ARMENIA PHARMACEUTICAL COUNTRY PROFILE

Transcription

1 ARMENIA PHARMACEUTICAL COUNTRY PROFILE i

2 ii

3 Foreword This 2010 Pharmaceutical Country Profile for Armenia has been produced by the Ministry of Health with support of the World Health Organization. This document contains information on structures, process and outcomes of the pharmaceutical sector in Armenia. Some of the data comes from global sources (e.g. the World Health Statistics) or from surveys conducted in the previous years, while other pieces of information have been collected at country level in The sources of data for each piece of information are presented in the tables that can be found at the end of this document. On the behalf of the Ministry of Health of the Republic of Armenia, I wish to express my appreciation towards Dr Lilit Ghazaryan from the Scientific Center of Drug and Medical Technology Expertise for her contribution to the data collection and to the development of this profile. It is my hope that partners, researchers and all those that are interested in the pharmaceutical sector of Armenia will find this profile a useful tool in their activities. Name: Tatul Hakobyan Function in the Ministry of Health: Deputy Ministry of Health on International Affairs and Human Resources Date: 13 August 2010 Signature iii

4 Table of content Foreword... iii Table of content... iv Introduction... v Section 1 - Health and Demographic Data... 1 Section 2 - Health Services... 3 Section 3 - Policy Issues... 7 Section 4 - Regulation...10 Section 5 - Medicines Financing...14 Section 6 - Pharmaceutical procurement and distribution in the public sector...17 Section 7 - Selection and rational use of medicines...17 Section 7 - Selection and rational use of medicines...18 Section 8 - Household data/access...20 References...21 ANNEX...26 Section 1 Health and Demographic data...28 Section 2 Health Services...31 Section 3 Policy issues...34 Section 4 Regulation...37 Section 5 Medicines Financing...44 Section 6 Pharm.procurement and distribution...48 Section 7 Selection and rational use...51 Section 8 Household data/access...55 iv

5 Introduction This Pharmaceutical Country Profile provides data on structures, processes and outcomes of the pharmaceutical sector of Armenia. The aim is to put together existing information and to make all relevant information on the pharmaceuticals sector available to the public in a user-friendly format. In 2010, country profiles similar to this one have been developed for 13 pilot countries. During 2011, the World Health Organization plans to support all WHO Member States to develop similar country profiles. The information is categorized in 8 sections, namely: (1) Health and Demographic data, (2) Health Services, (3) Policy Issues, (4) Regulation, (5) Medicines Financing, (6) Supply of Pharmaceuticals, (7) Rational Use of Medicines, and (8) Household Surveys. The indicators have been divided into two categories, namely "core" (most important) and "supplementary" (useful if available). The narrative profile is based only on the core indicators; while the tables in the annexes present all indicators. For each piece of information, we have tried to indicate the year and source of the data; these are used to build the references in the profile and are also indicated in the tables. If key national documents are available on-line, links are provided to the source documents so that the user can easily access these documents The selection of indicators for the profiles has involved all technical units working in the Essential Medicines Department of the World Health Organization as well as experts from WHO Regional and Country Offices, Harvard Medical School, Oswaldo Cruz Foundation (known as Fiocruz), University of Utrecht, the Austrian Federal Institute for Health Care and representatives from 13 pilot countries. Data collection in the pilot countries was conducted using a user-friendly electronic questionnaire that included a comprehensive glossary. Countries were requested not to conduct any v

6 additional surveys, but only to enter the results from previous surveys and to provide information available at the central level. To facilitate the work of national counterparts, the questionnaires were pre-filled using all data available at WHO HQ before being sent out to countries. A coordinator was nominated for each of the 13 pilot countries. The coordinator for Armenia was Dr Lilit Ghazaryan. The completed questionnaires were then used to produce the country profiles. In order to do this in a structured and efficient manner, a text template was developed. Member states took part in the development of the profile and, once the final product 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 web site of WHO. This profile will be regularly updated by country teams. If you have any suggestions on corrections to make please send them to Dr Lilit Ghazaryan, lili@pharm.am, Scientific Center of Drug and Medical Technology Expertise, N 1-15 Moskoyyan Str, Yeravan. vi

