Institutionalization of the Inter-Agency Advisory Council for the Implementation of Republic Act No. 9502

June 23, 2016

DOH ADMINISTRATIVE ORDER NO. 2016-0024

 

I. Rationale

Access to medicines is a multi-sectoral issue that cuts across health, social welfare, trade, financing even environment and policies that affects many stakeholders, patients, industry, healthcare professionals, civil societies, government, and the private sector. Chapter 1, Section 3 of the Republic Act (RA) No. 9502 otherwise known as the "Universally Accessible Cheaper and Quality Medicines Act of 2008," states that all doubts in the implementation and interpretation of the provisions of this Act, including its implementing rules and regulations, shall be resolved in favor of protecting public health. Issues on medicines access can be best deliberated by these relevant groups in order to assist the government in creating policies that are fair and transparent.

The Implementing Rules and Regulations (IRR) of RA 9502, Chapter 5, Rule 28, states that the Secretary of Health (SOH) may create advisory bodies and consultative councils from which advice may be sought in the implementation of a drug or medicine price monitoring and regulation policy. The Department Personnel Order No. (DPO) 2009-5171 formed the Advisory Council for price regulation, however the Council was renamed as Advisory Council for the implementation of RA 9502, through DPO No. 2013-5044, as concurred by the members after a thorough deliberation that centered on the overall implementation of the Law. Moreover, RA 9502 has amended policies on Intellectual Property, wherein patent exhaustion allowed the government to access high cost medicines that are of importance to the public, as well as the use of the Trade-Related Aspects of Intellectual Property (TRIPS) flexibilities.

Several council meetings were already held since the enactment of the Law that focused on strategic implementation areas such as the price regulation, health care financing, policies on Senior Citizens discount, Philippine National Formulary (PNF), Medicines Access Programs (MAPs), and other regulatory policies of the DOH and the Food and Drug Administration (FDA). Thus, it is imperative that the Advisory Council is reconstituted to address the needs of the people, especially on healthcare. Moreover, it serves as an avenue to bring together the government, private and professional organizations, academe, civil society and support groups to discuss relevant issues surrounding medicines access and to come up with sound policy recommendations. This multi-stakeholder collaboration would ensure the transparency of government actions and promote people empowerment.

II. Objectives

This Order aims to institutionalize the creation of the Advisory Council for the implementation of RA 9502 to achieve a balanced representation among key stakeholders involved in the access and use of essential medicines. The government recognizes that partnership with the different sectors is vital in the implementation of the Law.

III. Scope and Coverage

This Order shall apply to the Department of Health and its attached agencies [Food and Drug Administration (FDA) and Philippine Health Insurance Corporation (PhilHealth)], Department of Trade and Industry (DTI) and its attached agencies [National Consumers Affairs Council (NCAC), PITC Pharma, Inc. (PPI) and Intellectual Property Office (IPO)], Department of Finance (DOF) and its attached agencies [Bureau of Internal Revenue (BIR) and Bureau of Customs (BOC)], Department of Social Welfare and Development (DSWD), Office for Senior Citizens Affairs (OSCA), National Council on Disability Affairs (NCDA), Professional Regulation Commission (PRC), the developmental partners of the DOH such as the World Health Organization (WHO), European Union (EU), and member organizations involved in the implementation of RA 9502.

IV. Definition of Terms

A. Conflict of Interest shall mean a situation created when persons or entities in the public and/or private sectors that have personal, financial, or any other interest in the pharmaceutical and/or medical device industry, such as but not limited to, having existing ownership or investment therein, being an officer or member of the Board of Directors of a corporation (including its subsidiaries, affiliates and branches) or a partner in a partnership engaged therein and receiving any contribution there from. This includes receiving or accepting any offer or contribution there from.

B. Drug Price Reference Index (DPRI) refers to the list of ceiling prices of essential medicines for government bidding and procurement set by the DOH for all DOH Retained Hospitals and Regional Health Offices (RHOs).

C. Essential Medicines refer to medicines that satisfy the priority health care needs of the population and which are selected based on the evidence of their efficacy, safety and comparative cost-effectiveness. These medicines shall be made available and affordable at all times.

D. Maximum Retail Price (MRP) refers to the maximum price of medicines imposed at all levels of the supply chains, including but not limited to the manufacturer, trader, distributor, wholesaler, and retailer's price for a period of time as determined by the President of the Philippines.

E. Patient Support Group refers to societies and organizations, specializing both in general health improvement as well as illness-specific objectives, offer support groups as integral components of treatment plans for patients and their families. They may offer a variety of services, including educational materials, consultations, group therapy, team building activities, and other resources to teach individuals how to cope and adapt to the lifestyle that is often dictated by their illnesses.

