Pharmaceutical Sector Country Profile Questionnaire YEMEN

Transcription

1 Pharmaceutical Sector Country Profile Questionnaire YEMEN

2 Final Version. Page 2

3 Section 0 General nfo 0.01 Contact nfo Country (precoded) Yemen-RV Name coordinator Dr. Abdul Moneim Ali Al-Hakami Address (Street, City) Aljarda zone Phone number address sbdma@yemen.net.ye Web address nstitution Suprem Board for Medicines & Medical Appliances/ MoPHP

4 Section 1 Health and Demographic data 1.00 Respondent nformation Section Name of person responsible for filling out Survey section 1 Dr. Abdul Moneim Ali Al-Hakami Phone number address sbdma@yemen.net.ye Other respondents for filling out this section 1.01 Demographic and Socioeconomic ndicators Core questions (click here for help) Population, total (,000) 22, CSO Population growth rate (Annual %) CSO Total Gross Domestic Product (GDP) (millions US$) 26, World Bank data GDP growth (Annual %) World Bank data C GDP per capita (US$ current exchange rate) 2, MF, Comments and References Supplementary questions (click here for help) S Population < 15 years (% of total population) National Health Strategy S Population > 60 years (% of total population) WHS S Urban population (% of total WHS

5 population) S Fertility rate, total (Births per woman) WHS S Population living with less than $1.25/day (international PPP) (%) World Bank data S Population living below nationally defined poverty line (%) Fourth 5- year Plan S ncome share held by lowest 20% of the population (% of national income) World Bank dataa S Adult literacy rate, 15+ years (% of relevant population) WHS S Comments and References 1.02 Mortality and Causes of Death Core questions (click here for help) Life expectancy at birth for men (s) Life expectancy at birth for women (s) nfant mortality rate, between birth and age 1 (/1,000 live births) Under 5 mortality rate (/1,000 live births) cluster survey with multuiple indicators cluster survey with multuiple indicators cluster survey with multuiple indicators cluster survey with multuiple indicators 5

6 Maternal mortality ratio ( /100,000 live births) Please provide a list of top 10 diseases causing mortality cluster survey with multuiple indicators Disease 1 childhood diseases Disease 2 Malaria Disease 3 cardiovascular diseases Disease 4 TB Disease 5 Diarrhea Disease 6 respiratory infections Disease 7 malnutrition Disease 8 accidents of all kinds Disease 9 anemia Disease Please provide a list of top 10 diseases causing morbidity Disease 1 Bilharzias Disease 2 mumps Disease 3 intestinal parasites Disease 4 viral hepatitis Disease 5 TB 6

7 Disease 6 Malaria Disease Disease Disease Disease Comments and References More details in the main documents and narrative profile Supplementary questions (click here for help) S Adult mortality rate for both sexes between 15 and 60 years (/1,000 population) WHS S Neonatal mortality rate ( /1,000 live births) WHS S Age-standardized mortality rate by non-communicable diseases (/100,000 population) WHS S Age-standardized mortality rate by cardiovascular diseases (/100,000 population) WHS S Age-standardized mortality rate by cancer ( /100,000 population) WHS S Mortality rate for HV/ADS (/100,000 population) S Mortality rate for tuberculosis (/100,000 population) WHS S Mortality rate for Malaria (/100,000 population) WHS S Comments and References 7

8 Section 2 Health Services 2.00 Respondent nformation Section Name of person responsible for filling out this section of the instrument Phone number address Other respondents for filling out this section 2.01 Health Expenditures Core questions (click here for help) Total annual expenditure on health (millions NCU) Total annual expenditure on health (millions US$ average exchange rate) 257, NHA data 1, NHA data C Total health expenditure as % of Gross Domestic Product C Total annual expenditure on health per capita (NCU) 11, C Total annual expenditure on health per capita (US$ average exchange rate) General government annual expenditure on health (millions NCU) General government annual expenditure on health (millions US$ average exchange rate) Government annual expenditure on health as percentage of total government budget (% of total government budget) 72, NHA data NHA data NHA data

9 C Government annual expenditure on health as % of total expenditure on health (% of total expenditure on health) 2007 NHA data C Annual per capita government expenditure on health (NCU) C Annual per capita government expenditure on health (US$ average exchange rate) C Private health expenditure as % of total health expenditure (% of total expenditure on health) NHA data Population covered by a public health service or public health insurance or social health insurance, or other sickness funds of total population) National Health Strategy Population covered by private health insurance (% of total population) Total pharmaceutical expenditure (millions NCU) Total pharmaceutical expenditure (millions US$ current exchange rate) 78, NHA NHA C Total pharmaceutical expenditure per capita (NCU) 3, C Total pharmaceutical expenditure per capita (US$ current exchange rate) C Pharmaceutical expenditure as a % of GDP (% of GDP) C Pharmaceutical expenditure as a % of Health Expenditure (% of total health expenditure) Total public expenditure on 2, NHA 9

