KEMRI Champions Health-Tech Innovation with Regulatory Sandbox Workshop.

Director General, Ministry of Health Dr. Patrick Amoth gives his welcoming remarks.

On 29th, October 2024, KEMRI, in partnership with the University of Warwick, the Coalition for Health Research and Development, Jaza Rift Ventures, the Kenya National Innovation Agency, and Villgro Africa, hosted a healthtech stakeholders’ workshop in Nairobi. The event aimed to introduce and discuss the concept of a health-tech regulatory sandbox to inform and shape a more adaptive regulatory framework for health technology innovations in Kenya.

A regulatory sandbox serves as a controlled environment for emerging health-tech innovations, particularly when existing regulatory frameworks are insufficient or outdated. By relaxing certain regulations, the sandbox facilitates the development and testing of new health technologies while maintaining oversight and safety.

Director-General of the Ministry of Health Dr. Patrick Amoth, underscored the importance of this initiative, highlighting its transformative potential. “I am confident that today marks the beginning of a significant journey toward enhancing healthcare access through innovation. By strengthening biotechnology research and integrating clinical trials, we position Kenya as a regional leader in health-tech innovation,” stated Dr. Amoth.

Dr. Rose Bosire, representing the Acting Director-General of KEMRI, Prof. Elijah Songok, emphasized the urgent need for a regulatory sandbox, pointing out that complex and lengthy regulatory processes often hinder health-tech advancements. “KEMRI, with the highest number of clinical trials in the region, leads in innovating and testing medical technologies, devices, and systems.

*Senior Research Scientist Dr. Rose Bosire gives welcoming remarks on behalf of Ag. Director General, KEMRI during the workshop.*

*Chairperson SERU Committee Mr. Ambrose Rachier has a discussion with Senior Research Scientist Dr. Rose Bosire during the meeting.*

Yet, the African genome remains underrepresented in global health products. Regulatory hurdles and insufficient local investment create an environment that stifles solutions to our health challenges,” Dr. Bosire noted passionately.

Dr. Bosire called on stakeholders to provide critical insights to overcome these regulatory barriers and accelerate local innovation. She advocated for a streamlined regulatory process, free from duplicative requirements at both national and county levels, to facilitate smoother clinical trials and novel health solutions.

The workshop also served as a platform for expert discussions that will contribute to a blueprint for the proposed health-tech regulatory sandbox. Accompanying Dr. Bosire was a team from KEMRI’s Scientific and Ethics Review Unit (SERU), including Committee Chairs Dr. Ambrose Rachier and Nellback Katindi, Head of SERU Mr. Enock Kebenei, and other senior members. Mr. Samuel Omari, Head of the Innovation and Technology Transfer Division, and Dr. Fidellis Nduva, Senior Principal Research Scientist, were also in attendance.

*Research Scientist Mr. Geoffrey Ngasura giving his presentation on behalf of his group made during group discussions*

*Research Scientist Mr. Samuel Omari and Chairman AMREF Ethical Review Committee Prof. Mohammed Karama following the proceedings.*

The insights gained from this workshop are expected to pave the way for a more adaptable and supportive regulatory environment, ultimately fostering a robust health-tech ecosystem that can drive Kenya’s healthcare sector forward.