PALAU PHARMACEUTICAL COUNTRY PROFILE

Transcription

1 PALAU PHARMACEUTICAL COUNTRY PROFILE

2 Palau Pharmaceutical Country Profile Published by the Ministry of Health in collaboration with the World Health Organization September 2012 Any part of this document may be freely reviewed, quoted, reproduced, or translated in full or in part, provided that the source is acknowledged. It may not be sold, or used in conjunction with commercial purposes or for profit. This document was produced with the support of the World Health Organization (WHO) Representative Office in the South Pacific, and all reasonable precautions have been taken to verify the information contained herein. The published material does not imply the expression of any opinion whatsoever on the part of the World Health Organization, and is being distributed without any warranty of any kind either expressed or implied. The responsibility for interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. Users of this Profile are encouraged to send any comments or queries to the following address: The Chief Pharmacist Ministry of Health Belau National Hospital P.O. Box 6027 Koror, Republic of Palau or ii

3 Foreword The 2011 Pharmaceutical Country Profile for Palau was produced by the Ministry of Health, in collaboration with the World Health Organization. This document contains information on existing socio-economic and healthrelated conditions, resources; as well as on regulatory structures, processes and outcomes relating to the pharmaceutical sector in Palau. The compiled data comes from international sources (e.g. the World Health Statistics), surveys conducted in the previous years and country level information collected in More recent information is also included. The sources of data for each piece of information are presented at the end of this document. On behalf of the Ministry of Palau, I wish to express my appreciation to Clarette Matlab, Chief Pharmacist for her contribution to the process of data collection and the development of this profile. It is my hope that partners, researchers, policy-makers and all those who are interested in the Palau pharmaceutical sector will find this profile a useful tool to aid their activities. Dr. Selaima Lalabalavu Director of Hospital and Clinical services Ministry of Health Republic of Palau iii

4 Table of content Introduction... 1 Section 1 - Health and Demographic Data... 3 Section 2 - Health Services... 6 Section 3 - Policy Issues... 9 Section 4 - Medicines Trade and Production Section 5 - Medicines Regulation Section 6 - Medicines Financing Section 7 - Pharmaceutical Procurement and Distribution in the Public Sector Section 8 - Selection and Rational use of medicines Section 9 - Household Data/Access iv

5 Introduction This Pharmaceutical Country Profile provides data on existing socioeconomic and health-related conditions, resources, regulatory structures, processes and outcomes relating to the pharmaceutical sector of Palau. The aim of this document is to compile all relevant, existing information on the pharmaceutical sector and make it available to the public in a user-friendly format. In 2010, the country profiles project was piloted in 13 countries: en/index.html During 2011, the World Health Organization has supported all WHO Member States to develop similar comprehensive pharmaceutical country profiles. The information is categorized in 9 sections, namely: (1) Health and Demographic data, (2) Health Services, (3) Policy Issues, (4) Medicines Trade and Production (5) Medicines Regulation, (6) Medicines Financing, (7) Pharmaceutical procurement and distribution, (8) Selection and rational use, and (9) Household data/access. The indicators have been divided into two categories, namely "core" (most important) and "supplementary" (useful if available). This narrative profile is based on data derived from both the core and supplementary indicators. More recent information is included where relevant. For each piece of information, the year and source of the data are indicated; these have been used to build the references in the profile and are also indicated in the tables. If key national documents are available online, links have been provided to the source documents at the end of the document so that users can easily access them. The selection of indicators for the profiles has involved all technical units working in the Essential Medicines Department of the World Health Organization (WHO), as well as experts from WHO Regional and Country Offices, Harvard Medical School, Oswaldo Cruz Foundation (known as 1

6 Fiocruz), University of Utrecht, the Austrian Federal Institute for Health Care and representatives from 13 pilot countries. Data collection in all 193 member states has been conducted using a userfriendly electronic questionnaire that included a comprehensive instruction manual and glossary. Countries were requested not to conduct any additional surveys, but only to enter the results from previous surveys and to provide centrally available information. To facilitate the work of national counterparts, the questionnaires were pre-filled at WHO HQ using all publicly-available data and before being sent out to each country by the WHO Regional Office. A coordinator was nominated for each of the member states. The coordinator for Palau was Clarette Matlab. The completed questionnaires were then used to generate individual country profiles. In order to do this in a structured and efficient manner, a text template was developed. Experts from member states took part in the development of the profile and, once the final document was ready, an officer from the Ministry of Health certified the quality of the information and gave formal permission to publish the profile on the WHO website. This profile will be regularly updated by Pharmacy Department. Comments, suggestions or corrections may be sent to: Clarette Matlab PO. Box 6027 Ministry of Health Pharmacy Department Koror, Palau (96940) cmatlab@ymail.com 2