7 Section 1 - Health and Demographic Data This section gives an overview of the demographics and health status of Armenia. 1.1 Demographics and Socioeconomic Indicators The total population of Armenia in 2008 was 3,238,000 with an annual population growth rate of 0.2%. The annual GDP growth rate is 6.8%. The GNI per capita is US$ 3,350 [1] [2]. 1.2 Mortality and Causes of Death The life expectancy at birth for men is 66 years and for women is 73 years. The infant mortality rate is 22/1,000 live births. For children under the age of 5, the mortality rate is 24/1,000 live births. The maternal mortality rate is 76/100,000 live births [3]. The top 10 diseases causing mortality in Armenia are: 1. Diseases of the circulatory system (cardiovascular) 2. Neoplasm s 3. Diseases of respiratory system 4. Diseases of the digestive system 5. Endocrine system diseases, digestive disturbance, disturbance of metabolism and immunity 6. Accidents, poisonings, injuries 7. Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified 8. Diseases of the genitourinary system 9. Certain infections and parasitic diseases 10. Certain conditions originating in the perinatal period 1

8 The top 10 diseases causing morbidity in Armenia are: 1. Diseases of respiratory system 2. Diseases of the circulatory system (cardiovascular) 3. Diseases of the digestive system 4. Diseases of the genitourinary system 5. Diseases of the eye and adnexa 6. Endocrine system diseases, digestive disturbance, disturbance of metabolism and immunity 7. Mental and behavioral disorders 8. Certain infections and parasitic diseases 9. Diseases of nervous system 10. Injury, poisoning and certain other consequences of external causes [4]. 2

9 Section 2 - Health Services This section provides information regarding health expenditure and human resources in Armenia. 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 Armenia, the total annual expenditure on health (THE) in 2008 was AMD 136,919 million (Dram) (US$ 435 million). The total health expenditure is 3.8 % of the GDP. The total annual expenditure on health per capita was AMD 45,609 (US$ 145). The government annual expenditure 1 on health accounts for 43.7 % of the total expenditure on health, with a total per capita public expenditure on health of AMD 19,940 (US$ 64). The government annual expenditure on health represents 7.6% of the total government budget. The private health expenditure covers the remaining 56.3% of the total health expenditure. The whole population (100 %) has access to primary health care centres, but payments have to be made at the point of delivery. The total pharmaceutical expenditure (TPE) in Armenia in 2008 was AMD 23,103 million (US$ 75.5 million). The total pharmaceutical expenditure per capita was AMD 7,030 (US$ 23). The pharmaceutical expenditure accounts for 0.63 % of the GDP and makes up % of the total health expenditure (figure 1). 1 By government expenditure it is meant all expenditure from public sources, like central government, local government, insurance funds and parastatal companies. This follows the definition provided by WHO National Health Accounts. 3

10 Public expenditure on pharmaceuticals represents % of the total expenditure on pharmaceuticals (figure 2). The total public expenditure on pharmaceuticals per capita was AMD 1,372 (US$ 4.5). FIGURE 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health Expenditure in Armenia in % TPE Other Source: NHA, % FIGURE 2: Share of public and private sector to Total Pharmaceutical Expenditure in Armenia in % Public sector Private sector Source: NHA, % 4

