Afghanistan Pharmaceutical Country Profile

AFGHANISTAN

PHARMACEUTICAL COUNTRY PROFILE

Published by the Ministry of Public Health of Afghanistan in collaboration with the World Health Organization

December 2011

Any part of this document may be freely reviewed, quoted, reproduced, or translated in full or in part, provided that the source is acknowledged. It may not be sold, or used in conjunction with commercial purposes or for profit.

This document was produced with the support of the World Health Organization (WHO) Afghanistan Country Office, and all reasonable precautions have been taken to verify the information contained herein. The published material does not imply the expression of any opinion whatsoever on the part of the World Health Organization, and is being distributed without any warranty of any kind – either expressed or implied. The responsibility for interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.

Users of this Profile are encouraged to send any comments or queries to the following address:

B.Pharm. Abdul Hafiz Quraishi Director General of Pharmaceutical Affairs Ministry of Public Health Islamic Republic of Afghanistan

Email: [email protected]

Foreword

The 2011 Pharmaceutical Country Profile for Afghanistan has been produced by the Ministry of Public Health, in collaboration with the World Health Organization.

This document contains information on existing socio-economic and health- related conditions, resources; as well as on regulatory structures, processes and outcomes relating to the pharmaceutical sector in Afghanistan. The compiled data comes from international sources (e.g. the World Health Statistics), surveys conducted in the previous years and country level information collected in 2011. 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 Public Health of Afghanistan, I wish to express my appreciation to everyone involved to their contribution to the process of data collection and the development of this profile.

It is my hope that partners, researchers, policy-makers and all those who are interested in the Afghanistan pharmaceutical sector will find this profile a useful tool to aid their activities.

Pharmacist Abdul Hafiz Quraishi

Director General of Pharmaceutical Affairs

iii

Table of content

Afghanistan Pharmaceutical Country Profile ...... ii Foreword ...... iii Table of content ...... v Introduction ...... 1 Section 1 - Health and Demographic Data ...... 3 Section 2 - Health Services ...... 5 Section 3 - Policy Issues ...... 10 Section 4 – Medicines Trade and Production ...... 12 Section 5 – Medicines Regulation ...... 14 Section 6 - Medicines Financing ...... 21 Section 7 - Pharmaceutical procurement and distribution in the public sector ...... 25 Section 8 - Selection and rational use of medicines ...... 27 Section 9 - Household data/access ...... 32 List of key reference documents ...... 33

Introduction

This Pharmaceutical Country Profile provides data on existing socio-economic and health-related conditions, resources, regulatory structures, processes and outcomes relating to the pharmaceutical sector of Afghanistan. The aim of this document is to compile all relevant, existing information on the pharmaceutical sector and make it available to the public in a user-friendly format. In 2010, the country profiles project was piloted in 13 countries (http://www.who.int/medicines/areas/coordination/coordination_assessment/e n/index.html). During 2011, the World Health Organization has supported all WHO Member States to develop similar comprehensive pharmaceutical country profiles.

The information is categorized in 9 sections, namely: (1) Health and Demographic data, (2) Health Services, (3) Policy Issues, (4) Medicines Trade and Production (5) Medicines Regulation, (6) Medicines Financing, (7) Pharmaceutical procurement and distribution, (8) Selection and rational use, and (9) Household data/access. The indicators have been divided into two categories, namely "core" (most important) and "supplementary" (useful if available). This narrative profile is based on data derived from both the core and supplementary indicators. The tables in the annexes also present all data collected for each of the indicators in the original survey form. For each piece of information, the year and source of the data are indicated; these have been used to build the references in the profile and are also indicated in the tables. If key national documents are available on-line, links have been provided to the source documents so that users 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 (WHO), 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 all 193 member states has been conducted using a user- friendly electronic questionnaire that included a comprehensive instruction manual and glossary. Countries were requested not to conduct any additional surveys, but only to enter the results from previous surveys and to provide centrally available information. To facilitate the work of national counterparts, the questionnaires were pre-filled at WHO HQ using all publicly-available data and before being sent out to each country by the WHO Regional Office. A coordinator was nominated for each of the member states. The regional project manager for the Eastern Mediterranean Region was Dr Julian Renoldner.

The completed questionnaires were then used to generate individual country profiles. In order to do this in a structured and efficient manner, a text template was developed. Experts from member states took part in the development of the profile and, once the final document was ready, an officer from the Ministry of Health certified the quality of the information and gave formal permission to publish the profile on the WHO web site.

This profile will be regularly updated by the Ministry of Public Health. Comments, suggestions or corrections may be sent to:

B.Pharm. Abdul Hafiz Quaraishi Director General of Pharmaceutical Affairs Ministry of Public Health, Islamic Republic of Afghanistan Shahi Doshamshira Wali, near Ansari High School Kabul, Afghanistan [email protected]

Section 1 - Health and Demographic Data

1.1 Demographics and Socioeconomic Indicators

The estimated total population of Afghanistan in 2010 was 30 million with an annual population growth rate of 3.2% 1 . The annual GDP growth rate is 8.2 %2. The GDP per capita was US$ 501 (at the current exchange rate3).2 50% of the population is under 15 years of age, and 4% of the population is over 60 years of age. The urban population currently stands at 24% of the total population. The fertility rate in Afghanistan is 6.3 births per woman. 8% of the population is living with less than $1.25/day (international PPP). The adult literacy rate for the population over 15 years is 17%.4

1.2 Mortality and Causes of Death

The life expectancy at birth is 47 and 50 years for men and women respectively. The infant mortality rate (i.e. children under 1 year) is 134/1,000 live births. For children under the age of 5, the mortality rate is 199/1,000 live births. The maternal mortality rate is 1,400/100,000 live births.