7 Section 1 - Health and Demographic Data This section gives an overview of the demographics and health status of Palau. 1.1 Demographics and Socioeconomic Indicators The total population of Palau in 2009 was 20,000 with an annual population growth rate of 0.8%. The annual Gross Domestic Product (GDP) growth rate was -2.1%. The GDP per capita was US$ 9, (CHIPS 2011). Of the total population, 31% was under 15 years of age and 7% over 60 years of age. The urban population currently stands at 82% of the total population. The fertility rate in Palau is 1.8 births per woman. 1.2 Mortality and Causes of Death The life expectancy at birth is 61 and 68 years for men and women respectively (2010). The infant mortality rate (i.e. children under one year) is 12.2 /1,000 live births. For children under the age of 5, the mortality rate is also 1.2 /1,000 live births (WHO Western Pacific Statistical Table 5. Health Status Indicators). Great progress is being made in improving maternal health in Palau, and one death was reported in 2009 and none in 2010 (CHIPS 2011). The top diseases causing mortality in Palau are [WHO Western Pacific CHIPS 2011, data 2010]: Disease 1 Cardio/Cerebrovascular Disease 2 Cancer 3 Respiratory Disease 4 Kidney Disease 5 Septicaemia 6 Injury 7 Liver Disease 8 Complications of Childbirth/pregnancy 3

8 The top 10 diseases causing morbidity i (inpatient care) in Palau are [WHO Western Pacific CHIPS 2011, data 2010] Disease 1 Disease of the respiratory system 2 Complications of pregnancy, childbirth and puerperium 3 Disease of the genitourinary system 4 Disease of the circulatory system 5 Disease of the digestive system 6 Endocrine & metabolic system 7 Injury and poisoning 8 rmal childbirth and delivery 9 Disease of the nervous system 10 Infectious and parasitic diseases The adult mortality rate for both sexes between 15 and 60 years is 172/1,000 population, while the neonatal mortality rate is 7/1,000 live births. The age-standardised mortality rate by non-communicable diseases is 587/100,000, 390/100,000 by cardiovascular diseases and 91/100,000 by cancer. The mortality rate for tuberculosis is 3.0/100,000 and in Palau there is no malaria. i Leading causes of morbidity for inpatient care 4

9 Further information: Like many developing nations, Palau has recently undergone an epidemiological shift from diseases of the developing world, such as malnutrition and communicable diseases, to an increasing burden of diseases of the developed world, like diabetes, heart disease, obesity and kidney failure. While tuberculosis remains a problem and the prevalence of leprosy has increased slightly, modern lifestyle- related diseases are at the top of the list of major causes of death. A Document "Declaration of the State of Health Emergency on n- Communicable Diseases in Palau" was developed by MOH in April 2011 to respond to this health crisis with an urgent "whole of society" approach. The document explains that between , there were 168 cases of cancers diagnosed in Palau, the number of people registered in the Diabetes Registry has gone from 710 to 801 and the number of with heart diseases, kidney impairment, high blood pressure have all increased. There are 36 patients currently on hemodialysis with more than 100 on the renal impairment list. The prevalence of obesity in our school aged children (33%) and adult (58%); the prevalence of tobacco (29.9% of high school students is highest in the region) and alcohol use among the youth is high and increasing. All of these risk factors culminate in a Palauan population that is at risk of suffering NCDs or NCD related disabilities in this lifetime. The leading causes of death in Palau are heart disease, cancer, stroke and injuries which are all NCDs. In May 2011, Office of the President, Republic of Palau, through an Executive Order.295 declared a State of Health Emergency on n- Communicable Diseases within the Ministry of Health and ordered the Minister of Health to immediately establish programs to stop, reduce and eliminate the incidences of NCDs. 5

10 Section 2 - Health Services This section provides information regarding health expenditures and human resources for health in Palau. The contribution of the public and private sector to overall health expenditure is shown and the specific information on pharmaceutical expenditure is also presented. Data on human resources for health and for the pharmaceutical sector is provided as well. 2.1 Health Expenditures In Palau, the total health expenditure (THE) in 2009 was US$ million. The THE was 9.30% of the GDP, equivalent to US$ per capita (Global Health Expenditure Database NHA Indicators Palau, WHO). The general government ii health expenditure (GGHE) in 2009, as reflected in the National Health Accounts (NHA) was US$ million. That is 76.42% of the total expenditure on health, with a total annual per capita public expenditure on health of US$ Private health expenditure covers the remaining 23.58% of the total health expenditure. The GGHE represents 14.26% of the total government budget. Social security expenditure makes up 0.00% of government expenditure on health. Private out-of-pocket expenditure as % of private health expenditure is 40.32%. Premiums for private prepaid health plans are 43.32% of total private health expenditure. 2.2 Health Personnel and Infrastructure The health workforce is described in Table 1 below. There is one (0.5 /10,000) licensed pharmacist who works in the public sector. There are eight (4.00/10,000) pharmacy technicians and assistants (in all sectors). There are approximately eight times as many pharmacy technicians as pharmacists. A pharmacy technician training program began in 2004 in ii According to the NHA definition, by "government expenditure" it is meant all expenditure from public sources, like central government, local government, public insurance funds and parastatal companies. 6

