yemen pharmaceutical country profile

YEMEN

PHARMACEUTICAL COUNTRY PROFILE

ii

Yemen Pharmaceutical Country Profile

Published by the Ministry of Public Health & Population of the Republic of Yemen in collaboration with the World Health Organization

July 2012

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

conjunction with commercial purposes or for profit.

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

The Chief Pharmacist

Dr. Abdul Moneim Ali Al-Hakami

Email: [email protected]

This document was produced with the support of the World Health Organization (WHO) Yemen 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 Yemen has been produced by the

Ministry of 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 Yemen. 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 Yemen, I wish to express my appreciation to

Dr.Abdul Munaen Al-Hakami from Supreme Board for Medicine & Medical

Appliances for his 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 Yemen pharmaceutical sector will find this profile a useful tool to

aid their activities.

Name: Dr.Ahmed M. Aklan Al-Mashraqi Function in the Ministry of Health: Health Policy Unit Consultant Date: 18/5 / 2012

Signature:

v

Table of contents

Foreword .............................................................................................................. iii

Table of contents .................................................................................................. v

Introduction ........................................................................................................... 2

Section 1 - Health and Demographic Data ........................................................ 4

Section 2 - Health Services ................................................................................ 7

Section 3 - Policy Issues .................................................................................. 14

Section 4 – Medicines Trade and Production ................................................. 19

Section 5 – Medicines Regulation ................................................................... 21

Section 6 - Medicines Financing ...................................................................... 30

Section 7 - Pharmaceutical procurement and distribution in the public

sector ................................................................................................................. 37

Section 8 - Selection and rational use of medicines ...................................... 40

Brief conclusion: essential medicines and health technologies .................. 44

Key Documents ................................................................................................. 45

2

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 Yemen. 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/en/in

dex.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 8 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, and (8) Selection and rational use.

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

3

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 coordinator for Yemen was

Dr. Abdul Moneim Ali Al-Hakami.

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 Supreme Board for Drugs and

Medical Appliances. Comments, suggestions or corrections may be sent to:

Dr. Abdul Moneim Ali Al-Hakami

Aljarda zone

Sana’a city

Yemen

[email protected]

4

Section 1 - Health and Demographic Data

This section gives an overview of the demographics and health status of Yemen.

1.1 Demographics and Socioeconomic Indicators

The total population of Yemen in 2009 was 22,492,0351 with an annual

population growth rate of 3%1. The annual GDP growth rate is 3.022. The GDP

per capita was US$ 2,6063 (at the current exchange rate4).

46% of the population is under 15 years of age5, and 4% of the population is over

60 years of age. The urban population currently stands at 31% or the total

population. The fertility rate in Yemen is 5.2 births per woman. 17.53% of the

population is living with less than $1.25/day. The income share held by the

lowest 20% of the population is 7.18% (as a % of national income). The adult

literacy rate for the population over 15 years is 54.1 %.6

1.2 Mortality and Causes of Death

The life expectancy at birth is 61 and 62.9 years for men and women

respectively.7 The infant mortality rate (i.e. children under 1 year) is 68.5/1,000

live births. For children under the age of 5, the mortality rate is 78.2/1,000 live

births. The maternal mortality rate is 366/100,000 live births.

1.3 The top diseases causing morbidity in Yemen

Health Status (Morbidity and Death Causes)8

Existing health and vital statistics and data furnished in the 2009 Annual

Statistical Report by General Department for Information, Research and Health

Studies of MOPHP that the current morbidity and death causes are caused by

1 Central Statistical Organisation (CSO) (2009)

2 National Health Strategy 2010-2025

3 Fund for Peace Yemen Country profile 2011,

http://www.fundforpeace.org/global/states/ccppr11ye-countryprofile-yemen-11e.pdf 4 The exchange rate for calculation for NCU is at present 215 YR = 1 US$.

5 National Health Strategy 2010-2025

6 National Health Strategy (2010-2025)

7 Cluster survey with multiple indicators (2006)

8 The fourth five-year development plan (2011–2015)

5

infectious and endemic diseases which continue to pose real threat in the

Republic. Non-infectious diseases are also began to emerge despite improved

health infrastructure, health and medical staff in the public, military and private

sectors.

Morbidity (Patient pattern or the major morbidity causes) and causes of death It should be noted that analysis of patients pattern in Yemen, both at the

national or provincial level, was based on reports about patients’ frequency to

public health facilities and institutions exclusive in the the private sector, military,

police and other facilities. Table (1) shows the national patients pattern for most

common diseases in the Republic of Yemen in 2009.

Table 1: National patients pattern for most common diseases in the Republic of Yemen in 2009.

S Disease Pattern Annual Statistical Report 2009

GHOs 5-Year Plans 2011-2015 (2009)

Registered % Registered %

1 Respiratory system diseases 1014138 22.14% 834845 20.2%

2 Epidemiological surveillance diseases

958491 20.92% 1001789 24.3%

3 Gastric system diseases 322002 7.03% 289254 7%

4 Burns and wounds, accidents and causalities

254604 5.56% 138721 3.4%

5 Urinary – genital diseases 235665 5.14% 234871 5.7%

6 Intestinal parasites 219453 4.79% 269408 6.5%

7 Skin and tissues diseases 189510 4.14% 171384 4.2%

8 Anemia and Malnutrition 209691 4.58% 185969 4.5%

9 Eye diseases 145977 3.19% 139475 3.4%

10 Circulatory system diseases 128040 2.79% 70965 1.7%

11 Diabetes 49973 1.09% 55903 1.4%

12 Causalities and fractures 47358 1.03% 31294 0.8%

13 Psychiatric and neurological and behavioural diseases

20244 0.44% 26712 0.7%

14 Joints and bones diseases 19578 0.43% 82302 2%

15 Pregnancy and childbirth complications

5481 0.12% 63080 1.5%

16 Surgeries 0 0 42038 1%

17 Others 760944 16.61% 490356 11.9%

Grand Total 4581149 100% 4128366 100.2%

6

The national epidemiological surveillance list of the Ministry of Public Health and

Population indicates the most common epidemiological diseases in 2009 as in

Table (2) below.

Table 2: Most common epidemiological diseases in 2009

S Disease Pattern Total Yemen % S Disease Pattern Total Yemen

%

1 Non-bloody diarrhoea 171793 54.76% 14 Dengue Fever 163 0.05%

2 Bloody diarrhoea 29209 9.31% 15 Chicken pox 4847 1.55%

3 Malaria 34043 10.85% 16 Rabies 3263 1.04%

4 Typhoid 39770 12.68% 17 Multiple -causes Encephalitis and Meningitis

912 0.29%

5 Bilharzias 5134 1.64% 18 Leishmania 917 0.29%

6 Influenza 898 0.29% 19 Diphtheria 0 0.00%

7 Acute hepatitis A 4655 1.48% 20 Neonatal Tetanus 30 0.01%

8 Acute hepatitis (B+C) 2160 0.69% 21 Mollusk Acute Paralysis 184 0.06%

9 Mumps 5243 1.67% 22 German Measles 251 0.08%

10 TB 1696 0.54% 23 Rich Worm 0 0.00%

11 Measles (Suspected) 851 0.27% 24 HIV AIDS 112 0.04%

12 Whooping Cough 2500 0.80% 25 Cholera 0 0.00%

13 Malta Fever 4969 1.58% 26 Meningitis 97 0.03%

Grand Total 313697 100 %

Source: Annual Epidemiological Surveillance Report - 2009 issued by the General Department for Disease

Control and Epidemiological Surveillance, MoPHP .

