Challenges And Prospects Of The Regional Bioequivalence Center Initiative In Ethiopia A Qualitative Study.

Background: Evaluation of the interchangeability of multi-source generic drug products or bioequivalencernrnstudy has become a crucial activity since the share of generic medicines inrnhealthcare has enormously grown over the past few decades. Among four East African Countries,rnrnnamely, Ethiopia, Kenya, Uganda and Tanzania, there has been an initiative to establishrnan accessible and affordable BE center for the regional pharmaceutical manufacturers. Thisrnstudy aims at assessing the challenges and prospects of the bioequivalence center initiative inrnEthiopia. rnMethods: In-depth interview was conducted with individuals who were Ethiopian affiliates of thernRegional Bioequivalence initiative; local pharmaceutical manufacturers, Ethiopian Food andrnDrug Administration, Regional Bioequivalence Center and other key stakeholders who are involvedrnrnin the center capacity building. Data were collected using digital voice recorders, andrntranscribed. These data were analyzed using an inductive thematic analysis using Nvivo softwarernand the findings were presented in narratives using the respondent‟s own words as illustrations.rnResults: Based on the findings, four major themes, one as an opportunity and three as challenges,rnwerernidentified.rnThernmerernpresencernofrnthernRegionalrnBioequivalencernCenterrnbyrnitselfrnwasrnconsideredrnasrnanrnopportunityrnbyrnmostrnofrnthernparticipants.rnInrnaddition,rnarnrnnumber of favorable conditionsrnincludingrnawarenessrnandrndemandrnforrnproductrnqualityrnandrndiversity,rnthernpresencernofrnattractivernincentivernrnpackages for local pharmaceutical manufacturers and the proliferation of the genericrnrnmedicines market in the region were mentioned as opportunities. On the other hand, lackrnof resources and stakeholders‟ commitment as well as lack of regulatory enforcement were identifiedrnasrnchallenges.rnrnConclusions:rnrnThe Bioequivalence center initiative has not functioned well as initially planned.rnThe findings of this study suggest the need for government and key stakeholders to actively engagernrnin the program to make the initiative viable. The significance of supporting this initiativerncould positively contribute to the creation of a competitive local manufacturing sector that willrnengage in the production of therapeutically interchangeable generic products and ultimatelyrnsafeguard the health of the society at large.

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