11 conjunction with the University of Hawai`i, Hilo and the University of Alaska, with eight participants in the first class. There are 19 (12 /10,000) physicians and 93 (59.00 /10,000) nursing and midwifery personnel in Palau. The ratio of doctors to pharmacists is 1/19 and the ratio of doctors to nurses and midwifery personnel is 1/5. Table 1: Human resources for health in Palau Human Resources Licensed pharmacists (all sectors) 1 (0.5/10,000) Pharmacists in the public sector 1 Pharmaceutical technicians and assistants (all 8 (4.00 /10,000) sectors) Physicians (all sectors) 19 (12/10,000) Nursing and midwifery personnel (all sectors) 93 (59.00 /10,000) [Western Pacific CHIPS, 2010; Global Health Atlas, 2006] In Palau, there is a strategic plan for pharmaceutical human resource development in place. The health facilities are described in Table 2 below. There is one hospital and 96 hospital beds in Palau. There are 4 primary health care units and centres and 2 licensed pharmacies both operated by a physician. Table 2: Health centre and hospital statistics Infrastructure Hospitals 1 Hospital beds 96 Primary health care units and centres 4 Licensed pharmacies 2 In the past five years, only one Palau pharmacist has graduated (2008) as a first degree. 7

12 Further information and key findings: Since enactment of the mandatory retirement law, there has been a rapid reduction in the number of health workers, due to retirement of ageing staff. This has resulted in a critical shortage of health workers, particularly among the nursing force and allied health personnel. In addition, more staff members are needed as a result of the expanded main health facility and completion of the super dispensaries, and training of more local health workers is needed to allow them to replace expensive expatriate staff. Vigorous efforts are under way between the Ministry of Health and the Ministry of Education to ensure that an increased number of high- school graduates can stream into health careers. A United States federal grant from the Department of Education to the Ministry of Education to develop a Health Academy in the only public high school, Palau High School will assist. The Ministry of Health is a key partner in the initiative. Marketing efforts to increase the number of high- school students choosing nursing, medicine and allied health professions as careers are under way through development of two marketing videos Careers in nursing and Careers in health for Palau, the region and the world. A nursing programme was established in the Palau Community College in 1998 and continues to produce a minimum of two graduates a year, but numbers are insufficient to meet staffing requirements. Bridging programmes in nursing and other allied health fields are currently in place in the Palau Community College and within the Ministry of Health. Since 2001, the Ministry of Health has been partnered with Palau Community College (PCC) to participate in the College s Palau Area Health Education Center (AHEC), which is funded through the United States Department of Health and Human Services/Health Resources and Services Administration. The only pharmacy training available is on line with University of Alaska for certificate of pharmacy technician. other training is available Recommendations: The Pharmacy Strategic Plan (see Section 3) addresses challenges described in this section. It is recommended that activities in the Plan be prioritised and undertaken as soon as feasible to: Increase the Human Resources base Upgrade training, qualifications and performance of pharmacy staff in all pharmacy areas Develop a relevant continuing education programme and a supportive career structure. 8

13 Section 3 - Policy Issues This section addresses the main characteristics of the pharmaceutical policy in Palau. The many components of a national pharmaceutical policy are taken from the WHO publication How to develop and implement a national drug policy ( Information about the capacity for manufacturing medicines and the legal provisions governing patents is also provided. 3.1 Policy Framework In Palau, a National Health Policy (NHP) exists and the Palau Public Health Strategic Plan, exists. There is a Strategic Plan Document, Bureau of Hospital and Clinical Services, in place. A National Medicines Policy was developed in 2010 but it is not officially endorsed by the Government. The National Medicines Policy document covers following areas as detailed in Table 3. Pharmacy Strategic Plan for is currently being developed. Table 3: The National Medicines Policy cover Aspect of policy Selection of essential medicines Medicines financing Medicines pricing Medicines Procurement Medicines Distribution Medicines Regulation Pharmacovigilance Rational use of medicines Human Resource Development Research Monitoring and evaluation Traditional Medicine Covered 9

14 A policy or group of policies relating to clinical laboratories does not exist. Access to essential medicines/technologies as part of the fulfillment of the right to health, is recognized in the national legislation. There are no official written guidelines on medicines donations. There is no national good governance policy in Palau. A policy to manage and sanction conflict of interest issues in pharmaceutical affairs is not in place. There is a formal code of conduct for public officials. A whistleblowing mechanism that allows individuals to raise concerns about wrongdoing occurring in the public sector of Palau exists; there is an office for ombudsman within the government. Recommendations: The revised Pharmacy Practice Act should be passed as soon as possible. It is recommended that the Palau National Medicines Policy (NMP) be launched, circulated widely and owned by all stakeholders. Launching of the NMP should be followed promptly by development and circulation of a Pharmacy Strategic Plan for implementing the Policy; and engaging relevant stakeholders. Activities should be prioritised in collaboration with relevant colleagues. The timely implementation of activities in the Strategic Plan will fulfill the objectives of the Palau National Medicines Policy in all areas mentioned in Table 3, and will strengthen the pharmaceutical sector (public and private). Donation Guidelines should be prepared. 10

