afghanistan pscp narrative 2012-07-25 rev3 relating to the pharmaceutical sector in afghanistan. the...
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AFGHANISTAN
PHARMACEUTICAL COUNTRY PROFILE
ii
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.
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]
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.
iii
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
iv
v
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
1
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.
2
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
3
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
4
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.
5
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)
6
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
7
(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
public sector
1,250
Pharmacists in the Public Sector 600
Pharmaceutical technicians and assistants (all
sectors) (2011)
1,400 (0.47 /10,000)9
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)
8
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.
9
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)
10
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
implementation plan written in 2011 also exists.14
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/
11
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
12
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
public health
[No]
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]
13
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.
14
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
15
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
16
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
17
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
18
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
19
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
Psychotropic Substances, 1988
Yes
25 INCB
20
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.
21
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
22
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
23
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
24
%
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]
25
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
26
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.
27
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/
28
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
29
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 are in the national EML (mean)
89.2
% of medicines in outpatient public health care facilities that are prescribed by INN name (mean)
60
% of patients in outpatient public health care facilities receiving antibiotics (mean)
50.5
% of patients in outpatient public health care facilities receiving injections (mean)
5.5
% of prescribed drugs dispensed to patients (mean) (comment: only in the PHC facilities when drugs are available)
99
% 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
30
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
31
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.
32
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.
33
List of key reference documents
Document Exact title Author / Publisher
Year
File name
National Medicines Policy (NMP)
National Medicine Policy 2003
MoPH 2003 http://apps.who.int/medicinedocs/en/m/abstract/Js17404e/
NMP implementation plan
not available
National Medicines Act
Medicines Production and Importation Act
MoPH / Ministry of Justice
2006 http://moj.gov.af
Latest report on the national pharmaceutical market (any source)
Afghanistan Pharmaceutical Sector Development: Problems and Prospects - Southern Med Review Vol 4 Issue 1 April 2011
Harper, Jonathan; Strote, Gunnar
2011 http://apps.who.int/medicinedocs/en/m/abstract/Js18434en/
National pharmaceutical legislation for regulation
Medicine Law MoPH / Ministry of Justice (Official Gazett)
2006 http://moj.gov.af
Legal provisions on medicines price regulations
Medicines Production and Importation Act
MoPH / Ministry of Justice
2006 http://moj.gov.af
Medicines procurement policy
not available
National Essential Medicines List (EML)
National Essential Drugs List (EDL) - (Annex 1: Procedure for Application for Inclusion of Medicines on the Essential Drugs List of the Ministry of Public Health of Afghanistan)
GDPA / MoPH 2007 http://apps.who.int/medicinedocs/en/m/abstract/Js17405e/
National Standard Treatment Guidelines (STGs)
in development