Draft 'country profiles' CORE Armenia 22June … · official National Medicines Policy document exists in Armenia. It was updated in 2006 [10]. In fact the NMP is part of the NHP

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ARMENIA

PHARMACEUTICAL COUNTRY PROFILE

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iii

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

2010. 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

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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

v

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

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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,

[email protected] , Scientific Center of Drug and Medical Technology Expertise, N

1-15 Moskoyyan Str, Yeravan.

1

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

2

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].

3

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 expenditure1 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 16.87 % 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.

4

Public expenditure on pharmaceuticals represents 17.82 % 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 2008

Source: NHA, 2008

17%

83%

TPE

Other

FIGURE 2: Share of public and private sector to Total Pharmaceutical Expenditure in

Armenia in 2008

Source: NHA, 2008

18%

82%

Public sectorPrivate sector

5

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) 0.532/10,000 [6]

Pharmacists in the public sector 0.492/10,000 [4]

Pharmaceutical technicians and assistants (all

sectors)

Unknown

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

0 10 20 30 40 50 60

Pharmacists

Physicians

Nursing andmidwifery personnel

/ 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 1980-2009 is 962 and therefore the total number of pharmacists may be higher than the 163 reported in the Global Health Atlas.

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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]

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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 2006. 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 Yes

Medicines financing Yes

Medicines pricing Yes

Procurement Yes

Distribution Yes

Regulation Yes

Pharmacovigilance, Yes

Rational use of medicines Yes

Human resource development Yes

Research Yes

Monitoring and evaluation Yes

Traditional Medicine Yes

[10] [11]

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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 2016.

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

Yes

Bolar exceptions Yes

Parallel importing provisions Yes

[10]

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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

Yes

The production of pharmaceutical starting materials (APIs) Yes

The production of formulations from pharmaceutical starting

material

Yes

The repackaging of finished dosage form Yes

[10].

The percentage of market share by value of pharmaceuticals produced by

domestic manufacturers is 8 % [18].

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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

http://www.pharm.am. 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].

http://www.pharm.am

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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.

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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 non-

prescription 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].

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4.9 Controlled Medicines

Armenia is signatory to the:

- Single Convention on Narcotic Drugs, 1961

- 1972 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 [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].

4.10 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].

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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:

Public programmes exists providing free medicines for:

All diseases No

Any non-communicable diseases No

Malaria Yes

Tuberculosis Yes

Sexually transmitted diseases No

HIV/AIDS Yes

EPI Vaccines for children (expanded

programme of immunization)

Yes

[10] [28] [29].

Patients who cannot afford them No

Children under 5 Yes

Pregnant women No

Elderly persons No

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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].

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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 prices3 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 3.42.

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

(http://www.haiweb.org/GlobalDatabase/survey_result/Main.htm).

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 (http://erc.msh.org/mainpage.cfm?file=1.0.htm&module=DMP&language=English). For more information on the methodology WHO/HAI pricing survey, you can download a free copy of the manual at http://apps.who.int/medicinedocs/documents/s14868e/s14868e.pdf.

http://www.haiweb.org/GlobalDatabase/survey_result/Main.htm

http://erc.msh.org/mainpage.cfm?file=1.0.htm&module=DMP&language=English

http://apps.who.int/medicinedocs/documents/s14868e/s14868e.pdf

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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.

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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 2006. They cover primary care, secondary care and paediatric

conditions. A National Essential Medicines List (EML) exists in Armenia and it

has been updated in 2007. 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]. 88.6 % 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

19

The concept of EML Yes

Use of STGS Yes

Pharmacovigilance Yes

Problem based pharmacotherapy Yes

[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 Yes

Use of STGs Yes

Drug information Yes

Clinical Pharmacy Yes

Medicine Supply Management Yes

[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-the-

counter without a prescription. Injectable medicines are sold over-the-counter

without a prescription [10].

20

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].

21

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22

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[17] Law on inventions, utility models and industrial designs. Yerevan,

Intellectual Property Agency of the Republic of Armenia, 2008. Available at:

http://www.aipa.am/en/legislation/11/#pin, 22-06-2010.

[18] Armenian pharmaceutical industry handbook. USAID, UNPI, ADA, 2008.

Available at: http://www.caps.am/data.php/549.pdf, 22-06-2010.

[19] RA Government decree N 347. Yerevan, Scientific centre of drug and

medical technology expertise, 2001. Available at (Armenian only):

http://www.pharm.am/jurdocs_list.php?pg=3&id=2&langid=2, 22-06-2010.

[20] RA HM Order N 123-N. Yerevan, Scientific centre of drug and medical

technology expertise, 2006. Available at (Armenian only):


[21] List of registered drugs in Armenia. Yerevan, Scientific centre of drug and

medical technology expertise, 2010. Available at:

http://www.pharm.am/files/jfiles2/20100517_121858_en_reghavelenglish01.0

4-30.04.10.pdf, 23-06-2010.