15 Section 4 - Medicines Trade and Production 4.1 Intellectual Property Laws and Medicines Palau is not a member of the World Trade Organization. Legal provisions granting patents that cover pharmaceuticals, laboratory supplies, medical supplies or medical equipment do not exist. National Legislation has not been modified to implement the WTO s Trade- Related Aspects of Intellectual Property Rights (TRIPS)Agreement and current laws do not contain TRIPS-specific flexibilities and safeguards. Palau is not eligible for the transitional period to There are no legal provisions for data exclusivity for pharmaceuticals, patent term extension or linkage between patent status and marketing authorization. Palau is not engaged in capacity-strengthening initiatives to manage and apply Intellectual Property Rights in order to contribute to innovation and promote public health. 4.2 Manufacturing There are no licensed pharmaceutical manufacturers in Palau. Manufacturing capabilities are presented in Table 4 below. Table 4: Palau manufacturing capabilities Manufacturing capabilities Research and Development for discovering new active substances Production of pharmaceutical starting materials (APIs) The production of formulations from pharmaceutical starting material The repackaging of finished dosage forms 11

16 Recommendations: Legislation relating to any aspects of trade and production should be reviewed and updated to match the objectives of the National Medicines Policy and to ensure a legal base for trade and production of pharmaceuticals. It is recommended that Trade- Related Aspects of Intellectual Property Rights (TRIPS) compliant, health sensitive Laws be developed to enable access to affordable medicines that are needed to address the health problems of Palau. The Government should take advantage of all the flexibilities and safeguards within the TRIPS Agreement for the promotion of public health and ensuring access to pharmaceuticals. The implications of international trade and other treaties should be studied so as to safeguard the national interest concerning public health and ensure access to pharmaceuticals. In particular, any potential Free Trade Agreement will be examined in detail to ensure that flexibilities available under the TRIPS agreement are not affected. The Ministry of Health should collaborate with the other relevant Ministries concerned with trade and foreign affairs, and other relevant agencies in the area of Intellectual Property Rights in developing a legal framework that enhances access to essential medicines including grant of compulsory licensing and parallel importation and Government Use. Public health and access to pharmaceuticals must remain in the forefront while undertaking and signing any bilateral or international treaties or agreements. 12

17 Section 5 - Medicines Regulation This section details the pharmaceutical regulatory framework, resources, governing institutions and practices in Palau. 5.1 Regulatory Framework In Palau, legal provisions establishing the powers and responsibilities of a Medicines Regulatory Authority (MRA) don t exist and currently there is no MRA. 5.2 Marketing Authorization (Registration) In Palau, legal provisions do not require marketing authorization (registration) for all pharmaceutical products on the market. There are no legal provisions requiring an MRA to make the list of pharmaceutical products publicly available and update it regularly. 5.3 Regulatory Inspection In Palau, legal provisions permitting inspectors to inspect premises where pharmaceutical activities are performed exist. Such inspections are required by law, but are not a pre-requisite for the licensing of public and private facilities. Inspection requirements are not the same for public and private facilities. Inspections are carried out on a number of entities, outlined in Table 5. Table 5: Local entities inspected for GMP compliance Entity Local manufacturers Private wholesalers Retail distributors Public pharmacies and stores Pharmacies and dispensing points of health facilities Inspection Public facilities are inspected quarterly; private facilities are inspected when there is a need and availability of personnel. 13

18 5.4 Import Control Legal provisions requiring authorization to import medicines exist. Laws that allow the sampling of imported products for testing do not exist. Legal provisions requiring importation of medicines through authorized ports of entry do exist. Regulations or laws exist to allow for inspection of imported pharmaceutical products at authorized ports of entry. The legal provisions are with the Ministry of Commerce and Trade. 5.5 Licensing In Palau, legal provisions requiring manufacturers to be licensed do not exist. Legal provisions requiring manufacturers (both domestic and international) to comply with Good Manufacturing Practices (GMP) do not exist. Good Manufacturing Practices are not published by the government. However, currently there are no manufacturers. Legal provisions requiring importers, wholesalers and distributors to be licensed exist. Legal provisions requiring wholesalers and distributors to comply with Good Distribution Practices (GDP) do not exist but there is provision in the National Medicines Policy to cover GDP. Table 6: Legal provisions pertaining to licensing Entity requiring licensing Importers Wholesalers Distributors Legal provisions requiring pharmacists to be registered exist. Legal provisions requiring private pharmacies to be licensed exist. National Good Pharmacy Practice Guidelines are not published by the government. By law, a list of all licensed pharmaceutical facilities is not required to be published. 14

