Pharmaceutical Regulatory Framework In Ethiopia: A .
Pharmaceutical Regulatory Framework Sultan S. et al259ORIGINAL ARTICLEPharmaceutical Regulatory Framework in Ethiopia: A CriticalEvaluation of Its Legal Basis and ImplementationSultan Suleman1,2, Abdulkadir Woliyi3, Kifle Woldemichael4, Kora Tushune5,Luc Duchateau6, Agnes Degroote2, Roy Vancauwenberghe7#, Nathalie Bracke2,Bart De Spiegeleer2ABSTRACTBACKGROUND: Effective and enforceable national regulations describing the manufacture and(re)packaging, export and import, distribution and storage, supply and sale, information and pharmacovigilance of medicines are required to consistently ensure optimal patient benefit. Expansion ofpharmaceutical industries in many countries with advancement in transport technologies facilitated notonly trade of genuine pharmaceutical products but also the circulation of poor quality medicines acrossthe globe. In Ethiopia, even though “The Pharmacists and Druggists Proclamation No 43/1942” wasused to regulate both the professions and the facilities where they were practiced, comprehensiveregulation of the pharmaceutical market was introduced in 1964 by a regulation called “PharmacyRegulation No. 288/ 1964”. This legislation formed the legal basis for official establishment of drugregulation in the history of Ethiopia, enabling the regulation of the practice of pharmacists, druggistsand pharmacy technicians; manufacturing, distribution, and sale of medicines. In June 1999, a newregulation called the “Drug Administration and Control Proclamation No. 176/1999” repealed mostparts of the regulation 288/1964. The law established an independent Drug Administration and ControlAuthority (DACA) with further mandate of setting standards of competence for licensinginstitutions/facilities. DACA was re-structured as Food, Medicine and Health Care Administration andControl Authority (EFMHACA) of Ethiopia by the “Proclamation No. 661/2009” in 2010 bearingadditional responsibilities like regulation of food, health care personnel and settings. The mere existenceof this legal framework does not guarantee complete absence of illegal, substandard and falsifiedproducts as well as illegal establishments in the pharmaceutical chain. Therefore, the objective of theresearch is to assess the pharmaceutical regulatory system in Ethiopia and to reveal possible reasons fordeficiencies in the pharmaceutical chain.METHODS: An archival review, an in-depth interview of key informants and an institutions-basedcross-sectional survey study were conducted during March to April 2013. The comprehensiveness of thepharmaceutical law to protect public health relative to three selected African countries (South Africa,Tanzania and Uganda) and European Union, and implementation was assessed.RESULTS: The study revealed that Ethiopia does have a written national drug policy upon which theMedicines Regulatory Proclamation 661/2009 is based. According to this proclamation, the EthiopianThe Food, Medicines and Healthcare Administration and Control Authority is mandated to execute theregulatory activities as per the council of ministers regulation 189/2010. The legal framework for1School of Pharmacy, Jimma University, Jimma, EthiopiaDrug Quality and Registration (DruQuaR) Group, Faculty of Pharmaceutical Sciences, Ghent University, Ghent,Belgium3Food, Medicine and Healthcare Administration and Control Authority (FMHACA), Addis Ababa, Ethiopia4Department of Epidemiology, College of Health Sciences, Jimma University, Jimma, Ethiopia5Department of Health Service Management, College of Health Sciences, Jimma University, Jimma, Ethiopia6Department of Physiology and Biometrics, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium7Federal Agency for Medicines and Health Products, Brussels, BelgiumCorresponding Author: Sultan Suleman1, Email: sultan.suleman@ju.edu.et#Deceased and this manuscript is a tribute to him2
260Ethiop J Health Sci.Vol. 26, No. 3May 2016pharmaceutical regulation of Ethiopia was founded to fulfill all the medicines regulatory functionspotentially enabling to combat illegal, substandard and falsified medicines and illegal establishments.Moreover, all the key informants witnessed that the government is commited and proclamation 661/2009is comprehensive, but they stressed the compelling need of regulatory tools for effective implementation.From the institution-based cross-sectional study, it was revealed that there exist illegal sourcesformedicine in the pharmaceutical market. The main reasons for their existence were regulatory factorsincluding weak regulatory enforcement (64.5%), lack of informal market control (60.8%), weak portcontrol (50.0%), and poor cooperation between executive bodies (39.6%); and resource constraint(27.8%), which is an institutional factor.CONCLUSIONS: From legislative point of view, the medicines regulatory framework in Ethiopia fulfilsall regulatory functions required for effective medicines regulation. However, the existence of thelegislation