1 Data provided by Ministry of Public Health (MoPH), Afghanistan (2010) 2 World Bank data (2010), available at: http://data.worldbank.org/country/afghanistan 3 The exchange rate for calculation for AFN is 50 AFN = 1 US$, which is consistent with the timing of the collection of related NHA data. 4 National Risk and Vulnerability Assessment (NRVA) 2007/8 (2008), available online: http://ec.europa.eu/europeaid/where/asia/documents/afgh_nrva_2007-08_full_report_en.pdfZ

The top 10 diseases causing mortality in Afghanistan are Disease 1 Influenza & Pneumonia 2 Diarrhoeal diseases 3 Coronary Heart Disease 4 Malaria 5 Birth trauma 6 Low Birth Weight 7 War 8 Stroke 9 Malnutrition 10 Tuberculosis

The top 10 diseases causing morbidity in Afghanistan are Disease 1 Other cases 2 Acute Watery Diarrhoea 3 Cough and Cold 4 ENT 5 Peptic disorder 6 Urinary tract infections 7 Acute bloody diarrhoea 8 Musculoskeletal disease 9 Trauma 10 Pneumonia MoPH/ Health Management Information System (HMIS) (2011), www.moph.gov.af/hmis

The adult mortality rate for both sexes between 15 and 60 years is 399/1,000 population, while the neonatal mortality rate is 53/1,000 live births. The age- standardised mortality rate by non-communicable diseases is 1,117/100,000, 719/100,000 by cardiovascular diseases and 164/100,000 by cancer. The mortality rate for tuberculosis is 38/100,000. The mortality rate for Malaria is 0.3/100,000.

Section 2 - Health Services

This section provides information regarding health expenditures and human resources for health in Afghanistan. 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 Afghanistan, the total annual expenditure on health (THE) in 2008 was million AFN 52 billion (US$ 1,043 million). The total annual health expenditure was 10 % of the GDP (2008)5,6. The total annual expenditure on health per capita was 2100 AFN (US$ 42) (2010)7.

The general government health expenditure (GGHE) in 2008, as reflected in the national health accounts (NHA) was AFN 3,129 million (US$ 62.58 million) 8. That is, 6 % of the total expenditure on health, with a total annual per capita public expenditure on health of AFN 125 (US$ 2.52). The government annual expenditure on health represents 4% of the total government budget. Private health expenditure covers 76% and the donors and NGOs cover 18% of the total health expenditure.

Of the total population, about 80 % is covered by a public health service, public health insurance or social insurance or other sickness funds.

Total pharmaceutical expenditure (TPE) in Afghanistan in 2008 was 14,450 million AFN (US$ 289 million), which is a per capita pharmaceutical expenditure of 588 AFN (US$ 11.76)9. The total pharmaceutical expenditure accounts for 2.8 % of the GDP and makes up 28 % of the total health

5 NHA database, http://apps.who.int/nha/database 6 Global Health Observatory 7 Calculated based on data provided in GHO 8 According to the NHA definition, by "government expenditure" it is meant all expenditure from public sources, like central government, local government, public insurance funds and parastatal companies. 9 GDPA, MoPH (2011)

expenditure (Figure 1). Public expenditure on pharmaceuticals represents 1.68% of the total expenditure on pharmaceuticals, this converts into a per capita public expenditure on pharmaceuticals of 35 AFN (US$ 0.7)10.

FIGURE 1: Share of Total Pharmaceutical Expenditure as percentage of the Total Health Expenditure (2008). The THE in 2008 was 52,000 million AFN (US$ 1,043 million).

GDPA, MoPH (2011)

Total private expenditure on pharmaceuticals is unknown.

Private out-of-pocket expenditure as % of private health expenditure is 99.7%.9 Premiums for private prepaid health plans are 0 % of total private health expenditure.11

2.2 Health Personnel and Infrastructure

The health workforce is described in the table below and in Figure 3 and 4. There are 2,407 (0.80 /10,000) licensed pharmacists, of which 1,250

10 Calculated based on data provided by GDPA/MoPH (2011), based on a population estimate of 30 million. 11 National Health Accounts of Afghanistan year 2008-2009

(0.2/10,000) work in the public sector. There are 1,400 (0.47 /10,000) pharmaceutical technicians and assistants (in all sectors).

There are 7,248 (2.1 /10,000) physicians and 17,257 (5 /10,000) nursing and midwifery personnel in Afghanistan. The ratio of doctors to pharmacists is 3.0 and the ratio of doctors to nurses and midwifery personnel is 0.42.

