuance Where the issuance is drafted by an employee of lower rank, the initial review of the draft shall be carried out by the Administrative Officer or the Chief of the Technical Division, depending on whether the issuance is administrative or technical in nature. Certain types of issuance such as those on health policies or rules and regulations related to substantive health programs which are the subject matter of administrative orders should be reviewed by the Health Policy Development Staff. Other issuances dealing with personnel actions, e.g., assignments, designations, detail or transfer of personnel should be reviewed by the Administrative Service and, where legal matters are involved, by the Office of Legal Affairs. The process of review should also include, where their areas of competence is involved, the Financial Service, the Health Manpower Development Training Service (HMDTS), the Bureau of Food and Drugs (BFAD), the Radiation Health Service, etc. Higher-Order Reviews and Endorsement The Undersecretary concerned shall review any issuance emanating from any of the offices under his jurisdiction, and subsequently endorse the same to the Chief of Staff for further review. These higher-order reviews shall be undertaken to ensure the accuracy, consistency and conformity of the Issuance with existing policies and standards of the DOH. Depending on its nature and scope, an Issuance may or may not be elevated to the Secretary of Health for final approval and signing. Numbering, Filing, and Dissemination of Issuances For Department- and Office-wide Issuances, these shall be numbered, filed and disseminated by the Records Section of the Administrative Service. For other issuances, the Records Officer or Records Officer-designate shall be responsible for numbering, reproducing, and disseminating certified true copies of the issuances. They shall also be responsible for filing and safe-keeping of the original and duplicate copies of the issuances to include all corresponding attachments and supporting documents. Original copies shall be filed separately from the duplicates which bear the initials of the initiating, reviewing, and recommending officials, including the supporting papers.

COMMISSION ON AUDIT INTERNAL PROCEDURE FOR LEGISLATION (Based on phone interview with Director Marcelino Hanopol, COA Head Executive Assistant) A Legislative Issuance prepared by the COA normally comes in the form of a COA Resolution, whose Implementing Rules and Regulations (IRRs) are subsequently embodied in either a COA Circular or a COA Memorandum, depending on the scope of the IRRs application. COA Circulars are issuances whose application is limited to COAs internal operations, while COA Memoranda have a wider scope of application that covers all or part of general or local government operations. COA legislation normally start out as proposals for improvement or revisions in COA audit rules, based on findings and recommendations articulated in audit reports of field auditors. The proposal/audit report is first submitted to and reviewed by the appropriate COA Regional Cluster Director, and if found to be in order, is subsequently elevated to the COA Central Office where it undergoes further review by the Committee of Assistant Commissioners in the course of the Committees monthly meetings. The central level review, among others, involves validating the findings and recommendations of the proposal in other COA territorial jurisdictions. If the proposal is found to be meritorious, it is then elevated to the COA Commissioner for approval. Once approved, a COA Resolution and the corresponding COA Circular or Memorandum are issued to implement the proposed changes or improvements.

ANNEX 4

ANNEX 4 SUMMARY OF LAWS AND REGULATIONS REVIEWED

OVERALL SUMMARY OF LEGISLATIONS AND REGULATIONS REVIEWED

II. IMPLEMENTATION AREA I. POLICY PROGRAM MANAGEMENT 2 4 2 8 SERVICE DELIVERY 3 6 3 7 1 20 PROCUREMENT, DISTRIBUTION AND USAGE 2 2 4 1 4 13

Family Planning HIV/AIDS Anti-TB Vitamin A Cross-cutting Total

8 3 1 1 5 18

SUMMARY OF CROSS-CUTTING LAWS & ISSUANCES

TITLE OF LAW OR ISSUANCE I. Policy 1987 Constitution of the Republic of the Philippines

DESCRIPTION/ RELEVANT PROVISIONS

REMARKS

Declares the right to health as a State policy: In Oposa, et al. v. Factoran, et Art. II, Sec. 15. - "The State al., G.R. No. 101083 (30 July shall protect and promote 1993), the Supreme Court the right to health of the declared Art. II, Sec. 15 as a people and instill health source of positive right that is consciousness among directly enforceable through them." judicial action. This despite its being under the Declaration of Principles and State Policies section of the Constitution and not under the Bill of Rights. The Court held that [a]s a matter of fact, these basic rights [which include the right to health] need not even be written in the Constitution for they are assumed to exist from the inception of humankind. If they are now explicitly mentioned in the fundamental charter, it is because of the well-founded fear of its framers that unless the rights to a balanced and healthful ecology and to health are mandated as state policies by the Constitution itself, thereby highlighting their continuing importance and imposing upon the state a solemn obligation to preserve the first and protect and advance the second, the day would not be too far when

TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS

REMARKS all else would be lost not only for the present generation, but also for those to come generations which stand to inherit nothing but parched earth incapable of sustaining life.

Republic Act No. 5921, otherwise known as the Pharmacy Act of the Philippines

Provides for, among others, the control and regulation of the practice of pharmacy in the Philippines. Sec. 27 Every pharmacy, drugstore or hospital pharmacy, whether owned by the government or a private person or firm, shall at all times when open for business be under the personal and immediate supervision of a registered pharmacist: Provided, that no pharmacist shall have personal supervision of more than one such establishment. In case where a drug establishment operates more than one shift, each shift must be under the supervision and control of a registered pharmacist.