by its own is not a guarantee to prevent the existence of unauthorized/illegal medicine sourcessince this requires effective implementation of the legislation, which is in fact affected by thegovernments political commitment, resource and intergovernmental ubstandard/falsified medicines and sources, EthiopiaDOI: The fundamental purpose of medicine regulationis to protect public health and to ensure thatmedicines on national markets and in internationalcommerce are safe, effective and of good quality,and used in accordance with good practices.Medicines are important aspects of public healthand must be available and accessible to the public.To improve access to medicines, good governanceis crucial and contributes to health systemsstrengthening. Good governance in thepharmaceutical sector refers to the formulationand implementation of appropriate policies andprocedures that ensure the effective, efficient andethical management of medicine regulation, in amanner that is transparent, accountable andfollows the rule of law (1-4).Sincethemid-1930s,manynewpharmaceutical products have flourished and tradein the pharmaceutical industry has taken oninternational dimensions. However, the circulationof toxic, substandard and counterfeit drugs on thenational and international market has increased.This is mainly due to ineffective regulation ofproduction and trade in pharmaceutical products inboth exporting and importing countries. The use ofthese poor quality medicines may also threaten thehealth and lives of patients (5). WHO estimatesthat from one million deaths that occur frommalaria annually, 200,000 would be avoidable ifthe medicines available were effective, of goodquality and used correctly. A study conducted inSoutheast Asia in 2001 revealed that 38% of 104anti-malarial drugs on sale in pharmacies did notcontain any active ingredient and resulted in anumber of preventable deaths (6). Moreover, inefficiencies in medicines regulatory system candelay entry of needed medicines in a market;hence, a barrier to access for users and to theprofits and growth of the pharmaceutical business(7).According to WHO, about 20% of countrieshave well-developed and operational medicinesregulation. Of the rest, approximately half haveregulation of varying capacity and level ofdevelopment, and 30% have either no or verylimited medicines regulation; revealing that manylow-income countries cannot ensure safety,efficacy and quality of medicines circulating ontheir markets. The problems of ineffectiveregulation have global implications (8) andminimum requirements for effective medicinesregulation should exist in any country to counterpoor quality medicines (9).The situation is severe in sub-SaharanAfrican countries where there are limitedresources and pharmaceutical manufacturingcapacity with a high disease burden. Thus,parallel, unregulated medicines markets are posingserious risks for individual and public health (10).As far as Ethiopia is concerned, there is nocomprehensive evaluation of the basic medicinesregulatory framework and associated unregulatedmedicines and their sources.
Pharmaceutical Regulatory Framework Ethiopia is one of the sub-Saharan Africancountries where the pharmaceutical sector is beingguided by a national medicine policy (11). “ThePharmacists and Druggists Proclamation No43/1942” was the basis for pharmaceuticalregulation where both pharmacists and druggiststogether with the facilities where they practicedwere regulated. Comprehensive regulation of thepharmaceutical sector was started in the earlystages by a regulation called “PharmacyRegulation No. 288/ 1964”, which formed thelegal basis for official establishment of drugregulation in the history of Ethiopia. ThePharmacy and Laboratory Department under thethen Ministry of Health was responsible formedicines regulation until June 1999 when a newregulation called the “Drug Administration andControl Proclamation No. 176/1999” waspromulgated on 29 June 1999. Following thisproclamation, the regulatory component of thePharmacy Department was transformed to anindependent Drug Administration and ControlAuthority (DACA) of Ethiopia in September 2001(12). DACA was re-structured as Food, Medicineand Health Care Administration and ControlAuthority (EFMHACA) of Ethiopia by“Proclamation No. 661/2009” in 2010 bearingadditional responsibilities like regulation of food,health care personnel and settings (13).The rapid growth and development ofpharmaceutical sector after the downfall of theDergue regime in Ethiopia has led to the majorityof pharmaceuticals and medical supplies beingprovided by both the public and private sectors.Currently, there are 32 plants (small and largescale) involved in the manufacturing ofpharmaceuticals and related products of whichonly 12 are manufacturers of generic finishedpharmaceutical dosage forms. The remaining areinvolved in the small scale manufacturing ofmedical devices, supplies, laboratory reagents,cosmetics, and disinfectants (14). According