Кения ставит цель удвоить долю локального производства лекарств к 2026 году

The COVID-19 pandemic revealed gaps in global supply chains, especially for African countries like Kenya. With more than 35 licensed pharmaceutical manufacturing facilities, many of them underutilized, Kenya has the foundation for a stronger local manufacturing sector, but significant gaps remain. Import dependence has left the health system exposed to supply disruptions, with limited access to essential medicines, and with reduced preparedness for future health emergencies. Addressing these challenges has emerged as a regional priority across Africa, driving efforts to strengthen regional manufacturing capacity. Within this broader agenda, Kenya is taking steps to expand its manufacturing sector, contributing to a more sustainable and coordinated regional ecosystem for health products and technologies. In 2023, the Kenya government set a goal to increase the share of essential health products and technologies made locally from 20 to 50 percent by 2026, aligning this effort with the country’s push for universal health coverage. This move aims to make medicines more accessible and affordable while reducing reliance on imports. From challenge to action: Kenya’s manufacturing momentum To stimulate production and expand the market, the government has presented three broad strategies that it intends to focus on by 2030: accelerating priority regulatory and policy reforms, including World Health Organization (WHO) maturity level 3 standards; scaling up and diversifying local manufacturing; and generating demand and creating market assurance. Kenya’s targeted policy actions include establishing a semiautonomous secretariat with cross ministries, departments, and agencies to strengthen the industry ecosystem; harmonizing the cross-sectoral policies on local manufacturing for integrity in the regulatory pathways; and developing the workforce by scaling up training in pharmaceutical manufacturing. A major step forward in Kenya’s efforts is the creation of the Kenya BioVax Institute, a government-run organization. Most of Kenya’s more than 35 pharmaceutical manufacturing facilities focus on packaging or final-stage production of generic medicines and medical devices, rather than on vaccines, other complex biologics, and point-of-care diagnostics. BioVax is filling this gap by building the capacity to produce these essential products locally, reducing import dependence, and improving access to lifesaving medicines for faster, more reliable national and regional health security. Driving progress with strategic partnerships To accelerate its local manufacturing agenda, Kenya has partnered with technical organizations such as PATH. Under this broad partnership, PATH has provided technical assistance, policy development, and capacity-strengthening support to help develop a strong and sustainable pharmaceutical manufacturing ecosystem in the country. This has included working closely with the Ministry of Health’s Directorate of Health Products and Technologies to develop the Kenya Health Products and Technologies Local Manufacturing Strategy 2026–2030, and shaping the communication strategy for BioVax, ensuring clear and effective messaging to increase uptake of locally manufactured products by Kenyan companies. In partnership with the Pharmacy and Poisons Board, PATH has also facilitated Good Manufacturing Practices training for 100 personnel in local pharmaceutical facilities. PATH has been involved in legislative processes as well, including contributing technical input to the Kenya Health Products and Technologies Regulatory Authority Bill, which is currently in the legislative process. Strategic partnerships with the private sector are also expanding access to care. Through the Accord for a Healthier World initiative, Kenya has teamed up with Pfizer to provide access to 40 percent of WHO’s listed essential medicines at much lower costs. This partnership is expanding treatment options for a range of health challenges, including cancer, infectious diseases, and chronic conditions, making care more affordable and accessible for many Kenyans. “Kenya’s commitment to local manufacturing is a defining moment for health security in Africa. Strategic investment in local manufacturing can transform a country’s ability to protect its people and PATH is proud to stand with Kenya.”— Rachel Ndirangu, Regional Director, Advocacy & Public Policy Positioning Kenya in Africa’s manufacturing future PATH supported Kenya’s ratification of the African Medicines Agency treaty in 2023. This was an important step toward aligning national regulations with continental standards and creating a stronger, more predictable environment for medical product development and trade. Aligning Kenya’s policies with continental standards is essential to improving access to quality medicines and ensuring local manufacturers can bring products to market more efficiently, reducing delays and costs while creating the conditions for investments in local production to translate into sustainable access. The Pharmacy and Poisons Board, which oversees the safety and quality of medical products, is undergoing significant reforms with the goal of reaching WHO maturity level 3, a status that signals a stable, well-functioning regulatory authority capable of ensuring that medicines and health products are safe, effective, and of the highest quality. This will be critical not only for improving public trust in locally manufactured products but also for enabling Kenya to attract investment, participate in regional markets, and strengthen preparedness for future health emergencies. Kenya’s commitment to strengthening pharmaceutical manufacturing goes well beyond its own borders. The country is an active participant in the Platform for Harmonised African Health Manufacturing (PHAHM), a flagship initiative led by the Africa Centres for Disease Control and Prevention. PHAHM brings together African Union Member States, regional economic communities, and technical partners to coordinate and align efforts to boost local manufacturing across the continent. Through this platform, Kenya plays a key role in developing common regulatory pathways, pooled procurement strategies, and shared investment platforms, positioning itself as a leading force in Africa’s drive toward greater pharmaceutical sovereignty and the continent’s goal to produce 60 percent of its vaccines locally by 2040. Kenya’s approach represents Africa’s bold vision for health sovereignty, where local solutions are built for local needs. By investing in manufacturing and regulatory capacity, Kenya is not only strengthening its own health system but also contributing to continental efforts to improve access to quality-assured health products and enhance health security. PATH is proud to partner with the Kenya government. We stand committed to strengthening Africa’s regulatory ecosystem and supporting regional and local manufacturing to help the continent achieve its health and development goals.