11 The total private expenditure on pharmaceuticals is AMD 18,986 million (US$ 62). The market share of generic pharmaceuticals [branded and INN] by value is unknown, but 80% of the registered medicinal products are generics. The annual growth rate of the market is equally unknown, but the annual growth rate of imported medicines value is 28.3% [5]. 2.2 Health Personnel The health workforce is described in the table below and in figure 3. Licensed pharmacists (all sectors) /10,000 [6] Pharmacists in the public sector /10,000 [4] Pharmaceutical technicians and assistants (all Unknown sectors) Physicians (all sectors) 36.7/10,000 Nursing and midwifery personnel (all sectors) 48.8/10,000 [3] Figure 3: The density of the Health Workforce in Armenia Nursing and midwifery personnel Physicians Pharmacists / 10,000 population 2 No data is available at country level on the total number of pharmacists in the country. It is possible that the density of pharmacists is higher than the one reported here and calculated using data from the Global Health Atlas. This is because there are 1,560 licensed pharmacies and outlets in the country and the total number of pharmacists who graduated from is 962 and therefore the total number of pharmacists may be higher than the 163 reported in the Global Health Atlas. 5

12 In Armenia, there is a strategic plan for pharmaceutical human resource development in place [7] [8]. 2.3 Health Infrastructure The health centre and hospital statistics are described in the table below. Hospitals 0.4/10,000 [4] Hospital beds 43/10,000 [3] Primary health care units and centres 1.46/10,000 [4] Licensed pharmacies 4.82/10,000 [9] 6

13 Section 3 - Policy Issues This section addresses the main structure of the pharmaceutical policy in Armenia. Information about the capacity for manufacturing medicines and regulations regarding patents is also provided. 3.1 Policy Framework In Armenia, a National Health Policy (NHP) exists. It was updated in An official National Medicines Policy document exists in Armenia. It was updated in 2006 [10]. In fact the NMP is part of the NHP. Issues related to pharmaceuticals are also addressed in the "National Security Strategy of the Republic of Armenia". The NMP and group of policies cover: Selection of essential medicines Medicines financing Medicines pricing Procurement Distribution Regulation Pharmacovigilance, Rational use of medicines Human resource development Research Monitoring and evaluation Traditional Medicine [10] [11] 7

14 A NMP implementation plan does not exist [10]. Access to essential medicines/technologies as part of the fulfillment of the right to health, is recognized in the national legislation, "Law on Medicines of Republic of Armenia" [12]. There are official written guidelines on medicines donations [10]. The pharmaceutical policy implementation is not being regularly monitored/assessed. There is national good governance policy in Armenia. It is multisectoral. The Civil Service Council is responsible for it [13]. There is no policy in place to manage and sanction conflict of interest issues in pharmaceutical affairs. There is no a formal code of conduct for public officials. According to the Law on Human Rights defender, there is a whistle-blowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of Armenia [14] [15]. 3.2 Intellectual Property Laws and Medicines Armenia is a member of the World Trade Organization. The country has a patent law and the national Legislation has been modified to implement the TRIPS Agreement. Armenia is eligible for the transitional period to Current laws contain (TRIPS) flexibilities and safeguards. The following (TRIPS) flexibilities and safeguards are present in the national law: Compulsory licensing provisions that can be applied for reasons of public health Bolar exceptions Parallel importing provisions [10] 8

15 The country is engaged in initiatives to strengthen capacity to manage and apply intellectual property rights to contribute to innovation and promote public health [16]. There are no legal provisions for data exclusivity for pharmaceuticals. Legal provisions exist for patent extension [17]. There are no laws for linkage between patent status and marketing authorization. 3.3 Manufacturing There are 14 licensed pharmaceutical manufacturers in Armenia [9]. Armenia has the capacity for: The Research and Development for discovering new active substances The production of pharmaceutical starting materials (APIs) The production of formulations from pharmaceutical starting material The repackaging of finished dosage form [10]. The percentage of market share by value of pharmaceuticals produced by domestic manufacturers is 8 % [18]. 9