10 pharmaceuticals (millions NCU) Total public expenditure on pharmaceuticals (millions US$ current exchange rate) NHA C Share of public expenditure on pharmaceuticals as percentage of total expenditure on pharmaceuticals (%) NHA C Total public expenditure on pharmaceuticals per capita (NCU) C Total public expenditure on pharmaceuticals per capita (US$ current exchange rate) Total private expenditure on pharmaceuticals (millions NCU) Total private expenditure on pharmaceuticals (millions US$ current exchange rate) 75, NHA NHA Comments and References Supplementary questions (click for help) S Social security expenditure as % of government expenditure on health (% of government expenditure on health) NHA data S Market share of generic pharmaceuticals [branded and NN] by value (%) S Annual growth rate of total pharmaceuticals market value (%) S Annual growth rate of generic pharmaceuticals market value (%) 10

11 S Private out-of-pocket expenditure as % of private health expenditure (% of private expenditure on health) NHA data S Premiums for private prepaid health plans as % of total private health expenditure (% of private expenditure on health) NHA data S Comments and References 2.02 Health Personnel and nfrastructure Core questions (click for help) Total number of pharmacists licensed/registered to practice in your country 1, Yemen Health Progress During last 20 s C Pharmacists per 10,000 population Total number of pharmacists working in the public sector Total number of pharmaceutical technicians and assistants A strategic plan for pharmaceutical human resource development is in place in your country? Yemen Health Progress During last 20 s , Yemen Health Progress During last 20 s Total number of physicians 7, Yemen Health 11

12 Progress During last 20 s C Physicians per 10,000 pop Total number of nursing and midwifery personnel 3 17, Yemen Health Progress During last 20 s C Nurses and midwives per 10,000 pop Total number of hospitals Annual Statistical book- The General Department for Health Research & Studies- MoPHP Number of hospital beds per 10,000 pop Total number of primary health care units and centers Total number of licensed pharmacies WHS Third Five- Plan Forth Five- plan Comments and References Supplementary questions (click here for help) S Starting annual salary for a newly registered pharmacist 12

13 in the public sector (NCU) S Total number of pharmacists who graduated (first degree) in the past 2 years in your country S Are there accreditation requirements for pharmacy schools? S s the Pharmacy Curriculum regularly reviewed? S Comments and References 13

14 Section 3 Policy issues 3.00 Respondent nformation Section Name of person responsible for filling out this section of the instrument Phone number address Other respondents for filling out this section 3.01 Policy Framework Core questions (click here for help) National Health Policy exists. f yes, please write year of the most recent document in the "year" field National Health Policy mplementation plan exists. f yes, please write the year of the most recent document in the "year" Please provide comments on the Health policy and its implementation plan National Medicines Policy official document exists. f yes, please write the year of the most recent document in the "year" field National Health Strategy National Health Strategy National Health Strategy (NHS) was prepared through " Joint Health Sector Review" which was suported by 10 stackeholders (Local and foreign organizations and embassies ). the NHS was approved by Cabinat in 15/6/ 2010, w it is still under distribution but not planned WHO level Group of policies addressing pharmaceuticals exist National Medicines Policy covers the

15 following components: 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 National medicines policy implementation plan exists. f yes, please write year of the most recent document WHO level Policy or group of policies on clinical laboratories exist. f yes, please write year of the most recent document in the "year" field National clinical laboratory policy implementation plan exists. f yes, please write year of the most recent document in the "year" field Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or 15

16 national legislation? There are official written guidelines on medicines donations WHO level s pharmaceutical policy implementation being regularly monitored/assessed? Who is responsible for pharmaceutical policy monitoring? s there a national good governance policy? Multisectoral For the pharmaceutical sector Which agencies are responsible? A policy is in place to manage and sanction conflict of interest issues in pharmaceutical affairs There is a formal code of conduct for public officials s there a whistle-blowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of your country (ombudsperson)? Please describe: Comments and References 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, nter-country Training on Transparency Assessment nstrument, June 2012, Amman, Jordan. This participation will be the corner stone for implementing this policy. 16