toEFMHACA website (www.efmhaca.gov.et), thereare 133 importers, 272 wholesalers, 377pharmacies, 1699 drug shops and 1392 rural drugvenders currently existing in Ethiopia.Some primary data sources reveal that poorquality pharmaceutical products are in the marketbecause of in-efficiencies in pharmaceuticalregulatory functions in Ethiopia (15). In the pastfew years, more than 60% of foreignSultan S. et al261manufacturers have failed to comply with GMPand hence marketing authorization (16). In thearea of post-registration testing, low incomecountries tended to collect fewer samples andreport higher rates of products failing testing (17).For example, the result of trend analysis on thequality control laboratory tests carried out inEthiopia for samples submitted from the year2007-2011 shows that most failures of samplessubmitted for post-marketing surveillance (PMS)was higher (9.5%-15.5%) than samples submittedfor the purpose of marketing authorization (4.7% 10.7%) (16). Such public health problems shouldthus be investigated through critical evaluation ofthe legal basis and implementation of thepharmaceutical regulatory framework in Ethiopia.Regular regulatory systems assessment isimportant for the policy makers in designing orupdating policies and strategies to prevent publichealth from medicines whose safety, efficacy andquality are not ensured and authorized to circulatein the market. The legal basis of the existingpharmaceutical regulatory system in Ethiopia wascritically reviewed in comparison with relativelygood regulatory systems of three African countries(South Africa, Tanzania and Uganda) and thecurrentEUregulatorysystem.Thecomprehensiveness of the legislation to protect thepublic health was critically evaluated and itspractical implementation was assessed throughinstitution-based cross-sectional survey.METHODS AND MATERIALSThe study was conducted to critically assess thelegal framework of the pharmaceutical regulatorysystem based on Proclamation No.661/2009 andits implementation status on the institutionsregulated under the national medicine regulatoryauthority of Ethiopia. An archival review, in-depthinterviews (with key informants selected frominstitutions involved in the pharmaceutical sector)and institution-based cross-sectional survey usingsemi-structured questionnaires developed based onWHO guideline were used to gather data (18,19).A critical review on the drug regulation wasundertaken followed by semi-structured interviewswith key informants from academia, industry andEFMHACA to supplement information gatheredfrom the legal sources.
262Ethiop J Health Sci.For the review process, archival review guide wasused as a data collection tool. The tool wasdeveloped based on WHO guideline (20) andcontains detail description on the general contentof the medicine legislation and a checklist for thefunctions of the medicine regulatory authority asevaluation points. The basic purpose forrecord/archival review was to assess thecomprehensiveness of the legal framework toprotect public health in comparison to medicineregulatory authorities (MRAs) of three selectedAfrican countries (South Africa, Tanzania andUganda) and EU’s European Medicines Agency(EMA). According to a study conducted by WHOin 2006, South Africa had a “fully functional”MRA, where as Uganda had a “functional” MRA.The study further reported that the MRA ofTanzania and Ethiopia had “potential for effectiveregulation” (21). Therefore, the selection of thethree African countries was based on this literaturewhile EU was selected for its strict medicineregulatory system.The review process further assessed theavailability of basic resources to implement themedicines law in relation to marketingauthorization/regulatory approvals and regulatoryinspections/enforcement in Ethiopia. Overall,records on legal framework, resource forimplementation and implementation reports inprotecting public health were assessed. Financialand human resource documents, registry forregulatory approval/marketing authorization ofmedicines, breaches of the law related tounauthorized medicines and their sources, and theassociated regulatory measures taken on violationsin comparison to penalties provided in thelegislation and guidelines were the other focusareas in the record review. Moreover, referenceson quality of products from the national marketwere included.The purpose of in-depth interview was to getdetails and new insights from the right sources. Atotal of 12 key informants selected from differentinstitutions in Ethiopia (EFMHACA, customauthority, Ethiopian pharmaceutical pharmaceuticals manufacturers association andacademia) were interviewed. In-depth interviewswere conducted with individuals selected based ontheir involvement in the regulatory system, and/orrole as a representative of an industry orVol. 