The Case for an African Medical Devices Regulatory System
Imagine the predicament of a hairstylist in Africa who found the only tools available were those developed for styling hair in Europe. Or that of an Indian chef, if he must get his spices only from an American garden. The voltage might be wrong, and the spices unsuited to the dish. Fortunately, their customers would survive, though with less-coiffed hair and blander food than usual. What has this to do with medical devices, you might ask? Well, apply this train of thought to something as matter-of-life-and-death as this, and it takes on a whole new level of significance.
Medical devices by Africa for Africa—what could be more ideal?
Consider, for instance, that a diagnostic machine may be a life-saver in one locality and useless in another if it requires reliable electrical power that is just not available. Understanding the circumstances could imply designing a machine that is perhaps solar-powered or works on a mobile phone; to innovate, produce and regulate with African realities in mind. Medical devices by Africa for Africa—what could be more ideal? For starters it would mean focusing on the devices that are most appropriate for the continent’s medical needs and conditions, making them available and affordable, and setting up a system to regulate them. Quite a few impressive medtech innovations are coming out of Africa (more about that in a future article), but one of the greatest deterrents is the lack of a harmonized regulatory system for medical devices on the continent.
Lack of harmony stifles the flow
To begin to grasp the importance of harmony in the regulation of medical devices for Africa, think of what harmony does for a good choir, keeping in mind that some have hundreds of members. Harmony is what blends the individual voices and varied pitches to make the music flow. Currently, African countries are a choir out of harmony when it comes to regulation of medical devices; each singing as it pleases. The result? The flow of quality medical devices to the continent is stifled.
The WHO recommends that each country have legislation to define the scope of regulation which includes a definition of a medical device, and requires that only medical devices that are safe, of acceptable quality, and perform as intended be marketed. The legislation should also mandate the formation of a regulatory authority and establish the responsibilities and enforcement capabilities of that agency.
The reality is that the maturity of regulatory systems in Africa varies from country to country.
African countries have made great strides at regulation, setting up legislation and regulatory authorities. Young nations carrying heavy financial burdens must start somewhere. But perhaps the solution lies in doing it together, in strength and unity.
We still have a ways to go. Some countries don’t yet have this legislation in place, while a few of those that do have legislation don’t have a regulatory authority in place. Some with regulatory authorities have processes for regulating drugs, but not for medical devices. Since most medical devices are imported, import controls are crucial to safety. Some countries don’t have such controls in place. Many rely mostly on clearance from more established regions such as Europe, the U.S.A and Japan, to name a few. The reality is that the maturity of regulatory systems in Africa varies from country to country.
Different countries, different songs. Some perhaps beautiful on their own, others still in their composition stages. But taken as a whole, the lack of a harmonized regulatory system for Africa is a serious setback for the flow of quality medical devices. What if we could do it right together; once together instead of 54 different times separately? It’s worth considering.
Imagine the conundrum faced by a medical device manufacturer trying to introduce a device into several African countries. Consider, for instance, that the duration of license validity is country-specific. The manufacturers may find it easier to opt for just one or two markets, or perhaps give up on the African market altogether. In the end, the African healthcare system, and its end-users are the losers when the latest and best medical devices don’t make it across their borders.
Why Africa will benefit from harmonization
Economic empowerment will indisputably result from the harmonized regulation of medical devices. In low- and middle-income countries, substandard and falsified medical products resulted in an economic loss of a whopping $30.5 billion or so in medical expenditures in 2017, according to the WHO. The saying ‘it never rains but it pours’ has never rung so true as in this situation. That the countries which can least afford it are wasting scarce resources to buy substandard products, then having to dip deeper into their pockets to remedy the damage caused by such products is beyond perturbing. And the influx of substandard medical devices is just the beginning of a vicious cycle that progresses to poor health, loss of productivity, loss of income, and increased poverty. Harmonized regulation will introduce a system where countries in the continent can rely on each other’s information on product safety and performance, thus minimizing or even eliminating the entry of sub-standard devices.
in low- and middle-income countries, substandard and falsified medical products resulted in an economic loss of a whopping $30.5 billion
Increased innovation in African medical technology will result organically from a good harmonized regulatory system. Currently, most of Africa’s medical equipment is imported. Some of it is good and, as we have seen, some is substandard but finds its way in any way. African innovators currently face a Sisyphean task. in that, they must compete against the cheap devices coming in, and at the same time, negotiate their way around the myriad unharmonized regulations. Of course, increased local innovation will lead to more appropriate and hopefully more affordable medical devices, which are the perfect segue into the next and most important benefit—improving the quality of life.
Improved access to quality healthcare is the ultimate result of making quality and appropriate medical devices available because they are essential for the diagnosis and treatment of so many diseases. The right devices at the right price will undoubtedly increase access to quality healthcare. What should be kept in mind is that a good regulatory system is just one of three legs, so to speak; the other two are the cost of the devices and the right infrastructure that enables proper use of the devices.
There are already some projects on regulatory harmonization in Africa. These vary in scope and implementation maturity, but they are worth highlighting:
SADC Medical Devices Regulatory Harmonization project in collaboration with the World Bank: the aim of the project is to propose a regulatory framework for the region for regulating medical devices and IVDs (in vitro diagnostic devices);
Zazibona Collaboration: a medicines registration initiative where member states collaboratively perform assessments and inspections to reduce workload and timelines to registration;
African Standards Harmonization project: an initiative by ARSO (African Organization for Standardization) where harmonized technical standards are being written for multiple industries. The harmonized standard for medical devices and equipment is still currently ongoing
What Does the Future Hold for African Regulation?
While we can draw inspiration from the ongoing efforts mentioned previously, we, as a continent, are still far from an ideal system (if that’s even possible). The opportunity is ripe for African regulators and industry leaders to come together and innovate a fitting regulatory continental system. There are many lessons to be learned from more developed regions (think of the likes of Europe), however, the focus should be to not copy those systems but rather tailor them into a unified system that fits the various African markets. A system by Africa for Africa. The pessimists will say that there are too many hurdles to overcome, but consider this: when has achieved anything great ever been easy? Let’s build something great!