Azerbaijan PHARMACEUTICAL COUNTRY PROFILE

Transcription

1 Azerbaijan PHARMACEUTICAL COUNTRY PROFILE

2 Azerbaijan Pharmaceutical Country Profile Published by the Ministry of Health in collaboration with the World Health Organization 12/05/2011 Any part of this document may be freely reviewed, quoted, reproduced, or translated in full or in part, provided that the source is acknowledged. It may not be sold, or used in conjunction with commercial purposes or for profit. This document was produced with the support of the World Health Organization (WHO) Azerbaijan 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. ii

3 Foreword The 2011 Pharmaceutical Country Profile for Azerbaijan 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 Azerbaijan. The compiled data comes from international sources (e.g. the World Health Statistics 1,2 ), 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 Azerbaijan, I wish to express my appreciation to WHO Country Office in Azerbaijan for its 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 Azerbaijan pharmaceutical sector will find this profile a useful tool to aid their activities. Name: Rashida Abdullayeva Function in the Ministry of Health: Head of Drug Procurement Planning and Rational Drug Use; department of Innovation and Supply Centre Date: 12/05/2011 Signature iii

4 Table of content Foreword... iii Table of content... iv Introduction...1 Section 1 - Health and Demographic Data...2 Section 2 - Health Services...5 Section 3 - Policy Issues...9 Section 4 Medicines Trade and Production...11 Section 5 Medicines Regulation...13 Section 6 - Medicines Financing...20 Section 7 - Pharmaceutical procurement and distribution in the public sector...23 Section 8 - Selection and rational use of medicines...24 Section 9 - Household data/access...28 iv

5 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 Azerbaijan. 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 9 sections, namely: (1) Health and Demographic data, (2) Health Services, (3) Policy Issues, (4) Medicines Trade and Production (5) Medicines Regulation, (6) Medicines Financing, (7) Pharmaceutical procurement and distribution, (8) Selection and rational use, and (9) Household data/access. The indicators have been divided into two categories, namely "core" (most important) and "supplementary" (useful if available). This narrative profile is based on data derived from both the core and supplementary indicators. The tables in the annexes also present all data collected for each of the indicators in the original survey form. For each piece of information, the year and source of the data are indicated; these have been used to build the references in the profile and are also indicated in the tables. If key national documents are available on-line, links have been provided to the source documents so that users can easily access these documents. The selection of indicators for the profiles has involved all technical units working in the Essential Medicines Department of the World Health Organization (WHO), as well as experts from WHO Regional and Country Offices, Harvard Medical 1

6 School, Oswaldo Cruz Foundation (known as Fiocruz), University of Utrecht, the Austrian Federal Institute for Health Care and representatives from 13 pilot countries. Data collection in all 193 member states has been conducted using a 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 Azerbaijan was Rashida Abdullayeva. The completed questionnaires were then used to generate individual country profiles. In order to do this in a structured and efficient manner, a text template was developed. Experts from member states took part in the development of the profile and, once the final document was ready, an officer from the Ministry of Health certified the quality of the information and gave formal permission to publish the profile on the WHO web site. This profile will be regularly updated by the Ministry of Health of Azerbaijan. Comments, suggestions or corrections may be sent to: Rashida Abdullayeva Haji Hasan road 3 Baku AZ , Abdu_rashida@mail.ru 2

7 Section 1 - Health and Demographic Data This section gives an overview of the demographics and health status of Azerbaijan. 1.1 Demographics and Socioeconomic Indicators The total population of Azerbaijan in 2010 was 8,997,400 with an annual population growth rate of 1.0% 3. The annual GDP growth rate is 5.0% 4. The GDP per capita was US$5, (at the current exchange rate i ). 1.2 Mortality and Causes of Death The life expectancy at birth is 70.9 and 76.1 years for men and women respectively. The infant mortality rate (i.e. children under 1 year) is 11.1/1,000 live births. For children under the age of 5, the mortality rate is 14.4/1,000 live births. The maternal mortality rate is 24.3/100,000 live births 5. The top 10 diseases causing mortality in Azerbaijan are [Annual Statistical Report available on Disease 1 Diseases of the circulatory - cardiovascular system 2 Neoplasm s 3 Diseases of the digestive system 4 Accidents, poisonings, injuries 5 Diseases of respiratory system 6 Diseases of the genitourinary system 7 Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified 8 Endocrine system diseases, digestive disturbance, disturbance of metabolism and immunity 9 Certain infections and parazitic deseases 10 Congenital anomaly i The exchange rate for calculation for NCU is 1 AZN = USD (06/05/11-d/m/y) 3

