Pharmaceutical Laws and Legislation, Access; Quality and Rational use of Medicines IRI and Ethiopia

1. 9/20/2019 Pharmaceutical laws and regulations based on national drug policy criteria: Islamic Republic of Iran and Ethiopia Mende Mensa (PhD Scholar) Tehran University of Medical Sciences; Tehran September 2019 Presentation outline • • • • • Country overview Overview of Health policy National drug policy Core Principles of National drug policy National drug Policy of Islamic Republic of Iran and Ethiopia • • • • • Pharmaceutical Laws and Legislations, Directives Discussion on components of national drug policy in two countries What are challenges of Pharmaceutical sector? What lessons should Ethiopia Learn from IRI? Conclusion Country overview Ethiopia Islamic Republic of Iran/IRI • • Located in Eastern Africa b/n Sudan, Located in western Asia b/n the Persian Gulf, the Caspian Sea and the Gulf of Oman. Somalia, Eretria and Kenya • Bordered by more than 10 countries • The oldest civilization in human history with • One of the oldest civilizations in the world dating back to 3200-2800 BC. formal government dates back to 1000 BC. • Second populous country in Africa • Total Land area: 636,372 square miles • 12thlargest populous country in the world • Population density: 49.29 per Km2 • Population: 112,078,730 • 18thlargest country in the world • Population density: 110 per Km2. • Population: 82.91 million • Total land area: 386,102 sq. miles • Population below 15 yrs of age: 23.4% • Population below 15 yrs of age: 47% 1

2. 9/20/2019 Health systems framework Source: Shakerishvili G. Building on health systems frameworks for developing a common approach to health systems strengthening. Prepared for the World Bank, Global Fund to Fight AIDS, Tuberculosis and Malaria, and GAVI Alliance, Technical Workshop on Health Systems Strengthening, Washington, DC, June 25–27, 2009. Health and healthcare system in IRI • In the IRI constitution, the 12thclause of Article 3, the government is obligated to remove poverty, and deprivation in the terms of nutrition, housing, labor, public health, and to implement universal coverage of health insurance. • … Priority is given to basic curative and preventive services • Key health indicators • Life expectancy at birth: 75.7 years • Maternal mortality ratio/100,000 live births: 25 • Under-five mortality rate/1000 live births: 15.1 • Neonatal mortality rate/1000 live births: 9.6 • Probability of dying from NCDs between 30-70 years: 14.8% • Suicide mortality: 4.1% Organizational structure of public system • Iran’s health care delivery system can be defined in terms of three levels: (1) PHC network • Rural health houses • Rural health centers • Urban health posts and • Urban health centers (2) District health system, which is responsible for the planning, supervision, and support of the PHC network and district hospitals (3) Provincial and specialty hospitals. Source: Ramin MEHRDAD. Health System in Iran JMAJ 52(1): 69–73, 2009 2

3. 9/20/2019 Health and health care system in Ethiopia • In 1993 constitution, Article 51 (3) and 90 (1): the Federal Government shall establish and implement national standards and basic policy criteria for public health, and to the extent the country’s resources permit, policies shall aim to provide all Ethiopians access to public health and education, clean water, housing, food and social security. • Priority is given to prevention activities and supported by basic curative services. • Key health indicators: • Life expectancy at birth: 65.5 years • Maternal mortality ratio/100,000 live births: 412 • Infant mortality per 1,000 live births: 48 • Under-5 mortality rates per 1,000 live births: 67 • Child mortality per 1,000 live births: 20 • Probability of dying from NCDs between 30-70 years: 18.3% • Suicide mortality: 7.2% Health and health care system cont… • The health system is generally orientated to respond to acute episodes of illness, with focus on preventive care and basic curative services. • The health care system is organized in three levels. 1. Primary level healthcare • Rural Model health houses • Urban and rural Health posts • Urban and rural Health centers • District hospitals 2. Secondary level healthcare • General hospitals 3. Tertiary level healthcare • Specialized hospitals Health system challenges cont… Despite its consistent investment on healthcare the health status of the population is poor. SOURCE: Isham, 2012. 3

4. 9/20/2019 National drug policy overview • A national drug policy is a commitment to a goal and a guide for action. • It expresses and prioritizes the medium- to long-term goals set and strategies • It provides a framework within which the activities of the pharmaceutical sector can be coordinated. • A national drug policy is needed to: 1. Present a formal record of values, aspirations, aims, decisions and medium- to long- term government commitments; 2. Define the national goals and objectives for the pharmaceutical sector, and set priorities; 3. Identify the strategies needed to meet those objectives, and identify the various actors responsible for implementing the main components of the policy; 4. Create a forum for national discussions on these issues. HOW TO DEVELOP NATIONAL DRUG POLICY 10 4/18/2019 National drug policy overview • Goal of National drug policy is to Ensure: • Access (availability and affordability) • Quality (safety and efficacy) • Rational use of therapeutically sound and cost-effective use of drugs by health professionals and consumers and • Reduce the use of foreign exchange for import of pharmaceuticals. • Provide job opportunities in areas of dispensing, packaging and production of pharmaceuticals • Improve local production of pharmaceuticals Components of national drug policy 1. Legislative and regulatory framework 2. Choice of Essential medicines 3. Pharmaceutical Supply 4. Rational use of medicines 5. Affordability 6. Financial Strategies of medicines 7. Human resource development 8. Monitoring and Evaluation 9. Research 10.Technical cooperation among countries. 4

5. 9/20/2019 Why we need different national drug policies? 1. Structure of health care system 2. Number of trained health professionals (physicians and pharmacists) 3. The capacity of drug regulatory authority 4. The way in which pharmaceuticals are distributed 5. Level of funding available for pharmaceuticals 5