16 Section 4 - Regulation This section covers a broad range of pharmaceutical regulatory policy, institutions and practices in Armenia 4.1 Regulatory Framework In Armenia, there are legal provisions establishing the powers and responsibilities of the Medicines Regulatory Authority (MRA). The MRA is a scientific centre of drug and medical technology expertise under the Ministry of Health. The MRA has its own website and the URL address is The MRA is involved in harmonization/collaboration initiatives with the WHO, CIS (Commonwealth of Independent States, formerly the URSS) and EDQM (European Directorate for the Quality of Medicines and Health Care). An assessment of the medicines regulatory system has been conducted in the last five year [10]. 4.2 Marketing Authorization In Armenia, there are legal provisions requiring a marketing authorization (registration) for all pharmaceutical products on the market [10]. Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products [19] [20]. In 2007, the number of pharmaceutical products registered in Armenia was 3,900 [10]. Legal provisions require the MRA to make the list of registered pharmaceutical products publicly available regularly [19] and this register is updated every month. The updated list is available on the web [21]. Medicines are registered by their INN (International Non-proprietary Names) or Brand name + INN [10]. Legal provisions require a fee to be paid for Medicines Market Authorization (registration) based on applications [19]. 10

17 4.3 Regulatory Inspection In Armenia, legal provisions exist allowing for appointment of government pharmaceutical inspectors [22]. The Regulatory Authority has 4 inspectors [23]. Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed [10]. Legal provisions exist requiring inspection to be performed. Inspection is a pre-requisite for licensing facilities. Inspection requirements are the same for public and private facilities [22]. 4.4 Import Control Legal provisions exist requiring authorization to import medicines. Laws exist that allow the sampling of imported products for testing. Legal provisions exist requiring importation of medicines through authorized ports of entry. Regulations or laws exist to allow for inspection of imported pharmaceutical products at the authorized port of entry [24]. 4.5 Licensing In Armenia, legal provisions exist requiring manufacturers to be licensed [10]. Legal provisions exist requiring manufacturers to comply with Good Manufacturing Practices (GMP), but the latter are not published by the government [25]. GMP requirements are similar to EU GMP which are currently being translated. Legal provisions exist requiring importers, wholesalers and distributers to be licensed [10]. Legal provisions do not exist requiring wholesalers and distributors to comply with Good Distributing Practices. The GDP requirements are not published by the government. There are not legal provisions requiring pharmacists to be registered, but there are provisions requiring private and public pharmacies to be licensed [22]. National Good Pharmacy Practice Guidelines are not published by the government. 11

18 4.6 Market Control and Quality Control In Armenia, legal provisions exist for controlling the pharmaceutical market [12] [22] and a laboratory exists for Quality Control testing [23]. Samples are collected by government inspectors for post-marketing surveillance testing [10]. In the past 2 years, 18 samples were taken for quality control testing. Of the samples tested, 7 failed to meet the quality standards. The results are not publicly available [9] [23]. 4.7 Medicines Advertising and Promotion In Armenia, there are legal provisions to control the promotion and/or advertising of prescription medicines. The Ministry of Health is responsible for regulating promotion and/or advertising of medicines. Legal provisions prohibit direct advertising of prescription medicines to the public. Legal provisions require a pre-approval for medicines advertisements and promotional materials. Guidelines and Regulations exist for advertising and promotion of nonprescription medicines. There is no national code of conduct concerning advertising and promotion of medicines by marketing authorization holders [10]. 4.8 Clinical Trials In Armenia, legal provisions exist requiring authorization for conducting Clinical Trials by the MRA. Laws require the agreement by an ethics committee of the Clinical Trials to be performed. Registration of the clinical trials into international/national/regional registry is required by law [26]. 12

19 4.9 Controlled Medicines Armenia is signatory to the: - Single Convention on Narcotic Drugs, Protocol amending the Single Convention on Narcotic Drugs, Convention on Psychotropic Substances United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 [27]. Laws exist for the control of narcotic and psychotropic substances, and precursors [10]. The annual consumption of Morphine is 1.42 mg/capita [27] Pharmacovigilance In Armenia, there are legal provisions in the Medicines Act that provide for pharmacovigilance activities as part of the MRA mandate. Legal provisions exist requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA. Laws about monitoring Adverse Drug Reactions (ADR) exist in Armenia [12]. A national Pharmacovigilance centre linked to the MRA exists in Armenia and it has 3 full-time staff members. The centre has published at least one analysis report in the previous two years and it also publishes an ADR bulletin regularly. An official standardized form for reporting ADRs exists in Armenia. A national ADR database also exists. In the past 2 years, 141 ADR reports were sent to the WHO database in Uppsala. ADRs are monitored in at least one public health program [23]. 13

