YEMEN PHARMACEUTICAL COUNTRY PROFILE

Transcription

1 YEMEN PHARMACEUTICAL COUNTRY PROFILE

2 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. 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. 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 ii

3 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 healthrelated 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 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: iii

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5 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 Section 4 Medicines Trade and Production Section 5 Medicines Regulation Section 6 - Medicines Financing Section 7 - Pharmaceutical procurement and distribution in the public sector Section 8 - Selection and rational use of medicines Brief conclusion: essential medicines and health technologies Key Documents v

6 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 ( 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 online, 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 2

7 Austrian Federal Institute for Health Care and representatives from 13 pilot countries. Data collection in all 193 member states has been conducted using a userfriendly 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 sbdma@yemen.net.ye 3

8 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 22,492,035 1 with an annual population growth rate of 3% 1. The annual GDP growth rate is The GDP per capita was US$ 2,606 3 (at the current exchange rate 4 ). 46% of the population is under 15 years of age 5, 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 % of the population is living with less than $1.25/day. The income share held by the lowest 20% of the population is 7.18% (as a % of national income). The adult literacy rate for the population over 15 years is 54.1 % Mortality and Causes of Death The life expectancy at birth is 61 and 62.9 years for men and women respectively. 7 The infant mortality rate (i.e. children under 1 year) is 68.5/1,000 live births. For children under the age of 5, the mortality rate is 78.2/1,000 live births. The maternal mortality rate is 366/100,000 live births. 1.3 The top diseases causing morbidity in Yemen Health Status (Morbidity and Death Causes) 8 Existing health and vital statistics and data furnished in the 2009 Annual Statistical Report by General Department for Information, Research and Health Studies of MOPHP that the current morbidity and death causes are caused by 1 Central Statistical Organisation (CSO) (2009) 2 National Health Strategy Fund for Peace Yemen Country profile 2011, 4 The exchange rate for calculation for NCU is at present 215 YR = 1 US$. 5 National Health Strategy National Health Strategy ( ) 7 Cluster survey with multiple indicators (2006) 8 The fourth five-year development plan ( ) 4

9 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 Table 1: National patients pattern for most common diseases in the Republic of Yemen in S Disease Pattern Annual Statistical Report 2009 GHOs 5-Year Plans (2009) Registered % Registered % 1 Respiratory system diseases % % Epidemiological surveillance diseases % % 3 Gastric system diseases % % Burns and wounds, accidents 4 and causalities % % 5 Urinary genital diseases % % 6 Intestinal parasites % % 7 Skin and tissues diseases % % 8 Anemia and Malnutrition % % 9 Eye diseases % % 10 Circulatory system diseases % % 11 Diabetes % % 12 Causalities and fractures % % 13 Psychiatric and neurological and behavioural diseases % % 14 Joints and bones diseases % % 15 Pregnancy and childbirth complications 5481 % % 16 Surgeries % 17 Others % % Grand Total % % 5

10 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 % Dengue Fever 163 % Bloody diarrhoea % Chicken pox % 3 Malaria % Rabies % 4 Typhoid % Multiple -causes Encephalitis and Meningitis 912 % Bilharzias 5134 % Leishmania 917 % Influenza % 19 Diphtheria 0 % Acute hepatitis A % 20 Neonatal Tetanus 30 % Acute hepatitis (B+C) % 21 Mollusk Acute Paralysis 184 % Mumps % 22 German Measles 251 % TB 1696 % Rich Worm % 11 Measles (Suspected) 851 % HIV AIDS % 12 Whooping Cough 2500 % Cholera 0 % Malta Fever 4969 % Meningitis 97 % 0.03 Grand Total % Source: Annual Epidemiological Surveillance Report issued by the General Department for Disease Control and Epidemiological Surveillance, MoPHP. 6