26, No. 3May 2016stakeholder group. Interviewees were based withindifferent institutions and from various disciplines:pharmacy, law, chemistry, food technology andmanagement. Several of the individualsinterviewed were expert participants with workexperience of more than 20 years while theminimum work experience was 10 years. Points ofinterview included: (1) the problems related tosafety, efficacy and quality pharmaceuticals in themarket; (2) government’s political commitment atdifferentlevels;(3)adequacyandcomprehensiveness of the current legal provisionin addressing all the pharmaceutical regulatoryactivities; (4) the capacity and organization of theregulatory system at various levels in terms ofresources and regulatory infrastructures; (5)cooperation and collaboration between thesemedicine regulatory bodies at different level andtheir collaboration with other law enforcingagencies such as customs, police and judiciarybodies; and (6) the public support for medicineregulation particularly in reporting illegalmedicines circulation.Institutional-based cross-sectional surveywas conducted to assess the implementation ofthose regulatory functions described in ed based on WHO guideline containingpersonal information, details of generalinformation on medicines regulation, andunauthorized sources and/or products if any wasused to collect data. The institutions-based crosssectional study was conducted during March toApril 2013 to assess the existing regulatory systemand its implementation status in Ethiopia. Thesource population consisted of all pharmacyprofessionals working in EFMHACA andinstitutions regulated by EFMHACA. Selectedpharmacy professionals from EFMHACA withwork experience of two years and above as well astechnical managers and marketing personnel of theregulated institutions were included in the study.There were 346 institutions regulated byEFMHACA, from which a sampling frame of 30%(n 105) was randomly selected for the study.From each of the 105 institutions, two studyparticipants were purposively selected. Out of atotal of 84 pharmacy professionals in EFMHACA,52 participants were included. One hundred andninety-seven technical and marketing managers
Pharmaceutical Regulatory Framework participated in the study, making the total number249.Quantitative data were edited, coded, andanalyzed using SPSS Statistics version 16.0software. Descriptive analyses were conductedand outputs were presented using frequency tablesand charts. The data obtained from keyinformants’ interview were summarized, analyzedand presented in a descriptive way per thematicarea. Similarly, summaries were made from thearchival review findings on the critical features ofmedicine regulation. A multivariable logisticregression was used to investigate the relationshipbetween the different reported factors for theexistence of illegal pharmaceutical business.RESULTSThe legal basis of pharmaceutical regulation inEthiopia: archival reviewLegal framework: An overview of medicinesregulatory framework in Ethiopia, Tanzania,Uganda, South Africa, and EU is presented inTable 1, while the legal framework of therespective medicine regulatory authorities ispresented in Table 2. For all the countries, thereexists a well-defined law for medicine regulationwith clearly articulated objectives of protectingpublic health from unsafe, inefficacious and poorquality medicines. The medicine legislation ofEthiopia is based on proclamation 661/2009 withthe objective of safeguarding and protecting thepublic health through ensuring that all medicines(produced locally or imported) that circulate in themarket and used in the country are safe, effectiveand consistently meet the acceptable roclamations, while regulations are approved byCouncil of Ministers similar to that of Tanzania,Uganda and South Africa. In EU, legislations anddirectives are all approved jointly by the EuropeanParliament and the Council of EU.Governing body: A good medicines law createsadministrative governing bodies to put rules in topractice (22). In all the studied countries(Ethiopia, South Africa, Tanzania, Uganda andEU), medicine legislations ensure legal provisionsSultan S. et al263for the establishment of a governing body calledMRA responsible for enforcing the legislation.EFMHACA is empowered by the Council ofMinisters Legislation 189/2010 as the governingbody for medicine regulation in Ethiopia with itsorganizational structure presented in Figure 1.Food and Drugs Administration (TFDA), NationalDrug Authority (NDA) and Medicine ControlCouncil (MCC) in Tanzanian are the executiveorgans to enforce medicines law in Tanzania,Uganda and South Africa, respectively. TheEuropean Medicines Agency (EMA) isresponsible for enforcing medicines law in EU.The overall responsibility and accountabilityfor all aspects of medicine regulation is given to asingle agency in Tanzania, Uganda
6Department of Physiology and Biometrics, Faculty of Veterinary Medicine, Ghent University, Merelbeke, Belgium 7 Federal Agency for Medicines and Health Products, Brussels, Belgium Corresponding Author: Sultan Suleman 1 , Email: sultan.suleman@ju.edu.et
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