8 The top 10 diseases causing morbidity in Azerbaijan are [Annual Statistical Report available on Disease 1 Diseases of respiratory system 2 Certain infections and parazitic deseases 3 Diseases of the digestive system 4 Diseases of the circulatory - cardiovascular system 5 Diseases of the genitourinary system 6 Skin deseases 7 Diseases of nervous system 8 Endocrine system diseases, digestive disturbance, disturbance of metabolism and immunity 9 10 Blood disorders and immune system disturbances Pregnancy, labor, puerperal period 4

9 Section 2 - Health Services This section provides information regarding health expenditures and human resources for health in Azerbaijan. 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 Azerbaijan, the total annual expenditure on health (THE) in 2008 was 1,377 million AZN (US$1,742 million) 6. The total annual health expenditure was 3.3% of the GDP. The total annual expenditure on health per capita was AZN (US$199.55) 7. The general government ii health expenditure (GGHE) in 2010 was million AZN (US$543.2 million) 8. That is, 31.2% of the total expenditure on health, with a total annual per capita public expenditure on health of AZN (US$60.37). The government annual expenditure on health represents 3.8% of the total government budget 5. Private health expenditure covers the remaining 68.8% of the total health expenditure 6. Private out-of-pocket expenditure embodies 89.2% of the total private health expenditure. Of the total population, 100% is covered by public health service. There is no national health insurance in place in Azerbaijan. In 1999 a law on medical insurance has been approved in Azerbaijan, nevertheless this law remains inactive 9. There is no easily available data on total pharmaceutical expenditure (TPE) in Azerbaijan. The total public expenditure on pharmaceuticals in 2010 was million AZN (US$129.6 million) which amounts to around US$ 14.4 per capita 9. ii According to the NHA definition, by "government expenditure" means all expenditure from public sources, like central government, local government, public insurance funds and parastatal companies. 5

10 2.2 Health Personnel and Infrastructure The health workforce is described in the table below, and in figures 1 and 2. There are 1,923 (1.8/10,000) licensed pharmacists, of which 909 (0.9/10,000) work in the public sector. There are 922 (0.8/10,000) pharmaceutical technicians and assistants (in all sectors). There are approximately two times fewer pharmacy technicians than there are pharmacists. There are 32,800 (37/10,000) physicians and 62,900 (82/10,000) nursing and midwifery personnel in Azerbaijan. The ratio of doctors to pharmacists is 17 and the ratio of doctors to nurses and midwifery personnel is Table 1: Human resources for health in Azerbaijan Human Resource Licensed pharmacists (all sectors) 1,923 (1.8/10,000) 9 Pharmacists in the public sector Pharmaceutical technicians and assistants (all 922 (0.8/10,000) 9 sectors) Physicians (all sectors) 32,800 (37/10,000) 3 Nursing and midwifery personnel (all sectors) 62,900 (82/10,000) 3 6

11 Figure 1: The density of the Health Workforce 2010 in Azerbaijan (all sectors) Annual statistical report, 2010 Figure 2: Distribution of Pharmaceutical Personnel, Azerbaijan, 2010 Annual statistical report,

12 In Azerbaijan, there is a strategic plan for pharmaceutical human resource development in place 10. This strategic plan, "Guidelines to certification of persons carrying out medical and pharmaceutical activities, was approved by Ministry of Health in There are two key points in the document. Firstly pharmacists that have not continuously carried out activity within their specialty for over 5 years may be involved in pharmaceutical activity after having passed training in corresponding educational facilities. Secondly pharmacists who work in drugstores are obliged to undergo training within capacity building facilities at least once in five years. The health facility structure is described in the table below. There are 756 hospitals and 76/10,000 pop hospital beds in Azerbaijan. There are 1692 primary health care units and centres and 507 licensed pharmacies. Table 2: Health centre and hospital statistics Infrastructure Hospitals Hospital beds 76/10,000 pop 3 Primary health care units and centres Licensed pharmacies

