Accelerating CHANGE: Access to Generics Towards Universal Health Care (Forum Proceedings) by Jake Kho

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

FORUM PROCEEDINGS DEPARTMENT OF HEALTH - PHARMACEUTICAL DIVISION

Accelerating CHANGE: Access to Generics Towards Universal Health Care

FORUM PROCEEDINGS DEPARTMENT OF HEALTH - PHARMACEUTICAL DIVISION

Accelerating CHANGE: Access to Generics Towards Universal Health Care

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

ABBREVIATIONS ADR ALL ALLMAP AMR BnB DOH DP DP-TWG DPRI F1+ for Health FDA FGD GIDA GMAP GPP GPRA HBV HCV HTA KAP KII MAP MCP MDRP MEP MPR NCPAM NEMF NPC

Adverse Drug Reaction Acute Lymphoblastic Leukemia Acute Lymphoblastic Leukemia Medicines Access Program Antimicrobial Resistance Botika ng Bayan Department of Health Differentially-Priced Drug Pricing Technical Working Group Drug Price Reference Index FOURmula One Plus for Health Food and Drug Administration Focus Group Discussions Geographically Isolated and Disadvantaged Area Government-Mediated Access Prices Good Procurement Practice Government Procurement Reform Act Hepatitis B Virus Hepatitis C Virus Health Technology Assessment Knowledge, Attitude, and Practices Key Informant Interviews Medicines Access Programs Mexico City Principles Maximum Drug Retail Pricing Medicine Entitlement Program Medicine Price Ratio National Center for Pharmaceutical Access and Management National Essential Medicines Facility National Pharmacovigilance Center

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

PCSI PD PHAP PMP PND PNDP PV PWD QALY RA RHU SC SDG TSK-PAMPP UHC VAT WHO

Philippine Cancer Society Inc. Pharmaceutical Division Pharmaceutical and Healthcare Association of the Phlippines Philippine Medicines Policy Philippine National Drug Philippine National Drug Policy Pharmacovigilance Person with Disability Quality Adjusted Life Years Republic Act Rural Health Unit Senior Citizens Sustainable Development Goals Tulay sa Kalusuganâ&#x20AC;&#x201C;Palawan Access to Medicines Partnership Project Universal Health Care Value-Added Tax World Health Organization

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

TABLE OF CONTENTS Forum Overview

Welcome Remarks

Keynote Address

Message of Support

Philippine Medicines Policy 2018-2022

Pillar 1: Commitment to Safety, Efficacy, and Quality Food and Drug Administrationâ&#x20AC;&#x2122;s Current Initiatives Assessment of the Pharmacovigilance System in Cancer Medicine Entitlement Programs in the Philippines Open Forum

Pillar 2: Health Literacy and People Empowerment Impact Evaluation of the Expanded Senior Citizen Act of 2010 (RA 9994) on Drug Accessibility Among the Elderly A Situational Analysis on Access to Medicines of Persons with Disabilities Open Forum Pillar 3: Availability and Affordability A Study on Factors Influencing Drug Pricing Among Public National Hospitals Review of Drug Pricing Policy in the Philippines Strengthening of the DOH Pharmaceutical Chain Management System Palawan Access to Medicines Partnership Project: Impact of Differential Pricing on Access to Medicines Botika ng Bayan: Promoting Access to Quality Pharmacy Services in Public Health Facilities Open Forum

12 14 16 18 19 21 23 24 25 27 29 31 33 35

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Pillar 4: Networking and Partnerships Survival Analysis of Pediatric Acute Lymphoblastic Leukemia Patients Enrolled in the DOHâ&#x20AC;&#x2122;s NCPAM ALLMAP Access for Breast Cancer Quality Study: Preliminary study on the effect of the DOH-Philippine Cancer Society Inc. (PCSI) Patient Navigation Access Program for Breast Cancer Medicines on Quality of Care in the Medical Oncology Clinic in the Philippine General Hospital Review of the Implementation of the National Action Plan on Antimicrobial Resistance Open Forum

vii

37 38 40

42 44

Pillar 5: Good Governance A National Assessment on the Knowledge, Attitude, and Practices Among Filipino Physicians on Ethical Relations with the Pharmaceutical Sector Use of Discount Cards Among Patients and Physicians in Key Cities in the Philippines Effects of the Distribution of Product Samples to Patients and Physicians by Pharmaceutical Companies A Profile of the Philippine Pharmaceutical Industry Open Forum

Pillar 6: Ensuring Responsible Use Valuation of the Filipino Health Utilities using the EQ-5D-5L: How Filipinos Perceive States and Diseases Measured by EQ-5D-5L Ending the Silent Epidemic of Chronic Hepatitis in the Philippines 2017 Health Facility and Household Survey on Access to and Use of Medicines in the Philippines Open Forum

Closing Remarks

Photos

Acknowledgements

47 49 51 53 55

57 59 61 63

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Forum Overview Thirty years after the landmark Generics Act of 1988 and ten years after the Cheaper Medicine Act of 2008, the Department of Health (DOH) is launching its medium-term Philippine Medicines Policy (PMP) 2018-2022 to provide a roadmap for promoting and improving access to medicines, as part of the bigger agenda of attaining Universal Health Care (UHC). This forum features research on each of the six pillars of the PMP 2018-2022, summarized as CHANGE: C - Commitment to safety, efficacy, and quality, H - Health literacy and empowerment, A - Availability and affordability, N - Networking and partnerships, G - Good governance, accountability, and transparency, and E - Ensuring responsible use.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Welcome Remarks Anna Melissa Guerrero, MD, MPH Chief, Department of Health - Pharmaceutical Division Good morning. I am pleased to welcome everyone here at the Accelerating CHANGE: Access to Generics Towards Universal Health Care forum. Access to medicines is integral to the fulfillment of Universal Health Care and the achievement of better health outcomes for all Filipinos, so it is good to see that all of you are taking part in this event. Access to medicines is a collective responsibility that calls for collective action by public and private actors alike. While the majority of essential medicines are no longer protected by patents, availability of these products in many developing countries is often difficult and complex. Why so? Simply because there are different roadblocks along the delivery route that may include the distribution system itself within a community or country, the quality of the healthcare system, its general infrastructure, financial risk protection from accessing health care services, and government policies on import tariffs and taxes. Celebrating thirty years since the enactment of the Generics Act and ten years since the enactment of the Cheaper Medicines Act, the Department of Health today asserts its continued commitment to reliable access to qualityassured medicines by ensuring that all policies and programs are based on sound evidence. In this two-day forum, we invited health professionals and researchers to present policy-relevant research in key access to medicine reform areas from all over the country. As we share current efforts to ensure access to medicines, we hope that the sessions will be highly interactive with meaningful discussions. Thank you and good morning to everyone.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Keynote Address Assistant Secretary Attorney Charade Mercado-Grande Department of Health - Health Regulation Team Good morning, everyone. It is my honor to be your keynote speaker for today. It is nice to see our colleagues and collaborators in government, research, academe, patient groups, civil society organizations, and the pharmaceutical industry here in this forum. The global movement towards Universal Health Care started in 2008 and was further strengthened by an ambitious agenda as part of the Sustainable Development Goals: a safer, fairer, and healthier world by 2030 through Universal Health Care. The Department of Health continues its commitment to attaining Universal Health Care through the launch of FOURmula One Plus for Health. F1+ for Health aims to boost Universal Health Care through the strategic pillars of financing, service delivery, regulation, governance, and an encompassing initiative of performance accountability. F1+ for Health envisions that Filipinos will be one of the healthiest people in Southeast Asia by 2022 through leading the country in the development of a productive, resilient, equitable, and people-centered health system. We at the Department of Health recognize essential medicines as an indispensable component of attaining Universal Health Care. For the Philippines, this recognition is not new. This year, we celebrate thirty years since the enactment of the Generics Act of 1988 and ten years since the Cheaper Medicines Act of 2008.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

These two landmark legislations resulted in the implementation of programs and interventions that improved access to quality medicines. Today, generics are over 50% cheaper than their branded counterparts and account for 65% of the total pharmaceutical market. Patient perspective on the quality and efficacy of generics has improved and buying power has increased through greater options and accessibility. Under F1+ for Health, we continue our commitment to ensuring reliable access to qualityassured medicines through the improvement of mechanisms that guarantee equitable distribution of affordable health goods and improvement of procurement and supply chain management mechanisms to sustain their availability. To ensure the continued success of our initiatives, evidence should be made available to guide policy decision-making. For essential medicines, it is crucial that we generate and use evidence to guide policy in the areas of: 1) safety, efficacy, and quality, 2) health literacy, 3) availability and affordability, 4) partnerships, 5) good governance, and 6) ensuring responsible use of medicines. Todayâ&#x20AC;&#x2122;s forum is an important step in identifying evidence that supports our initiative towards enhanced access to medicines. I encourage all of you to support F1+ for Health through your contributions to health policy, research, and development for access to medicines. Let us all work together for a healthier Philippines. Thank you!