Table 1: Human resources for health in Afghanistan Human Resource Licensed pharmacists (all sectors) (2010) 2,407 (0.8 /10,000)12 Pharmacists and Assistant Pharmacists in the 1,250 public sector Pharmacists in the Public Sector 600 Pharmaceutical technicians and assistants (all 1,400 (0.47 /10,000)9 sectors) (2011) Physicians (all sectors) (2009) 7,248 (2.1 /10,000)5 Nursing and midwifery personnel (all sectors) 17,257 (5 /10,000) 5

12 GDPA, MoPH (2010)

Figure 3: The density of the Health Workforce in Afghanistan

GDPA, MoPH, GHO (2009, 2010, 2011)

Figure 4: Distribution of Pharmaceutical Personnel, Afghanistan (2011)

GDPA, MoPH (2011)

In Afghanistan, there is no strategic plan for the pharmaceutical sector alone, but it is included in the strategic plan of the Ministry of Public Health. A draft strategic framework for the human resource development of the pharmaceutical sector exists.

The health workforce is described in the table below and in Table 2. There are 160 hospitals and 4 /10,000 hospital beds in Afghanistan. There are 12,223 primary health care units and centres and 12,800 licensed pharmacies.

Table 2: Health centre and hospital statistics Infrastructure Hospitals 1609 Hospital beds (2009) 4/10,0005 Primary health care units and centres (2011) 12,22313 Licensed pharmacies (2011) 12,8009

The annual starting salary for a newly registered pharmacist in the public sector is 1200 USD (ca. 60,000 AFN). The total number of pharmacists who graduated (as a first degree) in the past 2 years is 150. There is a need for accreditation of pharmacy schools. The pharmacy Curriculum is regularly reviewed.

Additional information: Afghanistan’s focus in the area of health workforce is the training of midwifes and community midwifes. The private sector is currently establishing new schools for medical and pharmaceutical education. This includes the training of pharmaceutical technicians in some provinces in the country. The retention of this qualified workforce has been a challenge for the country, yet the government is currently developing specific plans to counteract this issue. Many international agencies such as USAID, WB, EU, WHO, UN agencies, Donor Agencies and International NGOs are supporting Afghanistan in this endeavour.

In addition, there are currently a number of hospitals and primary care units under construction in some parts of the country according to needs and population coverage. One can find a number of licensed pharmacies in the capital and the province capitals, although adequate distribution and hence access remains an area of concern.

13 MoPH (2011)

Section 3 - Policy Issues

This section addresses the main characteristics of the pharmaceutical policy in Afghanistan. The many components of a national pharmaceutical policy are taken from the WHO publication “How to develop and implement national drug policy” (http://apps.who.int/medicinedocs/en/d/Js2283e/). Information about the capacity for manufacturing medicines and the legal provisions governing patents is also provided.

3.1 Policy Framework In Afghanistan, a National Health and Nutrition Policy (NHNP) exists. It was updated in 2007 and again in 2012. An associated National Health Policy 14 implementation plan written in 2011 also exists.

An official National Medicines Policy (NMP) document exists in Afghanistan. It was developed in 2003 and its revision is under process.

A NMP implementation plan does not exist. Policies addressing pharmaceuticals exist as detailed in Table 2. Pharmaceutical policy implementations are not regularly monitored or assessed.

14 Policies (GDPP/ MoPH) National Health Policy (2007), National Health Policy Implementation Plan (2011). National Medicines Policy (2003), available online: http://apps.who.int/medicinedocs/en/m/abstract/Js17404e/

Table 3: The NMP covers Aspect of policy Covered Selection of essential medicines Yes Medicines financing No Medicines pricing No Medicines Procurement Yes Medicines Distribution Yes Medicines Regulation Yes Pharmacovigilance No Rational use of medicines Yes Human Resource Development No Research No Monitoring and evaluation No Traditional Medicine No

Neither a policy relating to clinical laboratories nor an associated national clinical laboratory policy implementation plan exists. Access to essential medicines/technologies as part of the fulfillment of the right to health, is not recognized in the constitution or national legislation. There are official written guidelines on medicines donations15. There is no national good governance policy in Afghanistan. A policy is not in place to manage and sanction conflict of interest issues in pharmaceutical affairs. There is no associated formal code of conduct for public officials. A whistle-blowing mechanism that allows individuals to raise concerns about wrongdoing occurring in the pharmaceutical sector of Afghanistan exists, but is not very strong. A pharmaceutical council does not exist in Afghanistan; however there are National Drug Importers Associations. USAID/SPS supports the GDPA in strengthening the pharmaceutical system. WHO provides technical support in policy and strategy issues.

15 Drug donation guideline, MoPH, 2003

Section 4 – Medicines Trade and Production 4.1 Intellectual Property Laws and Medicines

Afghanistan is not a member of the World Trade Organization and national legal provisions granting patents to manufacturers do not exist. There is no responsible institution working on Intellectual Property Rights, but TAFA (an in international NGO) has started some work in this area.

National Legislation has not been modified to implement the TRIPS Agreement and does not contain TRIPS-specific flexibilities and safeguards, presented in Table 4. Afghanistan is not eligible for the transitional period to 2016.