6. 9/20/2019 Indicators for monitoring national drug policies • Indicators should be clear, useful, measurable, reliable and valid. • WHO and MSH developed four categories of drug policy indicators for monitoring drug policies. • Background information, structural indicators, process indicators and outcome indicators. • Core indicators cover the following aspects: • Access to essential drugs, other indicators on drug financing, and public supply management; • Functions and efficiency of the drug regulatory authority, the quality control laboratory and how drugs are handled to maintain good quality • Drug prescribing and dispensing, use of the list of essential drugs and clinical guidelines; these provide information about drug use patterns National drug policy of IRI • Since the 1979 revolution, Iran has adopted a full generic-based NDP, with local production of essential drugs and vaccines as one of the main goals. • MOHME has a mission to ensure access to safe, effective and high quality medicines that are affordable for entire population. • Department of Food and Drug in the MOHME is in charge of policymaking and sustainability of supply for essential medicines • Medicinal Drug Planning Council in 1995, which is responsible for main policymaking on medicinal drugs. • The committee approved a 13-point NDP in 2003, revised in 2008, which has been at the core of action in the medicinal drug system. thdevelopment plan, physicians are urged not to prescribe items • Under article 93 of the 4 which are not in the list. National drug policy of Ethiopia • NDP of transitional government of Ethiopia has following objectives:- 1. To meet the country’s demand for essential drugs and to systematize, its supply, distribution and use. 2. To create conducive situations to make drugs affordable. 3. To ensure the safety, efficacy and quality of drugs. 4. To develop a domestic drug manufacturing capacity and gradual supply to the export market. 5. To expand the training of manpower and drugs research and development. 6. To devise ways and means for the utilization of traditional drugs in the regular health services after ensuring their safety and efficacy. 6

7. 9/20/2019 Legislative and regulatory framework • Legislations and regulations • Drug regulatory authority • Medicine registration and licensing • Pharmaceutical quality assurance including inspection and enforcement • Pharmacovigilance • Regulation of prescription and distribution • Infrastructure for good governance in medicines Legislative & regulatory framework of IRI • The IRI pharmaceutical legislative system is classified into five hierarchical levels. From Top Iran’s constitution to bottom regulations • Regulatory authority • IFDA under Department of Food and Drug in the MOHME • Objectives of IFDA • Regulation and registration of medicines, foods, cosmetics, medical devices, supplements herbal and managing supply chain of medicines The structure of pharmaceutical legislative system in Iran National Pharmaceutical legal framework of Ethiopia • Regulatory authority • EFDA Under FMOH • Mission: to promote& protect the public health by ensuring safety and quality of products and health services through; • Market Authorization/Product Registration; • Licensing of premises; • Market surveillance and Inspection; • Quality control testing; • Clinical Trial; • Vigilance and • Medicine and device promotion control. Structures of Pharmaceutical legal system of Ethiopia 7

8. 9/20/2019 Quality-related regulation in IRI • The Act of production and importation of pharmaceuticals(1989): 1. Establishment of a pharmaceutical manufacturing company must be licensed by both the ministry of industry and the MOH. 2. Pharmaceutical companies are obligated to introduce a responsible officer 3. Importation of products and API also must be under the authorization of MOH. 4. The first batch of each new product must be analyzed in MOH laboratories 5. Regular sampling of marketed products for post-marketing surveillance 6. The responsible officer Supervise preparation of data about all products and quality control process and QA related to the acquisition of a production license for a new product 7. Communicating regularly with the MOH about formulations and packaging of products 8. Preparing twice annually about the GMP status of the company for the FDO Quality regulation in Ethiopia • Proclamation 661/2009 under article 4(3-14) 1. The involvement of any person or institution in the pharmaceutical sector without being authorized or licensed is legally prohibited. 2. Establishment of a pharmaceutical manufacturing company must be licensed by both the ministry of industry and EFDA. 3. Importation of products and API also must be under the authorization of EFDA. 4. post-marketing surveillance is mainly by ADR reporting 5. Regional Regulatory Counterparts, which are either under regional health bureaus are autonomous, are mandated to regulate licensing and inspection of medicine retail outlets, and premises involved in the wholesale of pharmaceuticals in their respective regions 6. Medicines retail outlets and supply chain inspections are mandated to RRBs, while EFDA is responsible for manufacturers, importers and wholesales inspection and licensing. Discussion 1: Should Drug regulatory Authority be independent or Under MOH? Key policy issues on independence of a drug regulatory agency 8

9. 9/20/2019 Registration of new drugs to the NDL IRI • Criteria's to consider; Efficacy; Safety; Quality and Clinical use of information • IFDA has the responsibility of investigation and approval of new medicines for registration in the Iran Drug List (IDL). • Procedures followed by NDSC for registration of drugs 1. Admission of request for new drug registration by the committee 2. Consultation of relevant stakeholders who may affect accessibility, quality, and RU of drugs. 3. Preliminary evaluation of the submitted documents (safety, efficacy, and CE) 4. Evaluation of cost-effectiveness of medicine by national PE evaluation committee. 5. If the safety, efficacy, and cost-efficiency of the drug is approved and if the drug has been prescribed for a minimum of 3yrs in North American or West European countries 6. Registration of drug to the NDL and announcing to stakeholders. Registration of new drugs to the NDL IRI • All pharmaceutical products must be registered in NDL to be authorized for the market. Except for patients in critical situations (Act of Emergency Pharmaceutical Centers (EPCs) (2008) • Criteria's emphasized when registering the drug for marketing: 1. The drug accessibility throughout the nation and in all times (distribution charter). 2. Reasonable pricing so that the majority of people can afford it 3. Rationalizethe consumption of drugs through informing the physicians community 4. Quality assessment of the manufactured or imported drugs 5. Post marketing surveillance for rare events and ADR reporting (Yellow Forms) 6. GMP, GLP, compliance. 7. Clear announcement of regulations and pharmaceutical practices will be carried out though regular publication in periodicals, year books, electronic networks, and the Internet Product registration in Ethiopia • New drug registration in Ethiopia is mandated by law to EFDA under proclamation number 661/2009. Article 4(13): Registration of Medicines • Ethiopia has two important drug lists: NLM (> 1120 drugs) and EDL (> 380 drugs) • New medicines will be registered to national list of medicines for Ethiopia after rigorous review of documents and testing by EFDA and National drug advisory committee. 1. The following are EFDA requirements for registration of new drugs; • The applicant should submit the following documents; • Quality related documents • Non-clinical study reports,(PK, PD, Toxicology, Genotoxicity, other studies) • Details Clinical study reports 2. For multisource generic products having a molecule(s) already registered in Ethiopia and requiring BE study, • Reports of Human PK Studies needs to be supported with actual experimental evidence and where applicable reference to literature can be considered. 9