17 Section 4 Medicines Trade and Production 1.00 Respondent nformation Section Name of person responsible for filling out this section of the instrument Phone number address Other respondents for filling out this section 1.01 ntellectual Property Laws and Medicines Core questions (click here for help) Country is a member of the World Trade Organization WTO Legal provisions provide for granting of Patents on: 2007 WHO level Pharmaceuticals Laboratory supplies Medical supplies Medical equipment Please provide name and address of the institution responsible for managing and enforcing intellectual property rights Please provide URL National Legislation has been modified to implement the TRPS Agreement 2011 MOH Current laws contain (TRPS) 2011 MOH

18 flexibilities and safeguards Country is eligible for the transitional period to SBDMA Which of the following (TRPS) flexibilities and safeguards are present in the national law? 2011 SBDMA Compulsory licensing provisions that can be applied for reasons of public health Bolar exception Are parallel importing provisions present in the national law? The country is engaged in initiatives to strengthen capacity to manage and apply intellectual property rights to contribute to innovation and promote public health Are there legal provisions for data exclusivity for pharmaceuticals 2011 SBDMA 2011 MOH 2010 SBDMA Legal provisions exist for patent extension Legal provisions exist for linkage between patent status and Marketing Authorization 2010 SBDMA Comments and References Yemen is eligible if we revise and update NHP and get the awareness from MOPHP policy-maker to change the pharmaceuticals polices 4.02 Manufacturing Core questions (click here for help) Number of licensed pharmaceutical manufacturers in the country SBDMA 18

19 Country has manufacturing capacity R&D to discover new active substances Production of pharmaceutical starting materials (APs) Unknown Unknown 2011 SBDMA Production of formulations from pharmaceutical starting material Unknown Repackaging of finished dosage forms Unknown Percentage of market share by value produced by domestic manufacturers (%) SBDMA Comments and References Supplementary questions (click here for help) S Percentage of market share by volume produced by domestic manufacturers (%) SBDMA S Number of multinational pharmaceutical companies manufacturing medicines locally SBDMA S Number of manufacturers that are Good Manufacturing Practice (GMP) certified SBDMA S Comments and References 19

20 Section 5 Medicines Regulation 5.00 Respondent nformation Section Name of person responsible for filling out this section of the instrument Phone number address Other respondents for filling out this section 5.01 Regulatory Framework Core questions (click here for help) Are there legal provisions establishing the powers and responsibilities of the Medicines Regulatory Authority (MRA)? 2007 WHO level There is a Medicines Regulatory Authority 2007 WHO level f yes, please provide name and address of the Medicines regulatory authority The Medicines Regulatory Authority is: Supreme Board of Drugs and Medical Appliances (SBDMA) Yemen-Sana`a, sbdma@yemen.net.ye Part of MoH Semi autonomous agency Other (please specify) What are the functions of the National Medicines Regulatory Authority? 20

21 Marketing authorization / registration nspection mport control Licensing Market control Quality control Medicines advertising and promotion Clinical trials control Pharmacovigilance Other: (please explain) MRA participate and supervise all the govemental tenders Number of the MRA permanent staff SBDMA Date of response 17/12/ The MRA has its own website 2009 WHO f yes, please provide MRA Web site address (URL) The MRA receives external technical assistance SBDMA f yes, please describe: The MRA is involved in harmonization/ collaboration initiatives 2007 WHO level f yes, please specify GCC An assessment of the medicines regulatory system has been conducted in the last five years Medicines Regulatory Authority gets funds from regular budget of the 2010 SBDMA 2007 WHO level 21

22 government Medicines Regulatory Authority is funded from fees for services provided Medicines Regulatory Authority receives funds/support from other sources 2007 WHO level 2010 SBDMA f yes, please specify Revenues derived from regulatory activities are kept with the Regulatory 2010 SBDMA Authority The Regulatory Authority is using a computerized information management system to store and retrieve information on registration, 2010 SBDMA inspections, etc Comments and References 5.02 Marketing Authorization (Registration) Core questions (click here for help) Legal provisions require a Marketing Authorization (registration) for all pharmaceutical products on the market Are there any mechanism for exception/waiver of registration? Are there mechanisms for recognition of registration done by other countries 2007 WHO level 2010 SBDMA 2010 SBDMA f yes, please explain: 22

23 Explicit and publicly available criteria exist for assessing applications for Marketing Authorization of pharmaceutical products nformation from the prequalification programme managed by WHO is used for product registration Number of pharmaceutical products registered in your country Legal provisions require the MRA to make the list of registered pharmaceuticals with defined periodicity publicly available 2010 SBDMA 2010 SBDMA 9, WHO level 2007 Cabinet Decree.333/200 4 for regulation of trade and manufacturi ng of medicines, medical appliances and relatives bylaw f yes, how frequently updated f yes, please provide updated list or URL * Medicines registration always includes the NN (nternational nproprietary Names) Legal provisions require the payment of a fee for Medicines Marketing Authorization (registration) applications 2007 WHO level 2010 Cabinet Decree.333/200 4 for regulation of trade and manufacturi ng of 23

