A Competitive Analysis of the Drug Regulatory Affairs Regime in Kenya Using Porter’s Forces for Competence Powers

Abstract

This is an empirical research on the drug regulatory affairs regime in Kenya which is a key but neglected element in Pharmaceutical business development strategy. The purpose of the research is to do a competitive analysis of the key stakeholders within the regulatory regime in Kenya using the Porter’s forces for competence powers as a guide and based on the results make recommendations for developing a competitive drug regulatory strategy for operations in the Kenya Pharmaceutical market. The study employs the statistical analytical descriptive approach based on the literature review and fieldwork to answer the research questions. Nine (9) stakeholders have been identified and grouped into buyers, suppliers and new entrants into the drug regulatory affairs frame work in Kenya. These would form the independent variables for the study and a drug regulatory strategy the dependent variable. The population of the study consisted of Pharmacist working in thirty (30) multinational Pharmaceutical and Biotech companies and the Pharmacy and Poisons Board of Kenya. The sample size studied was sixty-six (66) Pharmacists in the proportion of fifty-six (56) and ten (10) from the respective groups. The study used a questionnaire to collect data. The data was analyzed using SPSS, mean, (T) tests as well as linear regressions to determine the level of contribution of each of the stake holders in developing a competitive regulatory strategy. In using Porter’s forces for competence powers to do a competitive analysis of the drug regulatory framework in Kenya, the researcher found that the buyers within the framework collectively have a very strong and significant effect on creating a drug regulatory strategy. The strongest of the buyer group is the multinational headquarters and the weakest the local marketing department. For the suppliers within the framework, the analysis of data collected for the research indicated that collectively they do not have a strong and significant effect on creating a drug regulatory strategy. The regulatory affairs professionals however who supply labour as an individual group have a very strong and significant effect on creating a drug regulatory strategy. The clinical investigators and patients that form the clinical trials both do not have an effect on creating a drug regulatory strategy. Competitive analysis of the new entrants within the drug regulatory framework in Kenya indicated that the technological innovations in regulatory affairs are the strongest of the new entrants and the outsourcing of regulatory affairs the weakest. The three variables together proved to have a very strong and significant effect as within the drug regulatory affairs framework in Kenya. In conclusion the findings indicated that there is a significant statistical effect for applying all three of Porter’s five forces studied on the drug regulatory framework in Kenya to create a drug regulatory strategy. Furthermore the findings indicated the ranks of competitive forces were as follows; the threat of new entrants into the regulatory framework in Kenya, the buyers and then the suppliers into the regulatory framework in Kenya. Based on the findings of the study, the researcher recommends the need for taking into consideration the use of not only the three forces studied in this research but the entire five forces to determine the competitiveness of other functional business units within the Pharmaceutical industry. Additionally also it directs future researchers to study the opportunities and threats for each of the variables within in the drug regulatory framework.