2021-06-30 11:00:22
Health diplomacy is more than ever in action. The former Minister of Health and Social Affairs of Mali and former director of UN AIDS, Michel Sidibé, took his side. He is active in the field to plead the cause of the African Medicines Agency (AMA). Charged, at the beginning of April, by the African Union (AU) with the establishment of this agency, with the title of special envoy, he hastened the pace by beginning, only a month after his appointment, a series of visits which took him to Mali, Benin, Senegal, Guinea, Sierra Leone, Rwanda, Zimbabwe, Ivory Coast, Ethiopia, Tunisia, Morocco, Algeria, Niger, Cameroon… Its goal: to collect the required number of ratifications of the treaty establishing it. His plea has all the more resonance as the Covid-19 pandemic has entered the continent’s precarious health equation.
Jeune Afrique: The African Medicines Agency is slow to set up, how can you convince your interlocutors of the need for its creation?
Michel Sidibé: Political leaders have understood that WADA is becoming an imperative necessity because Africa needs a health industry and a coordinated vision. It has 17% of the world’s population and has a disproportionate burden of disease. And it produces only 3% of the drugs consumed by its inhabitants with prices among the most expensive in the world, due to the multiple intermediaries in the pharmaceutical supply chains. As for vaccines, 99% come to us from outside. Not to mention the highest prevalence in the world of fake medicines, which represent on average 20% of the market, reaching 40% in some countries. However, only 6% of global health expenditure benefits it. When we know that 54 drugs can make it possible to control 90% of African pathologies and are not the subject of a license or patent, and could therefore be produced in Africa, it is time to act.
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To this assessment was added the Covid crisis. The African Medicines Agency will help us develop our production capacities and eliminate export controls on raw materials and equipment, clearly regulating active ingredients. Currently, some molecules wait five years to be authorized. The agency will not be another bureaucratic unit, it will serve to reduce our dependence on the outside. It will also allow us to start thinking about biosimilar drugs because we must not wait to turn to these technologies which represent a large market.
How could such an agency help the continent in the face of the Covid-19 pandemic?
Unfortunately, vaccination is progressing much too slowly in Africa, only 1.6% of the world’s vaccines have been administered there. Out of a total population of 1.3 billion, only 8 million have received two doses of the vaccine. At this rate we will find ourselves in 2024 without having achieved immunity on the continent. The crisis we are going through has increased the divisions. It is not just a public health crisis, but a social and political crisis with a human security dimension, which must alert us to the moral obligation to organize ourselves better to provide rapid access to services that can save the lives of left behind.
If we don’t pool our efforts quickly, we won’t get out of this.
In a context where the new variants identified in several countries such as Uganda could escape vaccine protection, the risk that the pandemic will continue uncontrollably exists here as elsewhere. We must therefore move towards vaccine production mechanisms. If we don’t quickly pool our efforts to Africanise our research and equip our national agencies, we won’t get out of it. The drug market represents 1.2 billion dollars in Africa. We will never have access to it without an ecosystem that allows us to have standards and regulations allowing us to invest in it.
Will this agency also provide the continent with better bargaining power for the licensed manufacture or purchase of vaccines?
Africa has found itself confronted with the total absence of a structure allowing it to carry a political voice, at a time when health diplomacy has become a reality. Harmonization of drug registration regulations will help our countries comply with best practices and standards, which will not only encourage the establishment of local production of drugs and vaccines but also facilitate access to financing, technologies and certain negotiated voluntary license transfers. The agency’s contributions will not only be technical but political. In the short term, it will make it possible to carry out group purchases. Today everyone is trying to negotiate on their side and even the AU does not have the capacity to do so for the continent. WADA and the Africa Center for Disease Control and Prevention, CDC, will be two lungs of the same body. The first will mainly ensure the regulations and the second the prevention, the communication strategy, the training of our national institutes to follow the evolution of future pandemics.
We have 90% of annual cases of malaria, discovered 140 years ago, and we still don’t have a vaccine
What could it bring in terms of research and development (R&D)?
By relying on the African Continental Free Trade Area (Zlecaf), the AMA will certainly make it possible to strengthen Africa’s capacity in this area. The continent has 90% of the annual cases of malaria, which was discovered around 140 years ago, and we still don’t have a vaccine! We can only blame ourselves. We need to appropriate our R&D according to the priorities of the continent, its diseases and pathologies. The agency will make it possible to pool skills because capacities exist but remain fragmented. It will also open up prospects for investing in the African pharmacopoeia, which could serve as a basis for the manufacture of drugs, as is the case with the Chinese pharmacopoeia, which provides active substances for 80% of the drugs manufactured in the world. In the meantime, we are missing out on that potential. WADA can help us drive new logics and long-term strategic visions by exploring the potential of our traditional medicine. In this very special time, we have the opportunity to build something completely different and create jobs in this sector.
Initially, will the AMA be satisfied with harmonizing the procedures at the level of the economic communities, failing to provide a single registration of medicines on a continental scale?
I think that we must work with all the national structures to gradually move towards a single registration. The sub-regions are working to create harmonized structures, four economic communities have already done so, and AMA will strengthen market integration communities at this level. All these questions will be decided later, when the treaty establishing the African Medicines Agency comes into force.
This treaty, adopted in 2019, has not yet been ratified by all its signatories. However, it is necessary that fifteen countries ratify it so that the agency can be created. You have already visited fifteen countries on the continent to speed things up, where are we?
We have about twenty signatories and of the thirteen countries that have ratified it, ten have deposited their instrument of ratification, a formality necessary for its validation. This treaty is consensual but we need to convince African leaders at the highest level to explain to them why this structure is concretely lacking on the continent. It was a subject that was, until then, often presented from a technical angle. We see a real enthusiasm because our advocacy is not dry, it is embodied by the daily reality of the pandemic. I am very satisfied with the reactions I was able to meet on the ground. In just a month and a half, several countries I visited have activated their ratification process, such as Sierra Leone, Algeria and Morocco. If things continue at this rate, it will be the treaty whose ratification will have been the fastest at the African level.
The harmonization of regulations poses significant technical but also financial challenges, can the cost of such an agency also represent a brake for certain States?
We must succeed in being creative. The regulatory mechanisms that such an agency will provide will compensate for other losses such as those related to counterfeit drugs. In Cameroon alone, they cause 400 billion CFA in losses for the state. It is all the more terrible as this parallel market enriches mafia networks. New markets will also open up with the AMA, which will enable African industrialists to set up profitable partnerships with northern industrialists. Taxes can also be considered on certain products to mobilize resources quickly.
Do you also come up against issues of national sovereignty?
I think that the notion of sovereignty will continue to exist but it will not represent a major sticking point insofar as sub-regional centers of excellence will be created and will ensure better market integration. By allowing joint purchases and by ensuring that the African pharmacopoeia develops, WADA will work in the interest of all. In Europe, for example, each country retains its own mechanisms and its sovereignty, but each time it has been necessary, the European Medicines Agency has taken precedence over decisions to avoid crises.
The future location of the agency’s headquarters is the subject of covetousness, behind the scenes are the discussions stumbling on this point?
This rather works in our favor because the first fifteen countries to ratify the WADA treaty will sit around the table to define the strategic framework in which the agency will evolve and will therefore be a source of proposals. All applications will also be analyzed with precise rules, as the AU has applied for a long time, according to criteria shared with all.
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