There is a monthly vaginal ring that can reduce a woman's risk of becoming infected with HIV through sexual relationships by about 30%. This ring, manufactured in Africa by the South African pharmaceutical company Kiara Health, has been registered in 11 countries on the continent. Each of these countries had to individually review the results of the drug's laboratory tests and clinical trials submitted by the International Association for Microbicides, which developed the ring.
To streamline this process in the future, the secret could lie with an African Medicines Agency (AMA), a young body that will examine new drugs and production facilities on behalf of African countries. They can then decide whether To the products locally, without having to go through the laborious process of verifying the data themselves or, in cases where a country does not have a regulatory authority, seek approval from the World Health Organization (WHO). wait medicine. WADA, which is not yet operational and will work on pilot projects next year, was officially established on November 5, 2021 as a specialized agency of the African Union and is based in Rwanda. So far, 37 of the 55 members of the African Union have ratified or are in the process of ratifying the agreement establishing the new body, including Zimbabwe, Uganda, Namibia, Lesotho, Kenya, Ghana, Senegal, Egypt, Rwanda or Tanzania.
The African agency will focus on drugs for conditions such as heart disease and diabetes, diseases such as malaria and tuberculosis, or tropical diseases that are no longer common in other parts of the world but affect poor countries.
WADA will focus on medicines for diseases of public health concern in Africa, such as heart disease and diabetes, diseases such as malaria and tuberculosis, or tropical diseases such as schistosomiasis and sleeping sickness, which are no longer common in other parts of the world , but they affect many poor people on the continent. Also drugs made up of so-called “complex molecules”, such as the mRNA vaccine – used against Covid – or the three-in-one pill against HIV, which contains dolutegravir, tenofovir and lamivudine. In this case, the substance that triggers the treatment or protective effect in the body consists of various chemical substances that are intelligently combined so that the patient has to take a lower dose or fewer tablets and has fewer side effects.
If WADA had been fully operational when the HIV vaginal ring became available in 2021, the agency's member countries would not have had to verify the effectiveness data themselves. Skhumbuzo Ngozwana, CEO of Kiara Health, points out that when the pharmaceutical company starts producing the ring – the exact date is not yet known – WADA could inspect the production facilities and make a recommendation for this process, rather than the teams from each country must travel to South Africa for this purpose. In this way, the company would be able to process orders from different countries more quickly, as the quality of its products would be quickly and comprehensively guaranteed. Ngozwana explains: “A well-functioning regulatory system is the foundation of any pharmaceutical industry; Above all, it is the safety barrier that protects public health.”
A long and arduous process
Before a drug can be marketed, it must be approved and registered by a country's drug regulatory authority. This means that although the medicines are manufactured by pharmaceutical companies, the regulator reviews the data supporting the effectiveness of the medicine and sets the rules for its marketing and sale so that the medicines for sale are safe and work as intended. They think they should do it. Regulators must also monitor drug use, investigate reported serious side effects, and review data collected when changes are made to the drug.
The agency can help reduce the spread of counterfeit medicines in Africa
This is a long and arduous process for which many African countries lack knowledge, money or legislation. A regional regulatory authority with applicable quality standards, operating methods, documentation and requirements can help speed up the evaluation process of a product and, if given the green light, forward it to a country's local authorities for their decision, if necessary, To it. This means that citizens have earlier access to new medicines and do not have to wait for an organization like the WHO to approve a drug – which can take a long time – until it is available in their country.
The existence of a central medicines authority does not necessarily mean that if a medicine passes the test, countries are obliged to keep it available in their pharmacies. Member States may decide whether to accept WADA's recommendation and, if so, what information should be included in the product leaflet or packaging.
Another positive effect of the new authority could be reducing the spread of counterfeit medicines, as long as the drug registration system is rigorous, has strict quality controls and as long as there are WADA officials monitoring the use of the region, says the director general of the South African Health Products Regulatory Authority ( SAHPRA), Boitumelo Semete-Makokotlela.
Rich countries that pay more
Once a country has ratified the WADA treaty, the new member must pay annual membership fees calculated based on the size of its economy. This means rich countries pay more for membership than poorer countries. Additional funding comes from fees that pharmaceutical companies have to pay to the authority to process their applications, as well as from donors. Only countries that have ratified the agreement and are paying members can use WADA assessments To medicines.
The idea behind creating a common medicines regulator for Africa is similar to that of the European Medicines Agency (EMA) in that people and goods can move freely between countries that are part of the Schengen area, says Chimwemwe Chamdimba, who leads the medicines harmonization regulatory program in Africa and will coordinate the process of establishing WADA until a Director General is appointed for the organization. But the African Medicines Agency will not be an exact copy of the EMA, he says. “We learn from what has already worked.”
A longer version of this report was originally published in English in Bhekisisa, a South African health journal. The Bhekisisa Center for Health Journalism newsletter can be found here.
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