There are a number of anecdotal stories of regulators being pressured to approve medical products and manufacturing sites without due processes being undertaken.
Dr. David Mukanga
When Ebola struck in West Africa in 2014, more cases and deaths were recorded than in all other outbreaks combined. Spreading across borders to kill tens of thousands, destroy communities and leave survivors in anguish, the epidemic was the largest and most complex since the virus was discovered.
Such devastation roused the international community and local actors into action, necessitating a coordinated response.
But at the same time, medicines were brought in and tested on patients by some groups without going through appropriate regulatory and ethical approvals by the responsible institutions.
There are a number of anecdotal stories of regulators being pressured to approve medical products and manufacturing sites without due processes being undertaken, and this could result into poor health outcomes.
On the other side, there are firsthand accounts of autonomous regulatory agencies withstanding this pressure. These are government agencies mandated by force of law to exercise independence in decision making over medicine regulation, with their autonomy guaranteeing independence from undue influence. This means agencies can make decisions on the basis of science and public health, and nothing else.
This is important because medicines are not ordinary consumer goods, and citizens are not able, alone, to determine if a medicine is safe, efficacious and of quality. So to mitigate such risks in Africa, it is of paramount importance that countries regulate medicines effectively.
To do this each country must have an autonomous regulatory agency. Yet a recent survey by the World Health Organization (WHO) shows that only 40% of countries in the WHO Africa Region have an autonomous or semi-autonomous Medicines Regulatory Agency
Without said agencies, nations stand the risk of failing in their duty to protect their citizens’ public health, as well as their national security by allowing the illegal manufacturing and trade of drugs to go undetected.
While working together regulators can achieve high standards through work-sharing with other agencies, there are vital functions that each country must undertake alone. These functions require a strong, autonomous, but right-sized agency so that access to medicines is not hindered by unjustified regulatory work.
Economically, without an autonomous agency, a country cannot provide the regulatory oversight necessary to ensure medicines produced locally are of quality for both the local and external markets. This means external markets will be reluctant to buy products from countries in which the regulator’s competency and independence are in doubt.
Therefore, by maintaining high regulatory standards, national regulatory authorities allow their national manufacturers to participate in global commerce. It also affords access to the World Health Organisation’s prequalification program and improves global supplies for the benefit of those most in need.
Take Kenya, where manufacturers are exporting across East Africa with one local manufacturer, Universal, selling WHO prequalified products. Or Uganda, where one manufacturer, QC Cipla, is selling WHO prequalified products for HIV and malaria that are exported across Africa, for the benefit of Africans and the Uganda’s economy.
An autonomous agency is also able to generate its own revenue through fees for services that allow it to hire and retain competent staff. These staff play not only a public health function, but advance national security through the agency’s regulatory mandate. Just imagine an entity that intentionally produces a falsified “drugs” with the intention to cause harm.
Fortunately, great steps have been taken in the East African Community in recent years. Since 2012, when the East African Community Medicines Regulatory Harmonization Initiative was launched, the goal of making more medicines available to more people across the region has been centre stage.
The initiative sought to reduce the amount of time taken to register essential medicines to treat priority diseases. More than that, it aimed to harmonize requirements across countries to increase collaboration, strengthen the regulatory capacity of partner states, and ensure the efficient evaluation of high-quality, safe health technologies.
How has this work-sharing and reliance been done? Each country contributes its expertise towards joint assessment of medicines, ensuring that even those that may be constrained with certain expertise benefit from the regional pool of experts, while their own capacity is built through this engagement.
And it has been successful: more drugs have been submitted for review under joint assessments; expertise is pooled; optimisation has brought efficiencies and cost savings that accrue to the health care system, taxpayer and patient. Yet, without autonomous agencies, progress will remain incomplete and frustrated.
Fortunately, within the EAC region, four of the six countries have an autonomous or semi-autonomous agency, with Rwanda and Burundi, the remaining two, close to setting up their own.
In February, the Rwandan parliament passed into law a bill to establish the Rwanda Food and Drugs Authority. A month later, the National Legislative Assembly of Burundi considered legislation establishing the Autorité Burundaise de Régulation des Médicaments et des Aliments (ABREMA).
Such progress across the East African Community is not just necessary, it is welcome and encouraging. Because while developments in medicine should always be celebrated, so too should these regulatory steps that will ensure safe access for millions of Africans.
The article is co-written by Dr. David Mukanga Senior Program Officer Global Health, Bill and Melinda Gates Foundation and Hon. Christophe Bazivamo Deputy Secretary General, Social and Productive Sectors, East African Community (EAC).