7

Section 2 - Health Services

This section provides information regarding health expenditures and human

resources for health in Yemen. 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 Yemen, the total annual expenditure on health (THE) in 2007 was 257,414

million Yemeni Rial (YR) (US$ 1,139.87 million). The total annual health

expenditure was 5.23% of the GDP of 2007. The total annual expenditure on

health per capita was 11,951 YER (US$ 60).

The general government9 health expenditure (GGHE) in 2007, as reflected in the

national health accounts (NHA) was YER 92,568 million (US$ 463.40 million).

That is, 40.65% of the total expenditure on health, with a total annual per capita

public expenditure on health of YER 4,093.27(US$ 20.22). The government

annual expenditure on health represents 4% of the total government budget.

Private health expenditure covers the remaining 66.91% of the total health

expenditure. Of the total population 30 % is covered by a public health service

public health insurance or social insurance or other sickness funds. (The Health

Insurance Law was prepared and approved by Presidential decree after it was

discussed by the parliament. Also the bylaw was prepared for approval by the

Cabinet.) 5

Total pharmaceutical expenditure (TPE) in Yemen in 2007 was 78,016 million YR

(US$ 392.14 million), which is a per capita pharmaceutical expenditure of

approximately 3,673 YER (US$ 18.46).The total pharmaceutical expenditure

9 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.

8

accounts for 2.11 of the GDP and makes up 30% of the total health expenditure

in 2007 (Figure 1). According to the General Government Budget Book 2012,

TPE in 2010 accounts for 40.40 % of THE.

According to NHA 2007 control of health spending in the pharmaceutical sector is

in need of cost-containment mechanisms. “by far, the existing issue that arose

was the need to control health spending in the pharmaceutical sector. On

average, pharmaceutical products account for a sizeable 40 %per cent of total

health expenditures. This spending pattern is likely due to self-prescribing

practices and over prescription of medical drugs by providers. Also, high

pharmaceutical expenditure may be due to high prices for brand name drugs and

high patient demand for medications.” (Yemen NHA 2007)

FIGURE 1: Share of Total Pharmaceutical Expenditure as percentage of the Total

Health Expenditure (NHA 2007) (see comments above)

NHA 2007

Total private expenditure on pharmaceuticals is 75,867.63 million YR

(US$ 381.34 million) which is 97.24% of TPE. Total public expenditure was

2,148.89 million YR (US$ 10.80 million).

30.31%

69.69%

TPE

other

9

FIGURE 2: Share of Total Pharmaceutical Expenditure by sector (2007)

NHA 2007

2.2 Health Personnel and Infrastructure

The health workforce is described in the table below and in Figure 3 and 4.

There are 1,024 (0.40 /10,000) licensed pharmacists10, of which 954 11 work in

the public sector. There are 1,553 (0.69/10,000) pharmaceutical technicians and

assistants (in all sectors). There are approximately 1.7 as many pharmacy

technicians as pharmacists.

There are 7,62912 (3 /10,000) physicians and 17,652 (7.3 /10,000) nursing and

midwifery personnel in Yemen. The ratio of doctors to pharmacists is 7.5 and the

ratio of doctors to nurses and midwifery personnel is 0.4313.

Table 3: Human resources for health in Yemen

Human Resource

Licensed pharmacists (all sectors) (2009) 1,02414 (0.4 /10,000)

Pharmacists in the public sector 954

Pharmaceutical technicians and assistants (all sectors) 1,553 (0.7/10,000)

Physicians (all categories/sectors) (2009) 7,629 15 (3.4/10,000)

10

Yemen Health Progress During last 20 Years 2010 11

The fourth five-year development plan (2011–2015) 12

Yemen Health Progress During last 20 Years 2010 13

The fourth five-year development plan (2011–2015) 14

Yemen Health Progress During last 20 Years 2010

2.76%

97.24%

Public sector

Private sector

10

Nursing and midwifery personnel (all sectors) (2009) 17,652 16 (7.3 /10,000)

Source: Yemen Health Progress during last 20 years (2010)

Figure 3: Distribution of Pharmaceutical Personnel, Yemen (2009)

Source: Yemen Health Progress During last 20 Years 2010

In Yemen, a strategic plan for pharmaceutical human resource development

does not exist.

Notes: 1- There is not a national strategic plan, but there is estimation of needs for

human resources from deferent levels of health institutions within preparing the each 5-year plan.

2- The Health human resources needed qualification through (University) during years of the Fourth5-Year Plan for the whole country will be:

• Pharmacists = 379 • Pharmacology = 945

3- The Qualification needs for technical staff through( health institutes) for

the whole country will be: • Pharmacist Technicians = 104517

15

7629 (all Categories) , Yemen Health Progress During last 20 Years 2010 16

17652 – 2009 , Yemen Health Progress During last 20 Years 2010 17

There are expectation not strategic plan for human resources during the NHS plan (The fourth five-year development plan (2011–2015))

40%

60%

Pharmacists

Pharmaceutical

technicians and

assistants

11

The health workforce is described in the table below. There are 230 hospitals

(general referral & rural) 18 and 7/10,000 hospital beds in Yemen. There are

3,668 19 primary health care units and centres and 3,09220 licensed pharmacies.

Table 4: Health centre and hospital statistics

Infrastructure

Hospitals 23021

Hospital beds (2009) (7 /10,000) 22

Primary health care units and centres 3,66823

Licensed pharmacies 277424

Drug stores 254024

Further information and key findings:

The highest area of priority for HR development is establishing of HR national strategy. New medical or pharmacy schools are opening. There is no national clear academic teaching. The yearly statistics indicators for teaching in Yemen indicate:

1. 9 Governmental Universities (2000-2012)

2. 18 Private Universities

Pharmaceutical technical training: As mentioned in the plan the training of health and technical areas indicated to train = 10,795,24 which mainly include Pharmacy Technicians as a one category from other categories of health and technician. As a truth situation, officially there is no training plans in public sector , except that in-service training which mainly lunched through the programs supported by Donors. Health private sector and companies have their training plans depending on types of health and pharmaceuticals activities.

Nine24 hospitals are planned during 2011-2015. The pharmacy care unit will be logically as the main components of these health facilities. The licensed pharmacies are widely located and concentrated in the capital/urban

18

2009 Annual Statistical Yearbook- The General Department for Health Research & Studies - MoPHP/ Third Five-Year Plan 2006-2011. 19

2009 Annual Statistical Yearbook-/ Third Five-Year Plan 2006-2011. 20

Report 2010 MoPHP 21

230 –Referral & General Hosp., Source: 2009 Annual Statistical Yearbook - The General Department for Health Research & Studies- MoPHP

22 Yemen Health Progress During last 20 Years 2010

23 Third Five-Year Plan 2006-2011

24 The fourth five-year development plan (2011–2015)

12

areas through pharmacy syndicate and High Medical Council. Unavailability of unified guidelines and formats for registration of pharmaceutical personnel. 25

Migration of workforce: The effect of migration on the workforce is not clear, as a result of unavailability of national situation investigations and evaluation for workforce either within MoPHP or Ministry of Civil Services, in addition to absent of effective coordination between the Government and the different public and private Academic Institutions. Policies addressing Emigration: There are no policies or programmes in place to address the emigration of locally qualified health professions. Emigration of local qualified health professional is continuing and increasing. Partners working in the areas discussed in this section: World Health Organization, GIZ, UNICEF

Key recommendations:

The Strategic tendency of the Manpower Axis: Improving, managing and regulating the health human resources to increase the performance and satisfaction levels and create a motivating and attracting workplace to ensure a similar increase in the quality of health services and satisfaction of beneficiaries all call for adopting the strategies as follows;

1. Building consensus around a clear and definite strategic vision to improve human

resources between MOPHP and the medical and health educational institutions, whether

public or private, and improving the educational and training plans while continuing the

rehabilitation process of technical and administrative staff to match the actual needs of

the society and the country in general.