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Message of Support Joseph Anthony Lachica, MD Office of Senator Risa Hontiveros In behalf of Senator Risa Hontiveros and her office, I would like to extend our congratulations to the Department of Health on the 30th year of the Generics Act. We have truly come a long way on this landmark legislation and we have done a lot of significant initiatives to attain our goal of universal access to medicines. Congratulations as well for organizing this event, which highlights this critical issue and brings together important stakeholders like researchers, policymakers, health care providers, civil society, and industry. This is indeed an opportunity for us to discuss access to medicines, particularly, on how we can consolidate the gains of the landmark legislation and DOH programs in the past 30 years, as we start to achieve Universal Health Care for our country. As one of the authors of the Cheaper Medicines Act of 2008, Senator Risa has always been a champion of access to quality medicines. This key interest is also matched with a strong support for programs and interventions that we feel address the barriers that prevent access, particularly to our poorest countrymen, to quality and affordable medicines. The door of our office is always open to the DOH and other stakeholders who share this advocacy. Thank you for inviting us and we hope this two-day event becomes fruitful to everyone.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Message of Support Albert Francis E. Domingo, MD, MSc World Health Organization Good morning, ladies and gentlemen. On behalf of the World Health Organization, we are thankful for being invited to this activity, Accelerating CHANGE: Access to Generics Towards Universal Health Care. Ensuring access to medicines is a function of adequate regulation. There has to be fairplay. It doesn’t matter if the supplier is from the public or private sector, as long as the rules of the game are well-established and, more importantly, enforced. In fact, if we are to discuss Universal Health Care from that perspective, the Philippine Constitution has already had a provision mandating Universal Health Care ever since it was written down in 1986. Article 13 Section 11 states that “the State shall adopt an integrated and comprehensive approach to health development which shall endeavor to make essential goods, health, and other social services available to all the people at affordable cost.” In 1988, the Generics Act was enacted. Ten years ago, the Cheaper Medicines Act was also enacted. Now the question is: Are we going to have a Universal Health Care Bill? But even if there is a law for Universal Health Care, it is one thing to have a policy and another thing to implement policy. Our out-of-pocket expenditures are at a high of 55% as of 2016. Most of this goes to expenditures for drugs and medicines. If we do not succeed in improving access to medicines, there will be no change that is necessary for us to achieve Universal Health Care. The Food and Drug Administration has always been the favourite delegate of these laws. But the Food and Drug Administration cannot do it alone and cannot facilitate drug access on its own. All of us, including the WHO, should support the FDA to facilitate drug access to all Filipinos. Thank you and good morning to everyone.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Philippine Medicines Policy 2018-2022 Anna Melissa Guerrero, MD, MPH Chief, Department of Health - Pharmaceutical Division The Philippine Medicines Policy was built on previous reform and policy initiatives such as the Philippine National Formulary, the Generics Act of 1988 and the Cheaper Medicines Act of 2008, among others. The Philippine National Formulary may be considered as the earliest effort to rationalize the use of and spending for drugs in the Philippines. It was created in 1988 as one of the main strategies under the first Philippine National Drug Policy. It was a crucial step to rationalize drug production, distribution, procurement and consumption to ensure access to health care and to promote rational use by health professionals and consumers. The Generics Act of 1988 requires all health professionals practicing both in public and private institution to write prescriptions using the generic name. The law further requires that any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines shall indicate prominently the generic name of the product. The Cheaper Medicines Act of 2008 intended to achieve universally accessible, cheaper, and quality medicines by pursuing an effective competition policy in the pharmaceutical sector. The DOH-Pharmaceutical Division (PD), formerly known as the National Center for Pharmaceutical Access and Management, was created in 2010 in pursuit of the Cheaper Medicines Act. The PD envisions that it will lead in ensuring that there is a conducive policy environment to universal access to quality essential medicines.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Despite these policy reforms, a study commissioned by the DOH to review the implementation of the Generics Act revealed that only two out of five consumers were offered a cheaper generic alternative by private drugstores. Patients rarely change the brand indicated in their prescriptions, thus defeating the intent of the law to ensure patient choice through generic prescribing and substitution. In addition, the pharmaceutical industry is demanding higher prices for most new products so that medicines are unaffordable even in middle- and high-income countries. Key essential medicines are disappearing from the market due in part to prices that have become so low that it is no longer commercially viable for manufacturers to supply them. The persistent wide variation of drug prices in the Philippines reflects the current practice of pharmaceutical players to strategize and maximize profit opportunities. Through socalled â&#x20AC;&#x2DC;market segmentationâ&#x20AC;&#x2122; and heavy promotional activities, physicians and pharmacists support the more expensive innovators and branded generic products despite the presence of cheaper generic alternatives. In response to these challenges, the DOH is launching its newest medium-term Philippine Medicines Policy 2018-2022 to provide a roadmap for promoting and improving access to medicines, as part of the bigger agenda of attaining Universal Health Care. The policy has six pillars, summarized as CHANGE: 1) Commitment to safety, efficacy, and quality, 2) Health literacy and empowerment, 3) Availability and affordability, 4) Networking and partnerships, 5) Good governance, accountability, and transparency, and 6) Ensuring responsible use.

Figure 1. The six pillars of PMP 2018-2022

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Attaining UHC means two main things. First, it means that all Filipinos will have a primary care team that ensures they visit the appropriate health care provider and get the appropriate services. Second, UHC entails predictable health care costs. The UHC Bill provisions on medicines and health technologies include: •• Institutionalizing Health Technology Assessment as a prerequisite for public financing of goods or services; •• Central price negotiations and fixed reimbursement and copayments by PhilHealth; •• Generics-only prescribing and generic substitution in pharmacies, and; •• Strict conflict of interest management and public disclosure of industry. There is a need for meaningful efforts by both the pharmaceutical industry and the government to 1) invest in new medicines, 2) provide full transparency on costs, prices, and who pays what beforehand, and 3) respect the legal space for governments to protect public health. Success in these efforts can guarantee people’s access to innovative and affordable medicines and allow the Philippines to reach the Sustainable Development Goal to ensure healthy lives and wellbeing for all, at all ages.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

PILLAR 1:

Commitment to Safety, Efficacy, and Quality Globalization of the pharmaceutical industry has led to increasing demands on regulatory agencies to ensure the safety and effectiveness of medicines marketed in their country. Quality guidelines assist the implementation of legislation for medicines and ensure that patients receive timely quality product.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Food and Drug Administration’s Current Initiatives Presenter: Atty. Katherine Austria-Locke Food and Drug Administration The Food and Drug Administration (FDA) is mandated to protect the general public by ensuring the safety, efficacy, and quality of health products. This includes food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostics reagents, and household/urban hazardous substances and/ or a combination of and/or a derivative thereof. The regulatory framework of FDA is divided into three components: •• Licensing and inspection - the FDA issues license-to-operate to establishments based on their compliance. •• Pre-marketing assessment - the FDA evaluates product applications based on technical and scientific standards to ensure that the health products are safe and effective. •• Post-marketing surveillance - ensures that all establishments continuously comply with the FDA standards and regulations. The current state and customer perception of the FDA is that it has multiple fragmented environments which lack defined interconnecting processes and workflows. This has led to reactive regulation, unpredictable outputs, increased complexity, a lack of standardization, role misalignment, and a costly and unfocused system duplication. In response to this, the FDA developed six imperative strategies: 1) smart regulation, 2) organizational reform and development, 3) establish a management information system & operational system, 4) strengthen enforcement, 5) strengthen public information & service, and 6) facility upgrade & improvement.

Figure 2. FDA’s six imperative strategies

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Smart regulation aims to focus on closing the policy gap through investments in policy evaluation and simplification. This includes 1) the repeal of outdated provisions and codifications, 2) identification of overlaps, gaps, inconsistencies, and/or obsolete measures, and 3) publication of manuals and active information dissemination. Organizational reform and development is the commitment to creating a positive work environment by investing in infrastructures. Priorities in this area are 1) organizational assessment and staff rationalization, 2) implementation of role-based training, 3) talent retention and succession planning, and 4) rightsizing staff levels for cost savings and agility. The establishment of a management information and operational system shall enable the improvement of systems and processes for the value of stakeholders. FDA is currently improving its e-portal but also wants to modernize its information technology infrastructures and establish a databank. The FDA is also developing a mobile app that can help stakeholders and the public access information at the convenience of their smartphones. Strengthening enforcement can encourage compliance with FDA regulations. Efforts under this strategy includes the activation of regional regulatory enforcement units and a compliance and enforcement program. The FDA aims to strengthen public information & service by:: •• Increasing public awareness and confidence in FDA as the national authority on health products; •• Ensuring accuracy of information and key messages delivered to target audience; •• Ensuring efficient dissemination of information to the public, and; •• Expanding the use of FDA website and social media to communicate safety and health information. To keep up with the changing times, the FDA also seeks to continually improve its facilities. The existing laboratory and office facilities were established in 1987. After 30 years, the facilities are already due for upgrade. Regional FDA offices are also undergoing upgrades to have greater monitoring and oversight capacity.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Assessment of the Pharmacovigilance System in Cancer Medicine Entitlement Programs in the Philippines Presenter: Johnette PeĂąas, RN LGU Lagonoy, Camarines Sur Thalidomide was a widely used drug for nausea in pregnant women that resulted in severe birth defects in thousands of children. The thalidomide tragedy triggered a global effort to avert its recurrence. In response, the Philippines formed the National Adverse Drug Reaction Advisory Committee in 1994 to ensure the safety of drug products in the Philippines. Most recently, in 2011, the DOH issued the national policy and program on pharmacovigilance (PV) which aims to establish and implement the National Pharmacovigilance Program.