[22] Law on licensing of Republic of Armenia. Yerevan, the Law of the Republic

of Armenia, 2001. Available at:

http://www.pharm.am/files/juristdocs/20080306_151440_en_drug_law.pdf

http://www.parliament.am/law_docs/271201HO272eng.pdf?lang=eng

http://www.csc.am/eng/

http://www.parliament.am/legislation.php?sel=show&ID=1457&lang=eng

http://www.ombuds.am/main/en/

http://www.aipa.am/en/legislation/11/#pin

http://www.caps.am/data.php/549.pdf

http://www.pharm.am/jurdocs_list.php?pg=3&id=2&langid=2


http://www.pharm.am/files/jfiles2/20100517_121858_en_reghavelenglish01.04-30.04.10.pdf

23


06-2010.

[23] Scientific Centre of Drug and Medical Technology Expertise (MRA). Yerevan.

Available at: www.pharm.am, 22-06-2010 (the annual report of the MRA is

available at:

http://www.pharm.am/files/reports/20100316_113304_en_Kentroni%20hashve

tvutun%20%20eng%202009.pdf, 22-06-2010.










[27] Report of the International Narcotics Control. Vienna, International

Narcotics Control Board, 2009. Available at: www.incb.org, 08-06-2010.

[28] RA Government decree N 1717-N. Yerevan, Scientific centre of drug and



[29] Law on HIV diseases prevention, 1997, Available at (Armenian only):

http://www.parliament.am/legislation.php?sel=show&ID=1574&lang=arm, 03-

08-2010.

[30] Armenia Health System Performance Assessment. Yerevan, Ministry of

Health of Armenia, 2009. Available at:

http://www.euro.who.int/__data/assets/pdf_file/0020/103385/E92994.pdf,

23-06-2010.


technology expertise, 2005. Available at (Armenian and Russian only):



http://www.pharm.am/files/reports/20100316_113304_en_Kentroni%20hashvetvutun%20%20eng%202009.pdf





http://www.parliament.am/legislation.php?sel=show&ID=1574&lang=arm

http://www.euro.who.int/__data/assets/pdf_file/0020/103385/E92994.pdf


24

[32] Law on consumer right protection, 2001, Available at (Armenian and

Russian only):

http://www.parliament.am/legislation.php?sel=show&ID=1506&lang=arm, 03-

08-2010

[33] Amendment on law on VTA AL 126. Yerevan, the Law of the Republic of

Armenia, 1997. Available at:


06-2010.

[34] Government decree 1904-N, 2002, Available at (Armenian only):

http://www.arlis.am/, 03-08-2010

[35] Law on procurements. Yerevan, the Law of the Republic of Armenia, 2004.

Available at:


06-2010.

[36] Hakobyan T, Nazaretyan M, Makarova T, Aristakesyan M, Margaryants H,

Nolte E. Armenia: Health system review. Health Systems in Transition, 2006;

8(6): 1–180. Available at:

http://www.euro.who.int/__data/assets/pdf_file/0004/96430/E89732.pdf, 23-

06-2010.

[37] The procurement system in the Republic of Armenia. Yerevan, Ministry of

Finance. Available at: http://www.gnumner.am/main.php?lang=3&id=1, 23-06-

2010.

[38] Essential medicines list. Yerevan, Scientific centre of drug and medical

technology expertise, 2006. Available at:

http://www.pharm.am/files/juristdocs/20080422_152636_en_English%20Essent

ial%20List.doc, 23-06-2010.

[39] Options for improving the supply and use of medicines for primary health

care in Armenia- MSF/USAID-2007. Available at:


16-08-2010.

http://www.parliament.am/legislation.php?sel=show&ID=1506&lang=arm


http://www.arlis.am/



http://www.gnumner.am/main.php?lang=3&id=1

http://www.pharm.am/files/juristdocs/20080422_152636_en_English%20Essential%20List.doc


25


technology expertise, 2002. Available at (Armenian only):

http://www.pharm.am/departments_view.php?pg=&id=18&langid=2, 22-06-

2010.

[41] Medical University, Available at: http://www.ysmu.am/ and National

Institute of Health. Available at: http://www.niharm.am 23-06-2010.

http://www.pharm.am/departments_view.php?pg=&id=18&langid=2

http://www.ysmu.am/

http://www.niharm.am

26

Armenia Pharmaceutical Country Profile

ANNEX

Survey Data

27

Respondent to the questionnaire: Lilit Ghazaryan +374-10-58-40-20 [email protected]

28

Section 1 Health and Demographic data 1.01 Demographic and Socioeconomic Indicators Core Questions Population, total (,000) 3,002 2007 World Health

Statistics Population growth rate (Annual %) 0.2 2008 World Bank,

Population GDP growth (Annual %) 6.8 2008 World Bank GNI per capita (US$ current exchange rate)

3,350 2008 World Bank

Comments According to the National Statistics data the total population size is 3,238,000 at the end of 2008

Supplementary questions Population < 15 years (% of total population)

19 2007 World Health Statistics

Population > 60 years (% of total population)


Urban population (% of total population)


Fertility rate, total (Births per woman)

1.4 2007 World Health Statistics

Population living with less than $1/day (international PPP) (%)


Population living below nationally defined poverty line (%)

51 2006 Options for Improving the Supply and use of Medicines for Primary Health Care in Armenia - MSF/USAID-2007

Income share held by lowest 20% of the population (% of national income)

8.6 2007 World Bank

Adult literacy rate, 15+ years (% of total population)