2. Adopting clear and fair policies (in coordination with the Ministry of Finance and the

Ministry of Civil Service) in;

o Job motivation and stability through paying salaries and incentives and Prioritizing the rural (remote) areas.

o Regular evaluation of the staff qualifications and performance and linking this to promotions and incentives.

3. Attracting the appropriate expertise to the governmental hospitals and health centers

and encouraging workers to seek rare specialties and setting standards for this.

4. Improving a unified framework for educational curricula for each health profession in

order to unify the educational standards and improve the quality of instruction methods

and implications, raise the quality of outputs of the health and medical educational and

25

WHO Data Collection Tool for the Assessment of Medicines Regulatory Systems 2008

13

training institutions to fit in the health situation in Yemen and respond to the needs.

5. Institutionalizing the continuous education to become obligatory and a prerequisite for

promotions, classification and motivation for all employees in the health institutions

within a national program and training the staff on the latest professional development

while revising the present training programs.

6. Clear classification of health and medical professions, preparation of the job description

based on efficiency and TORs, improving the standards of employing health staff and

encouraging the principle of self-sufficiency for governorates from the assistant health

staff through improving their health institutes.

7. Improving the system of regular assessment of performance in the health institutions

and applying the principle of reward and punishment.

8. Strengthening the existence of a unified system to register and permit the practice of

medical professions in cooperation with the competent bodies in order to build capacity

of setting a strategy of the workforce in quality and quantity, gender equality and equal

distribution of employees while working on prevention of overlaps, enhancing

coordination and clarity of roles.

9. Studying the duplicity of functions between the public and private sectors and providing

practical solutions to improve the current situation not in contradiction with the approved

strategies.

10. Executing a national inventory of health staff and gradually replacing the foreign staff

with national staff through supporting the local specialized training.

14

Section 3 - Policy Issues

This section addresses the main characteristics of the pharmaceutical policy in

Yemen. 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 Yemen, a National Health Policy (NHP) exists.26 It was updated in 2010.27 An

associated National Health Policy implementation plan does not exist.28

Excerpt from the National Health Strategy 2010-2015

“The Ministry of Public Health and Population has put so much work and efforts

into improving the health conditions for people through its constant attempts to

reform the health sector and modernize it. The policies and strategies that have

been adopted by the Ministry since the end of the 1990s were an obvious

extension of the issues adopted in the First National Conference for Health

Development in 1994.This strategy hasn't ignored or cancelled the

accomplishments of the previous strategies but rather it was built on their

success and is having its priorities updated in line with the national, regional and

international developments bearing in mind the national and local characteristics

and in consistency with the various economic, social, political and geographic

conditions. In 2007, MOPHP initiated, in cooperation with its health development

partners, the joint review of the health sector in which the Health Policies Unit

and Technical Support played a major role in cooperation between all parties and

partners along with leading this magnificent work under the instruction of the

26

National Health Strategy 2010-2025 27

Updated between 2006-2010 to be as (NHP/Strategy 2010-2025)

28 National Health Strategy (NHS) 2010-2025

15

Ministry's leadership. This process has been a key turning point in the MOPHP's

vision towards finding the practical and scientific solutions for the problems of the

health sector especially in light of the constantly declining health indicators

like the maternity mortality rates and morbidity rates and in light of the national

and international developments and the ongoing funding challenges of the health

sector in Yemen. Therefore, the review process relied on the up-to-date scientific

methods in analysis and interpretation to know the major challenges facing the

development and modernization of the health system in entirety.

The joint review process went through two main stages; assessing (analyzing)

the current situation of the health sector based on the internationally recognized

and certified framework of the European Quality Control Institution; and setting

the future tendencies towards the major challenges defined in the first stage

(Situation Assessment). This process has been the first of its kind to be

implemented by a national team and with a wide-range participation of all

stakeholders and beneficiaries. This process has offered a chance to learn

through the complicated analysis of health issues and national health policies. In

addition, the review team has been very careful to have the work being entirely

dependent on scientific and practical evidence and the involvement of every one

up until the production of this national health strategy. Therefore, this strategy is

very practical as it relied on firm basis and took the opinions of the beneficiaries

towards the services and service providers”.29

An official National Medicines Policy document exists in Yemen30. It was updated

in 1998.

A NMP implementation plan does not exist. Policies addressing pharmaceuticals

exist 31 (as detailed in Table 5). Pharmaceutical policy implementation is not

regularly monitored / assessed. There is no formal implementation plan and there

are no clear responsibilities.

29

National Health Strategy (NHS) 2010-2025 30

National Medicines Policy document 1998 31

Exist mainly as detailed in table 5, but is not as formal implementation and is not completely regularly monitored /assessed

16

Table 5: The NMP / group of policies cover32

Aspect of policy Covered

Selection of essential medicines [Yes]

Medicines financing [Yes]

Medicines pricing [Yes]

Medicines Procurement [Yes]

Medicines Distribution [Yes]

Medicines Regulation [Yes]

Pharmacovigilance [No]*

Rational use of medicines [No]

Human Resource Development [No]

Research [No]

Monitoring and evaluation [No]

Traditional Medicine [No]

*Not covered by NMP (1998); Yemen should consider the drawing up of a concrete and updated statement of National Drug Policy such has been adopted in many other WHO member states33

A policy relating to clinical laboratories does not exist.

Access to essential medicines/technologies as part of the fulfillment of the right to

health, is recognized in the constitution or national legislation.34

There are no official written guidelines on medicines donations35.

There is no national good governance policy in Yemen.36

32

National Medicines Policy document 1998 33

Mission to study the situation of Drug Policies in the Republic of Yemen 2-9 January 2006/ Dr M.N.G. Dukes MD LLM MA

34 Article (54) in the Yemeni Constitution 2004: Health care is a right for all citizens. the state shall

guarantee this by building various hospitals and health establishments and expanding their

care. The law shall organize the medical profession, the expansion of free health services and

health education among the citizens

35 Not available in NMP 1998

36 Not available in NMP 1998

17

Note: The national good governance policy in Yemen started in 2012 with

support of World Health Organization through invitation of 5 persons to

participate in Good Governance for Medicines Programme, Inter-Country

Training on Transparency Assessment Instrument, 17-19 June 2012, Amman,

Jordan. This participation will be the corner stone for implementing this policy.