Table 4: TRIPS flexibilities and safeguards are present in the national law Flexibility and safeguards Included Compulsory licensing provisions that can be applied for reasons of [No] public health Bolar exceptions16 [No] Parallel importing provisions [No]

There are no legal provisions for data exclusivity for pharmaceuticals, patent term extension or linkage between patent status and marketing authorization)

16 Many countries use this provision of the TRIPS Agreement to advance science and technology. They allow researchers to use a patented invention for research, in order to understand the invention more fully. In addition, some countries allow manufacturers of generic drugs to use the patented invention to obtain marketing approval (for example from public health authorities) without the patent owner’s permission and before the patent protection expire. The generic producers can then market their versions as soon as the patent expires. This provision is sometimes called the “regulatory exception” or “Bolar” provision. Article 30 This has been upheld as conforming with the TRIPS Agreement in a WTO dispute ruling. In its report adopted on 7 April 2000, a WTO dispute settlement panel said Canadian law conforms with the TRIPS Agreement in allowing manufacturers to do this. (The case was titled “Canada - Patent Protection for Pharmaceutical Products”) [In: WTO OMC Fact sheet: TRIPS and pharmaceutical patents, can be found on line at: http://www.wto.org/english/tratop_e/trips_e/tripsfactsheet_pharma_2006_e.pdf]

The country is not engaged in capacity-strengthening initiatives to manage and apply Intellectual Property Rights in order to contribute to innovation and promote public health.

4.2 Manufacturing There are 18 licensed pharmaceutical manufacturers in Afghanistan. Manufacturing capabilities are presented in Table 5 below.

Table 5: Afghanistan manufacturing capabilities9 Manufacturing capabilities Research and Development for discovering new active substances No Production of pharmaceutical starting materials (APIs) No The production of formulations from pharmaceutical starting material Yes The repackaging of finished dosage forms No

The percentage of the market share by value produced held by domestic manufactures is unknown.

Section 5 – Medicines Regulation

This section details the pharmaceutical regulatory framework, resources, governing institutions and practices in Afghanistan.

5.1 Regulatory Framework In Afghanistan, there are legal provisions establishing the powers and responsibilities of the Medicines Regulatory Authority (MRA). The MRA is responsible to regulate the medicines system both in public and in private sector and as well as in the medicine system of NGOs and other government departments, but the enforcement of the regulations is very poor in the country.

The MRA is a part of the MoPH (General Directorate of Pharmaceutical Affairs) with a number of functions outlined in Table 6. The MRA does not have its own website, but there is a folder by the name of GDPA in the website of the MoPH, for which the URL address is http://moph.gov.af (General Directorates Pharmaceuticals Affairs).

Table 6: Functions of the national MRA9 Function Marketing authorisation / registration Yes Inspection No Import control Yes Licensing Yes Market control Yes Quality control No Medicines advertising and promotion No Clinical trials control No Pharmacovigilance No

As of 2011, there was 175 permanent staff working for the MRA. The MRA receives external technical assistance from the WHO, USAID/SPS, HPIC, EC

to support its activities. The MRA is involved in harmonization/collaboration initiatives such as cooperation with police, the custom department and the security department. Funding for the MRA is provided through the regular government budget. The Regulatory Authority does not retain revenues derived from regulatory activities. This body does not utilize a computerized information management system to store and retrieve information on processes that include registrations, inspection etc.9.

In addition, there is another body within the MoPH called “Department of Health Regulations and Monitoring and Enforcement of the Health Regulations”, which is responsible for the licensing of the private clinics, hospitals and private health practitioners, as well as for inspecting the private pharmacies and hospitals. The MRA is responsible for licensing of the private pharmacies, drug wholesalers and drug importing companies

5.2 Marketing Authorization (Registration)

In Afghanistan, legal provisions require marketing authorization (registration) for all pharmaceutical products on the market 17 . Mutual recognition mechanisms are in place18. Explicit and publicly available criteria do not exist for assessing applications for marketing authorization of pharmaceutical products. In Afghanistan only pharmaceutical companies are registered, medicines are not registered. There are no legal provisions requiring the MRA to make the list of registered pharmaceutical products publicly available and update it regularly. Medicines always registered by their INN (International Non- proprietary Names) or Brand name + INN. Legal provisions require a fee to be paid for Medicines Market Authorization (registration) based on applications20.

17 GDPA / MOPH (2012)

18 Medicines’ production and importation and medical material / equipment Act of 2006 and Private Pharmacies’ Act of 2006

Marketing Authorization holders are required by law to provide information about variations to the existing Marketing Authorization. Legally, a Summary of Product Characteristics (SPC) of the medicines that are registered is not required to be published. Furthermore, legal provisions requiring the establishment of an expert committee involved in the Marketing Authorization process are not in place. Possession of a Certificate for Pharmaceutical Products is required as part of the Marketing Authorization application.9 A law requiring declaration of potential conflict of interests for experts involved in the assessment and decision-making for registration does not exist. Applicants may legally appeal MRA decisions.

The registration fee (per application) for a pharmaceutical product containing a New Chemical Entity (NCE) and for generic pharmaceutical products is AFN 5000 (US$ 100) 19 . The time limit for the assessment of all Marketing Authorization applications is three months.

5.3 Regulatory Inspection In Afghanistan, legal provisions exist allowing for appointment of government pharmaceutical inspectors. These are permitted to inspect premises where pharmaceutical activities are performed; such inspections are required by law and are a pre-requisite for the licensing of public and private facilities 20 . Where inspections are legal requirements, these are the same for public and private facilities. Inspections for GMP compliance are not carried out in Afghanistan.