10. 9/20/2019 Product registration in Ethiopia 3. For generic products requiring clinical equivalence study, in cases where comparative clinical evidence of a PK, BE study cannot be conducted, • Reports of Human PhD Studies 4. For Products Accepted by a Stringent Regulatory Authority. • The applicant who has submitted its application and registered its product with a regulatory authority of a member of the International Conference on Harmonization (ICH); or, Canada; Australia, Iceland and Norway; or the WHO Prequalification Program • Full information about administrative and product information and dossier overall summary and respective certificates • Due to lack of Pharmacooeconomic team there less attention given to this sector • Due to lack of human resources and facilities, the efficiency of product registration process at times is reported to be delayed. EFMHACA. Guidelines for registration of Medicines. Third Edition. 2014 Product registration in Ethiopia • Procedures for Addition of drug to national essential drug list in Ethiopia 1. Request for including drugs to EDL can be from any of relevant stakeholders. 2. NDAC consultation with technical working group composed of an internist, a nurse and pharmacists and then enriched through national consultative workshops. 3. Involving stakeholders (specialists from University and health facility). 4. During the revision process, several factors like safety, therapeutic efficacy, quality, affordability and availability were taken into consideration. 5. If NDAC technical working group and stakeholders agree on candidate drug the drug will be included in essential drug list and communicated through publications and EFDA webpage Discussion 2: Is there any advantage of having NDL and EDL in the country? Do you think that our healthcare system is able to provide to provide optimum care? Pharmaceutical promotion practices IRI • According to the 5thclause of the law of medical, pharmaceutical, edibles and potables (1955) and subsequent amendments • Prohibits announcing deceptive advertisements or those which are considered to be against technical rights, medical dignities, or public chastity by the MOH. • By the Act of Marketing and Advertisement for pharmaceuticals and biologics (2007) • Iran's MOH tries to organize marketing and promotional activities of pharmaceutical market (pharmaceuticals and biologics. • Herbal and natural medicines are exempted. 10

11. 9/20/2019 Pharmaceutical promotion practices IRI • Regarding Article 5, 6, 8 of this Act, 1. Introducing medicines is only permitted in scientific medical journals and websites. 2. Introducing medicines to medical professionals is permitted via providing free samples, brochures, catalogs, giving a speech in scientific seminars, E-mails, and also detailing. 3. The pharmaceutical institutions are allowed to employ medical representatives for introducing their products to medical professionals. 4. The bonus and incentives during the practices of presentation must be set in a way that does not motivate the target groups to violate professional principles. 5. The pharmaceutical firms’ bonuses to physicians: 1. Bonuses have to be related to treatments and could be used in favor of patients 2. Bonuses must have signs of that medicine or firm 3. Their values must not be extraordinary and should not motivate physicians to prescribe it irrationally 4. Bonuses have to be declared by the companies to the MOH every 3 months. Pharmaceutical promotion in Ethiopia • Article 4(50), sub articles 1-3 of proclamation No. 661/2009 clearly states: (1) Commercial advertisement of food, medicine or health service through mass media or other means shall be determined by directive issued by the executive organ; (2) Any mass media or advertising organ shall be obliged to respect the directive issued (3) The EFDA shall ensure the implementation of the food, medicine or health service commercial advertisement directive. Pharmaceutical promotion in Ethiopia • Pharmaceutical promotion directive of EFDA include: • Advertising prescription only drugs to the public is prohibited • Advertising of non-prescription drugs intended for the public shall be limited to poster and stickers displays and must be in accordance with law of country • Free medical samples can be used for promotional purpose only after the drug is registered and market authorized by the authority. • Samples may be provided to health personnel and It is prohibited to sell free medical samples. • The value of Promotional items , which are provided to health professionals free of charge during promotion, should not exceed 100 ETB. Discussion 3: What is your view about giving free samples for professionals during advertisement? 11

12. 9/20/2019 Substandard and counterfeit medicines • Report of counterfeit drugs report medicines by therapeutic class received in 2007 Counterfeit medicines IRI • The counterfeit medicines have also been mentioned in the law of medical, pharmaceutical, edibles and potables (1955), and subsequent amendments. • Article 18 of this law: • … counterfeit medicine is defined as any pharmaceutical product without passing the FDO regulatory process. • Practice • The Iranian pharmaceutical market is susceptible to the use of counterfeit medicines • Iran is one of the major transit routes for illicit narcotics produced in Afghanistan. • According to counterfeit medicine study out of 7910 sampled medicines 716 (9%) were found to be counterfeit. • About 21.8% could have been legally imported, because they are registered in IDL. While 64% were not existed in national drug list. Counterfeit medicines in Ethiopia • NDP under its section 7 mandates EFDA to • Establish an effective system of drug administration and control at all levels, especially by developing the capacity to ensure drug safety, efficacy and quality. • Make the necessary efforts to deter the illegal manufacturing, distribution and consumption of narcotics and psychotropic drugs. • Practice • Primary data sources revealed that • Poor quality pharmaceutical products are in the market because of in-efficiencies in pharmaceutical regulatory functions • Main factors contributing to the existence of illegal products in the market were: • Weak regulatory enforcement, poor inter-agency cooperation between law enforcing bodies and weak boarder control. 12

13. 9/20/2019 Why trafficking of counterfeit drugs? • • • • • • • • • • • • • An exceptionally profitable business Risks of Punishment are too low The lack of transnational jurisdiction and consensus Deficient health coverage systems Highly porous borders Anonymity of the internet Vulnerable supply chains Possibility of parallel import trading Populations’ lack of awareness and information Lack of means and training of players in the field Corruption Insufficient traceability and authentication of drugs Drug shortages and prices that are too high in emerging countries Discussion 4: How can we reduce drug counterfeiting and smuggling? Disciplinary investigation of professional violation • Disciplinary investigation of professional violation in IRI • According to the Act of Medical Council of Iran, in each strict, a disciplinary investigating committee consists of; • A judge, representative of forensic medicine organization, five physicians, one professional from each discipline who are responsible for investigating and judging professional violation of health-care providers. • Disciplining investigations and professional violations in Ethiopia • According to article 53, sub-articles 1-4 of Proclamation No 661/2009; licensed individuals who violate professional mandates described in the proclamation will be • Punished by imprisonment for maximum of 15 years and cash punishment maximum of 100,000 Ethiopian birr • Unless higher penalty is provided under criminal code. • There is no specific disciplinary committee Regulation of pharmaceutical trade-related aspect in IRI • Pharmaceutical-related internal property rights • Not being fully joined to the World Trade Organization, the Trade-Related Aspects of Intellectual Property Rights agreement is not signed by Iran but the World Intellectual Property Organization agreement has been accepted. • The patent, industrial designs, and trademarks registration law has also been approved by parliament in 2008 encompassing many issues • Domestic pharmaceutical companies are enjoying the production of new FDA-approved and under patent products. 13