Figure 3. Pharmacovigilance timeline

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

The Medicine Entitlement Program (MEP) is one of the access to medicine programs of the government which provides, but is not limited to, childhood and breast cancer medicines. The study aimed to assess the status of pharmacovigilance in cancer MEP in the Philippines through a descriptive crosssectional study design. Four methods were used: facility audit of the DOH-PD and National Pharmacovigilance Center (NPC) using the USAID Indicator-based PV assessment tool, review of NPC and MEP access sites records, telephone interviews, and a knowledge, attitude, and practices survey of health care professionals. The study found that specific provisions on PV in the national legislation exists. However, the National Policy and Program on PV was not being implemented fully. There was no designated staff, budget, guidelines, and trainings for cancer MEP. Five cancer treatment protocols were used in cancer MEP. All beneficiaries had at least one adverse event following chemotherapy. In access sites, 8% had documented adverse events. The number of adverse events ranged from one to 30 symptoms per patient. Upon verification with the NPC, there were no reported adverse events due to cancer MEP allocated drugs. While the FDA has a national adverse drug reaction database, no reports were generated and no analysis was conducted based on this data. There were no medication error and utilization studies conducted. Severe adverse drug reaction and treatment failures were not documented. While treatment protocols were available to patients, there were no medicine safety bulletins, safety alerts, or other medicine safety actions taken. The knowledge, attitude, and practices (KAP) survey results showed that level of knowledge and attitude was good while practice was very poor. It showed that knowledge on PV system and cancer adverse drug reactions had significant positive low correlation with practice. This study recommends the full implementation of the national PV policy, coupled with the conduct of trainings and budget allocation. An adverse drug reaction data collection and management system from the service provider to national level should be developed and implemented. Stakeholder compliance on adverse drug reaction reporting must be monitored. Finally, the NPC should strengthen its collaboration with FDA for quality control and testing of cancer MEP drugs.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Open Forum IT, systems maintenance, and client satisfaction at the FDA The FDA is often forced to turn away clients when systems are down. Currently, the issue has already been raised with management and there are ongoing discussions on how the agency can strengthen IT systems to handle the large amount of requests, and avoid causing extensive inconvenience to the public. Proactive steps in FDA post-market surveillance The FDAâ&#x20AC;&#x2122;s efforts in post-market surveillance are seemingly focused on reactive actions, such as responding to complaints and reports of adverse drug reactions (ADRs). In terms of taking proactive steps, the agency plans to continue encouraging submissions of these reports, through which ADR associations with registered products can be established and acted upon in line with the new Pharmacy Law. In addition, the FDA shall also endeavor the annual creation of a post-marketing surveillance plan. Lessening the processing and turnaround time Towards lessening processing or turnaround time for the registration of medicines and simplifying metrics for patients, there are ongoing initiatives at the FDA to categorize the 1) type of application, and 2) service expected. CDR operations are undergoing reorganizations. Particularly, the need to lessen the processing time for low-risk versus high-risk cases shall be addressed through a classification process similar to a triage system. Retained income of the FDA based on RA 9711 As stipulated in RA 9711, the FDA has the authority to retain income for the improvement of operations. However, this has yet to be achieved as conditions need to be fulfilled by the agency before retained income can be released from the national treasury. Recommendation to do an analysis of ADR reports based on MEP beneficiary profile As a recommendation, the distribution of patients based on social class should be included in the present assessment of pharmacovigilance among Cancer MEP beneficiaries.This may be further studied through the patient screenings currently done by social workers.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

General database of how drugs procured by the national government are performing Given the emphasis on cancer treatments and chemotropic drugs, it was discussed as a recommendation to include and prioritize medicines procured by the national government. Through this initiative, a database on how the wide array of drugs are actually performing can be developed. The need to address the knowing-versus-doing gap Overall, study findings and recommendations point to poor risk assessment and monitoring and evaluation across all levels of the system. In line with this, the release of an AO on DOHPD as well as a Manual of Operations for public health programs is recommended to address the know-do gap.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

PILLAR 2:

Health Literacy and People Empowerment Health literacy represents the cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand, and use information in ways which promote and maintain good health. This implies the achievement of a level of knowledge, personal skills, and confidence to take action to improve personal and community health by changing personal lifestyles and living conditions.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Impact Evaluation of the Expanded Senior Citizen Act of 2010 (RA 9994) on Drug Accessibility Among the Elderly Presenter: Mac Ardy J. Gloria, RPh, MPH, DipCE University of the Philippines, College of Pharmacy The Philippines is moving towards an aging population. In 2010, senior citizens constituted 6.8% of the Philippine population and accounted for 23.5% of the total health expenditure. In 2010, Republic Act (RA) 9994, also known as â&#x20AC;&#x153;The Expanded Senior Citizens Act of 2010â&#x20AC;?, was signed into law. Fundamentally, this law entitles senior citizens to 20% discount and exemption from the value-added tax (VAT) on the sale of medicines determined by the DOH. Given that medicine prices in the Philippines are considered high compared to its neighboring countries, RA 9994 was envisioned to improve accessibility of drugs among the elderly who are usually burdened with cost-intensive chronic illnesses and who have limited purchasing power. This study aimed to determine the impact of RA 9994 on drug accessibility among the elderly. The study employed a descriptive, cross-sectional design with two major methods of data collection: survey and key informant interviews. There were four groups of respondents: 1) elderly, 2) pharmacists or pharmacy operators, 3) pharmaceutical industry representatives, and 4) officers of pharmacy-related professional societies. The study sites included one province and one city each in Luzon (Manila and Pampanga), Visayas, (Iloilo and Bacolod City), and Mindanao (Cagayan de Oro and Iligan City). Mystery buyers were fielded to a sub-sample of pharmacy outlets. Among the surveyed drug outlets, 75% claimed they provide the mandated 20% discount. Only 50% of all outlets provided the 12% VAT exemption. Medium and large chain drugstores were able to provide both the discount and exemption but not independent drugstores. While 67% of the interviewed pharmacy personnel expressed that the law did not adversely affect their operations, more than 20% claimed that it has somehow slowed down their operations. This was attributed to the checking and verification of documents provided by the customers. Even with the privileges, 42% of the personnel interviewed said that senior citizens are unable to buy all their medicines because of limited financial ability and higher cost of medicines.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Figure 4. Provision of discounts and tax exemptions of drug outlets

Awareness of the policy seems to play a significant role in the availment by senior citizens and actual provision by drug outlets of the discount and exemption. There was a significantly higher proportion of respondents who were aware of the provisions that were given the 20% discount all the time (53%) and the 12% VAT exemption (49%). Of the senior citizens surveyed, less than 50% indicated that they were able to buy all their medications. The proportion was even lower in Mindanao, where only 36% were able to buy all medications. Adherence to regimen as a result of the provisions of the law was at 54%. Since many senior citizens are still not fully aware of the law and its provisions, a wider information dissemination campaign is warranted. Information dissemination can be facilitated by local governments through Rural Health Units (RHUs) and organized groups of senior citizens. It is important for the government to study the negative impact of the provisions to pharmacy retail outlets. The glaring information that not all outlets provide the mandated discount and tax exemption provide a signal for careful review on what prevents the outlets from dispensing these privileges. Clearer guidelines and massive information dissemination campaign on this area is needed. Subsequent monitoring is essential. The government should also look into the negative impact of the law to the business operations of drugstores. Since small and medium chain drugstores cannot provide the privileges, clients are referred to larger chain outlets. The substantial loss of clients may lead to the closure of the drugstore, which would then create a playing field of few pharmacy players. Such an environment may be conducive to higher drug costs due to lack of competition.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

A Situational Analysis on Access to Medicines of Persons with Disabilities Presenter: Marilyn E. Crisostomo, MPH, MSPH Macro Health Research Organization, Inc. A critical factor in ensuring a person with disability’s (PWD) access to health care services is to understand the current situation and environment, including their access to medicines. PWDs have greater unmet needs and experience poorer levels of health. RA 9442, also known as the Magna Carta for Disabled Persons, addresses the health inequities experienced by PWDs by granting rights and privileges for rehabilitation, self-development, and self-reliance, including access to medicines. In spite of this, hindrances still exist in the PWD’s access to medicines, with some drug stores refusing to follow the law. The study aimed to determine the magnitude of PWD access to medicines through the five A’s of Access: affordability, availability, accessibility, accommodation, and acceptability. The study employed a descriptive crosssectional study design divided into three steps: 1) desk review, 2) crosssectional survey of 1,200 PWDs in Luzon, Visayas, and Mindanao and 69 public and private pharmacies, and 3) identification of health policies. The study found that 78.1% of PWDs who consulted with a health care provider in the past 12 months were prescribed with medicine. However, only 30.6% of PWDs were employed, with 83.6% of those earning below the daily minimum wage. Lack of money was the main reason for PWDs being unable to take all prescribed medicines. Availability of medicines was rated poorer in the public sector compared to the private sector. However, 6.8% of PWDs were not able to obtain a medicine due to its unavailability in pharmacies, which are mostly private. Moreover, half of the medicines for a person’s disability were available in only 25% of private pharmacies observed. Only 57.9% of medicines were purchased in a pharmacy closest to the PWD’s home. Botika ng Barangay or Botika ng Bayan was a good strategy by the DOH. However, it had problems with financing and restocking of medicines.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

The study found that 24.1% of PWDs were not satisfied with the Magna Carta for Disabled Persons. Only 23.9% of PWDs always avail of their 20% discount while only 11.9% always avail the 12% VAT exemption. Table 1. Provision of Magna Carta for Disabled Persons Private Pharmacies

Government Pharmacies

Number

Percent

Number

Percent

20% discount

45.2

77.8

12% VAT Exemption

38.1

More than half of the PWDs interviewed were satisfied or very satisfied with the level of helpfulness of a pharmacist. Most of the pharmacies included in the study mentioned that PWDs that are able to purchase medicines have increased because of RA 9442. Smaller pharmacies in rural areas have a harder time implementing the law because the discounts for PWDs are larger than the mark-up price of drugs. There is a need to improve the implementation of the Magna Carta for Disabled Persons in terms of medicine access. The following recommendations are made: 1. Customize and expand the benefits according to the needs of the PWD, possibly through PhilHealthâ&#x20AC;&#x2122;s TSekAP. 2. Disseminate information on the benefits of PWDs under RA 9442. 3. Make telemedicine and home delivery available for PWDs. 4. Enact Communication Access Laws for PWDs and conduct related research. 5. Develop a central registry for medicine purchases of PWDs.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Open Forum Burden-sharing as stipulated in the provisions of the SC law Senior citizens (SC) bring forth losses to operations, but if burden sharing is applied, those losses can be avoided. At the losing end are the retailers who are not aware they are due reimbursements. In line with this, it is recommended to 1) strictly implement and educate retailers on reimbursement scheme of suppliers to retailers; 2) ensure strict monitoring of implementation; and 3) engage stakeholders across all levels of the supply chain. Burden-sharing in the PWD law Currently, there is confusion on the guidelines of burden-sharing, if even allowed for PWDs. Some large drugstore chains tried but were not successful in reimbursements. Some were hesitant, and some recommended putting the 70% into the payment of taxes. Impact of the PWD and SC laws on small-time retailers The impact of the SC and PWD laws to retailers, particularly small drug stores, must be considered in the review and drafting of policies. Drug stores with higher risk of losing businesses actually go as far as turning away SC buyers because the business cannot afford to provide the discounts.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

PILLAR 3:

Availability and Affordability Despite the fact that improved access to medicines and vaccines could save up to 10 million lives every year, the price, availability, and affordability of medicines remains a major obstacle. In developing countries, medicines account for up to 70% of overall health care expenditure. Overstretched healthcare budgets in most countries are unable to provide needed medicines to all citizens, forcing patients to pay for medicines themselves. As a result, many people endure financial hardship or even go without treatment.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