1.02 Mortality and Causes of Death Core questions Life expectancy at birth for men (Years)


Life expectancy at birth for women (Years)


Infant mortality rate, between birth and age 1 (/1,000 live births)


Under 5 mortality rate (/1,000 live births)


Maternal mortality ratio 76 2005 World Health

29

(/100,000 live births) Statistics Please provide a list of top 10 diseases causing mortality

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 para 10. Certain conditions originating in the perinatal period

2008 Health and Health Care of Armenia, Annual Statistical Report

Please provide a list of top 10 diseases causing morbidity

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

2008 Health and Health Care of Armenia, Annual Statistical Report

30

external causes Supplementary questions Adult mortality rate for both sexes between 15 and 60 years (/1,000 population)


Neonatal mortality rate (/1,000 live births)


Age-standardized mortality rate by non-communicable diseases ( /100,000 population)

1,064 2004 World Health Statistics

Age-standardized mortality rate by cardiovascular diseases (/100,000 population)


Age-standardized mortality rate by cancer ( /100,000 population)


Mortality rate for HIV/AIDS (/100,000 population)


Mortality rate for tuberculosis (/100,000 population)


Mortality rate for Malaria (/100,000 population)


31

Section 2 Health Services 2.01 Health Expenditures Core Questions Total annual expenditure on health (millions US$ average exchange rate)

435 2008 Calculated from the NHA

Total annual expenditure on health (millions NCU)

136,919 2008 National Health Accounts

Total health expenditure as % of Gross Domestic Product

3.8 2008 National Health Accounts

Total annual expenditure on health per capita (US$ average exchange rate)

145 2008 National Health Accounts

Total annual expenditure on health per capita (NCU)

45,609 2008 Calculated from the NHA

General government annual expenditure on health (millions US$ average exchange rate)


General government annual expenditure on health (millions NCU)


Government annual expenditure on health as percentage of total government budget (% of total government budget)


Government annual expenditure on health as % of total expenditure on health (% of total expenditure on health)


Annual per capita government expenditure on health (US$ average exchange rate)


Annual per capita government expenditure on health (NCU)


Private health expenditure as % of total health expenditure (% of total expenditure on health)


Total pharmaceutical expenditure (millions US$ current exchange rate)

75.5 2008 Calculated from the NHA

Total pharmaceutical expenditure (millions NCU)


Total pharmaceutical expenditure per capita (US$ current exchange rate)


Total pharmaceutical expenditure per capita (NCU)


Pharmaceutical expenditure as a % of GDP (% of GDP)


Pharmaceutical expenditure as a % 16.87 2008 Calculated from the

32

of Health Expenditure (% of total health expenditure)

NHA

Total public expenditure on pharmaceuticals (millions US$ current exchange rate)


Total public expenditure on pharmaceuticals (millions NCU)


Share of public expenditure on pharmaceuticals as percentage of total expenditure on pharmaceuticals (%)


Total public expenditure on pharmaceuticals per capita (US$ current exchange rate)


Total public expenditure on pharmaceuticals per capita (NCU)


Total private expenditure on pharmaceuticals (million US$ current exchange rate)


Total private expenditure on pharmaceuticals (millions NCU)


Comments The market share of generic pharmaceuticals is Not Available. 80% of registered medicinal products are generics. The Annual growth rate of pharmaceuticals is NA. The annual growth rate of imported medicines is 28.3%.

Supplementary Questions Social security expenditure as % of government expenditure on health (% of government expenditure on health)


Private out-of-pocket expenditure as % of private health expenditure (% of private expenditure on health)


Premiums for private prepaid health plans as % of total private health expenditure (% of private expenditure on health)


Comments Primary Health Care - 100% of population; number of hospital cases in 2008 is 237,300

2.02 Health Personnel and Infrastructure Core Questions Total number of pharmacists licensed/registered to practice in your country

163 2007 Global Health Atlas

Total number of pharmacists working in the public sector

151 2008 Health and Health Care of Armenia Annual Statistical Report

Total number of pharmaceutical NA - -

33

technicians and assistants A strategic plan for pharmaceutical human resource development is in place in your country?

Yes 2007 Strategy for higher education reforms

Total number of physicians 11,133 2006 World Health Statistics

Total number of nursing and midwifery personnel

14,806 2006 World Health Statistics

Total number of hospitals 130 2008 Health and Health Care of Armenia Annual Statistical Report

Total number of hospitals bed 13,209 2007 World Health Statistics

Total number of primary health care units and centres


Total number of licensed pharmacies 1,560 2010 MoH RA Comments The total number of pharmacists licensed/registered

to practice can not be 163, because there are 1560 licensed pharmacies and outlets in the country, and total number of pharmacists who graduated from 1980-2009 is 962

Supplementary Questions Starting annual salary for a newly registered pharmacist in the public sector - NCU

60,000 2010 Individual Report

Total number of pharmacists who graduated (first degree) in the past 2 years in your country


Are there accreditation requirements for pharmacy schools?

Yes 2010 Ministry of Education and MoH, government decree #867-2002

Is the Pharmacy Curriculum regularly reviewed?