24 medicines, medical appliances and relatives bylaw Comments and References There are no legal provisions, but there is a guide for the registered pharmaceuticals, but not updated and the last version available is from 1999 Supplementary questions (click here for help) S Legal provisions require Marketing Authorization holders to provide information about variations to the existing Marketing Authorization 2010 SBDMA S Legal provisions require publication of a Summary of Product Characteristics (SPCs) of the medicines registered 2010 SBDMA S Legal provisions require the establishment of an expert committee involved in the marketing authorization process 2007 WHO level S Certificate for Pharmaceutical Products in accordance with the WHO Certification scheme is required as part of the Marketing Authorization application 2007 WHO level S Legal provisions require declaration of potential conflict of interests for the experts involved in the assessment and decision-making for registration 2010 SBDMA S Legal provisions allow applicants to appeal against MRAs decisions 2010 SBDMA S Registration fee - the amount per application for pharmaceutical product containing New Chemical SBDMA 24

25 Entity (NCE) (US$) S Registration fee - the Amount per application for a generic pharmaceutical product (US$) SBDMA S Time limit for the assessment of a Marketing Authorization application (months) SBDMA S Comments & References Regulatory nspection Core Questions(click here for help) Legal provisions exist allowing for appointment of government pharmaceutical inspectors Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed 2010 SBDMA 2007 WHO level f yes, legal provisions exist requiring inspections to be performed nspection is a pre-requisite for licensing of: 2010 SBDMA Public facilities Private facilities nspection requirements are the same for public and private facilities Local manufactures are inspected for GMP compliance 2010 SBDMA 2007 WHO level Private wholesalers are inspected 25

26 Retail distributors are inspected Public pharmacies and stores are inspected Pharmacies and dispensing points of health facilities are inspected Please provide details on frequency of inspections for the different categories of facilities weak and irregular frequency and it is contradictory in some responsibilities between MRA (SBDM) and DG of Pharmaceutical affaires in the MoPHP Comments and References 5.04 mport Control Core Questions (click here for help) Legal provisions exist requiring authorization to import medicines Legal provisions exist allowing the sampling of imported products for testing Legal provisions exist requiring importation of medicines through authorized ports of entry Legal provisions exist allowing inspection of imported pharmaceutical products at the authorized ports of entry 2010 SBDMA 2010 SBDMA 2010 SBDMA 2010 SBDMA Comments and References 5.05 Licensing Legal provisions exist requiring manufacturers to be licensed 2007 WHO level Legal provisions exist requiring both domestic and international 2010 SBDMA 26

27 manufacturers to comply with Good manufacturing Practices (GMP) f no, please explain GMP requirements are published by the government Legal provisions exist requiring importers to be licensed Legal provisions exist requiring wholesalers and distributors to be licensed Legal provisions exist requiring wholesalers and distributors to comply with Good Distributing Practices 2010 SBDMA 2007 WHO level 2007 WHO level 2010 SBDMA When filling in this part, please also fill in the relevant questions in the procurement and distribution section (Section 7) National Good Distribution Practice requirements are published by the government Legal provisions exist requiring pharmacists to be registered Legal provisions exists requiring private pharmacies to be licensed Legal provision exist requiring public pharmacies to be licensed National Good Pharmacy Practice Guidelines are published by the government Legal provisions require the publication of a list of all licensed pharmaceutical facilities 2010 SBDMA 2010 SBDMA 2010 SBDMA 2010 SBDMA 2010 SBDMA 2010 SBDMA Comments and References 27

28 5.06 Market Control and Quality Control Core Questions (click here for help) Legal Provisions for regulating the pharmaceutical market exist Does a laboratory exist in the country for Quality Control testing? 2010 SBDMA 2010 SBDMA f yes, is the laboratory part of the MRA? Does the regulatory authority contract services elsewhere? f yes, please describe s there any national laboratory accepted for collaboration with WHO prequalification Programme? Please describe Medicines are tested: Yemen Quality Control Laboratory was evaluated by a WHO team, but the team did not complete his mission as a result of the crisis in 2011 ( Yemen Quality Control Documents ) 2010 SBDMA s For quality monitoring in the public sector (routine sampling in pharmacy stores and health facilities) For quality monitoring in private sector (routine sampling in retail outlets) When there are complaints or problem reports For product registration For public procurement prequalification For public program products prior to 28