Table 7: Local entities inspected for GMP compliance9 Entity Inspection Local manufacturers No Private wholesalers No Retail distributors No Public pharmacies and stores NO Pharmacies and dispensing points if health facilities No

19 GDPA/MoPH (2011) 20 Medicines’ Product and Importation Act of 2006

5.4 Import Control Legal provisions exist requiring authorization to import medicines. Laws exist that allow the sampling of imported products for testing. In addition importation of medicines is only allowed through authorized ports of entry.20 Regulations exist to allow for inspection of imported pharmaceutical products at authorized ports of entry, but due to lack of human and financial resources the inspection at the ports of entry are often not performed21.

5.5 Licensing In Afghanistan, legal provisions exist requiring manufacturers (both domestic and international) to be licensed20. Legal provisions exist requiring manufacturers (both domestic and international) to comply with Good Manufacturing Practices (GMP), but currently the GMPs are required only for the International manufacturers and not for the domestic manufacturers, because the GDPA has not developed GMP for the manufacturers yet. International GMPs are followed for the international manufacturers. Also importers and wholesalers are by law required to be licensed. Yet, legal provisions do not exist requiring these actors to comply with Good Distributing Practices.

Table 8: Legal provisions pertaining to licensing Entity requiring licensing Importers Yes Wholesalers Yes Distributors Yes

Good Distribution Practices are not published by the government, yet legal provisions exist requiring pharmacists to be registered22. Private pharmacies are required to be licensed. National Good Pharmacy Practice Guidelines do not exist and by law, a list of all licensed pharmaceutical facilities is not required to be published.

21 GDPA / MoPH (2011) 22 Medicines’ Production and Importation Act of 2006

5.6 Market Control and Quality Control In Afghanistan, legal provisions exist for controlling the pharmaceutical market22. A laboratory exists in Afghanistan for Quality Control testing. This laboratory is existing in the premises of MoPH under the direct supervision of the Minister of Public Health. The laboratory is not a functional part of the MRA. Existing national laboratory facilities have not been accepted for collaboration with the WHO pre-qualification Programme. Medicines are tested for a number of reasons, summarised in Table 9.

Table 9: Reason for medicines testing Medicines tested: For quality monitoring in the public sector23 No For quality monitoring in the private sector24 No When there are complaints or problem reports Yes For product registration Yes For public procurement prequalification No For public program products prior to acceptance and/or distribution No

There is no post-marketing surveillance testing system. In the past two years, 1,100 samples were taken for quality control testing. Of the samples tested, 20 (or 1.82 %) failed to meet the quality standards. The results are not publicly available9.

5.7 Medicines Advertising and Promotion In Afghanistan, legal provisions exist to control the promotion and/or advertising of prescription medicines (Medicines’ Production and Importation Act of 2006). GDPA of the MoPH is responsible for regulating promotion and/or advertising of medicines. Legal provisions prohibit direct advertising of prescription medicines to the public, and pre-approval for medicines advertisements and promotional materials is required. Guidelines and

23 Routine sampling in pharmacy stores and health facilities 24 Routine sampling in retail outlets

Regulations do not 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.

5.8 Clinical Trials In Afghanistan, legal provisions requiring authorization for conducting clinical trials by the MRA do not exist. There are no additional laws requiring the agreement by an ethics committee or institutional review board of the clinical trials to be performed. Clinical trials are not required to be entered into an international/national/regional registry by law.

Legal provisions do not exist for GMP compliance of investigational products. Sponsor investigators are not legally required to comply with Good Clinical Practices (GCP). National GCP regulations are not published by the Government. Legal provisions do not permit the inspection of facilities where clinical trials are performed.

5.9 Controlled Medicines Afghanistan is a signatory to a number of international conventions, detailed in Table 10.

Table 10: International Conventions to which Afghanistan is a signatory25 Convention Signatory Single Convention on Narcotic Drugs, 1961 Yes 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961 No Convention on Psychotropic Substances 1971 No United Nations Convention against the Illicit Traffic in Narcotic Drugs and Yes Psychotropic Substances, 1988

25 INCB

Laws for the control of narcotic and psychotropic substances and precursors do not exist, but Acts are available. The annual consumption of Morphine is 0.0 mg/capita (NA).

The legal provisions and regulations for the control of narcotic and psychotropic substances, and precursors have not been reviewed by a WHO International Experts or Partner Organizations to assess the balance between the prevention of abuse and access for medical need. Figures regarding the annual consumption of controlled substances in the country are not available.

5.10 Pharmacovigilance In Afghanistan, there are no legal provisions in the Medicines Act that provide for pharmacovigilance activities as part of the MRA mandate. Legal provisions do not exist requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA. Laws regarding the monitoring of Adverse Drug Reactions (ADR) do not exist in Afghanistan. A national pharmacovigilance centre linked to the MRA does not exist.

An official standardized form for reporting ADRs is not used in Afghanistan. Information pertaining to ADRs is not stored in a national ADR database. These reports are not sent to the WHO collaborating centre in Uppsala. There is no national ADR or pharmacovigilance advisory committee able to provide technical assistance or causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication in Afghanistan. A clear communication strategy for routine communication and crises communication does not exist. ADRs are not monitored in at least one public health program (example TB, HIV, AIDS). At the moment there is no pharmacovigilance system and steps have not been taken towards this initiative.