Yes 2010 Medical University

34

Section 3 Policy issues 3.01 Policy Framework Core Questions National Health Policy exists. If yes, please write year of the most recent document in the "year" field and attach document or provide URL below*

Yes 2006 WHO Level I

National Medicines Policy official document exists. If yes, please write the year of the most recent document in the "year" field and attach document or provide URL below*


Group of policies addressing pharmaceuticals exist. Please attach document or provide URL below *

Yes 2007 National Security Strategy of the Republic of Armenia

National Medicines Policy covers the following components:

Selection of Essential Medicines Yes Medicines Financing Yes Medicines Pricing Yes Medicines Procurement Yes Medicines Distribution Yes Medicines Regulation Yes Pharmacovigilance Yes Rational Use of Medicines Yes Human Resource Development Yes Research Yes Monitoring and Evaluation Yes Traditional Medicine Yes National medicines policy implementation plan exists.

No 2007 WHO Level I

Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or national legislation?

Yes 1998 Law on Medicines of RA

There are official written guidelines on medicines donations.


Is pharmaceutical policy implementation being regularly monitored/assessed?

No 2010

Is there a national good governance policy?

Yes 2001 Law on Civil Servicehttp://www.parliament.am/legis

Servicehttp://www

35

lation.php?sel=show&ID=1268&lang=eng

Multisectoral Yes

2001

For the pharmaceutical sector No

Which agencies are responsible? Civil Service Council http://www.csc.am/eng/ A policy is in place to manage and sanction conflict of interest issues in pharmaceutical affairs.

No 2010

There is a formal code of conduct for public officials.

No 2010

Is there a whistle-blowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of your country (ombudsman)?

Yes 2003 Law on Human Rights Defender. www.ombuds.am

Please describe: According to Law on Human rights defender http://www.parliament.am/legislation.php?sel=show&ID=1457&lang=eng

Comments The National Health Policy Document is a draft. The NMP is a part of this document

3.02 Intellectual Property Laws and Medicines Core Questions Country is a member of the World Trade Organization


Legal provisions provide for granting of Patents on pharmaceuticals


National Legislation has been modified to implement the TRIPS Agreement


Current laws contain (TRIPS) flexibilities and safeguards


Country is eligible for the transitional period to 2016


Which of 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 exception Yes 2007 WHO Level I

Are parallel importing provisions present in the national law?


The country is engaged in initiatives to strengthen capacity to manage and apply intellectual property rights

Yes 2006

National Health Policy (draft)

http://www.csc.am/eng/


36

to contribute to innovation and promote public health Are there legal provisions for data exclusivity for pharmaceuticals

No 2010

Legal provisions exist for patent extension

Yes 2008 Law on Inventions, Utility Models and Industrial designs

Legal provisions exist for linkage between patent status and marketing authorization

No 2010

3.03 Manufacturing Core Questions Number of licensed pharmaceutical manufacturers in the country

14 2010 MoH

Country has manufacturing capacity for:

2007 WHO Level I

R&D to discover new active substances

Yes

Production of pharmaceutical starting materials (APIs)

Yes

Production of formulations from pharmaceutical starting material

Yes

Repackaging of finished dosage forms

Yes

Percentage of market share by value produced by domestic manufacturers (%)

8 2007 Armenian Pharmaceutical Industry Handbook

Supplementary Questions Percentage of market share by volume produced by domestic manufacturers (%)

NA 2010

Number of multinational pharmaceutical companies manufacturing medicines locally

0 2010 MRA

Number of manufacturers that are GMP certified

0 2010 MRA

Comments GMP Certification procedure is in the stage of adoption

37

Section 4 Regulation 4.01 Regulatory Framework Core Questions Are there legal provisions establishing the powers and responsibilities of the medicines regulatory authority?


Part of MOH No Semi autonomous agency No Other (specify) Scientific Center of

Drug and Medical Technology Expertise under MoH

The MRA has its own website Yes 2007 WHO Level I

- If yes, please provide MRA Web site address (URL)

www.pharm.am

The MRA is involved in harmonization/ collaboration initiatives


- If yes, please specify WHO, EDQM, CIS An assessment of the medicines regulatory system has been conducted in the last five years.


Supplementary Questions Formal code of conduct exists for staff involved in medicines regulation


Medicines Regulatory Authority gets funds from regular budget of the government.

No 2007 WHO Level I

Medicines Regulatory Authority is funded from fees for services provided.


Medicines Regulatory Authority receives funds/support from other sources


- If yes, please specify Grants Revenues derived from regulatory activities are kept with the regulatory authority

Yes 2001 Government Decree #347

The Regulatory Authority is using a computerized information management system to store and retrieve information on registration, inspections, etc.