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 Yemen does not

exist.37


MEDICINE AND HEALTH TECHNOLOGY 38 Provision of the effective, safe and quality medicine in the health facilities will, with no doubt, lead to improving and boosting confidence in the health services. Previous experiences have proven that adopting a drug policy that is based on providing the basic drugs and establishing a drug fund within the basic medicines program had caused a positive improvement in the drug supply system, information system and improved skills of the medical and pharmaceutical staff. However, there was a negative turn towards the pharmaceuticals and drug sector leading to the cancellation of it from the health system structure and consequently the parcelling of its functions and tasks among all the Ministry's sectors. This turn has also led to weakening the application of the national drug policy and non-updating it despite the WHO's recommendations in this regard. The profession of pharmacists has become less trustworthy and less reliable. The provision of the right and appropriate mixture of health technology in the health facilities is of no less importance. The health technology (medical and health supplies) contribute to increasing the level of service and performance of workers provided that it abides by rules and standards that are compatible to the type of facility and service offered, those who operate and maintain such and optimally utilize them to improve the health of beneficiaries.

37

Not available in NMP 1998 38

National Health Strategy 2010-2025

18

The strategic tendency of medicine and health technology: The strategic tendency of the medicine and health technology axis is focused on ensuring the provision of effective, safe and quality medicine to the people and equity in obtaining them constantly as well as regulating the procedures of purchasing, registration, quality control, monitoring and inspection over the production sites, distribution, storage, pricing and rational use while supporting the increase in the government spending over medicine and the provision of devices, equipment and spare parts, methods of purchasing, storage, distribution and maintenance. The followed strategies in this regard include;

1. Regular revision and updating of the national drug policy and activating its components.

2. Studying the possibility of creating a unified and effective organizational entity for the pharmaceutical and drug aspects within the Ministry's setup and studying the possibility of creating a body for food and medicine that enjoys legal and legislative tasks and clear roles for this component and working with the relevant bodies to ensure food safety.

3. Reviewing the current situation of the medical supplies system in the public sector and reorganize it based on a clear national policy to ensure a sufficient and permanent flow of supplies in the health facilities starting with the need estimation up until selling it to the beneficiary while ensuring rationalization in prescription, disbursement and utilization. A strategic stock of emergency and disaster medicines shall be developed to cover a period of no less than three months.

4. Revising and controlling the medicine pricing and putting the necessary policies and measures in place to prevent any manipulation with prices and enforcing the laws that prohibit smuggling of drugs, rationalize and monitor importation.

5. Increasing the governmental budget allocations for medicine and medical equipment based on the individual standard in comparison with the regional criteria and creating extra financial resources for medicine and to accelerate joining the unified purchase system of the GCC countries to guarantee rationalization of expenditures and obtaining best drugs in the least possible price.

6. Developing in service training programs to raise the efficiency and skills of the pharmaceutical staff at various levels of the health system.

7. Developing an efficient and effective supply, maintenance and protection system for the medical supplies and devices and preparing a list of the minimum quantity to ensure constant availability.

19

Section 4 – Medicines Trade and Production

4.1 Intellectual Property Laws and Medicines

Yemen is not a member of the World Trade Organization. Legal provisions

granting patents to manufacturers do not exist.

An agency managing and enforcing Intellectual Property Rights does not exist in

Yemen. Note: There is no clear vision about IP rights because it is still under

negotiation with international agencies.

National Legislation has not been modified to implement the TRIPS Agreement

and does not contain TRIPS-specific flexibilities and safeguards, presented in

Table 6. Yemen is 39 eligible for the transitional period to 2016.

Table 6: 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 exceptions 40 [No]

Parallel importing provisions [No]

There are legal provisions for linkage between patent status and marketing

authorization, but no legal provisions for data exclusivity for pharmaceuticals and

patent term extension.41 39

Is eligible if we revise and update NHP and get the awareness from MOPHP policy-maker to change the pharmaceuticals polices 40

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 expires. 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]

20

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 10 licensed pharmaceutical manufacturers in Yemen. Manufacturing

capabilities are presented in Table 7 below.

Table 7: Yemen manufacturing capabilities

Manufacturing capabilities

Research and Development for discovering new active substances No

Production of pharmaceutical starting materials (APIs) Yes

The production of formulations from pharmaceutical starting material Yes

The repackaging of finished dosage forms Yes

In 2010, domestic manufacturers held 9.40 % of the market share by value

produced. No multinational pharmaceutical companies currently manufacture

medicines locally. There are 10 manufacturers that are Good Manufacturing

Practice (GMP) certified.42


Although the tested locally manufactured products showed excellent quality results,

trends of local pharmaceutical industry in Yemen still needs a great deal of attention

and improvement in different areas such as manufacturing, knowledge, attitude and

behavior, and concentration on industry policy to improve their awareness about use of

medicines and the importance of this issue to improve health status of the public43.

41

SBDMA, 2010 42

GMP certificate provide by (MRA /SBDMA) not from Independent authority) 43

YEMENI JOURNAL FOR MEDICAL SCIENCES (2010)

21

Section 5 – Medicines Regulation

This section details the pharmaceutical regulatory framework, resources,

governing institutions and practices in Yemen.

5.1 Regulatory Framework

In Yemen, there are legal provisions establishing the powers and responsibilities

of the Medicines Regulatory Authority (MRA).

The MRA is a semi-autonomous agency with a number of functions outlined in

Table 6.

The MRA has its own website, for which the URL address is www.sbd-ye.org

(Supreme Board of Drugs and Medical Appliances, SBDMA).

Table 8: Functions of the national MRA44

Function

Marketing authorisation / registration Yes

Inspection Yes

Import control Yes

Licensing Yes

Market control Yes

Quality control Yes

Medicines advertising and promotion Yes

Clinical trials control No

Pharmacovigilance No

MRA participates and supervises all government tenders Yes

As of 2011, there were 285 permanent staff working for the MRA. The MRA does

not receive official external technical assistance to support its activities. The MRA

44

presidential Decree No.231, for re-organization of the Supreme Board for Medicines & Medical

Appliances

22

is involved in harmonization/collaboration initiatives such as GCC. An

assessment of the medicines regulatory system has been conducted in the last

five year. Funding for the MRA is provided through the regular government

budget45. The Regulatory Authority retains revenues derived from regulatory

activities. This body utilizes a computerized information management system to

store and retrieve information on processes that include registrations and

inspections.

5.2 Marketing Authorization (Registration)

In Yemen, legal provisions require marketing authorization (registration) for all

pharmaceutical products on the market. Mutual recognitions mechanisms are not

in place. Explicit and publicly available criteria exist for assessing applications for

marketing authorization of pharmaceutical products46. In 2007, there were 9,500

pharmaceutical products registered in Yemen.

There are no legal provisions requiring the MRA to make the list of registered

pharmaceutical products publicly available and update it regularly.

There is a guide for the registered pharmaceuticals, but it has not been updated

since 1999.

Medicines are 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 applications.47

Marketing Authorization holders are required by law to provide information about

variations to the existing Marketing Authorization. Legally, a Summary of Product

45

MRA/ SBDMA is funded through the regular government budget and mainly funded by the revenues derived from regulatory activities.

46 Not available

47 Cabinet Decree No.333/2004 for regulation of trade and manufacturing of medicines, medical

appliances and relatives bylaw

23

Characteristics (SPC) of the medicines that are registered is not required to be

published. Legal provisions requiring the establishment of an expert committee

involved in the Marketing Authorization process are in place. Possession of a

Certificate for Pharmaceutical Products (that accords with the WHO Certification

scheme) is required as part of the Marketing Authorization application. By law,

potential conflict of interests for experts involved in the assessment and decision-

making for registration must be declared. Applicants may legally appeal MRA

decisions.