29 acceptance and/or distribution Samples are collected by government inspectors for undertaking post-marketing surveillance testing How many Quality Control samples were taken for testing in the last two years? Total number of samples tested in the last two years that failed to meet quality standards Results of quality testing in past two years are publicly available 2007 Cabinet Decree.333/200 4 for regulation of trade and manufacturi ng of medicines, medical appliances and relatives bylaw QC.analysi s documents QC.analysi s documents 2010 QC.analysi s documents Comments and References 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: The samples were tacking for testing for last two years ( ). (resource: QC.analysis documents) The results were publicly only to registration technical committee in the SBDMA Medicines Advertising and Promotion Core Questions (click here for help) Legal provisions exist to control the promotion and/or advertising of 2007 WHO level 29

30 prescription medicines Who is responsible for regulating, promotion and/or advertising of medicines? Please describe: Legal provisions prohibit direct advertising of prescription medicines to the public Legal provisions require a preapproval for medicines advertisements and promotional materials Supreme Board of Drugs & Medical Appliances/Scientific Department 2007 WHO level 2007 WHO level Guidelines/Regulations exist for advertising and promotion of nonprescription medicines A national code of conduct exists concerning advertising and promotion of medicines by marketing authorization holders and is publicly available 2007 WHO level 2010 SBDMA f yes, the code of conduct applies to domestic manufacturers only, multinational manufacturers only, or both Domestic only Multinational only Both f yes, adherence to the code is voluntary f yes, the code contains a formal process for complaints and sanctions f yes, list of complaints and sanctions for the last two years is 30

31 publicly available Comments and References 5.08 Clinical trials Core Questions (click here for help) Legal provisions exist requiring authorization for conducting Clinical Trials by the MRA Legal provisions exist requiring the agreement by an ethics committee/ institutional review board of the Clinical Trials to be performed Legal provisions exist requiring registration of the clinical trials into international/national/regional registry 2010 SBDMA 2010 SBDMA 2010 SBDMA Comments and References Supplementary questions (click here for help) S Legal provisions exist for GMP compliance of investigational products 2010 SBDMA S Legal provisions require sponsor, investigator to comply with Good Clinical Practices (GCP) 2010 SBDMA S National GCP regulations are published by the Government SBDMA S Legal provisions permit inspection of facilities where clinical trials are performed 2010 SBDMA S Comments and References 31

32 5.09 Controlled Medicines Core Questions (click here for help) The country has adopted the following conventions: Date Single Convention on Narcotic Drugs, The 1972 Protocol amending the Single Convention on Narcotic Drugs, Convention on Psychotropic Substances United Nations Convention against the llicit Traffic in Narcotic Drugs and Psychotropic Substances, Laws for the control of narcotic and psychotropic substances, and precursors exist Annual consumption of Morphine (mg/capita) 1992 Ministry of nterior,mo PHP 1996 nternation al Narcotics Control Board 1996 nternation al Narcotics Control Board 1996 nternation al Narcotics Control Board 1993 Law. 3 /1993 for struggler and control of narcotics & psychotropi c substances and precursors and its trade. (t is under the Ministry Of nterior nternation al Narcotics Control 32

33 Board Comments and References The current situation regarding the Narcotic Drugs regulations is sharing between Ministry of interior and MoPHP (SBDMA ), the two partners participated in some international meeting in 1987, which was hold periodically, the aim of this meeting was to discuss the international situations and the agreement for fighting the misuse of Narcotics Drugs. Supplementary questions (click here for help) n 1992 Yemen was signed the convention on Narcotics Drugs, 1961,through Yemen representative in the United Nation with participation of Ministry of interior and MoPHP (SBDMA ), n 1993, Yemen issued the ( Law. 3 /1993 for struggler and control of narcotics & psychotropic substances and precursors and its trade. (t is under the Ministry Of nterior) S The legal provisions and regulations for the control of narcotic and psychotropic substances, and precursors have been reviewed by a WHO nternational Expert or Partner Organization to assess the balance between the prevention of abuse and access for medical need Unknown S f yes, year of review S Annual consumption of Fentanyl (mg/capita) nternation al Narcotics Control Board S Annual consumption of Pethidine (mg/capita) nternation al Narcotics Control Board S Annual consumption of Oxycodone (mg/capita) S Annual consumption of Hydrocodone (mg/capita) 33