4.02 Marketing Authorization (Registration)

38

Core Questions Legal provisions require a marketing authorization (registration) for all pharmaceutical products on the market


Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products

Yes 1998/20012006/

Law on Medicines, Government Decree #347, MoH order #123-N

Number of pharmaceutical products registered in your country

3,900 2007 WHO Level I

Legal provisions require the MRA to make publicly available the registered pharmaceutical with defined periodicity

Yes 1998 Law on Medicines

- If yes, how frequently updated Monthly - If yes, please provide updated list or URL *

http://www.pharm.am/jurdocs_list2.php?pg=13&id=10&langid=2

Medicines are registered by their INN (International Non-proprietary Names) or Brand name + INN


Legal provisions require paying a fee for Medicines Market Authorization (registration) applications


Supplementary Questions Legal provisions require marketing authorization holders to provide information about variations to the existing marketing authorization

Yes 2001 Law on Medicines, Government Decree #347

Legal provisions require to publish the Summary Product Characteristics (SPCs) of the medicines registered

Yes 2006 MoH order #123-N

Legal provisions require the establishment of an expert committee involved in the marketing authorization process


Certificate for Pharmaceutical Products in accordance with the WHO Certification scheme is required as part of the marketing authorization application


Legal provision require declaration of potential conflict of interests for the experts involved in the assessment and decision-making for registration

No 2010

Legal provisions allow applicants to appeal against MRAs decisions


Registration fee - the amount per application for pharmaceutical product containing New Chemical Entity,NCE (US$)

4,800 2001 Government Decree #347

http://www.pharm.am/jurdocs_list2.php?pg=13&id=10&langid=2

39

Registration fee - the Amount per application for a multisource pharmaceutical product (US$)

1,900 2001 Government Decree #347

Time limit for the assessment of a marketing authorization application (Months)

6 2001 Government Decree #347

Comments MRA staff must fill the declaration according to internal rules. MoH order requires members of the Pharm committee giving a final recommendation to the MoH not to be a firm representatives.

4.03 Regulatory Inspection Core Questions Legal provisions exist allowing for appointment of government pharmaceutical inspectors

Yes 2001 Law on Licensing

Does the Regulatory Authority have inspectors?

Yes 2010 MRA

If yes, how many? 4 Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed


Legal provisions exist requiring inspection to be performed


Inspection is a pre-requisite for licensing of facilities


Inspection requirements are the same for public and private facilities


4.04 Import Control Core Questions Legal provisions exist requiring authorization to import medicines


Legal provisions exist allowing the sampling of imported products for testing


Legal provisions exist requiring importation of medicines through authorized ports of entry


Legal provisions exist allowing inspection of imported pharmaceutical products at the authorized port of entry


4.05 Licensing Core Questions Legal provisions exist requiring manufacturers to be licensed If yes please provide documents below. Please attach document or provide URL below *


40

Legal provisions exist requiring manufacturers to comply with Good manufacturing Practices (GMP)


GMP requirements are published by the government. If yes, please provide reference or URL below *

No 2010

Legal provisions exist requiring importers to be licensed


Legal provisions exist requiring wholesalers and distributors to be licensed


Legal provisions exist requiring wholesalers and distributors to comply with Good Distributing Practices

No 2010

National Good Distribution Practice requirements are published by the government

No 2010

Legal provisions exist requiring pharmacists to be registered

No 2010

Legal provisions exists requiring private pharmacies to be licensed


Legal provision exist requiring public pharmacies to be licensed


National Good Pharmacy Practice Guidelines are published by the government

No 2010

Comments GMP requirements are similar to the EU GMP which are at a translation stage.

Supplementary Questions Legal provisions require the publication of different categories of all pharmaceutical facilities licensed


4.06 Market Control and Quality Control Core Questions Legal Provisions for controlling the pharmaceutical market exist

Yes 1998/2001

Law on Medicines/ Licensing

Does a laboratory exist in the country for Quality Control testing?

Yes 2010 MRA

Samples are collected by government inspectors for undertaking post-marketing surveillance testing


How many Quality Control samples were taken for testing in the past two years?

18 2010 MRA and MoH

What is the total number of samples tested in the previous two years that failed to meet quality standards?

7 2010 MRA and MoH

41

Results of quality testing in past two years are publicly available

No 2010

4.07 Medicines Advertising and Promotion Core Questions Legal provisions exist to control the promotion and/or advertising of prescription medicines


Who is responsible for regulating, promotion and/or advertising of medicines? Please describe:

Ministry of Health

Legal provisions prohibit direct advertising of prescription medicines to the public


Legal provisions require a pre-approval for medicines advertisements and promotional materials


Guidelines/Regulations exist for advertising and promotion of non-prescription medicines


A national code of conduct exists concerning advertising and promotion of medicines by marketing authorization holders and is publicly available

No 2010

4.08 Clinical trials Core Questions Legal provisions exist requiring authorization for conducting Clinical Trials by the MRA


Legal provisions exist requiring the agreement by an ethics committee/ institutional review board of the Clinical Trials to be performed


Legal provisions exist requiring registration of the clinical trials into international/national/regional registry


Supplementary Questions Legal provisions exist for GMP compliance of investigational products

No 2010

Legal provisions require sponsor, investigator to comply with Good Clinical Practices (GCP)

No 2010

National GCP regulations are published by the Government.