The registration fee (per application) for a pharmaceutical product containing a

New Chemical Entity (NCE) is US$ 500, while this fee for generic pharmaceutical

products is US$ 250. The time limit imposed for the assessment of all Marketing

Authorization applications is 60 months.48

5.3 Regulatory Inspection

In Yemen, legal provisions exist allowing for appointment of government

pharmaceutical inspectors. Legal provisions exist permitting inspectors 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. Where inspections are legal requirements, these are the same for

public and private facilities. Inspections are carried out on a number of entities,

outlined in Table 9.41

Table 9: Local entities inspected for GMP compliance49

Entity Inspection Frequency

Local manufacturers Yes low

Private wholesalers Yes low

Retail distributors** Yes low

48

SBDMA Registration (?) www.sbd-ye.org/sbdye/files/pdf/2.pdf

49 Cabinet Decree No.333/2004 for regulation of trade and manufacturing of medicines, medical appliances and relatives bylaw

24

Public pharmacies and stores No low

Pharmacies and dispensing points if health facilities No low

* low and irregular frequency and it is contradictory in some responsibilities between MRA (SBDM) and DG of Pharmaceutical affairs in the MoPHP.

50

** Most of the retail distributors are working illegally.

5.4 Import Control

Legal provisions exist requiring authorization to import medicines. Laws exist that

allow the sampling of imported products for testing. Legal provisions exist

requiring importation of medicines through authorized ports of entry. Regulations

or laws exist to allow for inspection of imported pharmaceutical products at

authorized ports of entry.

5.5 Licensing

In Yemen, legal provisions exist requiring manufacturers to be licensed. 49 Legal

provisions exist requiring manufacturers (both domestic and international) to

comply with Good Manufacturing Practices (GMP). Good Manufacturing

Practices are published by the government.49

Legal provisions exist requiring importers to be licensed, however there are no

legal provisions requiring wholesalers and distributors to be licensed49. Legal

provisions requiring wholesalers and distributors to comply with Good Distributing

Practices do not exist.

Table 10: Legal provisions pertaining to licensing

Entity requiring licensing

Importers Yes

Wholesalers Yes

Distributors Yes

50

Presidential Decree No76 for MoPHP bylaw 2004 & Presidential Decree No. 231 for MRA/SBDM re-organizing 1999 )

25

Good Distribution Practices are published by the government.51 Legal provisions

exist requiring pharmacists to be registered. Legal provisions exist requiring

private and public pharmacies to be licensed. 52 National Good Pharmacy

Practice Guidelines are not published by the government. By law, a list of all

licensed pharmaceutical facilities is not required to be published.

5.6 Market Control and Quality Control

In Yemen, legal provisions exist for controlling the pharmaceutical market. 53

A laboratory does not exist in Yemen for Quality Control testing.54 The regulatory

authority does not contract services elsewhere.

Existing national laboratory facilities have been accepted for collaboration with

the WHO pre-qualification Programme.55 Medicines are tested for a number of

reasons, summarised in Table 11.

Table 11: Reason for medicines testing56

Medicines tested:

For quality monitoring in the public sector57 [Yes]

For quality monitoring in the private sector58 [Yes]

When there are complaints or problem reports [Yes]

For product registration [Yes]

For public procurement prequalification [Yes] 59

For public program products prior to acceptance and/or distribution [Yes] 60

51

Not available 52

For private pharmacies only ( Law No. 60 / 1999 / for private medical & health institutions ) 53

Available only ( Law No. 60 / 1999 / for private medical & health institutions ) 54

It is exist only within SBDM for quality control testing of physiochemical & Microbial testing of pharmaceuticals ( Director of Yemen Quality Control ) 55

Yemen Quality Control Laboratory was evaluated by WHO team , but the team did not complete his mission as a result of the crisis in 2011 ( Yemen Quality Control Documents )


appliances and relatives bylaw 57

Routine sampling in pharmacy stores and health facilities 58

Routine sampling in retail outlets 59

Post shipment (Yemen Quality Control Documents)

26

Samples are collected by government inspectors for undertaking post-marketing

surveillance testing61.

In the past 2 years, 81362 samples were taken for quality control testing. Of the

samples tested, 7263 (8.9%) failed to meet the quality standards. The results are

not publicly available. The results were available only to registration technical

committee in the SBDMA.

Note1: As a result of overloading of analysis of samples for new registration, we can inspect more samples in post-marketing surveillance, as Yemen Quality Control Director said. Note2: Joint Health System Review Mission Yemen- MoPHP ,WHO, GTZ RNE

/2007

5.7 Medicines Advertising and Promotion

In Yemen, legal provisions exist to control the promotion and/or advertising of

prescription medicines. Supreme Board of Drugs & Medical Appliances/Scientific

Department 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 Regulations do not exist for advertising and

promotion of non-prescription medicines. There is not a national code of conduct

concerning advertising and promotion of medicines by marketing authorization

holders.

5.8 Clinical Trials

60

Post shipment (Yemen Quality Control Documents)


appliances and relatives bylaw 62

813 samples (2009+2010), Yemen Quality Control Documents 63

72 samples, Yemen Quality Control Documents

27

In Yemen, legal provisions do not exist requiring authorization for conducting

Clinical Trials by the MRA. 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

Yemen is a signatory to a number of international conventions, detailed in

Table12.

Table 12: International Conventions to which Yemen is a signatory

Convention Signatory

Single Convention on Narcotic Drugs, 1961 Yes

1972 Protocol amending the Single Convention on Narcotic Drugs, 1961 Yes

Convention on Psychotropic Substances 1971 Yes

United Nations Convention against the Illicit Traffic in Narcotic Drugs and

Psychotropic Substances, 1988. Yes

Laws exist for the control of narcotic and psychotropic substances, and

precursors.64 The annual consumption of Morphine is 0.016232 mg/capita65. The

legal provisions and regulations for the control of narcotic and psychotropic

substances, and precursors have been reviewed by a WHO International Expert

64

Law No. 3 /1993 for struggler and control of narcotics & psychotropic substances and precursors and its trade. (under the Ministry Of Interior).

65 INCB (2009)

28

or Partner Organization to assess the balance between the prevention of abuse

and access for medical need.

Figures regarding the annual consumption of certain controlled substances in the

country are outlined in Table 12 S below.

Table 12 S: Annual consumption of selected controlled substances in Yemen65

Controlled substance Annual consumption

(mg/capita)

Morphine 0.016232

Fentanyl 0.015709

Pethidine 0.133264

Quantities imported during 201066

Controlled substance Quantities

Morphine 99153 mg

Fentanyl 31.65 gm

Pethidine 12.44 kg

5.10 Pharmacovigilance67

In Yemen, 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 Yemen.68 A national

pharmacovigilance centre linked to the MRA does not exist.

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

66

SBDMA, controlled substances Directorate 67

This subject is not available either in NMP or as national concept. 68

This subject is not available either in NMP, although the problems were rising but there is no official concern

29

including crisis communication in Yemen. A clear communication strategy for

routine communication and crises communication does not exist.

ADRs are not monitored in any public health programs.


Areas of regulation that could be strengthened or improved: Law No. 3 /1993 for struggler and control of narcotics & psychotropic substances and precursors and its trade. (It is under the Ministry Of Interior) Partners working or supporting initiatives in the areas discussed in this section: WHO

30

Section 6 - Medicines Financing

In this section, information is provided on the medicines financing mechanism in

Yemen, 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 Yemen, concessions are made for certain groups to receive medicines free of

charge (see Table 14). Furthermore, the public health system or social health

insurance schemes do not provide medicines free of charge for particular

conditions (see Table 14).