34 S S S Annual consumption of Phenobarbital (mg/capita) Annual consumption of Methadone (mg/capita) Comments and References 5.10 Pharmacovigilance Core Questions (click here for help) There are legal provision in the Medicines Act that provides for pharmacovigilance activities as part of the MRA mandate Legal provisions exist requiring the Marketing Authorization holder to continuously monitor the safety of their products and report to the MRA Legal provisions about monitoring Adverse Drug Reactions (ADR) exist in your country A national pharmacovigilance centre linked to the MRA exists in your country 2011 SBDMA 2011 SBDMA 2011 SBDMA 2011 SBDMA f a national pharmacovigilance centre exists in your country, how many staff does it employ fulltime f a national pharmacovigilance center exists in your country, an analysis report has been published in the last two years f a national pharmacovigilance center exists in your country, it publishes an ADR bulletin 34

35 An official standardized form for reporting ADRs is used in your country A national Adverse Drug Reactions database exists in your country How many ADR reports are in the database? How many reports have been submitted in the last two years? Are ADR reports sent to the WHO database in Uppsala? f yes, number of reports sent in the last two years s there a national ADR or pharmacovigilance advisory committee able to provide technical assistance on causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication? s there a clear communication strategy for routine communication and crises communication? n the absence of a national pharmacovigilance system, ADRs are monitored in at least one public health program (for example TB, HV, ADS)? Please describe how you intend to enhance the Pharmacovigilance system Comments and References Supplementary questions (click here for help) 35

36 S Feedback is provided to reporters S The ADR database is computerized S Medication errors (MEs) are reported S How many MEs are there in the ADRs database? S There is a risk management plan presented as part of product dossier submitted for Marketing Authorization? S n the past two years, who has reported ADRs? S Doctors S Nurses S Pharmacists S Consumers S Pharmaceutical Companies S Others, please specify whom S Was there any regulatory decision based on local pharmacovigilance data in the last 2 years? S Are there training courses in pharmacovigilance? S f yes, how many people have been trained in the last two years? S Comments and References 36

37 Section 6 Medicines Financing 6.00 Respondent nformation Section Name of person responsible for filling out this section of the instrument Ahmed M.Aklan Phone number address Ahmed.Aklan@yahoo.com Other respondents for this sections Yassin 6.01 Medicines Coverage and Exemptions Core Questions (click here for help) Do the followings receive medicines free of charge: 2011 MOH Patients who cannot afford them Children under Pregnant women Elderly persons Please describe/explain your yes answers for questions above s there a public health system or social health insurance scheme or public programme providing medicines free of charge for : t is very limited,specified only some medicines as chronic diseases as (Diabetic, Kidny replecement, and iron and folic acid for pregnants, imunization and primary child.illness ), All medicines included in the EML Any non-communicable diseases Malaria medicines Tuberculosis medicines

38 Sexually transmitted diseases medicines HV/ADS medicines Expanded Program on mmunization (EP) vaccines f others, please specify Please describe/explain your yes answers for questions above Although of availability of these medicines in NEML, but also each program has its own specific medicine list and policy. NCD:very limited, when it is available in primary health care facilities. Most of (Malaria, TB, STDs/HV/ADS &EP ) medicines are delivered through the Donors Does a national health insurance, social insurance or other sickness fund provide at least partial medicines coverage? Does it provide coverage for medicines that are on the EML for inpatients Does it provide coverage for medicines that are on the EML for outpatients Please describe the medicines benefit of public/social insurance schemes Currently the MoPHP was finished the socioal insurance law and bylaw,but practically still absent in public sector. n private sector there are different experiances in insurance implementation Do private health insurance schemes provide any medicines coverage? f yes, is it required to provide coverage for medicines that are on the EML? Comments and References The NEML concept is still unkown and not widly publictly in all health users 38

39 6.02 Patients Fees and Copayments Core Questions (click here for help) n your health system, at the point of delivery, are there any copayment/fee requirements for consultations n your health system, at the point of delivery, are there any copayment/fee requirements for medicines n practice, (even though this may be contrary to regulations) is revenue from fees or sales of medicines sometimes used to pay the salaries or supplement the income of public health personnel in the same facility? Please describe the patient fees and copayments system 2007 Cabinet Decree. 15/ 1999 for Community participatio n Ministerial Decree for Community participatio n WHO level During the availability of Drug Fund,there was a cost-recovery system (as Revolving Fund) for medicines and the medicines was available Comments and References The ministerial decree was issued for abolish DF and deliver medicines free of charge, this lead to absent of essential medicines Pricing Regulation for the Private Sector Core Questions (click here for help) Are there legal or regulatory provisions affecting pricing of medicines f yes, are the provisions aimed at Manufacturers 2010 SBDMA 39