No 2010

Legal provisions permit inspection of facilities where clinical trials are performed


4.09 Controlled Medicines

42

Core Questions The country is a signatory to conventions

Single Convention on Narcotic Drugs, 1961

Yes 2009 International Narcotics Control Board

The 1972 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

Yes 2009

International Narcotics Control Board

Laws for the control of narcotic and psychotropic substances, and precursors exist, If yes, please attach below *


Annual consumption of Morphine (mg/capita)

1.42 2009 International Narcotics Control Board

Comments The calculations are based on a total population size of 3,238,000

Supplementary Questions The laws and regulations for the control of narcotic and psychotropic substances, and precursors has been reviewed by a WHO International Expert or Partner Organization to assess the balance between the prevention of abuse and access for medical need

Yes 2009 Report

If yes, year of review. Please attach a copy of the review or provide link to it if available on the web *

www.scadarmenia.org

Annual consumption of Fentanyl (mg/capita)


Annual consumption of Pethidine (mg/capita)

0 2009 International Narcotics Control Board

Annual consumption of Oxycodone (mg/capita)


Annual consumption of Hydrocodone (mg/capita)


Annual consumption of Phenobarbital (mg/capita)


43

Annual consumption of Methadone (mg/capita)


4.10 Pharmacovigilance Core Questions There are legal provision in the Medicines Act that provides 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


Legal provisions about monitoring Adverse Drug Reactions (ADR) exist in your country


A national Pharmacovigilance centre linked to the MRA exists in your country

Yes 2010 MRA

If a national pharmacovigilance centre exists in your country, how many staff does it employ full-time

3 2010 MRA

If a national pharmacovigilance center exists in your country, an analysis report has been published in the previous two years.

Yes 2010 MRA

If a national pharmacovigilance center exists in your country, it publishes an ADR bulletin

Yes 2010 MRA

An official standardized form for reporting ADRs is used in your country.

Yes 2010 MRA

A national Adverse Drug Reactions database exists in your country.

Yes 2010 MRA

Are ADR reports set to the WHO database in Uppsala?

Yes 2010 MRA

If yes, number of reports sent in the past two years

141 2010 MRA

ADRs are monitored in at least one public health program (for example TB, HIV, AIDS)?

Yes 2010 MRA

Supplementary Questions How many ADR reports are in the database?

519 2010 MRA

How many reports have been submitted in the past two years?

143 2010 MRA

Feedback is provided to reporters Yes 2010 MRA The ADR database is computerized Yes 2010 MRA Medications errors (MEs) are Yes 2010 MRA

44

reported. How many MEs are there in the ADRs database?

30 2010 MRA

There is a risk management plan presented as part of product dossier submitted for Marketing Authorization?

No 2010 MRA

In the past two years, who has reported ADRs?

2010

MRA

Doctors Yes

Nurses No Pharmacists No Consumers Yes Pharmaceutical Companies Yes Was there any regulatory decision based on local PV data in the last 2 years?

No 2010

Are there training courses in Pharmacovigilance?

Yes 2010 MRA annual report

If yes, how many people have been trained in the past two years?

720

What is the percentage of preventable ADRs in the database for the past two years (%)?

9.9 2010 MRA

Comments The ADRs report is based on local data only.

Section 5 Medicines Financing 5.01 Medicines Coverage and Exemptions Core Questions If a public programme providing free medicines exists, medicines are available free-of-charge for:

Patients who cannot afford them No 2007 WHO Level I Children under 5 Yes 2007 WHO Level I Pregnant women No 2007 WHO Level I Elderly persons No 2007 WHO Level I Please describe/explain your yes answers for questions above

Government decree 17 17-N 2006

If a public programme providing some/all medicines free exists, the following types of medicines are free

All medicines for all conditions No Any non-communicable diseases No Malaria medicines Yes 2007 WHO Level I Tuberculosis medicines Yes 2007 WHO Level I

45

Sexually transmitted diseases medicines

No

HIV/AIDS medicines Yes 1997 Law on HIV disease prevention

EPI vaccines Yes 2007 WHO Level I If others, please specify Antipsychotics, antineoplastics and narcotics,

antidiabetics, antiepileptics, anticuagulants after valve prosthetics, colchicine, ciclosporin, erythropoietin, micofenolat mofetil and analogs.

Does a public health service, public health insurance, social insurance or other sickness fund provides at least partial medicines coverage

Yes 2009 Armenia Health System Performance Assessment. Government decree #1717-N-2006, MoH order #74-N-2005

Does it provide coverage for medicines that are on the EML for inpatients

Yes

Does it provide coverage for medicines that are on the EML for outpatients

Yes

Does it provide at least partial medicines coverage for inpatients

Yes

Does it provide at least partial medicines coverage for outpatients

Yes

Please describe/explain your answers for questions above

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.

Do private health insurance schemes provide any medicines coverage?

Yes 2009 Armenia Health System Performance Assessment 2009

If yes, is it required to provide at least partial coverage for medicines that are on the EML?

Unknown

5.02 Patients Fees and Copayments Core Questions In your health system, at the point of delivery, are there any copayment/fee requirements for consultations


In your health system, at the point of delivery, are there any copayment/fee requirements for medicines

Yes 2005 Government decree #1717-N-2006, MoH order #74-N-2005

Is revenue from fees or from the sale of medicines used to pay the salaries or supplement the income of public health personnel in the same facility

No 2007 WHO Level I

46

Please describe the patient fees and copayments system

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).