13 Section 3 - Policy Issues This section addresses the main characteristics of the pharmaceutical policy in Azerbaijan. 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 Azerbaijan, a National Health Policy (NHP) exists 12. It was updated in An associated National Health Policy implementation plan does not exist 11. However Azerbaijan is working on the improvement of free medical services and expansion of public programme coverage. An official National Medicines Policy (NMP) document does not exist in Azerbaijan. A NMP implementation plan also does not exist. Policies addressing pharmaceuticals exists, as detailed in Table 3. Pharmaceutical policy implementation is not regularly monitored/ assessed 9. Table 3: The group of policies cover 9 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 Covered No 9

14 Monitoring and evaluation Traditional Medicine A policy relating to clinical laboratories exists and was most recently updated in An associated National clinical laboratory policy implementation plan does not exist 9. Access to essential medicines/technologies as part of the fulfillment of the right to health, is recognized in the national legislation 14. There are official written guidelines on medicines donations 15. There is a national good governance policy in Azerbaijan 16. This Good Governance policy is multisectoral. The Ministry of Health is responsible for implementing this policy. There is no policy in place to manage and sanction conflict of interest issues in pharmaceutical affairs. A whistle-blowing mechanism that allows individuals to raise concerns about wrongdoing occurring in the pharmaceutical sector of Azerbaijan exists 17. There is a hot-line for complaints/requests established by Ministry of Health At the same time, persons interested may address the Human Rights Committee under the Parliament of Azerbaijan about any concerns they may have

15 Section 4 Medicines Trade and Production 4.1 Intellectual Property Laws and Medicines Azerbaijan is not a member of the World Trade Organization 18. Legal provisions for granting patents to manufacturers exist. These cover pharmaceuticals and medical equipment 19. Intellectual Property Rights are managed and enforced by State Committee for Standardization, Metrology and Patent of the Republic of Azerbaijan, National Legislation has not been modified to implement the TRIPS Agreement. However in 2006 the President of Azerbaijan signed a decree to approve the action plan for adoption of the Law About Patent in accordance with requirements of the WTO. One of the priorities within the action plan is dedicated to implement TRIPS patent and intellectual property rights. Azerbaijan is not eligible for the transitional period to The country is engaged in capacity-strengthening initiatives to manage and apply Intellectual Property Rights in order to contribute to innovation and promote public health. These include legal provisions for patent extension Manufacturing There are 3 licensed pharmaceutical manufacturers in Azerbaijan. Manufacturing capabilities are presented in Table 4 below. Table 4: Azerbaijan manufacturing capabilities 19 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 No No 11

16 In 2009, domestic manufacturers held 3.8% of the market share by value produced 22. There are no multinational pharmaceutical companies that manufacture medicines locally 9. Domestic manufactures are certified by a manufacturing license, this is the national analogue of GMP 9. 12

17 Section 5 Medicines Regulation This section details the pharmaceutical regulatory framework, resources, governing institutions and practices in Azerbaijan. 5.1 Regulatory Framework In Azerbaijan, 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 5. The MRA operates as an Analytical Expertise Centre of Medicine under MoH. The MRA has its own website, for which the URL address is Table 5: Functions of the national MRA 23 Function Marketing authorisation / registration Inspection Import control Licensing Market control Quality control Medicines advertising and promotion Clinical trials control Pharmacovigilance No As of 30/03/2011, there were 137 permanent staff working for the MRA 11. The MRA receives external technical assistance from WHO and MRAs of other countries to strengthen the capacity of experts to conduct specialized examinations 11. The MRA is involved in harmonization/collaboration initiatives such as DRUGNET WHO/EURO and CIS council. An assessment of the medicines regulatory system has been conducted in the last five year 24. Funding 13

18 for the MRA is not provided through the regular government budget. The MRA is funded from fees for services provided 19. 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, inspection etc Marketing Authorization (Registration) In Azerbaijan, legal provisions require marketing authorization (registration) for all pharmaceutical products on the market, however exceptions/waivers for registration do exist 25,26. Medicines for humanitarian purposes, rare medicines, medicines used to cure diseases that require specific treatment and WHO prequalification medicines without public registration in Azerbaijan may be imported only for non-commercial use. Mutual recognitions mechanisms are not in place 9. Explicit and publicly available criteria exist for assessing applications for marketing authorization of pharmaceutical products 27. In 2011, there were 3,703 pharmaceutical products registered in Azerbaijan. There are legal provisions requiring the MRA to make the list of registered pharmaceutical products publicly available and update it regularly. This register is updated every year. The updated list can be accessed through 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 11. The registration fee for both applications, new chemical entity (NCE) and generic pharmaceutical product, is 126 US$ 11. The expertise fee for a NCE is 1,386 US$ and for a generic the fee is 1,059 US$ Regulatory Inspection In Azerbaijan, legal provisions exist allowing for appointment of government pharmaceutical inspectors 28. Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed; such 14