Later amended by Executive Order No. 174 dated 22 May 1987. Sections relating to: a) responsibility for safety, efficacy, quality and purity of drugs; b) penal provisions for making false representation as a pharmacist; and c) the definition of "drug" were modified. There is the view that the requirement of having a registered pharmacist, even if the products are over-thecounter, adversely impacts upon the distribution process of pharmaceutical products, including those intended for family planning purposes.

Republic Act No. 7160,otherwise known as the Local Government Code of 1991, approved 10 October 1991

Declares local autonomy as State policy and provides for the operative principles of decentralization. Sets forth the powers and responsibilities of the local

TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS government units (LGUs). Recognizes every LGU as both a political subdivision of the National Government and as a corporate entity representing the inhabitants in its territory. Among its corporate powers are the power to enter into contracts and exercise such powers as are granted to corporations, subject to limitations provided in the Code or other laws. As a rule, the local chief executive cannot enter into a contract in behalf of the LGU without the prior authorization by its sanggunian. Includes health services as part of the basic services that the LGU must provide its constituents.

REMARKS

Republic Act. No. 7305: The Magna Carta of Public Health Workers, approved 26 March 1992, and its Implementing Rules and Regulations

Mandates the grant of certain benefits to improve the social and economic well-being, living and working conditions, skills and terms of employment of health workers. There are specific provisions on hours of work, salaries and allowances, housing, leave and retirement benefits, and other rights and privileges of health workers.

There is the view that R.A. No. 7305, by expressly requiring the grant of certain benefits (e.g., hazard pay) has made it difficult for LGUs to expand their health services. It has given an entitlement to the health workers without the commensurate increase in the resources of the LGUs. There is no distinction in the Magna Carta as regards the ability to pay of the LGUs.

TITLE OF LAW OR ISSUANCE Republic Act No. 7875: An Act Instituting a National Health Insurance Program For All Filipinos And Establishing The Philippine Health Insurance Corporation For The Purpose (National Health Insurance Act of 1995), approved 14 February 1995 II. Implementation A. Program Management B. Service Delivery Department Circular No. 195, s. 1993: Policies and Guidelines for the Implementation of Hospitals as Centers of Wellness Program, dated 1 December 1993

DESCRIPTION/ RELEVANT PROVISIONS Mandates the creation of a national health insurance system and the establishment of PHILHEALTH. The health insurance system is to cover those employed, selfemployed and indigents. LGUs to cover portion of the health insurance premiums of the indigents.

REMARKS

Directs DOH-retained hospitals to take the lead in preventing diseases and promoting healthy lifestyles among patients and their families, hospital personnel and the general public. This includes strengthening, among others, the following promotive/preventive programs: a) Mother & Baby Friendly Hospital Initiative; b) Anti-smoking Campaign; c) Family Planning Program; d) Maternal Care and Under Five Clinic; e) Blindness

TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS and Prevention Program; and f) AIDS Prevention, Education and Care. It also directs the development of one or more other programs suitable to the needs of specific localities, which includes Pulmonary TB Control.

REMARKS

C. Procurement, Distribution and Usage Department Order No. 104-C s. 1991: Mandatory Use of the Philippine National Drug Formulary (PNDF) Vol. I as the Basis for Procurement of Drug Products by the Department of Health (Amended by Department Order No. 31-F, s 1993), dated 4 April 1991 Directs the use of the PNDF Vol. I (or Essential Drugs List) in place of the DOH Drug Formulary in the requisition of drug products by regional, provincial, district, and city health offices, specialty and regional hospitals, national medical centers, and sanitaria. The respective Therapeutic Committees in these DOH field units and health facilities shall determine the types and quantities of drug products to be procured based on the PNDF. Procurement of drugs and medicines for Rural Health Units (RHUs) as well as primary care and municipal hospitals shall continue to be based on the list of Primary Medical Care Drugs (PMCD) prepared by the National

TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS Drug Committee. Where the required drugs are not listed in the PMCD and the PNDF, the agency or health facility shall write a request to the DOH justifying the purchase and approval. The DOH may refer such request to the National Drug Committee (NDC), as needed. Allows DOH hospitals and other offices to buy drugs/medicines made from plan materials that have complied with the requirements of the Bureau of Food and Drugs.

REMARKS

Department Order No. 31-F, s.1993: Amendment of the Mandatory Use of the Philippine National Drug Formulary (PNDF) as Basis for Procurement of Drug Products by the Department of Health, dated 25 January 1993 Administrative Order No. 23-C s. 2000: Policies and Guidelines on Over-the-Counter (OTC) Drug Products, dated 9 March 2000

Contains: a) a definition of OTC drugs; b) criteria for classification as an OTC drug; c) procedure for the registration of OTC drug products; and authority of the Secretary of Health to revoke/withdraw the approval of the classification of a drug as OTC As stated in the title.