20 Section 5 - Medicines Financing In this section, information is provided on the structure of user fees for medicines and on the existence of public programmes providing free medicines. Policies and regulations in place that affect the prices of medicines (e.g. price control and taxes) are presented. 5.1 Medicines Coverage and Exemptions In Armenia, there are Public Programmes in Armenia providing free medicines to: Patients who cannot afford them Children under 5 Pregnant women Elderly persons No No No Public programmes exists providing free medicines for: All diseases Any non-communicable diseases Malaria Tuberculosis Sexually transmitted diseases HIV/AIDS EPI Vaccines for children (expanded programme of immunization) No No No [10] [28] [29]. 14

21 The following medicines are also provided for free in Armenia: Antipsychotics, antineoplastic and narcotics, ant diabetics, antiepileptics, anticoagulants after valve prosthetics, colchicines, cyclosporine, erythropoietin, micofenolat mofetil and analogs. In Armenia, there is a public health service, public health insurance, social insurance or other sickness fund provides at least partial medicines coverage. It provides coverage for medicines that are on the Essential Medicines List (EML) for inpatients and outpatients. In 1999 the Basic Benefits Package was established. Based on a set of criteria, it defines vulnerable and special segments of the population that are eligible to receive medicines. Private health insurance schemes provide medicines coverage [30]. 5.2 Patients Fees and Copayments In the health system of Armenia, at the point of delivery, there are copayments/fee requirements for consultations and medicines. Revenue from fees or from the sale of medicines is not used to pay the salaries or supplement the income of public health personnel in the same facility. According to the Government Decree, for some of the defined population groups, the government is obligated to provide partial subsidies (e.g. people with third degree disabilities) [10] [28] [31]. 5.3 Pricing Regulation for the Private Sector (not including the non-profit voluntary sector) In Armenia, 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 exist mandating that retail medicine price information should be publicly accessible [32]. 15

22 5.4 Prices, Availability and Affordability of Key Medicines In 2001, a WHO/HAI pricing survey was conducted in Armenia. Only private sector pharmacies have been surveyed in the country. Prices of medicines have been compared to international reference prices 3 and expressed as a ratio of the international price (e.g. a price ratio of 2 would mean that the price is two times the international reference price). Since prices have been collected for a basket of medicines, the median price ratio has been selected to represent the situation in the country. Private patient prices were above international reference prices: the Median Price Ratio for originators was 10.4 and for generics Affordability of medicines is measured in terms of number of days of wage necessary to purchase treatment for a condition. The wage is the one of the lowest paid government worker. In the private sector of Armenia, it would take 2 days of wage to purchase treatment with co-trimoxazole for a child respiratory infection using generic medicines and 2.2 days using originators ( 5.5 Duties and Taxes on Pharmaceuticals (Market) There are no duties on imported raw materials nor on imported finished products. On the other hand, there is however a 20% VAT on medicinal products [33]. 3 The International reference price is the median of prices offered by international suppliers (both for profit and not profit) as report by MHS International Price Indicator Guide ( For more information on the methodology WHO/HAI pricing survey, you can download a free copy of the manual at 16

23 Section 6 - 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 Armenia. 6.1 Public Sector Procurement The public sector procurement in Armenia is centralized and decentralized. The public sector procurement is centralized under the responsibility of a procurement agency which is a government agency that procures all public goods [34] [35].The state procurement agency organizes procurement for medicines determined by the MoH and carries out tenders for the individual health facilities. The medicines are also purchased by health facilities and reimbursed by the MoH [36]. The public sector tender bids are publicly available and public sector awards are publicly available. Procurements are based on prequalification of suppliers [37]. 6.2 Public Sector Distribution The government supply system department in Armenia has a Central Medical Store at a National Level; the store is called Humanitarian Aid Center [9]. There are no public warehouses in the secondary tier of the public sector distribution. There are no national guidelines on Good Distribution Practices (GDP). There is not a licensing authority that issues GDP licenses. A list of GDP certified wholesalers does not exist and a list of GDP certified distributors does not exist in the public sector. 6.3 Private Sector Distribution Legal provisions exist for licensing wholesalers and distributors in the private sector of Armenia. A list of GDP certified wholesalers and distributors do not exist in the private sector. 17