14. 9/20/2019 Regulation of pharmaceutical trade-related aspect in Ethiopia • Patents for pharmaceutical products are granted by the Ministry of Sciences and Technology of Ethiopia. • Ethiopia is not a member of WTO and has only an observer status. • The Constitution of Ethiopia and the Investment Proclamation and the legal system protect private property. • Ethiopia is a member of Multilateral Investment Guarantee Agency (MIGA) which issues guarantees against risks to entrepreneurs that invest in signatory countries, • Ethiopia has signed Bilateral Investment Promotion and Protection Agreements as well as Avoidance of Double Taxation with many countries including India. • Ethiopia has made Free Trade Agreements with 15 countries, offering the country huge market opportunities in the USA and EU under different initiatives. Antitrust and antidumping legislation • Anti-trust laws protect the domestic producers and sustain them in markets. • Dumping occurs when a manufacturer exports its product at a price which is below the price at which the product is sold for in the market of origin. • Antitrust and antidumping legislation IRI • No unique antitrust law in Iran, but the related regulations are included in different articles of general policies of 44thprinciples of the constitution. • According to these policies, a competition committee is authorized to monitor the market environment and interfere in any case of monopoly formation. • In addition, the antidumping act was approved and implemented by the government in 2007. • Anti-trust & anti-dumping legislations Ethiopia • Ethiopia there is clear antitrust related policy in NDP, which recommends protecting the domestic producers and preventing their monopoly in local market. • With regard to anti-dumping law there is no Law for protecting exporters and there is no pharmaceutical export from the country except export of hard gelatin capsule shell by Sino Ethiopia Foreign investment industry IRI • According to the Foreign Investment Promotion and Protection Act (2002) approved by the parliament, to promote the attendance of foreign investors in Iran's market, • The total value of goods and services provided by foreign investment must be limited to 25% of the total values in that economic sector and 35% of subsector. • The foreign investments for export purposes (for industries other than oil) are exempted from this limitation. • And • To support the domestic pharmaceutical industries, a specific price scheme is applied to imported drugs. • A 3–4% tariff is added to the imported drug where there is no domestically manufactured similar drug, but the tariff goes up to 100% for those which have a similar dosage form produced in Iran. 14

15. 9/20/2019 Foreign investment in industry Ethiopia • NDP under section 7, subsections 4, 5 and 6: • Offer incentives to public and private industries involved in the production of raw materials; essential drugs and market them in their generic names. • Government procurement systems give preference to local pharmaceutical companies and offer advanced payment of up to 30% of the value of orders. • 100% exemption from payment of import customs duties and other taxes levied on imports to import all investment capital goods, such as plant machinery and equipment, construction materials, as well as spare parts up to 15% of the value of capital goods imported. • There are dedicated industrial parks for pharmaceutical manufacturing. Drug control laws and regulation in IRI • Drug control laws so far in IRI 1. Zero tolerance law after 1979-1989 2. Harm reduction (rehabilitation and treatment) • Methadone therapy for opioid addicts was restarted 2000, which was stopped in 1977 3. Raising the threshold that trigger death penalty in drug possession cases in 2018 • Systematic review conducted on smoking in Iran showed that; • The prevalence of cigarette smoking in Iran ranges from 0.4%- 41% • .. daily smoking in the whole country is 11.3% with no significant change from 1991 to 2008. • Smoking prevalence is 40% in males and 13% in female students in certain areas. • … Illicit drugs, including opium and heroin users as well as newer synthetic drug-dependent individuals reached 2-3 million in Iran • In 2017, Iranian officials claimed that the number of drug addicts in the country had doubled in the past six years alone. Golnar Nikpour. Drugs and Drug Policy in the Islamic Republic of Iran. Middle East brief. June 2018 Drug use control in Ethiopia • Proclamation no. 661/2009: Narcotic drugs, psychotropic substances and precursor chemicals: Article 4(18-22). • According to demographic health survey 2016: • Cigarette Smoking • Less than 1% of women and 4% of men smoke any type of tobacco. • The Trend of smoking is decreased by 2% in men age 15-49 from 2011 data • Smoking is associated with wealth status and (7% in poorest and 2% in richest) • Alcohol consumption • 35% of women & 46% of men reported drinking alcohol at some point in their lives. • Chewing chat • About that 12% of women and 27% of men report having ever chewed chat. • Chat consumption is inversely related to education and wealth status. 15

16. 9/20/2019 Birds eye view about Subs use Birds eye view about Subs use 16

17. 9/20/2019 Birds eye view about Subs use A graphical representation of the argument for legal drug regulation Birds eye view about subs use Education must instill the fundamental human values; it must broaden the vision to include the entire world and all mankind. My pain and my cure is from the friend. My closeness and my distance is from the friend. Should the butcher peel off my skin from my body, My soul will never depart from the friend. Baba Taher-e Oryan I have nothing to do with addiction, I deal with the fight against drugs, in this fight I confiscate their opium, I tear up their coupons; now whatever the government intends to do is none of my business. Ayatollah Khalkhali, Head of Anti-Narcotics (1980) Education has two important characteristics One is learning of a subject & skill. The other is the personality to apply this knowledge to the benefit of community. Basic components Pharmaceutical management Use Selection Procurement Distribution Managing Rational use Selection based on limited lists (NDL) Managing procurement Managing distribution Investigating medicine use Manage pharmaceutical prices Inventory management Promoting RU (Prescription, dispensing and use) Selection criteria Importation and port clearing Use of generic names Procurement methods Engage stakeholders (Community, Drug sellers Implementing and updating essential medicine lists Apply GP Practices Transport management Financial sustainability Supply chain security Medicine and therapeutic information center Waste management Pharmacovigilance 17

18. 9/20/2019 Financial sustainability Waste in pharmaceutical management and potential for improvement Accessibility related regulations • Sustainable access to medicines generally requires education, strategic management, regulation and financial protection of the public. 18

19. 9/20/2019 Good governance Medicine selection • • Rational selection and use of essential medicines Develop national treatment guidelines based on the best available evidence concerning efficacy, safety, quality, and cost-effectiveness; Develop a national list of essential medicines based on national treatment guidelines; Use a national list of essential medicines for procurement, reimbursement, training, donations and supervision. • • Advantages of a limited list of essential medicines WHO criterial for selection of essential medicines • Essential medicines are those that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in the appropriate dosage forms. • Choice depends on; • Pattern of prevalent diseases; treatment facilities; experience of personnel; financial resources; genetic, demographic and environmental factors. • Only medicines for which sound, adequate data on efficacy and safety are available from clinical studies and general use in variety of medical settings should be selected • When two or more medicines found to be similar quality and safety, the choice between them should be based on their relative efficacy, safety, quality, price and availability. • Compare total cost of treatment not only the unit cost of medicine • Affordability is considered as consequence of selection not precondition for selection • Most essential medicines should be formulated as single compounds. • Fixed-doses are acceptable if and only if there is advantage over loose-combinations Source: WHO 2007. 19