40 f yes, are the provisions aimed at Wholesalers f yes, are the provisions aimed at Retailers Please explain the positive answers above: (explain scope of provisions i.e generics vs. originator or subsets of medicines, EML etc.) Government runs an active national medicines price monitoring system for retail prices Regulations exists mandating that retail medicine price information should be publicly accessible if yes, please explain how the information is made publically available the medicine price exist to regulate the wholesalers and retailers according to our mark - up regulation SBDMA 2010 SBDMA Through stamping public price on the drug box Comments and References 6.04 Prices, Availability and Affordability Core Questions (click here for help) Please state if a medicines price survey using the WHO/HA methodology has been conducted in the past 5 years in your country. f yes, please indicate the year of the survey and use the results to fill in this table f no, but other surveys on medicines prices and availability have been conducted, please do not use them to fill in this section, but rather use the comment box to write some of the results and attach the report to the questionnaire Unknown 2006 WHO/HA Surveys of medicine prices and availability 40

41 Basket Of key medicines Public procurement Public patient Private patient Availability (one or both of) Mean (%) Orig LPG Median (%) Orig LPG Price Median Price Ratio Orig LPG Affordability Days wages of the lowest paid govt worker for standard treatment with co-trimoxazole for a child respiratory infection Number of days wages Orig LPG Comments and References : : 0.62 to Price Components and Affordability Core Questions (click here for help) Please state if a survey of medicines price components has been conducted in the past 5 years in your country Unknown

42 Median cumulative percentage markup between Manufacturer Selling Price (MSP)/ Cost nsurance and Freight (CF) price and final medicine price for a basket of key medicines in the public sector (Median % contribution) Median cumulative percentage markup between MSP/CF price and final medicine price for a basket of key medicines in the private sector (Median % contribution) Comment and References Supplementary questions (click here for help) S S S S S S Median percentage contribution of MSP/CF to final medicine price for a basket of key medicines in the public sector (Median % contribution) Median percentage contribution of MSP/CF to final medicine price for a basket of key medicines in the private sector (Median % contribution) Median manufacturer selling price (CF) as percent of final medicine price for a basket of key medicines (%) Median wholesaler selling price as percent of final medicine price for a basket of key medicines (%) Median pharmacist mark-up or dispensing fee as percent of retail price for a basket of key medicines (%) Median percentage contribution of the wholesale mark-up to final medicine price for a basket of key medicines (in the public and private sectors) (%) 42

43 S S Median percentage contribution of the retail mark-up to final medicine price for a basket of key medicines (in the public and private sectors) (%) Comment and References 6.06 Duties and Taxes on Pharmaceuticals (Market) Core Questions (click here for help) There are duties on imported active pharmaceutical ingredients (APs) There are duties on imported finished products VAT (value-added tax) or any other tax is levied on finished pharmaceuticals products There are provisions for tax exceptions or waivers for pharmaceuticals and health products 2004 Cabinet Decree for regulation of trade and manufacturi ng of medicines and medical appliances and its relatives 2007 WHO level 2011 MOH 2011 MOH Please specify categories of pharmaceuticals on which the taxes are applied and describe the exemptions and waivers that exist Comments and References 43

44 Supplementary questions (click here for help) S Duty on imported active pharmaceutical ingredients, APs (%) S Duty on imported finished products (%) S VAT on pharmaceutical products (%) S Comments and References 44

45 Section 7 Pharmaceutical procurement and distribution 7.00 Respondent nformation Section Name of person responsible for filling out this section of the instrument Ahmed M. Aklan Phone number address Ahmed.Aklan@yahoo.com Other respondents for filling out this section 7.01 Public Sector Procurement Core Questions (click here for help) Public sector procurement is: Date Decentralized Centralized and decentralized Please describe the Drug Fund increased transparency of procurement procedures through ntroduction on new buying procedures in and the DF have 5 regional stores were received their medicines directly fro suppliers after finalizing the precurment conditions centrally. 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 f public sector procurement is wholly or partially centralized, it is under the responsibility of a procurement agency which

46 is: Part of MoH Semi-Autonomous Autonomous A government procurement agency which procures all public goods Public sector requests for tender documents are publicly available Public sector tender awards are publicly available Procurement is based on prequalification of suppliers 2000 YemDAP final evaluation 2000 YemDAP final evaluation 2000 YemDAP final evaluation f yes, please describe how it works During the tendering period, there are 2 main activities for precurment - the suppliers who they are familiar with precurement agency, they accepted directly, The suppliers which is new, it should be pass throuh prequalification process Comments and References Supplementary questions (click here for help) S s there a written public sector procurement policy?. f yes, please write the year of approval in the "year" field 2000 YemDAP final evaluation S Are there legal provisions giving priority in public procurement to goods produced by local manufacturers? 2000 YemDAP final evaluation S The key functions of the procurement unit and those of the tender committee are clearly 2007 WHO level 46