5.03 Pricing Regulation for the Private Sector Core Questions Are there legal or regulatory provisions affecting pricing of medicines

No 2010

Government runs an active national medicines price monitoring system for retail prices

No 2010

Regulations exists mandating that retail medicine price information should be publicly accessible

Yes 2001 Law on consumer rights protection

Comments It needs to be clarified, what does it mean publicly available, national legislation required to give such information in pharmacy.

47

5.04 Prices, Availability and Affordability Core Questions Please state if a medicines price survey using the WHO/HAI methodology has been conducted in the past 5 years in your country.

No

Basket of key medicines Private patient

Orig. 10.4 Price Median Price Ratio

LPG 3.42

Orig. 2.2 Affordability Days’ wages of the lowest paid govt worker for standard treatment with co-trimoxazole for a child respiratory infection

Number of days' wages

LPG 2.0

5.05 Price Components and Affordability Core Questions Please state if a survey of medicines price components has been conducted in the past 5 years in your country. If yes, please indicate the year of the survey and use the results to fill in the questions below

No 2010

5.06 Duties and Taxes on Pharmaceuticals (Market) Core Questions There are duties on imported active pharmaceutical ingredients (APIs)

No 2010

There are duties on imported finished products

No 2010

VAT (value-added tax) or any other tax on pharmaceuticals

Yes 2000 Amendment on law on value added tax AL 126

- If yes, please specify categories of pharmaceuticals on which the taxes are applied

Medicinal products

Supplementary Questions Amount of duties on imported active pharmaceutical ingredients, APIs (%)

0 2010

Amount of duties on imported finished products (%)

0 2010

Amount of VAT on pharmaceutical products (%)

20 2000 Amendment on law on value added tax AL 126

48

Section 6 Pharm.procurement and distribution 6.01 Public Sector Procurement Core Questions Public sector procurement is 2006 Armenia Health

System Review Decentralized No Centralized and decentralized Yes Please describe SPA 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.

If public sector procurement is wholly or partially centralized, it is under the responsibility of a procurement agency which is:

2002/2004

Government decree 1904-N Law on procurements

Part of MoH No Semi-Autonomous No Autonomous No A government procurement Agency which procures all public goods

Yes

Public sector tenders bids documents are publicly available

Yes 2010 State procurement agency

Public sector awards are publicly available


Procurements are based on prequalification of suppliers


If yes, please describe how it works State procurement agency http://www.gnumner.am/ Supplementary Questions Is there a written public sector procurement policy?. If yes, please write the year of approval in the "year" field.

No 2010

Are there provisions giving priority in public procurement to goods produced by local manufacturers?


The key functions of the procurement unit and those of the tender committee are clearly separated


A process exists to ensure the quality of products procured

Yes 2004 Law on procurement

If yes, the quality assurance process includes pre-qualification of products and suppliers

Yes

If yes, explicit criteria and procedures exist for pre-qualification of suppliers

Yes

http://www.gnumner.am/

49

If yes, a list of pre-qualified suppliers and products is publicly available

Yes

List of samples tested during the procurement process and results of quality testing is available

Yes 2010 MRA

Which of the following tender methods are used in public sector procurement:

2007

WHO Level I

National competitive tenders Yes International competitive tenders No Direct purchasing Yes Comments There is a law on procurements: State procurement

agency http://www.gnumner.am/ 6.02 Public Sector Distribution Core Indicators The government supply system department has a Central Medical Store at National Level

Yes 2010 MoH

Number of public warehouses in the secondary tier of public distribution (State/Regional/Provincial)

0 2010

There are national guidelines on Good Distribution Practices (GDP)

No 2010

There is a licensing authority that issues GDP licenses

No 2010

List of GDP certified warehouses in the public sector exists

No 2010

List of GDP certified distributors in the public sector exists

No 2010

Comments The MoH has a CMS which is called Humanitarian Aid Center.

Supplementary Questions Which of the following processes at the Central Medical Store is in place

Yes 2003 MoH and Government Decree # 799-N

Forecasting of order quantities Yes Requisition/Stock orders Yes Preparation of picking/packing slips Yes Reports of stock on hand Yes Reports of outstanding order lines Yes Expiry dates management Yes Batch tracking Yes Reports of products out of stock Yes Percentage of selected medicines with at least one stock out in the past year (%)

2010 NA

Routine Procedure exists to track the Yes 2010 MoH

http://www.gnumner.am/

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expiry dates of medicines The Public Central Medical Store is GDP certified by a licensing authority

No 2010

The Public Central Medical Store is ISO certified

No 2010

The second tier public warehouses are GDP certified by a licensing authority

No 2010

The second tier public warehouses are ISO certified

No 2010

6.03 Private Sector Distribution Core Questions Legal provisions exist for licensing wholesalers in the private sector

Yes

Legal provisions exist for licensing distributors in the private sector

Yes

List of GDP certified wholesalers in the private sector exists

No

List of GDP certified distributors in the private sector exists

No

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Section 7 Selection and rational use 7.01 National Structures Core Questions National Standard Treatment Guidelines (STGs) for most common illnesses are produced/endorsed by the MoH. If yes, please insert year of last update of STGs in the "year" field and attach document or provide URL below*


If yes, STG's are applied to Primary care. Please use the "year" field to write the year of last update of primary care STGs.