F. Philippine National Formulary (PNF) is the integral component of the Philippine Medicines Strategic Directions on Access to Medicines for Filipinos (2011-2016) that lists the essential medicines of proven efficacy, safety and quality at affordable cost that are to be made available and accessible at all times.

G. Rational Use of Medicines (RUM) refers to the fundamental concept where patients receive medicines, when these are needed, that are appropriate for their clinical needs, in doses that meet the individual requirements for an adequate period of time, at the lowest possible cost, and that are administered by the right person.

H. TRIPS Flexibilities refer to range of rights, safeguards and options that Member States of the World Trade Organization (WTO) can exploit in their implementation of the TRIPS Agreement. These include but not limited to compulsory licensing, parallel importation, provisions relating to patentable subject matter, provisions relating to exceptions to patent rights, provisions relating to data protection, and provisions relating to abuse of rights, competition and the control of anti-competitive practices.

V. General Guidelines

A. The DOH and Department of Trade and Industry (DTI), as co-implementers of RA 9502, shall create the overall framework in the execution of the said Law which includes the oversight of the Advisory Council in terms of organizational structure, consultation process, and decision-making.

B. The Advisory Council shall be composed of a broad membership representing health, trade, finance, and social welfare sectors that are affected by cross-cutting issues that affect medicines access.

C. The Advisory Council shall ensure the participation of important stakeholders from the public and private sectors, recognizing that their interests/views must be considered by policy makers in crafting regulation and policy on medicines. These include healthcare professionals, healthcare organizations, the industry, academe, patients and patient organizations and civil society.

D. The broad functions of the Advisory Council shall pertain to stated provisions of RA 9502 which include:

1. Intellectual Property

2. Drug price monitoring and regulation

3. Financing

4. Strengthening of the Food and Drug Administration

5. Rational Use of Medicines

6. Pharmacy and healthcare professional practice

7. Pharmaceutical supply chain

VI. Specific Guidelines

A. Membership

The Members of the Advisory Council for the Implementation of RA 9502 are as follows:

Chairperson	:	Cluster Head in charge of the Pharmaceutical Division,
		Department of Health
Co-Chair	:	Department of Trade & Industry
Members	:
Government Agencies

1. Department of Health and its attached agencies:

a. Food and Drug Administration

b. Philippine Health Insurance Corporation

2. Department of Trade and Industry and its attached agencies:

a. National Consumers Affairs Council

b. PITC Pharma, Inc.

c. Intellectual Property Office

3. Department of Finance and its attached agencies:

a. Bureau of Internal Revenue

b. Bureau of Customs

4. Department of Social Welfare and Development

5. Office for Senior Citizens Affairs

6. National Council on Disability Affairs

7. Professional Regulation Commission

Developmental Partners

1. World Health Organization

2. European Union

3. Third member partner as identified by the SOH or Chief of the Pharmaceutical Division

Member Organizations (The list of the member organizations shall be presented through a Department Personnel Order issued by the Department of Health).

The member organizations shall be determined based on the following criteria:

1. Persons of moral and intellectual integrity.

2. Willingness to declare its perspective on relevant issues discussed by the Council.

3. Willingness to disclose conflicts of interest.

The Advisory Council members shall conform to the principles of transparency and integrity and shall therefore declare all the necessary circumstances. A member with his/her change in position of interest shall declare his/her conflict of interest during the Advisory Council meeting (Annex A).

B. Specific Functions of the Advisory Council

1. Discuss issues pertaining but not limited to the following:

a. Intellectual Property — TRIPS flexibilities including parallel importation

b. Drug price monitoring and regulation — DPRI, Electronic Drug Price Monitoring System (EDPMS), Senior Citizens/Persons with Disabilities (PWDs) discounts, Maximum Retail Price

c. Financing — PhilHealth packages and DOH budget for essential medicines

d. Strengthening of the Food and Drug Administration

e. Rational Use of Medicines — Philippine National Formulary, Antimicrobial Resistance, ethical marketing practices

f. Pharmacy and healthcare professional practice

g. Pharmaceutical supply chain

2. Upon comprehensive discussion and deliberations of all issues, the Chair shall consider the different views and interests of the members. The recommendations must be fair and transparent to all parties, safeguarding the welfare of the general public and reflecting the values of the bigger society. In such circumstances when there are vital issues that need to be resolved but no quorum can be established to convene the meeting, the Chair may issue a memorandum through ad referendum requesting for the positions of its members.