The enforcement of existing regulations should be strengthened and improved. SPS/USAID has started to help in strengthening the regulations.

Section 6 - Medicines Financing

In this section, information is provided on the medicines financing mechanism in Afghanistan, including the medicines coverage through public and private health insurance, use of user charges for medicines and the existence of public programmes providing free medicines. Policies and regulations affecting the pricing and availability of medicines (e.g. price control and taxes) are also discussed.

6.1 Medicines Coverage and Exemptions In Afghanistan, concessions are made for certain groups to receive medicines free of charge (see Table 12). Furthermore, the public health system provides medicines free of charge for particular conditions (see Table 13). All public health services are free of charge in Afghanistan according to the Constitutional law of Afghanistan.

Table 12: Population groups provided with medicines free of charge (Basic Package of Health Services (BPHS) and Essential Package for Hospital Services (EPHS) Patient group Covered Patients who cannot afford them Yes Children under 5 Yes Pregnant women Yes Elderly persons Yes

Table 13: Medications provided publicly, at no cost Conditions Covered All diseases in the EML Yes Any non-communicable diseases Yes Malaria Yes Tuberculosis Yes Sexually transmitted diseases Yes HIV/AIDS Yes Expanded Program on Immunization (EPI) vaccines for children Yes

A public health service, public health insurance, social insurance or other sickness fund provides at least partial medicines coverage (Public Health Law 2006). It provides coverage for medicines that are on the Essential Medicines List (EML) for inpatients and outpatients.26

Private health insurance schemes do not provide medicines coverage.

6.2 Patients Fees and Co-payments Co-payments or fee requirements for consultations are not levied at the point of delivery. Furthermore, there are no co-payments or fee requirements imposed for 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 Afghanistan Constitutional law, the health services should be provided by the government free of charge, so no public health facility is authorized to charge fees on patients’ consultation or medicines. In case medicines are not available patients can buy their medicine in private pharmacies.

26 Basic Package of Health Services for Primary Health Care facilities and Essential Package of Hospital Services for secondary and tertiary health care facilities

6.3 Pricing Regulation for the Private Sector27 In Afghanistan, there are legal or regulatory provisions affecting pricing of medicines 28 . These provisions are aimed at the level of manufacturers, wholesalers and retailers29.

The government does not run an active national medicines price monitoring system for retail prices. Regulations do not exist mandating that retail medicine price information should be publicly accessible.

6.4 Prices, Availability and Affordability of Key Medicines A WHO/HAI pricing survey has not been conducted in Afghanistan. Specific details regarding availability, pricing and affordability in the country are not available.

6.5 Price Components and Affordability A survey on medicine price components has not been conducted in Afghanistan.

6.6 Duties and Taxes on Pharmaceuticals (Market) Afghanistan imposes duties on imported active pharmaceutical ingredients (APIs) and duties on imported finished products are also imposed. Value- added tax or other taxes are imposed on finished pharmaceutical products.( Medicine Production and importation Act 2006) Provisions for tax exceptions or waivers for pharmaceuticals and health products are not in place. Any health, medical or pharmaceutical product imported for commercial purposes, will be charged duties. However, reliable data on duties and taxes is not available.

Table 14S2: Duties and taxes applied to pharmaceuticals

27 This section does not include information pertaining to the non-profit voluntary sector 28 Medicine Production and importation Act 2006, WHO Level I (2007) 29 Medicine Production and importation Act 2006

% Duty30 on imported active pharmaceutical ingredients, APIs (%) 8-10 Duty on imported finished products (%) 2.5 VAT on pharmaceutical products (%) 2

Further information and key findings: Key areas of concern regarding medicines financing:  The money charged for medicines does not go to the account of the GDPA or MoPH, it goes to the government and it cannot be used for the pharmaceutical affairs.  A significant amount of medicines enters the country illegally from the neighbour countries through open borders without duties paid.  Due to high corruption, some of the medicines are not charged duties properly or some of them are charged duties at disproportionate rates.  Change of medicines coverage over the past 10 years: There is a perceived improvement in medicines coverage; however data are not available.  Population or disease groups that still do not receive adequate coverage exist: people living in remote areas who are in need of medicines for communicable and non-communicable diseases. Access is limited due to lack of public services, insecurity, lack of transportation, harsh roads and other reasons.  Co-payments are not used as a method of financing the health system or to deter unnecessary demand. In the public sector all kind of health care services and medicines are given free of charge. According to the law health care should be free. However, the public sector can only provide less than 50% of the medicines for the people. Medicines not available in the public sector have to be purchased in private pharmacies out-of-pocket. These payments are going to private pharmacies revenue.  Trends regarding medicine pricing, availability and affordability:  Most of the medicines in the public sector are provided by donors free of charge. Pricing of medicines is not regulated adequately. Different companies import medicines with very different prices.  SPS/USAID is supporting initiatives to improve the selection, procurement, distribution, and rational use of drugs.  Recommendation: The imported active pharmaceutical Ingredients should be exempted from taxes.