20. 9/20/2019 List of Common Health problems Choice of standard medicines and non-drug treatments Medicine List Pharmaceutical supply Procurement Donation Distribution Production Rational Medicine Use training Supervision Monitoring Drug information Treatment Guidelines List of Essential Medicines Formulary Greater availability and more ration use of medicines Common health problems guide selection, training supply and medicine use Medicine selection • Medicine selection in IRI • The mission of Pharmaceutical accessibility of safe and affordable medicines. • Selection is done by national drug selection committee • Drugs are selected from IDL Generic name of drugs are used Iran MOHME as mandated by the law of Medical and act of parliament, is to ensure the availability, • Medicine selection in Ethiopia • According NDP Drugs drug selection is done by National drug advisory committee at central level and • By Drug and therapeutics committee at facility level • Drugs are selected from IDL Generic name of drugs are used Availability of drug in IRI • Public sector availability in Iran • According to survey conducted by ministry of health in 2014 the mean availability of generics in the public sector facilities was 75.2 %. • Geographic accessibility in Iran • Geographic is mentioned in Pharmacy Act (2006). • Article 11 of this Act discusses the number of pharmacies to be established. • Based on this article, one pharmacy is permitted for every 7000 population, and for areas with more than 300,000 population, one pharmacy is allowed for every 6000 population. • Moreover, according to the 12thArticle of this Act, one 24 h active pharmacy can be established for every 65,000 urban or rural populations. • In addition, based on the law of pharmaceutical supply in deprived regions and to ensure accessibility to medical services in these areas, if there are no volunteers from private or cooperative sectors for investing to establish pharmacies, the MOH is obligated to provide such services through its own health-care units. 20

21. 9/20/2019 Availability of drug in Ethiopia • Public sector availability • The median percentage availability of medicines in the public dispensaries was found 72.4%. • The availability of program medicines was >80%. • Median availability of medicines for chronic illness was 54.55% ( WHO target of 80%) • Mean availability of essential medicines for pediatrics was 43 % • Geographic accessibility in Ethiopia • Out of 1074 exit interviewed participants, 357(33%) said that they travelled greater than an hour to access the health facility. • While 48.7% travelled greater than an hour to reach at the hospitals and 22.1% to the health centers, only 11.2% had to travel greater than an hour to the nearby PMROs to purchase medicines. • Geographic accessibility is not well addressed. Affordability of pharmaceuticals • Approaches to improve affordability • Use available and impartial price information; • Allow price competition in the local market; • Promote bulk procurement; • Implement generics policies; • Negotiate equitable pricing for newer essential medicines for priority diseases; • Undertake price negotiation for newly registered essential medicines; • Eliminate duties, tariffs and taxes on essential medicines; • Reduce mark-ups through more efficient distribution and dispensing systems; • Encourage local production of essential medicines of assured quality when appropriate and feasible; • Include WTO/TRIPS compatible safeguards into national legislation and apply. Affordability of pharmaceuticals in IRI • The affordability of medicine for all people has been considered by both health insurance mechanisms and pharmaceutical pricing regulations. . • ….. all most all medicines cost less than 1 days’ salary was needed to purchase treatments as generics • Other medicines required more i.e. clozapine (4.8), atorvastatin (4.1 days’ salary), clopidogrel (3.6), carbamazepine (3.1) and amlodipine (1.9) days’ salaries respectively. • Medicines for cancer treatment are unaffordable • Pricing regulation in Iran • In June 2011, the new Pharmaceutical Pricing Act was introduced by the FDO • The country uses mixed pricing system (reference pricing and cost-plus) with different mark up system to make drugs affordable for the community 21

22. 9/20/2019 Affordability of pharmaceuticals in Ethiopia • According to the national survey on Pharmaceutical sector • Drugs for treating infectious diseases in are reasonably affordable • Drugs for treatment of chronic illness are not affordable in both private and public facilities • Requiring days’ wages ranging from 3.56 to 6.87 in Public health facilities and • 4.69 to 17.38 in Private medicine retail outlets. • The essential medicines for pediatrics were unaffordable for treatment of common conditions. • The price of medicines varies greatly in public and private facilities with average of 36% higher in private facilities. • There is no formal pharmaceutical price regulation in the country. Supply of pharmaceuticals Supply of pharmaceuticals • Approaches to improve pharmaceutical Supply • Local production • Supply system strategies and alternatives (Mix of public and private sectors) • Procurement mechanisms • Inventory control (including prevention of theft and waste) • Distribution and storage • Disposal of unwanted and expired medicines 22

23. 9/20/2019 Procurement • Managing procurement • An effective procurement seeks to ensure availability of right medicines, of right quantities at reasonable prices and recognizable standards of quality. • Pharmaceuticals can be obtained through purchase, donation or manufacturing. • Key functions of Procurement • Selection of medicines • Quantification, • Preparations of specifications and standards • Approval of suppliers (prequalification) • Adjudication and • Award of tender Key principles of pharmaceutical procurement • • • • • • • • • • • • • • Reliable and good financial management Procurement by generic name Clear specification of recognized pharmaceutical standards Limitation of procurement to essential medicine list Increasing procurement volume by aggregating demand Formal supplier qualification and monitoring Competitive procurement (open tender) Monopsony commitment (one buyer with many sellers) Order quantities based on reliable estimate of forecasted actual need Transparency and written procedures Separation of key functions Product quality assurance program Annual audit with published results Regular reporting of procurement performance indicators Procurement cycle • The procurement cycle includes most of decisions and actions that determine the specific medicine quantities obtained, price paid and qualities of medicine received Review Medicine Selection Reconcile needs and Funds (VEN, ABC) Determine quantities needed Collect consumption Information Choose procurement method Distribute Medicines Procurement cycle Locate and Select Supplier Make Payment Receive and Check medicines Specify Contract Terms Monitor order Status 23