A Study on Factors Influencing Drug Pricing Among Public National Hospitals Presenter: Cheyenne Ariana Erika M. Modina Epimetrics, Inc. The Philippine National Drug Policy (PNDP) is a response to ensure the provision of good quality, essential medicines to the people. Medicine purchase accounts for a significant portion of out-of-pocket expenditures for people, including those from the lower-income sector that the PNDP intended to serve. Although the Philippine Health Insurance Corporation (PhilHealth) reimburses inpatient medicines listed in the Philippine National Drug Formulary up to a ceiling, PhilHealth does not reimburse medicines for outpatient treatments. This study aimed to determine the factors associated with the variation in drug pricing among national public hospitals. The study employed a case-control study design, with a study population of 57 national public hospitals. It used a mixed-method approach across levels. The sample is representative of all levels, regions, and specialty; it also included nine hospitals under geographically isolated and disadvantaged area (GIDA). Six specialized hospitals (10.5%) were also included, the rest being general hospitals. NCR has the highest percentage of hospitals (22.8%), followed by Region VII with six hospitals (10.5%) and Region III with 5 hospitals (8.8%). Univariate, bivariate, and multivariate tests were done to analyze the data. The study was also able to describe the process of drug management in national public hospitals and how they fare with the World Health Organization (WHO) Good Procurement Practice (GPP) Principles through the conducted key informant interviews and administered GPP Checklist. Key stakeholders involved in deciding drug prices in hospitals were also identified. Sixty percent of hospitals were found to have a Price Ratio (PR) >1 and were procuring 6.44 times higher than the Drug Price Reference Index (DPRI). Factors that were significantly associated with PR>1 include: lack of proper procurement planning, propensity towards alternative modes of procurement (over competitive tender), and location in a GIDA. Hospitals were found to impose a 40.2% median retail price markup. Higher retail price markups of drugs were associated with a lower level of hospital operations, preference for branded over generic drugs, limitations in storage, and uncoordinated distribution of drugs.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Factors with significant relationship to the price ratio are: •• Being a GIDA hospital, •• Properly planning procurement, and •• Availability of indicator drugs. On the other hand, factors related to the hospital’s mark-up are: •• The hospital’s level, •• Their distance from the centroid, •• Their compliance to the WHO’s GPP principle on Quality Assurance, •• The relevance and expertise of their procurement staff on procurement functions, •• The percentage of generic drugs that they procure, and •• Time out of stock of the indicator drugs. Results also revealed that certain parts of the drug management cycle such as distribution both from warehouse and pharmacy were related to the mark-up. The policy recommendations are directed to the three main policies that affect the Drug Management Cycle namely: the DPRI, the Government Procurement Reform Act (GPRA), and the Generics Law. Future research should be done to include the “use” stage of the Drug Management Cycle and factors that influence drug prices in the supplier side. The DPRI should be volume-weighted and should be categorized per region. Moreover, hospitals within a GIDA region should have its own DPRI to contextualize procurement in hospitals, to allow flexibility, and to decrease failed biddings. The GPRA should develop specific policies for hospitals to actively seek the involvement of end-ser unit in procurement, create guidelines and protocols for hospitals to prevent and protect them from unlawful acts, explore alternative modes of procurement other than public bidding, and allow hospitals procuring in bulk to schedule deliveries. The Generics Law should be strengthened and advocated in all hospitals, crafting stricter policies on its implementation. The DOH should create more incentives for hospitals that do not procure any branded drugs. Other policies by regulatory agencies should also be improved to allow more suppliers for generic drugs to enter the local market, thus introducing more competition will also lower the prices of drugs.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Review of Drug Pricing Policy in the Philippines Presenter: Madeleine de Rosas-Valera, MD, MScIH The passage of the Generics Act of 1988 and the Universally Accessible Cheaper and Quality Medicines Act (RA 9502) was an attempt towards the widespread reduction of drug prices and improvement of overall access to essential drugs. Aside from these, existing laws and policies include Administrative Order (AO) 2012-0023-A and 2015-0051, International Procurement, and the Philippine National Drug (PND) Formulary. In line with these, the study aimed to 1) review the current pharmaceutical pricing policies and existing issuances of the DOH, 2) give recommendations on legislative and governance reforms, and 3) determine the formula for price mark-ups of medicines. Triangulation of methodologies involved a desk review of existing policies and laws on drug pricing, taxation, procurement, and registration; key informant interviews (KIIs) and focus group discussions (FGDs) to capture the different unwritten policies and procedures and the behavioral dimension that affects the implementation of pricing and procurement; and, site visits, document reviews and a workshop to draw or encapsulate the viewpoints of the stakeholders and increase the credibility of data collection, confirming the actual implementation of policies. On investigating the impact of RA 9502 on drug pricing, there was a significant reduction in prices of Maximum Drug Retail Pricing (MDRP)and Government-Mediated Access Prices (GMAP)-targeted drugs, and a greater reduction observed among innovators. As anticipated, there was at least 10% reduction among GMAP and innovator drugs; prices of competitor drugs, meanwhile, settled near the GMAP levels. A thorough review of national laws and regulations showed that there is no need to formulate new legislation for drug price regulation. These are already present and clearly stipulated in existing policies, namely: the Price Act (RA 7581, of 1992, Section 2), the Universally Accessible Cheaper and Quality Medicines Act (RA 9502, of 2008 Chapter 3, Section 17) and its implementing rules and regulations, and the Joint DOH-DTI-FDA Administrative Order No. 2008-01, Chapter IV, Rule 18, 19, 21.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Furthermore, the following issue in drug pricing also emerged: the inability of suppliers to deliver results in emergency purchases, leading to procurement failure. In relation, the lengthy supply chain and the many players involved also result to an increase in the number of mark-ups. In addition, though the quality of medicines is assured by the FDA, the belief that generic drugs are of poor quality still persists among Filipinos. It is recommended to initiate and establish a price monitoring and regulation system for drugs and medicines prices, as stipulated in the Price Act of 1992 (Section 2) and the Cheaper Medicines Act of 2008 (Chapter III, Section 17 and 18). It is in the powers of the Secretary of Health to implement it upon application. In particular, the following are emphasized: •• The development of the institutional framework for the Drug Price Regulatory and Monitoring System by the Secretary of Health, as per the provisions of RA 9502 (“initiate and establish a price monitoring and regulation system for drugs and medicines prices”) •• Secretary of Health to call upon and deputize the FDA or any agency or instrumentality of the national and local government to become the working arm of the Drug Pricing Technical Working Group (EDP-TWG), with adequate technically trained staff to a) calculate landed costs of drugs and medicines and suitable precise mark-ups for the distributors/wholesalers and retailers at the point of entry to the market and set the retail price of a drug using clear formula; and b) ensure strict uniform implementation and monitoring of the markets’ implementation of the set retail price of drugs set by the Board. •• Secretary of Health to demand back-up support from the Bureau of Customs, Bureau of Internal Revenue, DOH-PD, Department of Trade and Industry (DTI) to the EDP-TWG in data gathering and taxation analysis.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Strengthening of the DOH Pharmaceutical Chain Management System Presenter: Leonila M. Ocampo, RPH, MS Asia Pacific Institute for Medication Management Medicines and other pharmaceutical products and services are an integral part of any health care system. The complexity of the current political and economic environment in the Philippines emphasizes the need to assess the current country landscape, towards further strengthening and improving the current pharmaceutical supply system. The objectives of the study were to 1) strengthen the pharmaceutical supply management system of the DOH which includes selection of medicines, forecasting of quantities, procurement, storage and distribution, utilisation review and information flow and 2) to review and define the governance structure and implementation framework of the Pharmaceutical Supply Chain Management System in the DOH and its related agencies. The study employed qualitative data collection through document and policy reviews, KIIs, field visits, and attendance to relevant workshops that were held during the assignment period. A multi-stakeholder workshop was also conducted to validate the data, as well as a consultation with PD and other department heads, chiefs, and staff. The PMP aimed to establish a National Essential Medicines Facility (NEMF) to provide a national pooled procurement service for DOH programs, an e-procurement system for the public sector, and a system of consignment for medicines in situations where inadequate financing limits the availability in public health facilities. The NEMF, designed as a â&#x20AC;&#x153;pullâ&#x20AC;? system for distributing medicines to national and local government health facilities, has not yet been implemented but may be absorbed by a Pharmaceutical Supply Chain Management Unit. The E-procurement system, on the other hand, should ideally provide a web-based procurement, inventory, and tracking system for essential medicines at the national and local levels, towards better forecasting needs, monitoring of drug prices and adoption of good management practices. This development, however, has also not yet been implemented. Finally, the consignment of medicines, designed to be helpful in ensuring