19 5.6 Market Control and Quality Control In Palau, legal provisions do not exist for controlling the pharmaceutical market. A Medicines Quality Control Laboratory does not exist in Palau. The government does not contract services elsewhere but ad hoc tests are done in Australia. Medicines are tested for a number of reasons, summarised in Table 7. Table 7: Reason for medicines testing Medicines tested: For quality monitoring in the public sector iii For quality monitoring in the private sector iv When there are complaints or problem reports For product registration For public procurement prequalification For public program products prior to acceptance and/or distribution Samples are not collected by government inspectors for undertaking postmarketing surveillance testing. 5.7 Medicines Advertising and Promotion In Palau, legal provisions to control the promotion and/or advertising of prescription medicines do not exist. Legal provisions prohibit direct advertising of prescription medicines to the public and pre-approval for medicines advertisements and promotional materials is not required. Guidelines and Regulations for advertising and promotion of nonprescription medicines do not exist. There is no national code of conduct concerning advertising and promotion of medicines by marketing authorization holders. iii Routine sampling in pharmacy stores and health facilities iv Routine sampling in retail outlets 15

20 5.8 Clinical Trials In Palau, legal provisions requiring authorization for conducting Clinical Trials do exist. There are no laws requiring the agreement by an Institutional Review Board (IRB) of the Clinical Trials to be performed. Clinical trials are not required to be entered into an international/national/regional registry, by law. Legal provisions for GMP compliance of investigational products do not exist. Sponsor investigators are not legally required to comply with Good Clinical Practices (GCP). National GCP regulations are not published by the Government. There are no legal provisions permitting the inspection of facilities where clinical trials are performed. 5.9 Controlled Medicines v Palau is a signatory to a number of international conventions, detailed in Table 8. Table 8: International Conventions to which Palau is a signatory Convention Single Convention on Narcotic Drugs, Protocol amending the Single Convention on Narcotic Drugs, 1961 Convention on Psychotropic Substances 1971 United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 Signatory Figures regarding the annual consumption of certain controlled substances in the country are outlined in Table 8S below. v Laws for the control of narcotic and psychotropic substances and precursors exist [The Palau National Code, title 34, Division 4, Chapter 30, contains the "Controlled Substances Act" which controls narcotic and psychotropic medicines and illicit drugs]. 16

21 Table 8S: Annual consumption of selected controlled substances in Palau Annual Controlled substance consumption (mg/capita) Morphine Fentanyl Pethidine Methadone Pharmacovigilance In Palau, there are no legal provisions in the medicines act that provide for pharmacovigilance activities as part of an MRA mandate. Legal provisions requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA do not exist. Laws regarding the monitoring of Adverse Drug Reactions (ADRs) do not exist in Palau. The Pharmacy, Drugs and Therapeutic Committee is able to provide technical assistance or causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication in Palau. However, a clear communication strategy for routine communication and crises communication does not exist. ADRs are monitored in at least one public health program (e.g. tuberculosis, HIV programmes). There are no training courses in pharmacovigilance. Medication errors are reported to a quality assurance committee of the MOH but no real follow up is done. A number of steps are being considered in order to enhance the pharmacovigilance system. These include a strengthened role for the Pharmacy, Drugs and Therapeutic Committee, and development and promulgation of standard treatment guidelines for antibiotics. 17

22 Further information and key findings: The current legislation pertaining to medicines is contained in the Palau National Code, Title 34, Public Health, Safety and Welfare. 102, Promulgation of health regulations states: "The Director (Bureau of Health Services) shall, subject to the approval of the President, have powers to make such regulations as he deems necessary for the public health and safety respecting: "(q) foods, drugs and cosmetics, and the manufacture, compounding, processing, extracting, preparing, storing, selling and offering for sale or for consumption or use of any food, drug or cosmetic;". The following draft legislation has been prepared: - A Bill for an Act regarding the control of importation, manufacture, sale, distribution, and safe use of prescription and nonprescription drugs - Pharmacy Practice Act which empowers the Pharmacy Department to confiscate prescription medicines from stores but they have to be accompanied by the environmental health department. The Customs Department and the Ministry of Health has established a Memorandum of Understanding (MoU) on control of medicines brought into the country by passengers/tourists. Medicines confiscated by the Customs Department are brought to the hospital for further inspection by the Chief Pharmacist who decides if the person bringing in medicines will be allowed to retain them. Antibiotic Guidelines were prepared in Recommendations: New legislation (including the Pharmacy Practice (Bill) Act) regarding the control of importation, manufacture, sale, distribution, and safe use of prescription and nonprescription drugs should be reviewed to ensure support of the National Medicines Policy objectives and enacted as soon as possible. Implementation of the National Medicines Policy will address issues in this section. Regulations dealing with the licensing and regulation of importation, exportation, manufacture, sale, supply, storage, advertising and promotion of medicines should be developed and enforced. Products together with institutions and individuals handling them should be regulated through a registration/ licensing/authorisation process. Quality of processes and products should be ensured. Pharmacovigilance capacity should be developed along with a sound mechanism for recognizing, reporting and following up adverse medicines events. A clear communication strategy for routine communication and crises communication should be established. A strengthened role for the Pharmacy, Drugs and Therapeutic Committee should be developed, along with promulgation of the Antibiotic Guidelines. 18