30 Import tariff may apply to all imported medicines or there may be a system to exempt certain products and purchases. The import tax or duty may or may not apply to raw materials for local production. It may be different for different products. [In: HAI/WHO Measuring medicine prices, availability, affordability and price components (2nd Edition) and at: http://www.haiweb.org/medicineprices/manual/documents.html]

Section 7 - Pharmaceutical procurement and distribution in the public sector

This section provides a short overview on the procurement and distribution of pharmaceuticals in the public sector of Afghanistan.

7.1 Public Sector Procurement Public sector procurement in Afghanistan is both centralized and decentralized9.

The public sector procurement is centralized under the responsibility of a procurement agency which is semi-autonomous. Public sector request for tender documents are not publicly available and public sector tender awards are not publicly available. Procurement is based on the prequalification of suppliers.

According to the procurement rules at least three quotations are collected and based on the quotations, one supplier will be selected. Bidding methods differ depending on supplies. Procurement in the public sector is a very bureaucratic and prolonged process, which sometimes takes up to several months or a year to finalize procurement. The corruption in the public sector procurement is another risk factor, which is nowadays common in the country. Due to these factors, most of the vendors are not interested to participate in the public sector bidding process. Additionally putting some money in the bank as a guarantee for participating in the bidding process is another point, which discourages most of the vendors in the public sector.

There is no written public sector procurement policy and legal provisions that give priority to locally produced goods in public procurement do not exist

The key functions of the procurement unit and those of the tender committee are not clearly separated. A process exists to ensure the quality of products that are publicly procured; However only one quality control laboratory exists

for this process, which only tests the quantity of active ingredients in medicines, where there is no Quality Assurance System. The quality assurance process does not include the pre-qualification of products and suppliers.

A list of samples tested during the procurement process and the results of quality testing are not available. The tender methods employed in public sector procurement include, national competitive tenders, international competitive tenders and direct purchasing.

7.2 Public Sector Distribution The government supply system department in Afghanistan has a Central Medical Store at National Level also known as Central Stocks of the MoPH. There are 35 public warehouses in the secondary tier of the public sector distribution. There are no national guidelines on Good Distribution Practices (GDP). A licensing authority that issues GDP licenses does not exist.9

The percentage availability of key medicines at the Central Medical Store (CMS) is 80 %.9 The average stock-out duration at the CMS is 30 days. Routine procedure to track the expiry dates of medicines at the CMS exist. The Public CMS is not ISO certified; the second tier public warehouses are not. The second tier public warehouses are not GDP certified by a licensing authority.

7.3 Private Sector Distribution Legal provisions do not exist for licensing wholesalers or distributors in the private sector. A list of GDP certified wholesalers or distributors does not exist in the private sector9.

Section 8 - Selection and rational use of medicines

This section outlines the structures and policies governing the selection of essential medicines and promotion of rational drug in Afghanistan.

8.1 National Structures A National Essential Medicines List (EML) exists. The EML was lastly updated in 2007 and is publicly available. There are currently 430 medicines on the EML. Selection of medicines for the EML is undertaken through a written process. 31 A mechanism aligning the EML with the Standard Treatment Guidelines (STGs) is not in place.

National Standard Treatment Guidelines (STGs) for the most common illnesses are not produced/endorsed by the MoPH in Afghanistan. STGs for primary health care are under process and planned to be completed soon maybe by the end of 2012.

The percentage of the public health facilities that have a copy of the EML is unknown.

There is no public or independently funded national medicines information centre providing information on medicines to prescribers, dispensers and consumers. Public education campaigns on rational medicine use topics have not been conducted in the last two years. A survey on rational use of medicines has not been conducted in the previous two years. There is no national programme or committee, involving government, civil society, and professional bodies, to monitor and promote rational use of medicines.

31 National Essential Drugs List, December (2007), Islamic Republic of Afghanistan (Annex 1: Procedure for Application for Inclusion of Medicines on the Essential Drugs List of the Ministry of Public Health of Afghanistan) http://apps.who.int/medicinedocs/en/m/abstract/Js17405e/

A written National Strategy for containing antimicrobial resistance does not exist. Afghanistan’s Essential Medicines List (EML) includes formulations specifically for children. Criteria for the selection of medicines to the EML are explicitly documented.31 A national medicines formulary does exist.

A funded national intersectoral task force to coordinate the promotion of the appropriate use of antimicrobials and prevention of the spread of infection does not exist. A national reference laboratory or other institution does not have responsibility for coordinating epidemiological surveillance of antimicrobial resistance.

8.2 Prescribing Legal provisions do not exist to govern the licensing and prescribing practices of prescribers. Furthermore, legal provisions restricting dispensing by prescribers do not exist. Prescribers in the private sector dispense medicines (All the prescribers who have got licenses from the government, they are authorized to prescribe drugs, but there are some prescribers in the rural areas, who do not have any license and do the practice and they prescribe the drug). There are no regulations requiring hospitals to organize/develop Drug and Therapeutics Committees (DTCs).

The training curriculum for doctors and nurses is made up of a number of core components detailed in Table 16.

Table 16: Core aspects of the medical training curriculum (WHO Level I survey)15 Curriculum Covered The concept of EML No Use of STGS No Pharmacovigilance No Problem based pharmacotherapy Yes

Mandatory continuing education that includes pharmaceutical issues is not required for doctors, nurses or paramedical staff.