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

availability of essential medicines when DOH and LGU funding is insufficient, may be open to abuse by suppliers. This risk may even lead to higher prices than those obtained through competitive bidding. The workshop revealed a number of issues in human resources and practices. There is a shortage of pharmacists in LGUs, some RHUs do not participate in monitoring, and some RHU workers are resistant to change. The pharmacists also recognized the need to centralize all procurement due to the discrepancy and lack of instructions in the delivery of medicines, management of recalled medicines, disposal of expired medicines, and documentation. RHUs generally have limited space, shelving, and uncontrolled temperature. There is overstocking of slow-moving medicines. Medicines tend to expire due to the lack of coordination between DOH-PD and regional offices. In relation, the Complete Treatment Pack program allocations have been based on national rather than local prevalence rates, hindering responsive implementation. Generally, patients were aware that medicines are free at RHUs, but some are still uninformed. Some people believe that these medicines are donated by politicians and some politicians actually do hoard medicines for electioneering. Brand name medicines are often in use because patients are dependent on the behavior of prescribers. Marketing initiatives, such as commercials and celebrity recommendations, have a large impact in the preference for branded medicines. Patients believe that branded medicines are safer and more effective compared to generic alternatives. Efficient pharmaceutical chain management is essential in ensuring access to quality and cost-effective medicines and to prevent unnecessary wastage to occur. The following are recommended: •• Creation of a National Pharmaceutical Center that has three divisions: »» Pharmaceutical Supply Chain Management Division »» Quality Use of Essential Medicines Implementation Division »» Policy, Planning, Program Development and Research Division •• Development of Standard Operating Procedures that shall guide the center’s operations framework and operational system. •• Clear short-, medium-, and long-term implementation plans.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Palawan Access to Medicines Partnership Project: Impact of Differential Pricing on Access to Medicines Presenter: Troy Gepte, MD The Palawan Access to Medicines Partnership Project (PAMPP) is a unique public-private collaboration aimed at testing the feasibility of differential pricing in improving access to innovative medicines, through the implementation of the Tulay sa Kalusugan (TSK) program. Towards the improvement of health outcomes of Filipino patients and communities, the TSK-PAMPP program focused on the following thrusts: 1) strengthening health systems to improve service delivery, 2) innovative solutions for medicine access, and 3) engaging and empowering patients for better care. The project aimed to determine whether the use of differential pricing, in combination with health systems strengthening, is associated with improvements in 1) health service utilization, 2) quality of care, 3) affordability of and access to medicines, and 4) health outcomes. The project was carried out in Palawan from January 2015 to September 2017. Both highly urbanized communities and GIDAs were targeted. A total of 5,994 patients were screened in 2,727 pilot sites. The steps involved in the TSK-PAMPP program are outlined in Figure 5. Initially, patients undergo consultation at a rural health unit or government hospital. Those diagnosed with hypertension and/or diabetes are then enrolled to the TSK Project and given the Access to Medicine Card. Afterwards, the patient is given a special prescription for the purchasing of differentially-priced (DP) medicines at the DP Pharmacy, followed by further patient tracking and monitoring.

Figure 5. Steps of the TSK-PAMPP program.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Three months after enrolment, the health indicators of patients showed improvement. Specifically, diabetic patients taking DP medicines showed an average decline in their HBA1c levels by 1.70%. The blood pressure of hypertensive patients taking DP medicines also decreased by 142/88 mmHg. The illnesses of patients taking DP medicines were also observed to be less severe. Findings showed that the proportion of patients experiencing extreme negative outcomes was lower for those who took the DP medicines for both hypertension and diabetes. DP medicines were also associated with a reduction in the proportion of bad outcomes for diabetes patients in the upper income distributions. The TSK-PAMPP reinforced health systems strengthening, resulting in the delivery of quality health services to patients where and when they needed them. It provided various capacity-building trainings for doctors, nurses, and other healthcare workers towards the enhancement of patient adherence, clinical management, and supply chain management. In relation, the project also helped build reliable information systems for decision-making by establishing patient registries with the use of electronic medical records. The TSK-PAMPP enabled increased access to DP medicines for hypertension and diabetes. Individual pharmaceutical companies offered DP medicines for management of diabetes and hypertension. Kiosks were also set up in provincial and district hospitals, serving as pharmacies for DP medicines for easy patient access. In line with these initiatives, the project ensured the uninterrupted supply of quality medicines, with strict adherence to Good Distribution Practice. The program enhanced the use of health services by integrating patient education and empowerment. Enrolled patients were provided with health information about disease prevention, management, and control. Using basic technology, project nurses sent text messages to patients to remind them about upcoming check-ups and prescription refills. Throughout the project, patient clubs on hypertension and diabetes have been established for the continued exchange of information and activities. Overall, the TSK-PAMPP succeeded in exploring the impact of differential pricing in increasing access to medicines among lower- and middle-income population. The project facilitated collaborations across the government, academe, and private sector to successfully provide health solutions towards the quality and affordability of medicines, and the availability of and access to innovative medicines and health services. It is recommended that this pioneering collaboration be replicated in other parts of the country to validate the impact of differential pricing on access to medicines and strengthen positive outcomes in the communities.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Botika ng Bayan: Promoting Access to Quality Pharmacy Services in Public Health Facilities Presenter: Michael D. Junsay, RPh, CPS, MBA-H DOH-Pharmaceutical Division In the Philippines, out of pocket expenditures remain to be the major source of financing for healthcare access. Based on a 2012 report by the World Bank, 91% of medicines are paid out of pocket and only the remaining 9% are covered by government and insurance services. The Philippine pharmaceutical market, which was at 166 billion pesos in 2016, accounts for 44.5% of total health expenditures of Filipinos (See Figure 6). Though average medical expenditures are higher among the rich, 75% of the total share of expenditures is higher among the poor, signifying a heavier burden among poorer households.

Figure 6. Medicine access routine pathway in the Philippines.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

In line with the current administration’s commitment to health, the revival of Botika ng Bayan (BNB) near government centers was adapted as a strategy. The agency aimed to revitalize the BNB based on its potential to improve access to medicines and health services towards the achievement of universal healthcare in the Philippines. Currently, existing RHUs are being transformed into government-operated pharmacies, referred to as the ‘F1+ Botika ng Bayan’. The objectives of the F1+ BNB are to 1) ensure access to safe, effective and quality essential medicines, 2) reduce out-of-pocket expenses, 3) ensure proper management and implementation of Good Distribution and Storage Practices, 4) establish partnership with LGUs, and 5) provide good pharmacy services. Table 2. Features of the revitalized F1+ Botika ng Bayan

FEATURES OF THE F1+ BNB 1. Integrated Management of DOH Program Medicines and LGU Medicines by Pharmacists and Trained Pharmacy Support Workforce = Responsive medicines list (need = supply) 2. Provision of additional 26 types of essential medicines from DOH 3. FDA-Registered Drug Outlet: compliant to good storage, distribution, and pharmacy practices towards the assured quality of products 4. Patient medication profiling for an improved health service delivery network 5. Off-site access to medicines (for GIDAs and Urban Poor) through BHS and scheduled visits 6. Improved medicine supply and replenishment mechanism from DOH 7. Compassionate healthcare service delivery by trained dispensers of medicine for improved overall patient satisfaction

At present, RHUs already provide free medicines to patients through the different DOH programs. A typical RHU, however, still experiences challenges in ensuring availability of stocks due to multiple factors. This includes the lack of a clear coordinative mechanism for responsive replenishment, data quality issues, and the lack of a harmonized tool for data collection. While many other factors contribute to the supply chain management issues of DOH, the conversion of RHUs into BNB outlets presents a potentially effective strategy in addressing them. In line with this, the DOH and LGUs shall work together for joint implementation of the program towards ensuring good governance mechanisms and local accountability in the management of F1+ BNB outlets in all prioritized government health facilities. The DOH shall also partner with the Philippine Pharmacists’ Association in disseminating the benefits gained by patients through the services provided by the F1+BNB pharmacists.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Open Forum Harmonization of documents and procedures for pooled procurement Agreements were made on the possibility of focusing efforts towards pooled procurement through harmonization of documents and procedures, even if efforts are not technical/ technological right away. The use and applications of IT system to address profiling, needs of community, and feedbacking with actual usage towards pooled procurement might be pricey, but the benefits more than justify the costs. Budget allocation for pooled procurement With regard to financial capabilities, there is a need to build on reports of current actual usage (i.e. patient profiling process at the rural health unit) towards the possibility of the department getting the mandate on costing and quantification. Adoption of guidelines on pooled procurement Currently, there is a lack of knowledge on drug quantification among program implementers. However, pooled procurement is already being done in the Philippine Pharma Procurement, Inc., particularly in cancer medicines/programs. The program has 300+ pharmacists working in LGUs and RHUs for the collection of data for drug quantification.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Sustainability of the Botika ng Barangay/Bayan More than providing free medicines in communities, the BNB is in charge of licensing and provision of pharmaceutical services. Through the passage of the UHC bill, the health financing scheme for BNB will be taken from PhilHealth reimbursements. Moreover, there are no current plans to consider the adoption of a business model to sustain operations. Addressing the issue of medical missions Medical missions are a dole-out and do not provide a sustainable solution to increasing the publicâ&#x20AC;&#x2122;s access to medicines. These events can be lessened with the successful institutionalization of pharmaceutical services as an alternative, especially in far-flung areas. Furthermore, based on existing guidelines and if regulation will be strict, no medical missions will be allowed to carry out without proper regulation. Violations and penalties will be handed out in line with the pharmacy law and as part of the mandate of regulatory agencies. The role of PhilHealth and other fund providers for health services Based on the BNB pilot sites, the ongoing thrust of the LGU is the development of a onestop shop for health services. For instance, in San Mariano, Davao City, and San Remigio, the BNB location includes the offices for PhilHealth, SSS, and other fund providers.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

PILLAR 4:

Networking and Partnerships Several innovative approaches based on partnerships, intellectual property, and pricing are used to stimulate innovation, promote healthcare delivery, and reduce global health disparities. No single approach suffices, and therefore stakeholders need to further engage in partnerships promoting knowledge and technology transfer in assuring essential medicines to be manufactured, authorized, and distributed in low- and middle-income countries in an effort of making them available at affordable and acceptable conditions.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Survival Analysis of Pediatric Acute Lymphoblastic Leukemia Patients Enrolled in the DOH’s NCPAM ALLMAP Presenter: Vincent B. Aguilar, MD Bicol Regional Training and Teaching Hospital Survival rates of patients with Acute Lymphoblastic Leukemia (ALL) in the country remain poor due to various factors that hinder access to proper treatment. Financial constraints are considered one of the primary barriers, particularly the out of pocket expenses for chemotherapy drugs. In 2012, DOH-PD, then known as the National Center for Pharmaceutical Access and Management (NCPAM), began implementation of the Acute Lymphoblastic Leukemia Medicines Access Program (ALLMAP). Implemented in three pediatric cancer units of 15 hospitals across the country, the program provided free chemotherapy drugs to indigent patients, funds for the establishment of a data registry, and training of healthcare professionals directly involved in childhood cancer management. The study aimed to measure the impact of the NCPAM-ALLMAP on patient survival outcomes through a multi-center, retrospective study of newly diagnosed ALL patients from January 1, 2012 to December 31, 2015. The study reviewed charts of 1,340 patients enrolled in the program. Diagnosis was based on immunophenotyping in 697 patients and morphology in 643 patients, with a mean age at diagnosis of seven years old. At the end of the almost four-year period, 76% of patients were “without outcome of death”, 43% were alive, 24% died, 12% relapsed, and 30% abandoned treatment. The most common cause of death among ALL patients were sepsis and bleeding. These findings suggest that treatment abandonment and toxic death are significant problems that must be addressed.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