Comment: It is very limited, specified only some medicines as chronic diseases

as (Diabetic, Kidney replacement, and iron and folic acid for pregnant women,

immunization and primary child illness).

Table 14: Population groups provided with medicines free of charge 69

Patient group Covered

Patients who cannot afford them [Yes] for chronic diseases only

Children under 5 [Yes] only for EPI

Pregnant women [Yes] very limited if it is available

Elderly persons [Yes] for chronic diseases only

• Article (54) in the Yemeni Constitution 2004 states that: “Health care is

a right for all citizens. The state shall guarantee this by building various

hospitals and health establishments and expanding their care. The law

shall organize the medical profession, the expansion of free health

services and health education among the citizens.”

69

Cabinet Decree No. 15/ 1999 for Community participation

31

• Republican Resolution No (76): for the Year 2004- About the Bylaw of

the Ministry of Public Health and Population Article (3)/ 9 described that:

Giving care to child health together with providing drugs and vaccines at

suitable prices.

• Practically there is no active social health insurance scheme in public

health system, But currently there is (Presidential Decree No. 9 / 2011 for

social health insurance is issued and the MoPHP working now for

preparation its bylaw).

Table 14: Medications provided publicly, at no cost

70

All diseases in the EML [No]*

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]#

* very limited, when medicines are available in primary health care facilities. # Most of Malaria, TB, STDs/HIV/AIDS & EPI medicines are delivered through the donors.

The figures for the total money spent by the MoPH&P in 2006 must be acquired and money spent

per person must be calculated. According to last estimates it is less than US $ 0.34 per person

but exact figures should be made available. This is a very low level of financing for medicines –

combined with other mismanagement factors makes access to medicines by 40% poor population

extremely low. It is mentioned anecdotally that more than 90% of people, especially poor, buy

medicines out of pocket in Yemen. This is a serious situation. This suggested section should

objectively (as much as possible) present this situation with the help of figures. This critical part of

the problem is surprisingly missing from the report at present. (Source: The Joint Health Sector

Review “ RA EMRO WHO - Nov. 2007)

A public health service, public health insurance, social insurance71 or other

sickness fund does not provide at least partial medicines coverage.

70

Cabinet Decree No. 15/ 1999 for Community participation 71

Not available

32

It only provides coverage for some medicines that are on the Essential Medicines

List (EML) for inpatients and/or outpatients.72

Comment: Inpatients and out-patients have to buy the medicines out of pocket.

Exceptions are patients who are working with local private or international

organizations and are working under health insurance for these organizations.

Private health insurance schemes provide medicines coverage. They are

required to provide at least partial coverage for medicines that are on the EML

(comment: no specific legislation).

6.2 Patients Fees and Co-payments

Co-payments or fee requirements for consultations are levied at the point of

delivery.73 Furthermore, there are copayments or fee requirements imposed for

medicines74. 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

facility75. Revenue from fees or from the participation in health services is used to

pay as incentives for health staff and to support some maintenance in the health

facilities.76

Note: this system becomes uncontrolled as a result of unclear and overlapping of

the responsibilities between the health and local authorities.

6.3 Pricing Regulation for the Private Sector77

In Yemen, there are legal or regulatory provisions affecting pricing of

medicines.78 These provisions are aimed at the level of manufacturers,

wholesalers and retailers.

72

The availability of EML is mean nothing without the availability of medicines which is currently represent 18 % of the actual number of medicines in EML.

73 Cabinet Decree No. 15/ 1999 for Community participation




77 This section does not include information pertaining to the non-profit voluntary sector

78 The (Cabinet Decree No.333/2004 for regulation of trade and manufacturing of medicines,

medical appliances and relatives bylaw)

33

The government runs an active national medicines price monitoring system for

retail prices. Regulations exist mandating that retail medicine price information

should be publicly accessible.79 The public price is stamped on the packaging of

medicines.

6.4 Prices, Availability and Affordability of Key Medicines

In 2006, a WHO/HAI pricing survey was conducted in Yemen80. Table 15

provides specific details regarding availability, pricing and affordability in the

country.

Availability

Public sector availability of originator medicines was [zero] %, while availability of

the Lowest priced generic (LPG) medicines was 5%. Availability in the private

sector was higher for originator (50%) and for generics (90%)81.

Pricing

The Median Price Ratio is used to indicate how prices of medicines in Yemen

relate to those on the international market. That is, prices of medicines have

been compared to international reference prices82 and expressed as a ratio of the

national price to the international price. For example, a price ratio of 2 would

mean that the price is twice that of the international reference price. Since prices

have been collected for a predefined basket of medicines, the Median Price Ratio

has been selected to reflect the situation in the country.

79

The (Cabinet Decree No.333/2004 for regulation of trade and manufacturing of medicines, medical appliances and relatives bylaw)

80 WHO/HAI survey on medicine prices and availability (2006), published 2007, available at:

www.haiweb.org/medicineprices/surveys/200607YE/survey_report.pdf, 01-01-2012. 81

Medicine Prices in Yemen July 2006 82

The International reference price is the median of prices offered by international suppliers (both for profit and not profit) as report by MHS International Price Indicator Guide (http://erc.msh.org/mainpage.cfm?file=1.0.htm&module=DMP&language=English). For more information on the methodology WHO/HAI pricing survey, you can download a free copy of the manual at http://apps.who.int/medicinedocs/documents/s14868e/s14868e.pdf.

34

Public procurement prices were below international reference prices: the Median

Price Ratio for originators was [0.49 to 1.76] and for generics [0.62 to 0.83]. As

for patient prices, the Median Price Ratio in the public sector was 0 for originators

and 1.30 (0.86-1.55) for generics, while the private sector had higher prices,

18.11 (7.44-35.60) for originators and 3.5 (1.87-7.45) for generics.

Affordability

Affordability of medicines is measured in terms of the number of days’ of wages

necessary to purchase a particular treatment for a specific condition. The wage

considered is that paid to the lowest paid government worker in Yemen. Specific

data collected for the survey underlying this profile examined the number of days’

wages required to purchase treatment with co-trimoxazole for a child respiratory

infection; this was calculated to be 0 and 0.8 days’ wages for the purchase of

originator medicines by public and private patients respectively. In comparison,

the purchase of generic medication necessitated 0.1 days’ wages for public

patients and 0.2 for private patients. It is evident, therefore, that originator

medicines are less affordable in the private sector than in the public sector and

generic medicines are less affordable in the private sector than in the public

sector.

35

Table 15: Availability, Pricing and Affordability of medicines in Yemen

Public

procurement

Public patient Private

patient

Availability

Mean (%)

Originator

0 5% (0-

12.5%)

Lowest priced generic (LPG)

50%(17.5-90%) 90%(70-

97.5%

Median (%) Originator


Price

Mean Price

Ratio

Originator 0.49 to 1.76 18.11 (7.44-

35.60)

Lowest priced generic (LPG) 0.62 to 0.83 1.30 (086-1.55) 3.5 (1.87-

7.45)

Affordability

Number of

days’ wages

Originator


6.5 Price Components and Affordability

In 2006, a survey on medicine price components was conducted in Yemen. The

median cumulative percentage mark-up between the Manufacturer Selling Price

(MSP)/Cost Insurance and Freight (CIF) price and final medicine price for a

basket of key medicines was 0.1% in the public sector and 57.44 % in the private

sector.83

83

Medicine Prices in Yemen 2006

36

6.6 Duties and Taxes on Pharmaceuticals (Market)

Yemen imposes84 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. Provisions for tax

exceptions or waivers for pharmaceuticals and health products are in place85.


