Sub-Saharan Africa faces extreme challenges in public health, many of which can be addressed through innovative technologies such as fast and cheap diagnostic tests. Innovation in the sector is hindered, however, by poor or non-existent regulations around the testing and use of medical technology. South Africa has recently enacted laws to regulate medical device development, testing, and use; hopefully beginning a trend that will permeate the rest of the region.
The Southern African bioentrepreneurship space has recently seen innovations such as the TB Meningitis test by Antrum Biotech and the brucellosis test by LifeAssay Diagnostics. Both South African innovations have collaborations through SANBio across the SADC region, where there is little or no framework for regulation of medical devices.
For a long time, medical technologies have not been properly regulated in South Africa’s laws, instead being bunched up with other medicines control laws such as the Medicines and Related Substances Act of 1965. This has changed with the introduction of the amended Act 14 of 2015, which will establish a new regulatory authority for medical devices.
The World Health Organisation (WHO) lists on its website regulations of medical devices by state around the world, and in the SADC region, South Africa remains the only state with a proper framework that recognises medical devices in their own category. For example, while Namibia does have the Namibia Medicines Regulatory Council, it does not focus on medical devices.
On the other hand, South Africa established the South African Health Products Regulatory Authority (SAHPRA) in June 2017, which takes over from the Medicines Control Council (MCC) in implementing regulations for medical devices. The welcome establishment of this body is a stark difference from neighbouring countries in the region.
In Zimbabwe, regulatory legislation does not have a definition for what a medical device is, but it is mentioned by the country’s Medical Devices Unit, under the Medicines Control Authority. The regulatory body is responsible for quality control testing of only a limited amount of medical supplies or devices in line with international standards such as checks for poor workmanship.
Mozambique, Swaziland as well as Lesotho have no defined regulatory framework on the regulation of medical devices, and this might stifle the innovation and bioentrepreneurship in the sector. SANBio supports some projects that employ new medical devices for rapid, accurate diagnosis, where innovators partner with institutions spread across the region where regulations are not as clear cut as in South Africa.
This uncertainty might be a cause for concern for investors and entrepreneurs. On the other hand, the steps put in place as other governments create their own regulatory frameworks should not stifle innovation in the region. This is a sentiment that was shared by panelists at SANBio’s 2017 Annual Event, who suggested that researchers work and regulators should work together to avoid strangling emerging industries such as rapid diagnostic tests.
Dr Jeannette Lotter of South Africa’s MCC spoke at the 2017 annual event about the importance of the new regulations for safe and effective diagnostics in this emerging field, citing the innovation potential such a development unlocked. “There is a huge market for medical devices and diagnostics in southern Africa. If you build safety, efficacy and quality considerations into your research proposals from the design phase, the actual regulation should go very quickly,” she said.
Medical device regulatory frameworks go beyond making conducive environments for innovation; importantly they make for safer standards for the patients these devices will be used on. With better regulation will come better health outcomes, especially in an environment that takes the need for entrepreneurship into account.
It remains to be seen what other states in the region will do to follow in the footsteps of South Africa to recognise and regulate medical devices. Changing the regulatory environment for medical devices will require partnerships like SANBio within the region, that bring together states, researchers, entrepreneurs and regulators to make choices that will suit all parties with patient health, safety, and economic development as priorities.