23 Section 6 - Medicines Financing In this section, information is provided on the medicines financing mechanism in Palau, including the medicines coverage through public and private health insurance, use of user charges for medicines and the existence of public programmes providing free medicines. Policies and regulations affecting the pricing and availability of medicines (e.g. price control and taxes) are also discussed. 6.1 Medicines Coverage and Exemptions In Palau, there are no concessions made for certain groups to receive medicines free of charge (see Table 9). However, the public health system provides medicines free of charge for particular conditions (see Table 10). Table 9: Population groups provided with medicines free of charge Patient group Covered Patients who cannot afford them Children under 5 Pregnant women Elderly persons Medicines and services for these conditions are free of charge. TB, HIV, STI, leprosy Diseases covered by the Expanded Program on Immunization (EPI) Table 10: Medications provided publicly, at no cost Conditions Covered All diseases in the EML Any non-communicable diseases Malaria Tuberculosis Sexually transmitted diseases HIV- related disease Expanded Program on Immunization (EPI) vaccines for children 19

24 6.2 Patients Fees and Co-payments Co-payments or fee requirements for consultations are levied at the point of delivery. Furthermore, there are co-payments or fee requirements imposed for medicines as described in this section. The funds generated enter a Hospital Trust Fund as a supplement for purchase of pharmaceuticals and medical suppliers. The amount in the trust fund needed to purchase pharmaceuticals and medical supplies is made appropriate by the legislature every fiscal year. This is a complement to the US$ thousand appropriated every fiscal year from the local funds. 6.3 Pricing Regulation for the Private Sector vi In Palau, there are no legal or regulatory provisions affecting pricing of medicines. The government does not run an active national medicines price monitoring system for retail prices. Regulations mandating that retail medicine price information should be publicly accessible do not exist. 6.4 Prices, Availability and Affordability of Key Medicines A WHO/HAI pricing survey has not been conducted in Palau. Palau participates in the Price Information Exchange for Selected Medicines in the Western Pacific Region ( 6.5 Price Components and Affordability National Health Insurance and subsidies ensure affordability. National Health Insurance has two parts: 1. For Outpatient care it is called MSA (Medical Savings Account) 1.25% of the 2.5% premium we put in every two weeks. 2. The other 1.25% is for inpatient care. Individuals put in 2.5% and government cover for the other 2.5%. vi This section does not include information pertaining to the non-profit voluntary sector 20

25 There is subsidised coverage for medicines that are on the Essential Medicines List (EML) for inpatients and outpatients. All costs for inpatients and outpatients are subsidised and the patients are required to provide at least partial coverage for medicines that are on the EML - a flat rate of US$ 6.00 per a prescribed medicine. However, the national medicines insurance scheme (Medicines Savings Account MSA) allows the government to subsidise medicines so that patients do not pay the full cost of medicines and private health insurance schemes complement the MSA. Patients MSA is used to pay the $6.00 cost meaning they do not pay for anything unless they have used up their MSA, then they pay $6.00 out of pocket. Private health insurance is also available but not mandatory like the NHI. The medicines covered by these insurance schemes are those on the Essential Medicines List. 6.6 Duties and Taxes on Pharmaceuticals (Market) Palau does not impose duties on imported active pharmaceutical ingredients (APIs) or finished products. Value-added tax or other taxes are not imposed on finished pharmaceutical products. Provisions for tax exceptions or waivers for pharmaceuticals and health products are in place. 21

26 Further information and key findings: Draft health care reform legislation was developed with Technical Assistance (TA) from the Asian Development Bank (ADB) and submitted to Congress in July A National Medical Savings Fund would be established to receive mandatory contributions by the employed, employers, and the self- employed. Fund contributions would be invested, but would also finance the Palau Health Insurance (PHI) for catastrophic costs, individual medical savings accounts (MSAs) for outpatient care, and administration costs. The government would fund PHI costs for the nonworking elderly and nonworking disabled. PHI benefits would include inpatient care at Belau National Hospital and approved off- island care including associated medical evacuation. The Social Security Administration would be responsible for day- to- day operation of the Fund and PHI under the oversight of a newly established National Healthcare Financing Governing Committee. The legislation was enacted by Congress in January 2010 and signed by the President in May The Rules and Regulations were finalized and published in September 2010 and adopted in February The reform legislation partly addressed Palau s health care financing problems. The legislation likewise provided scope for widening private sector participation in some aspects of the system. Although Ministry of Health (MOH) policies support heavily subsidized medicine and medical supplies, it was expected that MOH would adjust the fees upward or downward to correct for divergence. The TA team recommended that MOH reconsider its policy of heavily subsidizing medicines and supplies, and allow the charges for these items to reflect their actual costs, this of course being prior to applying the sliding fee scale to these items as it does to services. vii vii Source: Asian Development Bank 22