24. 9/20/2019 Procurement environment Common procurement bottlenecks Step I. Supply Planning Inaccurate or omitted plan Budget cycle timing does not match the funding cycle Requisitions not submitted on time Inadequate or missing specifications Specification changes made after purchasing procedures are initiated Mid-term budget cuts; programmed funds withheld II. Purchasing Activity Problems with advertising Bid deadline extended to accommodate amendment of bidding documents Slow approval process Protests by losing bidders Cancellation of bid III. Contract Performance Overbooked manufacturing schedule Shipping problems Slow processing of documents No access to funds for port fees Irregularities in goods or documents Pharmaceutical registration issues Bottleneck Slow contract planning by procurement unit Raw materials shortage Quantification • Quantification answers, “How much should be procured and when should it be delivered?” • Need of quantification: • To ensure that drugs are available to treat the expected case • To promote & maintain the rational & economic use of drugs • To determine the right amount of drug products required. • Proper drug quantification avoids. • Overstocks, Stock outs and Shortage of the drugs • Methods of quantification • Consumption methods • Morbidity • Population method • Proxy consumption method 24

25. 9/20/2019 Issues to consider in quantification • Preparing an action plan for quantification • Using centralized or decentralized quantification • Using manual or computerized quantification process • Estimating the time required • Developing and organizing medicine list • Filling the supply pipeline • Estimating the procurement period • Considering the effect of lead time • Estimating safety stock • Adjusting for Losses and other changes • Cross checking the results of quantification • Estimating total procurement costs • Adjusting and reconciling final quantities • Preparing for possible program expansion (Scale-up) Steps in quantification 1. Describe the problem 2. Define the Scope, Purpose, and Timeframe of the Quantification Cadjusted for SO =??????????? ? ?????? ?? ??????????? ?????? ?? ????? 3. Collect Required Data for quantification Period in stock= Period in calculation – Stock Out period Calculated consumption = Beginning balance + Quantity received during the year ± Loss adjustments – Ending balance Loss adjustment = positive if the facility gains or receives the product or services (e.g. borrowing from other facilities, receiving from non-regular sources) Loss adjustment = negative if the facility losses the product (e.g. loan to other facility, expiry, damage or breakage, theft, etc…) 1. Services data 2. Logistics data 3. Demographic data 4. Data aggregation 5. Adjustment for stock outs Quantification methods 25

26. 9/20/2019 Managing procurement • Impact of Hidden cost on Total Cost Procurement methods 1. Open tender (Complex and cheap) 2. Restricted tender (pre-qualification) 3. Competitive negotiation (Buyer has bargaining power) 4. International or Local Shopping (No bargaining Power) 5. Direct Purchase (simplest and expensive) 6. E-Procurement (Internet based tendering) 7. Reverse auction (Variation of restricted tender on Internet) What are factors that can affect price of Pharmaceuticals: method, reorder frequency, volume, number of suppliers, duration of contract Managing procurement Quality assurance of Pharmaceuticals Ensuring quality of procured drugs important to protect patients form unwanted harms (toxicity, treatment failure, cost) and ensure public trust on health systems • Determinants of pharmaceutical quality 2. 3. 4. 5. 6. 7. 8. External Packaging Shipment and port conditions Warehouse conditions Transportation conditions Storage conditions Dispensing conditions Patient handling and use 1. Pharmaceutical production • Manufacturing process • Equipment and maintenance • Plant environment (temperature, humidity, cleanliness) • Pharmaceutical formulation (Active ingredients & additives) • Quality control • Immediate packaging Managing procurement • Key elements in Quality assurance of pharmaceutical procurement 1. Product selection (longer shelf-life, Avoid Products with stability problems if possible) 2. Product certifications (Pre-qualifications and GMP inspections, certification of pharmaceutical products, batch certificates) 3. Contract specifications (acceptable standards, labeling and packaging requirements) 4. Inspection of shipments (physical inspection of all shipments and sampling for analysis of suspected products) 5. Targeted laboratory testing (therapeutically critical drugs, BA problems, New suppliers, suppliers with quality difficulties in the past) 6. Product problem reporting system 26

27. 9/20/2019 Distribution management • Goal of distribution management • The primary goal of distribution management is to maintain steady supply of pharmaceuticals and supplies to facilities where they are needed while ensuring that resources are used in the most effective way. • A well-run distribution system should:- • Constant supply of medicines • Keep medicines in good condition • Minimize medicine losses caused by spoilage and expiry • Rationalize pharmaceutical storage points • Use available transports as efficiently as possible • Reduce theft and fraud • Provide information for forecasting medication needs • Incorporate quality assurance programs Typical pharmaceutical distribution system Distribution cycle Pharmaceutical Procurement Consumption Reporting Port clearing Dispensing to Patients Receipt and Inspection Distribution Cycle Inventor control Delivery Storage Requisition or Allocation of suppliers 27

28. 9/20/2019 Comparison of delivery and collection systems Design characteristics of distribution system Basic design features • In designing a distribution system or redesigning an existing system, the following important steps have to be considered 1. Determine number of storage levels in the system 2. Determine the location of storage sites 3. Decide at which level of the supply system decisions will be made concerning orders 4. Fix resupply intervals or frequency of placing orders 5. Select a collection or delivery methods for distributing medicines for user points 6. Select an appropriate mode of transport 7. Define the amount of inventory to be held at each level in the system 8. Develop a set of feasible and economical routes and develop a practical delivery schedule 9. Estimate the operating cost and assess the cost-effectiveness of contracting for storage and transport at one or more levels 10. Establish a warehouse management system based on set of SOPs 28

29. 9/20/2019 Distribution systems …. • Approaches to design level of distribution system Design Depends on • Geography • Population • Availability of storage space • staff • Availability and cost of transport • Political and other resource constraints • Diagram the existing system • Diagram three or four feasible alternative hierarchies • Estimate for possible values of factors (management complexity, Setup cost, operation cost, holding costs, delivery time etc.) • Diagram the current and proposed information flows • Select and implement the system that provides the best quality service with available funds Types of distribution systems • Based on which level of the system orders medicine Distribution system Definition Favoring environment • • Pull system This is also called the independent system or requisition system Each level of the system determines what is needed and at what quantity and places order to supply sources Lower level staff are competent in assessing and managing inventory Sufficient supplies are available A large number of product is being handled Field staff members are regularly evaluated and monitored Good data are available to decision makers • • • • • • • • • Push system It is also called allocation or rationing system Supply system at some level determines what quantities of medicines will be delivered to the lower level Delivery plan is made at the beginning of the planning period Lower level staffs are not competent Demand exceeds that supply A limited number of product is handled Disaster relief is needed or in satiation of short- term supply through kits • Distribution systems …. • Re-supply interval • It determines safety stock and maximum stock • Optimum re-supply interval should avoid stock-outs and minimize costs • Depends on: • Storage capacity at each level of the system • Availability, order size, Carrying capacity and transportation cost • Seasonal factors that influence transport reliability • Staffing level and competence at each level of the system • Other factors ( expiry, security against pilferage, cash flow etc.) 29

