A vote for the creation of the African Medicines Agency
That Africa soon establishes a body that will be responsible for regulating drugs and medical products across the continent is a positive development. In February 2019, the African Union adopted a treaty establishing the African Medicines Agency but, for take-off, it asked 15 African countries to sign it and notify the AU commission before it cannot be established.
And the other day, Cameroon officially notified the AU that it had ratified the treaty, bringing the number to the required 15. There will now be a 30-day waiting period before the establishment of the agency can begin. So, by November 5, it can officially start.
The other countries that have both ratified the AMA and deposited the instrument of ratification to the AU, which is a letter from the leader of that country that he has ratified the treaty, are Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Namibia, Niger, Rwanda, Seychelles, Sierra Leone and Zimbabwe. Three other countries have ratified the treaty but have not officially notified the AU, while eight others have signed the treaty but have not yet ratified it. WADA will be Africa’s second transcontinental health agency, following the creation of the African Centers for Disease Control and Prevention. It is always surprising that countries have been slow to become part of WADA because in 2019, when the decision was taken to establish it by the AU Assembly, it was unanimous.
The African agency will act as a similar agency in Europe, the European Medicines Agency. However, in Europe, the regulation of medicines involves around 50 regulatory authorities from the European Economic Commission and the EMA. EMA is at the center of coordination and supports relationships between more than 50 national agencies that regulate human and veterinary medicines.
There are real concerns on the part of some countries as to where WADA should be placed when they have their national drug agencies. WADA will not take over the work of a country’s drug regulatory agency, but will build capacity and harmonize drug regulation across the continent. It will also provide expertise lacking regulatory capacity, improve transparency and efficiency. In addition, WADA can strengthen the implementation of pharmacovigilance and the monitoring of clinical trials. A World Health Organization report indicates that only three of 46 African countries “had moderately developed capacity to regulate drug reviews and over 90% have minimal or no capacity.”
With the emergence of COVID-19, the global health system is not the same. Yet Africa has remained a bystander when it comes to COVID-19 vaccines. This is where WADA can play an important role. For example, the EMA is there to ensure the rapid development of these vaccines and treatments. It provides countries with the necessary support when reviewing the available scientific data on the disease. He also monitors potential treatments and works with them in clinical trials.
But maybe one of the main things WADA can do is help fight counterfeit and falsified drugs. It is a scourge mainly suffered by developing countries where counterfeit and poor quality drugs kill more than half a million people each year and are mainly responsible for the development of drug resistance against germs. In sub-Saharan Africa alone, fake antimalarials “could be responsible for up to 270,000 additional deaths per year,” according to a WHO study. Additionally, 42% of global seizures of counterfeit medicines come from Africa, underscoring the fact that this is primarily an African problem.
What compounds the problem, according to Muhammad Hamid Zaman, professor of biomedical engineering at Boston University, is that policymakers in developing countries prefer to seek solutions outside the continent. He said: “This myopia is a serious mistake that hinders innovation and progress. When it comes to tackling high-impact health challenges such as the proliferation of counterfeit or substandard medicines, local solutions and local innovations are not only likely to be at the heart of any successful effort; they have the potential to provide benefits that go far beyond the scope of the original problem.
Nonetheless, as I argued in a New York Times article in 2014, although counterfeit drugs are particularly problematic in developing countries, it has also become an issue in developed countries as supply chains have grown. into drugs develop. And with travel and globalization, no country can escape it. That is why a concerted global effort is needed. And for Africa, WADA can spearhead this fight in addition to helping individual countries through joint efforts in the fight against the cross-border trade in fake medicines.
Additionally, some African countries have better regulations than others. With these disparities, AMA will serve to synchronize them. WADA will advise on the marketing authorization process for priority drugs designated by national authorities and those proposed by pharmaceutical companies. This would improve access to safe, effective and good quality medicines.
It is still unclear how the new agency will be funded. In addition, nothing has been said about its location. But we think that as things arise, we will know more.
But where is Nigeria in all of this? Nigeria of all countries seems to have backed down in its support at the AU meeting. Unfortunately, too, South Africa and Ethiopia behave like Nigeria.
While it is safe to say that AMA’s fate is sealed, all countries in Africa should see that the agency is domesticated in their country. The continent has taken a bold step by giving birth to this new organism. AMA needs all the support it can get to fulfill its mission. Nigeria, as the continental leader, does not have to do business with AMA. He, along with others who are still in the hot seat on the issue, should act without further delay to approve and ratify the treaty. I believe it is the right thing to do.
- Dr Odoemena, physician, Lagos
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