If yes, STG's are applied to Secondary (hospitals). Please use the "year" field to write the year of last update of secondary care STGs.


If yes, STG's are applied to Paediatric conditions. Please use the "year" field to write the year of last update of paediatric condition STGs.


National essential medicines list (EML) exists. If yes, please write year of last update of EML in the "year" field and attach document or provide URL below.


If yes, number of medicines on the EML

293

If yes, there is a written process for selecting medicines on the EML

Yes

If yes, the EML is publicly available Yes

% of public health facilities with copy of EML (mean)- Survey data

NA

% of public health facilities with copy of STGs (mean)- Survey data

88.6 2007 Options for Improving the Supply and Use of Medicines for Primary Health Care in Armenia MSF/USAID-2007

A public or independently funded national medicines information centre provides information on medicines to prescribers, dispensers and consumers


52

Public education campaigns on rational medicine use topics have been conducted in the previous two years

Yes 2010 MRA

A survey on rational use of medicines has been conducted in the previous two years

No 2010

A national programme or committee (involving government, civil society, and professional bodies) exists to monitor and promote rational use of medicines

No 2010

A written National Strategy exists to contain antimicrobial resistance.

No 2010

Supplementary Questions The EML includes formulations specific for children

No 2010

There are explicit documented criteria for selection of medicines in the EML

No 2010

There is a formal committee or other equivalent structure for the selection of products on the national EML


If yes, provide the official documentation establishing the committee *

MoH order #965 2006

If yes, conflict of interest declarations are required from members of national EML committee

Yes

National medicines formulary exists Yes 2010 MRA Is there a funded national inter-sectoral task force to coordinate the promotion of appropriate use of antimicrobials and prevention of spread of infection?

No 2010 MRA

A national reference laboratory/or any other institution has responsibility for coordinating epidemiological surveillance of antimicrobial resistance

No 2007 WHO Level I

7.02 Prescribing Core Questions Legal provisions exist to govern the licensing and prescribing practices of prescribers

Yes 2002 Government decree #100

Legal provisions exist to restrict dispensing by prescribers


Regulations require hospitals to organize/develop Drug and Therapeutics Committees (DTCs)


53

The core medical training curriculum includes components on:

2010 Medical University. National Institute of Health

Concept of EML Yes Use fo STGs Yes Pharmacovigilance Yes Problem based pharmacotherapy Yes The core nursing training curriculum includes components on:

Concept of EML - Use of STGs - Pharmacovigilance - The core training curriculum for paramedical staff includes components on:

Concept of EML - Use of STGs - Pharmacovigilance - Mandatory continuing education that includes pharmaceutical issues is required for Doctors


Mandatory continuing education that includes pharmaceutical issues is required for Nurses

Yes 2002 Government decree #867

Mandatory continuing education that includes pharmaceutical issues is required for Paramedical staff


Prescribing by INN name is obligatory in:

Private sector No

Public sector No

Average number of medicines prescribed per patient contact in public health facilities (mean)

-

% of medicines prescribed in outpatient public health care facilities that are in the national EML (mean)

-

% of medicines in outpatient public health care facilities that are prescribed by INN name (mean)

-

% of patients in outpatient public health care facilities receiving antibiotics (mean)

-

% of patients in outpatient public health care facilities receiving injections (mean)

-

54

% of prescribed drugs dispensed to patients (mean)

-

% of medicines adequately labelled in public health facilities (mean)

-

Supplementary Questions A professional association code of conduct exists governing professional behaviour of doctors

Unknown 2010

A professional association code of conduct exists governing professional behaviour of nurses

Unknown 2010

Diarrhoea in children treated with ORS (%)

82.7 2007 Options for Improving the Supply and Use of Medicines for Primary Health Care in Armenia MSF/USAID-2007

7.03 Dispensing Core Questions Legal provisions exist to govern dispensing practices of pharmaceutical personnel

Yes 2002 MoH order #100

The basic pharmacist training curriculum includes components on:

2010 Medical University

Concept of EML Yes Use fo STGs Yes Drug Information Yes Clinical pharmacology Yes Medicines supply management Yes Mandatory continuing education tat includes rational use of medicines is required for pharmacists


Substitution of generic equivalents at the point of dispensing in public sector facilities is allowed

Yes 2010

Substitution of generic equivalents at the point of dispensing in private sector facilities is allowed

Yes 2010

Antibiotics are sold over-the-counter without a prescription


Injectable medicines are sold over-the-counter without a prescription


Supplementary Questions A professional association code of conduct exists governing professional behaviour of pharmacists

No 2010

Are the following categories of staff 2007 WHO Level I

55

prescribing prescription-only medicines at primary care level in the public sector? Doctors Yes Nurses No Pharmacists No

Section 8 Household data/access 8.01 Data from Household Surveys Core Questions What household surveys have been undertaken in the past 5 years to assess access to medicines?

According to the AHSP Assessment, a household survey was conducted in 2006, but the requested data are not included: http://www.euro.who.int/__data/assets/pdf_file/0020/103385/E92994.pdf.


Documents

Draft 'country profiles' CORE Armenia 22June … · official National Medicines Policy document exists in Armenia. It was updated in 2006 [10]. In fact the NMP is part of the NHP