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When Ebola hit West Africa in 2014, more cases and deaths were recorded than in all other foci combined. Extending beyond borders to kill tens of thousands of people, wiping out communities and leaving survivors in anguish, the epidemic has been the largest and most complex since the discovery of the virus
. At the same time, some groups have introduced and tested drugs on patients without the proper regulatory and ethical approvals from the responsible institutions.
There are a number of anecdotal stories of regulatory agencies under pressure from medical products and manufacturing sites without regular processes, which could lead to poor results for the health.
On the other hand, there are direct testimonials from autonomous regulatory agencies that support this pressure. These are government agencies mandated by law to exercise independence in decision-making on drug regulation, their autonomy guaranteeing their independence from undue influence. This means that organizations can make decisions based on science and public health, and nothing else.
This is important because drugs are not ordinary consumer goods and citizens are not able to determine if a drug is safe. and quality. So, to mitigate these risks in Africa, it is critical that countries effectively regulate drugs.
To do this, each country must have an autonomous regulatory agency. Yet, a recent study by the World Health Organization (WHO) shows that only 40% of countries in the WHO African Region have an autonomous or semi-autonomous Drug Regulatory Agency. Autonomous
Without these agencies, nations may fail to protect the public health of their citizens and their national security by allowing the illicit manufacture and trade of drugs to be undetected.
While working together, regulators can achieve high standards through shared work with other organizations.
These functions require a strong, self-sustaining but fair-sized agency so that access to medication is not hindered by unjustified regulatory work.
Economically, without an autonomous agency, a country can not provide the necessary regulatory oversight to ensure that locally produced medicines are of quality for local and external markets.
This means that external markets will be reluctant to buy products in countries where the jurisdiction and independence of the regulator are in doubt
Therefore, by maintaining high regulatory standards, national regulatory authorities allow their domestic manufacturers to participate in world trade.
to the World Health Organization Prequalification Program and improves global procurement for the benefit of the most needy.
Take Kenya, where manufacturers export to East Africa with a local manufacturer, Universal, which sells prequalified products through the WHO. Or in Uganda, where a manufacturer, QC Cipla, sells WHO prequalified products for HIV and malaria exported across Africa, to the benefit of Africans and the Ugandan economy.
An autonomous agency may also generate its own income fees for services that allow it to hire and retain qualified personnel. These employees not only play a public health role, but also advance national security through the agency's regulatory mandate. Imagine an entity that intentionally produces a falsified "drug" with the intention of causing harm.
Fortunately, great steps have been taken in the East African Community in recent years.
Since 2012 when the East African Community The Regulatory Harmonization Initiative has been launched, the goal of making more drugs available to a greater number of people In the region.
The initiative aimed to reduce the time required for the registration of essential drugs 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 effective evaluation of safe and high quality health technologies.
How was this shared work done?
Each country brings its expertise in joint drug evaluation, ensuring that even those who may be limited with certain skills benefit from the regional pool of experts, while their own capacity is built thanks to this commitment.
was successful: more drugs were submitted for review as part of joint evaluations; the expertise is pooled; optimization has resulted in efficiencies and savings for the health system, the taxpayer and the patient. Yet, without autonomous agencies, progress will remain incomplete and frustrated.
Fortunately, in the EAC region, four of the six countries have an autonomous or semi-autonomous agency, Rwanda and Burundi, the other two, close to creation.
In February, the Rwandan parliament passed a bill establishing the Food and Drug Authority of Rwanda.
A month later, the National Legislative Assembly of Burundi reviewed the law establishing the Burundian Drug Regulatory Authority. Foods (ABREMA).
Such progress across the East African Community is not only necessary, they are welcome and encouraging. For if advances in medicine are still to be celebrated, the regulatory measures that will ensure secure access to millions of Africans should also be celebrated.
Dr. David Mukanga is in charge of Global Health Program for the Bill and Melinda Gates Foundation and Hon Christophe Bazivamo is Assistant Secretary General for the Social and Productive Sectors of the East African Community ( CAE).
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