27 Section 7 - Pharmaceutical Procurement and Distribution in the Public Sector This section provides a short overview on the procurement and distribution of pharmaceuticals in the public sector of Palau. 7.1 Public Sector Procurement Public sector procurement of medicines in Palau is centralized under the responsibility of the Pharmacy Department, National Belau Hospital. There is a written public sector procurement policy. This policy was approved in Legal provisions that give priority to locally produced goods in public procurement do not exist. The key functions of the procurement unit and those of the tender committee are not separated. Tender specifications to ensure the quality of products that are publicly procured exist (see box: Further Information). A list of pre-qualified suppliers and products is not available. The tender methods employed in public sector procurement include national competitive tenders, international competitive tenders and direct purchasing. 7.2 Public Sector Distribution The government supply system department in Palau has a Central Medical Store (CMS) at National Level. It is a Pharmacy Department. There are no national guidelines on Good Distribution Practices (GDP). A licensing authority that issues GDP licenses does not exist. However GDP is covered in the National Medicines Policy. A list does not exist of GDP certified warehouses in the public sector. A number of processes are in place at the CMS as detailed in Table

28 Table 11: Processes in place at the Central Medical Store Process Forecasting of order quantities Requisition/Stock orders Preparation of picking/packing slips Reports of stock on hand Reports of outstanding order lines Expiry dates management Batch tracking Reports of products out of stock The percentage availability of key medicines at the CMS is 100%. The average stock-out duration at the CMS is 2-3 days. Routine procedures to track the expiry dates of medicines at the CMS exist. The Public CMS is not GDP certified by a licensing authority or ISO certified. 7.3 Private Sector Distribution Legal provisions for licensing wholesalers or distributors in the private sector do not exist. A list does not exist of GDP certified wholesalers or distributors in the private sector. 24

29 Further information and key findings: The Hospital Pharmacy conducts annual international tenders seeking bids for 350 items covering the needs of the country. Initially an invitation for Expression of Interest is made public. Interested parties must be prequalified if they are not previous suppliers. The tender specifications include generic name, quality standards (United States Pharmacopoeia (USP), British Pharmacopoeia (BP), International Pharmacopoeia (IP). Product certificates according to the WHO Certification Scheme on Pharmaceutical Products moving in International Commerce, must be submitted for each product to document that the products are approved for sale in the country of origin as well as conform to GMP and are regularly inspected. Forecasting is based on past consumption. Recommendations: The public sector procurement policy 2006 should be reviewed in the light of the Pharmacy Strategic Plan for implementation of the National Medicines Policy that addresses issues described in this section. It is recommended that necessary activities in the Plan concerned with the warehouse environment and procurement be prioritised and undertaken as soon as feasible to: Increase the Human Resources base as needed Upgrade training, qualifications and performance of pharmacy staff involved in procurement and supply management as needed Develop a relevant continuing education programme and a supportive career structure to sustain staff Develop SOPs to facilitate the work associated with procurement and supply management including Good Distribution Practices. 25

30 Section 8 - Selection and rational use of medicines This section outlines the structures and policies governing the selection of essential medicines and promotion of rational drug use in Palau. 8.1 National Structures A National Essential Medicines List (EML) exists. The EML was lastly updated in 2009 and is publicly available. There are currently 350 medicines on the EML. Selection of medicines for the EML is the responsibility of the Drugs, Pharmacy and Therapeutic committee and it is undertaken through a written process. A mechanism aligning the EML with the Standard Treatment Guidelines is in place. The Antibiotic Standard Treatment Guidelines was endorsed by the Minister of Health in February 2012 which promotes the quality use of antibiotics by aiming to standardize and contain the ever rising microbial resistance and cost of treatment. Of the public health facilities, 100% have a copy of the EML. There is no public or independently funded national medicines information centre providing information on medicines to prescribers, dispensers and consumers. Public education campaigns on rational medicine use topics have not been conducted in the last two years. A survey on rational use of medicines has not been conducted in the previous two years. There is no national programme or committee, involving government, civil society and professional bodies, to monitor and promote rational use of medicines. A written National Strategy for Containing Antimicrobial Resistance does not exist. Palau s EML does include formulations specifically for children. Criteria for the selection of medicines in the EML are not explicitly documented. A 26

31 formal committee (Drugs, Pharmacy and Therapeutic Committee) for the selection of medicines on the EML exists. A national medicines formulary (Belau National Hospital Formulary) exists and was last updated in A funded national inter-sectoral task force to coordinate the promotion of the appropriate use of antimicrobials and prevention of the spread of infection does not exist. A national reference laboratory or other institution does not have responsibility for coordinating epidemiological surveillance of antimicrobial resistance. 8.2 Prescribing Legal provisions to govern the licensing and prescribing practices of prescribers exist. Furthermore, legal provisions restricting dispensing by prescribers exist. However, prescribers in the private sector dispense medicines. There are regulations requiring to organize or develop Drug and Therapeutics Committees (DTCs) at the national level. The training curriculum for doctors and nurses is made up of a number of core components detailed in Table 12. Table 12: Core aspects of the medical training curriculum Curriculum The concept of EML Use of STGs Pharmacovigilance Covered viii Mandatory continuing education that includes pharmaceutical issues is required for doctors and paramedical staff. viii Use of STGs will be included in revised curriculum 27