A multivariate analysis of patient characteristics and survival outcomes showed that mortality was strongly correlated with the initial age during diagnosis at either greater than 10 years old or less than one year old. Based on these outcomes, it is acknowledged that a comprehensive national leukemia program is a necessary milestone. This program should include initiatives on infection control, standard clinical practice guidelines, and the creation of hospital registries. The results of the study provide relevant implications to future research and clinical practice, as follows: •• Risk-adapted treatment regimen as best-suited for the level of care. •• Health equity between low- and high-risk patients of ALL. •• Availability of access to safe blood during intensive chemotherapy. •• Initiatives towards infection control. •• Strengthening capacity of basic centers to become specialized. •• Creation of a hospital-based registry that contributes to the national cancer database registry. •• Unifying treatment protocols and data extraction forms that are specific to patients of ALL. •• Strategies that can address treatment abandonment.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Access for Breast Cancer Quality Study: Preliminary study on the effect of the DOH-Philippine Cancer Society Inc. (PCSI) Patient Navigation Access Program for Breast Cancer Medicines on Quality of Care in the Medical Oncology Clinic in the Philippine General Hospital Presenter: Rachael Marie B. Rosario, MD Philippine Cancer Society Inc. Breast cancer is the number one cause of cancer deaths among Filipino women, making up 15% of all cancer sites and 30% of all female malignancies. As a response, efforts have been focused on strengthening existing measures to decrease breast cancer mortality, which include screening programs and adjuvant chemotherapy. In May 2011, DOH and the Philippine Cancer Society, Inc.(PCSI) began the Breast Cancer Medicines Access Program scheme, with the goal of promoting early screening and cancer awareness, and improving survival rates of breast cancer among Filipinos. The program utilizes patient navigation in its implementation, providing monitoring of treatment response, occurrence of adverse drug experiences, research, coordination with health providers, and assistance to patients to overcome healthcare barriers and psychosocial support. The program also provides free adjuvant and neoadjuvant chemotherapy for patients with early breast cancer, free testing, and free tamoxifen for hormonal treatment. The main objective of the study was to assess the effect of the implementation of the DOH-PCSI program for nonmetastatic breast cancer on quality of care, using evidence-based quality indicators, and follow-up rates. As the program was in infancy at the time of the assessment, the use of follow-up rates and quality indicators were proposed as surrogate markers to survival outcomes.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

The study population included nonmetastatic breast cancer patients whose first consult was within January 2011 to June 2012. The proportions of fulfillment of each quality indicator of enrolled versus non-enrolled patients were gathered and compared through statistical analysis. The same method was also used for patients seen in 2011 versus 2012 and all patients enrolled in the program versus those excluded in 2012. This was done to reflect the impact of patient exclusion to the overall performance of the clinic. Among the 264 new breast cancer patients seen from January 2011 to June 2012, 88 metastatic or recurrent breast cancer patients were excluded. Of the 176 patients included, 90 were seen in 2011 and 86 were seen in the first half of 2012. The study found that there was a high lost to follow up rate in 2011 (62%) compared to 2012 (18%). It was also found that patients were lost to follow up even before finishing at least four cycles of chemotherapy (25.8%), or even prior to starting chemotherapy (39%). All of those lost to follow-up have not been initially enrolled in the DOH program, suggesting that access to free chemotherapy may be a significant factor between inclusion and exclusion in the program. The comparison of quality indicators between enrolled and non-enrolled patients from 2011 to 2012 showed that those included in the program had better performance in 12 out of 18 quality care indicators, with an absolute magnitude of 58.7% difference in proportions of fulfillment. A comparison of all patients in 2011 versus those in 2012 also showed a significant increase in eight out of 19 indicators. Overall, improvements in quality indicators with free services favor the patients in the program consistently in both magnitude and statistical significance. In line with these results, the study recommends a multidisciplinary effort in defining quality indicators in the local setting. Since this study only used the indicators as surrogates, benefits can be gained from the validation of these indicatorsâ&#x20AC;&#x2122; effects on clinical endpoints. It is also recommended that qualitative and quantitative studies further explore the impact of patient navigators in the program. The study suggests the triangulation of perceived strengths and weaknesses of navigation by the patients, physicians, and the navigators.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Review of the Implementation of the National Action Plan on Antimicrobial Resistance Presenter: Maria Christina Langit-Bagro, MD, MPM Alliance for Improving Health Outcomes As defined by WHO, antimicrobial resistance (AMR) is the ability of a microorganism to stop an antimicrobial from working against it. As a result, standard treatments become ineffective and infections persist and may spread to others. Beyond its impact on human and animal health, AMR also has significant economic implications. As a response to this issue, the 68th World Health Assembly declared resolution WHA 68.7 in 2015, establishing the Global Action Plan on antimicrobial resistance. The Food and Agriculture Organization, the World Organization for Animal Health, and the WHO formed a tripartite to combat AMR. Other initiatives, such as the â&#x20AC;&#x153;One Health Approachâ&#x20AC;? and the Western Pacific Action Plan, were also developed. The Philippine Action Plan to Combat AMR 2015-2017 served as the countryâ&#x20AC;&#x2122;s roadmap towards containing, controlling, and preventing antimicrobial resistance. This comprehensive plan emphasizes the One Health Approach, as it recognizes that the causes of AMR are inter-related and inter-sectoral (See Table 3). The seven key strategies outlined in the document are to 1) commit to a comprehensive, financed national plan with accountability and civic society engagement, 2) strengthen surveillance and laboratory capacity, 3) ensure uninterrupted access to essential medicines of assured quality, 4) regulate and promote rational use of medicines, including in animal husbandry and ensure proper patient care, 5) enhance infection prevention and control across all settings, 6) foster innovations, research and development, and 7) develop a risk communication plan to combat AMR.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Table 3. Vision, mission, and targets of the Philippine Action Plan to combat AMR 2015-2017

PHILIPPINE ACTION PLAN TO COMBAT AMR 2015-2017 VISION A nation protected against the threats of antimicrobial resistance

MISSION To implement an integrated, comprehensive and sustainable national program to combat AMR geared towards safeguarding human and animal health while preventing interference in the agricultural, food, trade, communication and environmental sectors

TARGETS •• Reduce by 30% carbapenem-resistant Enterobacteriaceae (E. coli and Klebsiella) infections acquired during hospitalization •• Maintain the prevalence of ceftriaxone-resistant Neisseria gonorrhoeae to 0% •• Reduce by at least 30% overall methicillin resistance in Staphylococcus aureus bloodstream infections compared to rates in 2014 •• Reduce by 30% multidrug-resistant Pseudomonas spp infections acquired during hospitalization compared to estimates in 2014 •• Reduce by 25% ciprofloxacin-resistant nontyphoidal salmonella infections compared to 2014

In line with this, the current review of AMR implementation aimed to identify achievements and challenges in implementation, map current stakeholders in human health and animal sectors, and identify priorities and action areas for recommendation to move activities forward in the country. The study utilized a qualitative, descriptive design consisting of desk reviews, KIIs, and validation meetings. Through sustained efforts, progress was attained in the seven key areas of the action plan. Achievements assessed across sectors involved in human and animal health. These include the 1) formulation of the action plan, 2) organization of the Inter-Agency Committee on AMR (ICAMR) and TWG, 3) budget allocation, 4) capacity building and trainings, and 5) the review, updating, and enforcement of policies, various communication initiatives and advocacy campaigns. Based on the findings, there is a need to integrate AMR with the existing programs of the DOH. A multisectoral approach must be prioritized by facilitating collaborations across sectors that are in line with the One Health Approach. The regulatory policy framework must also be reviewed and updated to reflect proper jurisdiction, mandates, and roles both for human and animal AMR. Moreover, there is a need for harmonized and streamlined AMR research that will effectively guide policy, which must include research on effective governance mechanisms, financing, and the economic implications of AMR. Ensuring food safety while balancing the need for antibiotics is another challenge that must be addressed.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Open Forum Approaches to reducing treatment abandonment Different countries take on different approaches to reducing treatment abandonment and increasing survival. For instance, in the US, those who practice treatment abandonment are sued, resulting to 0% rates. In Brazil, abandonment was lessened by the provision of free lodging, food, and medicines. In line with this, the development of a treatment design grounded in theory is recommended towards the reduction of treatment abandonment in the current Filipino context. Categorization of hospitals on the availability and scope of services The globally-adapted classification of health facilities as basic, limited, enhanced, and maximal was used to categorize hospitals included in the NCPAM-ALLMAP. Hospitals were classified only as basic and limited. “Basic” hospitals turn patients away and refer them to “limited” hospitals due to lack of resources and these result to the possibility of overwhelming the three “limited” hospitals. The best way to address this is to capacitate and strengthen the operations of basic hospitals. Implementation of a national cancer program Towards higher survival rates, there should be policies in place for the implementation of a national cancer program. Currently, much progress has been made in the fight for the passage of the cancer bill. The need to engage the community on AMR There is so much power that can be mobilized from the community towards unifying the voice of consumers to demand quality food from farmers. For instance, a fast food branch in one country pledged all organic and grass-fed products due to consumer pressure. In the Philippines, the current lack of community engagement on AMR may be due to gaps in policy and program implementation.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Challenges in the promotion of AMR messaging Some challenges faced in the promotion of AMR messaging is the full plate of barangay health workers and their possible inability to accommodate AMR duties. Another issue is the promotion of the responsible use of antibiotics. There are existing expectations among Filipinos that doctors must prescribe antibiotics all the time and a persistent mistaken belief that doctors who do not prescribe antibiotics are incompetent. There is a need to educate consumers on this issue. Other recommendations for Filipinos as â&#x20AC;&#x153;Partners for Changeâ&#x20AC;? The possibility of positive navigators as a tool to combat other cancers and diseases with long-care journey distress should be further explored through future research initiatives. As a recommendation for policy makers, access to hospitals in the rural areas should be improved.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