30. 9/20/2019 Distribution systems …. Comparison of three and four level distribution system Distribution systems …. Flow of Pharmaceuticals and Information in the Integrated Pharmaceutical Logistics System(IPLS) in Ethiopia Supply of pharmaceuticals IRI • Procurement system in Iran • In Iran the procurement system is identical between the public and private sectors. • All pharmacies in all sectors obtain their medicines from the same distributors. • Except for vaccines and a few medicines for rare diseases there is no centralized bulk purchasing or specific procurement system for public health facilities. • All responsibilities are differentiated in the pharmaceutical supply chain; the importers and the producers supply their medicines after registering them with the Iran Food and Drug Administration. • All pharmacies purchase from officially registered distributers and any direct relationship between pharmacies and importers or producers is prohibited. • Iran has implemented Pharmaceutical tracking and tracing system to ensure visibility of pharmaceuticals and in the supply chain. • In Iran, 96% of the medicine is produced locally and only 4% is being imported. However, in terms of value, 55% of the market belongs to local producers and 45% to the import market. 30

31. 9/20/2019 Supply of pharmaceuticals in Ethiopia • NDP of the country in section 2 describes drug supply related issues: • Procurement system in Ethiopia • Public sector procurement is pooled at the national level and PFSA at Federal Ministry of Health is responsible for public sector medicines procurement and distribution. • The procurement system is International competitive tender (85.8%), National competitive tender (11.93%) and Negotiation/direct purchasing (2.26%). • The procurement is overseen by a tender board/committee. • Public sector medicines procurement is based on the WHO’s prequalification system, • PFSA procures • Pharmaceutical that are registered by EFDA and • Products registered by Stringent regulatory agency, WHO Prequalified, and manufactured by EFDA GMP inspected manufacturers are procured by PFSA. • Inventory control is done by using IPLS and APTS • In terms of quantity, the industries cover only 15 percent of the national medicine demand. Pharmaceutical supply strategies • Systems for pharmaceutical supply can be described in terms of public and private role in financing, Whole sale distribution and retail distribution; • Fully public • Private supply to government heath services • Social health insurance system: Public funding from central budget and refunded from reimbursement premiums • Private financing and public supply: State supplies but paid by patients out of pocket • State whole sale monopoly: State supplies both private and public facilities • Fully private: Patients pay the whole cost of medicines and by them from retail pharmacies • Issues related leaving the pharmaceutical supply entirely to private market ( Equity, Information failure, Competition failure and Externalities) Rational use of medicines • Rational use of medicines is one of the pillars of National drug policy. It involves the entire process of medicine movement (i.e. from raw material production to clinical or patient use). • RU= Appropriate indication; Appropriate medication (quality, safety and efficacy and cost); Appropriate dosage, Appropriate patient, correct dispensing and patient adherence to treatment • Irrational Use= no medicine is needed, Wrong medicine, ineffective medicine, unsafe medicine, under use of effective medicines, over use • Impact of Irrational medicine use: AMR, Treatment failure, Increased cost, reduce patient trust on health system 31

32. 9/20/2019 Factors contributing to Irrational use: what factors are going to promote the rational drug use? Intervention strategies to improve medicine use 32

33. 9/20/2019 Framework for improving medicine use Regulatory measures to support rational use • Registration of medicines • Limiting prescription of medicines by level of prescriber; • Setting educational standards for health professionals and enforcing codes of conduct • Licensing of health professionals • Licensing of medicine outlets retail shops • Monitoring and regulating medicine promotion. Core interventions to promote more RU of medicines 1. A mandated multi-disciplinary national body to coordinate medicine use policies 2. Clinical guidelines 3. Essential medicines list based on treatments of choice 4. Drugs and therapeutics committees in districts and hospitals 5. Problem-based pharmacotherapy training in undergraduate curricula 6. Continuing in-service medical education as a licensure requirement 7. Supervision, audit and feedback 8. Independent information on medicines 9. Public education about medicines 10. Avoidance of perverse financial incentives 11. Appropriate and enforced regulation 12. Sufficient government expenditure to ensure availability of medicines and staff Potential benefits of STGS 33

34. 9/20/2019 Investigation medicine use Examine Measure the existing practice Diagnose Identify problems and causes Investing Medicine Use Follow up Measure outcomes Treat Design and implement intervention Source of quantitative medicine use data WHO medicine-use-indicators (outpatient facilities 34

35. 9/20/2019 Rational use of medicines IRI • Prescription Survey Committee Act (1996), several committees have been established in each province with the aim of improving the quality of medical services, reducing the irrational drug use, and facilitating medical and pharmaceutical planning. • Each committee monitors the prescriptions and uses audit measures to improve prescription patterns of physicians. • Practice • Different studies revealed the following: • Reduction in injections and antimicrobials use by about 16% in the past 10 years. • Increased Corticosteroids use by 10 % from 13% to 23% in 2013. • Qualitative and quantitative insufficiencies of prescription. • The quantitative insufficiencies; the high level of items in each prescription (3.5 items). • The qualitative issues include; drug interactions, illegible prescriptions etc. • Low utilization of diabetes medicines, perhaps due to under diagnosis and inadequate management of patients with diabetes. Rational use of medicines Ethiopia • Proclamation no. 2661/2009 under article 4(14): gives mandate to ensure Quality Standards and Appropriate Use of Medicine and article 4(39): describes requirements for Prescribing and Dispensing of Medicines • Practice • Availability of tools and services is below 70%, For example: • Availability of Medicine information services (33.3%) • Implementation of IPLS (63.89%). • Average number of medicines per-prescription was 2.25, and 99.67% from EML • Adequacy of labeling practice 19.9% (ranged from 1.78% to 52.63%) • Prescribers in public health facilities were found prescribing an antibiotic to 73.89% of patients of any age with non-pneumonia ARI. Discussion: Is Antimicrobial resistance revisiting the “tragedy of the commons”? Financial strategies for medicines • Financial risk protection is one important strategy of achieving universal health coverage agenda under sustainable development goals. • Approaches to enhance financial risk protection includes: • Government involvement in pharmaceutical market; • Using different financing mechanisms (public, user charge, HI, Donor) • Taking appropriate measures to improve efficiency and cost-effectiveness • Increase public funding for health, including for essential medicines; • Reduce out-of-pocket spending, especially by the poor; • Expand health insurance through national, local, and employer schemes; • Target external funding grants, loans, donations at specific diseases with high public health impact; • Explore other financing mechanisms, such as debt-relief and solidarity funds. 35