32 Prescribing by INN is obligatory in the public sector. Of the medicines prescribed in the outpatient public health care facilities, 100% are on the national EML. Of prescribed drugs, 100% are dispensed to patients. Of medicines in public health facilities, 100% are adequately labelled. Table 13: Characteristics of medicines prescribing Prescribing aspect % % of medicines prescribed in outpatient public health care facilities that are in the national EML (mean) 100 % of medicines in outpatient public health care facilities that are prescribed by INN (mean) % of patients in outpatient public health care facilities receiving antibiotics (mean) % of patients in outpatient public health care facilities receiving injections (mean) NA NA NA % of prescribed drugs dispensed to patients (mean) 100 % of medicines adequately labelled in public health facilities (mean) 100 A professional association code of conduct which governs the professional behaviour of doctors exists. Similarly, a professional association code of conduct governing the professional behaviour of nurses exists. 8.3 Dispensing Legal provisions to govern dispensing practices of pharmaceutical personnel exist in Palau. The basic pharmacist training curriculum includes a spectrum of components as outlined in Table 14. Table 14: Core aspects of the pharmacist training curriculum Curriculum The concept of EML Use of STGs Drug information Clinical pharmacology Medicines supply management Covered ix ix Use of STGs will be included in revised curriculum 28

33 Mandatory continuing education that includes rational use of medicines is required for pharmacists. Substitution of generic equivalents at the point of dispensing is allowed in public and private sector facilities. Sometimes, antibiotics are sold over-the-counter without a prescription. A professional association code of conduct which governs the professional behaviour of pharmacists exists. In practice, paramedics do sometimes prescribe prescription-only medicines at the primary care level in the public sector (even though this may be contrary to regulations). Nurses, pharmacists and personnel with less than one month of training do not. Prescriptions from the public health facilities are reviewed at the end of the week to check that they comply with prescribing provisions for the facility level, the prescribers level and any specific guidelines. Recommendations: The Pharmacy Strategic Plan addresses challenges described in this section. It is recommended that activities in the Plan be prioritised and undertaken as soon as feasible to: Increase the Human Resources base Upgrade training, qualifications and performance of pharmacy staff concerning rational use of medicines, the role of STGs and pharmacovigilance Develop STGs in other priority areas such as management of NCDs Develop SOPs to support rational use of medicines and prescribing, dispensing and appropriate communication with patients Develop a relevant continuing education programme and a supportive career structure 29

34 Section 9 - Household data/access In the past 5 years, no household surveys have been undertaken to assess the access to medicines. 30

35 List of key reference documents: Abbott F. WTO TRIPS Agreement and Its Implications for Access to Medicines in Developing Countries. Commission on Intellectual Property Rights - Study Paper IPR Commission. Available online Antibiotic Treatment Guidelines, 2012 Belau National Hospital Drug Formulary, 2006 Declaration of the State of Health Emergency on n-communicable Diseases in Palau, Available online Executive Order.217, Office of the President, Republic of Palau- Adopting Comprehensive Property Management Policies and Procedures Executive Order.295, Office of the President, Republic of Palau Global Health Expenditure Database NHA Indicators Palau, World Health Organization. Available online: Government of the Republic of Palau National Health Care Financing Act. Senate Bill. 8-48, SD1, Eighth Olbiil Era Kelulau, First Special Session, March. Koror. Hennicot, Jean-Claude Actuarial Assessment of Proposed Health Financing Schemes: Republic of Palau. Consultant s report. Manila (TA7079 PAL). International Narcotics Control Board (INCB), Available online: Ministry of Health, 2011, Palau. Available at: Palau National Medicines Policy Available from the Pharmacy Department. National Health Workforce Plan, Republic of Palau, Available from Ministry of Health. National Medicines Policy, Republic of Palau (Drafted in 2010) Palau Essential Medicines List, 2009 Palau Health Professionals Licensing Act (part of the Palau National Code, Title 34) Palau National Code, Title 34, Public Health, Safety and Welfare. Division 4, Chapter Palau Public Health Strategic Plan, Pharmacy Department, Belau National Hospital, Belau National Hospital Drug Formulary 2006, [pdf] Ministry of Health, Republic of Palau. Available online: Pharmacy monthly reports, Palau. Available from Pharmacy Pharmacy Practice (Bill) Act 2012 Pharmacy Strategic Plan Available from the Pharmacy Department. 31

36 Property management policies and procedures executive order.217 Public sector procurement policy Available from the Pharmacy Strategic Plan , Bureau of Hospital and Clinical Services Sustainable Health Care Financing in the Republic of Palau. Asian Development Bank. Available online: Technical assistance report Palau development of a sustainable health financing scheme (financed by the Japan Special Fund) Western Pacific CHIPS 2011, data Source- Public Health Data and Statistics, Epidemiology, Bureau of Public Health, Ministry of Health, Palau, WHO Western Pacific Statistical Table 5. Health Status Indicators World Bank. Available online: World Health Organization (WHO), World Health Statistics 2009, Geneva: WHO Press. Available online: World Health Organization (WHO), Western Pacific Country Health Information Profiles (CHIPS), 2010 Revision. Geneva: WHO Press. Available online: World Health Organization (WHO), World Health Statistics 2010, Geneva: WHO Press. Available online: World Trade Organization. Members and Observers. Available at: 32