By Cosmas Odoemena
That Africa will soon establish a body that will be responsible for regulating medicines and medical products across the continent is a positive development. In February, 2019, the African Union adopted a treaty to set up the African Medicines Agency but, for take-off, it required 15 African countries to sign it and notify the AU commission before it could be established. And just the other day, Cameroon formally notified the AU that it had ratified the treaty bringing the number to the needed 15. It will now require a 30-day waiting period before the setting up of the agency can commence. So, by November 5, it can formally start.
The other countries that have both ratified the AMA and deposited the instrument of ratification at the AU, which is a letter from the head of that country that it 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 formally notified the AU, while another eight have signed the treaty but are yet to ratify it. AMA will be the second cross-continental African health agency, after the establishment of the Africa Centers for Disease Control and Prevention. It’s still a surprise that countries have been slow to be part of AMA because in 2019 when the decision was taken to establish it by the AU Assembly it was unanimous.
The African agency will act like a similar one in Europe, the European Medicines Agency. However, in Europe, medicine regulation involves about 50 regulatory authorities from the 31 European Economic Commission and EMA. EMA is at the center of the coordination and supports relationships between more than 50 national agencies that regulate human and veterinary medicines.
There are genuine concerns by individual countries about where AMA should be placed when they have their national drug agencies. AMA will not take over the job of a country’s drug regulatory agency but will strengthen their capacity and bring harmony to the regulation of medicines across the continent. It will also provide expertise lacking in a regulatory capacity, improve transparency and efficiency. Furthermore, AMA can strengthen how pharmacovigilance is carried out and monitor clinical trials. A World Health Organisation report says that just three out of 46 African countries “had moderately developed capacity to regulate medicine assessments and more than 90% have minimal to no capacity.” With the emergence of COVID-19, the world’s health system has not been the same. Yet, Africa has remained an onlooker when it comes to COVID-19 vaccines. This is where AMA can play a strong role. For instance, EMA is there to see to the speedy development of these vaccines and treatments. It gives the countries the needed support while reviewing available scientific data on the disease. It also monitors potential treatments and collaborates with them during clinical trials.
But perhaps, one of the major things AMA can do is to help in the fight against fake and adulterated medicines. This is a scourge suffered mostly by developing countries where counterfeit and poor quality medications kill more than half a million people yearly and are mostly responsible for the development of drug resistance to microbes. In sub-Saharan Africa alone, fake antimalarial drugs “could be responsible for up to 270,000 additional deaths per year”, according to a WHO study. What’s more, 42% of global seizures of counterfeit medicines are from Africa, underlining the fact that it’s majorly an African problem.
According to Muhammad Hamid Zaman, a Professor of Biomedical Engineering, at Boston University, what compounds the problem is that policymakers in the developing countries prefer to seek solutions outside the continent. He said, “This shortsightedness is a grave mistake that impedes innovation and progress. When it comes to tackling high-impact health challenges like the proliferation of fake or inferior drugs, local solutions, and local innovations are not only likely to be central to 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 the New York Times in a piece in 2014, though counterfeit drugs are particularly problematic in developing countries, it has also become a problem in developed countries as drug-supply chains grow. And with travel and globalisation, no country may escape it. That’s why a global concerted effort is what is needed. And for Africa, AMA can spearhead this fight apart from assisting individual countries through joint efforts in fighting cross-border trading in fake medicines.
Moreover, some African countries have better regulations than others. With these disparities, AMA will serve to synchronize them. AMA will advise on the marketing authorization process for priority drugs named by national authorities and those proposed by pharmaceutical laboratories. This would lead to improved access to safe, effective, and good-quality medications. It’s still unclear how the new agency will be funded. Also, nothing has been said about where it will be sited. But it’s believed that as things shape up more will be known.
But where is Nigeria in all of this? Nigeria of all countries seems to have backpedalled in its support of it at the AU meeting. Unfortunately too, South Africa and Ethiopia are behaving like Nigeria. Though it is safe to say 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 in birthing this new body. AMA needs all the support it can get so that it can fulfill its mission. Nigeria as a continental leader has no business not having business with AMA. It should, along with others still pussyfooting on the issue, act without further delay to endorse and ratify the treaty. I believe it’s the right thing to do.
Dr. Odoemena, medical practitioner,
writes from Lagos