Assessing the viability of pharmaceutical technology transfer : a case of Kenya
Access to essential medicines in developing countries including Kenya has remained a concern. Past studies have pointed out technology transfer between innovator and local generic manufacturing companies as the possible solution to this problem of access. The current study assessed the viability of technology transfer as a solution to medicines access in Kenya. The study assessed the current situation with regard to medicines access and use of pharmaceutical technology transfer as a tool to bridge the gap in essential medicines access; identified the underlying barriers to pharmaceutical technology transfer and proposed a the lifecycle approach framework for technology transfer in the context of Kenya pharmaceutical industry. The study was supported by literature collected from various online sources to support the identified research problem. The research took a descripto-explanatory design using a combination of qualitative and quantitative methods. The study population was the 56 respondents selected in a non-probability purposive manner from the 46 pharmaceutical companies in Kenya operating under the umbrella trade associations of Kenya Association of Pharmaceutical Industry (KAPI) and Federation of Kenya Pharmaceutical Manufacturers (FKPM). The researcher used a self-administered questionnaire to collect information from industry participants and an interview guide to collect data from the Pharmacy and Poisons Board of Kenya. The study results indicated a 79% (n=44) response rate with respondents drawn from local manufacturers (38.6%), importers (25%) and innovator companies (29.5%). The study identified gaps in the medicines access in Kenya as perceived by 47.8% or the respondents mostly driven by the lack of government funding (84.1%), insurance reimbursement (49.1%), high cost of medicines (75.3%) and lack of manufacturing capacity (55.6%) & technology (61.4%). Additionally the study identified the cost of R & D (77.3%) and Manufacturing cost (72.7%) as the main hindrances for new product introduction in Kenya. It further identified technology transfer as one measure that can be used to bridge the gap of medicines access through improved manufacturing capacity and technology in Kenya (79.6% of respondents). The study identified qualified personnel ( r=.709, p=.013), manufacturing capacity ( r=.709, p=.013), intellectual property rules (r=-.729, p=.023), competition from imported products ( r=-.759, p=.002) and access to innovator companies (r=-.824, p=.014) as the main factors; while regulatory framework (r=.717, p=.910) and past failures (r=.258, p=.015) were shown to have minimal impact on pharmaceutical technology transfer in Kenya. Finally the study indicated that only 48.6% (n=17) of the respondent companies had plans for technology transfer, out of which only 47% (n=8) had a technology transfer framework in place which in itself was not effectively working (p=.106). The study proposed and verified a six step lifecycle based approach framework for pharmaceutical technology transfer for a new tablet formulation product. The study concluded that there was a gap in medicines access and identified the role that can be played by technology transfer premised on a feasible framework. The study recommends establishment of more awareness channels for technology transfer, fostering of collaborations between stakeholders and further studies on the lifecycle approach to technology transfer in real life setting.