Executive Order No. 40: Consolidating Procurement Rules and Procedures for All National Government

TITLE OF LAW OR ISSUANCE Agencies, GovernmentOwned or Controlled Corporations and Government Financial Institutions, and Requiring the Use of the Government Electronic Procurement System (Including subsequent Implementing Rules and Regulations)

DESCRIPTION/ RELEVANT PROVISIONS

REMARKS

SUMMARY OF FAMILY PLANNING LAWS & ISSUANCES

TITLE OF LAW OR ISSUANCE I. Policy 1987 Constitution of the Republic of the Philippines

DESCRIPTION/ RELEVANT PROVISIONS

REMARKS

Declares the following as State policies: Art. II, Sec. 12. - "The State recognizes the sanctity of family life and shall protect and strengthen the family as a basic autonomous social institution. It shall equally protect the life of the mother and the life of the unborn from conception . . ." Art. II, Sec. 14. - "The State recognizes the role of women in nation-building and shall ensure the fundamental equality before the law of women and men. Art. XV, Sec. 3(1): "The State shall defend (i) the right of spouses to found a family in accordance with their religious convictions and the demands of responsible parenthood."

No law or jurisprudence yet defining when conception begins.

Presidential Decree No. 79: Revising the Population Act of Nineteen Hundred and

Section 2. Declaration of Policy. The Government of the Philippines hereby declares that for the

P.D. No. 79 amended Republic Act No. 6365, otherwise known as the Population Act of the Philippines, which was

TITLE OF LAW OR ISSUANCE Seventy One ("Revised Population Act of the Philippines"), dated 8 December 1972

DESCRIPTION/ RELEVANT PROVISIONS purpose of furthering national development, increasing the share of each Filipino in the fruits of economic progress and meeting the grave social and economic challenge of high rate of population growth, a national program of family planning involving both public and private sectors which respects the religious beliefs and values of the individuals involved shall be undertaken.

REMARKS enacted into law on 15 August 1971. It essentially reiterated the policy in R.A. No. 6365 of establishing a family planning program which respects the religious beliefs and values of individuals. More significantly, it strengthened the Commission on Population (POPCOM) by expressly granting it the authority and responsibility to employ physicians, nurses, and midwives to provide, dispense and administer all acceptable methods of contraception to all citizens of the Philippines desirous of spacing, limiting or preventing pregnancies, provided only that these health workers, except physicians, have been duly trained and authorized by POPCOM in consultation with the appropriate licensing bodies. Further, POPCOM was authorized to utilize clinics, pharmacies and commercial channels of distribution for the distribution of family planning information and contraceptives. (Sec. 5) P.D. No. 79 was later amended by: (i) P.D. No. 1204, issued on 29 September 1977, which: (a) granted POPCOM also the power to authorize participating agencies

10

TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS

REMARKS in the national family planning, health and welfare program to employ health workers to provide, dispense and administer all acceptable methods of contraception to all citizens of the Philippines, and (b) modified the powers and responsibilities of the Chairman and Executive Director of POPCOM; (ii) Executive Order No. 160, issued on 13 April 1987, which expanded membership in POPCOM's Board of Commissioners from 5 to 14 (with 3 private sector representatives) and appointed Secretary of the Department of Social Welfare and Development (DSWD) as Chairman. Notwithstanding the amendments, the basic policy declared by P.D. No. 79 remained in place.

Department of Health Administrative Order No. 1-A s. 1998: Creation of a Philippine Reproductive Health Program, dated 15 January 1998

Declares adherence to the program of action of the 1994 International Conference on Population and Development, which includes "broadening of population policies and

This was subsequently modified by DOH A.O. No. 24-A, s. 1999, but continues to be acknowledged in subsequent DOH issuances like A.O. No. 132, s. 2004, which cited it as source document for the

11

TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS programs beyond family planning as the main program mechanism." Identifies 10 elements of the Philippine Reproductive Health (RH) Program, to wit: 1) Family Planning; 2) Maternal & Child Health, and Nutrition; 3) Prevention and management of abortion complications; 4) Prevention and treatment of Reproductive Tract Infections (RTIs) including STDs, HIV and AIDS; 5) Education and counseling on sexuality and sexual health; 6) Breast and reproductive tract cancers & other gynecological conditions; 7) Men's RH; 8) Adolescent RH; 9) Violence against women; and 10) Prevention and treatment of infertility and sexual disorders. Prescribes approaches to strengthen the Philippine RH Program by (a) Integrating HR services, emphasizing quality and expanding coverage through partnership programs with LGUs, NGOs and the private sector within the framework of the Health Sector Reform Agenda; and (b) Improving the general

REMARKS identification of family planning as one of the priority health care services of government.

Department of Health Administrative Order No. 24-A s. 1999: Strengthening the DOH Reproductive Health Program, dated 8 March 2000

12

TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS health of all Filipinos by promoting personal responsibility, and empowering communities to exercise HR rights through information dissemination the emphasize freedom of choice. It also expounds on the HR Program's vision, mission, goal, and general and specific objectives for 2004, implementing mechanism, and funding. Translates A.O. No. 24-A into a health policy.

REMARKS

Department of Health Administrative Order No. 43 s. 1999: Reproductive Health Policy, dated 24 April 2000

This A.O. is an exact replica of A.O. No. 24-A, with some changes incorporating the results of the writeshop on HR policy development initiated by the DOH, which was conducted on 8-10 December 1999. The writeshop resulted in a preamble, an enunciation of the DOH guiding principles with respect to RH, and strategies for the successful implementation of the policy.