36. 9/20/2019 Financial strategies for medicines in IRI • The provision of medicines throughout the supply chain across the country are monitored and regulated by the pharmaceutical procurement office in the Iran FDA. • Price regulation • Mixed Price regulation systems (i.e. Cost-plus and international reference pricing). • Health insurance • Health insurance system covers about 90% of the population. • The Insurance covers 90% and 70% of the cost of medicines on the Insured Drug List (a subset of the registered list) for inpatients and outpatients, respectively. • Treatment costs for certain illnesses are fully covered by the MOH, such as HIV/AIDS, malaria, tuberculosis and routine vaccines. Certain medicines are also subsidized by the government (patients pay less than 3% of the cost). Financial strategies for medicines in Ethiopia • No formal price control system. • Health care financing reform which allowed revenue retention and use, which has placed facilities in the competitive environment and led to increased price of pharmaceuticals. • Medicines are provided free of charge for patients with malaria, tuberculosis, sexually transmitted diseases, HIV/AIDS and vaccines and for those in extreme poverty • Health insurance system • Immature and young to contain cost related to pharmaceuticals in Ethiopia. • Currently the government started CBHI for informal workers as pilot in some regions • the contribution of the existing health insurance mechanisms to medicine financing pool is insignificant Human resource development • Enabling, empowering and motivating human resource is key for achieving the desired outcomes. • The role of government • Planning and overseeing training and development of human resources for the pharmaceutical sector • Human resource management and development plan • Education, training and courses, including minimum requirement of each discipline • National and international collaboration networks • Motivation and continuing education • Ethical framework and code of conduct 36

37. 9/20/2019 Human resource development • Human resource in Pharmaceutical sector in Iran • Human resource in IRI is well equipped with knowledge and technical skills • There are currently 0.2 pharmacist /1000 population • Human resource in Pharmaceutical sector in Ethiopia • Manpower Training and Utilization is stated in NDP with weak effort to implement it. • There is shortage with 2.38 pharmacists/ 100, 000 population • There is also technical capacity constraints and urban/rural and regional disparities, poor motivation, retention and performance. Monitoring and evaluation • Monitoring and evaluation • Responsibilities and commitment • Baseline survey of the whole country • Indicators for monitoring • Periodic monitoring • Independent external evaluation every two to three years • Monitoring and Evaluation in Iran • ……closely monitored under MOHME by IFDA and its subcommittees • Monitoring and evaluation in Ethiopia • Pharmaceutical sector at national level is monitored by law to EFDA and at regional level by Regional regulatory bodies Pharmaceutical research • Pharmaceutical production • Primary production • Production and preparation of raw materials/active ingredients • Secondary production: Production of finished product (tab, caps) • Tertiary production: Labelling and packaging • Issues that affect local production decisions • Human and physical infrastructure • Market factors • Regulatory and legal provisions • Economic incentives and disincentives • Duties and import controls • Collaboration and public-private partnerships HOW TO DEVELOP NATIONAL DRUG POLICY 111 4/18/2019 37

38. 9/20/2019 Pharmaceutical research in IRI • Research • Operational research and Pharmaceutical development and clinical research • Iranian pharmaceutical system has well developed research center for both basic and operational researches. • The basic research center is working on synthesis of basic active substances for most of health problems. For example, Design, Synthesis and Cytotoxic agents, Anticonvulsant and Anti-platelets. • Similarly operational research in IRI involves all sectors of pharmaceutical services including, distribution system, and rational drug use and pharmacoeconomicevaluation of the new therapies. • The Iranian pharmaceutical sector is well integrated with teaching universities in the country. • Most of the basic researches are conducted by professors in the teaching universities. https://www.researchgate.net/journal/1735-0328_Iranian_journal_of_pharmaceutical_research_IJPR Pharmaceutical sector research in Ethiopia • Research and Development is clearly stated under NDP: However • The pharmaceutical production is at infancy stage and until now there is no research and development of new active substances as well as production of pharmaceutical starting materials. • There is no drug development research and no active pharmaceutical production in the country despite rich biodiversity. • There are number of operational researches which are contributing to development the sector. For example: • Paradigm shift of pharmacy program from product based to patient focused care in 2009; • Introduction of CBHI system after reports of unaffordability of health care reports • The integration of pharmaceutical sector and Universities in Ethiopia is poor, only with a few contribution from Addis Ababa University for operational and policy related research activities Technical cooperation • Technical cooperation in IRI • Technical cooperation and Information sharing among countries is important for developing pharmaceutical sectors. • The intersectional collaboration in the highest political level for policy making in the health system has gained some success with establishment of the higher council of health under direct supervision of the president. • There is good integration of MOH and Universities under MOHME. • Technical cooperation in Ethiopia • National, Regional and International Relations: NDP (12) • National, regional and international relations shall be established with the aim of strengthening and expanding the sector. • Ethiopia has good alignment and harmonization within country, among countries • There is Weak integration of pharmaceutical sector with Industry. 38

39. 9/20/2019 Lessons Ethiopia should learn from IRI 1. Self-sufficiency and Domestic production 2. Ensuring affordability 3. Strengthening quality control 4. Securing supply chain 5. Health insurance 6. Pharmaceutical price control 7. Enhancing basic pharmaceutical research 8. Empowering university industry linkage 9. Introducing pharmacoeconomic evaluation 10. Enhancing availability of STGs and formularies Conclusion • In general Pharmaceutical laws and legislations in IRI are up-to-date and responsive to the current needs of the population. • Pharmaceutical policy, law and legislations of Ethiopia are comprehensive with little effort to implement them. • The NDP needs to be updated to respond the current changes in the sector Like, establishment of social insurance system, introduction of tracing and tracking system etc. • Ethiopia should work to improve domestic production and basic pharmaceutical research • Ethiopia should consider regulation of pharmaceutical price in the market to improve affordability and • Enhance availability of tools and systems to improve rational drug use and encouraging prescribers to adhere to STGs References • The following documents concerning IRI and Ethiopia were used: • Constitution • Health policy • Drug policy • Proclamations and legislations • Guidelines, directives and manuals • National pharmaceutical sector surveys • Operational and basic researches 39

40. 9/20/2019 Thank you very Much! 40