Kenya
Demographics
Kenya’s population is estimated to be around 55 million in mid-year 2023, according to world meter. HIV is the main cause of disease burden in Kenya, accounting for 24% of the country’s overall illness burden. The majority of diseases affecting the country are communicable (World Health Organization, 2018a). In 2021, the vaccination coverage for the third dose of the DTP-containing vaccine, Hepatitis B, Haemophilus influenzae type B, was 91%. BCG had a vaccination coverage rate of 97% in 2021 (World Health Organization, 2022a).
Guidelines and Regulations
Laws
Policies
Pharmaceutical Market
The Pharmacy and Poisons Board (PPB) is Kenya’s regulatory authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya. The Board regulates the practice of pharmacy and the manufacture and trade of drugs and poisons. Kenya is currently at WHO ML2. It has ratified the AU Model Law, but it has not ratified the AMA to date to enable overall regional harmonization. It is a member of the EAC and is currently undergoing a REC-MRH (regulatory manufacturing harmonization) program. Kenya is one of the fastest-growing economies in Africa and has the fastest-growing pharmaceutical market in Africa. It has over 35 licensed manufacturers. However, only nine drug manufacturers in Kenya produce drugs registered by the Pharmacy and Poisons Board. It is worth noting that Kenya mainly carries out secondary and tertiary manufacturing.
Due to the lack of local capability for API manufacturing, about 95% of APIs and excipients are imported, primarily from India. Kenya fails to manufacture enough drugs to meet domestic demand. As a result, around 70% of medications used locally are imported. Additionally, the top five firms export between 40 and 80 percent of their output, primarily to other East African countries (‘Kenya Pharmaceutical Industry’, 2020). With a market value of about USD 740 million in 2015, the pharmaceutical market in Kenya is the biggest and fastest-growing market in East Africa (Baldeh et al., 2023).
Vaccination Manufacturing Capacity
Recently, Moderna and the government of the Republic of Kenya came to an agreement to erect a mRNA manufacturing facility in Kenya. This will be the first mRNA manufacturing facility for Moderna in Africa (Pharmaceutical Technology, 2023). On top of this, the Kenya Biovax Institute was recently established with the help of the government of Kenya. In the future, Kenya Biovax Institute will manufacture, package, and commercialize specialized health products and technologies, such as vaccines, therapeutics, and other biomedical products (Biovax, 2022). Furthermore, Kenya will be a recipient of the mRNA technology transfer hub in the future (World Health Organization, no date).