PILLAR 5:

Good Governance Good governance encourages better management across all points of the pharmaceutical system, including registration, selection, procurement, distribution, and at the point of prescribing and dispensing medicines to the patient. Moreover, important decisions are made in the development of policies, allocation of resources, and throughout the process of managing medicines.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

A National Assessment on the Knowledge, Attitude, and Practices Among Filipino Physicians on Ethical Relations with the Pharmaceutical Sector Presenter: Katherine Ann Villegas-Reyes, MD, MPP Alliance for Improving Health Outcomes There is an inevitable interaction between physicians and the pharmaceutical industry, wherein ethical boundaries can be challenging. Due to this, the DOH and FDA adopted the Mexico City Principles (MCP) to properly guide the different players of the pharmaceutical sector in the Philippines. However, there are no available national level baseline information on the knowledge, attitude, and practices of physicians on interactions with the pharmaceutical industry This study aimed to assess the knowledge, attitude and practices among Filipino physicians on the ethical relation with the pharmaceutical sector, and to provide possible options on strengthening policy implementation. A prospective cross-sectional mixed method design was used in the study through a self-administered survey. Responses from 2,030 physicians were obtained. Results showed that awareness regarding MCP among Filipino physicians is low. Most physicians preferred receiving industry updates through formal venues such as conferences. Physicians favored activities that benefit patients and involve exchange of information such as roundtable discussions and medical representative visits. Results revealed a low appreciation of the concept of conflict of interest. Workplace, colleagues, and role models provided an accepting environment for physician-industry interactions.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Figure 8. Observed interaction practices between physicians and industry

With DOH at the forefront, increasing the knowledge of physicians should be approached through their preferred formal venues augmented by government websites as platforms. Sensitization on ethics and conflicts of interest should start at the academe and continue at the workplace. An integrative approach towards regulation of medicines promotion should be considered, linked with the entire effort of regulating medicines in the country.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Use of Discount Cards Among Patients and Physicians in Key Cities in the Philippines Presenter: Edwin C. Ruamero Jr., RPh, MPH Discount cards are used as a strategy by pharmaceutical companies to provide access to brand-name medications. In the Philippine context, AO 2015-0053 is the implementing guideline on the promotion and marketing of prescription pharmaceutical products and medical devices. However, there are no published data or formal studies which attempt to determine the effects of the the use of discount cards The study aimed to determine the 1) prevalence of use of discount cards among patients, 2) magnitude of distribution among physicians in relation to their prescribing behavior, and 3) adherence of patients to their medications. A survey was employed and random sampling was done in three sites: Manila, Cebu, and Davao. A total of 273 physicians were surveyed. Results were also obtained from FGDs and KIIs with patients, physicians, pharmacists, and medical representatives. Among patients surveyed, almost 75% strongly disagreed and disagreed that discount cards were useful only for those who can afford medicines. In addition, 55% agreed that medicines with discount cards were affordable and more than 90% agreed that discount cards could result in cost savings. Among physicians surveyed, 88.2% were aware of discount cards, which was considered as the most common promotional strategy by pharmaceutical companies. About 50% revealed that they offered discount cards to selected patients during visits. In addition, 28.1% reported that their preference of prescribing brands with discount cards slightly increased while 48.85% expressed no change. More than half of the physician respondents agreed that drugs with discount cards improved adherence of patients to their medications. Roughly half of the respondents agreed that drugs with discount cards were prescribed more than their generic counterparts due to better medication profiles. Over 85% agreed that discount cards could boost the sales of pharmaceutical companies.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Table 4. Survey on patient awareness of pharmaceutical promotions

Discount Cards Enrollment to patient programs Co-payments

Awareness on the following pharmaceutical promotions

Variables

Attributes

Manila No.

Cebu No.

Davao %

No.

Total

No.

1 - I offer them in my clinic

32.6

50.5

40.9

117

40.3

2 - I am aware of it

55.0

36.6

50.0

139

47.9

3 - It is the first time I heard about it

8.5

4.2

4.5

6.2

1 - I offer them in my clinic

24.8

21.1

31.8

25.2

2 - I am aware of it

53.5

61.1

42.4

155

53.4

3 - It is the first time I heard about it

15.5

2.1

18.2

11.7

3.9

4.2

7.6

4.8

2 - I am aware of it

31.0

45.3

19.7

33.1

3 - It is the first time I heard about it

54.3

32.6

54.5

137

47.2

1 - I offer them in my clinic

Discount cards have the potential of cost savings among patients with preference for branded medicines. However, its use is limited to patients in the higher income bracket. On the other hand, physicians are well aware of discount cards and perceived that discount cards help patients save on cost and improve their treatment adherence. Even though the direct benefits to physicians are unknown, discount cards still influences their prescribing behavior.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Effects of the Distribution of Product Samples to Patients and Physicians by Pharmaceutical Companies Presenter: Edwin C. Ruamero Jr., RPh, MPH Product samples are one of the most common gifts that pharmaceutical sales representatives distribute to physicians as part of their marketing strategy. There are neither published data nor formal studies which attempt to determine the effects of the distribution of production samples. The study aimed to 1) determine the effects of the distribution of product samples to physicians in terms of their prescribing behavior and 2) determine the effects of product samples on patients in terms of their treatment adherence. The study was conducted in three geographical sites: Manila, Cebu, and Davao. Validation FGDs with patients, physicians, pharmacists, and medical representatives were conducted. A KAP survey on product samples was also conducted on physicians and patients. Results showed that pharmaceutical promotion through the use of product samples may negatively influence professional behavior and rational prescribing of medicines. Distribution of product samples did not directly translate to increased adherence of patients to their medications. Most patients perceived that product samples help ease financial burden, presents an opportunity to save money, and are useful for testing effectiveness. Medication adherence was measured using a Morisky Medication Adherence Scale, showing low adherence (75.8%) of patients towards product samples. This may be due to patients completely stopping the medication when the supply of product samples run out.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Table 5. Perception of patients towards product samples Questions

Perceptions on benefits of product samples

Manila

Cebu

Davao

Total

Easing financial burden

Answers

323 (81.6%)

173 (92.5%)

189 (66.5%)

685 (81.0%)

Opportunity to save money

318 (84.8%)

169 (90.4%)

195 (68.7%)

682 (80.6%)

Useful for testing effectiveness

271 (32.0%)

167 (89.3%)

188 (66.2%)

626 (74.0%)

Building patientâ&#x20AC;&#x2122;s trust to physician

274 (73.1%)

169 (90.4%)

212 (74.6%)

655 (77.4%)

Improving adherance

298 (78.1%)

170 (90.0%)

178 (62.7%)

641 (75.8%)

The DOH and FDA should create a surveillance system that will enable the monitoring of the provision of product samples to patients. Patients should be aware of what product samples are and the generic counterparts of samples. Adequate information must be given on their medicines, which should be accurate and evidence-based. Product samples will be more useful if made available for catastrophic diseases, whose medications are usually patent-protected and expensive. Primary and secondary packaging of product samples should be recognizable and distinguishable from the usual packaging of drugs sold in the market.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

A Profile of the Philippine Pharmaceutical Industry Presenter: Aubrey D. Tabuga, PhD Philippine Institute for Development Studies The efficient production and distribution of quality, safe, effective, and affordable drug products are key elements towards achieving universal health care. Understanding the role of the pharmaceutical industry and its performance, structure, and challenges should be emphasized. The study aimed to provide a profile of the pharmaceutical industry using a descriptive mixed methods study design. The scope of the profile includes 1) the pharmaceutical market, 2) pharmaceutical regulation, 3) public and private drug expenditure, 4) drug pricing, purchasing decisions or formulary development, and 5) industry and trade. The Philippine pharmaceutical market is currently valued at â&#x201A;ą173 billion with an annual growth rate of 8%. Prescription drugs comprise 72% of the market while 28% are over the counter drugs. NCR has the largest market at 44%. The number of manufacturing establishments has decreased by half, with an estimate of over 200 establishments in 2010 to just over 100 in 2018. From 2011 to 2018, the units of registered drugs in the Philippines decreased from 10,500 to 6,800. In 2016, the value of total imports amounted to $2.8 billion and increased to $3.3 billion by June 2017. One hundred percent of active pharmaceutical ingredients are imported. Medicinal and pharmaceutical products are the top import of the Philippines, valued at $160 million as of June 2017. Compared to its neighboring countries, the Philippines has made little progress in pharmaceutical export. In 1996, the Philippine and Indonesian pharmaceutical export were valued at just under $100 million. Indonesia was able to double its exports within five years and now have an annual growth rate of 15%. In comparison, the Philippine pharmaceutical export grew only with an annual average of 4% since 1996.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Figure 9. Comparison of the Philippines with neighboring countries in Pharmaceutical Exports

Drug stores play a big role in retail channel distribution, with The Generics Pharmacy having the greatest number of stores nationwide. With the presence of more affordable generic drugs, medicine prices have gone down. Medicine prices vary depending on their type, brand, and where it is sold. According to DOHâ&#x20AC;&#x2122;s essential drug price monitoring system, medicines in hospitals are relatively more expensive compared to other outlets. However, some hospitals impose the same price for originator and generic versions of a medicine. Constraints in infrastructure and human resources, coupled with more stringent FDA requirements, affected the timely launch of drug products. This caused a delay in the return of investments of pharmaceutical companies. There is also confusion or misunderstanding between FDA and the industry due to lack of open communication. Smaller players are unable to penetrate the market due to their low capacity for marketing. There is a need for urgent and effective mechanisms to address FDAâ&#x20AC;&#x2122;s human resource and infrastructural constraints in addition to the needed improvement in monitoring the health product industry. The study suggests that FDA must improve its processes and simplify procedures. It may consider receiving applications for drug registrations concurrently with good manufacturing practice assessment. The FDA should come up with a readily available database that provides information on industry actors distinguishable by type and/or operation.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Open Forum Regulations on ethical relations with the biopharmaceutical sector There are ongoing initiatives to assess tools and regulatory activities better implemented through networks and not in isolated areas. Moreover, given the current health system reform, there is a need to place emphasis on system governance instead of focusing on isolated indicators to guide the solving of particular issues. Which should be prioritized? Whose responsibility is it? Which sector? These questions must be addressed before amending existing policies and setting indicators for specific areas of ethical regulation. Challenges in the implementation of AO 2015-0053 The Philippine Pharmaceutical Association (PHAP) has worked closely with DOH in the design of AO 2015-0053. However, challenges were faced in the cascading of the AO due to the full plate of the FDA. In line with this, there is a need to consider the urgency of issue and realize the necessity of the government to work with the industry. Illegal selling of samples The Integrity and Proficiency Program for the Pharmaceutical Sector by PHAP requires the passing of an integrity and proficiency exam and all medical representatives from PHAPmember companies are licensed by the Professional Regulation Commission. The reported selling of samples is thus met with much concern as this behavior is not allowed. Strict regulation is necessitated.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