19 inspections are required by law and are a pre-requisite for the licensing of public and private facilities 29. Where inspections are legal requirements, these are the same for public and private facilities 11. Inspections are carried out on a number of entities, outlined in Table 6. Table 6: Local entities inspected for GMP compliance 19 Entity Inspection Frequency Local manufacturers No certain frequency assigned Private wholesalers No certain frequency assigned r Retail distributors No certain frequency assigned Public pharmacies and stores No certain frequency assigned Pharmacies and dispensing points if health facilities No certain frequency assigned 5.4 Import Control Legal provisions exist requiring authorization to import medicines 30. 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, one sample from each imported batch is inspected

20 5.5 Licensing In Azerbaijan, legal provisions exist requiring manufacturers to be licensed 19. Legal provisions exist requiring manufacturers (both domestic and international) to comply with Good Manufacturing Practices (GMP). As explained in section 4.2 domestic manufacturers should present their manufacturing license when GMP is lacking. Good Manufacturing Practices are not published by the government 9. Legal provisions exist requiring importers/wholesalers/distributers to be licensed (see table 7) 19 and to comply with Good Distributing Practices 32. Table 7: Legal provisions pertaining to licensing Entity requiring licensing Importers Wholesalers Distributors Good Distribution Practices are published by the government 32. Legal provisions exist requiring pharmacists to be registered and requiring private pharmacies to be licensed 33. National Good Pharmacy Practice Guidelines are published by the government 32. A list of all licensed pharmaceutical facilities is not required to be published. 5.6 Market Control and Quality Control In Azerbaijan legal provisions exist for controlling the pharmaceutical market 34. A laboratory exists in Azerbaijan for Quality Control testing 11. The laboratory is a functional part of the MRA 11. Existing national laboratory facilities have not been accepted for collaboration with the WHO pre-qualification Programme 11. Medicines are tested for a number of reasons, summarised in Table 8. 16

21 Table 8: Reason for medicines testing 11 Medicines tested: For quality monitoring in the public sector iii For quality monitoring in the private sector iv When there are complaints or problem reports For product registration For public procurement prequalification For public program products prior to acceptance and/or distribution Samples are collected by government inspectors for undertaking post-marketing surveillance testing 19. In the past 2 years, 58,929 samples were taken for quality control testing. Of the samples tested, 39 (or 0.066%) failed to meet the quality standards. The results are not publicly available; they are only presented to corresponding bodies Medicines Advertising and Promotion In Azerbaijan, legal provisions exist to control the promotion and/or advertising of prescription medicines. Ministry of Health is responsible for regulating promotion and advertising of medicines 19. Legal provisions prohibit direct advertising of prescription medicines to the public under any circumstances and pre-approval for medicines advertisements and promotional materials is required for non-prescription medicines. Guidelines and Regulations exist for advertising and promotion of non-prescription medicines. There is a national code of conduct concerning advertising and promotion of medicines by marketing authorization holders. The code of conduct applies to domestic manufacturers and multinational manufacturers. The code contains a formal process for complaints and sanctions. It is not clear whether there is a publicly available list of the complaints and sanctions for the last two years 35. iii Routine sampling in pharmacy stores and health facilities iv Routine sampling in retail outlets 17

22 5.8 Clinical Trials In Azerbaijan, legal provisions exist requiring authorization for conducting Clinical Trials by the MRA. There are additional laws requiring the agreement by an ethics committee or institutional review board of the Clinical Trials to be performed. Clinical trials are required to be entered into a national registry, by law 36. Legal provisions exist for national GMP compliance of investigational products and require the sponsor, investigator to comply with good clinical practices (GCP) Controlled Medicines Azerbaijan is a signatory to a number of international conventions, detailed in Table 9. Table 9: International Conventions to which Azerbaijan is a signatory 37 Convention Signatory Single Convention on Narcotic Drugs, Protocol amending the Single Convention on Narcotic Drugs, 1961 Convention on Psychotropic Substances 1971 United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988 Laws exist for the control of narcotic and psychotropic substances, and precursors [Law of AR on "Narcotic drugs, psychotropic agents and their prerequisites" is available at ]. The annual consumption of Morphine is mg/capita 38. In 2010 the International Narcotics Control Board reviewed the legal provisions and regulations for the control of narcotic and psychotropic substances to assess the balance between the prevention of abuse and access for medical need

23 5.10 Pharmacovigilance In Azerbaijan, there are legal provisions in the Medicines Act that provide for pharmacovigilance activities as part of the MRA mandate. Legal provisions also 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) exist in Azerbaijan. A national pharmacovigilance centre linked to the MRA exists 41. The pharmacovigilance centre has 4 full-time staff members. The centre has not published an analysis report in the previous two years and it does not publish an ADR bulletin. An official standardized form for reporting ADRs is used in Azerbaijan. Information pertaining to ADRs is stored in a national ADR database The ADR database currently comprises 62 ADR reports, of which 62 have been submitted in the past 2 years, the database is not computerized. The reports are not sent to the WHO collaborating centre in Uppsala. Feedback is provided to reporters. There are no medication errors reported 11. There is no national ADR or pharmacovigilance advisory committee able to provide technical assistance or causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication in Azerbaijan. A clear communication strategy for routine communication and crises communication does not exist 11. A number of steps are being considered in order to enhance the pharmacovigilance system. These include: the attraction of a large number of physicians, the establishment of an e-database for a faster response and a better connection with the regions

24 Section 6 - Medicines Financing In this section, information is provided on the medicines financing mechanism in Azerbaijan, 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 Azerbaijan, concessions are not made for certain groups to receive medicines free of charge (see Table 11). Furthermore, the public health system or social health insurance schemes does provide medicines free of charge for particular conditions (see Table 12). Table 11: Population groups provided with medicines free of charge 9 Patient group Patients who cannot afford them Children under 5 Pregnant women Elderly persons Covered No No No No Table 12: Medications provided publicly, at no cost 9 Conditions All diseases in the EML Any non-communicable diseases Malaria Tuberculosis Sexually transmitted diseases Covered No No 20

25 HIV/AIDS Expanded Program on Immunization (EPI) vaccines for children Other immunobiologicals, erythropoietines, blood factors, immunodepressants- cyclosporine, micofenolat mofetil, takrolimus, antiretrovirals, neuroleptics, antineoplastics, narcotics, diabetics, antiepileptics etc. The public health system in Azerbaijan provides coverage for medicines that are on the EML for inpatients and outpatients. The non-communicable diseases it provides treatment for are: treatment of haemophilia and thalassemia, treatment of chronically renal failure - all haemodialysis expenses, blood donor ship programs expenses, diabetes mellitus, treatment of patients within privileged groups 9. As seen before in section 2.1, there is no national health insurance in place in Azerbaijan. In 1999 a law on medical insurance has been approved in Azerbaijan, nevertheless this law remains inactive 9. Private health insurance schemes provide medicines coverage 9. They are not required to provide at least partial coverage for medicines that are on the EML Patients Fees and Copayments Co-payments or fee requirements for consultations are not levied at the point of delivery. Furthermore, there are no copayments or fee requirements imposed for medicines. According to the order #141 by MoH of AR "About provision of healthcare to the population of Azerbaijan Republic" approved in 2005, all medical consultations and treatment within public facilities are free of charge. Paid medical services are offered only in private health facilities 9. 21

26 6.3 Pricing Regulation for the Private Sector v In Azerbaijan, there are no legal or regulatory provisions affecting pricing of medicines 9. The government does not run an active national medicines price monitoring system for retail prices. Regulations exist mandating that retail medicine price information should be publicly accessible. It is possible to acquire any price information in drugstores Prices, Availability and Affordability of Key Medicines No WHO/HAI pricing survey has been conducted in Azerbaijan Price Components and Affordability No survey on medicine price components has been conducted in Azerbaijan in the past 5 years Duties and Taxes on Pharmaceuticals (Market) Azerbaijan imposes duties on imported active pharmaceutical ingredients (APIs), but duties on imported finished products are not imposed. Custom rates for APIs range between 0.5-5%. Value-added tax (VAT) or other taxes are not imposed on finished pharmaceutical products; a VAT of 18% is levied on APIs 42. v This section does not include information pertaining to the non-profit voluntary sector 22

27 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 Azerbaijan. 7.1 Public Sector Procurement Public sector procurement in Azerbaijan is both centralized and decentralized 9. The Innovation and Supply Centre under the MoH organizes procurement for medicines determined by the MoH for the capital and medicines for all programs (programs available on only in Azeri) for the country and carries out centralized tendering. Regions of Azerbaijan organize local procurement for medicines 9. Public sector request for tender documents and public sector tender awards are publicly available. Procurement is based on the prequalification of suppliers Public Sector Distribution The government supply system department in Azerbaijan has a Central Medical Store (CMS) at National Level which is under the Innovation and Supply Centre 9. There are no public warehouses in the secondary tier of the public sector distribution. Medical goods are directly delivered from CMS to health facilities. There are national guidelines on Good Distribution Practices (GDP) 32. A licensing authority that issues GDP licenses exists. The licensing authority does accredit public distribution facilities 11. The CMS is GDP certified by this licensing authority, it is not ISO certified Private Sector Distribution Legal provisions exist for licensing wholesalers and distributors in the private sector 32. To obtain a license as a wholesaler or a distributor it is necessary to comply with the national GDP. A list of GDP certified wholesalers and distributors exists in the private sector

28 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 Azerbaijan. 8.1 National Structures A National Essential Medicines List (EML) exists. The EML was lastly updated in 2008 and is publicly available. There are currently 146 medicines on the EML. 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 44. National Standard Treatment Guidelines (STGs) for the most common illnesses are produced/ endorsed by the MoH in Azerbaijan. These were last updated in Specific STGs cover primary care (45 STGs), secondary care (19 STGs) and paediatric conditions (5 STGs) 12. All the public health facilities have a copy of the EML and the STGs 9. There is a public or independently funded national medicines information centre providing information on medicines to prescribers, dispensers and consumers 29. Public education campaigns on rational medicine use topics have been conducted in the last two years 45. A survey on rational use of medicines has been conducted in the previous two years 46. There is a national programme or committee, involving government, civil society, and professional bodies, to monitor and promote rational use of medicines 19. A written National Strategy for containing antimicrobial resistance has been developed, as well as a National Medicines formulary and criteria for the selection of medicines in the EML, but these documents have not yet been approved by MoH 9,19. 24

29 8.2 Prescribing Legal provisions exist to govern the licensing and prescribing practices of prescribers 19. Furthermore, legal provisions restricting dispensing by prescribers exist. There are regulations requiring hospitals to organize/develop Drug and Therapeutics Committees (DTCs) 19. Where there are requirements for DTCs, less than half of referral/general/ (regions/provinces) have one 19. The training curriculum for doctors and nurses is made up of a number of core components detailed in Table 13. Table 13: Core aspects of the medical training curriculum 19 Curriculum The concept of EML Use of STGS Pharmacovigilance Problem based pharmacotherapy Covered Mandatory continuing education that includes pharmaceutical issues is required for doctors and paramedical staff 19. Prescribing by INN name is not obligatory in the public/ private sector 19. The average number of medicines prescribed per patient contact in public health facilities is Of the medicines prescribed in the outpatient public health care facilities, 53% are prescribed by INN name 47. Of the patients treated in the outpatient public health care facilities, 84% receives antibiotics and 56% receive injections (see table 14) 47. Table 14: Characteristics of medicines prescribing 47 Curriculum % % of medicines prescribed in outpatient public health care facilities that unknown are in the national EML (mean) 25

30 % of medicines in outpatient public health care facilities that are 53 prescribed by INN name (mean) % of patients in outpatient public health care facilities receiving 84 antibiotics (mean) % of patients in outpatient public health care facilities receiving 56 injections (mean) % of prescribed drugs dispensed to patients (mean) unknown % of medicines adequately labelled in public health facilities (mean) unknown There is no professional association code of conduct governing the professional behaviour of physicians and nurses Dispensing Legal provisions in Azerbaijan exist to govern dispensing practices of pharmaceutical personnel 13. The basic pharmacist training curriculum includes a spectrum of components as outlined in Table Table 15: Core aspects of the pharmacist training curriculum 19 Curriculum The concept of EML Use of STGS Drug information Clinical pharmacology Medicines supply management Covered Mandatory continuing education that includes rational use of medicines is required for pharmacists 19. Substitution of generic equivalents at the point of dispensing is allowed in public and private sector facilities. Sometimes antibiotics and injectable medicines are sold over-the-counter without a prescription