Department of Health Administrative Order No. 50-A s. 2001: National Family Planning Policy, dated 17 September 2001

Prescribes the key policies for family planning services as an element of RH. These policies are aimed at achieving by 2004 (a) targeted reductions in the MMR, IMR, under-5 Mortality Rate, and Total Fertility Rate from 1998 levels; and (b) targeted

13

TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS increase in the Contraceptive Prevalence Rate from the 1998 level. It declares that family planning as a health intervention shall be made available to all men and women of reproductive age, and focuses on seven modern FP methods, namely: (a) natural FP; (b) pills; (c) condoms; (d) hormonal injectables/DepoMedroxyprogesterone Acetate; (e) intrauterine device; (f) lactational amenorrhea method (LAM); and (g) voluntary surgical sterilization such as bilateral tubal ligation and vasectomy. Transfers POPCOM from the National Economic and Development Authority to the Office of the President then attached to the Department of Health.

REMARKS

Executive Order No. 118, s. 2003, dated 24 March 2003

In 1971, POPCOM was placed by R.A. No. 6365 under the Office of the President. Under Letter of Implementation No. 37 dated 11 December 1975, it was attached to the Department of Health. On 30 January 1987, under E.O. No. 123, it was the attached to the DSWD. Three years later, on 18 June 1990, it was again transferred to the Office of the President by virtue of E.O. No. 408 dated 18 June 1990, but it was transferred again a year, this time to NEDA, under E.O. No. 476 dated 14 August 1991. The meaning of being attached

14

TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS

REMARKS to DOH was subsequently clarified in an advisory opinion of Hon. Manuel B. Gaite, Acting Deputy Executive Secretary for Legal Affairs, dated 21 May 2003 that it was only for purposes of policy and program coordination and will not affect the discharge by POPCOM of its functions under P.D. No. 79.

Department of Health Administrative Order No. 132, s. 2004: Creating the DOH Natural Family Planning Program and its Program Management, dated 7 January 2004

Establishes as a DOH mission to promote and teach, in partnership with local government units, NGOs, church groups and religious organizations, modern methods of natural family planning (NFP) to couples of reproductive age who prefer the approach over the use of artificial methods Declares the following NFP policies: (a) Recognition only of modern NFP methods that have been acknowledged by international authorities and NFP service providers, and subject to extensive testing to ascertain their efficacy and scientific validity (e.g., Billings Ovulation Method, Basal Body Temperature Method, Sympto-Thermal Method, and Lactational

15

TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS Amenorrhea Method) (b) Exclusion of methods that are not founded on fertility awareness on the part of the couple or of the woman whose ovulatory cycle is of concern (c) Use of Standard Days Method only as an adjunct with the other already established modern NFP methods (d) Fertility awareness as main mechanism of advocacy for NFP

REMARKS

II. Implementation A. Program Management Department of Health Administrative Order No. 50-A s. 2001: National Family Planning Policy, dated 17 September 2001 Designates the DOHCenter for Family and Environmental Health as lead agency for FP and management, with the POPCOM as primarily responsible for national population policy and advocacy. Mobilizes the DOH-Natural The executive issuances Family Planning ancillary to DOH A.O. No. 132, Management Committee s. 2004, are: (DOH-NFPMC) to report to (a) DOH Department Order the Director of the National No. 107, s. 2004, issued Center for Disease on 5 January 2004,

Department of Health Administrative Order No. 132, s. 2004: Creating the DOH Natural Family Planning Program and its

16

TITLE OF LAW OR ISSUANCE Program Management, dated 7 January 2004

DESCRIPTION/ RELEVANT PROVISIONS Prevention and Control and to coordinate the with the National NFP Committee. The DOH-NFPMC shall, among others, develop polices and guidelines for the strengthened implementation of the NFP Program and ensure that NFP is mainstreamed in all relevant DOH programs. Provides for the functions of the Regional NFP Program Manager.

REMARKS which created and identified the composition of the DOH-NFPMC; (b) DOH Department Memorandum No. 152, s. 2003, issued on 24 November 2003, which, among others, directed the Centers for Health Development (CHD) Directors and the Secretary of Health for ARMM to designate a point person as Regional NFP Program Manager who shall not, in any way, be connected with any existing FP Program associated with the use of artificial contraceptives or sterilization. The Memorandum emphasized that the NFP Program is a distinct program that is totally independent of the Family Planning Program of the DOH. This should, therefore, be replicated throughout the entire DOH structure.

B. Service Delivery Department of Health Order No. 2-C, s. 1992: Voluntary Surgical Emphasizes the need to establish voluntary surgical contraception centers in all

17

TITLE OF LAW OR ISSUANCE Contraception (VSC) of PFPP, dated 2 July 1992

DESCRIPTION/ RELEVANT PROVISIONS regional, provincial, city, and district hospitals of the government. However, determination, coordination, and referral of cases will be made through the local government structures. Directs the: a) Inclusion of LAM as an FP method option; b) Establishment of a set of implementing guidelines on FP delivery interface; training; LAM and breastfeeding advocacy; supervision, monitoring and evaluation; IEC messages/materials; collaboration among LGUs, NGOs, other GOs and the academe; c) Development of competencies at all levels to ensure effective breastfeeding and LAM implementation and monitoring; d) Maximization of the participation of women's, religious and other peoplebased groups in program implementation; and, e) Encouragement of further operational and clinical research on LAM/breastfeeding Directs the DOH-Center for Family and Environmental Health to ensure the expansion of FP insurance

REMARKS

Department of Health Circular No. 33-B, s. 1994: Policy on Lactational Amenorrhea Method (LAM) as a Family Planning Method, dated 14 February 1994

Department of Health Administrative Order No. 50-A s. 2001: National Family

18

TITLE OF LAW OR ISSUANCE Planning Policy, dated 17 September 2001

DESCRIPTION/ RELEVANT PROVISIONS benefits to include other FP services under the National Health Insurance Program. Requires all DOH-retained hospitals to ensure the provision of modern FP methods and to create itinerant teams available for dispatch to respond to the needs for surgical methods, especially in urban and rural poor communities.

REMARKS

C. Procurement, Distribution and Usage Republic Act No. 7392, otherwise known as the Philippine Midwifery Act of 1992, dated 10 April 1992 Defines the practice of midwifery as performing or rendering, or offering to perform or render, for a fee, salary, or other reward or compensation, services requiring an understanding of the principles and application of procedures and techniques in the supervision and care of women during pregnancy, labor and puerperium management of normal deliveries, including the performance of internal examination during labor except when patient is with antenatal bleeding; health education of the patient, family, and community; primary health care services in the community, This law supersedes R.A. 2644 The view that midwives cannot administer IUD without any written order from a physician has no basis under Republic Act No. 7392. The phrase in carrying out the written order of physicians refers to antenatal, intra-natal and postnatal care of the normal pregnant mother in giving immunization. Hence, it may be argued that the authority granted by P.D. No. 79 to midwives to provide, dispense, and administer all acceptable methods of contraception provided they have trained or authorized by POPCOM (or by its successor agency in the DOH) continues to hold. Further, the frontline role occupied by midwives in

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TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS including nutrition and family planning in carrying out the written order of physicians with regard to antenatal, intranatal and postnatal care of the normal pregnant mother in giving immunization, including oral and parenteral dispensing of oxytocic drug after delivery of placenta, suturing parietal lacerations to control bleeding, to give intravenous Vitamin K to the newborn . . . Requires the Procurement and Logistics Service to ensure that quality, legally, and medically safe contraceptives are available through the Contraceptive Distribution and Logistics Management Information System (CDLMIS).

REMARKS FP is evidenced by the fact that the definition of practice of nursing makes no express reference to FP, unlike that of midwifery.

Department of Health Administrative Order No. 50-A s. 2001: National Family Planning Policy, dated 17 September 2001

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SUMMARY OF HIV/AIDS LAWS & ISSUANCES

TITLE OF LAW OR ISSUANCE I. Policy R.A. 8504: Philippine AIDS Prevention and Control Act of 1998 (Including Implementing Rules and Regulations issued by the Philippine National AIDS Council), approved 13 February 1998

DESCRIPTION/ RELEVANT PROVISIONS

REMARKS

Promulgates policies and prescribes measures for the prevention and control of HIV/AIDS in the Philippines; institutes a nationwide HIV/AIDS Information and Educational Program; establishes a comprehensive HIV/AIDS monitoring system, and strengthens the Philippine National AIDS Council (PNAC). Implementing rules and regulations were subsequently formulated by the PNAC. Provides strategic directions for future activities and complements existing guidelines of the National AIDS/Sexually Transmitted Disease (STD) Prevention and Control Program Amends Administrative Order No. 57-A s. 1989, and sets forth policies to prevent the spread of HIV in the country. The policy statements cover:

DOH Administrative Order No. 2 s 1997: The National Policy Guidelines for the Prevention and Management of Sexually Transmitted Diseases, dated 20 February 1997 DOH Administrative Order No. 7-C s. 1995: Revised Policies for the Prevention and Control of HIV Infections/AIDS in the Philippines, dated 30

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TITLE OF LAW OR ISSUANCE March 1995

DESCRIPTION/ RELEVANT PROVISIONS Management of the National AIDS Control Program; Information, Education & Communication; Protective Measures to contain the spread of HIV; blood and blood products; HIV anti-body testing; patient confidentiality; HIV/AIDS statistics; Health care services; Discriminatory practices; AIDS in the workplace; and Empowerment of people with AIDS

REMARKS

II. Implementation A. Program Management Department Circular No. 51-A, s. 1987: Formation of Local AIDS Control Committee, dated 27 May 1987 Directs city and provincial health officers to form local AIDS control committees consisting of, among others, representatives from the Departments of Education, Culture and Sports, and Social Welfare and Development, and the Mayor's Offices. The Local AIDS Committee shall: a) Draft a local AIDS control plan; b) Formulate a rehabilitation plan for infected

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TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS individuals; and c) Monitor the enforcement of the Sanitation Code. Directs City Health Officers to assume responsibility over the local AIDS Control Committees

REMARKS

Department Order No. 196, s. 1987: Designation of All City Health Officers as ExOfficio Members of the AIDS Prevention and Control Committee of the Department of Health, dated 7 August 1987 Department of Health Order No. 52-B, s. 1993: Creation of the DOHAIDS Prevention Committee, dated 8 February 1993 Administrative Order No. 78 s 2002: Amendment to Administrative Order No. 7-C s.2001 Section A 1, 1.1, 2, 2.1 (Decentralization of some regulatory functions of the Bureau of Health Facilities and Services on Clinical Laboratories and HIV Testing Laboratories to the Centers for Health Development in the Transition Phase), dated 7 February 2002

Creates the DOH-AIDS Prevention Committee

Stipulates that the Bureau of Health Facilities shall conduct the inspection of clinical and HIV testing laboratories based in tertiary category hospitals, while those located in secondary and primary hospitals shall be inspected by the CHD, prior to renewal of licenses to operate.

Amends DOH A.O. No. 7-C, s. 2001, which earlier decentralized to CHDs the renewal of license to operate clinical laboratories and accreditation for HIV testing laboratories in the Transition Phase.

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TITLE OF LAW OR ISSUANCE B. Service Delivery Department Order No. 93-B, s 1987: Designation of the Research Institute for Tropical Medicine (RITM) as National Reference Laboratory for Testing for Human Immunodeficiency Virus (HIV), dated 21 May 1987 Department Circular No. 47, s. 1987: Revocation of Licenses of Hospitality Girls Found Positive for Antibody Against the Human Immunodeficiency Virus (AIDS Virus), dated 21 May 1987 Administrative Order No. 18 s. 1995: Revised Guidelines in the Management of HIV/AIDS Patients in the Hospital, dated 21 November 1995 (Amended by Administrative Order No. 9 s. 1997)

DESCRIPTION/ RELEVANT PROVISIONS

REMARKS

Enumerates the functions of RITM as National Reference Laboratory for Testing for HIV

Directs city health officers and rural health physicians to revoke licenses and provide counseling to commercial sex workers found positive for HIV/AIDS

Amends A.O. No. 27. Specific objectives are: (a) To organize HIV/AIDS Core Teams in each DOH hospital; (b) Formulate standardized guidelines in the management of HIV/AIDS; ( c) Provide holistic care to HIV/AIDS infected patients, their families, and significant others, including referrals

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TITLE OF LAW OR ISSUANCE

DESCRIPTION/ RELEVANT PROVISIONS and networking with NGOs and GOs; (d) To develop human resources necessary to carry out the guidelines; (e) To implement and operationalize HIV/AIDS related programmes in the hospital

REMARKS

Administrative Order No. 9 s 1997: Amendment to Administrative Order No. 18 s. 1995 Regarding the Guidelines in the Management of HIV/AIDS Patients in the Hospital, dated 10 May 1997 Administrative Order No. 16-A s 1997: Guidelines for the Management of Asymptomatic Women with RTI/STD, dated 26 August 1997

Amends A.O. No. 18 to include provisions on: (a) Criteria for the selections of HIV/AIDS Core Team (HACT) leader and members; (b) Guidelines on the performance of HIV/AIDS screening test on the referral system Provides directions on early case finding of asymptomatic women with RTI/STD in order to provide early treatment and prevent complications; also establishes standards for risk assessment, training, and referral for managing asymptomatic women with RTI/STD Amends A.O. No. 5 s. 1998 by providing improved guidelines on the management of vaginal discharge in

Administrative Order No. 5-A s. 2003: Revised National Sexually Transmitted Infections (STI) Case Management

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TITLE OF LAW OR ISSUANCE Guidelines, dated 10 January 1993

DESCRIPTION/ RELEVANT PROVISIONS women. These guidelines are seen to be more costeffective and have a better diagnostic validity than previous guidelines, and useful for health facilities with limited capabilities for etiological diagnosis of STI among patients with RTI and STI.

REMARKS

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TITLE OF LAW OR ISSUANCE C. Procurement, Distribution and Usage Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, approved 6 June 1997

DESCRIPTION/ RELEVANT PROVISIONS

REMARKS

Provides for strict patent rules.

Relevant if the required HIV/AIDS medicines are covered by Philippine patents. The Philippines has adopted the national exhaustion principle, which can be invoked by a patent owner to prevent the parallel import of patented drugs into the country.

Department Memorandum No. 5 s. 2002: Utilization of Family Planning Condoms for Use of the National AIDS/STD Prevention and Control Program and the Designation of Selected NGOs as Additional CDLMIS Condom Delivery Sites, dated 7 January 2002

Directs that FP condoms supplied through the Contraceptive Delivery Logistics Management Information System (CDLMIS) of the DOH should routinely be made available for use of the National AIDS/STD Prevention and Control Program, and designates selected NGOs as additional CDLMIS condom delivery sites

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SUMMARY OF Anti-TB LAWS & ISSUANCES

TITLE OF LAW OR ISSUANCE I. Policy Department of Health Circular No. 238, s 2003: Guidelines on the Use of Fixed-Dose Combination (FDC) Anti-TB Drugs Under the National TB Program (NTP), dated 30 July 2003 II. Implementation A. Program Management Administrative Order No. 2, s. 2000: Implementation Arrangement for the Project Entitled Establishment of the National Tuberculosis Reference Laboratory, dated 1 March 2001

DESCRIPTION/ RELEVANT PROVISIONS

Declares the policy shift of the National TB Control Program from single-drug formulation Short Course Chemotherapy to fixed-dose combinations for the following reasons: (i) enhanced treatment compliance; (ii) simpler management of drug supply; (iii) prevention of monotherapy or selective intake of ant-TB drugs; and (iv) reduction of risk of using Rifampicin for conditions other than TB. The Guidelines for the shift to FDCs are likewise provided.

Prescribes guidelines on implementation of the National Tuberculosis Reference Laboratory, particularly, the roles and responsibilities of the project's key players, namely, the heads of the RITM and the National Center for Health Facility Development, and the Bureau of International Health Cooperation. The definition of roles ensures that: a) the project objectives are in line with the overall objectives of the Health Sector Reform Agenda, particularly its Public Health Programs Reforms, and b) objectives of the project are accomplished on time, within budget, and in conformity with sound technical performance standards Creates Technical Working Groups for, among others, the TB Project to ensure project implementation and facilitate timely release of funds from the Global Fund for AIDS, TB and Malaria.

Department of Health Order No. 96-L, s.2003: Creation of Technical Working Groups for TB and Malaria Project Implementation Under the Global Fund for

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TITLE OF LAW OR ISSUANCE AIDS, TB and Malaria (GFATM), dated 21 May 2003 B. Service Delivery Department Circular No. 63, s 1988: Revised Manual of the National TB Control Program, dated 8 April 1988 Administrative Order No. 24-A s. 1996: Guidelines on the Implementation of the Directly Observed Treatment of Short Course Chemotherapy (DOTS) or "Tutok Gamutan" of TB Patients, dated 8 July 1996 Administrative Order No. 24-A s. 1997: Guidelines in the Implementation of Hospital-based TB Control Program under the Hospitals as Centers of Wellness Program, dated 21 October 1997

DESCRIPTION/ RELEVANT PROVISIONS

Approves and directs the adoption of a new manual of procedures for the NTP.

Defines: a) Target groups for DOTS; b) Persons who can serve as treatment partners of TB patients; c) Places and duration of supervised treatment; d) Procedures for carrying out DOTS; and e) End-of-treatment assessment and evaluation.

Defines how DOH retained hospitals should participate in the implementation of the National TB Control Program under the Hospitals as Centers of Wellness Program. Among others, the guidelines direct the organization of a TB Committee in the hospital, and a TB Clinic to be part of the hospital's outpatient services. Drugs and supplies are to be provided by the DOH regional field offices, except in the National Capital Region (NCR) where these shall be directly provided by the DOH-Tuberculosis Control Service. Provisions on policies and procedures covered: a) TB prevention; b) Case finding; c) Treatment and case holding; d) Health education/Community involvement; e)Supervision, monitoring and evaluation; e) Logistics; f) Records and reports; g) Referral system; and h) Research and training

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TITLE OF LAW OR ISSUANCE C. Procurement, Distribution and Usage Administrative Order No. 25 s. 1998: Guidelines for the Procurement of Anti-TB Drugs at the Regional Health Offices Using the 1998 National Tuberculosis Program (NTP) Funds, dated 11 December 1998 (Amended by A.O. No. 26 s. 1998) Administrative Order No. 19 s. 1999: Guidelines on the Utilization of Funds (Sub-Allotment) for the Procurement and Distribution of Anti-TB Drugs for the National TB Control Program Using 1998 CONAP and 1999 GAA, dated 11 June 1999

DESCRIPTION/ RELEVANT PROVISIONS

Addresses the problem of delays in the procurement of antiTB drugs. Decentralization of procurement to the DOH Regional Offices (or CHDs) was seen to fasttrack purchase and distribution of TB drugs; hence funds of the National TB Control Program for drugs for 1998 were sub-alloted to the CHDs. The guidelines cover: a) The amount of funds to be sub-alloted per region, including criteria for allocation; b) The kinds of anti-TB drugs to purchase; c) Procedure for allocation and distribution of drugs by CHDs; and d) Central office monitoring arrangements

Prescribes a new procurement procedure for anti-TB drugs which will involve the conduct of two national competitive biddings by the DOH Central Office to determine: 1) the unit price of each anti-TB drug to be delivered by the supplier to each regional office, and 2) the distribution price (for delivery from the Regional Health Offices (RHOs) to the different rural health units (RHUs). The Regional offices shall then be informed of the price of the drug and the distribution price, whereupon each office can place orders with the winning supplier, who shall deliver the goods directly to the Regional Field Health Office (RFHO) warehouse. The RFHO shall effect payment to the supplier, and subsequently contract the services of the winning distributor for delivery of the drugs to the different RHUs. Provides guidelines for procurement of TB staining kits by the 15 RFHO. The supplier shall be the winning bidder in the national competitive bidding conducted by the DOH Central office in May 1998. DOH Central shall furnish the RFHOs with the bidding document, whereupon the latter shall issue purchase orders to the supplier and be responsible for