PILLAR 6:

Ensuring Responsible Use Responsible use of medicines is an essential element in achieving quality of care for patients and the community. According to the WHO, responsible use implies that the activities, capabilities and existing resources of health system stakeholders are aligned to ensure patients receive the right medicines at the right time, use them appropriately, and benefit from them.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Valuation of the Filipino Health Utilities using the EQ-5D-5L: How Filipinos Perceive States and Diseases Measured by EQ-5D-5L Presenter: Hilton Lam, MHA, PhD University of the Philippines-National Institutes of Health, Institute of Health Policy and Development Studies Health technology assessment (HTA) has been recognized as a crucial tool for decision-making in public health. It involves the measurement of health benefits in the form of cases prevented, life years saved, disabilityadjusted life years, or quality-adjusted life years (QALY). QALYs are now recognized as a mainstay feature of HTA in different countries. QALY asserts that the time spent in a diseased state should not be valued the same way as time spent in a healthy state. One QALY is equivalent to one health life year and zero is interpreted as death or a state equivalent to death. The EQ-5D-5L is a multi-attribute tool to measure QALY in five dimensions: mobility, self-care, usual activities, pain or discomfort, and depression or anxiety. The tool generates 3,125 different health states and has been translated to 137 languages.

Figure 10. EQ-5D-5L dimensions

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Using the EQ-5D-5L tool, the study aimed to estimate utility values of the different health states of the general population in the Philippines. A subset of 329 multilingual individuals were asked to accomplish the survey twice at a two-week interval. Valuations between the first and second surveys were compared. Validation FDGs with bilingual Filipinos and a national FGD with social scientists, anthropologists, and other health professionals were conducted. The study found that Filipinos valued 98 of 3,125 health states as worse than death. On average, these 98 health states were valued as seven times worse than death. Filipinos valued a combination of not being able to move, not being able to care of themselves, not being able to do their day-to-day activities, extreme pain or discomfort, and extreme depression or anxiety as almost 30 times worse than death. Validation FGDs revealed this may be attributed to the altruistic nature of FIlipinos. When asked on their major concern when suffering from a serious disease, over 35% of respondents stated it would be the loss of ability to care for their family. This study estimated the Philippine utility values for EQ-5D-5L. It recommends the measurement of QALY of Filipinos suffering from the top causes of morbidities and mortalities and warehousing the results in a national database for HTA studies. More validation studies for the self-administration mode of the tool should be conducted in its Cebuano and Hiligaynon versions. It is also recommended to measure the health states of subpopulation or disease groups for comparison with the health states of the general public generated in this study.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Ending the Silent Epidemic of Chronic Hepatitis in the Philippines Presenter: Hilton Lam, MHA, PhD University of the Philippines-National Institutes of Health, Institute of Health Policy and Development Studies Unlike HIV, Malaria, and TB, the number of deaths from viral hepatitis per year in the Philippines has been steadily increasing since 2000. Hepatitis B (HBV) and Hepatitis C (HCV) accounted for 56% of all hepatocellular carcinoma cases in the country in 2015.

Figure 11. Mortality rates: viral hepatitis, HIV, Malaria, TB (2000-2015)

The study aims to estimate the burden of HBV and HCV in the Philippines through the use of the Center for Disease Analysis HBV and HCV model with Philippine data as inputs. Data inputs include the prevalence of serum positive individuals, prevalence by age and gender, treatment, vaccination, and rescue intervention. In 2017, the estimated prevalence of chronic HBV in the Philippines was 9.7%, representing 10 million chronic infections. It is expected that there will be a decrease in prevalence to 7% or 8.7 million chronic infections by 2030. Serum positive infants will decrease to 0.4% by 2030. It is projected that there will be an increase to 35% of hepatocellular carcinoma attributed to HBV by 2030. It is estimated that HBV-related mortality will increase to 25% by 2030.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

In 2017, it was estimated that the prevalence of chronic HCV in the Philippines was 0.58%, representing 614,000 infections. It is projected that prevalence will decrease to 0.45% or 576,000 infections by 2030. It is estimated that hepatocellular carcinoma due to HCV will increase to 30% by 2030. Liver-related deaths due to HCV will increase to 20% by 2030. The study is ongoing, thus complete validation of model outputs is pending. It is recommended that WHO strategies to reduce HBV and HCV are adopted and implemented. Financing models for direct interventions should also be explored.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

2017 Health Facility and Household Survey on Access to and Use of Medicines in the Philippines Presenter: Dennis B. Batangan, MD, MSc Institute of Philippine Culture, School of Social Sciences, Ateneo de Manila University The Philippines adopted the UN Sustainable Development Goals (SDG) for 2016 to 2030. Health target eight of SDG number three aims to achieve UHC through 1) financial risk protection, 2) access to quality essential health care services, and 3) access to safe, effective quality, and affordable essential medicines and vaccines for all. This study aimed to assess the countryâ&#x20AC;&#x2122;s capacity to implement a national medicines program. The WHO protocol for the Pharmaceutical Situation Assessment (PSA) was adopted. The study was conducted in six geographic sites: La Union, Pampanga, NCR, Palawan, Capiz, and Misamis Oriental. Medicine prices gathered during the survey were not expressed as currency units but as ratios relative to a standard set of international reference prices, computed as the Medicine Price Ratio (MPR). La Union (I) - 28 Pampanga (III) -29 NCR - 35 Palawan (IV-B) 16 Capiz (VI) - 26 Misamis Oriental (X) - 29

Figure 12. Study sites and number of health facilities surveyed

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Generic medicines have become more available predominantly in private sector outlets. As of 2017, the mean availability of originator brand medicines was 12% in the public sector and 29% in the private sector. For generic medicines, the mean availability in 2017 was 42% in the public sector and 45% in the private sector. However, branded and imported drugs were still highly preferred and perceived to be of better quality over generic medicines. There is a significant drop in the MPR for generic drugs in both public and private sector. In the public sector, procurements have the lowest MPRs for generic and innovator brands. The procurement price was 3.33 for branded medicines and 3.63 for generic medicines. Public sector prices decreased significantly from 30.23 in 2009 to 3.52 in 2017 for innovator brands, and from 9.78 in 2009 to 3.31 in 2017 for generic medicines. The affordability of lowest priced generics in the public sector improved but most conditions still required at least half a dayâ&#x20AC;&#x2122;s wage. Furthermore, less than half of all the prescriptions for acute and chronic illnesses were from medical professionals, with high prevalence of selfmedication noted among the respondents. Households perceived availability of medicines as higher in private health care facilities compared to public health care facilities. This study recommends the development of a policy using the 2017 PSA findings and its implications on the following: 1) access and availability of medicines, 2) trends in the medicine prices from public sector procurement, public sector patient prices, and private sector patient prices, 3) cost of medicines and affordability of medicines for selected diseases, 4) perception on the quality of services and medicines in the public and private facilities, and 5) rational use of medicine.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Open Forum Development of local QALY value sets for use and adoption Given that most Philippine studies used foreign value sets due to lack of local counterpart at the time, there is a need to update and validate past research using the QALY value sets that have been newly and locally developed. Foreign value sets are not able to capture the unique aspects of Filipino culture and context. Phenomenon of self-prescribing The habit of some Filipinos to self-prescribe may possibly be attributed to fear of spending on costs at health facilities. As recommendation, the factors that influence self-prescribing behavior among Filipinos should be further explored. Pricing of branded medicines Despite efforts of PHAP-member companies to regulate prices similar to outside countries, prices are reported as 22% more expensive. This may be influenced by different protocols of various facilities for procurement and whether the facility is public or private. It is recommended that other protocols for analyzing pricing and policy be explored. Further research on how policy and other factors influence pricing There were past attempts to conduct components studies in 2006 or 2007, but it was challenging to acquire data both from public and private entities. As a recommendation, a qualitative study and policy analysis on how policy influences pricing should be carried out.

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Closing Remarks Undersecretary Rolando Enrique E. Domingo, MD, DPBO Department of Health - Health Regulation Team Good afternoon and thank you to everyone for being a part of Accelerating CHANGE: Access to Generics Towards Universal Health Care. Over the past two days, we have listened to over 16 researchers and have been presented with valuable knowledge and information that can further advance evidence-based action towards improving access to medicines. We hope that everyone in this room may continue to contribute to the evidencegeneration, policy-making, and service delivery efforts that will support the access to medicine provisions of F1+ for Health as we aim to achieve Universal Health Care by 2030. I would like to express my sincerest gratitude to all our speakers, moderators, and participants for the meaningful discussions and active participation; our partner, the Philippine Council for Health Research and Development; and to the organizers of this event, the Alliance for Improving Health Outcomes, for making this event possible. This policy dialogue and research forum became a success thanks to everyoneâ&#x20AC;&#x2122;s enthusiasm. We hope that the lessons learned here will be incorporated into your actions as we strive towards the common goal of achieving better health outcomes for Filipinos. Thank you and have a safe trip home!

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

PHOTOS

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

This Policy and Research Forum is organized by:

FORUM PROCEEDINGS: Accelerating CHANGE: Access to Generics Towards Universal Health Care

Presented by: