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Draft, 8 October , 2013 STATE DRUG POLICY (2014-2020) 1 Draft, 8 October , 2013 Structure Introduction .....................................................................................................................................5 I. Situation Analysis ...................................................................................................................6 II. Principles, Goal and Objectives of State Drug Policy .....................................................9 III. Strategic Areas of Activity ............................................................................................... 10 1. 1.1. Ensuring affordability of drugs and medical items ..........................................................10 System of drugs selection .................................................................................................11 1.2. Public procurements ...............................................................................................................12 1.2.1. State Benefits Program, Health Insurance Additional Drug Package –regulation of demand through reimbursement mechanisms ............................................................................................. 13 1.2.2. Procurement of drugs and medical items for public health sector ......................................14 1.3. Regulation of Drug Pricing ....................................................................................................15 1.3.1. Reinforcing requirements for drugs and medical items wholesalers to reduce the supply chain ..............................................................................................................................................16 1.3.2 Mechanisms of price regulation ...........................................................................................16 1.4. Rational Use of Drugs ............................................................................................................17 1.4.1. Introduction of Clinical Guidelines and Protocols and improvement of education system at all levels on the issues of Rational Use of Drugs ..........................................................................18 1.4.2. Prescription Sale of Drugs ...................................................................................................19 1.4.3. Formation of adherence towards Rational Use of Drugs to fight against unethical marketing of drugs in health care system workers and population of Kyrgyz Republic...............19 2. System of Drugs Circulation .....................................................................................................20 2.1. Improvement of ensuring of quality, safety and efficacy of drugs and medical items ...........20 2.1.1. Improvement of drugs regulation system to ensureequal therapeutic efficacy of genericdrugs...................................................................................................................................21 2.1.2.Introduction of Good pharmaceutical practice standards (GPhP) ........................................22 2.1.3. Enforcement of Surveillance of pharmaceutical market .....................................................23 2.2. Improvement of the system of drugs and medical items supply ............................................24 2.2.1. Supply of narcotics and psychotropic drugs ........................................................................24 2.2.2. Supply of essential drugs with limited physical accessibility .............................................25 2.2.3. Disposal of unusable drugs ..................................................................................................26 2.3. Measures on elimination of Illicit drug sale and enforcement of sanctions for violation of norms and rules.............................................................................................................................. 26 3. Improvement of management of drug circulation .....................................................................27 3.1. Formation of state policy in the area of drug circulation, based on clear vision, continuity and feedback ..................................................................................................................................27 3.2. Removal of contradictions and gaps in the legislation ...........................................................27 2 Draft, 8 October , 2013 3.3. Institutional Strengthening .....................................................................................................29 3.4. Improvement of Human Resources ........................................................................................30 3.5. Development and implementation of the "Code of ethical conduct in the area of drug circulation ......................................................................................................................................31 3.6. Ensuring transparency in the area of drugs circulation and introduction of monitoring of pharmaceutical sector and drugs prices .........................................................................................32 3.7. Monitoring and Evaluation System of the State Drug Policy implementation ...............33 3 Draft, 8 October , 2013 List of Acronyms ADP Additional Drug Package CPs Clinical Protocols DDS&ME Department of Drug Supply & Medical Equipment EDL Essential Drug List GoKR Government of the Kyrgyz Republic HCO Health Care Organization HIF Health Insurance Fund HPAC Health Policy Analysis Center KR Kyrgyz Republic MHIF Mandatory Health Insurance Fund MIA Ministry of Internal Affairs MOH Ministry of Health OOPs Out of Pocket payments/expenditures RDU Rational Drug Use RMIC Republican Medical Information Center SBP State Benefits Program SDP State Drug Policy SSNC State Service of Narcotics Control 4 Draft, 8 October , 2013 Introduction The Constitution of the Kyrgyz Republic declares the right of every citizen to health protection. Ensuring access to drugs as an integral part of public health protection is one of the most important tasks of the State. Harmonious development of pharmaceutical sector is of great social and economic importance for Kyrgyzstan. The State Drug Policy (SDP) is an integral part of health policy on population health protection and is being developed in the framework of systemic reforms of health care system of the Kyrgyz Republic. This is a strategic document that defines principles, goals, objectives and priorities, set by the Government in the area of drug circulation; it outlines the framework within which the activities of public and private sectors, as well as all major participants of pharmaceutical industry shall be coordinated. The first SDP (1998) was adopted under the crisis in pharmaceutical sector, when the centralized system of supply, public/state regulation and quality assurance of drugs has fallen apart, resulting in severe shortage of drugs and import of substandard drugs into the country, development of drugs black market, and collapse of drug prescription dispensing system. The 1998 SDP stipulated immediate measures to establish national system of regulation of drugs circulation under the country's financial constraints and emerging private wholesale and retail network of pharmaceutical sector. Subsequent SDPs of 2002 and 2007 were aimed at implementation of next measures to ensure access to safe, effective and quality drugs and their rational use. This document is the fourth strategic document in the field of drugs circulation. It is a product of development of the Interagency Working Group, established by the Ministry of Health, with representatives of all relevant government agencies, civil society and experts, pharmaceutical business as members to this Working Group, with the technical support provided by World Health Organization. The fourth SDP was developed in the environment of the growing interest on the part of civil society, Parliament, executive structures in the area of drugs circulation. The development process was distinguished by transparency and was accompanied by extensive consultations; the document has primarily taken into consideration the interests, needs and expectations of citizens, balanced with the wishes of Health Care Organizations, pharmaceutical services providers and other stakeholders. Proper and full implementation of this SDP and the Plan of Actions will contribute to implementing the objectives of the National health reform program "Den - Sooluk " for 20122016 on improvement of population health outcomes by selected priorities and significant improvement of the key individual services quality. 5 Draft, 8 October , 2013 I. Situation Analysis In 1998 the Government of the Kyrgyz Republic (hereinafter KR) approved the first State Drug Policy (hereinafter SDP), aimed at improvement of public health by improving access to safe, effective and quality drugs. The SDP has already been revised twice to meet changing priorities and health policy of the KR (2002, 2007). Due to completion of the latest SDP implementation, it was evaluated, and the results of this evaluation enabled to identify areas for further development of drug supply system, and formed the basic principles for the new SDP for 2014 - 2020. Implementation of three SDPs is marked by substantial progress in the area of drug circulation. The first State Drug Policy has established the framework for managing drugs and medical items circulation, including both creation of the regulatory authority/body and establishment of procedures and mechanisms (registration, certification, licensing, control and analytical service, inspection). Under the SDP implementation, serious work has been done on development and revision of the legislation, regulating relations in the area of drugs and medical items circulation. As part of the SDP implementation, and to reduce population’s expenditures, special measures have been introduced, envisaging reimbursable (exempt) drug supply and promotion of good practice of drugs prescription and their rational use: supply of drugs at ambulatory level under the State Benefits Program (hereinafter SBP) and Additional Drugs Package of Mandatory Health Insurance (ADP HIF), selection of drugs for the List of Essential Drugs List (hereinafter EDL), development of clinical guidelines and clinical protocols (hereinafter CG/CP). Within the framework of drug supply programs, prescription dispensing and administration of drugs under generic names have been introduced. Besides, foundations for geographical and physical availability of drugs have been laid; the network of pharmacies has been significantly expanded, in rural areas included. Principles of evidence based medicine (hereinafter EBM) and rational use of drugs (hereinafter RDU) have been integrated into the curricula of medical education. Introduction of information technologies (hereinafter IT) has been started at the level of the Department of Drug Supply and Medical Equipment (hereinafter DDS&ME) (website, registers, etc.). However, despite these accomplishments, topical problems still remain, especially as far as affordability of drugs is concerned. Expenditures for drugs in the form of household general out of pockets payments (hereinafter OOPs) per capita are the highest among all health expenditures (Fig. 1). 6 Draft, 8 October , 2013 Fig.1.Per capita expenditures as OOPs by the levels of health services delivery (in Som)1 Ambulatory services, Drugs and Hospital services 800 700 667 2000 2003 600 2006 2009 470 500 400 335 300 247 172 200 100 42 51 168 164 94 81 112 0 Амбулаторные услуги Лекарственные средства Госпитальные услуги Source: CHS, 2011 Thus, during 2000-2009, inflation adjusted household expenditures on drugs have increased by almost 2 times. This increase was accounted for by high prices for drugs and excessive consumption of drugs by population, associated with both improper drug prescription practice of doctors, and increased scale of self-medication of the population. The situation is aggravated by the lack of information on rational drugs use in population, OTC drugs sale, when virtually all drugs can be freely purchased over the counter without prescriptions, with exception of narcotic and psychotropic drugs, which are subject to national control. The fact that medical professionals have low adherence towards Clinical Guidelines/Clinical Protocols (CP) is obvious. There are issues on insufficiently clear understanding related to general coordination, delineation of duties and responsibilities between organizations, involved in development, evaluation and introduction of CG/CPs upon administration of drugs for treatment. Health care organizations (hereinafter HCOs) do not adequately introduce CG/CPs, promote RDU concept among physicians, that creates “no alternative” information environment for unethical marketing of pharmaceutical companies; availability of incentives/financial rewards for doctors, paid by pharmaceutical companies, exacerbates the situation even further. Introduction of drug cost reimbursement programs (State Benefits Program and Additional Drug Package) is intended to reduce the financial burden of population related to expenditures on drugs through reimbursement of part of the drug’s cost and observance of proper drugs prescription practice, as well to reduce the number of hospital admissions by providing drugs for treatment of conditions, effectively managed at primary health care level (PHC). Analysis of these programs’ implementation indicated that there are barriers to their effective implementation. Implementation of these programs indicates inadequate or insufficient use of cheaper generic drugs. Use of cheaper generic drugs often faces resistance, as doctors and patients believe that expensive drugs under trade names are more efficient and qualitative2. At HPAC, Research Paper Document № 76, «Access to health services and patient’s Out of Pocket Expenditures in Kyrgyzstan: Survey of Households for 2001-2010 », www.hpac.kg 2 HPAC, Research Paper Document №67, «Research of Factors, influencing on use of generics», 2009, www.hpac.kg 1 7 Draft, 8 October , 2013 the same time, high price of drugs is not a guarantee of the quality, but this belief helps promoting expensive generic drugs under the trade names. The Mandatory Health Insurance Fund (MHIF) data analysis indicated that only 30% of funds, allocated for reimbursement of patients’ expenditures for drugs under the ADP HIF, actually are used for reimbursement of drugs under generic names, and70% - for reimbursement of more expensive generics under the trade names. It should be noted that at present, prices for generic drugs under the trade names are not much cheaper than the original drugs, and sometimes they are even higher, as the prices are influenced by aggressive promotion of drugs by pharmaceutical companies. Proper quality assurance/control of therapeutic efficacy of drugs remains as the matter of utmost importance, as there is a probability of having generics with low efficacy at the market. According to the findings of the survey/study of factors of generics use, about 60% of the interviewed physicians believe based on the their experience, that the efficacy of cheaper generics under INN is much lower compared to the one of expensive drugs under trade names. Currently, over 5500 drugs have market authorization in the country, and the number of registered drugs increases every year. Unfortunately, this factor is not indicating that all EDs are accessible for population, as same/one group reproduced generics are mostly registered. As for example, Diclofenac from 41 manufacturers and Ceftriaxone from 29 manufacturers are authorized in our country. It was assumed, that such a large number of produced analogues will promote reduction of prices, however, it did not happen due to aggressive promotion of drugs; on the other hand, this fact hinders the choice of drugs both among physicians and patients. The situation is aggravated by the lack of quite a number of necessary drugs at pharmaceutical market; moreover, some efficient and cheaper drugs are washed out from the market due to unjustified change of drugs prescription practice. Thus, review of the current EDL indicates, that the List contains 51 names of drugs, which are nor registered in the KR (16%), and hence, can’t be used on the country’s territory. In 2011, 63 names of drugs (15%) from the 2009 EDL were not imported into the country3. According to experts, this situation reflects weak mechanisms of drugs circulation and lack of active monitoring of registered drugs. It should be noted, that the list of market authorized drugs in a number of developed European countries does not exceed 1000-2500 names. The issues of quality of imported drugs remain topical, as according to the study on the quality of drugs in pharmaceutical sector4, only 30% of the products were from the manufacturers, which were audited by the World Health Organization (WHO) and EU for GMP standards compliance, or were imported from countries with stringent regulatory authorities. The study included 300 drugs from 33 INN (8.7% of the total number of drugs registered in 2008), used for treatment of most common diseases, such as cardiovascular, communicable, ulcerative diseases of gastrointestinal tract, i.e., representing more than 50% of the causes of morbidity and mortality in the Kyrgyz Republic. No subsequent studies that would indicate improvement were undertaken. Besides, there are challenges related to the presence of forged and substandard drugs at the market and their illegal sale, as surveillance system functions, stipulated by the current legislation, do not permit conducting special professional inspections to the full extent. 3Research 4 Paper № 77 « Assessment of implementation & efficiency of the State Drug Policy of the KR for 2007-2010» Quality of drugs in the sector of public procurements of the KR, WHO. 2008 8 Draft, 8 October , 2013 According to the findings of the independent study on the quality of drugs5 in pharmacies of different regions of the country, 18% of drug samples on average, purchased in pharmacies for testing/trials, did not have authorizations/certificates of the State regulatory body, i.e. most likely were imported illegally into the KR. With adoption of the Law "On the Fundamentals for Technical Regulation in the Kyrgyz Republic" and the policy of the Government aimed at improvement of investment environment and business support, a number of contradictions have emerged, hindering implementation of supervisory functions over drugs circulation. If, in case of consumer goods, their efficacy and quality are evaluated by the consumer, then drugs represent a special commodity, and the state must ensure and guarantee not only safety of drugs, but such characteristics as efficacy and quality, since health and life of the consumer depend on them. Thus, there are a number of outstanding topical issues in the area of drugs circulation of the KR. The most severe of them is the growing financial burden of population, directly related to the expenditures on drugs and limiting their accessibility. Unethical marketing of pharmaceutical companies, including active advertisement of drugs in mass media, contributes to further rise in prices for drugs, excessive consumption of drugs among population, both administered by doctors, and as a result of self-medication. Needs for further improvement of registration process in relation to safety, efficacy and quality of drugs remain in the area. Problems also persist in promoting principles of rational use of drugs in health care. Weakness of institutional capacity of management bodies in the sphere of drug circulation compounded by unceasing revisions of regulatory body, which is time and effort consuming, results in inadequate coordination and transparency in this area, poor interagency cooperation and contradictions in the current legislation. II. Principles, Goal and Objectives of State Drug Policy Principles: • Continuity of health care reforms policy; • Focus on ensuring equity in access to essential drugs for population, especially for vulnerable populations; • Recognition of drugs as special type of products, influencing on people’s health, the quality and efficacy of which can’t be objectively assessed either by the patient or by the doctor, prescribing drugs; •Continuous support of the Policy of generics use; • SDP with focus on ethical standards; • Transparency at all stages of drug circulation; • Wide involvement of all stakeholders into the process of formation, implementation, and evaluation of policy and feedback in the field of drugs supply. 5 Quality of drugs in the KR, Report on the Study of Pharmaceutical Market of the KR for presence of counterfeit and substandard drugs using Minilab, 2010 9 Draft, 8 October , 2013 Goal: Ensure accessibility of essential, safe, effective and quality drugs for the citizens of the Kyrgyz Republic and their rational use. Objectives: • III. Ensuring affordability of essential drugs and medical items; Ensuring presence on the market of safe, effective and high-quality generic drugs of clinical efficacy, equal to that one of original drugs; Enforcement of responsibility and role of MOH in coordination of the SDP and optimization of the structure for dug circulation management; Ensuring efficiency and transparency of drug procurements at all levels of health care; Development of efficient pricing policy; Development of response measures to aggressive and unethical promotion of drugs and medical devices; Prescription dispensing of limited list of drugs; Ensuring physical accessibility of all drugs , included into the EDL; Promotion and introduction of the rules of good pharmaceutical practices (GLP, GCP, GMP, GDP, GPP); Ensuring efficient and timely post-marketing control of safety, efficacy and quality of drugs; Ensuring coordination of activities of interested government agencies in the area of fight against illicit market of drugs and medical items (MI); Ensuring transparency of drugs and MI circulation through building of single information system; Strengthening of cadre capacity in drugs circulation area. Strategic Areas of Activity 1. Ensuring affordability of drugs and medical items The key objective of this SBP is improvement of economic affordability of drugs through refining existing procurement procedures and practices to implement internal economy reserves and rationalize expenditures, impacting on demand for drugs, as well as supply of drugs through introduction of new approaches of state influence on prices. It is proposed to regulate the demand for drugs through: - implementation of efficient strategy for selection of essential drugs and increase of demand for cheaper generics, under the condition of equal clinical efficacy; rationalization of practices of drugs use; improvement of drugs benefits program; optimization of the system of public procurements of drugs. 10 Draft, 8 October , 2013 The system of state influence on prices will be determined by the presence of weighted pricing policy regarding pharmaceutical industry to provide affordable prices for drugs, especially for the ones, included into the EDL. 1.1. System of drugs selection Under the conditions of low-budget and financial burden of the citizens in drug supply, in 1996 Kyrgyzstan has recognized the Concept of essential drugs, formulated by the WHO in 1975. To reduce expenditures on inefficient types of medical care and focus on providing equal access to the most effective and safest science-evidence-based drugs within the existing resources, the Essential Drugs List (EDL) was developed, which is updated and approved by the Government of the Kyrgyz Republic on a regular basis. Systematic update of the EDL by eliminating obsolete, irrelevant, unnecessary, less efficient and less safer drugs and by including cost-effective products with the best proven therapeutic effect and safety profile, enables to organize supply of drugs from the perspective of the patient and the real status of economy of the Kyrgyz Republic. Unfortunately, there is the probability of including unproven and ineffective drugs into the EDL due to imperfect processes of drugs selection for the EDL. Poor adherence and inadequate knowledge of professionals, involved into selection of drugs, decrease quality of the EDL. Since the state policy implies supply of the citizens with drugs primarily from the EDL, which is the basis for all drugs programs to be implemented in KR, as well as for public procurements, it becomes important to ensure high quality of the EDL. Inclusion of drugs into the EDL should be the result of competitive selection with the main criteria of safety, proven clinical efficacy and cost-effectiveness. At that, epidemiological situation in the country and health care priorities should be taken into account. Hospital lists of procured drugs are formed independently by hospitals but are based on the EDL. To improve access to drugs given the local and specific needs, it is allowed to include up to 20% of drugs on the hospital list, which are not included into the EDL. At that, the amount of funds, allocated for procurement of these additional drugs, is not regulated currently. This can lead to unjustified and irrational use of resources. Under this SBP, it is proposed to form the drugs selection system and form the EDL based on the following principles: • Social equity, equal access to basic health care. Drugs, used for treatment of socially significant diseases, should be primarily included into the EDL, as they impose the highest burden on the state, society and individual. • Selection, based on proven clinical value and safety, taking into account cost-effectiveness. Evidence-based drugs and effective drugs, selected according to the established objective medical standards, shall be included into the EDL and other drug lists. These are the drugs for treatment and prevention of diseases, which are really safe and beneficial, as confirmed by credible scientific evidence and international medical practice. • Transparency and involvement of general public into drugs selection process. The developed evaluations and justifications for decisions/conclusions on selection of drugs should be open and 11 Draft, 8 October , 2013 widely available for public review, discussion, criticism and administrative appealing. Improvement of the procedures for selecting drugs should be carried out through development of necessary regulatory and comprehensive regulatory and logistics documents in the framework of legislation. While developing restrictive drugs lists or formularies, it is necessary to minimize the possibility of abuse and reinforce responsibility for decision-making. To eliminate distortions in evaluations and opinions/conclusions, organizations and professionals, performing evaluation, selection and procurement of essential drugs(ED), should make decisions without involving people with potential conflict of interests, for example, specialists, associated with drug manufacturers and distributors. • Drug programs, envisaging partial reimbursed of the drugs cost, shall be based on the EDL. • Procurements of drugs from the state budget shall be made on the basis of the EDL. It is allowed to include up to 20% off the EDL drugs to the hospital lists; however, these drugs should have evidence of clinical efficacy, safety, cost-effectiveness and documented confirmation/justification of the necessity to be included into the list of procured drugs due to the local or specific characteristics of health care organization. In addition, the amount of funds to be allocated for procurement of drugs off the EDL, should be regulated. Concept of essential drugs selection will be developed, which will outline comprehensive and coherent system of drugs selection in the KR for all health care levels, as well as define the place and role of all participants, involved in the selection process, taking into account the potential conflict of interests, criteria for inclusion/exclusion of drugs and the procedures for the EDL compilation and revision/updating in compliance with WHO expert committee recommendations, and given the KR health care system priorities, pharmacovigilance and postmarketing control data. The process of formation of hospitals lists of drugs, lists of drugs for drug exemption programs, and other drugs lists will also be regulated. It would be necessary to train professionals, participating in drug selection (members of the National Drug Committee, Committees on Quality and Safety of health care in HCOs) in the principles and methods of essential drugs selection and critical evaluation of medical information, search for evidence and making calculations of cost-efficiency of drugs. 1.2. Public procurements The KR Government is the largest purchaser of drugs and medical items in the pharmaceutical sector, as it procures drugs and medical items in Health Care Organizations (HCO) and reimburses expenditures for drugs under the ADP HIF and SBP programs. It is estimated, that the share of public drug procurements makes about 30% of the total volume of retail sales of pharmaceutical market. In its search for ways to improve economic affordability of essential drugs for the public, the state might influence on the prices of drugs in exchange for guaranteed sales, i.e. offering win-win conditions for all market participants. Also, one of the most efficient ways to reduce prices for drugs and MI is ensuring transparency of procurements process, including data on prices and amounts of procured drugs and MI. In general, implementation of the principles of transparency, accountability and integrity in public procurements will lead to reduction of health expenditures and improvement of affordability of essential drugs. Under these conditions, the choice of interventions for implementing the capacity of the largest purchaser in the sector should be based on a balanced, well-thought, fair and responsible approach, without detriment to scrupulous market participants. 12 Draft, 8 October , 2013 1.2.1. State Benefits Program, Health Insurance Additional Drug Package –regulation of demand through reimbursement mechanisms Introduction of the system of reimbursed drugs supply of the KR citizens on outpatient basis under compulsory health insurance has become the key element in solving the issues of poor access of citizens to treatment with modern effective drugs. The main tool in drug supply system is reimbursement of a significant part of drug’s cost by the Government. The country has the experience in implementing program of drug cost reimbursement supply - Additional Drugs Package and drugs supply under the SBP, where the function of the primary payer and purchaser is played by the MHIF under the KR Government. Selection of drugs, sold under the drug reimbursement supply programs, is made from the drugs, included into the EDL and is based on the MOH strategy on identification of priority diseases, including monitored diseases in the country, clinical protocols on case management and price factor. But methodology and criteria for selection of drugs in the framework of reimbursement programs are not developed. Contractual process between the insurer and suppliers/providers of pharmaceutical services does not cover the issues of drugs pricing. Lack of transparent information system of monitoring over prices does not enable doctors and patients to know prices for drugs. Meanwhile, the exempt drug programs, if properly regulated, might have a great impact on curbing population’s expenditures on purchasing of drugs and improving affordability of drugs for people, especially for socially vulnerable groups. Unfortunately, funds, annually allocated for these programs, are not fully used for various objective and subjective reasons. Besides, population is either poorly informed or does not always have access to the drugs reimbursement programs. Local governance bodies are weakly involved into the issues of pharmaceutical network development and implementation of these programs. The current programs of target social assistance in Bishkek city to supply socially vulnerable population groups and chronic patients with drugs require coordination with state programs of drugs exempt programs as far as approaches and mechanisms of implementation are concerned. To strengthen the role of state drug supply programs on outpatient basis, as one of the factors, containing population expenditures, the principles and mechanisms of drugs exempt programs will be revised, including criteria for definition of the population exempt groups. Contract relations with pharmaceutical services providers will be improved with clear delineation of rights and duties of both parties, development of financial incentives for pharmacy facilities to contain prices for drugs. Drugs exempt programs should be developed under the conditions of transparency and accountability, wide information of patients and physicians through involvement of mass media, radio and TV, public awareness campaigns and creation of information platforms on drugs’ prices. 13 Draft, 8 October , 2013 1.2.2. Procurement of drugs and medical items for public health sector Public procurement system has all the health problems, identified in the Government's strategic document6 on improvement of public procurement system, namely, imperfect legal and regulatory framework, regulating all stages of public procurements process, low capacity of forecasting/planning the range of products of procuring entities, the volume of goods, volumes of works and services, and procurement methods, insufficient qualifications of members of tender committees, responsible persons in purchasing organizations, as well as existing cases of corruption offenses in the public procurement process, lack of awareness of potential suppliers about the ongoing public procurement and increase of their access to them, lack of an automated monitoring system and analysis of the use of budget funds, allocated for public procurements. The above problems are compounded by the fact that the pharmaceutical product, having s its own specific features due to the property, affects the health of people. Health care organizations should be able to select the most effective drugs, taking into account clinical experience, information about side effects and cost of treatment that requires special approaches. To select priority drugs and reduce the amount of procured drugs with lower economic efficiency, it is necessary to use such techniques, as «VEN / ABC-analysis." It is a common practice in line with international standards to conduct a preliminary selection of reliable suppliers of high quality products in order to prevent supply of sub-standard and counterfeit drugs and medical items. Drugs and medical devices have a limited shelf life, specific requirements for transport and storage, which determines the need for a coherent system of inventory management and supply of drugs and medical devices to ensure uninterrupted supply without accumulation of excess stocks. Kyrgyzstan lacks the system of control and monitoring of drug procurements for the entire supply chain in health care organizations. The lack of transparency in the conduct of procurement procedures is a serious threat to the system of supply of drugs and medical devices, as it increases the risk of purchasing drugs and medical items of low quality at high prices due to the impact on the procurement processes of various interest groups. In most health care organizations, the process of formation of bids and bid evaluation involves experts who do not have the appropriate competence. It is necessary to engage professionally trained staff for preparing specifications for tender documents and procurements. The documents related to procurements or tenders should indicate INN or other common names of drugs and medical devices. Health sector reforms aimed at giving greater autonomy to health care organizations, require application of different approaches and their combination for procurement of drugs and medical devices, such as: • Independent procurements of health care organizations that shall cover most of their needs for drugs and medical items 6 Resolution of the Kyrgyz Republic Government «On Approval of the Strategy for development of public procurements in the Kyrgyz Republic for 2012-2014» №661 as of 27 September 2012, Bishkek 14 Draft, 8 October , 2013 • Group procurements of health care organizations, united by territory principle or by levels of health care organizations (commonly used by all health care organizations to procure drugs in large quantities) • Centralized procurements at the national level (following the List, defined by the KR MOH) • Procurements through framework agreement procedures, which shall be applied at the central level by the Ministry of Health in cooperation with MHIF towards limited, coherent set of drugs and medical items. The framework agreement is declaration of intent to purchase specific goods from the group of purchasers, the estimated value of the summarized needs with no obligation to purchase them. The supplier shall offer products at the specified prices depending on individual needs, terms of payment, terms of delivery, delivery point. Health care organizations conclude individual contract with supplier without additional rechecking and modifications based on the framework agreement terms. • Procurements through UN agencies and other international organizations that specialize on procurement of specific goods (vaccines, drugs for treatment of tuberculosis, HIV/AIDS, malaria) Under this SDP and Strategy for development of public procurements for 2012-2014, comprehensive measures will be taken to improve the system of public procurements; a package of regulatory and legal documents has been developed to regulate public procurements, taking into account specific characteristics of pharmaceutical products and peculiarities of organization of procurements by HCOs, based on the principles of transparency and accountability. Planning/forecasting of drugs and medical items should be based on the VEN / ABC-analysis; management of all stages of the procurement cycle should be automated and integrated with the accounting 1C program in health care organizations and the system of electronic public procurements. Introduction of monitoring of drug and medical device procurements is an important mechanism of influence on procurement practices and improvement of efficiency of limited public funds distribution. Special attention should be given to development of human resources on procurements management at all levels, including the issues of development and evaluation of technical specifications. Actions will be taken to ensure strict compliance with all procurement procedures. Strengthening of public control is an important condition for rationalization of public funds spending, reduction of corruption risks and ensuring openness and transparency of public procurements. For this purpose it is necessary to ensure participation of representatives of civil society and NGOs in the procedures of procurements and access to detailed information on the tender procurements on the websites of MHIF, MOH, Ministry of Finance, which will enable to track the volumes of procurements and the prices for drugs. 1.3. Regulation of Drug Pricing The Kyrgyz Government policy focuses on formation of market economy and competitive environment, that’s why pharmaceutical market sets prices independently, proceeding from the population demand and purchasing power. The specificity of pharmaceutical market is its limited capacity, making it nonresistant to violent price fluctuations, implying supply interruptions resulting either in deficit or overstock of drugs and medical items. 15 Draft, 8 October , 2013 Low level of IT development and lack of continuous monitoring of prices for drugs in pharmacies does not enable to aggregate and analyze prices at the pharmaceutical market. Population "out of pocket" expenditures for health has increased by 3.5 times over the last 10 years, from 1.5 billion Soms in 2000 up to 5.6 billion Soms in 2009; in the structure of expenditures, 60% fall on drugs7. In the expenditures structure of people over 50 years of age, expenditures for drugs make about 1/3 of their income, which largely affects the socio-economic and psychological situation of low income groups of the population8. This situation in the pharmaceutical market indicates that there is a long-felt need to introduce mechanisms of the state influence on pricing processes through: a) reduction of suppliers’ chain, b) mechanisms of pricing for drugs and medical items from the EDL. 1.3.1. Reinforcing requirements for drugs and medical items wholesalers to reduce the supply chain Currently, there are about 300 pharmaceutical suppliers on the local pharmaceutical market. Abundance of drug wholesalers leads to the fact that the total volume of trade markups/margins (wholesale or retail) from the moment of the drug enters the country to the stage it is sold to the main consumer, varies widely compared to the purchased price. To address this issue, regulations or standards have to be improved, as well as licensing requirements, aimed at reducing the number of wholesale firms to the optimum level, given the limited capacity of the pharmaceutical market in the KR. Bona fide or conscientiously operating wholesalers should stay on the market, the ones, who observe the appropriate rules and maintain high professional standards of safety, quality and high level of competence of pharmaceutical sector workers - pharmacists. All stages of drugs delivery to the consumer require observance of strict professional standards. At the same time, the rules of wholesale should be enforced, monitoring of activity of wholesale pharmaceutical suppliers should be developed as well. 1.3.2 Mechanisms of price regulation Selection of pricing policy should be based on continuous monitoring of prices for drugs and medical items. The main directions of the pricing policy should be based on internationally recognized and most effective ways of regulating prices for drugs and medical items and should be pursued through: (a) government control of taxes, duties and other markups on drugs and (b) establishment of mechanisms for price regulation. Drugs and medical items under the Lists, defined by the Government (EDL and other lists of medical equipment, including supplies and commodities, reagents and pharmaceutical substances) should not be subject to value added tax (VAT) and other taxes and duties that affect the increase of their cost. Price regulation in pharmaceutical sector should be done through: HPAC: CHS, NHA – 2009. Policy Research Paper No 77 “Evaluation of implementation and efficiency if the SDP for 2007-2010”, HPAC. 7 8 16 Draft, 8 October , 2013 Regulation of trade margins/markups (wholesale and retail) for drugs, taking into account geographical and socio-economic criteria, Development and introduction of mechanisms of internal reference prices for drugs, included into the EDL. Reference pricing is part of a comprehensive national system of reimbursement of expenditures of citizens for purchasing drugs. It is inextricably linked to the implemented programs on drug exempt supply of citizens on ambulatory level, introduction of GMP international standards, development of regulatory tools, mechanisms and culture of rational drug use, sustainable market infrastructure, adequate funding. The system of internal reference pricing envisages establishment of the limit state reimbursement rate for drugs. Regulation of prices for drugs, included into the EDL through contracts between MOH/MHIF or group of health care organizations on the one hand and pharmaceutical suppliers on the other -through setting the limit prices for drugs for a certain period of time. The amount of procurements and payment terms shall be determined independently by each health care organization, based on its needs and financial capacities. Development of information technologies and continuous monitoring of prices for drugs and medical devices at all levels is a prerequisite for introduction of the state regulation of prices. Under the state reimbursement programs, it is necessary to further improve information systems on recording of drugs and medical items, dispensed through pharmacies network and subject to reimbursement. This includes creation of single information network between the MHIF and pharmaceutical institutions to ensure transparency and improve mutual accountability of all the structures, formation of a sustainable system of monitoring of drugs prices by specific groups, sold under these programs, as well as ensuring free access to the database on drugs retail price for public. 1.4. Rational Use of Drugs Administration of unjustified large number of drugs while ignoring their interaction (polypragmasy), as well as population behavioral stereotype to take drugs without prescriptions, have become a topical issue in the KR. According to the studies, conducted in the KR’s hospitals in 2009, patients receive 7-8 drugs per treatment course on average, and the maximum number reach up to 29 drugs per patient’s treatment course. According to the studies, simultaneous consumption/use of 2 drugs leads to adverse drug interactions in 6% of patients, 5 drugs - increases their incidence up to 50%, and taking of 10 drugs increases the risk of side effects or adverse reactions up to 100%. It should be noted that consumption/use of several drugs makes prediction of their pharmacological and adverse effects more difficult. Besides, polypragmasy leads to unjustified expenditures of patients, which have negative effect on the families’ budget. Irrational use of drugs is caused by inadequate level of knowledge of physicians in the area of RDU, inadequate introduction or lack of implementation of CG/CPs, aggressive marketing by pharmaceutical companies, administration of drugs, particularly injectable, at the patients’ request/demand, poor public awareness about drug safety, free sale of drugs subject to prescription sale only. 17 Draft, 8 October , 2013 The latest studies, carried out in Kyrgyzstan, indicate that 100% administration of injectables to children was observed in hospitals of the country, as well as irrational use of antibiotics, implying incorrect selection of drugs, duration of treatment course and unjustified administrations of drugs9; while at ambulatory health care level, every fourth patient purchases drugs in pharmacy without physicians’ prescription10. To address problems of irrational use of drugs, under this SDP it is proposed to create sustainable system of development and implementation of CG/CPs, providing sale of drugs by prescription from prescription list, improvement of pre-and post-diploma education in RDU issues and continuous training on RDU, ensuring prescription dispensing of prescription drugs, measures to change people's attitude to irresponsible use of drugs through mass media. 1.4.1. Introduction of Clinical Guidelines and Protocols and improvement of education system at all levels on the issues of Rational Use of Drugs Up to date, the following measures have been implemented: "Methodology for development of evidence based clinical guidelines" was approved; process of review and approval of CG/CPs have been improved. However, the activity on development of CG/CPs is limited, mechanisms for their introduction have not been worked out, i.e. the Coordinating body, procedures, instructions for CG/CPs development have not been approved yet; the capacity of expert bodies is not adequate; timely publication, dissemination and training in CG/CPs have not been worked out yet; there is no proper monitoring of introduction of CG/CPs and financial support of the entire process of their development and introduction. Ignoring any of these stages undermines the entire previous process. Each stage should follow a strict methodology. Introduction of CG/CP into clinical practice should be accompanied by the most efficient scientifically-justified methods of introduction taking into account the needs of the target audience and local conditions. The most important factor in the success of introducing CG /CP is training of health workers at all levels – pre-in- and post-diploma – continuous skills upgrading – in RDU principles and clinical protocols. By now, principles of evidence based medicine (EBM) and rational use of drugs (RDU) have been integrated into the curricula of medical education; a new specialty "Clinical Pharmacologist" has been introduced into higher medical education. Problems like lack of effective integration of the revised CPs into the educational process at pre-and postdiploma levels, including skills upgrading persist; not all practitioners are trained in current CPs; the activity of Quality Committees under HCOs is still inadequate. The necessity has emerged to create a sustainable system for development, implementation and monitoring of CG/CPs and their further promotion in health and education systems of the Kyrgyz Republic. Educational standards in the field of professional and postdiploma training to train medical and pharmaceutical professionals will include the issues of rational use of drugs, pharmaco-economic analysis, further strengthening of generics conception and ethical promotion of drugs. The activity of Quality Committees in HCOs is the key component and shall be activated in the area of RDU, pharmacovigilance, substitution of drugs and critical evaluation of information, received from pharmaceutical companies. 9 Policy Research Paper №68 «Situation Analysisof justification of hospitalization of children under 5 and pregnant women», HPAC, Bishkek 2009 10 Policy Research Paper №67, «Study of factors, influencing on use of generics», HPAC,2009 18 Draft, 8 October , 2013 1.4.2. Prescription Sale of Drugs Prescription sale of drugs is aimed at limiting uncontrolled use of drugs by population, especially antimicrobial drugs. To date, despite the relevant legal documents, drugs sale only by prescription does not work in full degree. Today any drug can be freely purchased in the KR pharmacies without prescription, with the exception of narcotic and psychotropic drugs, and potent drugs subject to the national control. Failure to comply with the rules of prescription sale of a number of drugs, especially anti-microbial ones, potentially endangers the health of every citizen and society in general. According to the analysis of data on the total consumption of antibiotics for the 2011, Kyrgyz Republic takes the seventh place among 33 Eurasian region countries, which participated in the global survey. At that, 46.8% of the country’s population take antibiotics on their own, without any prescription11., while in countries with a strong regulatory system of drugs circulation, antibiotics can’t be purchased without prescription. This results in leads to the situation when uncontrolled use of antibiotics leads to drug-resistant forms of microorganisms (not only bacterial, but viral, and fungal); in addition, it increases the number of complications from improper therapy, improper self-medication and non-adherence to dosage. The studies, conducted in the KR, have shown 100% resistance of typhoid fever germ and 93% of resistance of Salmonella germs to Ampicillin, which indicates the growth of microbial resistance to antibiotics12. The society may go back to the era when there antibiotics were not available, and when even a simple infection could mean a death sentence to the patient. Within the framework of this document, it is proposed to restore the prescription sale of drugs. In this case, it is proposed to change approaches through development of a limited list drugs to be sold through prescription. Introduction of this list should be accompanied by reinforcing of measures of administrative influence, necessary trainings of specialists, wide general activity on notification of population. Introduction of mandatory prescription sale of drugs from the specific drugs list may result in increased pressure on reimbursement programs, so it would be necessary to evaluate this intervention and take appropriate actions, for example, exclusion of antibiotics from the list of drugs under the HIF Additional Drug package Program, except for children under 5. 1.4.3. Formation of adherence towards Rational Use of Drugs to fight against unethical marketing of drugs in health care system workers and population of Kyrgyz Republic Improper unethical promotion of drugs by pharmaceutical companies leads to excessive use of drugs. In Kyrgyzstan most of physicians receive information about drugs, primarily from pharmaceutical companies, and not from independent sources. According to the results of the research, despite the a number of steps taken by the Ministry of Health to restrict the activities of pharmaceutical companies in health care organizations, 90% of the interviewed doctors reported that they met with representatives of private pharmaceutical companies during the last year, and 42% say that the frequency of contacts is at least 1 time a month13. As in many countries, excessive administration of expensive drugs is observed in the KR, caused by an extremely aggressive marketing. Expensive drugs are the ones which are primarily promoted to the market, promotion cost of which is already included into the price of drugs, 11 Momunova. А. Peculiarities of use anitmicrobal drugs for respiratory organs diseases. Central Asian-Medical Magazine 2003; 9: 208-210 Program for containment of resistance to anti-microbal drugs in the Kyrgyz Republic for 2009-2012, Decree №660 as of 22.09.2009 12 13 Policy Research paper № 77 « Evaluation of implementation and efficiency of the State Drug Policy of the Kyrgyz republic for 2007-2010», HPAC, Bishkek, 2012 19 Draft, 8 October , 2013 making them unreasonably expensive. Pharmaceutical companies are engaged in all kinds of activities to promote their products, including all marketing tools, such as: dissemination of information materials and organization of presentations, distribution of free samples of drugs and accruing bonuses, as well as uncontrollable drug advertising in mass media. RDU is the most important mechanism of counteraction against unethical marketing. Therefore, measures will be taken under this policy aimed at further introduction of RDU, building of single information –reference system on reliable methods of treatment and characteristics of drugs for health and pharmaceutical workers, enforcement of requirements towards knowledge of RDU during attestation of health and pharmaceutical workers, development of indicators on performance and activity of HCOs. One of efficient tools of countering aggressive marketing is provision of objective systematized information on drugs in the format of the national formulary of the main drugs. It is necessary to determine the status of the national formulary, institutionalize the process of its development and implementation in practice, with identifying sources of funding. Implementation of programs to counter unethical marketing through provision of independent, reliable information on drugs for health professionals and population requires cooperation with local administrations and self-governance bodies, development of measures to strengthen the responsibility of advertisers, advertisements disseminators for placing/publishing information about drugs without proper authorizations and permits. 2. System of Drugs Circulation 2.1. Improvement of ensuring of quality, safety and efficacy of drugs and medical items In the framework of the KR Law "On drugs”, the state system for ensuring safety and quality of drugs has been formed, which includes the following stages: - State registration; - Licensing of pharmaceutical activities of pharmacies; - Evaluation and attestation/confirmation of conformity of drugs and medical devices; - Pharmaceutical inspection (supervision); - Pharmacovigilance. The above procedures are designed to ensure quality, efficacy and safety of drugs and medical items through the entire chain of their circulation: manufacturer - wholesale - retail link / health care organization - consumer/patient. During the last few years, efforts were invested into comprehensive improvement of the system of state control of drugs and medical items quality and its institutional reinforcement. Thus, due to the entry of the Law "On regulatory legal acts of the Kyrgyz Republic" into force, the legislation related to regulation of drugs circulation has been fully updated. Within the framework of technical regulations, regulations have been introduced on safety of drugs and medical devices, national standards of best pharmaceutical practices have been approved. New laboratory facility has been introduced, and in this connection, the scope of the DDS&ME as the certification body has been expanded. 20 Draft, 8 October , 2013 There is a strong need for further improvement of registration system to ensure essential drugs presence at the market. Post-marketing control of the market of drugs and medical devices requires improvement as well. Unexpected control of pharmaceutical market is missing. Health professionals distrust some drugs and medical devices, and at that, there is no documented evidence of side effects or other claims about the quality of drugs and medical devices, which requires strengthening of pharmacovigilance system. Continuous improvement of regulatory activity requires allocation of state co-financing and improvement of material-technical base of the regulatory body and improvement of human resources capacity. All above problems in the area of regulation of drugs and medical items shall be addressed through introduction of good practices rules of pharmaceutical activity 2.1.1. Improvement of drugs regulation system to ensure equal therapeutic efficacy of generic drugs Original drugs comprise not more than 3% of the pharmaceutical market of KR. The market is primarily represented by generic drugs. From the legal perspectives, generic drugs, authorized to the country's pharmaceutical market have equal quality and efficacy. However, there is evidence of in equivalence of therapeutic efficacy of generics and distrust of doctors and patients to cheap generics14. Lack of information for physicians in public domain related to study of therapeutic equivalence of drugs, registered in the Kyrgyz Republic, also hinders proper therapeutic selection of drugs. Following WHO recommendations, procedure for registration of generic drugs in the Kyrgyz Republic is simplified compared to the registration procedure of original drugs. The Law on drugs in the KR stipulates an additional clause for the simplified registration of generics. In addition, the registration waver is applied to importing of drugs, approved by the KR MOH. The Law "On Drugs" stipulates the clause for importing drugs and medical devices under registration wavier rule in case of epidemics and emergencies. But there are no clearly defined criteria for applying the above clauses for authorizing drugs and medical devices to the market. The current simplified procedure for the state registration of generics should be applied only for drugs that are registered in the countries that are members of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), or in countries that are members to the International System of the Pharmaceutical Inspection Cooperation (PIC/S). After creation of national GMP inspectorate the procedure of simplified registration can be extended to drugs approved by the national GMP inspectors. This list should be complied and approved by the Government of the Kyrgyz Republic on a periodic basis. It would make sense of this List should also include the countries, with which the KR has inter-governmental agreements, in the area of drug supply in particular. It is also necessary to develop and adopt procedures to verify the origin of the drugs (supporting 14 Research Paper №67, «Study of factors, influencing on use of generic drugs», HPAC, Bishkek, 2009. 21 Draft, 8 October , 2013 documents from the regulatory authority, inspection of production, etc.). The process of drugs registration will be brought into compliance with the Good Regulatory Practice standards (GRP). The legal procedure for registration of biological products (biosimilars) analogues should be also defined. To increase credibility and confidence in the registration system, it is necessary to ensure the provision of publicly available relevant information about registered products, with the exception of the confidential part of the registration dossier. In order to ensure the rights of patients and physicians to obtain reliable information about drugs, the criteria for classifying information as confidential should be reconsidered. The process of decision making on registration of drugs and medical devices should be transparent and followed by mandatory publication of publicly available summary report of the registration / refusal of drugs and medical devices. To improve the efficiency of registration process it is necessary to continuously improve the competence of experts, including skills in interpretation of bioequivalence studies, as well as increase personal responsibility of experts in decision-making process. 2.1.2. Introduction of Good pharmaceutical practice standards (GPhP) Introduction of good pharmaceutical practice standards will result in significant improvement of the system of drugs and medical items circulation at all stages, ensure quality of drugs and medical items in the republic and will restore prescription sale of drugs. GPhP in the KR are based on international guidelines and should be widely expanded. The process of implementation and compliance with good pharmaceutical practice standards requires involvement of professional pharmaceutical associations. The entities of pharmaceutical activity (pharmacies, drugstores, pharmacy kiosks, wholesale warehouses, optics shops and medical equipment shops, manufacturing enterprises) should organize their activities in accordance with standards, approved by the good practice standards. Introduction of GPhP rules should be done gradually, allocating sufficient time needed by the entities of pharmaceutical activities to bring logistics, personnel qualification/competence and quality management system in compliance with the new adopted rules and standards. The period of transition of pharmaceutical activities entities towards introduction of GPhP standards should not exceed one term of licensed activity, but not later than 5 years from the date of publication of the GPhP Rules. Upon expiration of five years term since the date of GPhP rules publication, the licensing terms of pharmaceutical activity should strictly comply with the requirements of the adopted GPhP standards. The pharmaceutical activity entities, that have implemented the requirements of the adopted GPhP standards within the first 3 years after publication of the said standards, should be given preferences during public tenders on procurements of drugs and medical items. GPh practice rules, adopted in the KR, should be harmonized with international guidelines on good practices (GMP, GDP, GCP, GLP, GSP) and should be updated and improved continuously given the changes entered into international guidelines. The system should be created to assess the pharmaceutical activity entities for their compliance with the GPhP, with issuance of certificate. To this effect, it is necessary to set the 22 Draft, 8 October , 2013 system of continuous training of pharmaceutical inspection specialists in skills of GPHP compliance evaluation. 2.1.3. Enforcement of Surveillance of pharmaceutical market Due to the fact that drugs can cause irreparable damage to health if used incorrectly, they can lose their therapeutic properties during not improper management of drugs transportation and storage, so the extensive network of wholesale and retail pharmaceutical organizations of the country should be constantly controlled. In addition, there is an illegal drug market in the KR, as evidenced by a wide range of drugs in pharmacies compared to the official imports, which also carries potential risks for the health of people15. However, the current system of surveillance (pharmaceutical inspections) does not allow ensuring presence of only legal drugs in the sales network because of the requirement to notify the pharmacies and economic entities about the upcoming inspection ten days prior to the inspection. As a result, the pharmaceutical inspection can’t fully perform its functions, as for example, the element of suddenness of inspections is missing. The activity of pharmaceutical inspection should ensure that there are no unregistered, expired, poor quality and counterfeit drugs on the market of the country. Frequency of inspections should be based on the principles of risk assessment and management and should be regulated by the legislation on state control and surveillance. The market control system will be brought into compliance with Good Regulatory Practice (GRP), with organization of comprehensive system of market control. At that, access to information on the results of pharmaceutical inspections should be made available for public. Continuous professional training for pharmaceutical inspection specialists will be introduced. Mechanisms providing increase of responsibility and transparency of pharmaceutical inspectors activity will also be introduced. The system of getting feedback will be developed and implemented in the form of spontaneous reports from pharmaceutical and health care organizations, as well as from public to help to reduce the amount of substandard and counterfeit products on the market of drugs and medical devices. 2.1.4. Enforcement of Pharmacovigilance Health care workers and people often make claims to the quality of drugs and medical items, however, this information is not collected and analyzed, respectively, adequate measures are not taken. The system of pharmacovigilance is regulated by the Technical Regulations "On safety of drugs for medical use" through introduction of spontaneous reports on detected drug side-effects using “yellow cards”. Although ‘yellow cards” are continuously distributed among physicians with explanation of the procedure for filling them out, very few cases of side effects to drugs are reported by doctors, indicating that the level of adherence of physicians and efficiency of communication on pharmacovigilance issues is quite low. This is evidenced by reduction of the 15 Quality of drugs in the sector of public procurements of the KR, WHO. 2008 23 Draft, 8 October , 2013 number of spontaneous reports from doctors –from 57 reports in 2007 down to 17 reports in 2012 (DDS&ME website as of March 26, 2013). According to the research, 70% of the interviewed doctors responded that they had side effects to drugs in their practice, the most common manifestations of side effects being allergic reactions (55%) and intolerance of drugs (35%). However, only 6% of them indicated that they filled out "yellow" cards. The main reasons for non-use of "yellow card" is almost complete lack of awareness among physicians about the procedures to work with these cards. Thus, 65% of doctors responded that they did not have these forms; during discussions of this issue, the respondents often admitted that they had not even seen the "yellow cards" and have not heard of their existence16. For early detection of risks, associated with the use of drugs under normal use, it is necessary to improve the system of pharmacovigilance through introduction of Good pharmacovigilance practice (GPhP). Mechanisms for transfer of information of drug side-effects (“yellow cards”) from HCOs to the DDS&ME and feedback on each reported case will be developed. Development and introduction of automated database on drug side effects will imply the mechanisms for transfer of reports/messages both electronically and in hard copies. Special attention will be given to improvement of the capacity of HCOs in drugs safety issues 2.2. Improvement of the system of drugs and medical items supply 2.2.1. Supply of narcotics and psychotropic drugs Currently, physical accessibility of narcotic drugs in the country is limited for various reasons, including inadequate regulatory norms, wrong interpretation of legislative norms by HCOs, lack of knowledge in health care workers and legislators on treatment of pain and use of narcotic drugs, which all create excessive administrative barriers for issuance of prescriptions for narcotic drugs. Another reason is low accessibility of narcotic and psychotropic drugs in pharmacies, when patients with prescriptions can’t buy these drugs. The issue of access to these drugs is even more topical in remote regions. Inadequately rigid control and frequent inspections by the Ministry of the Internal Affairs, often without prescriptions, lead to the reluctance of retail pharmacies to have a range of narcotic and psychotropic substances, and reluctance of physicians to prescribe psychotropic drugs. Since a number of departments are engaged in regulation of this sphere, the problem of improving access to narcotic and psychotropic drugs should be addressed comprehensively and jointly with all the stakeholders in the interests of patients in the need of care. To decrease unnecessary sufferings of patients in need of narcotic drugs for painkilling purposes, it is necessary to adopt the strategies, aimed at removal of political, regulatory legal and administrative barriers for provision of palliative care. Strategy will be develop on improvement of narcotic and psychotropic drugs supply to patients for shorter and middle terms, and measures will be taken to train all stakeholders. 16 Policy Research Document № 77 « Evaluation of implementation and efficiency of the SDP of the KR for 2007-2010 .», HPAC, Bishkek, 2012 24 Draft, 8 October , 2013 2.2.2. Supply of essential drugs with limited physical accessibility The government policy in drug circulation area should be aimed at availability of essential drugs on the country market. However, some essential drugs are not available in the Kyrgyz Republic due to a number of reasons: 1) limited demand of drugs, used for treatment of rare diseases (orphan drugs); 2) limited purchasing power of the majority of population due the high cost of drugs, needed for treatment of severe diseases. So treatment of these diseases either lies as a hard burden on the shoulders of the patients and their families or makes treatment impossible altogether. Physical absence of these drugs on the local market forces patients to purchase them in other countries; 3) absence of demand for some affordable and efficient essential drugs due to the change of drugs administration practice by doctors for various reasons, including aggressive pressure of pharmaceutical firms. About 10 names of these drugs were not included in into the current EDL due to absence of their registration in the KR, and physical availability on the market respectively. With respect to high-cost essential drugs (including orphan drugs), the state should set itself the task of expanding access to these drugs through development of integrated strategies and technologies in line with the available resources, which should include measures to optimize the prices for new patented drugs and generics and improve procurement practices. It is necessary to incorporate the definition of rare diseases and orphan drugs into the KR legislation in order to provide access to the really necessary drugs and limit speculation of the concept of rare diseases. To reduce the cost of high cot drugs, mechanisms will be developed to ensure transparent information on prices and suppliers, proper planning and forecasting of demand, supply management. In order to reduce prices for generic drugs, the government will use negotiations and promotion competition between manufacturers. To reduce prices of the patented drugs, the government will hold active negotiations with their vendors to obtain the best achievable lower prices, provide donor supported programs, that provide free delivery and apply voluntary and compulsory licensing under the rules, described in the TRIPS Agreement. Patent laws of the Kyrgyz Republic should not contain the rules that limit access of drugs for the population. The issues will be addressed related to getting affordable and effective drugs to the KR pharmaceutical market, which are the drugs of choice in the national CG / CPs. Comprehensive measures should be planned, including, on the one hand, negotiations with pharmaceutical suppliers to bring these products to the market of the Kyrgyz Republic in line with the List, and work with physicians to change clinical practice under the CG/CPs on the other hand. Since many vital essential drugs are not registered in the country, the Ministry of Health should develop a strategy to provide the most favorable regime for all the above drugs, while ensuring their high safety, efficacy and quality. To this effect criteria for formation of the List of essential drugs will be developed, which are authorized for import into the KR without registration for a specified period of time, with their subsequent registration in the Kyrgyz Republic. The system for monitoring of availability of the above drugs will be created, which will include presence/availability of drugs in CG/CPs, Registers of patients in need, prices both in the country and outside, forecasts of consumption rates, regulatory status of drugs, etc. 25 Draft, 8 October , 2013 2.2.3. Disposal of unusable drugs Drug supply system faces the challenge of disposal of drugs, which have become unusable at various stages of supply. Accordingly, system of measures should be developed to prevent possibilities of using these drugs (timely withdrawal from the market, collection, storage and disposal). The general procedure for disposal of unusable drugs, described in the Technical Regulations "On safety of drugs for medical use", is triggered to this or that degree only in case unsuitable drugs emerge in the wholesale supply chain or at the fault of wholesale suppliers / manufacturers. But there are a number of circumstances in which there is uncertainty about application of the procedure of unsuitable drugs disposal: retail pharmacies periodically accumulate expired drugs in small quantities; application of the procedures for disposal of these drugs in accordance with the Technical Regulations is economically unjustified. There is no procedure for collecting, storing and disposing unusable drugs in health care organizations. Disposal of drugs involves additional expenditures. To facilitate the process of drugs disposal due to the necessity to prepare a number of authorization documents and other bureaucratic barriers, centralized procedures will be developed for disposal of unusable drugs depending on the location and conditions of their formation (wholesale warehouses, retail network, places of illicit sale of drugs). 2.3. Measures on elimination of Illicit drug sale and enforcement of sanctions for violation of norms and rules Illicit sale of drugs, when they are sold illegally among other goods typical for street sale, presents a serious threat to life and health of the population. Moreover, in contrast to consumer goods, negligence of the conditions of drugs storage and sale might result in serious consequences of consumer’s health. Along with this problem, there are issues of drugs counterfeit and sale of expired drugs in the sphere of legal drug circulation. r and quality remain unattended. Illegal sale occurs due to high incomes, concealment of revenues from taxation and minor penalties for this offense, which is equated to illegal trade of conventional consumer goods. Suppression of illicit trade of drugs and, consequently, reduction of poisoning risks for the population or other side effects, are possible, if the penalty for such offense is severe to the degree necessary to make it overweigh the possible benefit from illegal sale of drugs. All this is attributed to high revenues on the one hand and relatively low penalties for this offense on the other hand, i.e. punishment for this type of offense does not correspond to the severity of the caused damage, and the profit from this activity is significant. Suppression of illicit sale, fight against counterfeit and sale of counterfeit drugs and expired drugs and, therefore, mitigation of risks of poisoning or other adverse effects for the population are possible – conditioned that the punishment for such offenses are so serious, that will override potential profit from illegal drugs sale. To this effect the measures of administrative and criminal liability for illegal sale of drugs will be reinforced. It is also necessary to expand the powers, functions, rights and responsibilities of local governments and self-governance bodies to counter the illegal sale of drugs and medical devices. 26 Draft, 8 October , 2013 Punishment for counterfeiting of drugs and sale of expired drugs will also be reinforced. It is therefore proposed to amend the Administrative Code of the Kyrgyz Republic in a stepwise way. Together with increased liability for the illegal sale of medicines it is necessary to reduce the demand of the population for the products of the "black market" of drugs, including smuggling, counterfeit drugs and expired drugs. To reduce the demand for "black market" products, it is necessary to inform population on a regular basis about the dangers of purchasing drugs from illegal sellers and purchasing expired drugs. Population should also be informed about how to define legally operating pharmacies and pharmacies points, how to find out about the registered drugs, how to understand their shelf life. 3. Improvement of management of drug circulation Efficient management of drugs circulation sphere implies availability of capacity and mechanisms for formation of the state policy, adequate legislation, regulations, as well as availability of effective mechanisms to regulate processes and tools of control over the activity of drug circulation entities and ensuring transparency and accountability. 3.1. Formation of state policy in the area of drug circulation, based on clear vision, continuity and feedback Formation of state policy in health care, including drug circulation is the direct function of the KR MOH. Given the fact that drug circulation is the area of overlapping of interests, requirements and expectations of citizens, HCOs, suppliers of pharmaceutical services and other interested parties, inevitably implying conflict of interests, the process of development of state policy should envisage extensive consultations with all stakeholders. Despite the fact that the Law "On normative legal acts" requires mandatory public discussion of draft regulations, this process is not regulated at all and is limited to placing drafts of legal acts on the official website. That’s why, the normative legal act will stipulate the regulations for drafting of strategic/policy and regulatory documents with mandatory involvement of all stakeholders. Besides, the SDP implementation requires efficient inter-agency coordination and wide support of public. Regular monitoring of the SDP implementation with involvement of all stakeholders will be organized. Periodical reports on the SDP implementation will be published. 3.2. Removal of contradictions and gaps in the legislation The legislation, regulating business activity, as well as administrative responsibility, should be harmonized with the legal acts on drugs circulation of the KR. To develop business in the Kyrgyz Republic, the following measures were taken: conditions/terms for the start of business conduct have been simplified, mandatory state standards have become voluntary, the number of licenses has been significantly reduced, and licensing requirements for most of the activities have been simplified; the authorities of public 27 Draft, 8 October , 2013 bodies in regards to control-enforcement activities have been limited. These measures had a positive impact on development of “shuttle” and wholesale- retail trade, public catering and services. Possibilities of conducting illegal inspections of entrepreneurs and, therefore opportunities for corruption, have been reduced. The areas of business that require strict measures to ensure safety of life and health of citizens, special rules, procedures and regulations are implemented. E.g., the operation of the Law No 67 as of May 22, 2004 "On the basis of technical regulation in the Kyrgyz Republic" (Law of the Kyrgyz Republic No 299 dated 16 November 2009, No 171 dated October 14, 2011) does not cover application of measures to prevent occurrence and spread of mass communicable human diseases, prevention of human diseases, delivery of health care. But drugs, medical devices and medical equipment present part of measures for delivery of health care to the citizens of the country. However, drugs, medical devices and medical equipment fall within the scope of the Law "On the basis of technical regulation in the Kyrgyz Republic", contradicting the principles of rulemaking, stipulated by Law “On Regulatory Legal Acts of the KR”. For this reason, amendments will be entered into the legislation on technical regulation to introduce the concept of drugs as a special kind of product and their accompanying medical services as a special kind of service, which should be handled under special rules. Changes should, first of all, define mandatory observance of quality standards in the field of drug circulation; and secondly, should determine that the entrepreneurs, engaged in pharmaceutical business, should be controlled more strictly compared to those who do business with conventional products. For example, inspections of drugs without prior notice should be used, as well as selected inspections of drugs batches in pharmacies and stores, and other control and surveillance measures to detect smuggled drugs, counterfeited drugs, expired drugs and drugs of inadequate quality. Treating drugs and medical devices as conventional goods also impedes the efficient procurements of drugs and medical devices under the conditions of dynamic changes of modern pharmaceutical market, due to the fact that the main criterion in the legislation on procurements is the price, not the quality, safety and efficacy of drugs and medical devices. However, health care organizations should be able to select the most effective drugs based on clinical experience of drugs use and post-marketing surveillance data. In future, definition of drugs and medical devices as a special type of products will be stipulated in the Law on Public Procurements. Also, the legislation will entrench specific methods of organization of drugs procurements to achieve the most competitive prices for high-quality pharmaceutical products from the leading manufacturers in the global market. As drugs are treated in the Kyrgyz Republic as consumer goods, violations in the field of drugs circulation are also reviewed according to the standard procedures. However, unlike consumer goods, failure to follow the rules of storage, sale of drugs can lead to serious consequences for the health of the consumer. In this connection, will be substantially strengthened accountability for violations of rules for handling drugs. Will also be strengthened by the punishment of counterfeiting of drugs and sale of drugs with expired shelf life. It is therefore proposed to amend the Administrative Code of the Kyrgyz Republic. The definition of "drug” also requires legislative adjustment, as it has been repeatedly amended to address urgent political and regulatory challenges. This has resulted in the situation, when the term "drugs" includes unreasonably large number of different names of products, 28 Draft, 8 October , 2013 representing separate groups of products (medical devices, dietary supplements, pharmaceutical substances and materials, chemicals, reagents, test kits). Such a wide scope of products under the term "drugs" is accepted neither in any CIS or in the western countries. This leads to the fact that many goods groups that are not drugs by nature, are subject to the drugs requirements. So artificial barriers are created in circulation of these products on the market. The situation is particularly difficult for domestic drug manufacturers, as they have to go through the process of double registration - at the level of imports of pharmaceutical substance, and then - when registering the drug, produced from this drug substance. The Ministry of Health solves this current problem by including pharmaceutical substances into the list of unregistered drugs, but allowed for import and use on the territory of the Kyrgyz Republic, which generates significant bureaucratic barriers. Clear legal definition of drugs and medical devices, introduction of the concept of medical- pharmaceutical products in accordance with internationally accepted norms with subsequent changes to be entered into the Technical Regulations "On safety of drugs" would solve many issues of the pharmaceutical market. It is also necessary to remove contradictions and inconsistencies in interpretation of the Law "On Drugs", stipulating import of drugs and medical devices that are exempt from state registration. In addition, there is an urgent need for harmonization of the existing legal framework regulating the sphere of drugs circulation with the principles of the law on normative legal acts of the Kyrgyz Republic. 3.3. Institutional Strengthening The Government of the KR ensures pursuing single state policy in health care. The MOH is the authorized state body in the sphere of health protection in the Kyrgyz Republic. According to the functional classification, the Ministry’s system, as the central governance body, should delineate functions on development of sector policy (drafting legal acts, standards, rules, regulations) and functions to implement the sectoral policy (practical application of the legislation) in order to avoid conflict of interests and apply objective approach to development of certain norms. State management of drug circulation system should meet the following management principles, providing efficient and non-corrupt governance: • Clear separation of functions of policy development from the functions on implementation of the policy; • Public control over transparency of procedures on decision making and implementing decisions; • Strengthening of accountability of the DDSS&ME, creation of tools to measure efficiency of the regulatory authority; • Co-financing of regulatory bodies mainly from the state budget; • Establishment of internal system of performance assurance of the DDS&ME’s activity; • Availability of capacity at the Ministry of Health with appropriate resourcing Currently, in the central office of the Ministry of Health there is no institutional structure to ensure a full cycle of development of drug policy, including setting the problems, organization of consultations on their discussion, proposal of ways to address them, control of policy implementation, monitoring and evaluation. Efforts to create this organization structure are limited by financial resources. However, it has become topical to establish a department 29 Draft, 8 October , 2013 responsible for developing national drug policy, monitoring and evaluation of its implementation in the central office of the KR MOH, and to lay regulatory functions, coordination, surveillance and control exclusively upon the DDS&ME. So that the structure in the MOH Central Office responsible for drug policy performs its functions to full extend, its status should be not lower than the level of a separate unit; funding of the unit in charge of drug policy is envisaged from the national budget and grant funds in the amount, sufficient to carry out all functions of the unit, including computer hardware and software, office equipment, travel expenses, monitoring activities, evaluation of the SDP. Retraining and skills upgrading of skills and knowledge on the SDP issues of the SDP department/unit staff should be provided, as well as education and study tours in the countries, whose experience is most useful for implementation of the SDP in Kyrgyzstan It will be in the scope of work of the DDS&ME to coordinate the activities of state and local government agencies in the area of drugs circulation and control and surveillance of implementation of regulations, procedures and standards in the area of drugs circulation in all institutions, regardless of ownership forms and departmental affiliation. Based on the analysis of regulatory system compliance with good regulatory practice (GRP) with involvement of WHO and independent operational regulators of other countries, internal system of quality assurance of the DDS&ME activity will be organized, and all business processes will be developed and approved. The DDS&ME performance reviews will take place following the current KR legislation. The Public Steering Committee under the KR MOH will enforce control over transparency of procedures of DDS&ME and effectiveness of its performance, but unjustified revisions of regulatory agency diverting tremendous human and technical resources of DDS&ME must be stopped. Information on the decisions of the DDS&ME for wide public will be provided in a timely manner, including negative decisions, decisions on the budget of the Department indicating the sources of financing, the results of internal audit. Besides, the DDS&ME is currently financed only against the extra-budgetary resources. As the stability of the republican budget revenues increases, it would be necessary to shift to financing of the DDS&ME mainly to the national budget. The services have to be entered in the Register of public services accordingly. The cost of the license for pharmaceutical activity and registration of drugs will be estimated on the basis the market value, which should be the price for entry of drugs to the drugs market. However, the price of the market authorization should not be too high, given the constraints of sale of drugs in the rural areas. The cost of expert evaluation and tests on registration and certification will be estimated on the basis of the actual cost of the work and services for formation of incentives for development of scientific-intellectual capacity of expert bodies. 3.4. Improvement of Human Resources One of the main preconditions of sustainable development of the pharmaceutical industry is availability of highly professional pharmaceutical staff. The issue of planning of training of staff for public health sector under the conditions of market economy is very topical. It is 30 Draft, 8 October , 2013 necessary to develop the methodic for determining the needs for these professionals to place the budgetary quotas in higher and secondary educational institutions. Specialists with higher pharmaceutical education are trained in the KR by the KSMA. In almost all regions of the country, medical schools annually produce pharmacists with specialized secondary education on a contractual basis. At the same time, the quality of training in educational institutions in "pharmacy" does not meet modern requirements. As part of the reforming higher education, the specialty "pharmacist" has been renamed into "pharmacist". It was assumed that the specialty of "pharmacist", obtained upon graduation from a medical school, will be renamed as "pharmacist’s assistant," but it was not implemented. Thus, nowadays both higher educational and secondary special institutions issue diplomas in the specialty "pharmacist". The situation is aggravated by the fact that the regulations don’t stipulate mandatory requirements for qualification and experience of pharmaceutical workers; specialists with secondary education may hold positions requiring compulsory higher education, which is contrary to the requirements of international standards of good pharmacy practice. All this leads to significant problems in management of pharmaceutical personnel and pharmaceutical industry. In accordance with WHO criteria, Single Register of pharmaceutical workers is the efficient tool for monitoring of qualification of pharmacists in the system of continuous education and licensing of pharmaceutical activities. The information about the certified professionals and graduates should be available in public domain. It is planned to develop Strategy for human resources development in the pharmaceutical sector in view of the priority health care needs. Jointly with the Ministry of Education audits will be organized of all the institutions involved in training of pharmaceutical personnel in the specialty "pharmacy", to check their compliance with the requirements of educational standards; the issue of renaming qualification of specialists with secondary specialized pharmaceutical education will be addressed, and for this purpose consultations will professional communities will be held. The Nomenclature of pharmaceutical positions and job descriptions will be revised; incentives will be developed to attract specialists to work in hospital pharmacies; mechanisms will be created to retain graduates of regional educational institutions in rural pharmacies. 3.5. Development and implementation of the "Code of ethical conduct in the area of drug circulation Unethical promotion of drugs by pharmaceutical companies results in excessive use of drugs. Most of people, prescribing drugs, receive information primarily from pharmaceutical companies and not from independent, objective sources. As in many countries, excessive administration of expensive drugs is practiced in KR, caused by extremely aggressive marketing of pharmaceutical companies. The activity of pharmaceutical companies includes all marketing tools, ranging from dissemination of information materials and organization of presentations to distribution of free technical means, payment of costs of trips to different conferences and bonuses for sold drugs. According to the "WHO Ethical Criteria" scientific and educational/training activities should not be used for promoting drugs to the market, advertising drugs, prescribed or used for 31 Draft, 8 October , 2013 treatment of patients with severe medical conditions, which might be prescribed only by a qualified doctor. Medical representatives should not offer "incentives" to the people, prescribing drugs and pharmacists. In turn, people, prescribing drugs, and pharmacists, should not seek these "incentives." With that, the newest, and therefore the most expensive, but least-studied drugs are promoted to the market. Availability of sanctions for violations in the area of drugs circulation does not guarantee implementation of the legislation unless there is the system of ethical conduct. Since the majority of professionals, working in the area of drug circulation, are not civil servants, and employees of pharmaceutical industry – are individuals, the code of ethics of public servants and civil service legislation does not apply to them. That’s why to develop the Ethical Code will be developed, which will define conduct in this area. This Code will include the following aspects of behavior in handling drugs: • Identification of conflicts of interests; • Honesty in reporting, statement of facts, management of resources; • Making decisions based only on the facts; • Equity in application of rewards and punishments; • Transparency and openness in decision-making; • Protection of informants of unethical conduct; • Recruitment of staff only on the basis of competence, exclusion of nepotism, tribalism and fraternities; • Implementation of the legislation, banning inaccurate, misleading or unethical promotion of drugs; • Control of information, provided by pharmaceutical companies to medical personnel. The Code of Ethics will include the system of implementation, including organizational structure (for example, advice on ethics), measures of punishment and disclosure of violations of ethics in the area of drugs handling. 3.6. Ensuring transparency in the area of drugs circulation and introduction of monitoring of pharmaceutical sector and drugs prices Transparency of processes in the area of drug circulation is ensured primarily by automated processes of collection, processing, transfer of information and open access to it. Information systems of the DDS&ME are used to facilitate implementation of regulatory activities within the institution and to work with suppliers in the Single Window system. Availability/presence of databases in the DDS&ME promotes rapid display of regulatory decisions, guidelines, procedures and other documents on the website of the regulator and improvement of transparency of drugs circulation area. However, fragmentation of the DDS&ME information systems does not allow to improve business processes in the authorized agency itself and does not provide the health system with tools of informational support of public drug procurements and tasks related to automation of recording of drugs in HCOs. Information on the process of registration of drugs remains to be hard-to-reach. 32 Draft, 8 October , 2013 To improve access to information in this area, as well to improve transparency and openness, it is proposed to create Single information system of drug supply, which will cover all aspects of drugs circulation, starting with the date of registration and ending with their sale and disposal. Single information system will be built to provide access in two modes: for the authorized users and for common users. For authorized users with appropriate access, the system should enable them to track each batch of drugs arrived into the country or produced locally, so it would be possible to learn online where this or that batch of drugs or drugs in a given batch are that at any time. Temporary (until the registration procedure is over) online access to information on stages of proceeding of submitted documents will be provided. During the procedure of registration, licensing or certification, pharmaceutical companies should obtain all necessary information on the stages of the process. Health care providers and pharmacists will be continuously provided with permanent authorized access to all information, necessary for their work with drugs, including information on their efficacy, side effects, etc. It is planned to develop tool for building of automated system for collection and analysis of the information on the drugs, procured by HCOs, including codifiers of drugs and medical devices, which will be also used for the public electronic procurement system and other purposes, and VEN ABC analysis for improving drug supply management. Information on different aspects of pharmaceutical sector activity is collected by many agencies and departments (Ministry of Health, DDS&ME, RMIC, MHIF, etc.). However, the situation analysis indicates that the existing data is fragmented and does not enable to regularly assess the pharmaceutical sector status in the country . In addition, access to some types of information is limited or its collection is not carried out in the country altogether (for example, some parameters according to the international tool to assess pharmaceutical sector). Work will be carried out to form an integral M&E system to implement regular evaluation of the pharmaceutical sector activity by the key areas of activity and prices for drugs. 3.7. Monitoring and Evaluation System of the State Drug Policy implementation Monitoring and evaluation system shall take into account the structure of the new State Drug Policy and shall be based on the sequential approach, when getting results at one level leads to results at next level, thus ultimately ensuring achievement of the common goal. In practice, the following sequence of monitoring and evaluation has been set: contribution/input process - result - consequence - impact. Data collection will be carried out by selected indicators and markers, reflecting the progress on each of the above levels. The Marker, unlike the indicator, is the measure of tracking implementation of one- off, but key activity. This SDP focuses on new strategic interventions such as regulation of prices for drugs and medical devices, removal of accumulated contradictions in the existing legislation, development of missing practice guidelines, regulatory documents, including the "Code of Ethical Conduct in the sphere of drugs circulation". In this connection, the SDP Plan of Work shall include a large number of measures, which will be implemented once, but are necessary for next steps implementation. The markers are usually monitored/traced down only until the achievement of results. Collection of data on indicators will be based on two types of data sources: (i) routine sources when indicators are collected regularly and in accordance with the approved statistical 33 Draft, 8 October , 2013 forms , and (ii) assessment studies, which are necessary to evaluate the impact of the implemented SDP on drugs circulation. Some studies/surveys have already been conducted under the implementation of National health care reforms programs (e.g., CHS within the framework of "Den Sooluk " is carried out jointly with the National Statistical Committee every two years). Topics for other studies and surveys will be determined by the Ministry of Health annually subject to the needs assessment. The developed Package of indicators consists of the "Control Panel " and three sections linked to three priority areas of activity: "Ensuring affordability of drugs", "Drugs circulation system" and "Improvement of drugs circulation system management". The "Control Panel" is a set of the most important indicators related mainly to indicators of consequences / impact and enable decision-makers to quickly assess the changing situation in the field of drugs circulation and take necessary decisions. Indicators of the "Control Panel" will reflect implementation of the main objectives of the new SDP. They will enable to track down the process of the EDL formation in order to ensure inclusion of drugs with proven efficacy only , will provide information on changes of the situation with regard to ensuring affordability of essential drugs and medical devices for the population of the Kyrgyz Republic, will help to guarantee availability of safe, effective and quality drugs on the market through proper compliance with key procedures and will indicate strengthening of strategic management/stewardship in the sphere of drugs circulation. The basic Package of indicators includes indicators and markers, which were distributed by priority areas of the SDP. Benchmarks (based on 2012 data) and targets by years till 2020 have been identified for each indicator. It is assumed that the Package of indicators will be reviewed periodically (for example, during the mid-term evaluation of the SDP progress). Analysis and evaluation of the Indicators Package will be conducted at the level of the Ministry of Health. Summarized data on the previous year will be presented to the Government of the Kyrgyz Republic and the Parliament of the Kyrgyz Republic, as well as Development Partners and other stakeholders on an annual basis. Monitoring and evaluation of the SDP also envisage improvement of capacity in M&E area. To this end, regular trainings are scheduled for the professionals to be involved in M&E of drug circulation area, as well as decision-makers. It is assumed that wide access will be available to the results of the SDP M & E results, key areas of the pharmaceutical sector activity in general and prices for drugs and medical devices in particular. This will increase transparency and efficiency of management decisions in the field of drugs circulation of the KR. 34