11 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, million). The total annual health expenditure was 5.23% of the GDP of The total annual expenditure on health per capita was 11,951 YER (US$ 60). The general government 9 health expenditure (GGHE) in 2007, as reflected in the national health accounts (NHA) was YER 92,568 million (US$ 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$ 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. 7

12 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 % 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) 69.69% 30.31% TPE other NHA 2007 Total private expenditure on pharmaceuticals is 75, million YR (US$ million) which is 97.24% of TPE. Total public expenditure was 2, million YR (US$ million). 8

13 FIGURE 2: Share of Total Pharmaceutical Expenditure by sector (2007) 2.76% 97.24% Public sector Private sector NHA 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 pharmacists 10, of which 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, (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 Table 3: Human resources for health in Yemen Human Resource Licensed pharmacists (all sectors) (2009) 1, (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, (3.4/10,000) 10 Yemen Health Progress During last 20 Years The fourth five-year development plan ( ) 12 Yemen Health Progress During last 20 Years The fourth five-year development plan ( ) 14 Yemen Health Progress During last 20 Years

14 Nursing and midwifery personnel (all sectors) (2009) 17, (7.3 /10,000) Source: Yemen Health Progress during last 20 years (2010) Figure 3: Distribution of Pharmaceutical Personnel, Yemen (2009) 40% Pharmacists 60% Pharmaceutical technicians and assistants 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 = The Qualification needs for technical staff through( health institutes) for the whole country will be: Pharmacist Technicians = (all Categories), Yemen Health Progress During last 20 Years , Yemen Health Progress During last 20 Years There are expectation not strategic plan for human resources during the NHS plan (The fourth five-year development plan ( )) 10

15 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, primary health care units and centres and 3, licensed pharmacies. Table 4: Health centre and hospital statistics Infrastructure Hospitals Hospital beds (2009) (7 /10,000) 22 Primary health care units and centres 3, Licensed pharmacies Drug stores 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 ( ) 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 inservice 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. Nine 24 hospitals are planned during 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 Annual Statistical Yearbook- The General Department for Health Research & Studies - MoPHP/ Third Five-Year Plan Annual Statistical Yearbook-/ Third Five-Year Plan Report 2010 MoPHP Referral & General Hosp., Source: 2009 Annual Statistical Yearbook - The General Department for Health Research & Studies- MoPHP 22 Yemen Health Progress During last 20 Years Third Five-Year Plan The fourth five-year development plan ( ) 11

16 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

17 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. 13

18 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 ( 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 An associated National Health Policy implementation plan does not exist. 28 Excerpt from the National Health Strategy 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 Updated between to be as (NHP/Strategy ) 28 National Health Strategy (NHS)

19 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 Yemen 30. It was updated in 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) National Medicines Policy document Exist mainly as detailed in table 5, but is not as formal implementation and is not completely regularly monitored /assessed 15

20 Table 5: The NMP / group of policies cover 32 Aspect of policy Selection of essential medicines Medicines financing Medicines pricing Medicines Procurement Medicines Distribution Medicines Regulation Pharmacovigilance Rational use of medicines Human Resource Development Research Monitoring and evaluation Traditional Medicine Covered [Yes] [Yes] [Yes] [Yes] [Yes] [Yes] [No]* [No] [No] [No] [No] [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 states 33 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 donations 35. There is no national good governance policy in Yemen National Medicines Policy document 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 Not available in NMP

21 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, 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 Key recommendations: 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 National Health Strategy

22 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. 18

23 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 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 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: 19

24 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 Production of pharmaceutical starting materials (APIs) The production of formulations from pharmaceutical starting material The repackaging of finished dosage forms No Yes Yes 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 Key recommendations: 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 public SBDMA, GMP certificate provide by (MRA /SBDMA) not from Independent authority) 43 YEMENI JOURNAL FOR MEDICAL SCIENCES (2010) 20