47 separated S A process exists to ensure the quality of products procured 2000 YemDAP final evaluation S f yes, the quality assurance process includes pre-qualification of products and suppliers S f yes, explicit criteria and procedures exist for prequalification of suppliers S f yes, a list of pre-qualified suppliers and products is publicly available S List of samples tested during the procurement process and results of quality testing are available 2000 YemDAP Final evaluation S Which of the following tender methods are used in public sector procurement: 2007 WHO level S National competitive tenders S nternational competitive tenders S Direct purchasing S Comments and References 7.02 Public Sector Distribution Core Questions (click here for help) The government supply system department has a Central Medical Store at National Level Number of public warehouses in the secondary tier of public distribution 2000 YemDAP final evaluation YemDAP final 47

48 (State/Regional/Provincial) evaluation There are national guidelines on Good Distribution Practices (GDP) 2000 (Drug Fund catalogues for hospitals and districts procedures and supplies issued 2000 ) There is a licensing authority that issues GDP licenses f a licensing authority exists, does it accredit public distribution facilities? List of GDP certified warehouses in the public sector exists List of GDP certified distributors in the public sector exists Comments and References comments Supplementary questions (click here for help) S Which of the following processes is in place at the Central Medical Store: S Forecasting of order quantities S Requisition/Stock orders S Preparation of picking/packing slips S Reports of stock on hand 48

49 S Reports of outstanding order lines S Expiry dates management S Batch tracking S Reports of products out of stock S Percentage % availability of key medicines at the Central Medical Store card stock in National Program for Medical Supplies (NPMS) S Average stock-out duration for a basket of medicines at the Central Medical Store, in days S Routine Procedure exists to track the expiry dates of medicines at the Central Medical Store 2012 (NPMS) S The Public Central Medical Store is GDP certified by a licensing authority S The Public Central Medical Store is SO certified S The second tier public warehouses are GDP certified by a licensing authority S The second tier public warehouses are SO certified S Comments and References 17 of the NEDL was response to S 7.03 Private Sector Distribution Core Questions (click here for help) Legal provisions exist for licensing 2010 SBDMA 49

50 wholesalers in the private sector Legal provisions exist for licensing distributors in the private sector List of GDP certified wholesalers in the private sector exists List of GDP certified distributors in the private sector exists 2010 SBDMA 2010 SBDMA 2010 SBDMA Comments and References 50

51 Section 8 Selection and rational use 8.00 Respondent nformation Section Name of person responsible for filling out this section of the instrument Ahmed M. Aklan Phone number address Ahmed.Aklan@yahoo.com Other respondents for filling out this section 8.01 National Structures Core Questions (click here for help) National essential medicines list (EML) exists. f yes, please write year of last update of EML in the "year" field f yes, number of medicines on the EML (no. of NN) 2009 WHO level f yes, there is a written process for selecting medicines on the EML f yes, the EML is publicly available f yes, is there any mechanism in place to align the EML with the Standard Treatment Guidelines (STG) National Standard Treatment Guidelines (STGs) for most common illnesses are produced/endorsed by the MoH. f yes, please insert year of last update of STGs in the "year" field STGs specific to Primary care exist. Please use the "year" field to 2010 SBDMA 2001 WHO level

52 write the year of last update of primary care guidelines STGs specific to Secondary care (hospitals) exists. Please use the "year" field to write the year of last update of secondary care STGs STGs specific to Paediatric conditions exist. Please use the "year" field to write the year of last update of paediatric condition STGs 2001 YemDAP final evaluation 2010 HSDS EC commissio n - Taiz % of public health facilities with copy of EML (mean)- Survey data % of public health facilities with copy of STGs (mean)- Survey data A public or independently funded national medicines information centre provides information on medicines to prescribers, dispensers and consumers Joint health sector review team 2007 WHO level Public education campaigns on rational medicine use topics have been conducted in the previous two years A survey on rational medicine use has been conducted in the previous two years A national programme or committee (involving government, civil society, and professional bodies) exists to monitor and promote rational use of medicines A written National strategy exists to contain antimicrobial resistance. f yes, please write year of last update of the strategy in the "year" 2007 WHO level 2007 WHO level 52