3. The Chair and Co-chair shall balance the different positions of the Council members in adherence to the objectives of RA 9502. The recommendations made by the Council must be in line with the protection of public health and the objectives of RA 9502. The recommendations of the Council must express the intent of the law and not the personal or corporate interest of the members/associations.

4. Once the Council's recommendation is reached, it will be forwarded by the Chair to the SOH who will make the final decision.

5. The oversight and secretariat functions of the Advisory Council shall be under the DOH-Pharmaceutical Division (PD) as the duly delegated office by the SOH to monitor the implementation of RA 9502 based on Administrative Order (AO) No. 2010-0005. The secretariat shall compose of three (3) members who will perform the following functions:

a. Documentation of meetings

b. Convening of the Advisory Council members

c. Arranging the venue and food for the conduct of the meeting

d. Preparation and dissemination of necessary documents to the Advisory Council members

C. Frequency of Meetings of the Advisory Council members

The Council shall meet quarterly or not less than once every year or as the need arises. A quorum is established when majority (50% + 1) of the total number of the Council members is present in every meeting. It is the responsibility of the Council members to ensure that his/her organization is represented in the Council meetings. Each Council member shall have an alternate, and for any changes, the Advisory Council secretariat shall be informed.

D. Creation of Technical Working Groups (TWGs)

The Advisory Council shall create technical working groups (TWGs) with respective offices to act as Chair taking responsibility for crafting regulation and policies that fall under their jurisdiction. The Chair shall be responsible in convening relevant stakeholders and conducting consultations as necessary.

	Topic	Chair
1.	Intellectual Property	IPO
2.	Drug price monitoring and regulation	DOH-PD
3.	Financing	DOH and PhilHealth
4.	Strengthening of FDA	FDA
5.	Rational Use of Medicines	DOH-PD
6.	Pharmacy and healthcare professional practice	DOH-PD
7.	Pharmaceutical supply chain	DOH-PD
8.	Other topics as decided upon by the	DOH-PD
	inter-agency Council

VII. Roles and Responsibilities

A. Department of Health

The Department of Health shall:

1. Act as chair in the conduct of the Advisory Council meetings.

2. Undertake overall coordination with internal and external partners.

3. Undertake the overall management of the Advisory Council Secretariat function.

B. Food and Drug Administration

The Food and Drug Administration shall share its views and updates on the quality assurance of medicines.

C. Philippine Health Insurance Corporation

The Philippine Health Insurance Corporation shall share its views and updates on government financing including reimbursements of medicines and health services.

D. Department of Trade and Industry

The Department of Trade and Industry shall:

1. Act as co-chair in the conduct of the Advisory Council meetings.

2. Share its views on issues regarding the implementation of pricing policies for medicines.

E. National Consumer Affairs Council

The National Consumer Affairs Council shall share its views and updates related to consumer protection.

F. PITC Pharma, Inc.

The PITC Pharma, Inc. shall share its views and updates on the sourcing of medicines.

G. Intellectual Property Office

The Intellectual Property Office shall share its views and updates regarding patents, international agreements and the TRIPS flexibilities.

H. Department of Finance and Its Attached Agencies

The Department of Finance and its attached agencies shall share their views and updates related to financing, discounts on medicines, and other matters pertaining to the pricing of medicines.

I. Department of Social Welfare and Development and Office for Senior Citizens Affairs

The Department of Social Welfare and Development and Office for Senior Citizens Affairs shall share their views and updates on issues related to the Senior Citizens' discounts on medicines.

J. National Council on Disability Affairs

The National Council on Disability Affairs shall share its views and updates on disability issues, and relay concerns of the disability-related organizations.

K. Professional Regulation Commission

The Professional Regulation Commission shall share its views and inputs related to the professional and occupational standards and ethics, and career updates in the country.

L. Developmental Partners and Member Organizations

The developmental partners and member organizations shall share their views and updates on issues discussed related to the implementation of the law, and may give policy recommendations to the government.

VIII. Funding Support of the Program

The funding of all meetings and activities by the Advisory Council and its Technical Working Groups shall be borne by the DOH-Pharmaceutical Division subject to usual accounting rules and regulations.

IX. Separability Clause

If any provision in this Guideline or application of such provision to any circumstance is held invalid, the remainder of this issuance shall not be affected thereby.

X. Effectivity

This Order shall be effective within fifteen (15) days from publication in the Official Gazette.

(SGD.) JANETTE P. LORETO-GARIN, MD, MBA-HSecretary of Health

ANNEX A

Declaration of Conflict of Interest