25 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 (Supreme Board of Drugs and Medical Appliances, SBDMA). Table 8: Functions of the national MRA 44 Function Marketing authorisation / registration Inspection Import control Licensing Market control Quality control Medicines advertising and promotion Clinical trials control Pharmacovigilance MRA participates and supervises all government tenders Yes Yes Yes Yes Yes Yes Yes No No 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 21

26 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 budget 45. 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 products 46. 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 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 22

27 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 decisionmaking 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 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 Table 9: Local entities inspected for GMP compliance 49 Entity Inspection Frequency Local manufacturers Yes low Private wholesalers Yes low Retail distributors** Yes low 48 SBDMA Registration (?) 49 Cabinet Decree No.333/2004 for regulation of trade and manufacturing of medicines, medical appliances and relatives bylaw 23

28 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 licensed 49. 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 Wholesalers Distributors Yes Yes Yes 50 Presidential Decree No76 for MoPHP bylaw 2004 & Presidential Decree No. 231 for MRA/SBDM re-organizing 1999 ) 24

29 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 testing 56 Medicines tested: For quality monitoring in the public sector 57 [Yes] For quality monitoring in the private sector 58 [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] 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 ) 56 Cabinet Decree No.333/2004 for regulation of trade and manufacturing of medicines, medical 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) 25

30 Samples are collected by government inspectors for undertaking post-marketing surveillance testing 61. In the past 2 years, samples were taken for quality control testing. Of the samples tested, (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 / 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) 61 Cabinet Decree No.333/2004 for regulation of trade and manufacturing of medicines, medical appliances and relatives bylaw samples ( ), Yemen Quality Control Documents samples, Yemen Quality Control Documents 26

31 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 Yes Psychotropic Substances, Laws exist for the control of narcotic and psychotropic substances, and precursors. 64 The annual consumption of Morphine is mg/capita 65. 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) 27

32 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 Yemen 65 Controlled substance Annual consumption (mg/capita) Morphine Fentanyl Pethidine Quantities imported during Controlled substance Morphine Fentanyl Pethidine Quantities mg gm kg 5.10 Pharmacovigilance 67 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 28

33 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. Further information and key findings: 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 29

34 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 30

35 Republican Resolution No (76): for the Year 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 Any non-communicable diseases [No]* [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 insurance 71 or other sickness fund does not provide at least partial medicines coverage. 70 Cabinet Decree No. 15/ 1999 for Community participation 71 Not available 31

36 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 medicines 74. 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 75. 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 Sector 77 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 74 Cabinet Decree No. 15/ 1999 for Community participation 75 Cabinet Decree No. 15/ 1999 for Community participation 76 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) 32

37 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 Yemen 80. 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 prices 82 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: Medicine Prices in Yemen July The International reference price is the median of prices offered by international suppliers (both for profit and not profit) as report by MHS International Price Indicator Guide ( For more information on the methodology WHO/HAI pricing survey, you can download a free copy of the manual at 33

38 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 ( ) for generics, while the private sector had higher prices, ( ) for originators and 3.5 ( ) 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. 34

39 Table 15: Availability, Pricing and Affordability of medicines in Yemen Public Public patient procurement Availability Originator 0 Mean (%) Lowest priced generic (LPG) 50%( %) Median (%) Originator Lowest priced generic (LPG) Price Mean Price Originator 0.49 to 1.76 Ratio Lowest priced generic (LPG) 0.62 to ( ) Affordability Number of Originator days wages Lowest priced generic (LPG) Private patient 5% (0-12.5%) 90%( % ( ) 3.5 ( ) 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 % in the private sector Medicine Prices in Yemen

40 6.6 Duties and Taxes on Pharmaceuticals (Market) Yemen imposes 84 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 place 85. Further information and key findings: 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. 36

41 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 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 Buying procedures in 2000 (YemDAP - Final Evaluation, September 2002) 87 Joint Health System Review Mission Yemen Buying procedures in 2000 (YemDAP - Final Evaluation, September 2002) 89 YemDAP - Final Evaluation, September