Partners that are supporting initiatives in the areas discussed in this section: � WHO � UNFPA � GIZ � WB � USAID

There are trends toward the increasing of registration fee according to the Supreme Board for Medicines and Medical Appliances council (threefold).

84

Cabinet Decree No.333 ) 2004 for regulation of trade and manufacturing of medicines and medical appliances and its relatives.

85 Cabinet Decree No.333) 2004 for regulation of trade and manufacturing of medicines and

medical appliances and its relatives.

37

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 Yemen.

7.1 Public Sector Procurement

Public sector request for tender documents are publicly available and public

sector tender awards are publicly available. Procurement is based on the

prequalification of suppliers. 86

Currently Forecasting is based on previous year consumption and not on

morbidity burden and pattern. With sluggish, irregular and dried supply pipeline,

the consumption based forecasting is misleading. There is lack of transparency

in procurement. Storage conditions are not satisfactory and there is weak

inventory control. 87

Public sector procurement in Yemen is both centralized and decentralized.88

During the availability of National Drug Fund (1/1999) which had a headquarter office with main store in Sana'a, and four regional stores in Aden, Hodaidah, Mukallah and Dhamar. Governorates, districts and hospitals are supplied from these stores according to their request. and against payment of costs of the goods plus a service fee, the Drug Fund increased transparency of procurement procedures through Introduction on new buying procedures in 2000. The by-laws of the DF stress that it is financially and administrative independent, and that it is supervised by a Board of Directors, consisting of the Minister of Health (Chairman), and senior staff of various other Ministries, the Social Security Fund, representatives of donor countries and organisations, as well as the Executive Director of the Drug Fund.89

86

Buying procedures in 2000 (YemDAP - Final Evaluation, September 2002)

87 Joint Health System Review Mission Yemen 2007

88 Buying procedures in 2000 (YemDAP - Final Evaluation, September 2002)

89 YemDAP - Final Evaluation, September 2002

38

In 2004 the entire process of tendering for drug supplies, which had been handled by the Drug Fund itself, was handed back to the Ministry of Health’s central tendering unit, where it had resided at an earlier date. Certain organization changes were introduced abruptly in 2005, notably involving the assimilation of the Drug Fund into the Ministry of Health as a “National Drug Programme” and the introduction of the supply of free drugs to users of the Public Supply System, with total abolition of fees. 90 91

7.2 Public Sector Distribution

The government supply system department in Yemen has 92 a Central Medical

Store at National Level also known as Sana’a central medical store.93 There are

another 4 94 public warehouses in the secondary tier of the public sector

distribution. There are 95 national guidelines on Good Distribution Practices

(GDP). A licensing authority that issues GDP licenses does not exist.96

7.3 Private Sector Distribution

Legal provisions exist for licensing wholesalers and distributors in the private

sector.97 A list of GDP certified wholesalers and distributors does not exist in the

private sector.

90

Mission to study the situation of Drug Policies in the Republic of Yemen 2-9 January 2006/ Dr M.N.G.Dukes MD LLM MA

91 Cabinet Decree No. 274 /2006 for establishing of National Program for Medicines supplies

92 Cabinet Decree No. 274 /2006 for establishing of National Program for Medicines supplies

93 Cabinet Decree for Drug Fund No.332 /2000 for medicines supply

94 Another 4 regional medical stores /warehouses (Cabinet Decree for Drug Fund No.332 /2000

for medicines supply ). 95

Drug Fund catalogues for hospitals and districts procedures and supplies issued 2000

96 Not available for private sector

97 Cabinet Decree No. (333) 2004 for regulation of trade and manufacturing of medicines and

medical appliances and its relatives.

39


� Are there any apparent areas of inefficiency in the procurement and distribution processes?

� There is lack of transparency in procurement. Storage conditions are not satisfactory and there is weak inventory control. Transportation beyond governorate level is the responsibility of health facilities in most cases. There is no systematic analysis by the program of the medicine supply between different governorates and between primary and tertiary levels of health care. Reportedly there are problems on both accounts.

� Are any aspects of the procurement and distribution processes a focus for capacity building, policy change or the implementation of new legislation or processes in the near future?

There are not any aspects until now, but we expect these processes after updating the NMP at the end of 2012.

40

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 Yemen.

8.1 National Structures

A National Essential Medicines List (EML) exists. The EML was lastly updated in

2009 and is publicly available. There are currently 384 medicines on the EML.98

Selection of medicines for the EML is undertaken through a written process. A

mechanism aligning the EML with the Standard Treatment Guidelines (STGs) is

in place.

However, the last alignment between NEML & STG was in 2001. There was no

alignment between the last updating of EML and STGs in place.

National Standard Treatment Guidelines (STGs) for the most common illnesses

are produced / endorsed by the MoH in Yemen.99 These were last updated in

2010.100 Specific STGs cover primary care (updated in 2010).101

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.

98

Essential Medicines List (EML) Yemen (2009), digital copy available at EMP/EMRO. EML 2007 available at: www.who.int/selection_medicines/country_lists/yem_EDL_FINAL_2007.pdf

99 The last STGs produced / enforced was in 2001 which WHO and Netherland embassy

supported its preparation, printing, dissemination and training of health staff. 100

Was updated to cover primary care, it was prepared by supporting of European Committee through RHPP and it is still under revision.

101 There was a new STG to cover primary care, it was prepared by support of European

Committee through RHPP and it is still under revision.

41

A written National Strategy for containing antimicrobial resistance does not exist.

8.2 Prescribing

Legal provisions exist to govern the licensing and prescribing practices of

prescribers.102 Furthermore, legal provisions restricting dispensing by prescribers

exist.103 Prescribers in the private sector dispense medicines.104

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 curriculum105

Curriculum Covered

The concept of EML No

Use of STGS No#

Pharmacovigilance No

Problem based pharmacotherapy (PBP) No*

# There is no adherence to Standard Treatment Guidelines (in most cases they actually do not exist or are outdated) and there is no prescription audit. Parallel systems of medicines and commodities supply run by the vertical disease programs with least coordination with the central supply system managed by the national program for medicine supply. (The Joint Health Sector Review” Mission 2007)

* (PBP) training in pharmacotherapy in under graduate training was one component of the YemDAP program between 1999-2001 in the Universities and High Health Institutes.

Mandatory continuing education that includes pharmaceutical issues is not

required for doctors/nurses/paramedical staff.

Prescribing by INN name is not obligatory in the public and private sector. The

average number of medicines prescribed per patient contact in public health

102

( Law No (26) 2002 for practicing of Medical and pharmacy professions 103

(Cabinet Decree No. 333) 2004 for manufacturing & trading of Medicines & Medical Appliances and its relatives. 104

WHO level I survey (2007)

105 as a result of discussions with the pharmacy college teachers, they emphasized that there is

no any concern to put the concepts that mentioned in table 16 in the training curriculum.