Prescribing by INN name is obligatory in the public and private sector32. The average number of medicines prescribed per patient contact in public health facilities is 1.9. Of the medicines prescribed in the outpatient public health care facilities, 89.2 % are on the national EML and 60 % are prescribed by INN name. Of the patients treated in the outpatient public health care facilities, 50.5 % receives antibiotics and 5.5 % receive injections. Of prescribed drugs in the public sector (Basic Package of Health Services), 99 % of the drugs are dispended to patients (depending on availability). Of medicines in public health facilities, only 1.1 % is adequately labelled.33

Table 17: Characteristics of medicines prescribing Curriculum % % of medicines prescribed in outpatient public health care facilities that 89.2 are in the national EML (mean) % of medicines in outpatient public health care facilities that are 60 prescribed by INN name (mean) % of patients in outpatient public health care facilities receiving 50.5 antibiotics (mean) % of patients in outpatient public health care facilities receiving 5.5 injections (mean) % of prescribed drugs dispensed to patients (mean) (comment: only in 99 the PHC facilities when drugs are available) % of medicines adequately labeled in public health facilities (mean) 1.1 A professional association code of conduct which governs the professional behaviour of doctors and nurses does not exist.

8.3 Dispensing Legal provisions in Afghanistan do not exist to govern dispensing practices of pharmaceutical personnel. The basic pharmacist training curriculum includes a spectrum of components as outlined in Table 18.

32 Medicine Production and importation Act 2006 33 Drug Study 2008 in Afghanistan by SPS/MSH

Table 18: Core aspects of the pharmacist training curriculum Curriculum Covered The concept of EML No Use of STGS No Drug information Yes Clinical pharmacology Yes Medicines supply management Yes

Mandatory continuing education that includes rational use of medicines is not required for pharmacists.

Substitution of generic equivalents at the point of dispensing is not allowed in public and private sector facilities. Sometimes antibiotics are sold over-the- counter without a prescription. Sometimes injectable medicines are sold over- the-counter without a prescription. A professional association code of conduct which governs the professional behaviour of pharmacists does not exist. In practice, nurses, pharmacists, paramedics and personnel with less than one month of training do sometimes prescribe prescription-only medicines at the primary care level in the public sector (even though this may be contrary to regulations).28

Further information and key findings:

The issue of rational use of medicines is an issue with very low concern in the public and as well as in the private sector in Afghanistan.

Some examples of initiatives in the public sector were mentioned before, but the private sector is worse than the public, where you can find the retail sellers who sell the drug on the streets in very open areas under the direct sun light even in summer in some of the bazaars and cities. Most of these sellers are not health professionals and even some of them are illiterate. Moreover, sometimes you can find antibiotics on these streets sold by retail sellers without any prescription, such as rifampicin. In all of the private pharmacies, any kind of medicine can be bought at any time without prescription.

Further comments: . There is no harmonization between public and private sector distribution practices. . Core focus areas for policy-makers and implementing bodies in order to increase rational use of medicines in the country: It is planned to improve rational use of medicine in the public and private sector, through improving the capacity and awareness of the health professionals and patients. . Partners supporting respective initiatives are SPS/USAID working on rational use of medicines (training, social mobilization and awareness programs); and WHO.

Section 9 - Household data/access

Information derived from past household surveys in Afghanistan regarding actual access to medicines by normal and poor households is not available.

Further information and key findings:

According to the MoPH people living in remote areas and some population groups (i.e. nomads) have limited access to medicines.

The MoPH has started an initiative of mobile health centres and some clinics for nomads, but actually they are very limited and they cannot cover most of these populations.

USAID/SPS is working with the MoPH in providing essential medicines for primary health care facilities in 13 provinces of Afghanistan, where the BPHS is supported by USAID. The medicines in other 21 provinces are supported by WB and EC donors. HPIC, a Canadian agency, is providing medicines to some of the hospitals in Kabul city.

List of key reference documents

Document Exact title Author / Yea File name Publisher r National Medicines National Medicine MoPH 2003 http://apps.who.i Policy (NMP) Policy 2003 nt/medicinedocs /en/m/abstract/J s17404e/ NMP implementation not available plan National Medicines Medicines MoPH / Ministry 2006 http://moj.gov.af Act Production and of Justice Importation Act Latest report on the Afghanistan Harper, 2011 http://apps.who.i national Pharmaceutical Jonathan; nt/medicinedocs pharmaceutical Sector Development: Strote, Gunnar /en/m/abstract/J market (any source) Problems and s18434en/ Prospects - Southern Med Review Vol 4 Issue 1 April 2011 National Medicine Law MoPH / Ministry 2006 http://moj.gov.af pharmaceutical of Justice legislation for (Official Gazett) regulation Legal provisions on Medicines MoPH / Ministry 2006 http://moj.gov.af medicines price Production and of Justice regulations Importation Act Medicines not available procurement policy National Essential National Essential GDPA / MoPH 2007 http://apps.who.i Medicines List (EML) Drugs List (EDL) - nt/medicinedocs (Annex 1: Procedure /en/m/abstract/J for Application for s17405e/ Inclusion of Medicines on the Essential Drugs List of the Ministry of Public Health of Afghanistan) National Standard in development Treatment Guidelines (STGs)