24 Section 7 - Selection and rational use of medicines This section presents the structures and policies that are in place in Armenia for selection of essential medicines and promotion of rational drug use. 7.1 National Structures National Standard Treatment Guidelines (STGs) for the most common illnesses have been produced/endorsed by the MoH in Armenia. The national STGs were updated in They cover primary care, secondary care and paediatric conditions. A National Essential Medicines List (EML) exists in Armenia and it has been updated in There are 293 of medicines on the EML. There is a written process for selecting medicines on the EML. The EML is publicly available [10] [38] % of the public health facilities have a copy of the STGs [39]. A public or independently funded national medicines information centre provides information on medicines to prescribers, dispensers and consumers [10]. Public education campaigns on rational medicine use topics have been conducted in the last two years [23]. No surveys on rational use of medicines have been conducted in the previous two years. There is no national programme or committee to monitor and promote rational use of medicines. A written National Strategy to contain antimicrobial resistance does not exist. 7.2 Prescribing In Armenia, there are legal provisions to govern the licensing and prescribing practices of prescribers [40]. Legal provisions exist to restrict dispensing by prescribers [12]. Regulations require hospitals to organize/develop Drug and Therapeutics Committees (DTCs) [10]. The core medical training curriculum includes components on 18

25 The concept of EML Use of STGS Pharmacovigilance Problem based pharmacotherapy [41] [9] Mandatory continuing education that includes pharmaceutical issues is required for doctors, nurses and paramedical staff [10] [25]. Prescribing by INN name is not obligatory in the public and private sector. 7.3 Dispensing Legal provisions in Armenia exist to govern dispensing practices of pharmaceutical personnel. The core pharmacist training curriculum includes components on The concept of EML Use of STGs Drug information Clinical Pharmacy Medicine Supply Management [41] [9] Mandatory continuing education that includes pharmaceutical issues is required for pharmacists. Substitution of generic equivalents at the point of dispensing in public and private sector facilities is allowed. Antibiotics are sold over-thecounter without a prescription. Injectable medicines are sold over-the-counter without a prescription [10]. 19

26 Section 8 - Household data/access This section provides information about household surveys held in the past in Armenia regarding actual access to medicines by normal and poor households. In 2006 a household survey was conducted in Armenia for the 'Armenia: Health System Performance Assessment 2009', but the indicators are different from the Country Profiles Household Survey Indicators [30]. 20

27 References [1] National statistics data, Total population. Yerevan, Statistical Yearbook of Armenia, National Statistical Service of the Republic of Armenia, Available at: [2] Country data, Armenia. Washington, the World Bank, Available at: [3] World Health Statistics. Geneva, World Health Organization, Available through the Global Health Observatory: [4] 'Health and health care of Armenia' annual statistical report. Yerevan, MoH of Armenia; National Institute of Health, Available at: [5] National health accounts: country information Armenia. Geneva, World Health Organization, Available at: [6] Global health atlas. Geneva, World Health Organization, Available at: [7] Strategy for higher education reforms, 21 November 2003, #46 Government protocol, Yereavan, Available at (Armenian only): [8] Government program for Available at: [9] National institute of health. Republic of Armenia, Ministry of Health. Available at: [10] Country pharmaceutical situations. Fact book on WHO Level I indicators Geneva, World Health Organization, [11] National security strategy of the Republic of Armenia. Yerevan, National Security Council, Available at: [12] Law on medicines of Republic of Armenia. Yerevan, the Law of the Republic of Armenia, Available at: 21