42 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. 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 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 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. 38

43 Further information and key findings: 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

44 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 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 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: 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. 40

45 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 curriculum 105 Curriculum The concept of EML Use of STGS Pharmacovigilance Problem based pharmacotherapy (PBP) Covered No 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 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 No No* 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. 41

46 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) % of medicines in outpatient public health care facilities that are prescribed by INN name (mean) % of patients in outpatient public health care facilities receiving antibiotics (mean). % of patients in outpatient public health care facilities receiving injections (mean) % of prescribed drugs dispensed to patients (mean) % 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 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 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 / An intervention study to promote rational prescribing in districts supported by the European Support to Health Sector Reform )* - Prof. Dr. Ahmed Abdo-Rabbo / Law No. (26) 2002 for practicing of Medical and pharmacy professions 42

47 Table 18: Core aspects of the pharmacist training curriculum Curriculum The concept of EML Use of STGS Drug information Clinical pharmacology Covered [No] [No] [No] [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. Further information and key findings: 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

48 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. 44

49 Key Documents Document Exact title Author Publisher Year File name National Medicines Yemen National Policy (NMP) Medicines Policy NMP Not available implementation plan National Medicines Law No. (26) 2002 for Act practicing of Medical and pharmacy professions National Not available pharmaceutical human resources report or strategic plan Latest report on the Mission to study the national situation of Drug pharmaceutical Policies in the market (any source) Republic of Yemen 2-9 January 2006/ Dr M.N.G.Dukes MD LLM MA National Not available Pharmacovigilance Centre report (including Adverse Drug Reaction, ADR, analysis report in the last two years) National Cabinet Decree No. pharmaceutical (333) 2004 for legislation for regulation of trade and regulation manufacturing of Ministry of Public Health &Population (MoPHP) MoPHP Pharmaceutical Sector 1998 Yemen National Medicines Policy MoPHP MoPHP 2002 Law No. (26) 2002 for practicing of Medical and pharmacy professions Dr Dr M.N.G.Dukes MD 2006 Mission to study the M.N.G.Dukes LLM MA situation of Drug MD LLM MA Policies in the Republic of Yemen MoPHP Cabinet 2004 Cabinet Decree No. (333) 2004 for regulation of trade and manufacturing of 45

50 Annual report of quality control laboratories Annual report of national regulatory authority Legal provisions on medicines price regulations Medicines procurement policy National Essential Medicines List (EML) National Standard Treatment Guidelines (STGs) National Strategy for anti-microbial medicines and medical appliances and its relatives Annual report of quality control laboratories Annual Report for SBDMA Cabinet Decree No. (333) 2004 for regulation of trade and manufacturing of medicines and medical appliances and its relatives Cabinet Decree No. (333) 2004 for regulation of trade and manufacturing of medicines and medical appliances and its relatives National Essential Medicines (EML) National Standard Treatment Guidelines (STGs) Not available medicines and medical appliances and its relatives Supreme Medicines quality Yearly Medicines quality Board for control laboratories control laboratories Medicines & Report Directorate Annual Report Medical Appliances (SBDMA) SBDMA Annual Report for Yearly Annual Report for SBDMA SBDMA (MoPHP) Cabinet 2004 Cabinet Decree No. (333) 2004 for regulation of trade and manufacturing of medicines and medical appliances and its relatives (MoPHP) Cabinet 2004 Cabinet Decree No. (333) 2004 for regulation of trade and manufacturing of medicines and medical appliances and its relatives (MoPHP) MoPHP (Pharmacy 2009 National Essential affairs General Medicines (EML) Directorate ) with committee instantly established (MoPHP) MoPHP (Pharmacy affairs General Directorate ) with committee instantly established 2001 National Standard Treatment Guidelines (STGs) 46

51 resistance Any other medicines pricing/availability surveys, household surveys, and rational use surveys than the ones used to prefill in the instrument. Not available 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. 47