• Regional and global leaders have agreed that the goals of universal health coverage will not be met without innovation.
• New tools and technologies can help to overcome gaps in equitable access.
In February, at the African Union heads of state meeting, AU leaders committed to increasing domestic investment to achieve health for all. This is a welcome development, as the ambitious goals of providing access to quality, affordable healthcare for all Africans will not be accomplished with outside funds alone. Now the question turns to where and how leaders will prioritise those investments.
One such key area is research and development to advance new tools to deliver quality, affordable healthcare.
Regional and global leaders have agreed that the goals of universal health coverage will not be met without innovation. Despite vast improvements in health outcomes over the past several decades, we know that progress is not shared by all. Large inequities remain in access to care.
New tools and technologies can help to overcome those gaps in equitable access. Low-cost technologies can be deployed to stop preventable deaths, such as mothers dying during childbirth and children succumbing to infection before their fifth birthday.
The KFDA Bill will address the multiple laws and agencies involved in licensing health technologies and lessen the time it takes to introduce a medical product into the market and scale it up.
Data and digital tools like DHIS2 and Human Resource Information System (HRIS) can help governments better understand gaps in service and how to allocate resources. Delivery innovations such as drones and vaccine coolers can ensure that products and services reach more people, faster.
This type of innovation requires not only funding but also changes to policies and processes to overcome barriers to access. The Kenyan government has a real opportunity to achieve progress through the passage of the Kenya Food & Drug Authority Bill.
Africa faces numerous challenges to realising the promise of innovation for health for all. One major challenge that has garnered the attention of AU leaders is the disparate regulatory processes that too often delay products from having the impact they could.
While regulatory approvals are essential in ensuring safety and efficacy of health products, the fact that processes differ from country to country results in delays in introduction and scale-up. In addition, many regulatory agencies are under-resourced and over-burdened, creating bottlenecks and backlogs. At the regional level, efforts are underway to streamline regulatory processes across and within African countries.
Similarly, there are many bottlenecks in the regulation of health technologies and research clearance, as well as a duplication of roles in the government bodies involved. Regulatory agencies and research organisations are spread across ministries and are often governed by conflicting legislation. They have overlapping mandates, which leads to confusion for researchers and innovators attempting to navigate the system, and coordination.
For instance, both the Pharmacy and Poisons Act and the Food, Drugs and Chemical Substances Act include provisions on the manufacture, sale, and advertisement of drugs and medical devices.
Furthermore, there is no harmonised authority to give permits. Manufacturers, wholesalers, and distributors of health technologies are therefore required to obtain multiple licences and permits from different agencies, which can be time-consuming and costly.
Though Kenya’s post-marketing surveillance system is a model for the region, the legal framework has proven difficult to navigate, hence it is unclear which law is applicable or what agency has jurisdiction in setting punishments for counterfeit medical products or determining when intellectual property infringement has occurred.
The realisation of regulatory harmonisation through the KFDA Bill will improve access to essential health products for underserved populations thus addressing health inequities, reducing catastrophic expenditures and contributing to achievement of UHC.
The KFDA Bill will address the multiple laws and agencies involved in licensing health technologies and lessen the time it takes to introduce a medical product into the market and scale it up. It will reduce the burden on manufacturers, wholesalers, and distributors, eventually positively affecting the patient by lowering costs.
In this regard, we urge the government to take swift action to pass the KFDA Bill to advance Kenya’s efforts to streamline regulatory processes toward the path to achieving one of the Big Four agenda, universal health coverage.
Executive director, WACI Health, and member of the Coalition for Health Research and Development. [email protected]