Administrative Order No. 39, s 1999: Guidelines on the Utilization of Funds (Sub-Allotment) for the Procurement of TB

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TITLE OF LAW OR ISSUANCE Staining Kits for the National TB Control Program Using 1998 Continuing Appropriations (P 9.6 M), dated 9 September 1999 (Amended by Administrative Order No. 150, s. 2000) Administrative Order No. 1-A: Transitory Guidelines for the Utilization of DOHProcured AntiTuberculosis Drugs; Blister-Packed and Loose Preparations, for ShortCourse Regimens of Patient Classifications, dated 1 February 1995

DESCRIPTION/ RELEVANT PROVISIONS payment. Supplies shall be delivered directly by the supplier to the RFHOs, but distribution to provinces/cities shall be done by the RFHOs. The Bureau of Research and Laboratory of DOH Central shall be responsible for the qualitative analysis of the TB kits prior to delivery of the items to the RFHOs, based on samples from the supplier's warehouse.

Serves as a temporary guide to the allocation, distribution, and utilization of anti-TB drugs by the DOH Central Office to DOH Integrated Regional Field Offices and NGOs, pending the circulation of the approved new Manual of Operations of the NTP.

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SUMMARY OF VITAMIN A LAWS & ISSUANCES TITLE OF LAW OR ISSUANCE I. Policy Republic Act No. 8976 (Food Fortification Law) II. Implementation A. Program Management B. Service Delivery Department of Health Circular No. 197-A, s. 1989: Guidelines on Vitamin A Supplementation for the Prevention of Vitamin A Deficiency, Xerophthalmia and Nutritional Blindness (Superseded by DOH Circular No. 102-A, s. 1991), dated 13 October 1989 Provides guidelines for the classification and management of individuals identified as high risk for developing Vitamin A deficiency, xerophthalmia, and nutritional blindness. Mandates the fortification of rice and flour with micronutrients, including Vitamin A. DESCRIPTION/ RELEVANT PROVISIONS

Department of Health Revises the guidelines set forth in A.O. No. 197-A, s. 1989. Circular No. 102-A, s. 1991: Revised Guidelines on Vitamin A Capsule Supplementation for the Prevention of Vitamin A Deficiency, Xerophthalmia and Nutritional Blindness

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TITLE OF LAW OR ISSUANCE (Superseded by Department of Health Circular No. 52-A, S. 1993), dated 14 June 1991

DESCRIPTION/ RELEVANT PROVISIONS

Department Circular No. Provides the implementing guidelines for giving Vitamin A 60-A, s. 1992: during routine measles immunization. Implementing Guidelines on the Giving of Vitamin A during Routine Measles Immunization of the Expanded Program on Immunization, dated 15 April 1992 Department of Health Circular No. 52-A, s 1993: Revised Guidelines on High Dose Vitamin A Capsule Supplementation for the Elimination of Vitamin A Deficiency, dated 23 March 1993 (Amended by Administrative Order No. 3-A s.2000) [DEEMED REPEALED BY A.O. NO. 199, s. 2003] Department of Health Administrative Order No. 3-A s. 2000: Guidelines on Vitamin A and Iron Supplementation [REPEALED BY A.O. NO. 119, s. 2003] Supersedes Department Circular No 102-A s. 1991. Directs the adoption as principal preventive measures of Vitamin A Deficiency, the periodic supplementation of target populations with large doses of Vitamin A, and dietary and nutrition education of mothers to increase the family intake of Vitamin A rich-foods. It identifies and ranks by order of priority the population for Vitamin A supplementation, which includes Vitamin A deficient children 6-71 months old, infants 9-12 months old, high-risk pre-schoolers and school children, and lactating mothers, and prescribes the supplementation protocol for each of these target groups. Other provisions relate to packaging, handling and storage of Vitamin A capsules, and nutrition messages to be disseminated to each target group. Provides updated standards/guidelines for the prevention and control of micronutrient deficiencies, including Vitamin A

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TITLE OF LAW OR ISSUANCE Department of Health Administrative Order No. 102-A, s. 2002: Supplemental Guidelines on the Usage of 10,000 I.U. Vitamin A for Pregnant Women under the Vitamin A Supplementation Program, dated 22 April 2002 Department of Health Administrative Order No. 119, s. 2003: Updated Guidelines on Micronutrient Supplementation (Vitamin A, Iron and Iodine), dated 2 December 2003 C. Procurement, Distribution and Usage Department Circular No. 77-C s. 2003: Use of Vitamin A 10,000 I.U., dated 7 March 2003

DESCRIPTION/ RELEVANT PROVISIONS

Provides supplemental guidelines to A.O. No. 3-A s. 2000, relating to: a) Preventive supplementation for pregnant women without signs and symptoms of Vitamin A deficiency; and b) Therapeutic supplementation for pregnant women with signs and symptoms of Vitamin A deficiency like night blindness

Repeals A.O. No. 3-A s. 2000. Provides updated guidelines on micronutrient supplementation, including for Vitamin A.

Prescribes that Vitamin A 10,000 I.U. procured by foreignassisted projects which are near expiry dates be used for postpartum women, especially in areas with no or limited supply of Vitamin A 200,000 IU.

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