42

facilities is 3.3. Of the patients treated in the outpatient public health care

facilities, 66.8 % receives antibiotics and 57.8 % receive injections.106

Table 17: Characteristics of medicines prescribing * 107

Curriculum %

% of medicines prescribed in outpatient public health care facilities that

are in the national EML (mean) 67.35

% of medicines in outpatient public health care facilities that are

prescribed by INN name (mean) 31.6

% of patients in outpatient public health care facilities receiving

antibiotics (mean). 61.5

% of patients in outpatient public health care facilities receiving

injections (mean) 43

% of prescribed drugs dispensed to patients (mean) 2.5

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

*The intervention study 107

was carried out in rural areas, where 70% of the population lives in rural areas that are mainly provided with primary health care facilities and the problem is particularly serious in the rural health care facilities.

8.3 Dispensing

Legal provisions in Yemen exist to govern dispensing practices of

pharmaceutical personnel.108 The basic pharmacist training curriculum includes a

spectrum of components as outlined in Table 18.

106

WHO rational use database, An intervention study to promote rational prescribing in districts

supported by the European Support to Health Sector Reform )* - Prof. Dr. Ahmed Abdo-Rabbo /

2005 107

An intervention study to promote rational prescribing in districts supported by the European Support to Health Sector Reform )* - Prof. Dr. Ahmed Abdo-Rabbo / 2005 108

Law No. (26) 2002 for practicing of Medical and pharmacy professions

43

Table 18: Core aspects of the pharmacist training curriculum

Curriculum Covered

The concept of EML [No]

Use of STGS [No]

Drug information [No]

Clinical pharmacology [Yes]*

Medicines supply management [Yes]#

* Not covered by the pharmacist training curriculum # As a small part of Pharmaceuticals curriculum Aspects

Mandatory continuing education that includes rational use of medicines is not

required for pharmacists.

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

sector facilities, but not in private sector facilities. Sometimes antibiotics are sold

over-the-counter without a prescription. Sometimes injectable medicines are sold

over-the-counter without a prescription.


There is no systematic collaboration/ harmonisation between public and private sector distribution practices.

Rational Use of Drugs has been one of YemDAP's components that received support from the Government of the Netherlands. It was originally scheduled to run from March 1996 until March 2000, but funding was extended until December 2002.

44

Brief conclusion: essential medicines and health technologies

• Inadequate financing: The most important challenge is not having enough

financing available from the Government for meeting the essential medicine needs of the population.

• Inconsistent national medicines policy: The policy has become outdated and

is inconsistent with the actual policy and practice. This results in confusion and allow for varied practices in different governorates and levels of health care.

• Overlapping institutions: There are a number of government institutions

involved in managing medicine related affairs without a central level coordination and sometimes their responsibilities are not clear and are overlapping.

• Weak governance and management in medicine supply: There are problems

in every area of governance and management of medicine supply cycle: selection of essential medicines; forecasting of needs; procurement; storage; transportation; and use of medicines.

• Weak regulation of quality and safety of medicines: Major regulatory

challenges include: improvement in the performance of Supreme Board for Drugs and Medical Appliances; improvement in registration system; GMP inspections of the companies; lack of availability of pharmacists in private pharmacies; availability of unregistered medicines; availability of all kinds of medicines over the counter; etc.

• Availability of counterfeit medicines: Counterfeit medicines represent a major

public health risk and may account for a considerable percentage of the medicines currently on sale in the market. Anecdotal accounts of their availability are abounding.

• Irregular supply of medical devices and equipment: Inappropriate medical

devices and equipments are supplied at inappropriate level of health facilities without proper maintenance and availability of trained operators.

Although of a lot of time has passed since these conclusion, the situation is still as it is.

45

Key Documents

Document Exact title Author Publisher Year File name

National Medicines

Policy (NMP)

Yemen National

Medicines Policy

Ministry of

Public Health

&Population

(MoPHP)

MoPHP

Pharmaceutical

Sector

1998 Yemen National

Medicines Policy

NMP

implementation

plan

Not available

National Medicines

Act

Law No. (26) 2002 for

practicing of Medical

and pharmacy

professions

MoPHP MoPHP 2002 Law No. (26) 2002 for

practicing of Medical

and pharmacy

professions

National

pharmaceutical

human resources

report or strategic

plan

Not available

Latest report on the

national

pharmaceutical

market (any source)

Mission to study the

situation of Drug

Policies in the

Republic of Yemen 2-9

January 2006/ Dr

M.N.G.Dukes MD LLM

MA

Dr

M.N.G.Dukes

MD LLM MA

Dr M.N.G.Dukes MD

LLM MA

2006 Mission to study the

situation of Drug

Policies in the

Republic of Yemen

National

Pharmacovigilance

Centre report

(including Adverse

Drug Reaction,

ADR, analysis

report in the last

two years)

Not available

National

pharmaceutical

legislation for

regulation

Cabinet Decree No.

(333) 2004 for

regulation of trade and

manufacturing of

MoPHP Cabinet 2004 Cabinet Decree No.

(333) 2004 for

regulation of trade

and manufacturing of

46

medicines and medical

appliances and its

relatives

medicines and

medical appliances

and its relatives

Annual report of

quality control

laboratories

Annual report of

quality control

laboratories

Supreme

Board for

Medicines &

Medical

Appliances

(SBDMA)

Medicines quality

control laboratories

Report Directorate

Yearly Medicines quality

control laboratories

Annual Report

Annual report of

national regulatory

authority

Annual Report for

SBDMA

SBDMA Annual Report for

SBDMA

Yearly Annual Report for

SBDMA

Legal provisions on

medicines price

regulations

Cabinet Decree No.

(333) 2004 for


manufacturing of


appliances and its

relatives

(MoPHP) Cabinet 2004 Cabinet Decree No.

(333) 2004 for

regulation of trade


medicines and

medical appliances

and its relatives

Medicines

procurement policy

Cabinet Decree No.

(333) 2004 for


manufacturing of


appliances and its

relatives

(MoPHP) Cabinet 2004 Cabinet Decree No.

(333) 2004 for

regulation of trade


medicines and

medical appliances

and its relatives

National Essential

Medicines List

(EML)

National Essential

Medicines (EML)

(MoPHP) MoPHP (Pharmacy

affairs General

Directorate ) with

committee instantly

established

2009 National Essential

Medicines (EML)

National Standard

Treatment

Guidelines (STGs)

National Standard

Treatment Guidelines

(STGs)

(MoPHP) MoPHP (Pharmacy

affairs General

Directorate ) with

committee instantly

established

2001 National Standard

Treatment Guidelines

(STGs)

National Strategy

for anti-microbial

Not available

47

Available Documents:

1. NMP (it is available only as hard copy in English & Arabic with Dr. Mohamed Bin Shahna)

2. Law No. (26) 2002 for practicing of Medical and pharmacy professions (available only in

Arabic)

3. Mission to study the situation of Drug Policies in the Republic of Yemen 2-9 January

2006/ Dr M.N.G.Dukes MD LLM MA

4. Cabinet Decree No. (333) 2004 for regulation of trade and manufacturing of medicines

and medical appliances and its relatives (available only in Arabic)

5. Annual report of quality control laboratories (Available as hard copy in Arabic)

6. Annual Report for SBDMA (available only in Arabic)

7. Cabinet Decree No. (333) 2004 for regulation of trade and manufacturing of medicines

and medical appliances and its relatives (available only in Arabic)

8. National Essential Medicines (EML)

9. National Standard Treatment Guidelines (STGs)

All Documents are available in Arabic on a CD-ROM that was sent to Dr. Mohamed Bin Shahna

WHO/EMRO.

resistance

Any other

medicines

pricing/availability

surveys, household

surveys, and

rational use

surveys than the

ones used to prefill

in the instrument.

Not available