31 There is no professional association code of conduct governing the professional behaviour of pharmacists 9. In practice nurses, pharmacists and paramedics never prescribe prescriptiononly-medicines at the primary care level in the public sector. It does sometimes happen that personnel with less than one month training prescribe prescriptiononly-medicines at the primary care level in the public sector. 27

32 Section 9 - Household data/access A household survey is conducted annually; however indicators included in the Pharmaceutical Sector Country Profile have not been studied. The household survey that is conducted in Azerbaijan indicates only major questions on total private expenditures per capita (incl. treatment, diagnostics. etc.) 9. 28

33 List of key reference documents: 1 World Health Organization (WHO) (2010), World Health Statistics 2010, WHO Press, Geneva. Available online: accessed at November World Health Organization (WHO) (2009), World Health Statistics 2009, WHO Press, Geneva. Available online: accessed at November The State Statistic Committee of Azerbaijan Republic (2010), Annual Statistical Report. Available online: accessed at April Central Bank of Azerbaijan (2010) Available online: accessed at April The State Statistic Committee of Azerbaijan Republic (2009), Annual Statistical Report. Available online: accessed at April NHA data (2008) 7 Calculated based on data provided in [The State Statistic Committee of Azerbaijan Republic (2010), Annual Statistical Report. Available online: accessed at April 2011 & Central Bank of Azerbaijan (2010). Available online: accessed at April 2011] 8 Ministry of Finance, unpublished data (2010) 9 Ministry of Health, unpublished data (2010) 10 Decree # Cabinet of Minister (2010) 11 Medicines Regulatory Authority, unpublished data (2010) 12 Ministry of Health, unpublished data (2008) 13 Law on Medicines (2010) Available online: accessed at April Decree of Ministry of Health # 141, Law on Medicines (2005) Available online: accessed at April Amended Law on Medicines (2007) Available online: accessed at April Law of Azerbaijan about fighting corruption & Law of Azerbaijan about civil service (2005) Available online: & accessed at April Ministry of Health, unpublished data (2007) 29

34 18 World Trade Organization, accessed at April World Health Organization (WHO) (2007), WHO Level 1 Survey, Geneva 20 State Committee for Standardization, Metrology and Patent of the Republic of Azerbaijan, accessed at April Law on patent (2010) 22 Pharmexpert (2009) Available online: accessed at April Medicines Regulatory Authority Available online: accessed at April Ministry of Health, unpublished data (2009) 25 Decree # , Cabinet of Minister (2007) & Criminal Code # (2008) Available online: accessed at April Decree # , Cabinet of Minister (2007) Available online: accessed at April Medicines Regulatory Authority Available online: accessed at April Medicines Regulatory Authority, unpublished data (2006) 29 World Health Organization (WHO) (2007), WHO Level 1 Survey, Geneva & Ministry of Health, unpublished data (2010) 30 Decree # Cabinet of Minister - "Guidelines to Public Registration of medicines and registry support" (2006) 31 Medicines Regulatory Authority, unpublished data (2007) 32 Decree #153 of Ministry of Health (2006) Available on: accessed at April Law on medicines, Decree #153, Decree # (2006) Available on: accessed at April Law on medicines (2007) Available on: accessed at April Law of Azerbaijan 1047-III QD, Order#114 of MoH (2010) 30

35 36 Resolution #83, Cabinet of Ministers (2010) 37 International Narcotics Control Board (1999) & Law on Narcotic drugs, psychotropic agents and their pre-requisites (2005) Available online: accessed at April International Narcotics Control Board (2009) 39 Report of the International Narcotics Control Board (2010) Available online: accessed at April Medicines Regulatory Authority, unpublished data (2008) 42 Customs duties (2010) Available online: accessed at April Azerbaijan State Agency on Procurement, unpublished data (2010) 44 Ministry of Health (2008) 45 USAID/PHCS (2009) 46 USAID/PHCS (2008) 47 PHCS study (2009) 31